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

I:\MEPC\60\2-12.doc

INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION COMMITTEE 60th session Agenda item 2 MEPC 60/2/12 1 December 2009 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

Report of the eleventh meeting of the GESAMP-Ballast Water Working Group

Note by the Secretariat

SUMMARY Executive summary: This document contains the report of the eleventh meeting of the GESAMP-Ballast Water Work ing Group (GESAMP-BWWG) and includes the evaluation of proposals submitted for approval by China, Denmark, Japan and the Republic of Korea. Following the decision of MEPC 58, only the main body of the GESAMP-BWWG’s reports is translated in all the three work ing 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 11/6 (attached)

Introduction

1 The eleventh meeting of the GESAMP-B allast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters from 19 to 24 Oc tober 2009 and its report is attached to this document as GESAMP-BWWG 11/6.

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 8 of the attached report.MEPC 60/2/12 - 2 -

I:\MEPC\60\2-12.doc Action requested of the Committee

3 The Committee is invited to:

.1 agree that Basic Approval should no t be granted to ATLAS-DANMARK Ballast Water Treatment System – ABTS (w ith onboard generated ANOLYTE oxidant) submitted by Denmark in document MEPC 60/2 (see annex 4);

.2 agree that Final Approval be granted to JFE Ballast Water Management System (JFE-BWMS) that makes use of “TG Ballastcleaner ® and TG Environmentalguard ® ” submitted by Japan in document MEPC 60/2/2 (see annex 5);

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

.4 agree that Basic Approval be grante d to DESMI Ocean Guard Ballast Water Management System submitted by Denm ark in document MEPC 60/2/4 (see annex 7);

.5 agree that Basic Approval be granted to Blue Ocean Guardian (BOG) Ballast Water Management System submitted by the Republic of Korea in document MEPC 60/2/5 (see annex 8);

.6 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 Proce dure (G9) (see paragraphs 4.1.2 and 5);

.7 request that, for the purpose of c onsistency, information on Total Residual Oxidants (TRO) or Total Residual Chlorine (TRC) should be provided in the form of mg/L TRO or TRC as Cl 2 , for those systems using or producing oxidants to treat ballast water (see paragraph 4.1.3); and

.8 approve the report in general.

***I:\MEPC\60\2-12.doc GESAMP-BALLAST WATER WORKING GROUP Agenda item 6 GESAMP-BWWG 11/6 24 October 2009 Original: ENGLISH

REPORT OF THE ELEVENTH MEETING OF THE GESAMP-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 ........................................................................ 7

6 CONSIDERATION AND ADOPTION OF THE REPORT .................... 7GESAMP-BWWG 11/6 - 2 -

I:\MEPC\60\2-12.doc ANNEXES

Annex 1 List of members who attended the el eventh meeting of the GESAMP-BWWG

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

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

Annex 4 Review of proposals for approval of ballast water management systems that make use of Active Substances – ATLAS-DANM ARK Ballast Water Treatment System (ABTS) (with onboard generated ANOLYTE oxidant) – Submitted by Denmark for Basic Approval

Annex 5 Review of proposals for approval of ballast water management systems that make use of Active Substances – JFE Ballast Water Management System (JFE-BWMS) that makes use of TG Ballastcleaner ® andTG Environmentalguard ®

–

Submitted by Japan for Final Approval

Annex 6 Review of proposals for approval of ballast water management systems that make use of Active Substances – Sunrui Ballast Water Management System – Submitted by China for Basic Approval

Annex 7 Review of proposals for approval of ballast water management systems that make use of Active Substanc es – DESMI Ocean Guard Ballast Water Management System – Submitted by Denmark for Basic Approval

Annex 8 Review of proposals for approval of ballast water management systems that make use of Active Substances – Blue Ocean Guardian (BOG) Ballast Water Management System – Submitted by the Republic of Korea for Basic Approval- 3 - GESAMP-BWWG 11/6

I:\MEPC\60\2-12.doc 1 INTRODUCTION

1.1 The eleventh meeting of the GESAMP-B allast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters, London, from 19 to 24 October 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.

1.2 The meeting was opened by Mr. Dandu Pughiuc , Head, Marine Bios afety Section, who informed that nine new proposals for approval had been submitted for consideration by MEPC 60 in accordance with the agreed deadline of 28 August 2009. He conveyed the appreciation of the Director of Marine Environment Divisi on for the effort made by the members of the GESAMP-BWWG to have an additional meeti ng (the twelfth meeti ng) in December 2009, and to extend the eleventh meeting over the week end in the attempt to evaluate all the nine submissions. He drew the attention of the Gro up to the importance of reviewing the various proposals in the chronological order of their submi ssions to ensure comple te transparency and a fair treatment for all the proponent Member States. It has been noted, in this context, that the outcome of the GESAMP-BWWG 11 and GESA MP-BWWG 12 will be reported to MEPC 60.

