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MARINE ENVIRONMENT PROTECTION COMMITTEE 60th session Agenda item 2 MEPC 60/2/16 8 February 2010 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

Report of the twelfth meeting of th e GESAMP-Ballast Water Working Group

Note by the Secretariat

SUMMARY Executive summary: This document contains the report of the twelfth meeting of the GESAMP-Ballast Water Work ing Group (GESAMP-BWWG) and includes the evaluation of pr oposals submitted for approval by Germany, Norway and the Rep ublic of Korea. Following the decision of MEPC 58, only the main body of the GESAMP-BWWG’s reports is translated in all three working languages, with the annexes in English only. Strategic direction: 7.1 High-level action: 7.1.2 Planned output: 7.1.2.4

Action to be taken: Paragraph 3

Related document: GESAMP-BWWG 12/6 (attached)

Introduction

1 The twelfth meeting of the GESAMP-Ballast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters from 7 to 11 Decemb er 2009 and its report is attached to this document as GESAMP-BWWG 12/6.

2 The main purpose of this meetin g was to review the proposals for approval of ballast water management systems that make use of Active Subs tances to treat ballast water prior to discharge into the marine environment. The findings of th e Group are contained in annexes 4 to 7 of the attached report.

Action requested of the Committee

3 The Committee is invited to:

.1 agree that Basic Approval be grante d to Hyundai Heavy Industries Co., Ltd. (HHI) Ballast Water Management System (HiBallast) submitted by the Republic of Korea in document MEPC 60/2/6 (see annex 4);MEPC 60/2/16 - 2 -

I:\MEPC\60\2-16.doc .2 agree that Basic Approval be granted to Kwang San C o., Ltd. (KS) Ballast Water Management System “En-Ballast” submitted by the Republic of Korea in document MEPC 60/2/7 (see annex 5);

.3 agree that Basic Approval be grante d to OceanGuard Ballast Water Management System submitted by Norway in document MEPC 60/2/8 (see annex 6);

.4 agree that Basic Approval be granted to Severn Trent DeNora BalPure ® Ballast Water Management System submitted by Germany in document MEPC 60/2/9 (see annex 7);

.5 urge Administrations to thoroughly eval uate the application dossiers and confirm that they are satisfactory and comple te before submitting their proposals to the Organization in accordance with Pr ocedure (G9) (see paragraph 4.1.2);

.6 request Member States to submit their ap plication dossiers in electronic form on a voluntary basis, with the view to f acilitating the Group’s review process (see paragraph 5.1); and

.7 approve the report in general.

***I:\MEPC\60\2-16.doc GESAMP-BALLAST WATER WORKING GROUP Agenda item 6 GESAMP-BWWG 12/6 11 December 2009 Original: ENGLISH

REPORT OF THE TWELFTH MEETING OF THE GE SAMP-BALLAST WATER WORKING GROUP (GESAMP-BWWG)

Table of Contents

Section Page Number

1 INTRODUCTION ............................................................................... 3

2 ISSUES OF CONFIDENTIALITY .................................................... 3

3 TERMS OF REFERENCE AND TIME FRAME ............................ 4

4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES .......................................................................................... 5

5 ANY OTHER BUSINESS ...................................................... 9

6 CONSIDERATION AND ADOPTION OF THE REPORT .................. 9GESAMP-BWWG 12/6 - 2 -

I:\MEPC\60\2-16.doc ANNEXES

Annex 1 List of members who attended the tw elfth meeting of the GESAMP-BWWG

Annex 2 Agenda for the twelfth meeting of the GESAMP-BWWG

Annex 3 Terms of reference for the Technical Group (GESAMP-BWWG)

Annex 4 Review of proposals for appr oval of Ballast Water Management Systems that make use of Active Substances – Hyundai H eavy Industries Co., Ltd. (HHI) Ballast Water Management System (HiBallast) – Submitted by the Republic of Korea for Basic Approval

Annex 5 Review of proposals for appr oval of Ballast Water Management Systems that make use of Active Substances – Kwang San C o., Ltd. (KS) Ballast Water Management System “En-Ballast” – Submitted by the Republic of Korea for Basic Approval

Annex 6 Review of proposals for appr oval of Ballast Water Management Systems that make use of Active Substances – OceanGuard Ballast Water Management System – Submitted by Norway for Basic Approval

Annex 7 Review of proposals fo r approval of Ballast Water Ma nagement Systems that make use of Active Substances – Severn Trent DeNora BalPure ® Ballast Water Management System – Submitted by Germany for Basic Approval- 3 - GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc 1 INTRODUCTION

1.1 The twelfth meeting of the GESAMP-Ba llast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters, London, from 7 to 11 December 2009, under the chairmanship of Mr. Jan Linders. A list of members who atte nded this meeting is shown in annex 1 and the agenda, as adopted by the Group, is set out in annex 2 of this report.

1.2 The meeting was opened by Mr. Dandu Pughiuc , Head, Marine Bios afety Section, who conveyed the appreciation of the Director of Ma rine Environment Division, IMO, for the effort made by the members of the GESAMP-BWWG to ha ve this additional mee ting before MEPC 60 in the attempt to evaluate all the remaining fo ur submissions, which had been submitted before the deadline established for MEPC 60 (i.e. 28 August 2009).

1.3 Mr. Pughiuc expressed his appreciation for the effort made by the IMO consultants, Mr. John Crayford and Dr. Andrew Craven, for th eir hard work in preparing this meeting and reviewing a large amount of documentation ina relatively shor t period of time.

1.4 Finally, Mr. Pughiuc reported on the contra ctual arrangements and informed the Group on the logistics of the meeting. He also in formed the Group that, at the request of Dr. Stephan Gollasch, arrangement s had been made for him to be excused when the proposal for approval of the Severn Trent DeNora BalPure ® Ballast Water Management System (Germany) was reviewed, due to his involvement in the de velopment of this technology. Dr. Gollasch took no part in this evaluation a nd his contract was consequently reduced to ten working days.

2 ISSUES OF CONFIDENTIALITY

2.1 Four proposals for Basic Approval of ballast water management systems that make use of Active Substances had been submitted by the Republic of Kor ea (two proposals, MEPC 60/2/6 and MEPC 60/2/7), Norway (MEPC 60/2/8) and Germany (MEPC 60/2/9). All four submissions contained confidential supporting data.

2.2 The confidential nature of the informati on was recognized by the Group and was treated as such in order to protect the commercial intere sts of the manufacturers c oncerned. In order to ensure that the report did not contain any confidential info rmation, the Group noted that the Secretariat would liaise with the relevant Administrations prior to submitting the report to MEPC.

2.3 Pursuant to paragraphs 4.2.2, 8.1.1 and 8.1.2.7 of the “Procedure for approval of ballast water management systems that make use of Activ e Substances (G9)”, all information gathered, materials, notes and reports obtained or ma de out during the work of the GESAMP-BWWG, were, and will be, treated as c onfidential. In this respect all the members of the Group and the IMO consultants signed the Statements of Acceptance related to confidentiality.

2.4 The original copies of the Statements of Acceptance, duly signed and dated by all concerned, were filed with the T echnical Secretary of the Group and were kept together with the submissions.

2.5 The submissions (dossiers) were kept in a safe place in the IMO Headquarters and made available to the IMO consultant during the worki ng hours. For the duration of the meeting, the members of the Group consulted these dossiers, which were made available to them in the meeting room and kept back in the Organizatio n’s secure designated ro om after working hours.GESAMP-BWWG 12/6 - 4 -

I:\MEPC\60\2-16.doc 2.6 On completion of the work, the Chairman of the GESAMP-BWWG collected from the other members of the Group all the documents, dr afts and any other a ssociated records and reports, which were handed over to the Tec hnical Secretary of the GESAMP-BWWG for retention in confidence. All el ectronic records and data held on personal computers/laptops were destroyed when no longer necessary for the work of the GESAMP-BWWG.

3 TERMS OF REFERENCE AND TIME FRAME

3.1 The Group continued to conduct its work in accordance with the Terms of Reference approved by the MEPC as contained in annex 3 of this report.

3.2 The Group used the table below to determine the timetable for activities related to its regular meetings and agreed to decide, on a case-by-case basis, on the timing of additional meetings as appropriate.

TIMETABLE FOR ACTIVITIES RELA TED TO GESAMP-BWWG MEETINGS

Timeline Activity
28 weeks before MEPC Deadline for submission of app lication dossiers and related documents to be reviewed by the GESAMP-BWWG

(8 weeks) Preparation of the meeting, includ ing circulation of any relevant information provided by other delegations

20 weeks before MEPC GESAMP-BWWG Meeting

(1 week) Editing and completion of the draft report of the meeting

(3 weeks) Review and approval of the report by the GESAMP including response/clarification by the working group

(1 week) Administrations confirm that no c onfidential data are contained in the report

(1 week) Produce the final report addres sing the comments by GESAMP

13 weeks before MEPC Submission of the report of the meeting of the GESAMP-BWWG in accordance with the 13-week deadli ne (bulk documents) for MEPC

3.3 Bearing in mind that MEPC 61 was tenta tively scheduled from 11 to 15 October 2010 and considering the activities presented in th e table above, the Group agreed to tentatively schedule its thirteen th meeting from 24 to 28 May 2010 with a deadline for submission of documents on Thursday, 1 April 2010.- 5 - GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc 4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

4.1 General review of the submissions

4.1.1 The Group noted that four proposals for Ba sic Approval were submitted by the Republic of Korea (two proposals), Norway and Germany.

4.1.2 The Group also noted that, during this meeting, it had become necessary to obtain additional information or clarification from the three applicants, as the dossiers were either incomplete or, more commonly, the informati on provided was unclear, so slowing down the evaluation process. On the other hand, the Group agreed that Germany’s dossier was sufficient to complete the Basic Approval evaluation and no further clarification was required from the applicant. As a result, the Gr oup reiterated its request to MEPC to urge each Administration to check that all technical descrip tions and specifications of the BWMS and, in particular, those related to the operating conditions are included in each application. Equally important, all data pertaining to the safety of the ship and crew, hum an health and environmental exposure and risk need to be submitted also in each application.

4.2 Detailed review of the submissions

4.2.1 Details of the submissions review ed by the Group can be seen in:

Annex BWMS Administration

4 Hyundai Heavy Industries Co., Ltd. (HHI) Ballast Water Management System (HiBallast) Republic of Korea

5 Kwang San Co., Ltd. (KS) Ballast Water Management System “En-Ballast” Republic of Korea

6 OceanGuard Ballast Water Management System Norway

7 Severn Trent DeNora BalPure ® Ballast Water Management System Germany

4.2.2 Bearing in mind the criteria associated with Procedure (G9) and having reviewed all of the information related to these su bmissions, the Group recommended that:

.1 Basic Approval be grante d to Hyundai Heavy Industr ies Co., Ltd. (HHI) Ballast Water Management System (HiBa llast) (Republic of Korea);

.2 Basic Approval be granted to Kwa ng San Co., Ltd. (KS) Ballast Water Management System “En-Ballast” (Republic of Korea);

.3 Basic Approval be granted to OceanGuard Ballast Water Management System (Norway); and

.4 Basic Approval be granted to Severn Trent DeNora BalPure ® Ballast Water Management System (Germany).GESAMP-BWWG 12/6 - 6 -

I:\MEPC\60\2-16.doc 4.3 Specific comments related to Hyundai He avy Industries Co., Ltd. (HHI) Ballast Water Management System (HiBallast)

4.3.1 The Group noted that the HiBallast system co mprised an optional filtration stage followed by chemical treatment with oxidants produced by el ectrolysis. The electrolysis unit is in a sidestream of the main ballast. The resulting so lution of oxidants, produ ced by electrolysis, is injected back into the incoming ballast water at an appropriate rate to di sinfect it. Any excess oxidants are neutralized during di scharge of the ballast water.

4.3.2 The Group noted that the system was descri bed as having several different options of configuration and recommended that any applica tion for Final Approval should include all the required information for the sp ecific configuration proposed.

4.3.3 It was noted that no corrosion test results or human risk asse ssment had been presented in the application and that this should be rec tified in the application for Final Approval.

4.3.4 Furthermore, loading quantities, rather than leaching rates, should be used to estimate the Predicted Environmental Concentrations (P ECs) when running the MAMPEC model.

4.3.5 In addition, the Group emphasized the recomm endation that the applicant should provide the chronic ecotoxicity data for th e WET test as this was not reported in the application for Basic Approval.

4.4 Specific comments related to Kwang San Co., Ltd. (KS) Ballast Water Management System “En-Ballast”

4.4.1 The Group noted that the En-Ballast system comprised a filtration stage followed by electrolysis, which generates oxidants, primaril y sodium hypochlorite, in a sidestream off the main ballast water piping. The oxidants are then passed through a gas- freeing tank and then injected back into the ballast water in a cont rolled manner to disinfect it. Any excess oxidants would be neutralized with sodium thiosulpha te during discharge of the ballast water.

4.4.2 The Group also noted that no corrosion test resu lts or human risk assessment to the crew had been presented in the applicat ion and that this should be rectified in the application for Final Approval.

4.4.3 Furthermore, it was noted that the input da ta to MAMPEC were in correct which led to erroneous estimates of the Predicted Environmenta l Concentrations (PECs) and that this error should be rectified in the a pplication for Final Approval.

4.4.4 In addition, the Group emphasized the recomm endation that the applicant should provide the chronic ecotoxicity data for th e WET test as this was not reported in the application for Basic Approval.

4.5 Specific comments related to OceanGua rd Ballast Water Management System

4.5.1 The Group noted that the OceanGuard Ballast Water Management System is a system consisting of filtration, ultrasonic treatment and treatment with Active Substance sodium hypochlorite formed by in situ electrolysis of seawater, which has been submitted for Basic Approval by Norway.- 7 - GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc 4.5.2 Having reviewed all the data and informati on submitted by Norway with the application for Basic Approval and the information supplied by the applicant in respons e to questions posed by the Group during the GESAMP-BWWG meeti ng, the Group recommended to MEPC that Basic Approval be granted to the BWMS.

4.5.3 The Group made the following recommendations or requests for information, if this system is to be reviewed for Final Approval in the future:

.1 the Group recommended that the applicant ensures that the environmentally safe MADC is not exceeded over the entire range of relevant chemical properties and all possible holding times;

.2 the Group recommended that suitable monitoring and shut-down facility be incorporated to ensure that an MADC of 0.20 mg/L TRO as Cl 2 cannot be exceeded at any time;

.3 the Group recommended that if the applicant finds that there would be a possibility of lower degrad ation rates of TRO in th e ballast water tank, with respect to parameters other than salinity, for instance, DOC concentration and chlorine demands, then additional mitigation measures, such as neutralization, should be installed to ensure an envi ronmentally safe MADC under all possible conditions;

.4 the Group recommended that the applican t should carefully select multi-timing sampling during the tank holding time, accord ing to the applicant’s TRO dose, not only 2, 3 and 5-day holding time with 2 mg/L TRO but also 0, 1 and 2-day holding time with 1.5 mg/L TRO should be considered as sampling timings. The worst case scenario (concentr ations of Relevant Chem icals) observed among these multi-timings should be used for PEC calculations;

.5 the Group recommended that the applican t should consider the guidance provided in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16, in conducting corrosion tests;

.6 the Group recommended that the applicant should confirm by further testing, that there will be no unacceptable risks (to ship safety, human health or the environment) due to the chemical co mposition of treate d ballast water;

.7 the Group recommended that both acute and chronic ecotoxicity te stings of treated ballast water for at least three species s hould be performed in accordance with the full requirements of Procedure (G9);

.8 the Group recommended that the levels of hydrogen, methane and carbon monoxide gases in the air space of treated ballast water tanks should continue to be monitored throughout the remainder of land-based and shipboard testing to validate the assumption that the risks associated with these gases remain acceptable; andGESAMP-BWWG 12/6 - 8 -

I:\MEPC\60\2-16.doc .9 the Group recommended that an appropria te risk evaluation for human exposure to chemicals is performed and that measur es and procedures to mitigate such risks are identified and clearly addressed, in cluding consideratio n of operation units associated with personnel working inside the ballast tank and personnel working close to the system, with detailed expl anation of all proposed risk mitigation

measures.

4.6 Specific comments related to Severn Trent DeNora BalPure ® Ballast Water Management System

4.6.1 The Group noted that the Se vern Trent DeNora BalPure ® Ballast Water Management System is a system consisting of filtration a nd treatment by disinfecti on on uptake with Active Substance sodium hypochlorite formed by on-demand in situ electrolysis of seawater, followed by residual oxidant neutralization with sodium bisulfite on discharge, submitted by Germany for Basic Approval.

4.6.2 Having reviewed all the data and informati on submitted by Germany with the application for Basic Approval, the Group recommended to MEPC that Basic Appr oval be granted to the BWMS.

4.6.3 The Group made the following recommendations and requests for information, if this system is to be reviewed for Final Approval in the future:

.1 the Group recommended that a comprehens ive evaluation of the corrosion impacts on ships’ structures be conducted usi ng the maximum anticipated treatment concentration, 20 mg/L (TRO as Cl 2 ) and that a realistic TRO decay profile may be considered if the total corrosion loss over the ship’s life is to be projected. The Group noted, however, that such an analysis , while useful, is not necessary for the Group’s consideration. The Group r ecommended that corrosion testing be conducted, and invited the applicant to consider the guidance provided in section 5.1 of the “Report of the ei ghth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16;

.2 the Group recommended to take into consideration the human exposure during sampling of ballast water at discharge (inhalation, dermal c ontact), as well as during the periodic sediment cleaning (inhalation, dermal contact). These scenarios should also be considered in the conceptual exposure model (CEM);

.3 the Group recommended that the data sets on the analysis of Active Substance, Relevant Chemicals and Other Chemicals in treated ballast wate r should be further investigated during land-base d and shipboard testing;

.4 the Group recommended that confirmation by further testing should be performed, that there will be no unaccep table risks (to ship safety, human health or the environment) due to the chemical com position of ballast wa ter treated by this BWMS;

.5 the Group recommended that all missing information concerning the environmental exposure assessment using an appropriate model be provided;- 9 - GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc .6 the Group recommended a verification that the residual oxidant neutralization with sodium bisulfite on discharge is effec tive at all times (MADC < 0.2 mg/L TRO as Cl 2 ); and

.7 the Group recommended that both acute an d chronic ecotoxicity testings of treated ballast water be performed in accordance with the full requirements of Procedure (G9) at the maximum proposed treatment dose.

5 ANY OTHER BUSINESS

5.1 The Group discussed the possibili ty of shifting from paper dossi er to electronic dossier in the near future. Lack of additional copies of the dossier affected the Group’s evaluation efficiency as the members of the Group had to wait for their turn to get hol d of the dossier. The efficiency would be improved if the dossier coul d be made available on CD, which could then be copied onto the members’ computers during the meeting for their simultaneous inspection. And, at the end of the meeting, the same procedure concerning confidentiality should be followed both for the paper dossier and electron ic dossier. It was therefore proposed to recommend to MEPC the submission of electronic dossiers on a voluntary basis.

6 CONSIDERATION AND ADOPTION OF THE REPORT

6.1 A draft report of the tw elfth meeting of the GE SAMP-BWWG was produced on Friday, 11 December 2009 and, after a paragr aph-by-paragraph review, the Group agreed on the final text and requested the Secretariat to make the necessary editorial changes to ensure consistency with IMO documents’ format and style.

6.2 The Chairman expressed his appreciation fo r the long hours and substantial efforts made by the members of the Group throughout the w eek and closed the meeting at 17 h 30.

***GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc ANNEX 1

LIST OF MEMBERS WHO ATTEN DED THE TWELFTH MEETING OF THE GESAMP-BWWG

Mr. Jan Linders (Chairman) Senior Risk Assessor National Institute for Public Health and Environment – Expert Centre on Substances Anthonie van Leeuwenhoeklaan 9 RIVM-SEC P.O. Box 1 NL-3720 BA Bilthoven The Netherlands E-mail: Tel: Fax: jan.linders@rivm.nl +31 30 274 3164 +31 30 274 4401

Ms Teresa Borges Senior Technical Officer General-Directorate of Health (Environmental Health Division) Avenida Rio de Jane iro, no 58, 3o dto 1700-338 Lisbon Portugal E-mail: Tel:

Mobile: tborges@dgs.pt +351 2 1843 0599

+351 9 1779 8048

Mrs. Annette Dock Director Adalia Toxicology Consultants Runslingan 3E SE-187 72 TÄBY Sweden E-mail: Tel: Fax:

Mobile: “ Adalia AB ” <info@adalia.se> +46 8 510 149 36 +46 8 510 126 02

+46 70 483 11 23

Dr. Stephan Gollasch GoConsult Grosse Brunnenstr. 61 22763 Hamburg Germany E-mail: Tel:

Mobile : sgollasch@aol.com +49 40 390 54 60

+49 177 590 54 60

Mr. Shinichi Hanayama Senior Research Fellow Maritime Technology Department Ocean Policy Research Foundation (OPRF) Kaiyo Senpaku Bldg. 1-15-16, Toranomon Minato-ku, Tokyo 105-0001 Japan E-mail: Tel: Fax: s-hanayama@sof.or.jp +81 3 3502 1886 +81 3 3502 2033GESAMP-BWWG 12/6 ANNEX 1 Page 2

I:\MEPC\60\2-16.doc Mr. Edward Lemieux Director Center for Corrosion Sc ience and Engineering Naval Research Laboratory, Code 6130 4555 Overlook Avenue, SW Washington, DC 20375 USA E-mail: Tel: Fax:

Mobile: edward.lemieux@nrl.navy.mil (202)-404-2123 (Office) 305-293-4213

240-475-6918

Dr. Kitae RHIE Professor of Biology Department Kyung Hee University #1 Hoe-ki Dong Dong-dae-moon Ku Seoul 130-701 Republic of Korea

Current postal address: Dr. Kitae RHIE c/o Chesapeake Biol ogy Laboratory-UMCES P. O. Box 38 One Williams Street Solomons, MD 20688, USA E-mail: Tel:

Fax:

Mobile:

Tel:

Mobile: rhiekt@khu.ac.kr +82 (2) 961-0603

+82 (2) 961 0244

+82 16-9343-3860

410-326-7218

310-626-7621

Mr. David Tongue Marine Manager International Chamber of Shipping 12 Carthusian Street London EC1M 6EZ United Kingdom E-mail: Tel: Fax:

Mobile: david.tongue@marisec.org +44 20 7417 2860 +44 20 7417 8877

+44 78 5539 1258

IMO-GESAMP CONSULTANTS

Mr. John Crayford 2 Dunmow Hill, Fleet Hampshire GU51 3AN United Kingdom E-mail: Tel: j.crayford@ntlworld.com +44 (0)1252 672245

Dr. Andrew Craven 23 Wenlock Drive, Escrick York YO19 6JB United Kingdom E-mail: Tel: Fax: andrew.craven7@btinternet.com +44 (0) 7849 070 668 (Mobile) +44 (0) 1904 728 428 (H)GESAMP-BWWG 12/6 ANNEX 1 Page 3

I:\MEPC\60\2-16.doc IMO SECRETARIAT

Mr. Miguel Palomares Director Marine Environment Division International Maritime Organization 4 Albert Embankment London SE1 7SR United Kingdom E-mail: Tel: Fax: mpalomares@imo.org +44 (0)20 7587 3218 +44 (0)20 7587 3210

Mr. René Coenen IMO Technical Secretary to GESAMP Marine Environment Division International Maritime Organization 4 Albert Embankment London SE1 7SR United Kingdom E-mail: Tel: Fax: rcoenen@imo.org +44 (0)20 7587 3239 +44 (0)20 7587 3261

Mr. Dandu Pughiuc IMO Technical Secretary to GESAMP-BWWG Marine Environment Division International Maritime Organization 4 Albert Embankment London SE1 7SR United Kingdom E-mail: Tel: Fax: dpughiuc@imo.org +44 (0)20 7587 3247 (Direct) +44 (0)20 7587 3261

Mr. Huang Tianbing Technical Officer, Marine Biosafety Section Marine Environment Division International Maritime Organization 4 Albert Embankment London SE1 7SR United Kingdom E-mail: Tel: Fax: thuang@imo.org +44 (0)20 7463 4198 (Direct) +44 (0)20 7587 3261

***GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc ANNEX 2

AGENDA FOR THE TWELFTH MEETING OF THE GESAMP-BWWG

1 Introduction

2 Issues of confidentiality

3 Terms of reference and time frame

4 Review of proposals for approva l of ballast water management systems that make use of Active Substances

.1 Republic of Korea – Hyundai Heavy Industries Co., Ltd. (HHI) Ballast Water Management System (HiBallast) for Basic Approval

.2 Republic of Korea – Kwang San Co., Ltd. (KS) Ballast Water Management System “En-Ballast” for Basic Approval

.3 Norway – OceanGuard Ballast Water Management System for Basic Approval

.4 Germany – Severn Trent DeNora BalPure ® Ballast Water Management System for Basic Approval

5 Any other business

6 Consideration and adoption of the report

***GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc ANNEX 3

TERMS OF REFERENCE FOR THE TECHNICAL GR OUP (GESAMP-BWWG)

1 Consideration of developmen t of necessary methodologies and information requirements in accordance with the “Procedure for approval of ballast water management systems that make use of Active Substances (G9)” (adopted by resolution MEPC. 169(57 )) for consideration by MEPC 60.

2 For Basic Approval, the Group should revi ew the comprehensive proposal submitted by the Member of the Organization along with any additional data submitted as well as other relevant information available to th e Group and report to the Organization.

In particular, the Group should undertake:

.1 scientific evaluation of the data set in the proposal for approval (see paragraphs 4.2, 6.1, 8.1.2.3, 8.1.2.4 of Procedure (G9));

.2 scientific evaluation of the assessment report contained in the proposal for approval (see paragraph 4.3.1 of Procedure (G9));

.3 scientific evaluation of th e risks to the ship and pers onnel to include consideration of the storage, handling and app lication of the Active Substance (see paragraph 6.3 of Procedure (G9));

.4 scientific evaluation of any further information submitted (see paragraph 8.1.2.6 of Procedure (G9));

.5 scientific review of the risk characterization and an alysis contained in the proposal for approval (see paragraph 5.3 of Procedure (G9));

.6 scientific recommendations on whether th e proposal has demonstrated a potential for unreasonable risk to the environment, human health, property or resources (see paragraph 8.1.2.8 of Procedure (G9)); and
.7 preparation of a report a ddressing the above-mentioned aspects for consideration by MEPC (see paragraph 8.1.2.10 of Procedure (G9)).

3 For Final Approval, the Gr oup should review the discharg e testing (field) data and confirm that the residual toxi city of the discharge conforms to the evaluation undertaken for Basic Approval and that the previous eval uation of the risks to the ship and personnel including consideration of the storage, handling and applicat ion of the Active Substance remains valid. The evaluation will be reported to the MEPC (see paragraph 8.2 of Procedure (G9)).

4 The Group should keep confidential all data , the disclosure of which would undermine protection of the commercial interests of the applicant, including intellectual property.

***GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc ANNEX 4

REVIEW OF PROPOSALS FOR APPRO VAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

Hyundai Heavy Industries Co. Ltd. (HHI) Ball ast Water Management System (HiBallast)

Submitted by the Republic of Korea for Basic Approval

0 SUMMARY

0.1 Having considered all of the data provided by the applicant, the Group recommended that Basic Approval be granted to the HiBa llast Ballast Water Management System.

0.2 The Group noted that the HiBallast system co mprised an optional filtration stage followed by chemical treatment with oxidants produced by el ectrolysis. The electrolysis unit is in a sidestream of the ballast main and the resultant solution of oxidants are injected back into the incoming ballast water at an appropriate rate to disinfect it. Any excess oxidants are neutralized during discharge of the ballast water.

0.3 The Group noted that the applicant had desc ribed different options in its application for Basic Approval and recommended that any app lication for Final Approval include all results related to the conf iguration proposed.

0.4 Whilst recognizing the various options associ ated with the system, the Group noted that the analytical and ecotoxicity test results were obtained from unfiltered, treated and neutralized ballast water. In addi tion, it was assumed that thiosulphate had been used as a neutralizer and this application was assessed on this basis.

0.5 The Group noted that, although no corrosion test results were presented, the applicant had indicated that these would be available for c onsideration as part of its application for Final Approval. The Group invited the applicant to consider the guidance provided in section 5.1 of the “Report of the eighth meeting of th e GESAMP BWWG”, contained in MEPC 59/2/16.

0.6 The Group noted that the hazard identifica tion index (HAZID study) was conducted in order to identify potential hazardous events and to provide guidance on how such hazards to ship and crew might be managed during the desi gn and operation of the system. The Group considered that this was a useful approach.

0.7 The Group agreed that the main potential risk to the crew will be due to exposure to high concentrations of disinfectant through leakage and when mixing sodium thiosulphate for the neutralizing process. Whilst rec ognizing that the measures (correc tive actions) to be put in place in order to minimize the chances of the crew co ming into contact with the Active Substances or the treated ballast water, the applicant had not carried out a human risk assessment concerning the crew and the general public.GESAMP-BWWG 12/6 ANNEX 4 Page 2

I:\MEPC\60\2-16.doc 0.8 Whilst an environmental risk assessment had been carried out, the Group noted that the applicant had calculated the PECs using the MAMP EC model into which leaching rates had been put rather than loading rates. The Group reco mmended that the quantity of chemicals released into the environment be calculated using the maximum ballast water discharge concentrations multiplied by the total daily volume of ballast water released to the port.

0.9 The environmental risk assessment indicated that the system should not cause any unacceptable risk to the marine environment.

0.10 Notwithstanding those observations made in this report, the Group would like to draw attention to the following specific points to be addressed in the applica tion for Final Approval:

.1 the results of corrosion testing, as recommended, should be included in the application;

.2 monitors and failsafe systems should be put in place to ensure that the levels of hydrogen do not reach dangerous concentrations;

.3 all relevant information and the quantif ication of the risks associated with the exposure of the crew to high concentra tions of disinfectant through leakage and mixing of sodium thiosulphate should be provided by the applicant according to the principles of Human Exposure Assessment (MEPC 56/2/2, annex 9);

.4 in addition the Group consid ered that the risks to th e General Public (swimming and eating fish from the coastal area) as a result of effluent discharge of treated ballast water should be assessed by th e applicant and resu ltant information provided;

.5 the required chronic toxicity test re sults, in accordance with Procedure (G9), should be provided as it was missing in the application for Basic Approval; and

.6 the TRO sensors’ sensitiv ity, reliability and its use in the neutralizer control should be confirmed as being appropri ate to maintain the MADC of TRO.

0.11 Notwithstanding the above, th e Group recommended that all of the recommendations, raised in this report be taken into cons ideration prior to making an application for Final Approval.

1 INTRODUCTION

1.1 Data used to evaluate this system we re extracted from ME PC 60/2/6 and were supplemented by additional info rmation provided to the Group.

2 DESCRIPTION OF THE SYSTEM

2.1 The Group noted that the HiBallast syst em comprised the following components:

.1 an optional 50 μm filtration unit;GESAMP-BWWG 12/6 ANNEX 4 Page 3

I:\MEPC\60\2-16.doc .2 an electrolysis unit to generate Active Substances;

.3 a neutralization unit to remove residual TRO;

.4 a system control unit; and

.5 a sampling unit.

2.2 The Group noted that the system diverts pa rt of the incoming ballast water to the electrolyser which produces a c oncentration of >1000 mg/L of oxida nts. This solution is then injected back into the incoming ballast water to act as a disinfectant and it was noted that, in order to meet the D-2 standards, about 5 mg/L of oxidants are n eeded when the ballast water is filtered first and about 15 mg/L when it is not.

2.3 Furthermore, it was noted that 1.3 to 1.7 times the stoichiometric equivalent of thiosulphate was needed for neutralization to be effective and, in addition, it was noted that the applicant had indicated that th e detection limit was <0.22 mg/L TR O, measured as chlorine, at the time of ballast water discharge. The Group was not satisfied with the high detection limit of TRO and agreed that the maximum allowabl e discharge concentration of TRO should be <0.20 mg/L, as Cl 2, when applying for Final Approval and th is value also needs to be verified by the analytical method used.

2.4 A schematic representation of the system is shown below:

2.5 It was noted that, during el ectrolysis, chlorine and hydrogen are generated as by-products of the process and that these gases are to be either vented to the atmosphere or discharged using a water eductor, dependant upon the installation, location and custom er requirements for the ship to which the ballast water treatment system is to be fitted.

2.6 It was noted that the applican t did not specify the actual neut ralizing agent to be used but indicated that it could be either sodium thiosulp hate or sodium bisulphite. The Group carried out its evaluation, based on the data supplied by the applicant, which had been generated from tests in which sodium thiosulphate had been used as the neutralizing agent.GESAMP-BWWG 12/6 ANNEX 4 Page 4

I:\MEPC\60\2-16.doc 2.7 The Group recommended that the applicant provide monitoring and control of the TRO upon discharge to ensure that the MADC is not exceeded. The Group could not form an opinion on the reliability or accuracy of control scheme used for neut ralization from the information provided.

3 CHEMICALS ASSOCIATED WITH THE SYSTEM

3.1 The Group noted the results of chemical an alysis of ballast water treated with the HiBallast system, including neutralization on day 5, as shown in the table below:

Active Substances and by-products of “HiBallast”

Component Chemical Name CAS Number Unit MDL (Minimum Detection

Level) Conc. at 33/20 (PSU) AS, RC, BP or Other 6

Initial TRO (measured as chlorine) 1 N.A. mg/L 0.22* 10.8 ** /15.5 ** 8.86/12.6 AS
Discharged TRO (measured as chlorine) 1 N.A. mg/L 0.22* ND/ND AS FRO (measured as chlorine) 2 N.A. mg/L 0.05 ND/ND AS Chlorine 7782-50-5 AS Bromine 7726-95-6 AS Sodium hypochlorite 7681-52-9 AS Sodium hypobromite 13824-96-9 AS Hypochlorous acid 7790-92-3 Hypobromous acid N.A. CRO (measured as chlorine) 3 N.A. AS Chloramines 4 N.A. AS Bromamines 5 N.A. AS Sodium bromate 7789-38-0 μg/L 0.10 26.6/32.1 RC Halogenated Aliphatic and Aromatic Compounds including THMs N.A. RC
1,1,1-Trichloroethane 71-55-6 μg/L 0.01 ND/ND RC 1,1,2-Trichloroethane 79-00-5 μg/L 0.01 ND/ND RC 1,1-Dichloroethane 75-34-3 μg/L 0.01 ND/ND RC 1,1,2,2-Tetrachloroethane 79-34-5 μg/L 0.01 ND/ND RC 1,1,1,2-Tetrachloroethane 630-20-6 μg/L 0.01 ND/ND RC 1,2,3-Trichlorobenzene 87-61-6 μg/L 0.01 ND/ND RC 1,2,3-Trichloropropane 96-18-4 μg/L 0.01 ND/ND RC 1,2,4-Tribromobenzene 615-54-3 μg/L 0.01 ND/ND RC 1,2,4-Trichlorobenzene 120-82-1 μg/L 0.01 ND/ND RC 1,2-Dibromo-3-chloropropane 96-12-8 μg/L 0.01 ND/ND RC 1,2-Dichloropropane 107-06-2 μg/L 0.01 ND/ND RC 1,3,5-Tribromobenzene 626-39-1 μg/L 0.01 ND/ND RC 2-Chlorotoluene 95-49-8 μg/L 0.01 ND/ND RC 4-Chlorotoluene 106-43-4 μg/L 0.01 ND/ND RC Bromobenzene 108-86-1 μg/L 0.01 ND/ND RC Bromochloromethane 74-97-5 μg/L 0.01 ND/0.25 RC Chlorobenzene 108-90-7 μg/L 0.01 ND/ND RC cis-1,2-dichloroethene 156-59-2 μg/L 0.01 ND/ND RC Dibromochloromethane 124-48-1 μg/L 0.01 0.75/6.96 RC Dibromomethane 74-95-3 μg/L 0.01 3.37/0.73 RC Dichlorobromomethane 75-27-4 μg/L 0.01 0.15/0.51 RC Dichloromethane 75-09-2 μg/L 0.01 0.16/1.57 RC Tetrachloroethene 127-18-4 μg/L 0.02 ND/ND RC Tetrachloromethane 56-23-5 μg/L 0.01 ND/ND RCGESAMP-BWWG 12/6 ANNEX 4 Page 5

I:\MEPC\60\2-16.doc Component Chemical Name CAS Number Unit MDL (Minimum Detection

Level) Conc. at 33/20 (PSU) AS, RC, BP or Other 6
trans-1,2-dichloroethene 156-60-5 μg/L 0.02 0.01/ND RC Trichloromethane 67-66-3 μg/L 0.02 0.20/0.10 RC Tribromomethane 75-25-2 μg/L 0.01 0.25/111 RC Halogenated Aceto-nitriles N.A. Trichloroacetonitrile 545- 06-2 μg/L 0.01 0.02/ND RC Dichloroacetonitrile 3018-12-0 μg/L 0.02 0.04/0.14 RC Bromochloroacetonitrile 83463-62-1 μg/L 0.01 ND/ND RC Dibromoacetonitrile 3252-4 3-5 μg/L 0. 01 0.01/0.32 RC Chloral hydrate 302-17-0 μg/L 0.02 0.02/0.01 RC Chloropicrin 76-06-2 μg/L 0.01 0.45/1.54 RC Halogenated Acetic Acids N.A. 2-monochloroacetic acid 79-11-8 μg/L 0.04 ND/ND RC 2,2-dichloroacetic acid 79-43-6 μg/L 0.01 ND/ND RC 2,2,2-trichloroacetic acid 76-03-09 μg/L 0.01 ND/ND RC 2-monobromoacetic acid 79-08-3 μg/L 0.01 5.66/6.35 RC 2,2-dibromoacetic acid 631-64-1 μg/L 0.01 55.1/32.0 RC 2,2,2-tribromoacetic acid 75-96-7 μg/L 0.01 14.9/13.8 RC 2,2-bromochloroacetic acid 5589-96-8 μg/L 0.01 ND/ND RC 2,2,2-bromodichloroacetic acid 71133-14-7 μg/L 0.01 ND/ND RC Dalapon acid N.A. μg/L 0.05 ND/ND RC Halogenated Phenols N.A. Chlorinated Phenols N.A. RC 2-Chlorophenol 95-57-8 μg/L 0.4 ND/ND RC 3-Chlorophenol 108-43-0 μg/L 0.5 ND/ND RC 4-Chlorophenol 106-48-9 μg/L 0.5 ND/ND RC 2,3-Dichlorophenol 576-24-9 μg/L 0.4 ND/ND RC 2,4-Dichlorophenol 120-83-2 μg/L 0.8 ND/ND RC 2,5-Dichlorophenol 583-78-8 μg/L 0.9 ND/ND RC 2,6-Dichlorophenol 87-65-0 μg/L 0.8 ND/ND RC 3,4-Dichlorophenol 95-77-2 μg/L 0.9 ND/ND RC 3,5-Dichlorophenol 591-35-5 μg/L 0.6 ND/ND RC 2,3,4-Trichlorophenol 15950-66-0 μg/L 1.0 ND/ND RC 2,3,5-Trichlorophenol 933-78-8 μg/L 0.8 ND/ND RC 2,3,6-Trichlorophenol 933-75-5 μg/L 0.4 ND/ND RC 2,4,5-Trichlorophenol 95-95-4 μg/L 0.8 ND/ND RC 2,4,6-Trichlorophenol 88-06-2 μg/L 0.4 ND/ND RC 3,4,5-Trichlorophenol 609-19-8 μg/L 1.0 ND/ND RC 2,3,4,5-Tetrachlorophenol 4901-51-3 μg/L 0.3 ND/ND RC 2,3,4,6-Tetrachlorophenol 58-90-2 μg/L 0.3 ND/ND RC 2,3,5,6-Tetrachlorophenol 935-95-5 μg/L 0.4 ND/ND RC Pentachlorophenol 87-86-5 μg/L 0.4 ND/ND RC Brominated Phenols N.A. ND/ND RC 2,4-Dibromophenol 615-58-7 μg/L 0.5 ND/ND RC 2,6-Dibromophenol 608-33-3 μg/L 0.4 ND/ND RC 2,4,6-Tribromophenol 118-79-6 μg/L 0.5 ND/ND RC Neutralizing Agent N.A. OC Sodium thiosulphate 7772-98-7 OC Gas Hydrogen Gas (% vol) 1333-74-0 % 0.1 87.9/93.5 BP Ozone Gas 10028-15-6 μL/L 0.2 Negligible BP Oxygen Gas 7782-44-7 % 0.1 NA BP Chlorine Gas 7782-50-5 μL/L 0.5 Negligible BPGESAMP-BWWG 12/6 ANNEX 4 Page 6

I:\MEPC\60\2-16.doc Note: 1: Total Residual Oxidants, which was measured by the method using DPD ( N,N - diethyl-p-phenylenediamine) 2: Free Residual Oxidants, which wa s measured by the method using the ortho-tolidine 3: Combined Residual Oxidants, which was measured by the method using DPD ( N,N - diethyl-p-phenylenediamine) 4: A mixture of mono- and di- chlo ramines, and nitrogen trichloride 5: A mixture of mono- and di- brom amine, and nitrogen tribromide 6: AS (Active Substances), RC (Rel evant Chemicals), BP (By-Products) ND: Not detected; NA: Not analysed. *: The Group considered this MDL to be too high **: Estimated concentration of disinfectant as injected TRO

3.2 The Group noted that FRO was measured by the method using the or tho-tolidine, which had been replaced by other methods using DPD b ecause of its carcinogenic properties. From the viewpoint of GHS, the Group invited the applicant and the test facility not to use the method using the ortho-tolidine anymore even if it is still in common on domestic standards.