1.3 Mr. Pughiuc expressed his appreciation for the effort made by the IMO Consultant, Mr. John Crayford, for his hard work in prepari ng this meeting and reviewing a large amount of documentation in a relatively short period of time.

1.4 Finally, Mr. Pughiuc reported on the contract ual arrangements and informed the Group on the logistics of the meeting. He also in formed the Group that, at the request of Dr. Frank Stuer-Lauridsen, arrangements had been made for him to be excused when the proposal for approval of the DESMI Ocean Guard Ballast Water Management System (Denmark) is reviewed, due to his involvement in the deve lopment of this technology. Dr. Stuer-Lauridsen took no part in this evaluation and his contract was consequen tly reduced to 11 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 Denmark (two proposals, MEPC 60/2 and MEPC 60/2/4), China (MEPC 60/2/3) and th e Republic of Korea (MEPC 60/2/5), and one proposal for Final Approval had been submitted by Japan (MEPC 60/2/2). All five 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 Consultant signed the Statements of Acceptance related to confidentiality.

2.4 The original copies of these Statements, dul y signed and dated by all involved, were filed with the Technical Secretary of the Group and wi ll be kept together with the submissions.GESAMP-BWWG 11/6 - 4 -

I:\MEPC\60\2-12.doc 2.5 The submissions (dossiers) were deposited in a safe place in the IMO Headquarters and made available to the Consultant, at his request, during the working hours. They were available for consultation by the members of the Group for the duration of the meeting in the meeting room and returned to the Organization’s designated room after the working hours.

2.6 On completion of the work, the Chairman of the GESAMP-BWWG obtained from the other members all the documents, drafts and any other associated records and reports, which were transmitted to the Technica l Secretary of the GESAMP-BWWG for retention in confidence. All electronic records and data held on personal computers/laptops were destroyed when they were 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 The Group reconfirmed that the next m eeting of the GESAMP-BWWG, i.e. the twelfth meeting, will take place from 7 to 11 December 2009, to review the remaining four proposals received before the deadline of 28 August 2009.

3.4 Bearing in mind that MEPC 61 was te ntatively scheduled from 27 September to 1 October 2010 and considering the activities contained in the table above, the Group agreed to tentatively schedule its th irteenth meeting from 24 to 28 May 2010 with a deadline for submission of documents on Thursday, 1 April 2010.- 5 - GESAMP-BWWG 11/6

I:\MEPC\60\2-12.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 had been submitted by China, Denmark (two proposals) and the Republic of Korea and one proposal for Final Approval had been received from Japan.

4.1.2 The Group noted that, during this meeti ng, it was necessary to request additional information or clarification from all the applicants, as the dossiers were either incomplete or, more commonly, the information provided was uncl ear, so slowing down the evaluation process. As a result, the Group reiterated its request to ME PC to urge each Administration to check that all technical descriptions and specifications of the ballast water management systems (BWMS) and, in particular, those related to the operating conditions are included with each application. Equally important, all data pert aining to the safety of the sh ip and crew, human health and environmental exposure and risk need to be su bmitted with each application. Every application has to be fully evaluated by the Group and, whethe r it is recommended for approval or not, it is the Group’s experience that those applications finally assessed as not recommended for approval usually take up the greater proportion of the meeting’s time. An application that is not recommended for approval may, therefore, deny other potential applicant the chance of an early and possibly successful evaluation.

4.1.3 Moreover, the Group requested that, for the purpose of consistency, information on Total Residual Oxidants (TRO) or Total Residua l Chlorine (TRC) should be provided in the form of mg/L TRO or TRC as Cl 2, for those systems using or produc ing oxidants to treat ballast

water.

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 ATLAS-DANMARK Ballast Water Treatment System (ABTS) (with onboard generated ANOLYTE oxidant) Denmark

5 JFE Ballast Water Management System (JFE-BWMS) that makes use of “TG Ballastcleaner ® and TG Environmentalguard ® ” Japan

6 Sunrui Ballast Water Management System China 7 DESMI Ocean Guard Ballast Water Management System Denmark

8 Blue Ocean Guardian (BOG) Ballast Water Management System The Republic of KoreaGESAMP-BWWG 11/6 - 6 -

I:\MEPC\60\2-12.doc 4.2.2 Bearing in mind the criteria associated with Procedure (G9) and having reviewed all of the information associated with these submissions, the Group recommended that:

.1 Basic Approval should not be gran ted to ATLAS-DANMARK Ballast Water Treatment System (ABTS) (with onboard generated ANOLYTE oxidant) (Denmark);

.2 Final Approval be granted to JF E Ballast Water Management System (JFE-BWMS) that makes us e of “TG Ballastcleaner ® and TG Environmentalguard ® ” (Japan);

.3 Basic Approval be granted to Sunrui Ba llast Water Management System (China);

.4 Basic Approval be granted to DESMI Ocean Guard Ballast Water Management System (Denmark); and

.5 Basic Approval be granted to Blue Ocean Guardian (BOG) Ballast Water Management System (the Republic of Korea).