3.3 The Group noted the complete data set of ecotoxicity, toxi city and physical properties shown in Book IV, Appendix IV of the confidential data provided by the applicant and summarized in appendix 1 of this document.

4 QUESTIONS PUT TO THE APPLICANT, THE RESPONSES AND THE GROUP’S REACTION

4.1 The following questions were put to the applicant prior to the meeting:

Question 1 I would be most grateful if you could ask the appropriate person in Hyundai if they could provide me with an electr onic copy (in Word for Windows format) of their submission to IMO which was the first document in the confidential dossier headed MEPC 60/0/0.

This document contains some important data which was omitted from the scaled-down version submitted to MEPC as MEPC 60/2/6.

Answer 1 HHI will provide electronic copy of confidential dossier. Please find the file attached.

Reaction 1 The Group was satisfied with this response.GESAMP-BWWG 12/6 ANNEX 4 Page 7

I:\MEPC\60\2-16.doc Question 2 Further to my last email, could you al so ask Hyundai why, in table 7.1, some of the R&S phrases associated with a given chem ical appear to be either repeated or make other phrases redundant.

e.g., 1,1,2-Trichloroethane R20/21/22-40-66-39 R23/24/25-23/24/25-11 S9-36/37-46-45-16

In the above R23/24/25 overrules (replaces) R20/21/22 and is also repeated in the same line.

Answer 2 I sincerely apologize to make confusi on as you pointed out. There were some typographical errors in the DSCL (EEE) Hazard classification and have been corrected as follows:

R20/21/22-40-66-39 R39/23/24/25-23/24/25-11 S9-36/37-46-45-16

In the meantime, we received some advice from specialist in REACH that all related R&S phrases should be thoroughly described regardless of lower or higher rank. However, because the meaning of R23/24/25 is mo re severe than R20/21/22, as you mentioned, the classifi cation R20/21/22 was deleted and other classification codes were checked again in the same manner.

For 1,1,2-Trichloroethane, you will find its corrected phrases in the enclosed file as follows:

R40-66-39/23/24/25-23 /24/25-11, S9-36/37-46-45-16

Reaction 2 The Group noted this response.

Question 3 I am a little confused by some of the information related to the use of the MAMPEC model which I hope the applicant will be ab le to help me with.

There is a reference to “Leaching rate s” for various chemicals in table 8.12. As I understand it, the leaching rates are only used to estimate the amount of chemical going into the water from antifouling paints and has no relevance for this particular exercise.

Would it be possible to have (In WF W) format, a copy of the two MAMPEC screens used to input the ha rbour and emission details al ong with an input screen for the chemical tribromomethane?

The input screen for the emissions input is particularly important to show the relationship between the ballast water concentration of chemical, the total ballast water output/day, and the resultant PEC.GESAMP-BWWG 12/6 ANNEX 4 Page 8

I:\MEPC\60\2-16.doc If you could also add the total output of BW/day as used in these runs it would be appreciated.

Answer 3 For the meaning of “leaching rates”, I abso lutely agree with you. However, in our calculation using MAMPEC, the leaching rate was used to simulate rate of discharge. Of course, it is possible to input emission rate directly. However, we used pre-calculated leaching rates to obtain proper emission rates. Therefore, the result is exactly same.

With regarding to your request, window word format figures were attached, as follows:

Figure 1 :. Screenshot of emission i nput menu for Tribromomethane on Day 1GESAMP-BWWG 12/6 ANNEX 4 Page 9

I:\MEPC\60\2-16.doc Figure 2 : Screenshot of emission input menu for Tribromomethane on Day 5

The total discharge rate of ballast water used in MAMPEC simulation was estimated on the following basis. You can also find the ca lculation basis in page 83 and Table 8.3 of confidential dossier.

.1 in a certain ship, the discharge qu antity of ballast water is proportional to loading quantity of ship;

.2 in a certain port, the sum of loading quantity of all ships is proportional to export tonnage;

.3 the ballast water capacity is proportional to the dead weight tonnage of the ship and it was assumed that the balla st water capacity is about 35% of DWT of the ship;

.4 in the case of Rotterdam, it wa s found that the e xport tonnage is about 108,295,000 ton/year. Therefore, with this assumption, the total ballast water quantity coul d be estimated as 103,844 m 3 /day. The data source of outgoing loads of Rotterdam port is published data of Rotterdam Port Authority.

Reaction 3 The Group was satisfied with this response.GESAMP-BWWG 12/6 ANNEX 4 Page 10

I:\MEPC\60\2-16.doc Question 4 I am guessing that the applicant used the detection limit for each chemical as the concentration in ballast water to input values into MAMPEC, e.g., 1,2,3-trichloropropane was not detected in the ba llast water but the MDL was 0.01 μg/L. Is this correct?

What is the assumed daily TOTAL discharge of ballast water which will be multiplied by the above number to get th e total daily output of that chemical?

Answer 4 HHI used the MDL values, for chemicals which were not detected in small-scale tests, as an input value for MAMPEC simulation. In addition, as you mentioned above, the discharge rate can be calculated by the multiplication of the total ballast water discharge rate and th e chemical concentration.

Reaction 4 The Group was satisfied with this res ponse and considered that compounds found in concentrations below the detection li mits do not need to be subject to the MAMPEC Calculations

.
Question 5 To be absolutely sure th at I understand correctly, pleas e could either confirm the following or provide the correct details used to run MAMPEC.

Discharge volume of water from the port = 103844 m^3/d. Concentration of e.g., bromofor m on day 1 (table 8.7) = 8.8 mg/m^3

Therefore the daily load of bromoform used to calcul ate the PEC of 2.05 mg/m^3 = 8.8 x 103844/1000 = 91.027 g/d

Or, to put it another way, Can the day 1 values in table 8.7 be put next to the corresponding chemicals in ta ble 8.13 to show the concen tration in ballast water which provided a calculated PEC.

Answer 5 We apologize for our mistake in the MAMPEC simulation.

After receiving your e-mail, we checke d the results of MAMPEC modelling again and we found our mistake. As we had mentioned in the previous e-mail, we used the leaching rate to simulate emission ra te in our calculation using MAMPEC. However, in the conversion of leaching ra te, we made an error on the calculation of chemical concentration as shown in the following table.GESAMP-BWWG 12/6 ANNEX 4 Page 11

I:\MEPC\60\2-16.doc Example of Bromoform

Description Bromoform concentration (μg/L) Discharge volume based on 91 ships (m 3 /day) Surface Area of a ship (m 2 ) Leaching rate based on single ship (μg/cm2/d) No. of ship Result (g/day) PEC (μg/L)

Old 8.8 103,844 15,640 5.842885 91 83158.2752 2.05
New* 8.8 103,844 - - - 913.8272* 0.0225
Correction 8.8 103,844 15,640 0.064208** 91 913.8272 0.0225

* Revised emission rate from MAMPEC simulation, which ** Newly estimated leaching rate

PEC values are overestimated 91 times as a result of double multiplication of ship numbers, 91. Consequentl y, we recalculated all the chemical concentration correctly and changed the results of MAMPEC simulation as follows:

.1 confidential and non-conf idential document for IMO Basic Approval, Table 8.12/8.13/8.14/8.18; and

.2 appendix VII, Environmental risk as sessment report, Ta ble 5.6/5.7/ 5.8/7.1.

Figure 1 : Input form of old calculation to est imated emission rate of Bromoform on Day 1GESAMP-BWWG 12/6 ANNEX 4 Page 12

I:\MEPC\60\2-16.doc Figure 2 : Input form of revised calculation to estimated emission rate of Bromoform on Day 1

Reaction 5 The Group was satisfied with this response.

Question 6 In your application, refe rence is made to hydrogen and chlorine gases being created and removed by either venting to atmosphere or discharged using a water eductor.

Please could you indicate the levels of gases being produced and are there any monitors to detect the le vels of gases being produce d. If the levels reach a dangerous concentration, are there any safeguards in place?

Answer 6 In our application, hydrogen gas generated from the electrolyzer could be vented by either via a conventional venting system or the newly proposed (data deemed to be confidential and removed at the re quest of the submitting Administration) venting system. It is needless to say th at safety is the minimum requirement the system which shall be met, in both cases.

Some safety functions were prepared a nd the validity of safety functions will be verified during land-based type approval test to ensure safety level of HiBallast system. Please refer to the attachment to find the details of the safety functions and level of gases.GESAMP-BWWG 12/6 ANNEX 4 Page 13

I:\MEPC\60\2-16.doc .1 Level of gases being produced

As mentioned in our application, the level hydrogen gas, which was produced in electrolysis, is about 90%. For more detailed data, please re fer to Table 4.1 in document of proposal.

Unfortunately, there is no evidence to show th at the level is either safe or not, because there are no available data about safe co mposition of hydrogen gas mixture with various gases such as oxygen, nitrogen, chlorine and water vapour. According to the literature, a mixture of hydrogen and air and a mixture of hydrogen and pure oxyge n, have explosion ranges between 3.5 and 95.8% v/v of hydrogen as shown in Table 1. [1]

Therefore, the levels of hydrogen above 95.8% and under 3.5% are safe regardless of other gas compositions, temper ature, and ignition source.

In the case of using an eductor venting system, the gas compositions of the gas separator should be in the range above upper explosion level (hereafter referred as “UEL”). Besides, in the case of using a blower or fan venting system, the gas produced will be vented with air dilution to maintain a ga s composition under the lower explosion level. Of course, the conventional gas venting syst em is good and HHI will adopt this system selectively. However, as mentioned in propos al, the merit of the eductor venting system is short piping to minimize risk of hydrogen leakage.

As we understood, the concern is whether the pr oduced gas mixture is safe or not. In our view, the gas produced from electrolysis is a mixture of nitrogen, oxygen, chlorine, water, and hydrogen. HHI believe that hydrogen is predominant and the content is above the UEL. To provide background data, HHI will measure the composition of hydrogen during land-based type approval tests and subm it the precise levels of hydrogen and other gas compositions to determine whether the gas produced by the HiBallast system is safe

Table 1 : Flammable concentration range in various gases. [1]

.2 Monitors to detect the le vel of gases being produced

In our original design concept, the head-spa ce of the gas separator will be maintained above atmospheric pressure and so there is no ai r inflow into gas separa tor. So, if the gas composition in the head space gas is verified as being in the safe range under normal operating conditions, there is no possibility of explosion in the head-space. Therefore, monitoring of gas content in the head-space is not considered necessary and the pressure in the head-space will be monitored instead.GESAMP-BWWG 12/6 ANNEX 4 Page 14

I:\MEPC\60\2-16.doc However, the hydrogen concentration will be monitored both at the outside of separator and the inside of the cofferdam.

In addition, if the gas content in gas separa tor changes due to modifications in operating conditions, monitoring of gas content insi de head-space of gas separator can be considered and adopted as a part of the modified design.

.3 Safeguards

As a safety function, the system and el ectrolysis unit will be shutdown when hydrogen gas is detected outside of the gas separato r or inside of the cofferdam. Our design philosophy incorporates this safety function whic h is critical in ensu ring that the system remains in a safe condition. Additionally, to minimize risk of explosion, the separator will be maintained with minimum volume of head-space during operation and shutdown.

For more detail information, please refe r to appendix VI, system description part.

Reference: [1] Bjerketvedt, Dag et al, “Gas Explosion Handbook”, Journal of Hazardous Materials 52 (1997) pp 1-50

Reaction 6 The Group noted this response.

4.2 The following questions were put to the applicant during the meeting:

Question 1 Are there any results for chronic toxicity testing? If your answer is negative, could you clarify the reasons for this omission?

In this context, we would like to empha size that it is stated, in the confidential version, in paragraph 8.2.4:

“The chronic toxicity test and the risk characterization for the seawater treated from “HiBallast” are required to estimate the potential risk for aquatic ecosystem.”

Response 1 We did not perform the chronic toxicity test.

Completion of chronic toxicity tests takes about 28 days for zooplankton, although the test duration varies with experimental taxa (e.g., algae, invertebrates and fish). The basis of the chronic toxicity test dur ation with aquatic organisms is given in annexes 1, 2 and 3 and is referenced to the OECD guidelines 201, 211 and 212.

We already recognized the importance of chronic toxicity tests for the aquatic ecosystem. However, we will carry out th e chronic toxicity test in the land-based test through intensive preparation.

Reaction 1 The Group was satisfied with this response.GESAMP-BWWG 12/6 ANNEX 4 Page 15

I:\MEPC\60\2-16.doc Question 2 At the QAPP for “HHI BWMS” and test re port of chemical analysis, there is no description of the analytical method fo r FRO. Could you provide details of the analytical method used for FRO and provide the distinguishing definition between TRO and FRO in your report?

Response 2 The test method used for FRO measurem ent is “Standard methods for Drinking Water” which is published by Ministry of Environment, Korea. Unfortunately, this standard method is described Korean in Annex 6.

Reaction 2 The Group was satisfied with this response.

Question 3 In the Table 2.4 of your confidential version report, it is noted that the measurement of TRO was performed the by US EPA’s titration method. Is there a difference between TRO values manually measured and those measured by the TRO sensor?

Response 3 In case of “ATI Q45H-79-1/USA” TRO sensor, we could no t found the difference between TRO values of EPA method and those of TRO sensor. We will also use this TRO sensor during land- based test. EPA test method is attached in Annex 7.

Reaction 3 The Group noted this response.

Question 4 At test Nos. 1-1 and 1-2, how much equi valent of sodium thiosulphate was added against each TRO for the two salinity test waters? Which TRO values were used to estimate the demands of the neutralizer (sodium thiosulphate) i.e. were the TRO values measured manually or by the TRO sensor?

Response 4 As we mentioned in the dossier, sodium thiosulfate was added at about 1.3 and 1.7 times of equivalent for ballast water. Of course, these figures reflect the results of lab-scale test. The TRO was measured manually using US EPA’s titration method.

However, we are considering appropr iate fine tuning on addition of the neutralization agent during the land-based test of ‘Hiballast’ for the Final Approval. Also, we will collect all da ta from different operational conditions during land-based tests and sea trials.

Reaction 4 The Group noted this response.

Question 5 It is noted that it took almost one month before the chemical analysis was completed i.e. sampling for ballasting was started on 25 th Feb 2009 and the chemical analyses were finished on 20 th Mar 2009. What was the actual date for the measurement for the TRO and other volatile compounds for samples S33T1D0, S33T3D5 and S33T3D5N?

Response 5 Please refer to the appendix , Page 29, “Figure 4 Flow chart of sample custody”, and, administration procedures for testi ng which are briefly described in the following flow chart.GESAMP-BWWG 12/6 ANNEX 4 Page 16

I:\MEPC\60\2-16.doc According to the test laboratory (Korea Testing & Research Institute, KTR), all samples taken from lab-scale test were measured on that day.

Receipt

Sampling

Sample transfer

(Site → KTR)

Testing

Input of data

Identification of test report

Issue of test report “D” day “D-n” day

“D+0” day

“D+0” or “D+20” day

10 days Receipt

Sampling

Sample transfer

(Site → KTR)

Testing

Input of data

Identification of test report

Issue of test report “D” day “D-n” day

“D+0” day

“D+0” or “D+20” day

10 days

Reaction 5 The Group was satisfied with this response.

Question 6 The Group noted that the starting date fo r the all acute toxici ty testing was one day after the sampling date reported in the aquatic toxicity test report. The Group understands that the TRO had been already neutralized before sampling so that degradation of TRO during this one day is irrelevant. However, the Group consideres that there is s till a possibility that volatil e organic compounds, such as THMs, could be reduced during this period. This potential error may significantly underestimate the total toxicity.

How were the samples kept during this period; was chemical analysis undertaken before and after this period and, if so, can you provide the results.

Response 6 At that time, the temperature of samples was too cold (data deemed to be confidential and removed at the request of the submitting Administration) to perform the test. Therefore, the temper ature of samples was increased gradually during a day based on EPA 821-R-02-013 (see, Annex 4), and the test was initiated on the next day.

Custody of test substance was based on Short-term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters of Freshwater Organisms, 4th Edition, EPA 821-R-02-013 (see, annex 4). Ther efore, the test substance was kept in a constant temperature room at 4.GESAMP-BWWG 12/6 ANNEX 4 Page 17

I:\MEPC\60\2-16.doc Measured water quality (pH, DO, Temperatur e, etc.) for acute toxicity test with aquatic organisms (algae, invertebrate and fish) was given in the final report, and the results indicated in anne x 5 are shown again in here.

Reaction 6 The Group was satisfied with this response.

Question 7 It is noted that the neutralization will be done according to the concentration of TRO during the discharge of the treated wa ter. How was this measured? How do you ensure that the TRO levels never exceed 0.2 mg/l TRO?

Response 7 TRO measurement of lab-scale test was performed under batch type. The concentration of TRO was measur ed by US EPA’s titration method.

The ‘HiBallast’ system includes the neut ralization unit to remove the TRO. As shown in the chemical analysis result of the lab-scale test, the TRO is completely removed after the addition of neutralizing ag ent in the de-ballasting process. In addition, because the ‘HiBallast’ system has a control system to correct and monitor (data deemed to be confidential and removed at the request of the submitting Administration) we do anticipate that the TRO levels to be discharged never exceed 0.2 mg/l TRO.

Reaction 7 The Group was satisfied with this response.

Question 8 It is noted that the operating te mperature range of the system is between 15 and 33 o C? What is the reason for th is limitation and how will the system perform under higher or lower water temperatures?

Response 8 The operating temperature range is between 15 and 33°C which is a normal condition with a conservative viewpoint. We believe that the ‘HiBallast’ system has a capability of acting in the range of 10 and 40°C. However, this worst case brings increase of power consumption.

Reaction 8 The Group noted the limitation associated with this system.

Question 9 ‘From appendix 2, summary of chemical analysis at Feb 25 th 2009:

.1 Are there any analytical data for other chemicals in both salinities of treated water at ‘5 days before neutralization’;

.2 It is noted that the generation and degradation of the bromate ion is completely different in the testing of marine and brackish wa ter. Is there a scientific explanation for this?

Response 9 .1 As neutralization is a compulsory process in the ‘HiBallast’ system during the de-ballasting, we paid no attention to analysis of the chemicals in both salinities of treated water at ‘5 days before neutralization’.GESAMP-BWWG 12/6 ANNEX 4 Page 18

I:\MEPC\60\2-16.doc .2 We think that there is no scient ific causal relationship in bromate concentrations between tested seawat er and brackish water. We will verify this phenomenon during land-based test in detail.

Reaction 9 The Group noted this response.

5 WHOLE EFFLUENT TESTING (WET)

5.1 Acute ecotoxicity tests

5.1.1 The Group noted that the applicant had carri ed out acute eco-toxi city tests on treated ballast water with the results shown in the tables below:

Acute aquatic toxicity of 33 PSU ba llast water treated by “HiBallast”

LC50 and/or EC50 Species End point Conc.(%) Reference/Comments

Algae Skeletonema costatum 72 h EC50 69.30 OECD 201

Crustacean Tigriopus japonicus 48 h EC50 48 h LC50 > 100 > 100 OECD 202

Fish Paralichthys olivaceus 96 h LC50 > 100 OECD 203

Acute aquatic toxicity of 20 PSU ba llast water treated by “HiBallast”

LC50 and/or EC 50 Species End point Conc.(%) Reference/Comments

Algae Skeletonema costatum 72 h EC50 63.01 OECD 201

Crustacean Tigriopus japonicus 48 h EC50 LC50 48 h > 100 > 100 OECD 202

Fish Paralichthys olivaceus 96 h LC50 > 100 OECD 203

5.1.2 The Group noted that simulated ballast water wa s used in the laborato ry-scale tests. The ballast water samples were prepared with five days holding time and then neutralized with thiosulphate. The doses used were 1.3 and 1.7 times the stoichiometric equivalent for TRO concentrations which were measured manually. The Group also noted that, before starting the exposure, a one day preparation period was needed to harmonize th e temperature of the ballast water with that of the control water before the organisms could be tested.

5.1.3 From these results, the Group noted that, whils t the “HiBallast” system had an acute toxic effect on the growth of the diatom , Skeletonema costatum , other organisms were not affected by the same treated water.

5.1.4 The Group was generally satisfied with QA/QC for these tests. However, it was noted that the acute toxicity was higher than that expe cted from the reported concentration of TRO and other by-products af ter neutralization. The Gr oup invited the applicant to check this apparent anomaly which could have been caused by a high PO C in the original G8 test water. If the applicant ascertains that the high POC was the cause of this anomaly, then a modification of the testing procedure, such as pre-filtering process before e xposure would be acceptable.GESAMP-BWWG 12/6 ANNEX 4 Page 19

I:\MEPC\60\2-16.doc 5.2 Chronic ecotoxicity tests

5.2.1 The Group noted that the chronic toxicity test s were not performed in this application for Basic Approval. It was also noted that the applicant had recognize d the need for chronic toxicity testing and further risk character ization according to the results of acute toxicity tests above.

5.2.2 The Group emphasized that Procedure (G9) clearly requires both acute and chronic ecotoxicity testing for Basic Approval. The Gro up recalled that it had, previously, made a case for waiving the chronic toxicity testing for some BWMS applications for Final Approval providing the chemical analysis de monstrated that the concentrati ons of chemical by-products are similar to those provided in the application for Basic Approval.

5.2.3 However, in this case, the Group recommended that, for Final Approval, in addition to the required acute toxicity test results, chronic toxic ity test results, carried out in accordance with Procedure (G9), should also be provided as these were missing in the application for Basic Approval, because the analogy with earlier systems are not valid in this case.

6 HUMAN HEALTH ASSESSMENT

6.1 The Group noted the various chemicals associated with this system and agreed that these presented the following potential hazards to the crew and/or general public:

.1 Sodium hypochlorite is: .1 severely corrosive to skin at concentrations > 5%;

.2 Trihalomethanes and in particular bromoform are: .1 toxic by inhalation, if swallo wed and in contact with skin; .2 irritating to the skin, ey es and respiratory system; and .3 may cause cancer.

.3 Other halogenated aliphatic and aromatic compounds .1 toxic by inhalation, if swallo wed and in contact with skin; .2 may cause cancer; and .3 may be reprotoxic.

.4 halogenated acetonitriles .1 harmful by inhalation, if swallo wed and in contact with skin; and .2 irritating to skin, eyes and the respiratory system

.5 halogenated acetic acids

.1 corrosive or irritant depending on concentration; .2 toxic by all routes of exposure; and .3 may be carcinogenic.GESAMP-BWWG 12/6 ANNEX 4 Page 20

I:\MEPC\60\2-16.doc .6 halogenated phenols .1 harmful if swallowed; and .2 irritating to skin and eyes.

.7 sodium thiosulphate .1 irritating to skin ey es and respiratory system.

7 RISKS TO THE SAFETY OF THE SHIP, THE CREW AND THE GENERAL PUBLIC

7.1 Corrosion

7.1.1 The Group noted that the appli cant had not carried out any corro sivity testing at this stage but had indicated that long-term corrosivity testing would be car ried out during land-based tests in accordance with IMO Performance Standard for Protective Coating (PSPC) guideline.

7.1.2 The Group recommended that the applicant follow the recommenda tions for corrosion testing as referred to in paragraph 5.1 of the eighth session of the Ballast Water Working Group report (MEPC 59/2/16).

7.2 Explosion and/or fire

7.2.1 The Group noted that both chlorine gas a nd hydrogen gas are produced as a by-product of hydrolysis. These gases are to be vented to atmosphere or discharged using a water eductor.

7.2.2 The Group noted that a gas separator is incl uded in the system following electrolysis and that the gases collected are either to be diluted with forced air and vented to the open deck or discharged overboard using a water eductor. In the case of gase s being vented to the open deck, forced air dilution is to be ar ranged to ensure that the hydrogen content of the vented air/gas mixture remains below 1% by volume, and that the outflow is monitored so that automatic shut down will occur if the hydrogen content increases to wards the lower explosive limit. In the case of discharge of the produced gases by water educ tor, the gases are to be discharged directly overboard with the water stream powering the eductor. A hydrogen monitor is also to be installed in the space that will initiate shut dow n if hydrogen leakage from the enclosed system

occurs.

7.2.3 The Group noted that the applicant intends to utilise the main ba llast water overboard connection for the discharge of hydrogen gas when a water eductor system is used for this purpose. The Group considered th at, if the overboard connection is above the ships waterline, there is a potential for hydrogen gas to accumulate in the immediate vicinity of the overboard connection to such an extent that it might be within the explosive range. As a result, the Group recommended that this arrangement is only us ed when the overboard discharge remains below the waterline at all times.

7.2.4 The Group agreed that the safety precautions to be put in plac e with this system would be adequate to reduce the risks of explosion and/ or fire due to the production of hydrogen to an acceptable level provided the above concern is taken into account.GESAMP-BWWG 12/6 ANNEX 4 Page 21

I:\MEPC\60\2-16.doc 7.3 Human Exposure to chemicals

7.3.1 The Group noted that the applicant had identif ied the various hazards, attributed to the chemicals associated with this system, by using the Hazard Iden tification index (HAZID study) and had described various measures to either re duce the likelihood of exposur e or to be taken in the event of exposure.

7.3.2 Such measures included:

.1 the use of non-corrosive materials, wh ere appropriate, to reduce the risk of leakage caused by damage to materials of construction;

.2 taping of all joints where leakage may occur;

.3 proper training of crew;

.4 provision of appropriate safety equipment; and

.5 advice on actions to be taken in the event of exposure.

7.3.3 The Group agreed that such measures when put in place should be adequate to reduce the risks to the crew associat ed with such chemicals.

7.3.4 In addition, the applicant identified the need to develop “hazardous exposure scenarios” (App. V, Book IV, confidential dossier) related to some operational units which were considered relevant for crew exposure assessm ent. These included the potential failure of the electrolyzer enclosure leading to a leakage of the disinfection solution (<2000 mg/L) from the electrolyzer, the disinfectant supply or the inlet pipe.

7.3.5 The Group agreed that the main potentia l risks to the crew would be from:

.1 exposure to high concentration disinfectant through leakage; and

.2 exposure to the neutralizing agent wh en mixing sodium thiosulphate powder.

7.3.6 The Group considered that al l relevant information and th e quantification of the risks associated to these specific s cenarios should be provided, by th e applicant, for Final Approval according to principles of Human Expos ure Assessment (MEPC 56/2/2, annex 9).

7.3.7 The Group considered that the risks to th e General Public (swimming and eating fish from the coastal area) as a result of effluent discharge of treated ballast water ha d, also, to be addressed by the applicant and information to be provided at the Final Approval stage.

7.3.8 The Group noted the importance placed on the selection of appropriate materials and construction joint details for th e parts of this system that may be exposed to the high concentrations of oxides formed during electrolysis which remain until diluted by injection into the ballast water main piping. It is recommended that such material and construction details are included in the operating manual so as to ensure correct repair in the event of failure being experienced in this part of the system.GESAMP-BWWG 12/6 ANNEX 4 Page 22

I:\MEPC\60\2-16.doc 7.3.9 The Group noted that the applicant was using sodium thiosulphate as the TRO neutralizer for the purposes of applying for Basic Approval. It is recomme nded that detailed procedures appropriate to the use of this chemical should be clearly identified and in cluded in the operating manual for handling, system top-up and emergency act ions in the event of spillage together with identification of the appropriate materials for the construction of the storage tanks and filling and supply piping.

7.3.10 The Group agreed that such mitigation meas ures should be adequate to reduce the risks associated with such chemicals to an acceptable level and all such measures should be clearly identified and included in the ballast wa ter treatment system operating manual.

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Calculation of Predicted Envi ronmental Concentrations (PEC)

8.1.1 The Group noted that the applicant had employed the MAMPEC model to estimate the PECs of the various chemical by-products generated by this system.

8.1.2 The applicant had used the de fault commercial har bour using statistical data for the Port of Rotterdam to predict total daily discharge of ballast water and chemicals with which it is associated.

8.1.3 The Group noted the results of this ex ercise as shown in the table below:

Chemical BW Conc (μg/L) Max PEC (μg/L) 1,2,3-Trichloropropane 0.01 2.20E-03 Dibromochloromethane 0.75/6.96 3.98E-01 Dibromomethane 3.37/0.73 3.00E-01 Dichlorobromomethane 0.15/0.51 5.39E-02 Dichloromethane 0.16/1.57 1.03E-01 trans-1,2-dichloroethene 0.01 1.29E-03 Trichloromethane 0.2/0.1 3.14E-02 Tribromomethane 0.25/1.1 2.05E+00 Trichloroacetonitrile 0.02 5.73E-03 Dichloroacetonitrile 0.04/0.14 1.96E-02 Dibromoacetonitrile 0.01/0.32 5.72E-03 Chloral hydrate 0.02/0.01 1.16E-02 2-monochloroacetic acid 0.04 2.33E-02 2,2-dichloroacetic acid 0.01 5.82E-03 2,2,2-trichloroacetic acid 0.01 5.81E-03 2-monobromoacetic acid 5.66/6.35 1.36E+00 2,2-dibromoacetic acid 55.1/32 7.27E+00 2,2,2-tribromoacetic acid 14.9/13.8 5.82E-03 2,2-bromochloroacetic acid 0.01 5.82E-03 Bromate ion (Sodium bromate) 26.6/32.1 1.50E+01

8.1.4 The Group agreed with the calculation re sults achieved by the applicant using the model MAMPEC.GESAMP-BWWG 12/6 ANNEX 4 Page 23

I:\MEPC\60\2-16.doc 8.2 Calculation of PEC/PNEC ratios

8.2.1 The Group noted the calculated PEC/PNEC ratios as shown in the table below:

Chemical compounds Available data Assessment Factor End point (mg/L) PNEC (μg/L) PEC (μg/L) PEC/PNEC

1,2,3-Trichloropropane Daphnia magna (Crustacea/acute/LC50/48hrs) 1000 20 20 0.0022 0.0001

Dibromochloromethane Selenastrum capricornutum (Algae/acute/EC50/72hrs) 1000 9.6 9.6 0.398 0.04

Dibromomethane NA - NA - 0.3 -

Dichlorobromomethane Selenastrum capricornutum (Algae/acute /EC50/72hrs) 1000 12 12 0.054 0.005

Dichloromethane Oryzias latipes (Fish/chronic/NOEC) 1000 75 75 0.103 0.001
trans-1,2- dichloroethene Daphnia magna (Crustacea/acute/LC50/24hrs) 1000 110 110 0.00129 0.00001

Trichlorimethane Ceriodaphnia dubia (Crustacea /chronic/NOEC) 1000 3.4 3.4 0.0314 0.00009

Tribromomethane Brevoortia tyrannus (Fish/acute/LC50/96hrs) 1000 9 9 2.05 0.22

Trichloroacetonitrile Daphnia magna (Crustacea/acute/EC50/48hrs) 1000 0.044 0.044 0.00573

Dichloroacetonitrile NA - NA - 0.0196 -

Dibromoacetonitrile Pimephales promelas (Fish/acute/LC50/96hrs) 1000 0.55 0.55 0.00573 0.01

Chloral hydrate Daphnia magna (Crustacea/acute/EC50/48hrs) 1000 500 500 0.0116 0.00002

2-monochloroacetic acid Brachydanio rerio (Fish/ chronic/NOEC) 1000 25 25 0.0233 0.0009

2,2-dichloroacetic acid Nitocra spinipes (Crustacea/acute/LC50/96hrs) 1000 21 21 0.00582 0.0003

2,2,2-trichloroacetic acid Salmo gairdneri (Oncorhynchus mykiss) (Fish/acute/LC50/96hrs) 1000 1050 1050 0.00581 0.000006

2-monobromoacetic acid Daphnia magna (Crustacea/Chronic/NOEC) 1000 16 16 1.36 0.09

2,2-dibromoacetic acid Pimephales promelas (Fish/acute/LC50/96hrs) 1000 69 69 7.27 0.1
2,2,2-tribromoacetic acid NA - NA - 0.00582 -
2,2-bromochloroacetic acid NA - NA - 0.00582 -

Sodium bromate Bass prolarvae (Fish/acute/LC50/96hrs) 1000 30.8 30.8 15 0.5GESAMP-BWWG 12/6 ANNEX 4 Page 24

I:\MEPC\60\2-16.doc 8.3 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

8.3.1 The Group noted the assessment of PBT criteria associated w ith the various chemical by-products associated with this syst em as shown in the table below:

Chemical P *1) (Yes/No) (Half-life, days) B *2) (Yes/No) (BCF: l/kg wet-wt) T *3) (Yes/No) (NOEC)
1,2,3-Trichloropropane No 38 days in water No BCF: 5.3-13.0 NA

Dibromochloromethane No 38 days in water No BCF: 12.78 NA

Dibromomethane No 15 days in water No BCF: 3.23 NA

Dichlorobromomethane No 38 days in water No BCF: 10.01 NA

Dichloromethane No 38 days in water No BCF: 2.0-5.4 No Fish:75mg/l
trans-1,2-dichloroethene No 38 days in water No BCF: 12.92 NA

Trichloromethane No 38 days in water No BCF: 1.4-4.7 No Crustracean:15mg/l

Tribromomethane No 38 days in water No BCF: 7.1-21.2 NA

Trichloroacetonitrile Yes 60 days in water No BCF: 12.66 NA

Dichloroacetonitrile No 38 days in water No BCF: 3.0 NA

Dibromoacetonitrile No 38 days in water No BCF: 1.09 NA

Chloral hydrate No 38 days in water No BCF: 1.63 NA

Chloropicrin Yes 60 days in water No BCF: 11.95 NA

2-monochloroacetic acid No 15 days in water No BCF: 1.04 No Fish:12.5mg/l
2,2-dichloroacetic acid No 15 days in water No BCF: 1.68 NA

2,2,2-trichloroacetic acid No 38 days in water No BCF: 0.4-1.0 No Algal: 0.01

2-monobromoacetic acid No 8.7 days in water No BCF: 1.1 NA

2,2-dibromoacetic acid No 15 days in water No BCF: 1.29 NA

2,2,2-tribromoacetic acid No 15 days in water No BCF: 5.19 NA

2,2-bromochloroacetic acid No 15 days in water No BCF: 1.24 NA

*1) Cited from http://www.pbtprofiler.net *2) Refer to Table 5.4 *3) Refer to Table 5.2 NA: No Available DataGESAMP-BWWG 12/6 ANNEX 4 Page 25

I:\MEPC\60\2-16.doc 8.4 Interpretation of the results

8.4.1 The Group agreed that:

.1 the PEC/PNEC ratios for all of the potential chemical by-products indicated that there would be no unacceptable risk to the marine environment;

.2 none of the by-products met the PBT criteria which would have prevented the system for being used to treat ballast water; and

.3 whilst it was recognized that WET showed that treated ballast water showed some ecotoxicological effects, it was recognized that these would be diluted to an acceptable level.

8.4.2 Based on the above observations , the Group agreed th at the chemical by-products of this system should not pose any unacceptable risk to the marine environm ent in the quantities produced, if neutralizatio n is carried out adequately in every ballast water discharge.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Having considered all of the information provided by the applicant, the Group agreed that:

.1 although no corrosion testin g results had been provide d, the concentration of various chemicals in the treated ballast water should not cause undue concern with regard to further full-scale tests being carried out onboard;

.2 all relevant information and the quan tification of the risks associated with exposure to the crew of hi gh concentrations of disinf ectants through leakage and to sodium thiosulphate when mixing, should be provided by the applicant for Final Approval according to principl es of Human Exposure Assessment (MEPC 56/2/2, annex 9);

.3 the risks to the General Public (swimmi ng and eating fish from the coastal area), as a result of exposure to the discharged treated ballast water, should be addressed by the applicant and information be provided in the application for Final Approval;

.4 the environmental risk assessment indicat ed that the system should not cause any unacceptable risk to the marine environment;

.5 with regard to the intention to disc harge the back-flush effluent from the automatic ballast water filte r (if fitted) through the ball ast water system overboard connection, it was recommended that, where this arrangement is to be used, the possibility of contamination of the ball ast water discharge line with untreated organisms and pathogens contained in the filter effluent should be fully considered and appropriate safeguards incl uded in this part of the system to prevent such an situation occurring;GESAMP-BWWG 12/6 ANNEX 4 Page 26

I:\MEPC\60\2-16.doc .6 to recommend that consideration be give n to incorporating a shut down feature in the treatment control system in the event of a neutralizing system failure, during discharge, to prevent the po ssibility of excess levels of TRO being discharged to the receiving water environment;

.7 the required chronic toxicity test re sults, in accordance with Procedure (G9), should be provided as it was missing in the application for Basic Approval;

.8 the TRO sensor sensitivit y, reliability and its use in the neutralizer control should be confirmed as being appropriate to maintain the MADC of TRO; and

.9 the evaluation of a BWMS, by the Group, is dependent upon the specific results of the analytical testing performed. Such results are affected by the system configuration. The Group noted that the a pplicant had described different options in its application for Basic Approval, as described in section 2 of this annex including filter/no filter, di fferent dose rates, different neutralizing chemicals, and recommended that any application for Final Approval include all results related to the configuration proposed.

9.2 Notwithstanding the above comments, the Gr oup agreed that the HiBallast BWMS should be recommended for Basic Approval.

* * *GESAMP-BWWG 12/6 ANNEX 4 Page 27

I:\MEPC\60\2-16.doc APPENDIX

SUMMARY OF KEY DATA FOR CHEMICALS ASSOCIATED WITH THE HIBALLAST SYSTEM

1 AQUATIC TOXICITY

1.1 Acute aquatic toxicity

Substances F C A * Species End point L(E)C50 (mg/L) NOEC (mg/L) Reference /
comments

Active Substances

Sodium hypochlorite F Oncorhynchus kisutch LC50/96hrs/ Marine 0.026-0.038 - IUCLID dataset, 2000

C Daphnia magna EC50/96hrs 2.1 - IUCLID dataset, 2000

A Thalassiosira guilardii EC50/24hrs 0.075 - IUCLID dataset, 2000

Monochloramine F Oncorhynchus clarki LC50/96hrs 0.074-0.094 - PAN Pesticide DB

C Ceriodaphnia dubia LC50/24hrs 0.016-0.02 - PAN Pesticide DB

A NA NA - - -

Relevant Chemicals

Sodium bromate F Bass prolarvae LC50/96hrs 30.8 - HSDB,2009

C Crassostrea gigas( mollusc ) EC50/24hrs/SW 170 - ECOTOX DB

A Skeletonema costatum -/7days/SW 0.125- >16 - ECOTOX DB

1,1,2-trichloroethane F Pleuronectes platessa LC50/96hrs/ Marine 55 - IUCLID dataset, 2000

C Eliminius modestus LC50/48hrs 7.5 - IUCLID dataset, 2000

A Phaeodactylum tricornutum EC50/96hrs 60 - IUCLID dataset, 2000 1,1,2,2- Tetrachloroethane F Lepomis macrochirus LC50/96hrs/SW 13 - ECOTOX DB

C Americamysis bahia LC50/96hrs/SW 9.02 - ECOTOX DB

A Skeletonema costatum EC50/96hrs/FW 6.44 - ECOTOX DB
1,2,3- Trichlorobenzene F Oryzias latipes LC50/96hrs NOEC/14days 3.2 0.32 NITE web site

C Daphnia magna EC50/48hrs NOEC/21days 0.46 0.17 NITE web site

A Selenastrum capricornutum EC50/72hrs/ NOEC/72hrs 1.6 0.23 NITE web site 1,2,3- trichloropropane F Lepomis macrochirus LC50/96hrs/FW NOEC/96hrs 75 10 IUCLID dataset, 2000

C Daphnia magna LC50/48hrs NOEC/48hrs 20 5.6 IUCLID dataset, 2000

A Phaeodactylum tricornutum EC50/7days 34 - IUCLID dataset, 2000GESAMP-BWWG 12/6 ANNEX 4 Page 28

I:\MEPC\60\2-16.doc Substances F C A * Species End point L(E)C50 (mg/L) NOEC (mg/L) Reference /
comments 1,2,4- Trichlorobenzene F Jordanella floridae LC50/96hrs/FW 1.217 - IUCLID dataset, 2000

C Daphnia magna EC50/48hrs NOEC/0.1days 1.4 0.79 NITE web site

A Selenastrum capricornutum EC50/72hrs 5.7 - NITE web site

2-Chlorotoluene F Salmo gairdneri LC50/96hrs/FW 2.3 - IUCLID dataset, 2000

C Daphnia magna EC50/48hrs NOEC/21days 0.7 0.31 NITE web site

A Selenastrum capricornutum EC50/72hrs NOEC/72hrs 7.8 2.6 NITE web site

4-Chlorotoluene F Oryzias latipes LC50/96hrs 6.1 - NITE web site

C Daphnia magna EC50/48hrs NOEC/21days 2.0 0.32 NITE web site

A Selenastrum capricornutum EC50/72hrs 6.1 - NITE web site

Bromobenzene F Pimephales promelas LC50/96hrs/FW 5.6 - ECOTOX DB

C Daphnia magna EC50/24hrs 1.6 - ECOTOX DB

A NA NA - - -

Bromochloromethane F Cyprinus carpio LC50/3- 5day/FW 61-95 - ECOTOX DB

C NA NA - - -

A NA NA - - -

Chlorobenzene F Lepomis macrochirus LC50/96hrs/FW 4.5 - IUCLID dataset, 2000

C Daphnia magna EC50/48hrs NOEC/48hrs 19.9 6.25 IUCLID dataset, 2000

A Selenastrum capricornutum LC50/96hrs 12.5 - IUCLID dataset, 2000 Cis-1,2- dichloroethene F Oryzias latipes LC50/67/96hrs/ 67 - NITE web site

C Daphnia magna EC50/40/48hrs/ 40 - NITE web site

A Daphnia magna EC50/21days NOEC/21days 17 4.5 NITE web siteDibromochloromethane F Oryzias latipes LC50/96hrs NOEC/21days 79 3.2 NITE website

C Daphnia magna EC50/48hrs 27 - NITE web site

A Selenastrum capricornutum EC50/72hrs NOEC/72hrs 9.6 4.5 NITE website

Dibromomethane F NA NA - - -

C NA NA - - -

A NA NA - - -

Dichlorobromometane F Oryzias latipes LC50/96hrs NOEC/21days 28 0.78 NITE web site

C Daphnia magna EC50/48hrs NOEC/21days 29 0.79 NITE web site

A Selenastrum capricornutum EC50/72hrs 12 NITE web siteGESAMP-BWWG 12/6 ANNEX 4 Page 29

I:\MEPC\60\2-16.doc Substances F C A * Species End point L(E)C50 (mg/L) NOEC (mg/L) Reference /
comments

Dichloromethane F Pimephales promelas LC50/96 hr/Fresh 177 IUCLID, 2000

C Palaemonetes pugio LC50/48hrs 108.5 IUCLID, 2000

A Skeletonema costatum EC50/-hrs >660 IUCLID, 2000

Tetrachloroethene F Oncorhynchus mykiss LC50/96hr/FW 4.99 IUCLID, 2000

C Daphnia magna EC50/48hrs 7.49 IUCLID, 2000

A Selenastrum capricornutum EC50/72hrs NOEC/72hrs 27 9.1 NITE web site

Tetrachloromethane F Oryzias latipes LC50/96hrs 7.6 NITE web site

C Daphnia magna EC50/48hrs NOEC/21days 8.1 0.49 NITE web site

A Selenastrum capricornutum EC50/72hrs NOEC/72hrs 0.46 0.12 NITE web site trans-1,2- dichloroethene (dichloroethene) F NA NA - - -

C Daphnia magna LC50/24hrs/FW <110 ECOTOX DB

A NA NA - - -

Trichloromethane

(Chloroform) F Oncorhynchus mykiss LC50/96hrs 18 IUCLID, 2000

C Daphnia magna EC50/48hrs 29 IUCLID, 2000

A Chlamydomonas reinhardii EC50/72hrs 13.3 IUCLID, 2000

Tribromomethane F Brevoortia tyrannus LC50/96hrs 9-15 ECOTOX DB

C Penaeus aztecus LC50/96hrs 20-33 ECOTOX DB

A Skeletonema costatum LC50/96hrs 12.3 ECOTOX DB

Trichloroacetonitrile F Oryzias latipes LC50/96hrs 0.072 NITE web site

C Daphnia magna EC50/48hrs 0.044 NITE web site

A NA NA - - -

Dichloroacetonitrile F NA NA - - -

C NA NA - - -

A NA NA - - -

Bromochloroacetonitrile F NA NA - - -

C NA NA - - -

A NA NA - - -

Dibromoacetonitrile F Pimephales promelas LC50/96hrs 0.55 ECOTOX DB

C NA NA - - -

A NA NA - - -GESAMP-BWWG 12/6 ANNEX 4 Page 30

I:\MEPC\60\2-16.doc Substances F C A * Species End point L(E)C50 (mg/L) NOEC (mg/L) Reference /
comments
Chloral hydrate F Leuciscus idus melanotus LC50/48hrs/FW 1720 ECOTOX DB

C Daphnia magna EC50/48hrs/FW 500 ECOTOX DB

A Scenedesmus quadricauda LOEC/-/FW 2.8 ECOTOX DB
Chloropicrin F Oncorhynchus mykiss LC50/96hrs/FW 0.014-0.019 ECOTOX DB

C Daphnia pulex EC50/ 48hrs/FW 0.047-0.086 ECOTOX DB

A NA NA - - -

2-monochloroacetic acid F Oryzias latipes LC50/96hrs 72 NITE web site

C Brachionus calciflorus LC50/48hrs NOEC/- 68.9 40 EURA RPT.

A Selenastrum capricornutum EC50/72hrs NOEC/72hrs 0.16 0.033 NITE web site 2,2-dichloroacetic acid F NA NA - - -

C Nitocra spinipes LC50/96hrs 21-25 ECOTOX DB

A NA NA - - -
2,2,2-trichloroacetic acid F Salmo gairdneri LC50/96hrs 1050 IUCLID, 2000

C Daphnia magna EC50/48hrs 2000 IUCLID, 2000

A Chlorococcales EC10/24hr 1000 IUCLID, 2000 2-monobromoacetic acid F NA NA - - -

C Daphnia magna EC50/24hrs 65 ECOTOX DB

A Scenedesmus subspicatus EC50/72hrs 0.2-1.4 ECOTOX DB
2,2-dibromoacetic acid F Pimephales promelas LC50/96hrs 69 ECOTOX DB

C NA NA - - -

A NA NA - - -
2,2,2-tribromoacetic acid F NA NA - - -

C NA NA - - -

A NA NA - - -
2,2- bromochloroacetic acid F NA NA - - -

C NA NA - - -

A NA NA - - -
2,2,2- bromodichloroacetic acid F NA NA - - -

C NA NA - - -GESAMP-BWWG 12/6 ANNEX 4 Page 31

I:\MEPC\60\2-16.doc Substances F C A * Species End point L(E)C50 (mg/L) NOEC (mg/L) Reference /
comments

A NA NA - - -

Sodium thiosulfate F Notropis atherinoides LC50/5days/FW 2 IUCLID, 2000

C NA NA - - -

A Ankistrodesmus falcatus LC50/1hr 64 IUCLID, 2000

* Note: F is Fish; C is Crustacean; and A is Algae.

1.2 Chronic aquatic toxicity

Substances F C A Species End point L(E)C50 (mg/L) NOEC (mg/L) Reference /
comments

Active Substances

Sodium hypochlorite F Oncorhynchus gorbuscha NOEC/23days - 0.042 PAN Pesticide DB

C Dreissena polymorpha LC50/295hrs 1.0 - IUCLID dataset, 2000

A NA NA - - -

Relevant Chemicals

1,1,2-trichloroethane F Pleuronectes platessa LC50/56day NOEC/56days 5.5 3 IUCLID dataset, 2000

C Daphnia magna EC50/21days NOEC/21days 32 18 IUCLID dataset, 2000

A NA NA - - -
1,1,2,2- Tetrachloroethane F Jordanella floridae LOEC/10day - 7.23 ECOTOX DB

C Daphnia magna LC50/28day 14 - HSDB,2005

A NA NA - - -
1,2,4- Trichlorobenzene F Pimephales promelas NOEC/32day/ FW - 0.5 IUCLID dataset, 2000

C Daphnia magna EC50/28day 0.36-0.6 - IUCLID dataset, 2000
A Green Algae EC50/96hr NOEC/96hr 24 5.6 PAN Pesticide DB

2-Chlorotoluene F Pimephales promelas NOEC/30 day NA 2.9 Ichem,2001

C Daphnia magna NOEC/21day - 0.14 Ichem dataset,2001

A Scenedesmus subspicatus LC50/72h >60 - Ichem dataset, 2001

Chlorobenzene F Oryzias latipes NOEC - 0.25 NITE web site

C Daphnia magna EC50/14days 2.5 - IUCLID dataset, 2000

A NA NA - - -GESAMP-BWWG 12/6 ANNEX 4 Page 32

I:\MEPC\60\2-16.doc Substances F C A Species End point L(E)C50 (mg/L) NOEC (mg/L) Reference /
comments

Dichloromethane F Oryzias latipes LC50/21day NOEC 106 75 IUCLID dataset, 2000

C NA NA - - -

A NA NA - - -

Tetrachloroethene F Oryzias latipes NOEC - 1.0 NITE web site

C Daphnia magna EC/28day 0.51 - IUCLID data -set,2000

A NA NA - - -

Trichloromethane

(Chloroform) F Oncorhynchus mykiss LC50/648hrs/ FW 2.03 - IUCLID dataset, 2000

C Daphnia magna EC50/16day NOEC/16day 60 15 IUCLID dataset, 2000

A NA NA - - -

Trichloroacetonitrile F Cyprinodon variegatus LC50/<20 days 7.1 - HSDB2009

C NA NA - - -

A NA NA - - -

2-monochloroacetic acid F Brachydanio rerio NOEC/28days - 12.5 EURA RPT.

C Daphnia magna NOEC/21day 32 - EURA RPT.

A NA NA - - -
2,2,2-trichloroacetic acid F Pimephales promelas LC50/96hrs 2000 - OECD-SIDS

C NA NA - - -

A Chlorella pyrenoidosa NOEC/14days - 0.01 OECD-SIDS

Sodium thiosulfate F Oncorhynchus mykiss LC50/18month/ FW 600 - IUCLID dataset, 2000

C NA NA - - -

A NA NA - - -

1.3 Endocrine disruption

1.3.1 No reports on the endocrine disruption poten tial of Active Substances and Relevant Chemicals were found in the literature. Comm only, it was known that the chemicals such as Dichloro-diphenyl-trichloroethane (DDT), Poly chlorinated biphenyls (PCB’s), Bisphenol A, Polybrominated diphenylethers (PBDEs), and a va riety of Phthalates, et c. are classified as endocrine disruptors. However, no potential endoc rine disrupting chemicals had been detected in the treated water.

1.4 Sediment toxicity

1.4.1 No report on the sediment toxicity, relate d to algae, crustacea and fish, for Active Substances and Relevant Chemi cals were found in the literatu re. The sorption behaviour ofGESAMP-BWWG 12/6 ANNEX 4 Page 33

I:\MEPC\60\2-16.doc substances in the sediment (soils or sludge ) can be described through parameters of the adsorption coefficient (K oc ), which is defined as the ratio between the concentration of the substance in the soil/sludge and the concentrati on of the substance in the aqueous phase at adsorption equilibrium. Therefore, the K oc value is a useful indicator of the binding capacity of a chemical on organic matter of the sediment and a llows comparisons to be made between different chemicals.

1.4.2 Most of K oc values for Active Substances and Rele vant Chemicals are less than 500 l/kg. Therefore, these compounds are unlikely to have the sediment toxicity. The K oc of 1,2,3-Trichloroben zene and 1,2,4-Trichlor obenzene are estima ted as 1,383 l/kg and 1,356 l/kg, respectively. Because the octanol/water partition coefficients (K ow ) are also more than 3, these chemicals may have effect on the sediment toxicity. K oc values for the Active Substances and Relevant Ch emicals are summarized in the table. The Relevant Chemicals, 1,2,4-Trichlorobe nzene and 1,2,3-Trichlorobenzene have K oc values larger than 500 l/kg, but these compounds were not detected in discharged water on day 5 in small-scale test.

1.5 Bioavailability/biomagnification/bioconcentration

1.5.1 The bioaccumulative potential of an organic chemical substance builds up in tissues of living organisms as a result of direct exposure to polluted wa ter, air or so il, or through consumption of contaminated food. The log K ow value can be used as a screening tool to indicate a bioaccumulation potential, but on ly direct measurement of the BAF or BCF gives a reliable indication of a substance’s ability to bioaccumulate.

1.5.2 Most of log K ow values for Active Substances and Rele vant Chemicals are less than three except some chemicals. However, the BCF of th ese chemicals are less than the EU criteria to determine the PBT screening. Therefore, it is exp ected that the potential for the bioavailability, biomagnification and bioconcentration is unlikely to have an effect on the aquatic organisms.

1.6 Food web/population effects

1.6.1 Based on the K oc and BCF, it is anticipated that the potential for bioaccumulation in the food chain could be negligible because th ese factors do not exceed the BCF criteria.

2 DATA ON MAMMALIAN TOXICITY

2.1 General

2.1.1 The Group noted that mammalian toxicity data for the Active Substances and Relevant Chemicals had been obtained from literature sour ces such as Toxicology Data Network (ToxNet), the International Uniform Chemical Informati on Database (IUCLID), the EU Risk Assessment Report, and WHO guidelines for drinking water quali ties, etc. The detailed mammalian toxicity data for the Active Substances a nd Relevant Chemicals are given in appendix 4 of Book IV of the confidential data supplied by the applicant.

2.1.2 The Group noted the data related to mammalia n toxicity for each chemical by-product, in appendix IV of book IV of the confidential dossier and summari sed in the tables below:GESAMP-BWWG 12/6 ANNEX 4 Page 34

I:\MEPC\60\2-16.doc 2.2 Acute mammalian toxicity

Chemical Exposure
route Species Value Reference

Sodium hypochlorite 1) Oral LD 50 2) Dermal LD 0 3) Inhalation LC 50 1) Rat 2) Rabbit 3) Rat 1) >5000 mg/kg 2) >10000 mg/kg 3) >10.5 mg/l IUCLID, 2000

Monochloramine Oral Mice (male) NOAEL = 30 mg/kg/d WHO, 2004

Sodium bromate 1) Oral LD 50 2) Oral LD 50 1) Rats, mice, hamsters 2) Human 1) 280 - 495 mg/kg 2) Probable oral Lethal

Dose 5-50mg/kg HSDB, 2009

1,1,2-Trichloroethane 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LC 50 1) Rats, mouse and

dog 2) Rabbit and

Guinea pig 3) Rat, mouse 1) 100-1140 mg/kg 2) 963-5377 mg/kg 3) 2.3-9.02 (mg/l/6hrs) IUCLID, 2000

1,1,2,2-Tetrachloroethane 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LD 50 1) Rats 2) Rabbits 3) Rats 1) 250 mg/kg 2) 6360 mg/kg 3) 8.6 (mg/l/4hrs) HSDB,2005

1,2,3-Trichlorobenzene Oral LD 50 Rats and mice 756 -766 mg/l HSDB,2004

1,2,3-Trichloropropane 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LC 100 1) Rats 2) Rabbits 3) Rats 1) 125-505 mg/kg 2) 250-2457 mg/kg 3) 697-2000 (mg/l/4hrs) IUCLID, 2000

1,2,4-Trichlorobenzene 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LC 0 1) Rats 2) Mice 3) Rats 1) 550-1107 mg/kg 2) 300-305 mg/kg 3) 418 (mg/l/4hrs) IUCLID, 2000

2-Chlorotoluene 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LD 50 1) Rats 2) Rats 3) Rats and mice 1) 1659-5700 mg/kg 2) > 1083 mg/kg 3) > 20 (mg/l/1hr) IUCLID, 2000

4-Chlorotoluene 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LD 50 1) Rats 2) Rabbits 3) Rats 1) 1920-3600 mg/kg 2) > 2000 mg/kg 3) 26.9 (mg/l/1hr) IUCLID , 2000

Bromobenzene Oral LD 50 Rats 2383-3629 mg/kg HSDB,2003

Bromochloromethane 1) Oral LD 50 2) Inhalation LC 50 1) Rats and mice 2) Mice 1) 4300-5000 mg/kg 2) 3000 (mg/l/7hrs) HSDB,2005

Chlorobenzene 1) Oral LD 50 2) Dermal LD 100 3) Inhalation LC 50 1) Rats 2) Rats 3) Rats and mice 1) 1110-11100 mg/kg 2) 2200 mg/kg 3) 1886-2965 (mg/l/6hrs) IUCLID, 2000

cis-1,2-dichloroethene Oral Rats NOAEL 97mg/kg/d ATSDR, 1996

Dibromochloromethane 1) Oral LD 50 2) Oral LD 50 1) Rats 2) Mice 1) 370-760 mg/kg 2) 667-1524 mg/kg HSDB,2006

Dibromomethane Inhalation LC 50 Rats 40 (g/m 3 /2hrs) HSDB,2002

Dichlorobromomethane 1) Oral LD 50 2) Oral LD 50 1) Rats 2) Mice 1) 969-1388 mg/kg 2) 1820 mg/kg HSDB,2009

Dichloromethane 1) Oral LD 50 2) Inhalation LC 50 1) Rats 2) Mice 1) 1410-2524 mg/kg 2) 16200 (mg/l/8hrs) IUCLID, 2000

Tetrachloroethene 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LC 50 1) Rats 2) Rabbits 3) Mice 1) 250-8850 mg/kg 2) 3245 mg/kg 3) 20.2 (mg/l/6hrs) IUCLID, 2000

Tetrachloromethane 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LC 50 1) Rats 2) Guinea pig 3) Mice 1) 2350-6770 mg/kg 2) 2100-8500 mg/kg 3) 59.9 (mg/l/8hrs) IUCLID, 2000

trans-1,2-dichloroethene 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LC 50 1) Rats and mice 2) Rabbits 3) Mice 1) 2100-10000 mg/kg 2) LOAEL 170mg/kg 3) 21723 (mg/l/6hrs) ATSDR, 1996

Trichloromethane 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LD 50 1) Rats 2) Rabbits 3) Mice 1) 908-2000 mg/kg 2) 3980 mg/l 3) 6.15 mg/l IUCLID, 2000

Tribromomethane 1) Oral LD 50 2) Oral LD 50 1) Rats 2) mice 1) 933-1388 2) 707-1550 ATSDR, 2005

Trichloroacetonitrile N.A.GESAMP-BWWG 12/6 ANNEX 4 Page 35

I:\MEPC\60\2-16.doc Chemical Exposure
route Species Value Reference

Dichloroacetonitrile 1) Oral LD 50 2) Oral LD 50 1) Mice 2) Rats 1) 270-279 mg/kg 2) 330-339 mg/kg HSDB, 2009

Bromochloroacetonitrile N.A.

Dibromoacetonitrile 1) Oral LD 50 2) Oral LD 50 1) Mice 2) Rats 289-303 mg/kg 245-361 mg/kg HSDB,2009

Chloral hydrate 1) Oral LD 50 2) Dermal LD 50 1) Rats 2) Rats 1) 200-500 mg/kg 2) 3030 mg/l HSDB,2009

Chloropicrin 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LC 50 1) Rats 2) Rats 3) Rats 1) 37.5-250 mg/kg 2) 100 mg/kg 3) 14.4 (mg/l/4hrs) HSDB,2009

2-monochloroacetic acid 1) Oral LD 50 2) Dermal LD 50 3) Inhalation LC 50 1) Rats 2) Rabbits 3) Rats 1) 55 mg/kg 2) 250 mg/kg 3) 180 (mg/l/4hrs) EURA RPT.

2,2-dichloroacetic acid 1) Oral LD 50 2) Dermal LD 50 1) Rats and mice 2) Rats 1) 2,820- 5,520 mg/kg 2) 795 mg/kg WHO, 2005

2,2,2-trichloroacetic acid 1) Oral LD 50 2) Dermal LD 50 1) Rats and mice 2) Rats 1) 3,320- 4,970 mg/kg 3) >2,000 mg/kg WHO, 2004

2-monobromoacetic acid Oral LD 50 Rats 177 mg/kg WHO, 2004 2,2-dibromoacetic acid Oral LD 50 Rats 1737 mg/kg WHO, 2004 2,2,2-tribromoacetic acid N.A. 2,2-bromochloroacetic acid N.A. 2,2,2-bromodichloroacetic acid N.A.
Sodium thiosulphate Oral LD 50 Rats >5,050 mg/kg PMEP

2.3 Effects on skin and eye

Skin and eye effects

Chemical Skin Eye Reference

Sodium hypochlorite 1) Rabbit: Irritation test, Severely irritant at 6.25% 2) Guinea pig: FHSA method 5.0-5.25% sol. FAC, Slightly irritant 3) Human: Patch test 0.1-2% sol., Positive 4) Rabbit: FHSA/Draize method, 4.74% sol. FAC, Severely irritant 1,2,4) EU RA Report, 2007 3) IUCLID, 2000

Monochloramine N.A. N.A. Sodium bromate Human: irrita ting Human: irritating HSDB, 2009
1,1,2-Trichloroethane Rabbit: Dr aize test, Highly irritating Rabbit: Draize test, slightly irritating IUCLID, 2000

1,1,2,2-Tetrachloroethane Dog: irritating Guinea pig: Irritating Exposed at 576ppm HSDB, 2005
1,2,3-Trichlorobenzene Rat: irritation Human: irritation at 3-5ppm HSDB, 2004
1,2,3-Trichloropropane Rabbit: Intact and abraded skin irritation test, Slightly irritating Rabbit: Moderately irritating IUCLID, 2000
1,2,4-Trichlorobenzene Rabbit: Slightly irri tating Rabbit: Slightly irritating IUCLID, 2000
2-Chlorotoluene Rabbit: OECD404, Slightly irritating Rabbit: OECD405, No irritating IUCLID, 2000
4-Chlorotoluene Rabbit: slightly irritati ng Rabbit: slightly irritating IUCLID, 2000 Bromobenzene Human: Irritant HSDB, 2003 Bromochloromethane N.A.

Chlorobenzene Rabbit: OECD guide line 404, Moderately irritating Rabbit: OECD guideline 405, Not irritating IUCLID, 2000
cis-1,2-dichloroethene Human: Irritation HSDB, 2003

Dibromochloromethane Rats and mice: Gavage for up to 2 years, No histological alterations Rats and mice: Gavage for up to 2 years, No histological alternations ATSDR, 2005GESAMP-BWWG 12/6 ANNEX 4 Page 36

I:\MEPC\60\2-16.doc Chemical Skin Eye Reference

Dibromomethane N.A. Dichlorobromomethane N.A. Dichloromethane Rabbit: Draize test, High ly Irritating Rabbit: Irritating IUCLID, 2000 Tetrachloroethene Rabbit: Hi ghly irritating Rabb it: Slightly irritating IUCLID, 2000

Tetrachloromethane Rabbit: Dr aize test, Irritating Rabbit: Draize test, Slightly irritating IUCLID, 2000
trans-1,2-dichloroethene N.A.

Trichloromethane Rabbit: Drai ze test, Highly irritating Rabbit: Draize test, Highly irritating IUCLID, 2000

Tribromomethane Human: Irritant (Redness) Human: Irritant (Redness, Pain) MSDS

Trichloroacetonitrile N.A. N.A. Dichloroacetonitrile N.A. N.A. Bromochloroacetonitrile N.A. N.A. Dibromoacetonitrile N.A. N.A. Chloral hydrate N.A. N.A. Chloropicrin N.A. N.A. 2-monochloroacetic acid Human: Extremely haza rdous Human: Extremely hazardous MSDS 2,2-dichloroacetic acid Human: Extremely ha zardous Human: Extremely hazardous MSDS 2,2,2-trichloroacetic acid Human: Ve ry hazardous Human: Hazardous MSDS 2-monobromoacetic acid N.A. N.A. 2,2-dibromoacetic acid Human: Causes burns Human: Causes burns MSDS 2,2,2-tribromoacetic acid N.A. N.A.
2,2-bromochloroacetic acid Human: Causes burns Human: Destructive to tissue of mucous membrane. MSDS
2,2,2-bromodichloroacetic acid N.A
Sodium thiosulfate Human: Slightly hazardous Human: Hazardous MSDSGESAMP-BWWG 12/6 ANNEX 4 Page 37

I:\MEPC\60\2-16.doc 2.4 Repeated dose toxicity

Chemical Exposure route Species Value Reference

Sodium hypochlorite 1) Oral: 90days, dose up to 25mg Cl/kg/d 2) Oral: 13weeks, dose up to 118 mg NaClO/kg/d 1) Rats 2) Rats 1) NOAEL 17-25mg/kg/d 2) Decrease in body

weight gain was observed in both sexes. No histological changes attributable to the
treatment. OECD SIDS, 2004

Mono-chloramine Oral: 90days, dose up to 200 mg/l Mice NOAEL 8.6-9.2 mg/kg/d WHO, 2004

Sodium bromate Oral: 2 weeks, dose 0, 10.8, 54, 108, 270 or 540 mg/kg/d Mice NOAEL 108 mg/kg/d WHO, 2005

1,1,2-Trichloroethane Inhalation: 6 months (5days/week, 7hrs/day) 15ppm(83mg/m 3 ) Rats No histopathological changes observed during
necropsy IUCLID, 2000

1,1,2,2-Tetrachloroethane N.A.

1,2,3-Trichlorobenzene Oral: 90days dose up to 1,000ppm in corn oil Rats High dose groups of treated males had a general trend towards lower wt. gain HSDB,2004

1,2,3-Trichloropropane Oral: 90days dose to 1.5, 7.4, 14.7, 59 mg/kg /d Rats LOAEL 1.5mg/kg/d IUCLID, 2000

1,2,4-Trichlorobenzene Inhalation: 15days (6hrs/day), dose to 0.15mg/l Rats NOAEL 0.15mg/l IUCLID, 2000

2-Chlorotoluene Oral: 90 days (daily), dose to 30, 100, 300 mg/kg/d Dogs NOEL: 300mg/kg/d for female, 100mg/kg/d for male IUCLID, 2000

4-Chlorotoluene Oral gavage: 14days, daily, dose to 200, 600, 1800 mg/kg/d Rats NOAEL 600 mg/kg IUCLID, 2000

Bromobenzene N.A. Bromochloromethane N.A.

Chlorobenzene Inhalation: 24weeks (5days/week, 7hrs/day) dose to 75 or 250ppm Rats Small effect on the food utilization IUCLID, 2000

cis-1,2-dichloroethene Oral gavage: 90days, dose to 32, 97, 290, 870 mg/kg/d Rats NOAEL 32 mg/kg/d ATSDR, 1996

Dibromochloromethane Oral: 14days dose to 0,37,74,147 mg/kg/d Mice NOAEL 37 mg/kg/d. ATSDR, 2005

Dibromomethane Inhalation: 90 days (6hrs/day), dose to 25, 75, 150ppm Rat, dog No gross or histological changes HSDB, 2002

Dichlorobromomethane Oral: 25-30 days, dose to 0, 8, 41, 68 mg/kg/d for male and 0, 14, 72, 116 mg/kg/d for female Rats NOAEL 68 mg/kg/d (M) NOAEL 116 mg/kg/d (F) ATSDR, 2005

Dichloromethane N.A.

Tetrachloroethene Inhalation: 2 weeks (5d/week, 6hr/day) dose to 100, 200, 425, 875, 1750ppm Rats 2/5 males and 3/5 females died at 1750ppm. Body weights reduced (72%) in males at 1750ppm IUCLID, 2000

Tetrachloromethane Inhalation: 90days, dose to 0, 25ppm Rats Fatty change in all livers, and some cirrhosis of the liver observed IUCLID, 2000

trans-1,2-dichloroethene N.A. Trichloromethane N.A.

Tribromomethane (bromoform) 1) Oral: 90 days, dose to 0, 0.65, 6.1, 57 or 218 mg/kg/d (male) and 0, 0.64, 6.9, 55 or 283 mg/kg/d (female) 2) Oral: 13 weeks (5days/week),

dose to 0, 25, 50, 100 or 200 mg/kg/d (rats) and 0, 25, 50, 100, 200 or 400 mg/kg/d (mice) 1) Rats 2) Rats

and mice 1) NOAEL 57 (male), 55 (female) 2) NOAEL 25 (rats), 100

(mice) ATSDR, 2005GESAMP-BWWG 12/6 ANNEX 4 Page 38

I:\MEPC\60\2-16.doc Chemical Exposure route Species Value Reference

Trichloroacetonitrile N.A. Dichloroacetonitrile N.A. Bromochloroacetonitrile N.A. Dibromoacetonitrile N.A. Chloral hydrate N.A. Chloropicrin N.A.

2-monochloroacetic acid 1) Oral: 13 weeks (5d/w) dose to 0, 25, 50, 100, 150 or 200 mg/kg/d 2) Oral: 13 weeks (5d/w) dose to 0,

30, 60, 90, 120 or 150 mg/kg/d 1) Mice 2) Rats 1) NOAEL 100 2) NOAEL 30 EURA RPT.

2,2-dichloroacetic acid 1) Oral: 3 months dose sodium dichloroacetate to 0, 125, 500 or 2000 mg/kg/d 2) Oral: 13 weeks, dose(by

capsule) to 0, 50, 75 or 100 mg/kg/d 3) Oral: 90days, dose(by capsule)

to 0, 12.5, 39.5 or 72 mg/kg/d 1) Rats 2) Beagle

dogs 3) Beagle

dogs 1) LOAEL 125 2) LOAEL 50 3) LOAEL 12.5 WHO, 2005

2,2,2-trichloroacetic acid Oral: 90 days, dose to 0, 4.1, 36.5 or 355 mg/kg/d 1) Rats (male) NOAEL 36.5 WHO, 2004

2-monobromoacetic acid N.A.

2,2-dibromoacetic acid 1) Oral: 13 weeks, dose 0, 125, 250, 500, 1000 or 2000 mg/L 2) Oral: 6 months, dose 0, 20, 72

or 161 mg/kg/d 1) Rats and mice 2) Rats 1) NOAEL 500 (mice), 1000 (rats) 2) NOEL 20 WHO, 2004

2,2,2-tribromoacetic acid N.A. 2,2-bromochloroacetic acid N.A.
2,2,2- bromodichloroacetic acid N.A.

Sodium thiosulfate N.A.

2.5 Chronic mammalian toxicity

Chemical Exposure route Species Value Reference

Sodium Hypochlorite Oral: 12 months, dose up to 100 mg/l Rats Decrease of blood glutathione with 10, 100 mg/l, increase of osmotic fragility after 6 months. In animals exposed for 3 months, the 3H-thymidine incorporation into nuclei of rat kidney and testes in the 100mg/l group was increased. IUCLID, 2000

Mono-chloramine 1) Oral: 2years, dose up to 200mg/l 2) Oral: 2years, dose up to

200mg/l 1) Rats 2) Mice 1) NOAEL 5.2-5.7mg/kg/d 2) NOAEL 9.8-10.6mg/kg/d WHO, 2004

Sodium bromate 1) Dermal: 51weeks (2/week) dose 0.2 ml of KBrO3 solution in acetone (40mg/ml) 2) Oral: 100 weeks, dose 0, 1.1,

6.1, 12.9 or 28.7 mg/kg/d 3) Oral: 100 weeks, 0, 6.9, 32.5

or 59.6 mg/kg/d 1) Mice 2) Rats 3) Mice 1) No skin tumors 2) NOAEL 1.1 3) NOAEL 59.6 WHO, 2005

1,1,2-Trichloroethane NA
1,1,2,2-Tetrachloroethane Oral: 78 weeks (5days/week), dose up to 284 mg/kg/d Mice NOAEL 284 mg/kg/d ATSDR, 2005GESAMP-BWWG 12/6 ANNEX 4 Page 39

I:\MEPC\60\2-16.doc Chemical Exposure route Species Value Reference
1,2,3-Trichlorobenzene N.A. 1,2,3-Trichloropropane N.A. 1,2,4-Trichlorobenzene N.A. 2-Chlorotoluene N.A. 4-Chlorotoluene N.A. Bromobenzene N.A. Bromochloromethane N.A. Chlorobenzene N.A. cis-1,2-dichloroethene N.A.

Dibromochloromethane Oral: 2 years (5days/week) 0, 40, or 80 mg/kg gavage doses Rats LOAEL = 28 mg/kg/d ATSDR, 2005 Dibromomethane N.A.

Dichlorobromomethane Oral: 52weeks, dose to 0, 22, 39 mg/kg/d Rats NOAEL 22 mg/kg/d ATSDR, 2005

Dichloromethane Inhalation: 2years (6hr/day, 5days/week) Rats NOAEL 200ppm IUCLID, 2000

Tetrachloroethene Inhalation: 8-10 months, 3hrs/day, dose to 14.5ppm Rats antibodies to typhoid antigens IUCLID, 2000

Tetrachloromethane Oral: 2years, dose to 80, 200ppm Rats Mortality increased from age 14 months. No treatment-related effects on weight gain, food consumption IUCLID, 2000

trans-1,2-dichloroethene N.A. Trichloromethane N.A.

Tribromomethane (bromoform) 1) Oral (diet) 24 months, 0, 22,

90 or 364 mg/kg/d (male) and 0, 38, 152 or 619 mg/kg/d(females) 2) Oral: 103 weeks (5 days per week), dose to 0, 100 or 200 mg/kg/d

3) Oral: 103 weeks (5 days per week), dose to 0, 50 or 100 mg/kg (male) and 0, 100 or 200 mg/kg (female) 1) Rats 2) Rats 3) Mice 1) NOAEL 22 (male), 38 (female) 2) LOAEL 100 3) NOAEL 100 (male)

NOEL 100 (female) ATSDR, 2005

Trichloroacetonitrile N.A. Dichloroacetonitrile N.A. Bromochloroacetonitrile N.A. Dibromoacetonitrile N.A. Chloral hydrate N.A. Chloropicrin N.A.

2-monochloroacetic acid 1) Oral: 103weeks (5days/week), dose to 0,15, 30 mg/kg/d 2) Oral: 103weeks

(5days/week), dose to 0, 50,

100 mg/kg/d 1) Rats 2) Mice 1) LOAEL=15mg/kg 2) LOAEL=50mg/kg EURA RPT.

2,2-dichloroacetic acid 1) Oral: 75 weeks, dose to 0, 7.6 or 77 mg/kg/d 2) Oral: 100 weeks, dose to 0,

3.6, 40.2 or 139.1 mg/kg/d 1) Mice (male) 2) Rats

(male) 1) NOAEL 7.6 2) NOEL 3.6 WHO, 2005

2,2,2-trichloroacetic acid Oral: 51-82weeks, dose to 0, 78, 262 or 784 mg/kg/d Mice (female) NOAEL 78 WHO, 2004

2-monobromoacetic acid N.A. 2,2-dibromoacetic acid N.A. 2,2,2-tribromoacetic acid N.A. 2,2-bromochloroacetic acid N.A. 2,2,2-bromodichloroacetic acid N.A. Sodium thiosulphate N.A.GESAMP-BWWG 12/6 ANNEX 4 Page 40

I:\MEPC\60\2-16.doc 2.6 Developmental and reproductive toxicity

Chemical Exposure route Species Value Reference

Sodium hypochlorite Oral: 2 1/2 months, daily in drinking water prior to and throughout gestation 1, 10, 100 mg/l Rats Slight decrease of fetal weight and increase of skeletal variants in both high concentration
grou p s, increase of total variations (skeletal and soft tissue) in the high concentration
group. IUCLID, 2000

Mono-chloramine Oral: 66-76days, dose up to 10mg/kg/d Rats NOAEL 10mg/kg/d WHO, 2004

Sodium bromate Oral: 35 days, dose 2.2, 7.7 or 22 mg/kg/d Rats NOAEL 7.7 LOAEL 22 WHO, 2005

1,1,2-Trichloroethane Gavage: Gestationa l days 8 to 12, 350 mg/kg/day Mice Mortality(3/30) in treated mice(0/30 in control group) No effects noted on material weight gain IUCLID, 2000

1,1,2,2-Tetrachloroethane Inhalation: 9 moths (4hrs/day) dose to 2ppm Rats (male) No gross malformations were observed in the offspring HSDB, 2005

1,2,3-Trichlorobenzene Gavage: 6days and 15day of gestation, dose to 150, 300, 600 mg/kg Rats Dams did not exhibit any signs of toxicity HSDB, 2004

1,2,3-Trichloropropane Inhalation: 16 weeks (6hrs/day, 5day/week) dose to 5, 15ppm Rats NOAEL 5ppm IUCLID, 2000

1,2,4-Trichlorobenzene Gavage: Day 9-10 of gestation and section on day 14 of gestation, dose to 36, 120, 360, 1200 mg/kg/d Rats NOAEL 36mg/kg/d IUCLID, 2000

2-Chlorotoluene 1) Gavage: dose to 2700mg/kg 2) Gavage: 95days, dose to

0,5,20,80 mg/kg/d 1) Rats 2) Dogs 1) Microscopically all the males showed a reduction in spermatogenesis 2) No pathological alteration 1) IUCLID, 2000 2) ICHEM, 2001

4-Chlorotoluene Inhalation: 6-28 days of gestation, dose to 1.5, 4.0, 10 mg/l Rabbit Maternal effects higher than 4mg/l IUCLID, 2000 Bromobenzene N.A.