4.3 Specific comments related to ATLAS-DA NMARK Ballast Water Treatment System (ABTS) (with onboard generated ANOLYTE oxidant)

4.3.1 The Group noted the system was conceptual only although it was already being used to treat sewage water, apparently effectively, and that the data ha d been generated in association with this parallel applica tion of the proposed technology.

4.3.2 The Group considered that much of the da ta required for Basic Approval was either missing from the application and much of that which was provided was regarded by the Group as not relevant.

4.4 Specific comments related to JFE Ballast Water Management System (JFE-BWMS) that makes use of “TG Ballastcleaner ® and TG Environmentalguard ® ”

4.4.1 The Group approved the approaches taken by the applicant to show that there would not be any unacceptable risks to the environment, the crew , the general public or the safety of the ship.

4.4.2 Whilst recommending that Final Approval be gr anted to this system, the Group identified a number of issues that would require consid eration by the Administration prior to issuing a Type Approval Certificate.

4.5 Specific comments related to Sunrui Ballast Water Management System

4.1 The Group approved the approaches taken by th e applicant to show that there would not be any unacceptable risks to the environment, the crew, the safety of the ship or the general public eating seafood. However, the Group noted that other aspects of the Human Exposure Scenario had not been addressed and recommended that this should be taken into account in the application for Final Approval.

4.2 The Group recommended that comprehensive co rrosion testing should be addressed in the application for Final Approval.- 7 - GESAMP-BWWG 11/6

I:\MEPC\60\2-12.doc 4.6 Specific comments related to DESMI O cean Guard Ballast Water Management System

4.6.1 The Group noted that this system did not gene rate any significant qua ntities of chemical by-products and so it was not nece ssary to apply the usual pro cesses of risk assessment. However, the Group recommended that, for Fi nal Approval, any model used to estimate environmental or human exposures should be suppor ted by all of the appropriate input data used by the applicant, even when such da ta are based on limits of detection.

4.7 Specific comments relate d to Blue Ocean Guardi an (BOG) Ballast Water Management System

4.7.1 Due to the fact that none of the potential chemical by-produc ts were found in the treated ballast water at levels greater th an those in the control (untreated ) water, the Group agreed that there would be no unacceptable risks to the e nvironment, the crew a nd general public from chemicals produced by this system. In addition, the Group also agreed that it was unlikely that there would be unacceptable risks to the safety of the ship caused by corrosive effects of any associated chemicals. Nevertheless, the Group r ecommended that appropriate corrosivity testing be carried out and the results included in the application for Final Approval.

5 ANY OTHER BUSINESS

5.1 The Group requested MEPC to ur ge Administrations to check th at all of the requirements of Procedure (G9) had been met before submitting an application for either Basic or Final Approval. In making such a reque st, the Group wished to point out that a considerable amount of time can be wasted in ascertaining this requiremen t, particularly when an application is based on a conceptual system, even when such a system might be being used in another, unrelated, application where seawater is not the base medium of the treatment.

6 CONSIDERATION AND ADOPTION OF THE REPORT

6.1 A draft report of the el eventh meeting of the GE SAMP-BWWG was produced on Saturday, 24 October 2009 and, after a paragra ph-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 11/6

I:\MEPC\60\2-12.doc ANNEX 1

LIST OF MEMBERS WHO ATTEN DED THE ELEVENTH 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 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 11/6 ANNEX 1 Page 2

I:\MEPC\60\2-12.doc Mr. Edward Lemieux Director Center for Corrosion Science 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-mails: 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

Dr. Frank Stuer-Lauridsen LITEHAUZ ApS Diplomvej 381 DK 2800 Lyngby Denmark E-mail: Tel:

Mobile: fsl@litehauz.dk +45 8870 8675

+45 2023 0202

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 CONSULTANT

Mr. John Crayford 2 Dunmow Hill Fleet Hampshire GU51 3AN United Kingdom E-mail: Tel: j.crayford@ntlworld.com +44 (0)1252 672245GESAMP-BWWG 11/6 ANNEX 1 Page 3

I:\MEPC\60\2-12.doc GESAMP

Mr. Martin Soderberg GESAMP Officer Marine Environment Division International Maritime Organization 4 Albert Embankment, London SE1 7SR United Kingdom E-mail: Tel: Fax