Bromochloro-methane Inhalation: 114days (7hrs/day, 5days/week), dose up to 267 mg/kg/d Guinea Pigs LOAEL 124.29 – 129.53 mg/kg/d EPA/600/8- 91/016, 1990

Chlorobenzene Inhalation: Day 6-15 of gestation (6hrs/day) dose to 0, 75, 210, 590 mg/l Rats NOAEL 210ppm(maternal) NOAEL 590ppm(teratogen) IUCLID, 2000
cis-1,2-dichloroethene N.A.

Dibromochloro-methane 1) Oral: 17, 170 or 685 mg/kg/d 2) Oral: 6-15days of gestation,

gavage dose to 0, 50, 100, 200 mg/kg/d 1) Mice 2) Rats 1) dose (685 mg/kg/d): a marked reduction in fertility, decreases in litter size 2) Maternal weight gain was

significantly decreased at highest dose level HSDB,2006

Dibromomethane N.A.

Dichlorobromo-methane 1) Oral: GD 6-15, gavage (Corn oil) dose 0, 50, 100, 200 mg/kg/d 2) Oral: GD 6-15, gavage dose 0,

25, 50, 75 mg/kg/d 1) Rats 2) Rats 1) NOAEL 100 mg/kg/d 2) LOAEL 25 mg/kg/d ATSDR, 2005

Dichloromethane Inhalation: 7hr s, dose to 1250ppm Rats NOAEL 1250ppm IUCLID, 2000

Tetrachloroethene Inhalation: GD 0-21 (3weeks, 5d/week, 7hrs/day) , dose to 500ppm Rats and rabbits No evidence of material toxicity IUCLID, 2000

Tetrachloromethane Inhalation: 10.5 months, dose to 50, 100, 200, 400ppm Rats Liver cirrhosis observed at 100-400ppm. Dose effect of conceived litters is not observed. IUCLID, 2000
trans-1,2-dichloroethene N.A.GESAMP-BWWG 12/6 ANNEX 4 Page 41

I:\MEPC\60\2-16.doc Chemical Exposure route Species Value Reference

Trichloromethane N.A.

Tribromomethane (bromoform) 1) Oral: GD 6-15, gavage dose to 0, 50, 100 or 200 mg/kg/d 2) Oral: 105 days, gavage dose to 0,

50, 100 or 200 mg/kg/d 1) Rats 2) Mice 1) NOAEL 50 (developmental), 200 (maternal) LOAEL 100 (developmental) 2) NOAEL 100 (developmental /

maternal) LOAEL 200 (developmental / maternal) ATSDR, 2005

Trichloroacetonitrile N.A. Dichloroacetonitrile N.A. Bromochloroaceto-nitrile N.A. Dibromoaceto-nitrile N.A. Chloral hydrate N.A. Chloropicrin Pup NOEL > 1.5ppm HSDB, 2009

2-monochloroacetic acid Oral: gestation days 1 to 22 (GD 1-22), dose to 0 or 193 mg/kg/d Rats NOAEL 193 (developmental) LOAEL 193 (maternal) WHO, 2004

2,2-dichloroacetic acid 1) Oral: GD 6-15, dose to 0, 14, 140 or 400 mg/kg/d (first) and 0, 900, 1400, 1900 or 2400 mg/kg/d(second) 2) Oral: 14 days, dose to 0, 18, 54,

160, 480 or 1,440 mg/kg/d 1) Rats 2) Rats 1) NOAEL 14 (maternal and developmental) 2) NOAEL 18 WHO, 2005

2,2,2-trichloroacetic acid 1) Oral: GD 6-15, dose to 0, 330, 800, 1200 or 1800 mg/kg/d 2) Oral: GD 1-22, dose 0 or 290

mg/kg/d 1) rats 2) rats 1) LOAEL 330 (maternal and developmental) 2) LOAEL 290 (maternal,

reproductive and developmental) WHO, 2004

2-monobromoacetic acid N.A.

2,2-dibromoacetic acid 1) Oral: GD 1-8, dose 0, 62.5, 125 or 250 mg/kg/d 2) Oral: Beginning 14 days prior to

cohabitation and continuing through gestation and lactation (63-70 days of treatment), dose 0, 125, 250, 500 or 1,000ppm 1) Rats (female) 2) Rats 1) NOAEL 125mg/kg 2) NOAEL 66 mg/kg (male), 60

mg/kg (female) WHO, 2004

2,2,2-tribromoacetic acid N.A.

2,2-bromochloroacetic acid Oral: during cohabitation and separated after mating. gestation day 6 to onset of birth (pregnant rats) dose 0, 60, 200 or 600ppm Rats NOAEL 19 mg/kg LOAEL 50 mg/kg WHO, 2004

2,2,2-bromodichloroacetic acid N.A.

Sodium thiosulphate 1) oral gestation days 6 to 15 0, 5.5, 25.5, 118 or 550 mg/kg/d 2) oral gestation days 6 to 15

0, 4, 19, 86 or 400 mg/kg/d 3) oral gestation days 6 to 15

0, 4, 19, 86 or 400 mg/kg/d 4) oral gestation days 6 to 18

highest dose level of 580 mg/kg/d 1 ) mice 2 ) rats 3 ) hamsters 4 ) rabbits 1,2,3,4) No indication of any effect 1,2,3,4) PMEPGESAMP-BWWG 12/6 ANNEX 4 Page 42

I:\MEPC\60\2-16.doc 2.7 Carcinogenicity

Chemical Species Method Details Results Reference

Sodium hypochlorite Mouse Dermal Exposure: 300days >10% effective chlorine sol. No skin tumors, no leukemia. IUCLID, 2000

Mono-chloramine Rats and Mice Oral: 2year bioassays, 0, 50, 100 or 200 mg/l Increases in leukemia incidence in dosed female rats were small and not clearly dose-related. WHO, 2004

Sodium bromate 1) Rats 2) Rats 3) Mice 1) Oral: 104weeks, dose 0, 0.7, 1.3, 2.5, 5.6, 12 or 33 mg/kg/d 2) Oral: 104weeks, dose 0 or

32.3 mg/kg/d 3) Oral: 100weeks, dose 0, 6.9,

32.5 or 59.6 mg/kg/d 1) Significantly increased dysplastic foci in the kidney ( ≥ 1.3 mg/kg/d). 2) Increased dysplastic foci and

renal adenomas 3) Increased renal adenomas and

carcinomas (6.9 mg/kg/d). Not increased renal tumors (32.5 or 59.6 mg/kg/d) WHO, 2005

1,1,2-Trichloroethane Rats Gavage: 78weeks (5days/week), 46-92mg/kg/d No effects were noted on weight gain and mortality. IUCLID, 2000
1,1,2,2- Tetrachloroethane Rats and mice Inhalation: 11 months (3-4 hrs/day), dose up to 14.6ppm Liver damage, involving increased metabolic activity at 14.6ppm HSDB,2005

1,2,3-Trichlorobenzene N.A.

1,2,3-Trichloropropane Rats and mice Gavage: 104weeks (1 injection/day, 5days/week) Dose to 3, 10, 30 mg/kg/d to rats , dose to 6, 20, 60 mg/kg/d to mice Significant lower survival. Lower mean body weight of high dose. IUCLID, 2000

1,2,4-Trichlorobenzene Mice Dermal: 2 years (twice a week), dose to 0.03ml of a 30%, 60% sol. Tumors developed in lung, kidney, stomach, urinary bladder, mammary gland and skin. IUCLID, 2000

2-Chlorotoluene N.A.
4-Chlorotoluene Mice In vitro transformation of cells Negative IUCLID, 2000 Bromobenzene N.A. Bromochloro-methane Human EPA/600/8-87-045 B2, Probable human carcinogen EPA, IRIS

Chlorobenzene 1) Rats 2) Mice 1) Gavage: 103weeks (5days/week) 2 year carcinogenesis 2) Gavage: 103weeks

(5days/week) dose to 30, 60 mg/kg/d(male), 60, 120 mg/kg/d(female) 1) Negative 2) Negative IUCLID, 2000

cis-1,2-dichloroethene Human Not classifiable as to human carcinogenicity EPA, IRIS

Dibromochloromethane 1)Mice 2)Human 1) Positive carcinogenic evidence 2) Not classifiable as to its

carcinogenicity to humans 1)HSDB, 2006 2)IARC, 1991 Dibromomethane N.A.Dichlorobromomethane Rat(M/F) Positive /kidney, Intestine
tumors HSDB,2009

Dichloromethane 1) Rats 2) Mice No data 1) NOEL 5mg/kg 2) NOEL 185mg/kg IUCLID, 2000

Tetrachloroethene Mice Inhalati on: 2 years, 100ppm Liver tumors IUCLID, 2000

Tetrachloromethane Rats Oral: 78 weeks (5times/week), gavage dose to 47, 94 mg/kg male and 80, 160 mg/kg female Neoplastic nodules of the liver occurred IUCLID, 2000
trans-1,2- dichloroethene N.A.

Trichloromethane N.A.GESAMP-BWWG 12/6 ANNEX 4 Page 43

I:\MEPC\60\2-16.doc Chemical Species Method Details Results Reference

Tribromomethane (bromoform) 1) Rats 2) Mice 1) Oral: 103 weeks (5 days per week), gavage dose in oil, 0, 100 or 200 mg/kg/d. 2) Oral: 103 weeks (5 days per

week), gavage dose in oil, 0, 50 or 100 mg/kg/d (male) and 0, 100 or 200 mg/kg/d (female). 1) Increased adenomatous polyps or adenocarcinomas. 2) No statistically significant

increases in the incidence of any neoplastic lesion in any dose group compared to controls. ATSDR, 2005

Trichloroacetonitrile N.A. Dichloroaceto-nitrile N.A.

Bromochloroacetonitrile Mice An increase in the proportion of animals with lung tumors and number of tumors per mouse was observed HSDB,2009

Dibromoaceto-nitrile N.A.

Chloral hydrate Mice Carcinogenic (hepatocellular neoplasia) in the male mouse, but not in the rat HSDB, 2009

Chloropicrin Mice LOAEL 0.5ppm HSDB, 2009

2-monochloroacetic acid 1) Rats and mice 2) rats 1) 2years, dose to 0, 15 or 30 mg/kg/d for rats and 0, 50 or 100 mg/kg/d for mice 2) Oral: 2years, dose to 0, 3.5,

26.1 or 59.9 mg/kg/d No evidence WHO, 2004

2,2-dichloroacetic acid Mice (male) Oral: 61 weeks, dose to 0 or 1000 mg/kg/d An increase in hepatocellular carcinomas was observed in 81% of treated animals WHO, 2005

2,2,2-trichloroacetic acid 1) Mice (female) 2) Rats

(male) 1) Oral: 104 weeks, dose 0, 71 or 583 mg/kg/d 2) Oral: 2 years, dose 0, 3.6,

32.5 or 364 mg/kg/d 1) Liver tumor (adenomas + carcinomas) in the high-dose group, LOAEL 71 2) NOAEL 32.5 WHO, 2004

2-monobromoacetic acid N.A.

2,2-dibromoacetic acid Rats Oral: 2years, dose 0, 50, 500 or 1,000 mg/L Some evidence of carcinogenic activity NTP (2007)
2,2,2-tribromoacetic acid N.A.
2,2-bromochloroacetic acid Rats and mice Oral: 2years, dose 20, 250, 500 or 1,000 mg/L Clear evidence of carcinogenic activity NTP (2008)
2,2,2- bromodichloroacetic acid N.A.

Sodium thiosulphate N.A.

2.8 Mutagenicity/genotoxicity

Chemical Species Method Details Results Reference

Sodium hypochlorite 1) Hamster cells 2) Mice 1) Route: treated for three hours with 0.5 μ g/mL 2) Oral: dose up to 8 mg/kg/day

for 5 days 1) Positive (+S9) 2) Negative OECD SIDS, 2004

Monochloramine 1) Bacillus subtilis 2) Mouse 1) Weakly mutagenic 2) Negative WHO, 2004

Sodium bromate 1) Chinese hamster fibroblasts 2) Mouse bone

marrow cells 1) Chromosomal aberration assay 2) Micronucleus test 1) Increase in the frequency of exchange-type aberrations 2) Increased micronuclei WHO, 2005GESAMP-BWWG 12/6 ANNEX 4 Page 44

I:\MEPC\60\2-16.doc Chemical Species Method Details Results Reference
1,1,2- Trichloroethane N.A.
1,1,2,2-Tetrachloroethane N.A.
1,2,3- Trichlorobenzene N.A.

1,2,3- Trichloropropane 1) Bacterial Mammalian cell 2) Mice 1) Gene conversions 2) Oral: dose up to 120 mg/kg/d 1) Positive. 2) The average estrous cycle

length was significantly increased for all 1,2,3- trichloropropane-exposed females of the F1 generation, with the lowest dose being 30 mg/kg/d ICHEM

1,2,4- Trichlorobenzene Salmonella typhimurium Ames test 1-5 ul/plate Negative IUCLID, 2000

2-Chlorotoluene Bacterial Mammalian cell In vitro No mutagenic activity ICHEM. 2001

4-Chlorotoluene Salmonella typhimurium Ames test 7 doses of 0.02-1.17ul per plate Negative IUCLID, 2000

Bromobenzene Chinese hamster ovary cell In vitro chromosomal Dose: 50, 160, 500 ug/ml Negative CCRIS, 2006

Bromochloromethane N.A.

Chlorobenzene 1) Mice 2) Drosophila

melanogaster 1) Cytogenetic assay IP: single, dose up to 1000mg/kg 2) Inhalation: 4hrs, dose to

900ppm 1) Positive only one of two series with 1000 mg/kg 2) Negative IUCLID, 2000

cis-1,2- dichloroethene Humans or animals Non-positive results EPA, IRIS

Dibromochloromethane Mice Positive mutagenicity data HSDB, 2006

Dibromomethane N.A.Dichlorobromomethane N.A.

Dichloromethane N.A. Tetrachloroethene N.A.Tetrachloromethane Rats Inhalation: 300-1000ppm No teratogenicity IUCLID, 2000
trans-1,2- dichloroethene N.A.

Trichloromethane N.A. Tribromomethane (bromoform) N.A.

Trichloroacetonitril

e N.A.

Dichloroacetonitrile 1) S. typhimurium 2) S.

cerevisiae. 1) Mutagenic 2) Not mutagenic HSDB, 2009

Bromochloroacetonitrile N.A.

Dibromoacetonitrile Salmonella typhimurium Ames fluctuation test No muta genic effect was found HSDB, 2009

Chloral hydrate Salmonella typhimurium Mutagenic HSDB, 2009

Chloropicrin 1) mouse lymphoma 2) Rabbits 1) 0.038-16 nl/ml 1) Did not induce a mutagenic 2) NOAEL 0.4ppm (maternal)

NOAEL 1.2ppm (developmental) HSDB, 2009GESAMP-BWWG 12/6 ANNEX 4 Page 45

I:\MEPC\60\2-16.doc 2.9 Toxicokinetics

Chemical Results

Sodium bromate Bromate is rapidly absorbed from the gastrointes tinal tract, at least in part unchanged. It is distributed throughout the body appearing in plas ma and urine unchanged and in other tissues as bromide. Bromate is reduced to bromide in several body tissues, probably by GSH or other sulfhydryl-containing compounds. Most bromate is ex creted in the urine, either as bromate or bromide, but some may leave the body in the feces. Bromine has been detected in adipose tissue of mice following long-term treatment with bromate.

Monochloramine In rats, the oral route is rapidly and readily absorbed from the gastrointestinal tract. In humans, most of the monochloramine from drinking-water would reach the stomach intact but would rapidly decay in stomach fluid.

Bromochloromethane Bromochloromethane is rapidly absorbed by rats in biphasic manner following acute inhalation exposure, but quantitative data ar e not available regarding the extent of inhalation exposure or the rate or extent of oral exposure. There appe ars to be some distribution of bromide to the brain of dogs during subchr onic inhalation exposure.

Monochloroacetic acid monochloroacetic acid is rapidly absorbed and systemically distributed following direct skin contact covering at least 10% of the skin surface.

Dichloroacetic acid Dichloroacetic acid is rapidly absorbed into the bloodstream from the gastrointestinal tract in rats and mice and via both the oral and dermal routes in humans. Dichloroacetic acid is dechlorinated to glyoxylate and then oxidized to oxalate, all of which are excreted in the urine. Transamination of glyoxylate forms glycine an d can distribute the label from dichloroacetic acid to urinary glycine conjugates, such as hippuric acid. In rats, dogs, and humans given single doses of sodium dichloroacetate intrav enously, average half-lives of the parent compound in plasma were 2.97, 20 .8, and 0.43 h, respectively.

Trichloroacetic acid Trichloroacetic acid is rapidly absorbed from the ga strointestinal tract in rats and by both the dermal and oral routes in humans. Trichl oroacetic acid was metabolized by reductive dehalogenation to dichloroacetic acid. Further re ductive dehalogenation of dichloroacetic acid to monochloroacetic acid and ul timately to thiodiglyc olate has been proposed as a metabolic pathway. The mean elimination half-life of trichloroacetic acid in urine was 45.6 h in humans, compared with 11.0 h in rats, suggesting that elim ination of trichloroacetic acid in rats is more rapid.

Bromochloroacetic acid Bromochloroacetic acid was systemically abso rbed following gavage dosing, with peak concentrations in blood occurring 1.5 h after dosi ng. The oral bioavailability was estimated to be 47%.

Monobromoacetic acid No studies of the absorption, distribution, metabolism or excretion of monobromoacetic acid have been identified in the literature.

Dibromoacetic acid Following gavage exposure in rats, the concentr ation of dibromoacetic acid in blood peaked within 1 h after dosing, suggesting rapid intest inal absorption. The oral bioavailability of dibromoacetic acid was estimated to be 30%. Dibromoacetic acid metabolites appear to be rapidly excreted, and dibromoace tic acid does not exhibit ev idence of bioaccumulation.GESAMP-BWWG 12/6 ANNEX 4 Page 46

I:\MEPC\60\2-16.doc 3 DATA ON ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

3.1 Modes of degradation (biotic; abiotic)

3.1.1 The Group noted the information shown in the table below which was mainly from National Institute of Technology and Evaluation database.

Biodegradation for Relevant Chemicals

Chemical Biodegradation Results Reference

Sodium bromate N.A. Sodium thiosulphate N.A.
1,1,2-Trichloroethane 28days, MITI-I(OECD TG 301C) Non-biodegradability GC 5% NITE Database

1,1,2,2-Tetrachloroethane 28days, MITI-I(OECD TG 301C) Non-biodegradability TOC 0%, GC 10% NITE Database

1,2,3-Trichlorobenzene 2weeks, MITI-I(OECD TG 301C) Non-biodegradability BOD 0%, GC 0% NITE Database

1,2,3-Trichloropropane 4weeks, MITI-I(OECD TG 301C) Non-biodegradability BOD 0%, GC 8% NITE Database
1,2,4-Trichlorobenzene Activated sludge, Aerobic=56% after 5day IUCLID, 2000 2-Chlorotoluene Activated sludge 10mg/l, Aerobic=0% after 28day IUCLID, 2000 4-Chlorotoluene MITI-I(OECD TG 301C) Non-biodegradability NITE Database Bromobenzene MITI-II(OECD TG 302C) N on-biodegradability NITE Database Bromochloromethane MITI-I(OECD TG 301C ) Non-biodegradability NITE database Chlorobenzene MITI-II(OECD TG 302C) N on-biodegradability NITE database cis-1,2-dichloroethene MITI-II(OECD TG 302C) Non-biodegradability NITE database

Dibromochloromethane Aerobic, a static flask screenin g procedure and incubation 28 days, 25-39% loss HSDB,2006

Dibromomethane No significant biotic or abiotic degr adative processes have been reported in natural waters or soil. HSDB,2002

Dichlorobromomethane Aerobic, a static flask screeni ng procedure and incubation 28days, 51-59% loss HSDB,2009
Dichloromethane MITI-I(OECD TG 301C) Non-biode gradable BOD 13% GC 1% NITE database Tetrachloroethene MITI-I(OECD TG 301C) Non-bi odegradable BOD 11% GC 0% NITE database

Tetrachloromethane 2weeks(MITI-I(OECD TG 301C) Non-biodegradability BOD 0% TOC 0% NITE database
trans-1,2-dichloroethene Closed Bottle Test(OECD TG 301D) Non-bi odegradable BOD 0% NITE database

Trichloromethane MITI-I(OECD TG 301C) Non-biodegradable BOD 0% GC 4.6% 2weeks NITE database
Tribromomethane MITI-I(OECD TG 301C) Non-bi odegradable GC 0% 4weeks NITE database

Trichloroacetonitrile It is a by-product of water chlorina tion and hydrolyzes quickly, therefore biodegradation is not expected to be an important fate in the environment. HSDB, 2009

Trichloroacetonitrile It is a by-product of water chlorina tion and hydrolyzes quickly, therefore biodegradation is not expected to be an important fate in the environment. HSDB, 2009

Bromochloroaceto-nitrile It is a by-product of water chlorina tion and hydrolyzes quickly, therefore biodegradation is not expected to be an important fate in the environment. HSDB, 2009

Dibromoaceto-nitrile It is a by-product of water chlorina tion and hydrolyzes quickly, therefore biodegradation is not expected to be an important fate in the environment. HSDB, 2009

Chloral hydrate Biodegradation data for chloral hydrate were not available HSDB, 2009

Chloropicrin MITI-I(OECD TG 301C) Non-biodegradable GC 4% BOD 0% TOC 0%, 4weeks Anaerobic, activated sludge inoculums at 20 °C : Aerobic biodegradation rate: 1.5/day Half-life: 0.46day NITE database HSDB2009

2-monochloroacetic acid MITI-I(OECD TG 301C) Ready biodegradable GC 100% BOD 65% TOC 99.8% 3weeks NITE DatabaseGESAMP-BWWG 12/6 ANNEX 4 Page 47

I:\MEPC\60\2-16.doc Chemical Biodegradation Results Reference

2,2-dichloroacetic acid MITI-I(OECD TG 301C) Ready biodegradable HPLC 100% BOD 97% TOC 94% 2weeks NITE Database

2,2,2-trichloroacetic acid MITI-I(OECD TG 301C) 4weeks, Non-biodegradable BOD 7%, TOC 42% NITE Database

2-monobromoacetic acid MITI-I(OECD TG 301C) 3weeks, Readily biodegradable BOD 65%, GC 100%, TOC 99.8% NITE Database

3.1.2 The Group noted that the applicant had i ndicated that TRO, sodium hypochlorite and sodium hypobromite are rapidly degraded in na ture and they are not considered to be bio-accumulated on aquatic organisms.

3.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

3.2.1 The bioaccumulation factors (BCF s ) and octanol-water partition coefficient (K ow s) for the Active Substances and Relevant Chemicals are listed in Table 5.4 of section 5.1.5. The adsorption coefficients (K oc s) for the Active Substances and Relevant Chemicals are given in section 5.1.4.

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

Because of low Log P ow and no bioavailability, there was no report on persistence and identification of main metabolites in Active Subs tance. For Relevant Chemicals, the Level III Fugacity models of the EPI suit v.4.0 uses thr ee environmental compartm ents (water, soil, and sediment) to determine the persistence of a chemical in the environment. It has estimated that any chemical is expected to be found predominantly in any compartment and its persistence estimate is based on its transformation in this medium (h alf-life). The persistence of the above by-products is given in sections 5.1, 8.1 and 8.2.

3.4 Reaction with organic matter

When natural organic matter is treated with hypochlorite species (HOCl, OCl), high molecular weight chlorinated compounds form in the first st ep that is followed by the cleavage of benzene rings into trihalomethanes and haloacetic acids. For most of Relevant Chemicals, there is no accumulation through aquatic organisms. And there is no information which is available on reaction with organic matter by Relevant Chemicals.

3.5 Potential physical effects on wildlife and benthic habitats

No data were available for potential physical e ffects on wildlife and benthic habitats. Most of Active Substances and Relevant Chemicals have low K ow and BCF values. Therefore, effects on wildlife and benthic habitats by treated ballast water w ould be expectedly low.

3.6 Potential residues in seafood

For Active Substances and Relevant Chemicals, th ere is no potential concen tration of food chain. Due to low K ow and BCF values, it is unlikely that these will be accumulated through the food chain.GESAMP-BWWG 12/6 ANNEX 4 Page 48

I:\MEPC\60\2-16.doc 3.7 Any known interactive effects

There is no study of interactive effects on Ac tive Substances and Relevant Chemicals.

3.8 Physical and chemical properties for th e Active Substances and Relevant Chemicals (G9: 4.2.1.4)

The physical and chemical properties for the Ac tive Substances and Relevant Chemicals are briefly described in Table 5.14 and detail ed in appendix 4 “Chemicals data-set”.

Table 5.14 : Physical and chemical pr operties for the Active Substances and Relevant Chemicals

Chemical MP BP FA DE VP VD WS DC CM AT Sodium hypochlorite 18 96 Non 1210 1740 • 293000 • Y Non

Monochloramine • • • • • • • • • •
Sodium bromate 381 1390 381 3339 5.6E-16 • 364000 • • • 1,1,2-trichloroethane -35 113 Non 1.44 225 4.21 4400 • Y 460 1,1,2,2-Tetrachloroethane -43. 8 146.5 Non 1595 615.95 5.79 2900 • Y Non

1,2,3-Trichlorobenzene 53.5 218.5 112.7 1453.3 28 6.26 18 • • • 1,2,3-trichloropropane -14. 7 156.85 180 1388.9 492 5.1 1750 • • 304 1,2,4-Trichlorobenzene 17 213.5 105 1459 21.5 6.26 19 • • 571
2-Chlorotoluene -35.59 158.97 49 1082.6 350 • 374 • • •
4-Chlorotoluene 7.5 162.4 49 1069.7 374 4.37 106 • • 595
Bromobenzene -30.6 156.2 51 1495.2 557.3 5.41 410 • • 565
Bromochloromethane -87.9 68 Non 1934.4 18932 • 16700 • Y Non
Chlorobenzene -45.2 131.7 29.2 1105.8 1200 3.88 502 • Y 638 Cis-1,2-dichloroethene -80 60.1 2.2 1283.7 23998 3.54 6410 • • 460
Dibromochloromethane -20 121.3 Non 2451 10133 • 2700 • • Non
Dibromomethane -52.5 97 N on 2496.9 5866.2 6.05 11900 • Y Non
Dichlorobromometane -57 90 Non 1980 666.1 • 3968 • • Non

Dichloromethane -95 39.75 Non 1326 7653 2.93 13700 • • 605
Tetrachloroethene -22.3 121.3 Non 1620 1900 5.7 160 • Y Non
Tetrachloromethane -23 76.8 Non 1594 11940 5.32 793 • • •

Dichloroethene -49.8 48.7 2.2 1257 44129 3.67 6300 • • 460
Trichloromethane -63.4 61.17 Non 1476 20829 4.12 8000 • Y Non
Tribromomethane 8.69 149.1 Non 2879 718.9 8.7 3100 • Y •
Trichloroacetonitrile -42 85.7 195 1440 9879 • 715 • • •
Dichloroacetonitrile • 112 • 1369 376 • 33500 • Y •
Bromochloroacetonitrile • 138 • 1680 121.7 • 18700 • • •

Dibromoacetonitrile • 68 • 2296 40.13 • 9600 • • •

Chloral hydrate 57 96 • 1908 1999 5.1 793000 • • •

Chloropicrin -64 112 Non 1645 3200 5.7 1620 • Y •
2-monochloroacetic acid 63 189.3 126 1370 8.7 3.26 860000 2.85 Y 500 2,2-dichloroacetic acid 9.7 194 • 1563 23.9 4.45 1.0E+6 1.26 • • 2,2,2-trichloroacetic acid 57.5 195.5 Non 1613 8 • 54000 0.51 • •
2-monobromoacetic acid 49 208 113 1934 15.9 • 1.8E+6 2.89 • • 2,2-dibromoacetic acid 48 232 113 • 3.07 • 2.1E+6 1.48 • • 2,2,2-tribromoacetic acid 129 245 • • 0.037 • 200000 0.72 • • 2,2-bromochloroacetic acid • 215 110 1985 18.7 • 250000 1.40 • • 2,2,2-bromodichloroacet ic acid • • • • 4.8 • 4900 0.72 • • Sodium thiosulphate 48.3 100 Non 1667 • • 209000 • • •GESAMP-BWWG 12/6 ANNEX 4 Page 49

I:\MEPC\60\2-16.doc Note: MP : Melting Point, °C BP : Boiling Point, °C FA : Flammability(Flash point for liquids, °C ) DE : Density, kg/m 3 VP : Vapour Pressure, Pa VD : Vapour Density, Pa WS : Water solubility, mg/l DC : Dissociation Constant, pKa CM : Corrosivity to the Materials or equipment of normal ship Construction, Yes/No Details in appendix 4 AT : Autoignition Temperature Non : Non-Flammable • : No available data

3.9 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5)

Procedures for sampling, transferring and analysis methods are described in detail in appendix 2 (QAPP by KTR).

***GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc ANNEX 5

REVIEW OF PROPOSALS FOR APPRO VAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

Kwang San Co., Ltd. (KS) Ballast Wat er Management System “En-Ballast”

Submitted by the Republic of Korea for Basic Approval

0 SUMMARY

0.1 Having considered all of the data provide d by the applicant, the Group recommended that Basic Approval be granted to the En-B allast Ballast Water Management System.

0.2 The Group noted that the En-Ballast system comprised a filtration stage followed by electrolysis which generates oxidants, primarily sodium hypochlorite, in a sidestream off the main ballast water piping. The oxidants are then passed through a gas- freeing tank and then injected back into the ballast water in a cont rolled manner to disinfect it. Any excess oxidants would be neutralized with sodium thiosulpha te during discharge of the ballast water.

0.3 The Group noted that no corro sion tests had been carried ou t but would be available for consideration in the application for Final Approval. The Group i nvited the applicant to consider the guidance provided in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

0.4 Having noted that hydrogen gas is generate d, during electrolysis , and is vented to atmosphere and that a suitable monitoring and control systems is to be put in place to ensure that the concentration does not reach the Lower Explosive Limit, the Group was satisfied that the risks associated with hydrogen could be mitigated to an acceptable level by such controls.

0.5 The Group also noted that the applicant had st ated that there would be no risk to human health from the chemicals associated with the syst em as the ship’s personn el would not come into contact with it. As a result, no human risk as sessment had been carried out for the crew. The Group could not agree with this assumption as there will always be a risk of equipment break-down and leakage, especially as the TRO concentration produced by the electrolyser is considered to be high at 500-2000 mg/L. Furthermor e, the risks associated with the loading and mixing of the neutralizer chemical, sodium thiosulphate, requires proper assessment with appropriate risk mitigation measures and procedures to be put in place and clearly detailed in the system operating manual. The Group recommended that these basic operational concerns be fully addressed in any app lication for Final Approval.

0.6 The Group noted that the applicant had not provided information regarding the identification and description of the unit operations associated with this system. The Group also noted that information regardi ng the Human Exposure Scenario (MEPC 56/2/2, annex 9) was not provided. Therefore, the risks to the crew coul d not be quantified because the potential exposure situations had not been id entified by the applicant.

0.7 The Group noted that the applicant had carri ed out a risk assessment for the general public based on the MOS approach. The calcula ted MOS values, provided, were found to be considerably higher than the MO Sref (100) and therefore no unacc eptable risk was anticipated.GESAMP-BWWG 12/6 ANNEX 5 Page 2

I:\MEPC\60\2-16.doc 0.8 The Group noted the environmental risk assessment carried out by the applicant. However, it was noted that the applicant had not performed the MAMPEC calculations correctly. The load of the system into the receiving harbour , as reported in the do ssier, was not correct (a factor of 1000 too low) and the degradation of the substances was not converted to the correct unit (a half-life in days results in a rate in d -1 (k = ln(2)/DT50).

0.9 Consequently, the PEC and PEC/PNEC results , as calculated by the applicant, were not accepted by the Group. However, a recalculation with the correct inpu t values for MAMPEC still resulted in PECs and PEC/PNEC values that did not show any unacceptable risk to the environment.

0.10 The Group noted that there would be no unaccep table risk associated with this system providing that the neutralization step is perf ormed adequately during every ballast water discharge. However, the Group noted that the control scheme for maintaining the MADC of TRO using TRO sensors were still under developmen t. In an application for Final Approval the neutralization control system shoul d be fully documented to give confidence in its reliability.

0.11 Notwithstanding those observations made in this report, the Group would like to draw attention to the following specific points to be addressed in the applica tion for Final Approval:

.1 the results of corrosion testing, as propos ed, should be included in the application for Final Approval, taking into consid eration the Group’s recommendation for comprehensive testing;

.2 monitors and failsafe systems should be put in place, as indicated by the applicant in response 3 in section 4, to ensure that the levels of hydrogen and chlorine to not reach dangerous concentrations;

.3 a comprehensive risk assessment for th e crew and the general public should be carried out to cover various exposure scenarios;

.4 the required chronic toxicity test re sults, in accordance with Procedure (G9), should be provided, as it was missing in the application for Basic Approval; and

.5 the TRO sensors’ sensitiv ity, reliability and its use in the neutralizer control should be confirmed as being appropri ate to maintain the MADC of TRO.

0.12 In addition to the specific points made above, the Group recommended that all of the concerns addressed in this report be taken into consideration pr ior to making an application for Final Approval.GESAMP-BWWG 12/6 ANNEX 5 Page 3

I:\MEPC\60\2-16.doc 1 INTRODUCTION

1.1 Data used to evaluate this system we re extracted from ME PC 60/2/7 and were supplemented by additional info rmation provided to the Group.

2 DESCRIPTION OF THE SYSTEM

2.1 The Group noted that the En-B allast system comprises:

.1 an automatic back-flush filtration (50μm) module;

.2 an electrolysis unit which generates, primarily, a high concentration of sodium hypochlorite (500- 2000 mg/L of TRO) whic h is then injected in to the ball ast water;

.3 a neutralization module which neutralizes the treated ballast water, with sodium thiosulphate, prior to its discharge to the sea; and

.4 a control system which monitors the TRO being produced, controls the amount of electrolysis, to ensure dosage TRO levels of 7 mg/L and controls the amount of sodium thiosulphate being added to the ballast water during di scharge to ensure that the TRO concentrati on is kept below 0.2 mg/L.

2.2 A schematic representation of the system, as supplied by the appli cant is shown below:

2.3 The Group noted that 500-2000 mg/L of TRO, as chlorine, are generated by electrolysis in the form of a solution which is in jected into the ballast water main.

2.4 The TRO dosage concentration is controlled to a level of 7 mg/L in the ballast water to ensure adequate disinfection.

2.5 In addition, the Group noted, with re spect to the control scheme, that:

.1 a conductivity sensor, installed at the head of the electrolysis module, is used to set the electric current magnitude of the rectifier;GESAMP-BWWG 12/6 ANNEX 5 Page 4

I:\MEPC\60\2-16.doc .2 an online TRO sensor, installed at the e nd of the electrolysis module, is used to control the electric current ma gnitude of the rectifier during ballasting to maintain the level dosage level 7 mg/L TRO;

.3 a flow-rate transmitter is used to control the electric current magnitude of the rectifier in proportion to the flow-rate; and

.4 pressure transmitters, installed at the in let of the filtration module and at the outlet of the electrolysis module, are used to measure any pressure drop so that appropriate controls may be applied.

2.6 However, the Group noted that the applicant had indicated that the intended TRO sensor was not suitable for use with seawater and that an alternative TRO sensor was to be used in this system. The Group recommended the sensor, eventual ly selected, be verified as appropriate for the application intended.

2.7 It was also noted that th e applicant indicate d that the hydrogen and chlorine gases generated as part of the electrolys is process are to be safely vent ed to the open deck with a degas blower.

3 CHEMICALS ASSOCIATED WITH THE SYSTEM

3.1 The Group noted that the En-Ballast system produces:

.1 free chlorine in the form of hypochlo rous acid (HOCl) in equilibrium with hypochlorite ion (OCl - );

.2 hypobromous acid (HOBr in equilibrium with hypobromite ion (OBr - );

.3 chloroamines and bromines; and

.4 free hydroxyl radicals which are very short lived and so did not need to be considered further for risk assessment.

3.2 It was also noted that the applicant rega rded these as Active Substances and, when considered as a whole, could be grouped as Total Residual Ox idants (TRO) and Free Residual Oxidants (FRO).GESAMP-BWWG 12/6 ANNEX 5 Page 5

I:\MEPC\60\2-16.doc 3.3 Concentrations of TRO and FRO, found by the applicant, are shown in the table below:

Concentrations of Free Residual Oxidant (FRO) and Total Residual Oxidant (TRO)

Salinity 35 PSU 23 PSU FRO 3 TRO 3 FRO 3 TRO 3 Time MDL (mg/L) 0.05 0.2 0.05 0.2 Test water 1 ND ND ND ND Control ND ND ND ND Electrolyzer 180.00 460.0 280.00 495.0 Day 0

Treated 3.00 4.1 2.80 5.2 Control ND ND ND ND Day 1 Treated 1.40 2.3 1.00 1.8 Control ND ND ND ND Treated 0.80 1.4 0.15 0.25 Day 5 Treated after neutralization < 0.05 < 0.2 NA 2 NA 2

1 Test waters including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8). 2 The water is not neutralized because th e concentration of TRO is <0.25 mg/L. 3 FRO was measured by method using the ortho-tolidine and TRO was measured by the method using DPD ( N,N -diethyl-p-phenylenediamine).

3.4 The Group noted that FRO was measured by the method using the or tho-tolidine, which had been supplanted by other methods using DP D because of its carcinogenic properties. From the view point of GHS, the Group invited to the a pplicant and test facility not to use the method using the ortho-tolidine anymore even if it is still in common on domestic standards.

3.5 The Group noted that during th is initial testing, neutralization was deemed unnecessary for a discharge concentration of 0.25 mg/L TR O. The Group recommended that an MADC for TRO of 0.20 mg/L or lower should be maintained at all times to gain acceptance for Final Approval.

3.6 In addition to the Active Substances, the resu lts from the analysis of Relevant Chemicals in ballast water are shown in appendix 1.

3.7 From the results shown in the tables in appendix 1, th e Group noted that thirty-two compounds were detected in test water, contro l water and treated water. Of these, those identified as being produced by the En-Ballast BWMS were the subject of further risk
assessment.

3.8 In addition to the Relevant Chemicals iden tified, the Group noted th at the applicant had also identified the following “Other Chemicals”:

.1 Ozone;

.2 chlorine dioxide; and

.3 sulphide.GESAMP-BWWG 12/6 ANNEX 5 Page 6

I:\MEPC\60\2-16.doc 4 QUESTIONS PUT TO THE APPLI CANT WITH RESPONSES AND THE GROUP’S REACTION

4.1 Questions raised pr ior to the meeting

4.1.1 The following questions were pu t to the applicant and their responses are shown together with the Group’s reactions.

Question 1 In section 7.4 of their a pplication (Human Exposure Scenario), there is a table showing the potential exposure to various ch emicals which is used to calculate the MOS.

Please could you provide details of how the exposure was calculated and, if possible, could you pr ovide a worked example for one of the chemicals e.g., tribromomethane.

Response 1 We calculated MOS according to GE SAMP-BWWG 3/9 (MEPC 56/2/2, annex 9, 2007).

In case of tribromomethane, assuming th at the exposure of a human population in drinking water is 0.232 mg/L, obtained from the treated water analysis result, for 60 kg person consuming on average 2 L of water/day.

And LOAEL of tribromomethane is 100 mg/kg/day in mice. Therefore we can calculate MOS on the followed equation.

Then, we obtain 12,931, MOS value of tribromomethane.

Reaction 1 The Group noted this response.

Question 2 In paragraph 7.2 of the submission (Risks to human health), it is stated that “ship’s personnel would not be expected to co ntact Active Substances and Relevant Chemicals under normal operation”. Howeve r, this does not take account of the following situations:

.1 Entering the ballast tank post discharge;GESAMP-BWWG 12/6 ANNEX 5 Page 7

I:\MEPC\60\2-16.doc .2 Sampling operations and other un it operations which might bring personnel into contact with the treated ballast water;

.3 Accidental exposure due to equipment malfunction.

Please could you explain why these s ituations were not addressed in your application.

Response 2 There are no gases in the tr eated water. Therefore, toxi cities and risks to the ship’s crews and other inte rested persons from gas expo sure would not be expected.

Table 1 shows the margin of safety (MOS) with maximum concentration in the “En-Ballast” BWMS.

These MOS value are s ubstantially higher than th e MOSref (100), except for chloropicrin, and we expect that crews a nd other interested persons will not have any harmful effects on accidental exposure.

Since we selected the highest concentrations obtained from the electrolyzer’s chemical analysis, MOS value of chlor opicrin is lower than the MOSref.

While the MOS values for the electroly zer’s products are lower than MOSref, the MOS value for the treated water is higher th an MOSref. Therefore, we expect that chloropicrin can cause toxicity to human when exposed to water through immediate electrolysis.

Chloropicrin is a hazardous and colourless liquid with intensely irritating tear gas odour. This may cause severe eye irritati on with corneal injury which may result in permanent impairment of vision, even blindness. It also causes painful irritation of the eyes at 1 ppm or less and a concentration of 15 ppm for longer than 1 minute is intolerable to humans. Chloropicrin may cause severe skin burns and is classified as corrosive according to DOT guidelines. Chloropicrin is also toxic to fish and othe r aquatic organisms.

In the event of accidental exposure, immedi ately evacuate the area of spill or leak. Use a NIOSH/MSHA approved self-contai ned breathing apparatus and other appropriate personal protective equipment fo r entry into affected area to correct problem. Move leaking or damaged containe rs outdoors or to an isolated location, observing strict safety precautions. Wo rk upwind if possible. Allow spilled material to evaporate or absorb onto vermiculite, dry sand, earth or similar absorbent material which may be disposed of on site, or at an approved disposal facility. Do not permit entr y into spill area or cleanup area by unprotected persons until concentration of chloropicrin is determined to be less than 0.1 ppm.

If sampling operations and other unit ope rations which might br ing personnel into contact with the treated ballast water, personnel should wear protective clothing. Open the container only in a well-ventila ted area wearing protective clothing and respiratory protection if necessary.

Avoid eye, skin and clothing cont act. Do not breathe mist or vapour.GESAMP-BWWG 12/6 ANNEX 5 Page 8

I:\MEPC\60\2-16.doc Reaction 2 The Group was satisfied with this response.

Question 2.1 With regard to question 2, perhaps I made a mistake in referring to gases in the air above the ballast water. What I meant to refer to were those chemicals produced in the ballast water, as a result of trea tment, which then partition out into the air above. These are the vapours which the crew could be exposed to in the event of having to enter the tank.

Response 2.1 Hydrogen gas – As a side reaction of electro-chemical production of chlorine, hydrogen gas is produced on cat hode of electrolytic cell.

Hydrogen gas is removed by air blowers of electrolysis module before the treated ballast water enters ballast tank and so there is little hydrogen gas in ballast tank.

Chlorine gas – As a side reactio n of electrochemical production of chlorine, chlorine gas is produced on anode of elect rolytic cell. However, chlorine gas produced during electrolysis is removed by air blowers before the treated ballast water enters ballast tank.

When the treated ballast water cont aining hypochlorous acid and hypochlorite is exposed to the atmosphere, liquid chlori ne in the treated water vaporizes to chlorine gas. So chlorine gas may exist in ballast tank after de-ballasting operation.

Chlorine gas has an irritating odour and is harmful if inhaled, respiratory tract burns, skin burns and eye burns. The r ecommended exposure limits of chlorine gas are; TLV (threshold limit value) as TWA (time weighted average) is 0.5 ppm, as STEL(short term exposure limit) is 1 ppm.

It is recommended that the MSDS of chlorine gas is supplied to manage safe handling.

In the event of having to enter the ballast tank, the chlorine gas in ballast tank should be diluted and vented out by gas freeing fan.

Also crews should put on goggles , rubber shoes, glove, respirator.

Reaction 2.1 The Group noted this response.

Question 3 In your application, reference is made to hydrogen gas being produced and that this is diluted and vented to atmos phere to keep the concentration <1%.

Please could you tell me how the con centration of hydrogen is monitored to ensure that levels are kept safe.

Is there any sort of shut-dow n facility should the levels rise.

Response 3 During electrochemical process, hydrogen is generated as a by-product on cathode of electrolytic cell. Hydrogen is highly explosive, it is should be removed as soon as possible when it is generated. The El ectrolysis module has air blowers which blows the air into th e NaOCl storage tank.GESAMP-BWWG 12/6 ANNEX 5 Page 9

I:\MEPC\60\2-16.doc Hydrogen accumulated in NaOCl storag e tank is diluted by air blowing and vented overboard by internal pr essure of NaOCl storage tank.

We can select the capacity of the air blow ers because it is possible to calculate the volume of hydrogen gas generate d during electrolysis process.

A hydrogen concentration sensor will be equipped on ventilation pipe to monitor the concentration of the hydrogen gas. If the concentration of hydrogen gas is between 1~3%, En-Ballast system gives th e alarm, and if the concentration of hydrogen gas is over 3%, then En-Ba llast system is to shut down.

Blowers are not applied in lab scale En-Ballast for Basic Approval because lab-scale En-ballast is very small scale. However, we will apply air blowers for dilution of hydrogen in land-based “En-Ballast” for Final Approval.

If the parts of En-Balla st system such as electrol yzer, connection piping, NaOCl storage tank and pumps are damaged by mechanical defect, hydrogen can leak out, so hydrogen gas detector should be installed to detect leakage of hydrogen.

When hydrogen gas detector detects th e leakage the hydroge n gas, En-Ballast system should be automatically shut down and would be isolated from main ballast line by emergency isolation valves.

Reaction 3 The Group were satisfied with this response.

Question 4 In tables 20 and 21 of your submission to IM O, there is a reference to “sulphide”. I cannot see where this chemical comes from. Should it be a reference to sodium thiosulphate? If not, where does the sulfide come from?

Response 4 Sulphide rarely exists in natural seaw ater. Also sulfide doesn’t come from Sodium thiosulphate as neutralizing agen t. Meanwhile, a high portion of sulphide in the seawater may be responsible for metal corrosion.

Refer to the following:

“Many metal sulphides are so insoluble in water that they are probably not very toxic. But dissolved free sulphides (S -2 , H 2 S and HS - ) are very aggressive species for the corrosion of many metals such as steel, stainless steel, and copper. Sulfides present in aqueous solution are responsible for stress corrosion cracking (SSC) of steel. Also, micr obially-induced corrosion (M IC) or biogenic sulphide corrosion are also caused by sulfate re ducing bacteria producing sulphide.”

We made efforts to analyze as many kinds of chemicals as possible. Sulfide was only one of the chemicals to be analyzed. As shown in tables 20 and 21, sulfide was not detected in the result of chemical substances analysis.

Reaction 4 The Group were satisfied with this response.GESAMP-BWWG 12/6 ANNEX 5 Page 10

I:\MEPC\60\2-16.doc 4.2 Questions raised during the meeting

4.2.1 The following questions were put to the app licant during the meeti ng and their responses are shown together with the Group’s reactions.

Question 1 In the QAPP for “EnBallast” and test re port of chemical analysis, there is no description of the analytical method fo r FRO. Could you provide details of the analytical method used for FRO and provide the distinguishing definition between TRO and FRO in your report?

Response 1 FRO analysis was performed according to “Drinking Water Quality Standard and Test ES 05310.1, Korea : 2008”. This method is the ortho-tolidine method but we could not find the documentation in E nglish. We will send this to you immediately we find the document in English.

FRO includes hypochlorous acid (HOCl), hypochlorite ion (OCl - ), hypobromous acid (HOBr), hypobromous ion (OBr-), Chlorine(Cl - ), Bromine(Br - ) and so on. FRO react rapidly with ammonia and ami no nitrogen compounds in seawater and this react produces chloramines and br omamines which are called ‘Combined Residual Oxidants’.

FRO is a more powerful disinfection ag ent than ‘Combined Residual Oxidants’ TRO includes FRO and ‘Combined Residual Oxidants’.

Reaction 1 The Group noted this response.

Question 2 The Group noted that the starting date, as reported in the aquatic toxicity test report, for the all acute toxicity testing was one day after the sampling date. The Group understands that the TRO had been al ready neutralized be fore sampling so that degradation of TRO during this one day is irrelevant. However, the Group bconsidered that there is still a possibil ity that volatile organic compounds, such as THMs, could be reduced during this pe riod and this may underestimate the total toxicity significantly.

How the samples were kept during this period; was chemical analysis undertaken before and after this period and, if so, can you provide the results.

Response 2 Samples were carried by a refrig erator car and were kept at 20 °C during transportation. These samples were transported to the laboratory within one hour and were kept at 4 °C under dark condition in a 200 litre PE bottle.

(Refer to appendix 4, section 3, non- confidential version report 3.1.8, 3.2.8, 3.3.8)

Reaction 2 The Group noted this response.GESAMP-BWWG 12/6 ANNEX 5 Page 11

I:\MEPC\60\2-16.doc Question 3 Are there any results for chronic toxicity testing? If your answer is negative, could you clarify the reasons for this omission?

Response 3 We did not performe chronic toxicity test ing in the laboratory-scale test because chronic toxicity testing requires a large amount of control a nd treated water and requires long period. However, we will have chronic toxicity test data from the full scale land-based test.

Reaction 3 The Group were satisfied with this response

Question 4 In the Table 7 of your non-confidential version report, it is noted that the measurement of TRO was performed the by US EPA’s titration method. Is there a difference between TRO values manually measured and those measured by the TRO sensor?

Response 4 We failed to get effective values from the TRO sensor in the laboratory scale test. What we learned from the laboratory sc ale test is that a TRO sensor, using amperometric method, was not suitable for s eawater. As a result, we have been testing another TRO sensor using DPD meth od, and were able to obtain consistent results from that sensor.

Reaction 4 The Group was satisfied with this response

Question 5 It is noted that it took almost two months before the chemical analysis was completed i.e. sampling for ballasting was started on 28 th April 2009 and the chemical analyses were finished on 12 th June 2009. What was the actual date for the measurement for the TRO and othe r volatile compounds against sample named S33S1D0, S33S2D5 and S33S5D5?

Response 5 TRO measurements for 33PSU water were performed on 2009/5/13 (0 day), 2009/5/14 (1 day) and 2009/5/18 (5 day).
TRO measurements for 20PSU water we re performed on 2009/5/20 (0 day), 2009/5/21 (1 day) and 2009/5/25 (5 day).
The measurement of S33S1D0 wa s performed on 2009/5/13 (0 day),
The measurement of S33S2D5and S33S5D 5 was performed on 2009/5/18 (5 day). (Refer to appendix 3 ‘Analysis results of water collected from the En-Ballast BWM system”)

Reaction 5 The Group was satisfied with this response.

Question 6 In the table 3, on page 9 of the “syste m description of the laboratory-scale “En-ballast” BWM system (appendix 1 of do ssiers), the sensitivity of TRO sensor can be selected from three ranges; 0- 0.2 mg/L, 0-2 mg/L and 0-20 mg/L. Do you have any plan for the setting of MADCs fo r TRO which could be set to less than 0.22 mg/L under the control using 0-2 mg/L?GESAMP-BWWG 12/6 ANNEX 5 Page 12

I:\MEPC\60\2-16.doc Response 6 As shown as Response 4, the TRO sensor which was used for laboratory-scale test was found to be unsuitable for seawater. We will use the TRO sensor which utilizes the DPD method of which the ra nge of measurement is 0~10mg/L. The resolution is 0.01mg/L and the accuracy is 0.02mg/L. If we set the upper limit of the measured value of TRO to 0.18mg/L, even though in the worst case, the actual value of TRO will not overrun the limit for discharge of 0.2mg/L, we will reflect this idea in our land-based test for Final Approval.

Reaction 6 The Group was satisfied with this response

Question 7 Are there any analytical data for other ch emicals in both salinities of treated water at “5 day before neutralization”;

Response 7 As you know, we analyzed treated and control water as below;

0 day 1 day 5 day 35 PSU Control Immediately after electrolysis (storage tank for electrolysis water) Treated Control Treated Control Treated (after neutralization)

23 PSU Control Immediately after electrolysis (storage tank for electrolysis water) Treated Control Treated Control Treated (not neutralization)

There are no more data in both salinities of treated water at “5 day before neutralization”.

Reaction 7 The Group noted this response

5 WHOLE EFFLUENT TESTING

5.1 Acute ecotoxicity tests

5.1.1 The Group noted the results from the acute eco toxicity tests carried out on treated ballast water, Whole Effluent Tests (WET) as shown in the tables below:

Acute aquatic toxicity of 35 PSU ballast water treated by the “En-Ballast” BWMS

LC 50 and/or EC 50 Species End point Conc.(%) Reference

Algae Skeletonema costatum 72 h EC 50 90.19 Tested (OECD 201)

Crustacean Tigriopus japonicus 48 h EC 50 48 h LC 50 >100 >100 Tested (OECD 202)

Fish Paralichthys olivaceus 96 h LC 50 >100 Tested (OECD 203)GESAMP-BWWG 12/6 ANNEX 5 Page 13

I:\MEPC\60\2-16.doc Acute aquatic toxicity of 23 PSU ballast water treated by the “En-Ballast” BWMS

LC 50 and/or EC 50 Species End point Conc.(%) Reference

Algae Skeletonema costatum 72 h EC 50 68.53 Tested (OECD 201)

Crustacean Tigriopus japonicus 48 h EC 50 48 h LC 50 >100 >100 Tested (OECD 202)

Fish Paralichthys olivaceus 96 h LC 50 >100 Tested (OECD 203)

5.1.2 The Group noted that the simulated ballast wate r of the laboratory-sca le test was used for these tests. The 33 PSU ballast water were prep ared with five days holding time and neutralized with thiosulphate. In contrast , the 23 PSU ballast water samples were prepared with five days holding time without any neutralization, because th e TROs were less than 0.25 mg/L. The Group also noted that, before starting the exposure, a one day preparation period was needed to adjust the temperature between the ballast water a nd control water for test organisms.

5.1.3 From these results, the Group agreed that the “En-Ballast” system had an acute toxic effect on the growth of diatom , Skeletonema costatum only. Other organism s were not affected by the same treated seawater.

5.1.4 The Group was satisfied with QA/QC for thes e tests in general. However, the Group considered that the acute toxicity against the diatom was higher than th at predicted from the concentration of TRO and that fr om similar BWMS with neutrali zation. The Group invited the applicant to re-check the apparent anomaly of this toxicity which might have been caused by high POC in the original G8 test water. If the applicant finds the reason for this anomaly, a modification of the test procedure, such as pr e-filtering before exposur e, might be accepted.

5.2 Chronic ecotoxicity tests

5.2.1 The Group noted that the chronic ecotoxicity tests had not been performed in this application for Basic Approval. The Group also not ed that the applicant had recognized the need for chronic toxicity testing and further risk ch aracterization according to the results of acute toxicity tests above. It was agr eed that the chronic eco toxicity tests should also be provided as these were missing in the application for Basic Approval.

5.2.2 The Group emphasized that Procedure (G9) clearly requires both acute and chronic ecotoxicity testing for Basic Approval. The Gro up recalled that it had, previously, made a case for waiving the chronic toxicity testing for some BWMS applications for Final Approval providing the chemical analysis de monstrated that the concentrati ons of chemical by-products are similar to those provided in the application for Basic Approval.

5.2.3 However, in this case, the Group recommended that, for Final Approval, in addition to the required acute toxicity test results, chronic toxic ity test results, carried out in accordance with Procedure (G9), should also be provided as these were missing in the application for Basic Approval, because the analogy with earlier systems are not valid in this case.GESAMP-BWWG 12/6 ANNEX 5 Page 14

I:\MEPC\60\2-16.doc 5.3 Biomagnification

5.3.1 In addition, some data on bioavailability/biomagnification had been provided for the Active substances and Relevant Chemicals as shown in appendix 2.

6 HUMAN HEALTH ASSESSMENT

6.1 The Group noted the various chemicals associated with this system and agreed that these presented the following potential hazards to the crew and/or general public:

.1 sodium hypochlorite in equilibrium with hypochlorous acid is: .1 severely corrosive to skin at concentrations > 5%;

.2 trihalomethanes and, in particular, bromoform are: .1 toxic by inhalation; .2 harmful if swallowed; .3 irritating to the skin and eyes; and .4 may also be a human carcinogen,

.3 halo-acetic acids and in particular dibromoacetic acid .1 acutely toxic if swallowed; .2 acutely toxic if inhaled; .3 acutely toxic in contact with skin; and .2 corrosive to skin,

.4 halo-alkanes/alkenes .1 harmful if swallowed, inhale d or in contact with the skin; .2 narcotic; and .3 irritating,

.5 halo-aromatics .1 harmful if swallowed, inhale d or in contact with the skin; .2 skin irritant; and .3 possible carcinogen,

.6 halo-acetonitriles .1 harmful by inhalation, if swallowe d and in contact with the skin; and .2 irritating to skin, eyes and the respiratory system,

.7 halo-phenols .1 harmful if swallowed; and .2 irritant to skin and eyes; and

.8 Sodium thiosulphate .1 irritating to skin, eyes and the respiratory system.GESAMP-BWWG 12/6 ANNEX 5 Page 15

I:\MEPC\60\2-16.doc 7 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC

7.1 Risks to the safety of the ship – Corrosion

7.1.1 The Group noted that the applicant had indica ted that corrosion test s will be carried out with on steel exposed to the treated water of HOCl for a peri od of six months following an aging period of two months. This test is to be carried out in parall el with the full-scale land-based testing. The Group noted that these tests alone are unlikely to be sufficient to make a comprehensive assessment of the corrosivity of this Active Substance.

7.1.2 The Group invited the applican t to consider the guidance pr ovided in section 5.1 of the “Report of the eighth meeting of the GE SAMP-BWWG”, contained in MEPC 59/2/16.

7.1.3 The Group recognized that the selection of corrosion resistant mate rials and construction details for the electrolysis unit and piping containing the concentr ated solution of TRO prior to injection into the main ballast piping will be cruc ial to the expectation of continued integrity of the system. The same considerations apply to the storage tank and supply piping for the neutralization system. The Group, consequentl y, recommended that these details be fully considered and clearly identified in the opera ting manual for this treatment system when any submission is presented for Final Approval.

7.2 Risks to the safety of the ship – Fire and/or explosion

7.2.1 The Group noted that free hydrogen gas is gene rated as a by-product of electrolysis and that the Lower Explosion Limit (LEL) of hydrogen is 4%. However, it was noted that the system dilutes any such gas produced to ensure that limits are kept below 1%.

7.2.2 As a result, the Group agreed that the risks of fire and/or explosion due to the production of hydrogen were acceptable providing the risk mitig ation measures identified in the submission are applied as indicated.

7.3 Risks to the Crew from exposure to treated ballast water

7.3.1 The Group noted that the applicant had stat ed that, under normal operations, there would be no risk to human health associated with trea ted ballast water as the ship’s personnel would not come into contact with it.

7.3.2 The Group could not agree with this assump tion as there will always be a risk of equipment breakdown and leakage, especially as the TRO concentration produced by the electrolyser is considered high at 500 mg/L-2000 mg/L. Furthermor e, the risks associated with the loading and mixing of the neutralizer chemical , sodium thiosulphate, requires full assessment with appropriate risk mitigation measures and pro cedures to be put in place and clearly detailed in the system operating manual. The Group re commended these basic operational concerns be fully addressed in any application for final approval.

7.3.3 Notwithstanding the above obs ervations, the Group noted th at the applicant did not provide information regarding the identification a nd description of the unit operations associated with this system where crew exposure could take place. Therefore, th e Group considered that there was a level of uncertainty concerning the safety of this system as presented.GESAMP-BWWG 12/6 ANNEX 5 Page 16

I:\MEPC\60\2-16.doc 7.3.4 The Group recommended that such info rmation should be fully supported and documented in any application for Final Approval.

7.4 Risks to the general public from exposure to treated ballast water

7.4.1 The Group noted that the applicant had carried out a risk assessment, assuming that the exposure would be to undiluted tr eated ballast water and so the ge neral public w ould be exposed to the maximum concentration of each chem ical produced as a result of the treatment.

7.4.2 The results of this risk assessm ent are shown in the table below:

Compounds Value 1 (mg/kg/day) Maximum concentration (mg/L) Exposure (mg/kg/day) MOS

Chlorine dioxide LOAEL: 2 0.02 6.67E-04 3,000 Bromate ion NOAEL: 7.7 0.00217 7.23E-05 106,452 Dibromochloromethane NOAEL: 40 0.00879 2.93E-04 136,519
Dibromomethane Not found 0.00041 1.37E-05 NA Dichlorobromomethane NOAEL: 13.4 0.00019 6.33E-06 2,115,789 Tribromomethane LOAEL: 100 0.232 7.73E-03 12,931 Dibromoacetonitrile NOAEL: 8.2 0.00103 3.43E-05 238,835 Chloral hydrate NOAEL: 1.89 0.00002 6.67E-07 2,835,000 Chloropicrin NOAEL: 0.002 0.00034 1.13E-05 176 2-monochloroacetic acid NOAEL: 193 0.0429 1.43E-03 134,965 2,2-dichloroacetic acid NOAEL: 3.9 0.00541 1.80E-04 21,627 2,2-dibromoacetic acid NOAEL: 25 0.00179 5.97E-05 418,994 2,2,2-tribromoacetic acid Not found 0.00129 4.30E-05 NA Dalapon acid Not found 0.0503 1.68E-03 NA

7.4.3 The Group concurred with the applicant that the MOS values for exposure to bromoform, having been calculated using an unrealistic and c onservative scenario, infer that there will be no unacceptable risk to the general public when swim ming in the coastal area where treated ballast water has been discharged.

7.4.4 However, the Group considered that the MOS for chloropicrin (176) is close to MOSref (100). As chloropicrin is considered to be highly toxic (harmful if swallowed, very toxic by inhalation, irritating to eyes, skin and respir atory system, may cause sensitization by skin contact), the Group recommended that the presence of chloropicrin be further assessed as part of the testing for Final Approval and the need for risk mitigation measures.

7.4.5 The Group considered the risk assessment for the general population exposed to the chemical by-products of this system from eati ng fish. It was agreed that there was a low potential for these chemicals to be bioconcentrated and so there should be no unacceptable risk to the general population (see ta ble under section 8.3.1).GESAMP-BWWG 12/6 ANNEX 5 Page 17

I:\MEPC\60\2-16.doc 7.4.6 Notwithstanding the above observations, and having considered all of the information provided by the applicant, the Gr oup agreed that there should be no unacceptable risks to the general public from exposure to ba llast water treated by this system.

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Calculation of Predicted Envi ronmental Concentrations (PEC)

8.1.1 The Group noted that the applicant had em ployed the MAMPEC model to estimate the PECs of those chemicals produced by the system.

8.1.2 It was also noted that, to obtain such PEC estimates, the default commercial harbour using statistical data for the Port of Rotterdam had been used in the MAMPEC model, the results of which are shown below:

Estimation of PECs for chemicals produced by the “En-Ballast” BWMS

MAMPEC result ( μ g/L) Compounds 1 Load (g/day) 2 Maximum concentration ( μ g/L) 3 Half-life (day) Harbour Chlorine dioxide 0 0 15 0 Bromate 0.8613207 2.17 15 2.00E-06 Dibromochloromethane 3.4889443 8.79 38 4.96E-06 Dibromomethane 0.1627380 0.41 15 3.81E-07 Dichlorobromomethane 0.0754151 0.19 38 1.01E-07 Tribromomethane 92.085904 232 38 1.24E-04 Dibromoacetonitrile 0.4088296 1.03 38 5.51E-07 Chloral hydrate 0.0079384 0.02 38 1.07E-08 Chloropicrin 0.1349534 0.34 60 1.38E-07 2-monochloroacetic acid 17.027953 42.9 15 4.05E-05 2,2-dichloroacetic acid 2.1473480 5.41 15 5.07E-06 2,2-dibromoacetic acid 0.7104903 1.79 15 1.68E-06 2,2,2-tribromoacetic acid 0.5120293 1.29 15 1.21E-06 Dalapon acid 19.965176 50.3 38 2.69E-05

1 Active Substance and Relevant Chemicals. 2 Load amount estimated from the OECD-EU commercial harbour (Rotterdam), 396,922 m 3 per day of discharge. 3 The worst case applied.

8.1.3 The Group disagreed with the calculations presented by the applicant because some incorrect data had been used when running MA MPEC. Firstly, the load of the substances presented in the table in 8.1.2 was a factor of 1000 too low compared to the results of the calculations with MAMPEC as pres ented in annex 6 of the confid ential information and secondly the maximum worst case concentration was not always used. Thirdly, in the input values for all substances the half-life as presented in the tabl e were inserted in MAMPEC under de heading of the degradation rate when the following valu e should have been used: k = ln(2)/DT50.GESAMP-BWWG 12/6 ANNEX 5 Page 18

I:\MEPC\60\2-16.doc 8.1.4 The Group recalculated the co ncentrations for bromoform in the harbour using the data provided with corrected load and half-life values. The result obtained was a maximum concentration of 5.27 μg/L.

8.2 Calculation of PEC/PNEC ratios

8.2.1 The Group noted the results of calculating the PEC/PNEC ratios for those chemicals produced by the system, as shown in the table below:

PEC/PNEC ratio from MA MPEC modelling result

Compounds Toxicity (mg/L) Assessment factor PNEC ( μ g/L) PEC ( μ g/L) PEC/PNEC ( μ g/L)
Chroline dioxide 2.6 100 26.00 0 0 Bromate ion 0.125 1000 0.13 2.00E-06 1.60E-05 Dibromochloromethane 34 1000 34.00 4.96E-06 1.46E-07 Dibromomethane - - - 3.81E-07 - Dichlorobromomethane 1.424 1000 1.42 1.01E-07 7.09E-08 Tribromomethane 10 100 100 1.24E-04 1.24E-06 Dibromoacetonitrile 0.55 1000 0.55 5.51E-07 1.00E-06 Chloral hydrate 2.8 1000 2.80 1.07E-08 3.82E-09 Chloropicrin 0.0165 1000 0.02 1.38E-07 8.36E-06 2-monochloroacetic acid 32 100 320.00 4.05E-05 1.27E-07 2,2-dichloroacetic acid 1485 1000 1485.00 5.07E-06 3.41E-09 2,2-dibromoacetic acid 69 1000 69.00 1.68E-06 2.43E-08 2,2,2-tribromoacetic acid - - - 1.21E-06 - Dalapon acid 10 1000 10.00 2.69E-05 2.69E-06

* No toxicity value (see Table 30).

8.2.2 The Group did not agree with the PEC/PNEC -ratios as presented in the table of 8.2.1 because the PECs are not correct.

8.2.3 The Group performed a recalculation of the PEC/PNEC ratio for bromoform using the PEC of section 8.1.4. The ratio PEC/PNEC = 5.27/100 = 0.0527, which is still <1. Therefore, the Group agreed that the EnBallast system should not cause any unacceptable environmental risks. However, it was recommended that th e applicant should redo the calculations with the correct input data in the a pplication for Final Approval.GESAMP-BWWG 12/6 ANNEX 5 Page 19

I:\MEPC\60\2-16.doc 8.3 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

8.3.1 The Group noted the PBT characteristics of those chemicals produced by the system as shown in the table below:

PBT evaluation based on water

Compounds Persistent (y/n) (V a /T b /H c ) Bioaccumulative d (y/n) Toxic (y/n)

Chlorine dioxide No 3.0501/w/15 d in water No Log Pow = -3.22 No Acute LC 50 : 2.6 mg/L/24 hr (algae)

Bromate No 3.0226/weeks/15 d in water No Log Pow = 0.63 No NOEC: >0.125 mg/L/168 hr (algae)

Dibromochloromethane No 2.6386/weeks-months/38 d in water No Log Pow = 1.70 No LC 50 : 34 mg/L/72-1200 hr (fish)

Dibromomethane No 2.8729/weeks/15 d in water No Log Pow = 1.52 Not found

Dichlorobromomethane No 2.5197/weeks-months/38 d in water No Log Pow = 1.61 No LC 50 : 1.424 mg/L/9 months (fish)

Tribromomethane No 2.7275/weeks-months/38 d in water No Log Pow = 1.79 No NOEC: 10 mg/L/96 hr (algae)

Dibromoacetonitrile No 2.7353/weeks-months/38 d in water No Log Pow = 0.47 No Acute LC 50 : 0.55 mg/L/96 hr (fish)

Chloral hydrate No 2.4219/weeks-months/38 d in water No Log Pow = 0.98 No Acute LOEC: 2.8 mg/L/NR e (algae)

Chloropicrin No 2.1043/months/60 d in water No Log Pow = 1.32 No Acute LC 50 : 0.0165 mg/L/96 hr (fish)

2-monochloroacetic acid No 3.1818/weeks/15 d in water No Log Pow = 0.34 No NOEC: 32 mg/L/504 hr (crustacea)
2,2-dichloroacetic acid No 2.9325/weeks/15 d in water No Log Pow = 0.52 No EC 03 : 1,485 mg/L/168 hr (algae)
2,2-dibromoacetic acid No 3.1403/weeks/15 d in water No Log Pow = 0.70 No Acute LC 50 : 69 mg/L/96 hr (fish)
2,2,2-tribromoacetic acid No 2.7827/weeks/15 d in water No Log Pow = 1.71 Not found

Dalapon acid No 2.6894/weeks-months/38 d in water No Log Pow = 1.68 No Acute LC 50 : 10 mg/L/24 hr (fish)
a Numerical value from model; b Words assigned, representing ex pected total degradation time; c Half-life; d U.S EPI suite 2008; e Time information not reported.GESAMP-BWWG 12/6 ANNEX 5 Page 20

I:\MEPC\60\2-16.doc 8.4 Interpretation of the results

8.4.1 The Group agreed that:

.1 the recalculated PEC/PNEC ratios base d on corrected MAMPEC input for all of the potential chemical by-products do not result in unacceptable risk to the environment; based on the laboratory test wi th treated ballast water some effects may be expected on the local scale;

.2 none of the by-products met the PBT cr iteria which would ha ve prevented the system from being used to treat ballast water; and

.3 whilst it was recognized that WET showed that treated ballast water showed some ecotoxicological effects, it was recognized that these would be diluted to an acceptable level.

8.4.2 Based on the above observations , the Group agreed th at the chemical by-products of this system should not pose any unacceptable risk to the marine environm ent in the quantities produced, if neutralizatio n is carried out adequately in every ballast water discharge.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Having considered all of the information provided by the applicant, the Group agreed that:

.1 ballast water treated by this system s hould not cause any unacceptable risk to the marine environment:

.2 ballast water treated by this system s hould not cause any unacceptable risk to the safety of the ship;

.3 ballast water treated by this system s hould not cause any unacceptable risk to the crew or general public;

.4 the required chronic toxicity test re sults, in accordance with Procedure (G9), should be provided, as it was missing in the application for Basic Approval;

.5 the TRO sensors’ sensitiv ity, reliability and its use in the neutralizer control should be confirmed as being appropriat e to maintain the MADC of TRO; and

.6 the neutralization control system shoul d be fully documented to give confidence in its reliability.

9.2 Furthermore, the Group was not satisfied with the high det ection limit of TRO as 0.2 mg/L could infer 0.249 mg/L. As a result, it was recommended that that the maximum allowable discharge concentration of TRO should be 0.20 mg/L as Cl 2, or lower when applying for Final Approval and this value also needs to be verified by the analytical method used.GESAMP-BWWG 12/6 ANNEX 5 Page 21

I:\MEPC\60\2-16.doc 9.3 The Group recommended that information rega rding the identificati on and description of the unit operations asso ciated with this system and the Human Exposure Scenario (MEPC 56/2/2, annex 9) should be fully supported and documented so that it can be taken into account if the system has to be reviewed fo r Final Approval in the future.

9.4 The Group recommended that the presence of ch loropicrin be further assessed as part of the testing for Final Approval and the need for risk mitigation measures.

* * *GESAMP-BWWG 12/6 ANNEX 5 Page 22

I:\MEPC\60\2-16.doc APPENDIX 1

CONCENTRATION OF RELEVANT CHEMICALS IN TREATED BALLAST WATER

1.1 Concentration of halogenated volatile organic compounds in 35 PSU seawater

35 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test water 1 Control Electro -lyzer Treated Control Treated Control Treated(neutralized) Absorbable organic halogens (AOX) 0.01 0.46 0.52 1.14 0. 46 0.85 0.77 0.68 0.84

1,1,1-Trichloroethane 0.01 0.01 0.01 0.07 0.01 N.D N.D N.D N.D 1,1,2-Trichloroethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D 1,1-Dichloroethane 0.01 0.42 N.D 0.38 0.25 N.D 0.13 N.D N.D 1,1,2,2- Tetrachloroethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D
1,1,1,2- Tetrachloroethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

1,2,3-Trichlorobenzene 0.01 0.29 0.25 0.22 0.18 N. D 0.02 N.D N.D 1,2,3-Trichloropropane 0.01 N. D N.D 0.01 N.D N.D N.D N.D 0.01 1,2,4-Tribromobenzene 0.02 N.D N.D N.D N.D N.D N.D N.D N.D 1,2,4-Trichlorobenzene 0.01 0.30 0.27 0.26 0.21 N.D N.D N.D N.D 1,2-Dibromo-3- chloropropane 0.02 N.D N.D N.D N.D N.D N.D N.D N.D

1,1-Dichloroethene 0.02 0.25 0.20 N.D N.D N.D N.D N.D N.D 1,2-Dichloropropane 0.02 N.D N.D 0.01 N.D N.D N.D N.D N.D 1,3,5-Tribromobenzene 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

2-Chlorotoluene 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

4-Chlorotoluene 0.01 N.D 0.05 0.13 0.04 N.D N.D N.D N.D

Bromobenzene 0.01 N.D N.D 0.20 N.D N.D N.D N.D N.D

Bromochloromethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

Chlorobenzene 0.01 0.26 0.27 0. 33 0.24 0.20 0.21 0.16 0.15 cis-1,2-dichloroethene 0.02 N.D N.D 0.20 N.D N.D N.D N.D N.D

Dibromomethane 0.01 N.D N.D 1.04 0.70 N.D 0.62 N.D 0.41

Dichloromethane 0.02 0.54 N.D 0. 40 0.17 0.47 0.26 0.42 0.33

Tetrachloroethene 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

Tetrachloromethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D trans-1,2- dichloroethene 0.02 N.D N.D N.D N.D N.D N.D N.D N.D

Dibromochloromethane 0.01 N. D ND 19.2 1.65 0 4.75 0 8.79

Dichlorobromomethane 0.01 N.D ND 6.02 5.14 0 0.29 0 0.19

Trichloromethane 0.01 0.24 0.25 1.20 0 0.16 0 0 0.00

Tribromomethane 0.01 N.D 0.47 90. 9 41.1 0.44 120 0.37 232

1 Test waters including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8).GESAMP-BWWG 12/6 ANNEX 5 Page 23

I:\MEPC\60\2-16.doc 1.2 Concentration of halogenated volatile organic compounds in 23 PSU seawater

23 PSU Day 0 Day 1 Day 5

MDL ( μ

g/L) Test
water 1 Control Electrolyzer Treated Control Treated Control Treated (notneutralized) 2 Absorbable organic halogens (AOX) 0.01 0.53 0.46 0.85 0.43 0.48 0.70 0.79 0.77

1,1,1-Trichloroethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D 1,1,2-Trichloroethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D 1,1-Dichloroethane 0.01 0.91 0.85 N.D N.D N.D N.D N.D N.D 1,1,2,2-Tetrachloroethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D 1,1,1,2-Tetrachloroethane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D 1,2,3-Trichlorobenzene 0.01 N.D N.D N.D N.D N.D N.D N.D N.D 1,2,3-Trichloropropane 0.01 N. D N.D N.D N.D N.D N.D N.D N.D 1,2,4-Tribromobenzene 0.02 N.D N.D N.D N.D N.D N.D N.D N.D 1,2,4-Trichlorobenzene 0.01 N.D N.D N.D N.D N.D N.D N.D N.D 1,2-Dibromo-3- chloropropane 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

1,1-Dichloroethene 0.01 0.43 0.42 0.54 0.52 0.15 0.38 N.D 0.20 1,2-Dichloropropane 0.01 1.13 1.29 0.06 0.01 0.03 N.D N.D N.D 1,3,5-Tribromobenzene 0.02 N.D N.D N.D N.D N.D N.D N.D N.D

2-Chlorotoluene 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

4-Chlorotoluene 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

Bromobenzene 0.01 N.D N.D N.D N.D N.D N.D N.D N.D

Bromochloromethane 0.01 N.D N. D 0.52 0.41 N.D 0.11 N.D 0.02

Chlorobenzene 0.01 0.29 0.21 0. 30 0.29 0.23 0.24 0.20 0.15 cis-1,2-dichloroethene 0.01 N. D N.D N.D N.D N.D N.D N.D N.D

Dibromomethane 0.01 N.D N.D 5.92 5.11 N.D 1.29 N.D 0.48

Dichloromethane 0.01 1.60 0.58 8.63 4.83 0.44 0.99 N.D 0.66

Tetrachloroethene 0.02 N.D N.D N.D N.D N.D N.D N.D N.D

Tetrachloromethane 0.02 N.D N.D N.D N.D N.D N.D N.D N.D trans-1,2-dichloroethene 0.01 0.24 0.24 N.D N.D 0.09 N.D N.D N.D

Dibromochloromethane 0.01 3.70 3. 86 13.8 6.25 3.78 9.11 2.27 12.6

Dichlorobromomethane 0.01 3.29 3.57 4.82 3.82 3.16 0.42 1.06 N.D

Trichloromethane 0.01 4.44 3.61 5.44 4.83 3.37 4.08 1.78 4.17

Tribromomethane 0.01 2.03 2.57 55.7 34.0 1.93 127 1.85 205

1 Test water including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8). 2 The water is not neutralized because the concentr ation of TRO is < 0.25 mg/L, see chapter 3.3.GESAMP-BWWG 12/6 ANNEX 5 Page 24

I:\MEPC\60\2-16.doc 2.1 Concentration of haloacetonitriles in 35 PSU seawater

35 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test
water 1 Control Electro -lyzer Treated Control Treated Control Treated(neutralized) Trichloroacetonitrile 0.001 N. D N.D N.D N.D N. D N.D N.D N.D
Dichloroacetonitrile 0.01 0.13 0.13 105 0. 30 0.14 0.21 0.19 0.09
Bromochloroacetonitrile 0.001 N.D N.D 2.69 N.D N.D N.D N.D N.D
Dibromoacetonitrile 0.001 0. 12 0.14 8.71 2.20 0.13 1.19 N.D 1.03 Chloral hydrate 0.001 N.D N.D 8.63 0.12 N.D 0.09 N.D 0.02 Chloropicrin 0.001 0.01 0.01 80.7 3.61 0.01 3.23 0.01 0.34

1 Test waters including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8).

2.2 Concentration of haloacetonitriles in 23 PSU seawater

23 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test
water 1 Control Electro -lyzer Treated Control Treated Control Treated (notneutralized) 2
Trichloroacetonitrile 0.001 N.D N.D 2.59 N.D N.D N.D N.D N.D
Dichloroacetonitrile 0.01 0.49 0.47 28.0 3.15 0.41 2.32 0.43 0.14
Bromochloroacetonitrile 0.001 N.D N.D 5.85 N.D N.D N.D N.D N.D
Dibromoacetonitrile 0.001 0. 15 0.14 38.2 30 .1 0.04 29 .5 0.05 22.1 Chloral hydrate 0.001 0.27 0.21 17.0 0.08 0.25 0.13 0.23 0.13 Chloropicrin 0.001 0.09 0.28 95.7 3.62 0.25 4.81 0.23 2.83

1 Test water including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8). 2 The water is not neutralized because the concentr ation of TRO is < 0.25 mg/L, see chapter 3.3.

3.1 Concentration of halo acetic acids in 35 PSU seawater

35 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test
water 1 Control Electro -lyzer Treated Control Treated Control Treated(neutralized) 2-monochloroacetic acid 0.21 4.46 4.83 169 27.4 4.77 48.7 3.41 42.9 2,2-dichloroacetic acid 0.12 N.D N.D 6.09 6.78 N.D 6.13 N.D 5.41 2,2,2-trichloroacetic acid 0.03 1.10 1.14 46.1 14.7 1.27 0.65 1.53 0.51
2-monobromoacetic acid 0.09 N.D N.D 2.85 2.45 N.D N.D N.D N.D 2,2-dibromoacetic acid 0.03 0.71 0.75 8.50 4.74 0.77 2.03 0.78 1.79 2,2,2-tribromoacetic acid 0.47 N.D 1.13 31.4 13.3 N.D 1.32 N.D 1.29 2,2-bromochloroacetic acid 0.07 28.0 27.1 41.7 22.2 26.3 23.5 26.1 20.6
2,2,2-bromodichloroacetic acid 0.08 6.10 6.76 9.43 5.45 5.56 1.43 5.29 1.25
Dalapon acid 0.15 10.5 10.2 613 292 11.4 113 12.8 50.3GESAMP-BWWG 12/6 ANNEX 5 Page 25

I:\MEPC\60\2-16.doc 1 Test water including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8).

3.2 Concentration of halo acetic acids in 23 PSU seawater

23 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test
water 1 Control Electro -lyzer Treated Control Treated Control Treated (not

neutralized) 2
2-monochloroacetic acid 0.21 20.9 20.8 332 41.9 18.5 38.4 18.6 20.7 2,2-dichloroacetic acid 0.12 N.D N.D 11.5 1.25 N.D N.D N.D N.D 2,2,2-trichloroacetic acid 0.03 7.86 7.85 212 8.50 2.07 5.88 0.58 4.90
2-monobromoacetic acid 0.09 2.85 2.95 11.7 10.5 2.72 3.04 N.D 1.60 2,2-dibromoacetic acid 0.03 1.14 1.09 26.2 18.3 1.08 15.7 1.05 11.6 2,2,2-tribromoacetic acid 0.47 11.1 10.9 15.9 12.2 N.D 11.0 11.0 5.41 2,2-bromochloroacetic acid 0.07 22.5 20.5 161 40.1 27.2 42.9 32.1 47.32,2,2-bromodichloroacetic acid 0.08 3.56 3.56 71.9 4.66 3.31 4.32 3.28 3.87
Dalapon acid 0.15 16.9 15.1 515 108 8.68 24.8 8.54 10.3

1 Test water including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8). 2 The water is not neutralized because the concentra tion of TRO is < 0.25 mg /L, see see chapter 3.3.

4.1 Concentration of chlorinated phenols in 35 PSU seawater

35 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test
water Control Electro -lyzer Treated Control Treated Control Treated(neutralized) 2-Chlorophenol 0.5 ND ND ND ND ND ND ND ND 3-Chlorophenol 0.5 ND ND ND ND ND ND ND ND 4-Chlorophenol 0.4 ND ND ND ND ND ND ND ND 2,3-Dichlorophenol 0.3 0.78 0.58 0.60 0.81 ND ND ND ND 2,4-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 2,5-Dichlorophenol 0.3 3.45 3.62 2.28 2.25 3.54 2.36 2.22 1.94 2,6-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 3,4-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 3,5-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 2,3,4-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND 2,3,5-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND 2,3,6-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND 2,4,5-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND 2,4,6-Trichlorophenol 0.4 ND ND ND ND ND ND ND ND 3,4,5-Trichlorophenol 0.3 ND ND ND ND ND ND ND ND 2,3,4,5-Tetrachlorophenol 0.4 ND ND ND ND ND ND ND ND 2,3,4,6-Tetrachlorophenol 0.3 ND ND ND ND ND ND ND ND 2,3,5,6-Tetrachlorophenol 0.6 ND ND ND ND ND ND ND ND Pentachlorophenol 0.4 ND ND ND ND ND ND ND NDGESAMP-BWWG 12/6 ANNEX 5 Page 26

I:\MEPC\60\2-16.doc 1 Test water including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8).

4.2 Concentration of chlorinated phenols in 23 PSU seawater

23 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test
water 1 Control Electro -lyzer Treated Control Treated Control Treated (notneutralized) 2 2-Chlorophenol 0.5 ND ND ND ND ND ND ND ND 3-Chlorophenol 0.5 ND ND ND ND ND ND ND ND 4-Chloophenol 0.4 ND ND ND ND ND ND ND ND 2,3-Dichlorophenol 0.3 1.89 1.26 0.80 0.50 0.76 0.61 ND ND 2,4-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 2,5-Dichlorophenol 0.3 3.55 3.82 2.78 2.65 3.12 2.44 2.15 1.54 2,6-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 3,4-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 3,5-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 2,3,4-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND 2,3,5-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND 2,3,6-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND 2,4,5-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND 2,4,6-Trichlorophenol 0.4 ND ND ND ND ND ND ND ND 3,4,5-Trichlorophenol 0.3 ND ND ND ND ND ND ND ND 2,3,4,5-Tetrachlorophenol 0.4 ND ND ND ND ND ND ND ND 2,3,4,6-Tetrachlorophenol 0.3 ND ND ND ND ND ND ND ND 2,3,5,6-Tetrachlorophenol 0.6 ND ND ND ND ND ND ND ND Pentachlorophenol 0.4 ND ND ND ND ND ND ND ND

1 Test waters including organism ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8). 2 The water is not neutralized because the concentra tion of TRO is < 0.25 mg/L, see see chapter 3.3.

5.1 Concentration of bromated phenols in 35 PSU seawater

35 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test
water 1 Control Electro -lyzer Treated Control Treated Control Treated(neutralized) 2,4-Dibromophenol 0.4 ND ND ND ND ND ND ND ND 2,6-Dibromophenol 0.8 0.95 0.82 0.65 ND ND ND ND ND 2,4,6-Tribromophenol 0.5 ND ND ND ND ND ND ND ND

1 Test water including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8).GESAMP-BWWG 12/6 ANNEX 5 Page 27

I:\MEPC\60\2-16.doc 5.2 Concentration of bromated phenols in 23 PSU seawater

23 PSU Day 0 Day 1 Day 5

MDL ( μ g/L) Test
water 1 Control Electro -lyzer Treated Control Treated Control Treated (notneutralized) 2 2,4-Dibromophenol 0.4 ND ND ND ND ND ND ND ND 2,6-Dibromophenol 0.5 0.98 1.05 ND ND ND ND ND ND 2,4,6-Tribromophenol 0.5 ND ND ND ND ND ND ND ND

1 Test water including organisms ( ≥ 50 μm, ≥ 10-50 μm), starch, and glucose to correspond with Guidelines (G8). 2 The water is not neutralized because the concentra tion of TRO is < 0.25 mg /L, see see chapter 3.3.

* * *GESAMP-BWWG 12/6 ANNEX 5 Page 28

I:\MEPC\60\2-16.doc APPENDIX 2

BIOCONCENTRATION DATA FOR ACTIVE SUBSTANCES AND RELEVANT CHEMICALS

BIOCONCENTRATION OF ACTIVE SUBSTANCES

Active Substance Measured/Calculated (L/Kg wet-weight) Reference

3.16 (Regression-based estimate) Chlorine dioxide (ClO 2 )

0.89 (Arnot-Gobas) US EPA (EPI suit. 2008)

3.16 (regression -based estimate) Bromate (BrO 3 - )

1.13 (Arnot-Gobas) US EPA (EPI suit. 2008)

Bioconcentration of Relevant Chemicals

Relevant Chemical Measured/Calculated (L/Kg wet-weight) Reference

3.96 (Regression-based estimate) Dibromochloromethane

3.23 (Arnot-Gobas) US EPA (EPI suit, 2008)

Dibromomethane 4 L/kg wet-wt HSDB, 1990 3.00 HSDB, 2008 Dichlorobromomethane 3.20 PBT Profiler, 2006 Tribromomethane 2-20 L/kg wet-wt Kenaga, 1980 3 L/Kg wet-wt HSDB, 2008 Dibromoacetonitrile 3.2 L/Kg wet-wt PBT Profiler, 2006 Chloral hydrate 3.00 HSDB, 2008 11.10 US EPA (EPI suit, 2008) Chloropicrin 8.00 HSDB, 2008 3.16 US EPA (EPI suit, 2008) 2-monochloroacetic acid 3.20 HSDB, 2008 3.16 US EPA (EPI suit, 2008) 2,2-dichloroacetic acid 3.20 HSDB, 2008 3.16 US EPA (EPI suit, 2008) 2,2-dibromoacetic acid 0.17 HSDB, 2008 3.162 (regression-based estimate) 2,2,2-tribromoacetic acid

5.185 (Arnot-Gobas) US EPA (EPI suit. 2008)

3.162 (regression-based estimate) Dalapon acid

5.624 (Arnot-Gobas) US EPA (EPI suit. 2008)

***GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc ANNEX 6

REVIEW OF PROPOSALS FOR APPRO VAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

OceanGuard Ballast Water Management System

Submitted by Norway for Basic Approval

0 SUMMARY

0.1 Having reviewed all the data and informati on submitted by Norway with the application for Basic Approval and the information received from the applicant during the GESAMP BWWG meeting, the Group recomme nded to MEPC that Basic Approval be granted to this BWMS.

0.2 The Group noted that the OceanGuard Ballast Water Management System (BWMS) is the technology of Qingdao Headway Technology Co. Lt d. of China and uses a combination of filtration and in situ Electrolysis enhanced by Ultrasonic Treatment (referred to in the application as EUT) of seawater to produce the Active Subs tance sodium hypochlorite to treat the ballast water, without the addition or mixing of any other chemicals.

0.3 The Group noted that the original dossier submitted by the applicant proposes to treat seawater (33 PSU) at 1 mg/L (as Cl 2 ) initial maximum TRO dose a nd brackish water (22 PSU) at 2 mg/L (as Cl 2 ) initial maximum TRO dose. Whilst the original dossier was based on the above control scheme, as a result of th e Group’s questions during the GESAMP-BWWG meeting, the applicant provided a revised contro l scheme in which the treatment maximum TRO dosages for the BWMS would be 2 mg/L (as Cl 2 ) for the treatments with more than 2 days’ holding time, and 1.5 mg/L (as Cl 2 ) for the treatments with less th an or equal to 2 days’ holding time, respectively.

0.4 The Group recognized that the applicant has provided information on environmental risk assessment for aquatic organisms and has proposed a maximum allowable discharge concentration (MADC) for the Active S ubstance of 0.2 mg/L (TRO as Cl 2 ) without any neutralization measures or mon itoring at discharge. The Group c onsidered that the applicant’s approach to ensuring MADC for the Active Substa nce is not sufficient a nd recommended that the applicant ensures that the environmentally safe MADC is not exceeded over the entire range of relevant chemical properties and all possible holding times. The Group considered that this could not be achievable when a 1.5 mg/L (TRO as Cl 2 ) dosed ballast water wa s discharged in the period up to 2 days, without a neutralization step.

0.5 The Group recommended that suitable monitoring and shut-down facility be incorporated to ensure that a MADC of 0.20 mg/L TRO as Cl 2 cannot be exceeded at a ny time, full details of such an arrangement should be provided in any application for Final Approval.

0.6 The Group noted that the applicant intends to conduct corrosion tests and to submit the resultant data in their application for Final Appr oval. The Group invited the applicant to consider the guidance provided in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/ 2/16, in conducting these corrosion tests.GESAMP-BWWG 12/6 ANNEX 6 Page 2

I:\MEPC\60\2-16.doc 0.7 The Group considered that the information provided by the appli cant in the submitted dossier is sufficient to allow the Group to recomm end Basic Approval but is not sufficient for full evaluation of the potential risks posed by the treated ballast water with the revised dose settings described in 0.3 above. However, in view of th e similarity with other evaluated BWMS which use electrolysis, the Group believed that this BWMS would not give rise to risks substantially different from those other systems. The Group recommended that an application for Final Approval of this system should include conf irmation by further testing, that there will be no unacceptable risks (to ship safety, human health or the environment) due to the chemical composition of ballast water treated by this BWMS.

0.8 The Group noted the information submitted by the applicant on the assessment of Human Exposure Scenario related to the BWMS which included the analysis of the potential human health risks associated with occupational exposure scenar ios (personnel working inside the ballast tank and personnel working close to the BWMS) and the exposure of the general public (sea bathers in the harbour areas including children, adu lts and elders).

0.9 The Group noted that the applicant used th e MAMPEC-model version 2 to calculate the Predicted Environmental Concentrations for diffe rent Relevant Chemicals. The Group accepted the MAMPEC calculations of the applicant which were based upon the OECD-EU commercial harbour and the ballast water discharge description of the Port of Rotterdam.

0.10 The Group recommended that both acute and chr onic ecotoxicity testing of treated ballast water with the revised TRO dose settings describe d in 0.3 above for at l east three species should be performed in accordance with the full requirem ents of Procedure (G9), to be reviewed for Final Approval.

0.11 In conclusion, having reviewed all the information submitted by Norway in the application for Basic Approval and the informa tion supplied by the app licant in response to questions posed by the Group during this GE SAMP-BWWG meeting, th e Group agreed to recommend to the MEPC that Basic Approval be granted to the OceanGuard BWMS. The Group recommended that in any future submissi on for Final Approval of this BWMS, the recommendations given in this re port are taken into account.

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted fr om that supplied by Norway in document MEPC 60/2/8 and in the confidential dossier, which was supplemented by additional information provided by the applicant after a re quest for further information by the Group during its meeting.

2 COMPLETENESS OF DOSSIER AND APPLICANT RESPONSES TO DATA REQUESTS FROM THE GROUP

2.1 As the Group recognized that the chemical analysis and ecotoxicity testing reports provided by the applicant did not include QA/QC documentation, the Group was of the opinion that some of the test procedures and methods may not have been performed in accordance with the Guidelines (G8) and Proce dure (G9). The QAPP report provide d by the applicant was for the full-scale land-based testing in the future, not for the pilot testing already provided in the dossier for Basic Approval.GESAMP-BWWG 11/6 ANNEX 6 Page 3

I:\MEPC\60\2-16.doc 2.2 During the GESAMP-BWWG meeting, the Group posed to the applicant a total of six questions on issues it felt need ed further clarification in orde r to complete the evaluation for Basic Approval. The Group’s questions (in bold text ), the applicant’s res ponses (in plain text) and the reactions of the Group (in italic text ) are noted below, in numerical order of the individual questions.

Question 1

The production of carbon monoxide and meth ane – The applicant stated in paragraph 4.4 of non-confidential version as follows: “C arbon monoxide, methane and hydrogen sulfide are the products from the incomplete oxida tion of TRO and the organics in a high concentration of the organics in the water.”

.1 As indicated in table 3.1, even after this treatment heterotrophic bacteria are still alive with high concentration bo th in seawater and brackish water.

.2 So not the oxidation but biological fermentation against organic compounds in BW will occur during tank holding time.

.3 This is why these gases are detected only at brackish water, which contains more organic compounds according to G8 requirement.

.4 That means that their dose of TRO is not enough against heterotrophic bacteria.

Response 1

.1 The biological efficiency of Ocean Guard BWMS is achieved by Hydroxyl radicals, not TRO. Carbon monoxide , methane are the products from the incomplete oxidation of TRO and the orga nics in a high con centration of the organics in the water, and no hydrogen sulfide are de tected during the whole testings.

.2 During tank holding time, it is oxidation that occurs, not biological fermentation against organic compounds. Th e reasons are as following:

.1 If it is biological fermentation, th ere should be Carbon monoxide in control water. However, no Carbon monoxide is detected in control water.

.2 If it is biological fermentation, there should be decrease in DO. However, no decrease is detected. Please refer to the following data of pilot testing report from NIVA (Ref. P21—P22, NIVA report).

Group reaction – The Group noted the response.

Question 1 (continued)

So first of all, how they coll ected the gas for the analysis in Table 4.3? Was this sampling directly done from the simulated BW tank? How much is the distance from the water level? And at the sampling time, did they recognize a smell?GESAMP-BWWG 12/6 ANNEX 6 Page 4

I:\MEPC\60\2-16.doc Response 1 (continued):

.1 Testing method for the analysis in Table 4.3 (Ref. P19 , NIVA report).

.2 Gas phase parameters Gas phase parameters were measured in the headspace in each tank (i.e. empty space between tank roof and water surface) for analysis of O2, H2, CH4, H2S and Cl2 gas. Gas was measured using handheld gas sensors (Dräger X-am 5000 and GasAlert MicroClip RW), sensors which have been developed and is used for portable monitoring of gases for personnel working in potentially hazardous areas. Gas was measured on day 0 and day 5.

Yes, the sampling was directly from the simulated BW tank. At the sampling time, no smell was recognized.

Group reaction – The Group noted the response.

Question 1 (continued)

Finally, could you provide the chemical parame ters (DO, POC, DOC and) of control and treated water? If not in their reports, pl ease ask additional information for that.

Response 1 (continued)

.1 Kindly please refer to the following in fo regarding DO from NIVA pilot testing report. (Ref. P23—P24, NIVA report). Data of POC, DOC (Ref. P22—P23, NIVA report)

Group reaction – The Group noted the response.

Question 2

The threshold between seawater and brackish water - The applicant proposes to treat seawater (ca. 33 PSU) at 1 mg/L (as Cl2) in itial maximum TRO dose and brackish water (ca. 22 PSU) at 2 mg/L (as Cl2) initial maxi mum TRO dose. What is the changeover point or threshold of PSU for changing TRO from 2 mg/L to 1 mg/L? Are there any possibilities that other parameters, such as DOC will affect the G8 efficacy?

Response 2:

.1 From landbased testings in NIVA (please see the following two tables), the biological efficiency of OceanGuard BW MS is achieved by Hydroxyl radicals, not TRO. In the updated OceanGuard BW MS, there is no changeover point or threshold of PSU for changing TRO.

.2 There are two modes of Ocean Guard BWMS as following:

.1 In MODE 1, i.e. where the estimated ballast water storage time is longer than 2 days, the maximum allowed TRO concentration is 2 mg/L.GESAMP-BWWG 11/6 ANNEX 6 Page 5

I:\MEPC\60\2-16.doc .2 In MODE 2, i.e. where the estimated ballast water storag e time is shorter than 2 days, the maximum allowed TRO concentration is 1.5 mg/L.

Group reaction – The Group noted this response but questioned the valid ity of the argument presented that the MADC of 0.2 mg/L TRO as Cl 2 can be maintained at all times using the dosing rates specified.

Question 3

It is noted in the submitted dossier that th e intention was to treat marine water with a dosage of 1 mg/L TRO and brackish water with a dosage of 2 mg/L TRO. We now note from your initial replies to earlier questions that the dosage has been changed to depend upon intended holding time in the ballast tank , i.e. > 2 days hold ing time, TRO dosage maximum = 2 mg/L, and < 2 days holding time , TRO dosage maximum = 1.5 mg/L. Please clearly indicate the maximum dosages appl icable and under which conditions and PSU ranges these apply.

Response 3:

.1 Maximum TRO dosages applicable of OceanGuard BWMS is 2 mg/L (For < 2 days holding time, TRO dosage maximum = 1.5 mg/L). These settings apply to all conditions and PSU ranges. Please be noted that the 2 mg/L and 1.5 mg/L as mentioned refer to the online data.

Group reaction – The Group noted this response but questioned the validity of the argument presented that the MADC of 0.2 mg/L TRO as Cl 2 can be maintained at all times using the dosing rates specified.

Question 4

It is noted that the maximum discharge level of TRO is stated as 0.2 mg/L. The TRO level at discharge is dependent upon the concen trations of chlorine demanding organic compounds, especially in brackish waters, and the tank holding ti me. It is noted that there is conflicting information on the degradation rate of TRO that may be expected. The Group has concern that the information provided in the dossier does not give confidence that the discharge TRO level of maximu m 0.2 mg/L can be ensured at all times. How is the maximum discharge TRO level to be assu red to ensure environmental acceptability, without incorporating a TRO neutralization system?

Response 4:

.1 According to the landbased testings, TR O level is set within a fixed range. Biological efficiency of OceanGuard BW MS is achieved mainly by the hydroxyl radicals, not the TRO. A certain level of TRO is to make sure the sustaining biological efficiency for a period of holding time, to inhibit the growth of organisms. From testing data in landbase d testings, it can be indicated that IMO D-2 Requirements can be achieved with the maximum initial TRO level of 1.5 mg/L or 2 mg/L.GESAMP-BWWG 12/6 ANNEX 6 Page 6

I:\MEPC\60\2-16.doc .2 Please refer to the following table showi ng the TRO decay. It can be indicated that TRO concentration in treated water on Day 1 or Day 2 can fully meet the IMO requirements of TRO <0.2 mg/L. On Day 5 before discharge, TRO level is <0.1 mg/L. Meanwhile, during deballas ting, only ultrasound part is operated, which will not increase the TRO level.

.3 In conclusion, discharge TRO level of OceanGuard BWMS can completely be assured to be lower than 0.2 mg/L, to ma ke sure the environmental acceptability without incorporating a TR O neutralization system.

Group reaction – The Group noted this response but questioned the valid ity of the argument presented that the MADC of 0.2 mg/L TRO as Cl 2 can be maintained at all times using the dosing rates specified.

Question 5

Can you provide any literature or scientific reasoning for the production or presence of carbon monoxide from the incomplete oxidation of organics during electrolysis? The Group notes the assertion of this possibility by NIVA but no justification was provided.

Response 5:

.1 Please refer to Attachment 2 MSDS (P 6, ref. 10. STABILITY AND REACTIVITY). Some chemicals are added into testing water (i nfluent water), includi ng starch, in order to make sure the compliance with G8 requirements. Production or presence of carbon monoxide in trace as detected is from reactions of TRO and starch.

Group reaction – The Group noted this response.

TRO Decay (Data from Landbased Testings in NIVA)GESAMP-BWWG 11/6 ANNEX 6 Page 7

I:\MEPC\60\2-16.doc Question 6

Can you provide any literature or scientific reasoning for the presence of methane? Were either carbon monoxide or methane measured or detected in the control tank water? Is the system expected to result in th ese products when in service?

Response 6

.1 Gas measurements have been carried out both in treated tank and contro l tank water, through pilot testing, la ndbased testing and sh ipboard testing. For all testing cycles carried out, no carbon m onoxide or methane is detected in control tank.

.2 Reasoning for th e presence of methane is as follow ing. TRO are substa nces with very strong oxidizing prop erty, and can have redox reac tions (oxidation and reduction reactions) with many diffe rent organics, with methan e as one of the outcomes.

.3 During pilot testings and landbased te stings, carbon monoxide and methane is detected in very low concentration (Note: concentration of me thane detected in landbased testings is very low, and for some cycles, even no methane is detected). During shipboard testing, only low concen tration of carbon monoxi de is detected, with no methane. When in service, there is the possibility of resulting in these products, however, the concentration is su re to be very low and insignificant.

Group reaction – The Group noted this response.

3 DESCRIPTION OF THE SYSTEM

3.1 Working Principles of the BWMS

3.1.1 Overview

3.1.1.1 The Group noted that the OceanGuard BW MS presented for Basic Approval utilizes automatic back-flushing mechanical filtration (50μ m) followed by an elect rolysis component that produces sodium hypochlorite in situ , as Active Substance, with ultr asonic treatment of the ballast water. The Group noted that balla st water goes through th e filter and the ultr asonic treatment and electrolysis in the EUT unit during ballasting. Duri ng de-ballasting, only the ultrasonic treatment phase is used. Figure 1 sche matically shows the BWMS being reviewed for Basic Approval.

Figure 1 – Schematic process diagram of BWMSGESAMP-BWWG 12/6 ANNEX 6 Page 8

I:\MEPC\60\2-16.doc 3.1.1.2 The Group recalled that sodium hypochlor ite is determined as TRO (expressed as mg Cl 2 /L). The Group noted that according to th e applicant, the biological efficacy of the BWMS is achieved mainly thr ough Active Substance generated in the water as hydroxyl radicals, not TRO. The ultrasonic treatment acts as a supplementary part, to enhance the biological efficacy. However, the Group reco mmended that the applicant expl ains the role of the hydroxyl radicals at Final Approval as a substantial difference with other BWMSs using electrolysis.

3.1.1.3 The Group recognized that the applicant stat ed in their original application dossier to treat seawater (33 PSU) at 1 mg/L (as Cl 2 ) initial maximum TRO do se and brackish water (22 PSU) at 2 mg/L (as Cl 2 ) initial maximum TRO dose. However, after communication with the applicant during the GESAMP-BWWG meeting, the applicant proposed that maximum TRO dosages applicable for OceanGuard BWMS would be 2 mg/L for the treatments with more than 2 days’ holding time, and 1.5 mg/L for the treatments with less than or equal to 2 days’ holding time, respectively. The applicant claimed th at these settings for TRO dose could ensure the MADC of 0.2 mg/L (as Cl 2 ) without any neutralization. Th e Group considered that the applicant’s approach to ensuring MADC for the Active Substance is not sufficient and recommended that the applicant ensures that th e environmentally safe MADC is not exceeded over the entire range of relevant chemical prope rties and all possible holding times. The Group considered that this could not be achievable when a 1.5 mg/L (TRO as Cl 2 ) dosed ballast water was discharged in the period up to 2 days, without a neutralization step.

3.1.1.4 The Group noted that the small-scale test ing of the ballast wate r treatment technology for Basic Approval has been carrie d out by NIVA at their test facilities near Oslo in Norway in January 2009. Also the Group noted that the sma ll-scale tests have been carried out using medium salinity brackish water (between 3 a nd 32 PSU, ca. 22 PSU) and high salinity seawater (>32 PSU, ca. 33 PSU) according to Guidelines (G8). However, the Group recognized that certain of the conditions may not have been fu lly achieved according to the Guideline as the testing may not have been performed under adequate QAPP.

3.1.1.5 As the BWMS does not require the st orage of chemicals on board ship, the Group recognized that there will not be any a ssociated storage safety problems.

3.1.2 Description of test system used for Basic Approval

3.1.2.1 The Group noted that according to the appl icant, simulative seal ed ballast tanks for treated and control ballast water were set up according to the IMO requirements. Tests with seawater (ca. 33 PSU) and brackish water (ca. 22 PSU) were carried out in different time periods, but with the same procedure and a flow rate of 2 m 3 /h. Ballasting of treat ed water and control water was on the same day. Test water was pumpe d in, through the filter and the complete EUT unit treatment, into the 1 m 3 treated ballast tank. On day 5, the pum p was used to mix the water in the tank and treated water was di scharged with ultrasonic treatme nt only (see Figure 1 above).

3.2 Safety and Control

3.2.1 The Group noted that the control unit for the entire system is in charge of various types of sensors, handling of alarm signals, as well as st artup and shutdown of the system and it contains controlling procedures and displa ys the operating conditions of the BWMS. The applicant states that if the treatment system fa ils, it will make an audio and light alarm and automatically switch to a safe mode. Data of operating conditions of the system can be recorded, memorized, displayed and printed. Authoriz ed operators can take contro l and make manual adjustments through this control unit. The Group additiona lly recommended that suitable monitoring andGESAMP-BWWG 11/6 ANNEX 6 Page 9

I:\MEPC\60\2-16.doc shutdown facility be incor porated to ensure that a MADC of 0.20 mg/L TRO as Cl 2 cannot be exceeded at any time, full details of such an arra ngement should be provided in any application for Final Approval.

3.2.2 The Group noted that according to the applican t, parameters like salinity, flow rate, TRO and EUT power consumption can be measured by the sensors. The control unit can respond to the system conditions and initiate adjustments accurately in time to get an ideal treatment effect. Salinity, flow rate and TRO are very important pa rameters in the process. The most suitable initial operational mode of the EUT unit can be set by the cont rol unit through the internal memory procedures. With the TRO sensors, po wer supply parameters can be adjusted by the control unit, so that suitable initial TRO level can be set to ensure the biological treatment efficacy and also to limit the discharge toxicity. Data from TRO sensors are transmitted to the control unit. If the data indicate that TRO is higher than the required va lue set, parameters of EUT power supply will be adjusted to lower the initi al TRO level, and vice versa. Therefore, the initial concentration of TR O will remain in a range of constant concentration.

3.2.3 The Group noted that the applicant has provi ded some information on fire prevention and exposure to gases from the BWMS. In test s with 33 PSU seawater treated at 1 mg Cl 2 /L initial TRO dose and 22 PSU brackish water treated at 2 mg Cl 2 /L initial TRO dose, no hydrogen, chlorine, hydrogen sulfide, or surplus oxygen were de tected. In the tests, on day 0, just after the treatment, 25 ppmV carbon monoxide and 2.5% LEL (lower explosive limit) methane were detected. However, on day 5, th ese gases were not detected. Although the Group agreed with the applicant’s conclusion that the levels of th ese gases encountered duri ng testing to date would not cause significant concern, it is recommended that the levels of hydr ogen, methane and carbon monoxide gases in the air space of treated water tanks continue to be monitored throughout the remainder of land based and shipboard testing to validate the assumption that the risks associated with these gases remain acceptable.

3.2.4 The Group recognized that the probability of leaking or breakdown of the BWMS in normal working conditions should be small. Acco rding to the applicant, once any error occurs, the system will be stopped automatically and in stantly, and there will be light and sound alarms at the same time and that when carrying out re pairs, the operators should follow the existing safety protection measures on boa rd. It was noted by the Group that the applicant considers that the risk of exposure to chemicals is sma ll with this BWMS, but nevertheless the Group considered this possibility to remain an impor tant and relevant consideration, and recommended that an appropriate risk evalua tion for all eventualities is pe rformed and that measures and procedures to mitigate such risks identified are clearly addressed in any submission for Final Approval.GESAMP-BWWG 12/6 ANNEX 6 Page 10

I:\MEPC\60\2-16.doc 3.3 Chemical processes involved in the BWMS - Active Substance (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.3.1 The Group recalled the chemical reactions invo lved in the electrolysis of natural sea water. In the BWMS under cons ideration, according to the appli cant, the Active Substance is applied at up to the maximum allowable initial dose of 2 mg/L (as TRO Cl 2 ) into the ballast water. According to the applicant, in the te sts for Basic Approval with the initial TRO dose of 2 mg/L (as TRO Cl 2 ), after 1 day storage, the TRO level was generally below 0.2 mg/L, with some exceptions, however, the Group noted that according to the table supplied by the applicant in response to the Group’s Question 4, this was not the case.

3.3.2 The Group believed that the obs erved TRO degradation rates may significantly vary with respect to parameters other than salinity, such as DOC concentration and chlorine demands. The Group concluded that this will need confirming during the tests performed for Final Approval using seawater and brackish water with lower content of DOC. If the applicant finds that there would be any possibility of lower de gradation rates of TRO in the ballast tank, then additional mitigation measures, such as neutralization, should be installed to ensure an environmentally safe MADC under all possible conditions.

3.3.3 In the case of Relevant Chemicals, the Group recognized that trihalomethanes (THM), haloacetic acids (HAA) and sodium bromate are included amongst many possible disinfection by-products. A selected list of Relevant Chemi cals is presented by the applicant in Table 1 below, which includes AOX, EOX, bromate ion, THM, phenols and other halogenated organics. As is shown in Table 1, tribromomethane is th e main THM in the tested halogenated organics listed. In the test cycles se lected by the applicant, i.e. seawater (33 PSU) treated with 1 mg Cl 2 /L initial TRO, and brackish wate r (22 PSU), treated with 2 mg Cl 2 /L initial TRO, the maximum levels detected are as fo llows: dibromochloromethane 5 μg/L, tribromomethane 150 μg/L, dibromoacetic aci d 5.9 μg/L, 2,4,6-tribromophenol 0.1 μg/L and bromate ion 3.5 μg/L (refer to section 3.5, NIVA report). Theref ore, these five Relevant Chemicals are identified by the applicant and listed separately in Table 2.

3.3.4 However, the Group noted that the TRO dose for high salinity water (33 PSU) was initially set by the applicant as 1 mg/L which is only half of that in the applicant’s revised proposal. The Group considered that the results for high salinity water did not simulate the treatment proposed, and recommended that ad equate testing should be performed during land-based testing for Final Approval. Also th e Group recommended that the applicant should carefully select multi-timing sampling for chemical analysis and ecotoxicity testing during the tank holding time. Particularly for this BWMS according to the applicant’s TRO dose, not only 2, 3 and 5 days’ holding time with 2 mg/L TRO but also 0, 1 and 2 days’ holding time with 1.5 mg/L TRO should be considered as sampling timings. The worst case scenario (concentrations of Relevant Chemicals) obser ved among these multi-timings should be used for PEC calculations at Final Approval.GESAMP-BWWG 11/6 ANNEX 6 Page 11

I:\MEPC\60\2-16.doc Table 1 : Relevant Chemicals co ncentration in seawater (33 PSU) and brackish water (22 PSU) tests, as selected by th e applicant for further development (samples are collected after 5-day storage)

Component Unit Seawater (33 PSU) Day 5 Brackish water (22 PSU)

Day 5 Trichloromethane μg/L <0.50 <0.50 Bromodichloromethane μg/L <0.50 <0.50 Dibromochloromethane μg/L 1.7 5 Tribromomethane μg/L 44 150 Monochloroacetic acid μg/L <0.50 <0.50 Dichloroacetic acid μg/L <0.30 <0.30 Trichloroacetic acid μg/L <0.20 <0.20 Monobromoacetic acid μg/L <0.20 <0.20 Dibromoacetic acid μg/L 0.66 5.9 Bromochloroacetic acid μg/L <0.10 <0.10 Bromodichloroacetic acid μg/L <0.10 <0.10 Dibromochloroacetic acid μg/L <0.10 <0.10 Tribromoacetic acid μg/L <0.10 <0.10 2,4-Dibromophenol μg/L <0.10 <0.10 2,6-Dibromophenol μg/L <0.10 <0.10 2,4,6-Tribromophenol μg/L <0.10 0.1 1,2-Dibromomethane μg/L <1.0 <1.0 1,2,3-Trichloropropane μg/L <1.0 <1.0 2-Chlorotoluene μg/L <0.50 <0.50 4-Chlorotoluene μg/L <0.50 <0.50 1,2-Dibromo-3- chloropropane μg/L <1.0 <1.0

1,3,5-Tribromobenzene μg/L <1.0 <1.0 AOX mg/L 0.02 0.1 EOX mg/L <0.010 0.012 Bromate ion μ g/L 1.0 3.5

Table 2 : Selected Relevant Chemicals in treate d ballast water (the highest concentration in the tested waters of different quali ty, as selected by the applicant)

Name Concentration (μg/L) Dibromochloromethane 5 Tribromomethane 150 Dibromoacetic acid 5.9

Tribromophenol 0.1

Bromate ion 3.5GESAMP-BWWG 12/6 ANNEX 6 Page 12

I:\MEPC\60\2-16.doc 3.3.5 The applicant indicated that the list for Re levant Chemicals may be incomplete at this point and that this area is to be further invest igated during land-based and shipboard testing for Final Approval (see paragraph 3.3.4).

3.3.6 In the case of Other Chemicals, the Group noted that the applicant has presented some information on concentrations of various gases produced by the BWMS. The information from the applicant in this ar ea is shown in Table 3.

Table 3 : Concentration of gases detected from the BWMS (Refer to section 3.2, NIVA report)

Gas Unit Salinity (PSU) TRO (m g /L ) Day 0 Day 5
33 1 0 0 Hydrogen % LEL
22 2 0 0
33 1 0 0 Chlorine ppmV
22 2 0 0
33 1 20.9 20.9 Oxygen % v/v
22 2 20.9 20.9
33 1 0 0 Carbon
monoxide ppmV
22 2 25 0
33 1 0 0 Hydrogen
sulfide ppmV
22 2 0 0
33 1 0 0 Methane % LEL
22 2 2.5 0

4 HUMAN HEALTH ASSESSMENT

4.1 Considerations for Risk Assessment

4.1.1 The Group noted that the applicant had assess ed the toxicological hazards and potential human exposure associated with chemicals of potential concern generated by the BWMS, which include the Active Substance sodi um hypochlorite and Relevant Chemicals such as chloroform, bromoform, dibromoacetic acid, bromate, carbon monoxide and methane. The applicant used as the worst-case approach the concentrations of tribromomethane (bromoform) as detected in the treated ballast water and several exposure paramete rs to assess dermal exposure to crew and oral, dermal exposure to the general public as describe d in the confidential part of the dossier.

4.1.2 The Group noted that the measured concentr ations of the detected substances in the discharged treated ballast wate r were below the threshold values for drinking water (WHO, 2005) except in the case of tribromo methane (bromoform) where an exposure assessment and risk evaluation were performed. The Group concurred w ith the applicant that the MOS assessment of tribromomethane for crew (occupational exposure) and the general public should not pose any unacceptable risk to human health.GESAMP-BWWG 11/6 ANNEX 6 Page 13

I:\MEPC\60\2-16.doc 4.2 Assessment of exposure to Ship’s Crew

4.2.1 The Group noted that the applicant assessed two occu pational exposure scenarios, personnel working inside the ballast tank and pe rsonnel working close to the BWMS, considering dermal exposure as the exposure route of c oncern, and taking into consideration several assumptions as described in the c onfidential part of the dossier.

4.2.2 Although the Group recognized that the applicant had performed a useful tiered exposure assessment, it also considered that the chosen occupational scenarios were not sufficiently described in order to ca pture the real exposure situations. Therefore th e Group considered that the operation units associated with “personnel working inside the ballast tank and personnel working close to the BWMS” should be fully described for Final Approval.

4.2.3 The Group concurred with the applicant that under normal conditions the ship’s crew (including BWMS operators) would not be exposed to sodium hypochlorite and by-products in the treated ballast water unless there is a failure of the system or when performing service on the system. The Group recognized that the risks associ ated with these scenarios can be mitigated by numerous system safety measures (leak detection, gas removal, equipment isolation, stray current protection, interlocks, etc) and by following the use of appropriate personal protective equipment when performing maintenance and/or repair on th e system, and such mitigation measures should be detailed in the applic ation for Final Approval.

4.2.4 In addition, the Group noted that the em ission concentration of carbon monoxide (25 ppmV) as measured in the treated ballas t water was well below the permissible exposure level (PEL), for 8 hours, set by US OSHA (50 ppmV). However, other occupational exposure levels (OELs) are set at 25 ppmV with short e xposures limited to 100 ppmV, therefore, the Group recommended that carbon m onoxide should be further monitored during testing, as recommended in section 3, and additional risk mitigation measures (e.g., PPE/RPE) should be put in place as appropriate.

4.3 Exposure of General Public through the environment and by the Food Chain

4.3.1 The Group noted that the applicant considered the exposure to the general public taking into account as the worst case s cenario, the sea bathers in the ha rbour areas (child ren, adults and elders) being exposed by the de rmal route to bromoform.

4.3.2 The Group considered that sea bathers in the har bour areas could potentially be exposed to discharged treated ballast water however concentrations in ballast water would be diluted in the sea water to which bathers could be exposed. In addition, as discussed above, the measured ballast water concentrations of various chemic als were generally lower than their respective reference values. Therefore, no adverse health effects would be expected from bathers exposed to diluted concentrations of these chemicals.

4.3.3 The Group concurred with the applicant that the general public pot entially exposed via consuming seafood from the harbour area where the treated ballast water ma y be discharged is unlikely to be exposed to chemicals generate d by the system due to low bioaccumulative potential (log K ow less than 4) and consequently would not be expected to persist in the food chain.GESAMP-BWWG 12/6 ANNEX 6 Page 14

I:\MEPC\60\2-16.doc 4.4 Conclusion on Human Health assessment

4.4.1 The Group considered that the semi-quantita tive human exposure assessment submitted by the applicant is sufficient to recommend that Basic Approval is granted to the BWMS.

5 RISKS TO SAFETY OF THE SHIP , ITS CREW AND THE GENERAL PUBLIC

5.1 Safety of the ship

5.1.1 The Group noted that the pr oposed specific countermeasures to be employed in this system to deal with envisaged emergency and sa fety problems during the ballast water treatment have been summarized above. In particular a summary of the va rious safety measures developed by the applicant is given above in section 3.

5.1.2 The Group noted that according to the applicant, all the unit s of this system, including the pipelines and ballast tanks are made of anti-corrosion materials or have anti-corrosion coatings. In this system, organisms are killed by a certain concentration of oxidants and there is the possibility of enhancing the corrosion to balla st tanks by the oxidants from this system. However, the degradation rate is very fast when the concentration of the oxidants is low, so the possibility of corrosion is predicted by the applicant to be very low.

5.1.3 The Group recommended that comprehensiv e corrosion testing be conducted for Final Approval, taking into account the guidance in section 5.1 of the “R eport of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

5.1.4 The applicant has considered the produc tion of hydrogen gas during electrolysis and concluded that the levels produced should not pose any unacceptable risk to the ship. The Group also notes that no gas separator is included in th e system to mitigate the risk of the production of hydrogen during electrolysis, but also recognizes that such gas production will be lower than experienced in other systems utilizing electrolys is due to the lower levels of oxidants being generated in this system. The Group also noted that limited quantities of methane and carbon monoxide were found to occur when the test wa ter was treated by this system. Although the Group agrees with the applicant’ s conclusion that the levels of these gases encountered during testing to date would not cause significant concern, it is reco mmended that the levels of hydrogen, methane and carbon monoxide gases in the air space of treated wa ter tanks continue to be monitored throughout the remainder of land- based and shipboard testing to validate the assumption that the risks associated w ith these gases remain acceptable.

5.2 Safety of the crew

5.2.1 The Group considered that risk to safety of the ships’ crew (BWMS operators included) by exposure to chemicals and treated ballast wa ter during normal operation of this treatment system can be accepted based on the measures developed by the applicant for installation onboard ship. A summary of the various safety me asures developed by the applicant is given above in section 3. The Group considered that in this system, the risk to ships’ crew is judged to be appropriately managed based on the facts that the Active Substance is produced in situ as well as that system components are adopte d that are expected to minimi ze the exposure risk of ships’ crew to chemicals and ballast water before and after treatment, through the exposure routes of concern assessed, as discussed above in section 4, however emergency scenario events remain to be fully addressed.GESAMP-BWWG 11/6 ANNEX 6 Page 15

I:\MEPC\60\2-16.doc 5.3 Safety of the general public

5.3.1 The Group considered that the operation of th is system should pos e no unacceptable risk to the health of the general public according to the outcome of the human exposure routes of concern assessed, as discu ssed above in section 4.

6 ENVIRONMENTAL RISK ASSESSMENT

6.1 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

6.1.1 The Group noted that the appli cant has made a listing of pers istence (P), bioaccumulation (B) and toxicity (T) criteria fo r the Active Substance and Relevant Chemicals found in the treated ballast water and this is presented in the dossier for Basic Approval. Although sodium hypochlorite shows significan t chronic toxicity and tribromomethane is fairly persistent in the environment, no Active Substance or Relevant Chemical fulfilled more than one of the PBT criteria, and none therefore are e ligible for a PBT classification.

6.1.2 Based on these results, the Group concluded that these chemicals should not be classified as PBT-substances.

6.2 Acute ecotoxicity testing of treated ballast water

6.2.1 The Group noted that acute aquatic ecotoxicity tests for the treated ba llast water produced by the BWMS were carried out by the applicant on algae, invertebrates and fish with treated water sampled on day 5. The 1 mg/L (as Cl 2 ) initial maximum TRO dose was chosen for full ecotoxicity testing of seawater (33 PSU). The test concentrati ons of 2 mg/L and 4 mg/L TRO were only tested with respect to marine algal growth inhibiti on. The 4 mg/L (as Cl 2 ) initial maximum TRO dose was chosen for full ecotoxicity testing of brackish water (22 PSU), based on the rapid decay of TRO in brackish water and lo w concentrations of TRO measured on day 5. The test concentrations of 1 mg/L and 2 mg/L (TRO as Cl 2 ) in brackish water were only tested with respect to algae toxicity.

6.2.2 Seawater testing results

6.2.2.1 The Group noted that results of ecotoxi city testing performed on treated seawater (33 PSU), sampled on day 5, are shown in Table 4. Results are presented as percentage (%) of treated ballast water. Dilution wa ter is non-treated ballast water.GESAMP-BWWG 12/6 ANNEX 6 Page 16

I:\MEPC\60\2-16.doc Table 4 : Ecotoxicity tests pe rformed on treated seawater (33 PSU), sampled on day 5

Test and initial TRO dose (as Cl 2 ) Species Test Result

Marine algae growth inhibition 1 mg/L Skeletonema costatum EC 10 = 92% EC 50 = >100%

Marine algae growth inhibition 2 mg/L Skeletonema costatum EC 50 = 33% EC 10 = 30%

Marine algae growth inhibition 4 mg/L Skeletonema costatum EC 50 = 18% EC 10 = 11%

Acute invertebrate 1 mg/L Acartia tonsa LC 50 = >100% NOEC = 56% Acute fish 1 mg/L Scophthalmus maximus LC 50 = >100% NOEC = ≥ 100%

6.2.2.2 According to the results, th ere is residual ecotoxici ty of seawater treat ed with the 1 mg/L initial TRO, however, after diluti on, it is safe to discharge to the environment. The Group noted that there was ecotoxicity at 2 and 4 mg/L of TRO on Skeletonema costatum with 33% and 18% of EC 50 at 5 days in the seawater ecotoxicity testing, respectively.

6.2.2.3 The Group was of the opinion that the resu lts with a TRO dose of 2 mg/L in seawater clearly indicated that unacceptable acute or short term risks could occur at discharge. The Group strongly recommended that furthe r measurement and assessment w ould be needed for the setting of TRO dose and MADC, particularly for wate rs with lower DOC concentrations. The Group invited the applicant to reconsider the installation of a neutralization system in this BWMS.

6.2.3 Brackish water testing results

6.2.3.1 The Group noted that results of ecotoxici ty testing performed on treated brackish water (22 PSU) sampled on day 5, are shown in Table 5. Results are presented as percentage (%) of treated ballast water. Dilution wa ter is non-treated ballast water.

Table 5 : Ecotoxicity test perfor med on treated brackish water (22 PSU) sampled on day 5

Test and initial TRO dose (as Cl 2 ) Species Test Result

Marine algae growth inhibition 1 mg/L Skeletonema costatum EC 50 = >100% EC 10 = ≥ 100% Marine algae growth inhibition 2 mg/L Skeletonema costatum EC 50 = >100% EC 10 = ≥ 100% Marine algae growth inhibition 4 mg/L Skeletonema costatum EC 50 = >100% EC 10 = 82% Acute invertebrate 4 mg/L Acartia tonsa LC 50 = >100% NOEC = ≥ 100% Acute fish 4 mg/L Scophthalmus maximus LC 50 = >100% NOEC = ≥ 100%GESAMP-BWWG 11/6 ANNEX 6 Page 17

I:\MEPC\60\2-16.doc 6.2.3.2 The Group noted that ecotoxicity testing of treated brackish wa ter indicates that no ecotoxicity to these indicator test organisms will be caused by the brackish water treated by the 2 mg/L initial TRO dose, even without dilution.

6.2.4 The results in the Tables 4 and 5 show th at the ecotoxicity of treated seawater and brackish water is different. No ecotoxicity will be caused by th e brackish water treated by the 2 mg/L initial TRO after 5 days holding time.

6.3 Chronic ecotoxicity tests

6.3.1 The Group noted that the chronic toxicity test s were not performed in this application for Basic Approval. It was also noted that the applicant had recognize d the need for chronic toxicity testing and further risk character ization according to the results of acute toxicity tests above.

6.3.2 The Group emphasized that Procedure (G9) clearly requires both acute and chronic ecotoxicity testing for Basic Approval. The Gro up recalled that it had, previously, made a case for waiving the chronic toxicity testing for some BWMS applications for Final Approval providing the chemical analysis de monstrated that the concentrati ons of chemical by-products are similar to those provided in the application for Basic Approval.

6.3.3 However, in this case, the Group recommended that, for Final Approval, in addition to the required acute toxicity test results, chronic toxic ity test results, carried out in accordance with Procedure (G9), should also be provided as these were missing in the application for Basic Approval, because the analogy with earlier systems are not valid in this case.

6.4 Conclusion on WET-tests

6.4.1 The Group concluded that the applicant has provided information on acute aquatic ecotoxicity testing of the treated ballast water th at is sufficient to reco mmend Basic Approval. However, the Group was of the opin ion that the information is not sufficient for full evaluation of the potential risks posed by the treated ballast water with the revised TRO dose settings. The Group recommended that both acute and chronic ecotoxi city testing of treated ballast water for at least 3 species with the revised TRO dose setti ngs described in 3.1.1.3 should be performed in accordance with the full requirements of Procedure (G9), to be reviewed for Final Approval. Also the Group recommended that the applicant should carefully select multi-timing sampling during the tank holding time (see 3.3.4).

6.5 Risk assessments of chem icals for aquatic organisms

6.5.1 MAMPEC Modelling and Predicted Environmental Concentration (PEC)

6.5.1.1 The Group noted that the applicant had employed the MAMP EC model in this application for Basic Approval to calculate PE C values of Active Substance and Relevant Chemicals in the harbour water after discharge of treated ballast water. The version 2.0 of MAMPEC is applied by the appl icant in this study. The appli cant states that ballast water discharging capacity of OECD -EU commercial harbour has an exchange volume of 51,117,000

m 3 (refer to ESD). The daily volume of discharged treated ballast water is simulated as 300,000 m 3 /d, according to the description of Port of Rotterdam in document MEPC 57/2/7. Concentration of sodium hypochlorite Active S ubstance in the discharged ballast waterGESAMP-BWWG 12/6 ANNEX 6 Page 18

I:\MEPC\60\2-16.doc is 0.05 mg/L. The results presented by the applican t show the calculated c oncentration of Active Substance in the Harbour and the Surroundings, as follows:

Average concentration of the Harbour: 1.51x10 -2 μg/L (= PEC); Maximum concentration of the Harbour: 3.27x10 -2 μg/L; Average concentration of the Surroundings: 7.72x10 -4 μg/L; Maximum concentration of the Surroundings: 4.00x10 -3 μg/L.

6.5.1.2 The Group noted that the MAMPEC model version 2.0 had been used to calculate the Predicted Environmental Concentr ations (PEC) of the Active Substance and Relevant Chemicals associated with this system, using the OECD -EU commercial harbour and the ballast water discharge description of the Port of Rotte rdam as the model harbour. The Group accepted the MAMPEC calculations of th e applicant and was able to reproduce the values of the calculated concentrations of the Active Substance in the har bour and the surroundings as stated above.

6.5.2 Aquatic Ecotoxicity and Predicte d No-Effect Concentration (PNEC)

6.5.2.1 The Group noted that the applicant has prov ided a comprehensive data-base of acute and chronic aquatic ecotoxicity data in the present dossier, for both the Active Substa nce and Relevant Chemicals. Key data for the Active Substance are summarized in Table 6. The Group noted that the applicant has calculated the PNEC value for the Active Substance using the lowest value of the data against different species. The assessment factor is selected according to the Methodology for information gathering and th e conduct of work of the GESAMP-BWWG. According to the shortest period LC 50 of species from two different trophic levels, and lowest chronic NOEC of species from several different trophic levels, the factor is decided by the applicant to be 50.

Table 6 : Summary of Key Acute and Chronic Aquatic Ecotoxicity Data, for the Active Substance, and Calc ulation of PNEC Value (a s presented by applicant)

Species Effect Value (μg/L) Minimum Assessment factor PNEC Menidia beryllina (fish/sea) 96hLC 50 128 Mysid (crustacea/sea) 96hLC 50 62 Menidia peninsulae (fish/sea) NOEC (28d) 40

Dreissena polymorpha (mollusc/fresh) NOEC (20d) 500

Crassostrea virginica (sea) NOEC (13d) 7 Natural algae (algae/fresh) NOEC (24d) 79 NOEC (7d) 3 3 (μg/L) 50 0.06 μg/LGESAMP-BWWG 11/6 ANNEX 6 Page 19

I:\MEPC\60\2-16.doc 6.5.3 Risk to the aquatic envi ronment – PEC/PNEC Ratio

6.5.3.1 The Group noted that the calculation of the PEC/PNEC ra tio by the applic ant uses the values obtained above and gives the following result:

PEC/PNEC = 0.0151 μg/L / 0.06 μg/L = 0.252 (ratio is <1). Therefore, this value of the PEC/PNEC ratio is less than 1 and therefore should indicate no unacceptable effects caused by the Active Substance TRO to the environment when discharging treate d ballast water.

6.5.4 Relevant Chemicals

6.5.4.1 The Group recognized that the applicant, in addition to the above assessment of the Active Substance, had employed the MAMPEC mode l in this application for Basic Approval to calculate PEC values of selected Relevant Chem icals in the harbour wa ter after discharge of treated ballast water. Comparison was then made with PNEC values obtained for the different Relevant Chemicals.

6.5.4.2 The Group noted that the applicant refers to Table 2 where concentr ations of 5 selected Relevant Chemicals in treated ballast water are presented (the highest c oncentration found in the tested waters of different quality). The a pplicant then notes that concentrations of dibromochloromethane, dibromoacetic acid, 2,4 ,6-tribromophenol and bromate ion, even in undiluted treated water, are lower than the PNEC value, so they should not have any effects on the aquatic environment when be ing discharged. Concentrations of tribromomethane in undiluted treated water exceed the relevant PNEC value, so treated water needs to be diluted in order to make sure it will not cause any effects to aqua tics. By adopting the MAMPEC model scenario, the PEC/PNEC ratio of tribromomethane calculated by the applicant is lower than 1. Therefore, it is presumed by the applicant that the possibility of ecotoxicity from the treated ballast water to the environment caused by Relevant Chemicals is insignificant after dilution by port seawater.

6.6 Conclusion from Environmental Risk Assessment

6.6.1 The Group recognized that the applicant has provided information on environmental risk assessment for aquatic organisms and has proposed a maximum allowable discharge concentration (MADC) for the Active S ubstance of 0.2 mg/L (TRO as Cl 2 ). The Group considered that the applicant’s approach to ensuring MADC for the Active Substance is not sufficient and recommended that the applicant en sures that the environmentally safe MADC is not exceeded over the entire range of relevant chem ical properties and all possible holding times.

6.6.2 The Group noted that the applicant has provi ded information on acute aquatic ecotoxicity testing of the treated ballast water that is su fficient to recommend Basic Approval. The Group recommended that both acute and chronic ecotoxic ity testing of treated ballast water with the revised TRO dose settings described in 3.1.1.3 for at least 3 species should be performed in accordance with the full requirements of Procedur e (G9), to be reviewed for Final Approval.

6.6.3 The Group agreed with the MAMPEC modeling to calculate the Pred icted Environmental Concentrations (PEC) of the Active Substance a nd Relevant Chemicals associated with this system and accepts the MAMPEC calculations of the applicant.GESAMP-BWWG 12/6 ANNEX 6 Page 20

I:\MEPC\60\2-16.doc 7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to safety of the ship

7.1.1 The Group noted that specific countermeasures can be employed in this system to deal with envisaged emergency and safety problems during the ballast water treatment to reduce any inherent risk to an acceptable level.

7.1.2 The Group recommended that comprehensive co rrosion testing be c onducted, taking into account the guidance in section 5.1 of th e “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

7.1.3 The Group considered that sufficient info rmation had been provided by the applicant addressing risks to the safety of the ship to allow the Group to r ecommend Basic Approval for the OceanGuard BWMS to permit further developm ent of this ballast water treatment system.

7.2 Risks to the crew and general public

7.2.1 The Group recommended that an application for Final Approval of this system should include a full description of the operation units associated with “personnel working inside the ballast tank and personnel working close to th e BWMS” and the inhalation route of exposure should also be evaluated in terms of potential adverse health effects.

7.2.2 The Group recommended that the level of car bon monoxide gas in the air space of treated ballast water tanks should continue to be mon itored throughout the remainder of land based and shipboard testing to validate the assumption that the risks associated with this gas remain acceptable.

7.3 Risks to the environment

7.3.1 The Group was able to recommend Basi c Approval for the BWMS, but the Group considered that the information provided by the applicant in the submitted dossier is not sufficient for a full evaluation of the risks posed by the treated ballast water with the applicant’s revised dose setting described above. The Group c onsidered that the appl icant’s approach to ensuring MADC for the Active Substance is not sufficient and recommended that the applicant ensures that the environmentally safe MADC is not exceeded over the enti re range of relevant chemical properties and all possible holding times.

7.4 Recommendation

7.4.1 Having reviewed all the data and information submitted by Norway for Basic Approval and the information supplied by th e applicant in response to que stions posed by the Group during this GESAMP-BWWG meeting, the Group was ab le to recommend Basic Approval for the OceanGuard BWMS.

7.4.2 The Group made the following recommendations or requests for information, if this system is to be reviewed for Final Approval in the future:

.1 The Group recommended that the applican t ensures that the environmentally safe MADC is not exceeded over the entire range of relevant chemical properties and all possible holding times;GESAMP-BWWG 11/6 ANNEX 6 Page 21

I:\MEPC\60\2-16.doc .2 The Group recommended that suitable m onitoring and shut-down facility be incorporated to ensu re that a MADC of 0.20 mg/L TRO as Cl 2 cannot be exceeded at any time;

.3 The Group recommended that if the a pplicant finds that there would be any possibility of lower degrad ation rates of TRO in th e ballast water tank, with respect to parameters other than salinity, such as DOC concentration and chlorine demands, then additional mitigation measur es, such as neutralization, should be installed to ensure an environmentally safe MADC under all possible conditions;

.4 The Group recommended that the appli cant should carefully select multi-timing sampling during the tank holding time, accord ing to the applicant’s TRO dose, not only 2, 3 and 5 day holding time with 2 mg/L TRO but also 0, 1 and 2 day holding time with 1.5 mg/L TRO should be consid ered as sampling timings. The worst case scenario (concentrations of Rele vant Chemicals) observed among these multi-timings should be used for PEC calculations;

.5 The Group recommended the applicant to consider the gui dance provided in section 5.1 of the “Report of the ei ghth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16, in conducting corrosion tests;

.6 The Group recommended the applicant to confirm by further testing, that there will be no unacceptable risks (to ship safe ty, human health or the environment) due to the chemical compositi on of treated ballast water;

.7 The Group recommended that both acute and chronic ecotoxicity testing of treated ballast water with the revised TRO dose settings for at least 3 species should be performed in accordance with the full requirements of Procedure (G9);

.8 The Group recommended that the le vels of hydrogen, methane and carbon monoxide gases in the air sp ace of treated ballast wate r tanks continue to be monitored throughout the remainder of la nd based and shipboard testing to validate the assumption that the risks associated with these gases remain acceptable; and

.9 The Group recommended that an appropria te risk evaluation for human exposure to chemicals is performed and that measur es and procedures to mitigate such risks are identified and clearly addressed, in cluding consideratio n of operation units associated with personnel working inside the ballast tank and personnel working close to the system, with detailed expl anation of all proposed risk mitigation

measures.

***GESAMP-BWWG 12/6

I:\MEPC\60\2-16.doc ANNEX 7

REVIEW OF PROPOSALS FOR APPRO VAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

Severn Trent DeNora BalPure ® Ballast Water Management System

Submitted by Germany for Basic Approval

0 SUMMARY

0.1 Having reviewed all the data and informati on submitted by Germany with the application for Basic Approval, the Group recommended to ME PC that Basic Approval be granted to the Ballast Water Management System.

0.2 The Group noted that the Severn Trent De Nora BalPure Ballast Water Management System (BWMS) uses a combination of filtration and on-demand in situ electrolysis of seawater to produce the Active Substance sodium hypochlorite to treat the ballast water by disinfection on uptake, followed by residual oxida nt neutralization with sodium bisulfite on discharge.

0.3 The Group noted that Active Substance sodium hypochlorite is not stored on board, but is generated by in situ electrolysis at a concentration of ~ 100 0 mg/L before being injected into the ballasting system. As the sodium hypochlorite en ters the ballast system it is diluted to a maximum concentration of 20 mg/L (as Cl 2 ) initial TRO dose ( normally ~ 10 mg Cl 2 /L TRO). The Group noted that the concentration of th e Active Substance (TRO) is controlled using oxidation-reduction poten tial (ORP) technology.

0.4 The Group noted that sodium bisulfite is a dded to ballast water di scharge at a slight excess (<2 mg/L) to ensure complete neutralizati on of the TRO, and control of this addition is accomplished using oxidation-reduction poten tial (ORP) technology. The Group noted that according to the applicant, due to the neutraliza tion step during ballast water discharge, the TRO in treated water discharge should be undetectable by the normal analytical method employed. The Group noted that the discha rge and predicted environmenta l concentration (PEC) for TRO proposed by the applicant is 0 mg Cl 2 /L.

0.5 The Group noted that treated ballast water discharge may contain sodium bisulfite, but recognized that in seawater bisulfite is reduced to bisulfate, and u ltimately to sulfate ions. In the marine environment, sulfate ion is ubiquitous (seawater typically contains approximately 3 g/L of sulfate ion) and therefore the Group consider ed that the discharge or environmental concentrations of sodium bisu lfite would not pose an unaccep table environmental risk.

0.6 As the BWMS requires the storage of sodium bisulfite on board sh ip, the applicant had recognized that there were associated storage sa fety problems and has iden tified appropriate risk mitigation measures. The Group reviewed th ese potential risks and found the mitigation measures proposed to be acceptable.GESAMP-BWWG 12/6 ANNEX 7 Page 2

I:\MEPC\60\2-16.doc 0.7 The Group recognized that the applicant has pr ovided information on system controls and safety considerations for installation of the BW MS on board ship, togeth er with provisions for maintenance and emergency operations of the syst em. As such the Group considered that this information provided by the applicant is sufficient to allow the Group to recommend Basic Approval.

0.8 The Group noted that the applicant indicated th at corrosion is of signi ficant concern. The applicant cited literature to i ndicate hypochlorite in levels co mmensurate with ballast water treatment will reduce the time for steel replacement in a ship by less than 5%. However, the Group did not agree with the provided analyses and cited several discrepancies with published and accepted corrosion rates. The Group considered that an analysis of the potential corrosion impacts of the Active Substance in the provid ed report alone is insufficient. The Group recommended that comprehensive corrosion testi ng be conducted, and invi ted the applicant to consider the guidance in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

0.9 The Group noted the provision by the app licant of some analytical results for the Active Substance, Relevant Chemicals and Other Chemicals in treated ballast water. As such the Group considered that this information provi ded by the applicant in the submitted dossier is sufficient to allow the Group to recommend Basi c Approval. The Group recommended that an application for Final Approval of this system s hould include confirmation by further testing, that there will be no unacceptable risks (to ship safet y, human health or the environment) due to the chemical composition of ballast water treated by this BWMS.

0.10 The Group noted the information submitted by the applicant on human health assessment that includes occupational exposure (BWMS techni cians, ship’s crew and dock workers) and the exposure of the general public (beachgoers and consumers of seafood). As such the Group considered that this information provided by the applicant in the submitted dossier is sufficient to allow the Group to recommend Basic Approval.

0.11 Notwithstanding, the Group recommended to the applicant to take in to consideration the exposure during sampling of ballast water at discha rge (inhalation, dermal contact), as well as during periodic sediment cleani ng (inhalation, dermal contact). These scenarios should also be considered by the applicant in the conceptual exposure model (CEM) for Final Approval.

0.12 The Group noted that the applicant had not performed an environmental exposure assessment using an appropriate model for Basic Approval and the applican t indicated that such an analysis would be performed for Final Ap proval. The Group was of the opinion that this should be considered as an omission in the Ba sic Approval dossier, but b ecause of the extensive chemical analysis of the treated ballast water an d the results of the acute and chronic ecotoxicity testing, the Group considered this was acceptable in this par ticular case due to the other information provided. The Group recommended th at all missing information be provided for Final Approval as indi cated by the applicant.

0.13 The Group noted that the applicant has pr ovided information on environmental risk assessment for aquatic organisms and has proposed a maximum allowable discharge concentration (MADC) for the Active Substance of 0 mg/L (TRO as Cl 2 ) to be achieved using residual oxidant neutralization w ith sodium bisulfite on discharg e. The Group considered that this is acceptable subject to the applicant verifying that the neutralization is effective at all times (MADC < 0.2 mg/L TRO as Cl 2 ).GESAMP-BWWG 12/6 ANNEX 7 Page 3

I:\MEPC\60\2-16.doc 0.14 The Group noted that there was algal toxi city existing with 66.1% of E(L)C50 with brackish water at 9.1 mg/L (TRO as Cl 2 ) at 5 days after treatment and with neutralization. Consequently, the Group recommended that due to the algal toxicity, both acute and chronic ecotoxicity testing of treated ba llast water be performed in accordance with the full requirements of Procedure (G9) at the maximum proposed tr eatment dose, for review at Final Approval.

0.15 In conclusion, having reviewed all the information submitted by Germany in the application for Basic Approval, the Group agreed to recommend to the MEPC that Basic Approval be grante d to this BWMS. The Group r ecommended that in any future submission for Final Approval of this BWMS, th e recommendations given in this report are taken into account.

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted fr om that supplied by Germany in document MEPC 60/2/9 and in the confidential dossier.

2 COMPLETENESS OF DOSSIER AND APPLICANT RESPONSES TO DATA REQUESTS FROM THE GROUP

2.1 Having reviewed all the data and informa tion submitted by Germany for Basic Approval, the Group agreed that the information contained in the dossier was suffi cient to complete the Basic Approval evaluation and no further clarification was re quired from the applicant.

3 DESCRIPTION OF THE SYSTEM

3.1 Working Principles of the BWMS

3.1.1 Overview

3.1.1.1 The Group noted that in the BalPure BW MS, ballast water trea tment is accomplished using a simple three-step process of filtration, injection of Active Substance sodium hypochlorite (NaOCl) solution, and re sidual oxidant neutra lization. The first pha se is filtration using a 40 micron stainless steel mesh filter. The second phase of the treatment process is electrochemical generation on-demand in situ of the biocide solution. This involves passing a small supply (1/100 of total ballast flow) of seawat er, either from the incoming ballast water line or sea cooling water, through electrolytic cells, where it is subjected to medium amperage, low voltage direct current. The resu lting disinfectant solution is inject ed directly into the incoming ballast water line. Any residua l oxidant at discharg e is neutralized usi ng sodium bisulfite (NaHSO 3 ). Figure 1 schematically shows the BWMS being reviewed for Basic Approval.GESAMP-BWWG 12/6 ANNEX 7 Page 4

I:\MEPC\60\2-16.doc Figure 1 – Schematic process diagram of BWMS

3.1.1.2 The Group noted that the Active Substan ce sodium hypochlorite is determined as TRO (expressed as mg Cl 2 /L) in the dossier. The Group noted that the Active Substance is not stored on board, but is generated in situ at a concentration of ~ 1000 mg/L before being injected into the ballasting system. As the sodium hypochlorite en ters the ballast system it is diluted to a maximum concentration of 20 mg/L (as Cl 2 ) initial TRO dose ( normally ~ 10 mg Cl 2 /L TRO). The Group noted that the concentr ation of the sodium hypochlorite solution is controlled using oxidation-reduction poten tial (ORP) technology.

3.1.1.3 The Group noted that sodium bisulfite (38% aqueous solution) is added to ballast water discharge at a slight excess (<2 mg/L) to ensure complete oxidant neutralization of the TRO, and control of this addition is accomplished usi ng oxidation-reduction potential (ORP) technology. The Group noted that according to the applicant, due to the neutralization step during ballast water discharge, the TRO in treated water discharge should be undetectable by the normal analytical method employed.

3.1.1.4 The Group recognized that treated ballast water discharge may contain sodium bisulfite, but in seawater bisulfite is reduc ed to bisulfate, and ultimately to sulfate ions. In the marine environment, sulfate ion is ubiquitous and theref ore, the Group considered that the discharge or environmental concentrations of sodium bisu lfite should not pose unacceptable environmental risks.

3.1.1.5 As the BWMS requires the storage of sodi um bisulfite (38% aqueous solution) on board ship, the applicant had recognized that there we re associated storage safety problems and has identified appropriate risk mitigation measures . The Group reviewed these potential risks and found the mitigation measures proposed to be acceptable.

3.1.1.6 The Group noted that according to the applicant, the BalPure BWMS can be applied to ships with ballast water flow requirements from 100 to 10,000 cubic meters per hour. The system can be delivered as a complete system on one skid or divided into seven separate smaller skids based on specific unit operation (pumpi ng, hypochlorite generation, hydrogen-hypochlorite separation, bisulfite storage, bisulfite metere d addition, instrument an d controls, and power rectification).

3.2 Safety and Control

3.2.1 The Group noted that the BalPure BWMS is designed to adjust the hypochlorite production rate by monitoring the operating voltage of the electrolytic cel ls and increasing the rectifier operating amperage to sustain the TRO concentration required to treat incoming ballastGESAMP-BWWG 12/6 ANNEX 7 Page 5

I:\MEPC\60\2-16.doc water. These adjustments are small and used to control the hypochlor ite production rate to a narrow range. According to the applicant, by monitoring the operating voltage of the electrolytic cells and adjusting the amperage applied, the Programmable Logic Controller (PLC) programming of the BalPure system guarantee s effective operation over a wide temperature and/or PSU range.

3.2.2 The Group noted that operati onal control of the BalPure system is accomplished by the main control panel or by the remote panel lo cated in the cargo control room. Together, the control panel and the transformer/ rectifier unit comprise the main PLC control and rectification components. The control panel prov ides a visual display of the stat us of the rectifier DC voltage and current, and can alert the operator of any syst em alarms via the opera tor interface terminal (OIT). The main control panel also has a lo cal emergency stop push button. All major equipment such as booster pumps, bisulfite metering pumps, and hydrogen blowers can be controlled from the main control panel. Other system monitoring and c ontrol devices include a magnetic flow transmitter to monitor the flow of s eawater at the electrolysis inlet, transformer temperature switches that monitor the internal te mperature of the rectifie r, and airflow switches that monitor the hydrogen gas dilution blowers.

3.2.3 The Group noted that accordin g to the applicant, during the automatic ballasting mode, the system will sense that adequate seawater flow is available using a flow meter in the main ballast line. Once the system is primed with sufficient water (an approximate 1 minute cycle), the transformer/rectifier will s upply DC current to the electr olysis unit and initiate the electrochemical generation process. The hypochlor ite production rate is primarily tied to the ballast flow rate and achieves the pre-set re quired oxidant concentr ation by modulating the rectifier output amperage to coin cide with the ballast flow rate . The produced oxidants are then injected into the main ballast line. If necessa ry, the system may also be operated in manual mode.

3.2.4 The Group noted that the BalPure BWMS re mains in a stand-by mode until the flow meter in the main ballast line detects ballast water flow and activates the BalPure system. Using an inline booster pump, the BalPure system typically receives <1% of the total incoming ballast water flow as a side-stream off the main ballast intake line. An inlet flow transmitter, designed to protect the treatment system, will shut down the electrical current to the electrolysis unit should seawater flow through th e electrolyser drop below 80% of the design flow rate. The filtered seawater passes through a heat sink where it absorbs excess heat generated by the siliconcontrolled rectifiers . The seawater then passes through a seri es of electrolytic cells, which are connected to the transformer/rectifier. The electr olysis units then genera te the Active Substance along with hydrogen gas (H 2 ) as a by-product.

3.2.5 The Group noted that according to the applicant, the BalPur e system has several safety mechanisms that are engineered into the syst em to ensure that hydrogen gas is effectively removed from the ship. These include a patent ed cyclone separator de vice that removes the hydrogen gas from the biocide solution and re dundant non-sparking blowers to reduce the concentration of hydrogen gas to <1% within a vent lin e to the atmosphere outside the ship. Additionally, a hydrogen gas detect or is located in the space(s) where hydrogen gas may enter should a BalPure system failure occur. The PL C monitors and controls all of these safety features and will result in an alarm condition sh ould the system require maintenance. The Group recalled that the LEL (Lower Explosive Limit) for hydrogen gas is 4% and the operating limitations on the system therefore provide a safety factor which is consid ered by the Group to be acceptable.GESAMP-BWWG 12/6 ANNEX 7 Page 6

I:\MEPC\60\2-16.doc 3.2.6 The Group noted that in the de-ballast mode of operation, the last pha se of the treatment process, residual oxidant present in the ballast tank is neutralized w ith sodium bisulfite just prior to discharge from the ship. Complete neutraliza tion of residual oxidants is ensured using ORP technology and bisulfite metering pumps. Two ORP probes are used ; one confirms the presence of residual oxidant exiting the ballast tanks, while the second probe monitors and controls the addition of sodium bisulfite to neutralize TRO during ballast wa ter discharge. The first ORP probe is located upstream of the bisulfite injec tion point, and the second ORP probe is located downstream of the bisulfite inject ion point. As a fail-safe measure, the BalPure system is fitted with two redundant bisulfite metering pumps; one pump is the primary dosing pump and the second is an on-line ready spare.

3.2.7 The Group recognized that the only chemical that will require on board storage and handling is the neutralizing agent, sodium bisulf ite (38% aqueous solution). Moreover the Group recognized that this is non-fla mmable and does not present any on board fire risk. With the BalPure system, sodium bisulfite is stored in stainless steel tanks designed for installation in a marine setting. The Group considered that th e only potential activities that may require “handling” of bisulfite is either system main tenance or chemical re-supply operations. Normal operation of the BalPure system involves automa tic chemical dosing and does not require contact with any chemicals. Proper personal protective equipment (PPE) will be worn and only properly trained BalPure technicians or representatives will be allowed to perform sodium bisulfite re-supply.

3.2.8 The Group noted that according to the applicant, in the event there is an accidental release of sodium bisulfite on board shi p, the spill should be contained and neutralized with an alkali such as sodium carbonate, sodium bicarbonate, soda ash, lime or limestone granules. All spilled material and neutralization resi dues must be disposed of in accordance with applicable regulations. Decomposition of sodium bisulfite may liberate sulfur dioxide, which can be harmful when inhaled. Adequate ventilation and respiratory protection are required in any area of accidental release. The Group considered that in the event of a marine environment release, sodium bisulfite is water soluble and will not ca use unacceptable environmental impacts as it will quickly be converted to sulfate. Overall, the Group concluded that the potential risks from sodium bisulfite (38% aqueous solution) storage have been adequately addressed and are minimal.

3.3 Chemical processes involved in the BWMS – Active Substance (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.3.1 The Group recalled the chemical reactions involved in the electr olysis of natural seawater. The Group also recalled that Active Subs tance sodium hypochlorite is determined as TRO (expressed as mg Cl 2 /L), and the dosing concentration of TRO in this BWMS has been fully discussed above at section 3.1.1.2. In a ddition, the Group noted that the applicant has performed analyses for TRO levels in treated ballast water and the results are presented in the appendix, section 4 (Table A4).

3.3.2 The Group recognized that during the electrol ysis process, hydrogen gas is produced. For this reason, H 2 is classified as a Relevant Chemical , however, the hydroge n gas produced is immediately separated from the solution and rem oved from the system via ventilation to the atmosphere – see above at sect ion 3.2.5. The Group concluded that the risks asso ciated with hydrogen gas are being adequately addressed.GESAMP-BWWG 12/6 ANNEX 7 Page 7

I:\MEPC\60\2-16.doc 3.3.3 The Group noted that the applicant has provid ed analyses of trea ted ballast water for Active Substance, Relevant Chemicals and Other Chemicals as part of this application for Basic Approval. In the case of Relevant Chem icals and Other Chemical s, the Group recognized that trihalomethanes (THM), haloacetic acids (HAA) and sodi um bromate are disinfection by-products (DBP), and the applicant has perfor med analyses for these chemicals in treated ballast water – see appendix, section 6 (Tables A6, A7 and A8).

3.3.4 The applicant identified the preliminary nature of the data sets provided on the analysis of Active Substance, Relevant Chemicals and Other Chemicals in treated ballast water in this submission and that this is to be further inves tigated during land-based a nd shipboard testing for Final Approval.

4 HUMAN HEALTH ASSESSMENT

4.1 Considerations for risk assessment

4.1.1 The Group noted that the risk assessment methodology used by the applicant was based on the identification of complete exposure path ways concerning the different exposure scenarios which could represent a human health concern (U S EPA, 1989). On every situation, the complete exposure pathway required four key elements : chemical sources; migration routes (i.e. environmental transport); potentially expos ed human receptors; and routes of exposure to impacted media (e.g., ingestion of chemicals in water). Potential human receptor groups and exposure routes are described in the Conceptu al Exposure Model (CEM) as presented by the applicant. Intake factors (Exposure Factors Handbook, US EPA, 1997) were used to determine the amount of chemicals of potential concern (COPC) that each receptor is potentially exposed to via each exposure route, and were used to ev aluate both cancer risk and non-cancer hazard.

SOURCES

Primary Secondary Tertiary

Vessel Surface

Seawater

Dock/Shoreline



### • Pathway is or might be complete; sufficient data available for quantitative evaluation

X Pathway is or might be complete, but judged to be minor; not evaluated quantitatively

1 STDN Technician exposure considered worst-case scenario for anyone working onboard vessel.
2 Not evaluated quantiatively in risk assessment; semi-qualitatively evaluation provided.

Pathway is not complete; no evaluation required General Public Off Board

Dock Workers



### • X Spills/Leaks from Storage Tanks, Pipelines or BWTS Vapors/Indoor Air

Vapors/Outdoor Air



### • STDN Technician

X 1

X



### • Release from Ballast Tanks

Dermal Contact/ Incidental Ingestion X Inhalation X On Board

X Dermal Contact/ Incidental Ingestion

Inhalation

X Exposure Routes



### •

X 2 Ship's Crew

Figure 2 – Conceptual Human Exposure Model, BalPure SystemGESAMP-BWWG 12/6 ANNEX 7 Page 8

I:\MEPC\60\2-16.doc 4.1.2 The Group noted that the applicant assess ed the toxicological hazards and potential human exposure associated with COPC generated by the BalPure system. The primary sources of COPC included the in situ production of sodium hypoc hlorite, the sodium bisulfite storage tanks and associated pipelines, and th e treated ballast water itself.

4.1.3 The Group noted that the applicant has identi fied the following chemicals associated with the BalPure system as possible COPC - sodium hypochlorite (TRO), THM, HAA, bromate and sodium bisulfite. Only exposure to COPC resu lting from leaks of storage tanks, pipelines and ballast tanks discharges were ev aluated quantitatively by the app licant in the risk assessment.

4.1.4 The Group noted that the ap plicant considers that no exposure is antici pated during normal operating conditions due to the fact that chemicals used in the BalPure system are contained within a closed system (sodium hypochlorite is produced in situ and is injected directly into the ballast system; sodium bisulfite is injected into the ballast water as it is discharged from the ship).

4.2 Assessment of exposure to ship’s crew and BWMS technicians

4.2.1 The Group noted that according to the applicant under normal conditions the ship’s crew (including BWMS technicians) would not be expos ed to sodium hypochlorite and by-products in the treated ballast water unless there is a failure of the system or when performing service on the system. The risks associated with these scenarios are mitigated by numerous system safety measures (leak detection, hydrogen gas removal, equipment isolati on, stray current protection etc) and by following the use of appr opriate personal protective e quipment (PPE) when performing maintenance and/or repair on the system. Ther efore, the Group recognized that under normal operating conditions, neither BWMS t echnicians nor the ship’s crew is expected to have contact with the system-related COPC.

4.2.2 In addition to the above mentioned anticipat ed exposure situations the Group considered that the applicant should provi de information regarding exposure during sampling of ballast water during discharge (inhalation, dermal contact) , as well as during periodic sediment cleaning (inhalation, dermal). These scenarios should also be considered in the conceptual exposure model (CEM).

4.2.3 Furthermore, the Group recommended that ap propriate precautionary measures should be followed when any operator enters the ballast tanks for inspection or for sampling operational procedures and cleaning operations.

4.3 Exposure of general public throug h the environment and food chain

4.3.1 The Group noted the description made by th e applicant regarding the exposure of the general public (beachgoers):

- incidental ingestion of ballast water COPC discharged to seawater near the shoreline;

- dermal contact with ballast water CO PC discharged to seawater near the shoreline; and
- inhalation of ballast water COPC vapours or mists in outdoor air near the shoreline.GESAMP-BWWG 12/6 ANNEX 7 Page 9

I:\MEPC\60\2-16.doc 4.3.2 According to the applicant the potentially complete and quantifia ble exposure pathways for swimmers include: incident al ingestion of and dermal contact with hypochlorous acid, bromate, THM, HAA, sodium bisulfite, and recently discharged ballast water. It is conservatively assumed that maximum residua l ballast water COPC concentrations are diluted 100-fold prior to contact with beachgoers.

4.3.3 Chemicals detected in discharged treated ballast water may pos e a threat to seafood consumers only if they tend to bioaccumulate (Log K ow >3 or a bioconcentration factor > 2000). The COPC identified in this ri sk assessment all have Log K ow values less than 3 and therefore are not expected to pers ist in the food web.

4.3.4 The Group concurred with the view of the a pplicant that no adverse health effects would be expected from either bathers exposed to diluted concentrations of these chemicals or consumers of seafood.

4.4 Conclusion on Human Health assessment

4.4.1 The Group accepted that the applicant has asse ssed qualitatively and quantitatively the potential human exposures and health effects. Ov erall, the risk assessmen t determined that risks to all human receptor groups from the BalPure system under normal operating conditions do not pose any unacceptable risk. Hazards for the general public/beachgoers are well below levels of concern; actual risks to these receptors are expected to be even lower, as they are unlikely to be repeatedly exposed to treated ba llast water as assumed in this risk evaluation. Since the risk assessment only evaluated direct exposure via inge stion and dermal contact with chemicals or ballast water, as these were considered the mo st relevant pathways, fu rther semi-quantitative evaluation of the inhalation pathway was performe d by the applicant for the volatile THM. This assessment demonstrated that conservative co ncentrations of airbor ne THM generated by a release of ballast water were well below occupa tional exposure limits taki ng into consideration a dilution factor of 10.

4.4.2 The Group considered that the human exposure assessment submitted by the applicant makes possible to conclude that the operation of this BWMS poses no unacceptable risk to ships’ crew, technicians and to the general public.

5 RISKS TO SAFETY OF THE SHIP , ITS CREW AND THE GENERAL PUBLIC

5.1 Safety of the ship

5.1.1 The Group noted that specific countermeasures that can be employed in this system to deal with envisaged emergency and safety problem s during the ballast water treatment have been summarized above. In particular a summary of the various safety measures developed by the applicant is given above in section 3.2.

5.1.2 The Group noted that the appli cant indicated that corrosion is of significant concern. Further, the applicant cited and reviewed a series of corrosion tests conducted by BMT Fleet Technology Limited (BMT) as well as th eir conclusion based on work by Paik et al. that hypochlorite in levels commensurat e with ballast water treatment will reduce the time for steel replacement in a ship by less than 5%. Howeve r, in reviewing the cited report by BMT, the Group did not agree with interp retation of the work by Paik et al . In particular, the provided equation for corrosion loss, incorrectly defines the parameter t r as the thickness of steel at time T after construction. In fact, the Paik et al. model indicates that t r is the total material loss overGESAMP-BWWG 12/6 ANNEX 7 Page 10

I:\MEPC\60\2-16.doc time T. The Group also notes ot her discrepancies in the BMT te sting including the inappropriate substitution of salt water for natural seawater and the substantial difference in corrosion rates in untreated water from published and accepted values. With respect to the latter, BMT concluded that the natural corrosion rate of bare steel is between 0.1 and 1.4 mm/year for immersion in freshwater and 0.75 mm/year in seawater immers ion. However, these ar e substantially higher than the generally accepted corrosion rate values, including those used by Paik et al. of 0.1 and 0.2 mm/year for immersed, static corrosion in freshwater and seawat er, respectively. The Group considered that an analysis of the potenti al corrosion impacts of the Active Substance on this report alone is insufficient. If the app licant intends to use the corrosion accumulation model provided by Paik et al. the Group recommended that the applicant considers the original reference material.

5.1.3 The Group also noted that the applicant pr esented through the use of BMT’s literature review and impact assessment using the Paik et al. model for total corrosion loss over the life of the ship on the basis of intermittent exposur e to the Active Substance. While the Group considered this a useful extensi on of the corrosion analyses, an es timation of total corrosion loss is unnecessary for the Group’s consideratio n. The Group recommended a comprehensive corrosion analysis which establishes the anticipated corrosion rates of the ship’s structures when exposed to the Active Substance. It is unders tood that the cumulative corrosion losses over the life of the ship will be dependent on ship operatio ns and Active Substance decay rates, which are naturally difficult to predict for all conditions. If such an analysis is provided, however, the Group recommended that the app licant provides analyses for both typical and worst case conditions.

5.1.4 The Group recommended that comprehensive co rrosion testing be c onducted, taking into account the guidance in sec tion 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

5.1.5 The Group considered that sufficient info rmation had been provided by the applicant addressing risks to the safety of the ship to permit further devel opment of this BWMS.

5.2 Safety of the crew

5.2.1 The Group considered that no unacceptable ri sk to safety of the ships’ crew (BWMS operators included) by exposure to chemicals and treated ballast water should be posed based on the measures developed by the applicant for inst allation on-board ship. A summary of the various safety measures developed by th e applicant is given above in section 3.2. The Group considered that in this system, the risk to ships’ crew is judged to be appropria tely managed based on the facts that the Active Substance is produced in situ as well as that system components are adopted that are expected to minimize th e exposure risk of ships’ crew to chemicals and ballast water before and after treatment, through the exposure r outes of concern assessed, as discussed above in section 4.

5.3 Safety of the general public

5.3.1 The Group considered that the system as presented would pose no unacceptable risk to the health of the general public according to the outcome of the human exposure routes of concern assessed, as discu ssed above in section 4.GESAMP-BWWG 12/6 ANNEX 7 Page 11

I:\MEPC\60\2-16.doc 6 ENVIRONMENTAL RISK ASSESSMENT

6.1 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

6.1.1 The Group noted that the applicant has made a comprehensive listing of P, B and T criteria for the Active Substance and Relevant Ch emicals found in the treate d ballast water, with results being presented in the appe ndix, section 2 (Table A2).
6.1.2 Based on these results, the Group concluded that none of these chemicals should be classified as PBT-substances.

6.2 Ecotoxicity testing of treated ballast water

6.2.1 The Group noted that the applicant has perf ormed acute and chronic aquatic ecotoxicity testing of treated ballast water from the BalPur e system, and full results are presented in the appendix, section 7 (Tables A9 – acute and A10 – chronic). The Group noted that the applicant performed the acute testing with fr esh water at 6.7 mg/L (TRO as Cl 2 ), with brackish water at 9.1 mg/L (TRO as Cl 2 ), with seawater at 4.3 mg/L (TRO as Cl 2 ), and chronic testing with seawater at 15.0 mg/L (TRO as Cl 2 ), using the treated ballast water with neutralization.

6.3 Acute aquatic ecotoxicity testing

6.3.1 The Group noted that acu te aquatic ecotoxicity tests were performed at differing hypochlorite concentrations. Tests were conducted us ing algae, invertebrates, and fish in fresh water, brackish water, and seaw ater – a total of 9 tests were performed. The samples were collected for toxicity testing on Day 0 (immediate ly after addition of hypochlorite), and on Day 2 and Day 5 after treatment. Following the co llection of Day 5 samples, residual TRO was neutralized with sodium bisulf ite and a second Day 5 post-neutra lization sample was collected for toxicity testing. The neutraliz ed water was then held an additi onal 5 days (i.e. 10 days after hypochlorite treatment) and then te sted for aquatic toxicity.

6.3.2 The Group noted from the re sults presented that eco toxicity was observed for all species in the samples collected immediately after hypochlorite tr eatment (Day 0) and some ecotoxicity was observed in the Day 2 and Day 5 pre-neutralization samples, with the exception of freshwater fish. With the exception of one data point (96-hour exposure EC50 of 66.1% for the marine algal diatom Skeletonema in brackish water), ecotoxicity was not observed in the Day 5 post-neutralization samples. From this single result, the Group recogni zed that less than a tw o-fold dilution of the treated ballast water would be required to reach a concentration less than the EC50 for Skeletonema.

6.4 Chronic aquatic ecotoxicity testing

6.4.1 The Group noted that chronic aquatic ec otoxicity tests were conducted using treated ballast water samples collected du ring the full-scale study. The chronic tests were performed on seawater samples only. Samples were collected from ballast water treated with hypochlorite at 15 mg Cl 2 /L TRO concentration and then held for 2 days. After 2 days the treated water was neutralized with an excess concen tration of ~ 2 mg/L sodium bisu lfite. Five concentrations of treated sample using a 0.5x dilutio n series were tested. Bioassa ys were conducted using 7-day tests with a mysid ( Americamysis bahia ) and a larval fish ( Menidia beryllina ), a 48-hour larval development test using a mussel ( Mytilus galloprovincialis ), and a 48-hour germination and germ tube length test using the giant kelp ( Macrocystis pyrifera ).GESAMP-BWWG 12/6 ANNEX 7 Page 12

I:\MEPC\60\2-16.doc 6.4.2 The Group noted that results for the chroni c ecotoxicity tests indi cated that no toxicity was observed with the treated water samples for any species tested at any concentration. The highest concentration with no observed effect (NOEC) was therefore 100 per cent sample.

6.4.3 In summary, the Group concluded that whol e effluent ecotoxicity testing (acute and chronic endpoints) of neutralized ballast water discharge indicates no apparent toxicity for all species and endpoints tested (E(L)C50 and/or NOEC values of ≥ 100% treated ballast water), except one single acute endpoint for the marine algal diatom Skeletonema in brackish water. The Group noted that there was algal toxicity exis ting with 66.1% of E(L)C50 with brackish water at 9.1 mg/L (TRO as Cl 2 ) at 5 days after treatment and with neutralization. Consequently, the Group recommended that due to the algal toxicity, both acute and chronic ecotoxicity testing of treated ballast water be performed in accordance w ith the full requirements of Procedure (G9) at the maximum proposed treatment dose, for review at Final Approval.

6.5 Risk assessments of chem icals for aquatic organisms

6.5.1 Prediction of discharge and environmen tal concentrations for Active Substance TRO

6.5.1.1 The Group noted that according to the app licant, due to the TRO neutralization during ballast water discharge, the TRO concentration in treated water discharged to the environment will be undetectable by the normal analytical method. The Group noted th at the applicant has proposed a maximum allowable discharge conc entration (MADC) for the Active Substance of 0 mg/L (TRO as Cl 2 ) to be achieved using residual oxi dant neutralization with sodium bisulfite on discharge. The Group considered that this is acceptable s ubject to the applicant verifying that the neutraliza tion is effective at all times (MADC < 0.2 mg/L TRO as Cl 2 ).

6.5.1.2 The Group noted that according to the applicant, PEC values will be derived using appropriate emission scenario modeling based on an alysis of treated ballast water samples drawn from the full-scale land-based testing and will be presented for Final Approval.

6.5.2 Aquatic Ecotoxicity and Predicte d No-Effect Concentration (PNEC)

6.5.2.1 The Group noted that a literature search was conducted by the applicant to locate existing acute and chronic aquatic ecotoxicity da ta for the substances associated with this system. A complete base-set for fish, crustaceans and al gae was not located for all substances and in some cases, the data do not meet validity criteria . However, the data have been provided by the applicant as supporting information and were used to derive PNEC values as calculated by the applicant, which are presented in the appendix, section 1 (Table A1).

6.6 Conclusion from Environmental Risk Assessment

6.6.1 The Group recognized that the applicant ha s proposed a maximum allowable discharge concentration (MADC) for the Active Substance of 0 mg/L (TRO as Cl 2 ) to be achieved using an oxidant neutralization step at discharge with sodi um bisulfite. The Group considered that this is acceptable subject to the applicant verifying that the neutralization is effective at all times (MADC < 0.2 mg/L TRO as Cl 2 ).GESAMP-BWWG 12/6 ANNEX 7 Page 13

I:\MEPC\60\2-16.doc 6.6.2 The Group noted that the applicant had not performed an environmental exposure assessment using an appropriate model for Basic Approval and the applican t indicated that such an analysis would be performed for Final Ap proval. The Group was of the opinion that this should be considered as an omission in the Ba sic Approval dossier, but b ecause of the extensive chemical analysis of the treated ballast water an d the results of the acute and chronic ecotoxicity testing, the Group considered this was acceptable in this par ticular case due to the other information provided. The Group recommended th at all missing information be provided for Final Approval as indi cated by the applicant.

6.6.3 The Group agreed that the proposed BWMS should not pose any unacceptable risks for the environment.

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to safety of the ship

7.1.1 The Group noted that specific risk mitigation m easures are to be employed in this system to deal with envisaged emergency and safety problems during the ballast water treatment and have been described and discussed above.

7.1.2 The Group considered that sufficient info rmation had been provided by the applicant addressing risks to the safety of the ship to permit further developm ent of this system.

7.1.3 The Group recommended that corrosion test ing be conducted, taking into account the guidance in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

7.2 Risks to the crew and general public

7.2.1 The Group considered that this BWMS should not pose any unacceptable risk to the health of the crew and the genera l public regarding the exposure to chemicals and treated ballast water, based on the information provided and on the incorporation of the risk mitigation measures proposed by the applicant.

7.3 Risks to the environment

7.3.1 The Group concluded that base d on the applicant’s proposal for a MADC of the Active Substance and the Group’s evaluation of the info rmation provided on acute and chronic aquatic ecotoxicity testing of treated ballast water, to gether with other information provided in the dossier, that the risks to the environment posed by use of this system should be acceptable, subject to the applicant verifying that th e neutralization is effective at all times.

7.4 Recommendation

7.4.1 Having reviewed all the data and inform ation submitted by Germany for Basic Approval, the Group was able to recommend to MEPC to give Basic Approval for the BalPure BWMS.

7.4.2 The Group made the following recommendations and requests for information, if this system is to be reviewed for Final Approval in the future:GESAMP-BWWG 12/6 ANNEX 7 Page 14

I:\MEPC\60\2-16.doc .1 The Group recommended that a comp rehensive evaluation of the corrosion impacts on ships’ structures be c onducted using the maximum anticipated treatment concentration, 20 mg/L (TRO as Cl 2 ) and that a realistic TRO decay profile may be considered if the total corrosion loss over the ship’s life is to be projected. The Group noted however that su ch an analysis, while useful, is not necessary for the Group’s consideration. The Group recommended that corrosion testing be conducted, and invited the app licant to consider the guidance provided in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16;

.2 The Group recommended to take into consideration the human exposure during sampling of ballast water at discharge (inhalation, dermal c ontact), as well as during periodic sediment cleaning (inha lation, dermal). These scenarios should also be considered in the c onceptual exposure model (CEM);

.3 The Group recommended that the data sets on the analysis of Active Substance, Relevant Chemicals and Other Chemicals in treated ballast wate r should be further investigated during land-base d and shipboard testing;

.4 The Group recommended that confir mation by further te sting should be performed, that there will be no unacceptable risks (to ship safety, human health or the environment) due to the chemical composition of ballast water treated by this BWMS;

.5 The Group recommended that all missing information concerning the environmental exposure assessment using an appropriate model be provided;

.6 The Group recommended verification that the residual oxidant neutralization with sodium bisulfite on discharge is e ffective at all ballast discharges with MADC < 0.20 mg/L TRO as Cl 2 ; and

.7 The Group recommended that both acute a nd chronic ecotoxicity testing of treated ballast water be performed in accordan ce with the full requirements of Procedure (G9) at the maximu m proposed treatment dose.

* * *GESAMP-BWWG 12/6 ANNEX 7 Page 15

I:\MEPC\60\2-16.doc APPENDIX

Severn Trent DeNora BalPure Ballast Water Management System Submitted for Basic Approval by Germany

1 Effects on Aquatic Organisms – Inform ation used to Derive PNEC Values (As presented by applicant)

Table A1 : PNEC Value Summary

Substance Lowest Effect Concentration (mg/L) Assessment Factor PNEC Value (μg/L) Reference/Comments

Active Substances

TRO (Fresh water) Insufficient Data Located -- 0.06 (as TRC) Based on EU Sodium Hypochlorite RAR suggested PNEC for TRC in fresh water TRO (Saltwater) 0.062 1000 0.062 HOCl 0.032 1000 0.032

HOBr Data Not Located -- 0.032 Estimated based on HOCl toxicity data Relevant Chemicals Bromate 13.6 1000 13.6 THMs

Chloroform 1.5 100 15 / 146 146 μg/L to be used as PNEC for Total THMs

Bromoform 12.3 1000 12.3 / 146 146 μg/L to be used as PNEC for Total THMs

Dibromochloromethane (DBCM) Data Not Located -- Not Derivable Use EU Sodium Hypochlorite RAR suggested PNEC for Total THMs

Dichlorobromomethane (DCBM) Data Not Located -- Not Derivable Use EU Sodium Hypochlorite RAR suggested PNEC for Total THMs

Total THMs -- -- 146 Based on EU Sodium Hypochlorite RAR suggested PNEC for Total THMs HAAs

Bromochloroacetic acid Data Not Located -- 0.85 Based on EU Sodium Hypochlorite RAR suggested PNEC for HAAs Monochloroacetic acid Insufficient Data Located -- 0.85 Based on EU Sodium Hypochlorite RARGESAMP-BWWG 12/6 ANNEX 7 Page 16

I:\MEPC\60\2-16.doc Substance Lowest Effect Concentration (mg/L) Assessment Factor PNEC Value (μg/L) Reference/Comments

suggested PNEC for HAAs

Dichloroacetic acid Insufficient Data Located -- 0.85 Based on EU Sodium Hypochlorite RAR suggested PNEC for HAAs Trichloroacetic acid 500 1000 500

Monobromoacetic acid Insufficient Data Located -- 0.85 Based on EU Sodium Hypochlorite RAR suggested PNEC for HAAs

Dibromoacetic acid Insufficient Data Located -- 0.85 Based on EU Sodium Hypochlorite RAR suggested PNEC for HAAs Other Chemicals

Sodium bisulfite Insufficient Data Located -- Not Derivable

2 Screening for Persistence (P), Bioa ccumulation (B) and Toxicity (T) (As presented by applicant)

Table A2 : PBT Criteria Evaluation

Substance Persistence (P) Half-life: >60 days in marine water (MW), or >40 days in fresh water (FW) , or >180 days in marine sediment (MS),

or >120 days in freshwater sediment (FWS) (YES or NO) Bioaccumul ation (B) BCF >2,000 or Log Kow ≥ 3

(YES or

NO) Toxicity (T) Chronic NOEC <0.01mg/L

(YES or NO)

Active substances

Hypochlorous acid No FW: 15 days (EPI Suite, 2009c) No Log Kow = - 0.87 No Lowest NOEC = 0.042 mg/L (Fish)

Hypobromous acid No FW: 15 days (EPI Suite, 2009b) No Log Kow = - 0.78 No based on hypochlorous acid Relevant Chemicals

Bromate No FW: 15 days (EPI Suite, 2009a) No Log Kow = - 4.6 No Lowest NOEC = 8 mg/L (Crustacean)GESAMP-BWWG 12/6 ANNEX 7 Page 17

I:\MEPC\60\2-16.doc Substance Persistence (P) Half-life: >60 days in marine water (MW), or >40 days in fresh water (FW) , or >180 days in marine sediment (MS),

or >120 days in freshwater sediment (FWS) (YES or NO) Bioaccumul ation (B) BCF >2,000 or Log Kow ≥ 3

(YES or

NO) Toxicity (T) Chronic NOEC <0.01mg/L

(YES or NO)

THMs

Chloroform No FW: 4.4 days; Not expected to adsorb to sediment. (HSDB/TOXNET 2009f) No BCF = 2.9-10.35 No Lowest NOEC = 1.5 mg/L (Fish)

Bromoform No FW: 7.1 days; Not expected to adsorb to sediment. (HSDB/TOXNET 2009l) No BCF = 14 No Lowest NOEC = 8.5 mg/L (Fish)

Dichlorobromomethane No FW: 5 days; Not expected to adsorb to sediment. (HSDB/TOXNET 2009c) No BCF = 7 No LC50 = 72 mg/L (Fish)

Chlorodibromomethane No FW: 6 days; Not expected to adsorb to sediment. (HSDB/TOXNET 2009e) No BCF = 9 No LC50 = 34 mg/L (Fish) HAAs

Bromochloroacetic acid No biodegradation data available. Not expected to adsorb to suspended solids or sediment. (HSDB/TOXNET 2009b) No Log Kow = 0.61 Data not located.

Monochloroacetic acid No FW: 14 days (Ellis, et al. 2001); Not expected to adsorb to sediment. (HSDB/TOXNET 2009d) No Log Kow = 0.22 No Lowest NOEC = 0.13 mg/L (Algae)

Monobromoacetic acid No half-life data available; Not expected to adsorb to sediment. In aqueous biodegradation screening tests, reached 82% of its theoretical BOD when using pre-acclimatized inoculums (HSDB/TOXNET 2009a) No Log Kow = 0.41 No NOEC = 3.2 mg/L (Crustacean)

Dichloroacetic acid No FW: 4 days (Ellis et al. 2001); Not expected to adsorb to sediment. (HSDB/TOXNET 2009h) No Log Kow = 0.92 No EC03 = 1485 mg/L (Algae)

Dibromoacetic Acid No FW: 14 days (HSDB/TOXNET 2009g) No BCF = 0.17 No Lowest LC50 = 69 mg/L (Fish)

Trichloroacetic acid No FW: 40 days (Ellis et al 2001); Not expected to adsorb to sediment. (HSDB/TOXNET 2009m) No BCF = 0.1-1.7 No Lowest NOEC = 100 mg/L (Algae)GESAMP-BWWG 12/6 ANNEX 7 Page 18

I:\MEPC\60\2-16.doc Substance Persistence (P) Half-life: >60 days in marine water (MW), or >40 days in fresh water (FW) , or >180 days in marine sediment (MS),

or >120 days in freshwater sediment (FWS) (YES or NO) Bioaccumul ation (B) BCF >2,000 or Log Kow ≥ 3

(YES or

NO) Toxicity (T) Chronic NOEC <0.01mg/L

(YES or NO)

Other Chemicals

Sodium bisulfite No FW: 15 days (HSDB/TOXNET 2009) No BCF = 3.2 No Lowest LC50 = 100 mg/L (Fish)

3 Properties of Treated Ballast Water (As presented by applicant)

Table A3 : Physical and Chemical Properties of Treated Ballast Water

Physical/Chemical Property Treated Ballast Water Density (20oC; kg/m3) Same as seawater Oxidation/Reduction potential <200 mV*

Corrosivity to materials Similar to untreated ballast
water

Reactivity to container material Similar to untreated ballast
water pH See Table 26 Salinity See Table 26 TOC See Table 26 DOC See Table 26 Other known’s None

* ORP as measured in ballast water af ter neutralization with sodium bisulfite.

4 Total Residual Oxidants (TRO) in Treated Ballast Water (As presented by applicant)

Table A4 : Total Residual Oxidant (TRO) measured as Total Chlorine (The Day 0 value represents the applied concentration of the Active Substance)

Day Treatment Tank 1 * TRO (mg/L) Treatment Tank 2 TRO (mg/L) Reference

Fresh Water 5-Dec (Day 0) 6.7 5.7 Sosik & Herwig, 2009 7-Dec (Day 2) 2.3 1.5 Sosik & Herwig, 2009 10-Dec (Day 5) 1 0.5 Sosik & Herwig, 2009 15-Dec (Day 10) 0 0 Sosik & Herwig, 2009GESAMP-BWWG 12/6 ANNEX 7 Page 19

I:\MEPC\60\2-16.doc Day Treatment Tank 1 * TRO (mg/L) Treatment Tank 2 TRO (mg/L) Reference

Brackish Water 9-Dec (Day 0) 9.1 10.5 Sosik & Herwig, 2009 11-Dec (Day 2) 6.3 N/A Sosik & Herwig, 2009 14-Dec (Day 5) 4.8 3.9 Sosik & Herwig, 2009 19-Dec (Day 10) 0 0 Sosik & Herwig, 2009 Saltwater 9-Dec (Day 0) 4.3 4.5 Sosik & Herwig, 2009 11-Dec (Day 2) 3.6 N/A Sosik & Herwig, 2009 14-Dec (Day 5) 3.1 N/A Sosik & Herwig, 2009 19-Dec (Day 10) 0 N/A Sosik & Herwig, 2009

* Samples from Tank 1 were collected for DBP and toxicity evaluation.

5 Water quality parameters in Treated Ballast Water (As presented by applicant)

Table A5 : Summary of Water Quality Parameters

Parameter Fresh water Brackish Water Seawater Reference

Initial POC (mg/L) 2.81 2.72 1.37 Sosik & Herwig, 2009 Initial DOC (mg/L) 3.72 5.69 4.23 Sosik & Herwig, 2009 Initial TSS (mg/L) 34.46 76.09 3.75 Sosik & Herwig, 2009 Salinity range (PSU) 0.62 – 0.64 21.54 – 21.75 30.48 – 30.57 Sosik & Herwig, 2009

pH range 7.23 – 7.74 7.15 – 8.26 7.46 – 7.97 Sosik & Herwig, 2009 Temperature range (°C) 10.9 – 13.16 6.72 – 9.75 6.43 – 9.36 Sosik & Herwig, 2009

6 Disinfection By-Products (DBP) in Treated Ballast Water (As presented by applicant)

The samples collected on Day 0 and Day 2 were an alyzed prior to the neutralization step. The samples collected on Day 5 and Day 10 were analy zed after neutralization with sodium bisulfite.

Table A6 : Levels of Trihalomethane s (THM) and Haloacetic acids (HAA) in Treated Fresh Water

FRESHWATER
Day 0 Day 2 Day 5* Day 10* Reference
THM (EPA Method 524.2) μ g/L μ g/L μ g/L μ g/L

chloroform 21.6 42.2 52.9 43.1 Sosik & Herwig, 2009

dichlorobromomethane 33.2 70.8 90.2 73.6 Sosik & Herwig, 2009GESAMP-BWWG 12/6 ANNEX 7 Page 20

I:\MEPC\60\2-16.doc FRESHWATER
Day 0 Day 2 Day 5* Day 10* Reference

chlorodibromomethane 71.8 127 157 123.7 Sosik & Herwig, 2009

bromoform 69.7 92.1 100 95 Sosik & Herwig, 2009

Total THM 196.3 332 400 335.4 Sosik & Herwig, 2009 HAA (EPA Method 552.1)

bromochloroacetic acid 23.4 49.7 38.3 44.2 Sosik & Herwig, 2009

monochloroacetic acid 3.9 2.5 2.7 2.8 Sosik & Herwig, 2009

dichloroacetic acid 18.4 38.8 33.7 39.5 Sosik & Herwig, 2009

trichloroacetic acid 33 42.2 47.7 56.3 Sosik & Herwig, 2009

monobromoacetic acid 2.4 3.3 3.3 2.1 Sosik & Herwig, 2009

dibromoacetic acid 36 51.1 47.4 54 Sosik & Herwig, 2009 Total HAA (6) 93.7 137.9 134.8 154.7 Sosik & Herwig, 2009

“*” = Experimental tanks were neutralized with sodium bisulfite.

Table A7 : Levels of Trihalomethane s (THM) and Haloacetic acids (HAA) in Treated Brackish Water

BRACKISH WATER
Day 0 Day 2 Day 5* Day 10* Reference

THM μ g/L μ g/L μ g/L μ g/L

chloroform 0 0.5 0.6 0.5 Sosik & Herwig, 2009

dichlorobromomethane 2.4 6.4 6.3 4.6 Sosik & Herwig, 2009

chlorodibromomethane 13.4 42.8 45.7 34.1 Sosik & Herwig, 2009

bromoform 209 854 1046 782.8 Sosik & Herwig, 2009

Total THM 225 904 1099 822 Sosik & Herwig, 2009 HAA

bromochloroacetic acid 11.2 7.8 9.4 7.1 Sosik & Herwig, 2009 monochloroacetic acid 7.4 12.1 15.3 0 Sosik & Herwig,GESAMP-BWWG 12/6 ANNEX 7 Page 21

I:\MEPC\60\2-16.doc BRACKISH WATER
Day 0 Day 2 Day 5* Day 10* Reference

2009

dichloroacetic acid 2.9 1.2 2.4 3.7 Sosik & Herwig, 2009

trichloroacetic acid 0 1.5 1.5 0.7 Sosik & Herwig, 2009

monobromoacetic acid 8.4 8.4 6.1 3.5 Sosik & Herwig, 2009

dibromoacetic acid 117.9 219 156.3 193 Sosik & Herwig, 2009 Total HAA (6) 136.6 242.2 181.6 200.9 Sosik & Herwig, 2009

Bromate 0 33 23 42 Sosik & Herwig, 2009

“0” = Level below detectable limits, <2 μ g/L. “*” = Experimental tanks were ne utralized with sodium bisulfite.

Table A8 : Levels of Trihalomethane s (THM) and Haloacetic acids (HAA) in Treated Seawater

SEAWATER
Day 0 Day 2 Day 5* Day 10* Reference

THM μ g/L μ g/L μ g/L μ g/L

chloroform 0 0 0 0 Sosik & Herwig, 2009

dichlorobromomethane 0 0 0 0 Sosik & Herwig, 2009

chlorodibromomethane 0.7 2.7 3.4 2.2 Sosik & Herwig, 2009

bromoform 32.6 106.9 117.9 90.1 Sosik & Herwig, 2009

Total THM 33.3 109.6 121.3 92.3 Sosik & Herwig, 2009 HAA

Bromochloroacetic acid 0 0 0 0 Sosik & Herwig, 2009

monochloroacetic acid 5.3 12.8 9.9 0 Sosik & Herwig, 2009

dichloroacetic acid 0 0 0 0 Sosik & Herwig, 2009

trichloroacetic acid 0 0 0 0 Sosik & Herwig, 2009

monobromoacetic acid 0 1.4 2.2 0 Sosik & Herwig, 2009 dibromoacetic acid 12.5 19.6 24.7 19.3 Sosik & Herwig,GESAMP-BWWG 12/6 ANNEX 7 Page 22

I:\MEPC\60\2-16.doc SEAWATER
Day 0 Day 2 Day 5* Day 10* Reference

2009 Total HAA (6) 17.8 33.8 36.8 19.3 Sosik & Herwig, 2009

Bromate 0 13 23 14 Sosik & Herwig, 2009 “0” = Level below detectable limits, <2 μ g/L. “*” = Experimental tanks were ne utralized with sodium bisulfite.

7 Ecotoxicity Testing of Treated Ballast Water (As presented by applicant)

Table A9 : Acute Aquatic Ecotoxicity - Treated Ballast Water

TestSubstance F C A Species Days after treatment,

Pre/Postneutralization Test Type E(L)C5 0 % sample NOEC % sample References/ comments

Freshwater (average conductivity 1002 μS/cm)

0 72h growth (OECD

201) 7.76 <6.25 Nautilus Environmental, 2009

2 72h growth (OECD

201) 11.5 <6.25 Nautilus Environmental, 2009

5-pre 72h growth (OECD

201) >100 25 Nautilus Environmental, 2009

5-post* 72h growth (OECD

201) >100 100 Nautilus Environmental, 2009 A Selenastrum capriconutum

5+* 72h growth (OECD

201) >100 100 Nautilus Environmental, 2009 6.7 mg/L HOCl

C Daphnia
magna 0 48h survival (OECD

202) 3.13 <6.25 Nautilus Environmental, 2009GESAMP-BWWG 12/6 ANNEX 7 Page 23

I:\MEPC\60\2-16.doc TestSubstance F C A Species Days after treatment,

Pre/Postneutralization Test Type E(L)C5 0 % sample NOEC % sample References/ comments

2 48h survival (OECD

202) 3.13 <6.25 Nautilus Environmental, 2009

5-pre 48h survival (OECD

202) 41.4 25 Nautilus Environmental, 2009

5-post* 48h survival (OECD

202) >100 100 Nautilus Environmental, 2009

5+* 48h survival (OECD

202) >100 100 Nautilus Environmental, 2009

0 96h survival (OECD

203) 4.03 <6.25 Nautilus Environmental, 2009

2 96h survival (OECD

203) 43.8 25 Nautilus Environmental, 2009

5-pre 96h survival (OECD

203) >100 100 Nautilus Environmental, 2009

5-post* 96h survival (OECD

203) >100 100 Nautilus Environmental, 2009 F Pimephalus promelas

5+* 96h survival (OECD

203) >100 100 Nautilus Environmental, 2009

Brackish water (average salinity 22.14 PSU)

9.1 mg/L HOCl A Skeletonema
costatum 0 96h survival

(EPA OPPTS 850.5400) 8.61 <6.25 Nautilus Environmental, 2009GESAMP-BWWG 12/6 ANNEX 7 Page 24

I:\MEPC\60\2-16.doc TestSubstance F C A Species Days after treatment,

Pre/Postneutralization Test Type E(L)C5 0 % sample NOEC % sample References/ comments

2 96h survival

(EPA OPPTS 850.5400) 15.9 12.5 Nautilus Environmental, 2009

5-pre 96h survival

(EPA OPPTS 850.5400) 16.4 12.5 Nautilus Environmental, 2009

5-post* 96h survival

(EPA OPPTS 850.5400) 66.1 50 Nautilus Environmental, 2009

5+* 96h survival

(EPA OPPTS 850.5400) >100 100 Nautilus Environmental, 2009

0 96h survival

(EPA OPPTS 850.1035) 5.94 6.25 Nautilus Environmental, 2009

2 96h survival

(EPA OPPTS 850.1035) 17.7 12.5 Nautilus Environmental, 2009

5-pre 96h survival

(EPA OPPTS 850.1035) 17.5 12.5 Nautilus Environmental, 2009

5-post* 96h survival

(EPA OPPTS 850.1035) >100 100 Nautilus Environmental, 2009

5+* 96h >100 100 Nautilus C Americamysis bahiaGESAMP-BWWG 12/6 ANNEX 7 Page 25

I:\MEPC\60\2-16.doc TestSubstance F C A Species Days after treatment,

Pre/Postneutralization Test Type E(L)C5 0 % sample NOEC % sample References/ comments

survival

(EPA OPPTS 850.1035) Environmental, 2009

0 96h survival

(EPA OPPTS 850.1075) 11.7 6.25 Nautilus Environmental, 2009

2 96h survival

(EPA OPPTS 850.1075) 28.4 25 Nautilus Environmental, 2009

5-pre 96h survival

(EPA OPPTS 850.1075) 22.6 12.5 Nautilus Environmental, 2009

5-post* 96h survival

(EPA OPPTS 850.1075) >100 100 Nautilus Environmental, 2009 F Cyprinodon variegatus

5+* 96h survival

(EPA OPPTS 850.1075) >100 100 Nautilus Environmental, 2009

Saltwater (average salinity 31 PSU)

0 96h survival

(EPA OPPTS 850.5400) 33.4 25 Nautilus Environmental, 2009

2 96h survival

(EPA OPPTS 850.5400) 34.5 25 Nautilus Environmental, 2009

5-pre 96h 38 25 Nautilus survival Environmental, (EPA 2009 4.3 mg/L HOCl A Skeletonema
costatumGESAMP-BWWG 12/6 ANNEX 7 Page 26

I:\MEPC\60\2-16.doc TestSubstance F C A Species Days after treatment,

Pre/Postneutralization Test Type E(L)C5 0 % sample NOEC % sample References/ comments

OPPTS 850.5400)

5-post* 96h survival

(EPA OPPTS 850.5400) >100 100 Nautilus Environmental, 2009

5+* 96h survival

(EPA OPPTS 850.5400) >100 100 Nautilus Environmental, 2009

0 96h survival

(EPA OPPTS 850.1075) 10.5 6.25 Nautilus Environmental, 2009

2 96h survival

(EPA OPPTS 850.1075) 16.7 12.5 Nautilus Environmental, 2009

5-pre 96h survival

(EPA OPPTS 850.1075) 16.8 12.5 Nautilus Environmental, 2009

5-post* 96h survival

(EPA OPPTS 850.1075) >100 100 Nautilus Environmental, 2009 C Americamysis bahia

5+* 96h survival

(EPA OPPTS 850.1075) >100 100 Nautilus Environmental, 2009

0 96h survival

(EPA OPPTS 850.1075) 24.3 25 Nautilus Environmental, 2009

2.5-pre 96h 28.3 12.5 Nautilus 4.3 mg/L HOCl F Cyprinodon variegatusGESAMP-BWWG 12/6 ANNEX 7 Page 27

I:\MEPC\60\2-16.doc TestSubstance F C A Species Days after treatment,

Pre/Postneutralization Test Type E(L)C5 0 % sample NOEC % sample References/ comments

survival

(EPA OPPTS 850.1075) Environmental, 2009

5-pre 96h survival

(EPA OPPTS 850.1075) 35 25 Nautilus Environmental, 2009

5-post* 96h survival

(EPA OPPTS 850.1075) >100 100 Nautilus Environmental, 2009

5+* 96h survival

(EPA OPPTS 850.1075) >100 100 Nautilus Environmental, 2009

F = Fish, C = Crustacean, A = Algae; * Samp les neutralized with sodium bisulfite.GESAMP-BWWG 12/6 ANNEX 7 Page 28

I:\MEPC\60\2-16.doc Table A10 : Chronic Aquatic Ecotoxicity - Treated Ballast Water

Test Substance F C A Species Days after hypochlorite treatment, plus neutralization Test Type E(L)C50 % Sample NOEC % Sample References/ comments

Seawater (average salinity 36 PSU)

F Menidia beryllina 2 days 7-day survival(EPA R821-02- 014) >100 100 Nautilus Environmental, 2007

F Menidia beryllina 2 days 7-day survival(EPA R821-02- 014) >100 100 Nautilus Environmental, 2007

C Americamysis bahia 2 days 7-day survival(EPA R821-02- 014) >100 100 Nautilus Environmental, 2007

C Americamysis bahia 2 days 7-day survival(EPA R821-02- 014) >100 100 Nautilus Environmental, 2007

B Mytilus galloprovincialis 2 days 48 h larval development (EPA 600- R-95-136) >100 100 Nautilus Environmental, 2007

A Macrocystis pyrifera 2 days 48 h germination (EPA 600- R-95-136) >100 100 Nautilus Environmental, 2007 15.0 mg/L HOCl

A Macrocystis pyrifera 2 days 48 h germ tube length (EPA 600- R-95-136) >100 100 Nautilus Environmental, 2007

F = Fish, C = Crustacean, B = Bivalve, A = Algae

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