Mobile: msoderbe@imo.org +44 (0)20 7463 4139 (Direct) +44 (0)20 7587 3210

0755 269 9604

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 11/6

I:\MEPC\60\2-12.doc ANNEX 2

AGENDA FOR THE ELEVENTH MEETING OF THE GESAMP-BWWG

1 Introduction

2 Issues of confidentiality

3 Terms of reference and time frame

4 Review of proposals for a pproval of Active Substances

.1 Denmark ATLAS-DANMARK Ballast Water Treatment System (ABTS) (with onboard generated ANOLYTE OXIDANT) for Basic Approval

.2 Japan: JFE Ballast Water Manageme nt System (JFE-BWMS) that makes use of TG Ballastcleaner ® and TG Environmentalguard ® for Final Approval

.3 China: Sunrui Ballast Water Management System for Basic Approval

.4 Denmark: DESMI Ocean Guard Ballast Water Management System for Basic Approval

.5 Republic of Korea: Blue Ocean Guardian (BOG) Ballast Water Management System for Basic Approval

5 Any other business

6 Consideration and adoption of the report

***GESAMP-BWWG 11/6

I:\MEPC\60\2-12.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 11/6

I:\MEPC\60\2-12.doc ANNEX 4

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

ATLAS-DANMARK Ballast Wate r Treatment System (ABTS) (with onboard generated ANOLYTE oxidant)

Submitted by Denmark for Basic Approval

0 SUMMARY

0.1 Having reviewed all of the data provi ded by Denmark with the application for Basic Approval together with additional inform ation received from th e applicant, the Group recommended that Basic Approval should not be granted to the ATLAS-DANMARK Ballast Water Treatment System (ABTS).

0.2 The Group noted that this proposed system was conceptual only. However, it was recognized that such a system was already bei ng used to treat sewage water, apparently effectively, and that data had been generated in association with this parallel application of the proposed technology.

0.3 Whilst it was recognized that the analysis had been carri ed out on the treated sewage water in order to give some indication of the amount of chemical by-products, which might be expected from a system installed on board sh ip, the Group concluded th at a more detailed analysis of such chemicals s hould be carried out before the system can be recommended for Basic Approval.

0.4 The Group noted that the applicant did not provide information regarding the identification and description of the unit operations associated with this system. The Group also noted that information regarding the Human Expo sure Scenario (MEPC 56/2/2, annex 9) had not been provided.

0.5 The Group will require that this informati on should be fully supported and documented so that it can be taken into account should th e system again be submitted for review for Basic Approval in the future.

0.6 The Group had the following concerns with information in the dossier:

.1 the dossier describes a conceptual tr eatment of ballast water based on the electrolysis of seawater. It described tw o stages of treatment; at uptake and during tank holding time. The dossier only provi ded information about the planned TRO concentration of ANOLYTE to be injected into the ballast water at uptake. Adequate information had not been pr ovided to determine the intended TRO concentration during tank holding time. The dossier neither provided information on the intended control scheme nor the dos age of Active Substance concentrations during tank holding time. The applicant had provided a theoretical control scheme using an ORP sensor, for which the correlation with TRO had not been established and which is known to be affected by pH;GESAMP-BWWG 11/6 ANNEX 4 Page 2

I:\MEPC\60\2-12.doc .2 the chemical analysis provided was from a different treatment system to the proposed system and, therefore, could not be accepted as representative of the “Simulated Ballast Water Discharg e” required for Basic Approval. Notwithstanding this observation, the chem ical analysis report did not include Quality Control (QC)/Quality Assurance (QA) documentation (G9 4.2.4);

.3 whole effluent ecotoxicity testing (W ET) had not been performed (G9 5.2.1.1) on simulated ballast water discharge; and

.4 the Group noted that the dossier lacked detailed information on the prediction of discharge and environmental concentration of the Active Substances and Relevant Chemicals identified

. 0.7 The Group stressed that each application is ev aluated on its own merits as a “stand-alone” dossier.

0.8 The Group noted that the system is intende d to maintain an ANOLYTE concentration in the ballast tanks to achieve an Oxidation Redu ction Potential (ORP) of +400mV. This will require the further addition of oxidant to the ta nk throughout the holding time. As the system does not incorporate a neutraliza tion step prior to discharge, the risks from residual TRO concentrations upon discharge need to be carefully assessed.

0.9 The Group was not able to estimate the disc harge concentration in the system with repeated treatment with confidence and so encourag ed the applicant to consider the neutralization of the Active Substances before discharge through operational or technical measures.

1 INTRODUCTION

1.1 The data used to evaluate ABTS were ex tracted from the Danish submission to the sixtieth session of MEPC as document MEPC 60/2.

2 DESCRIPTION OF THE SYSTEM

2.1 The Group noted that the system proposed will involve the following stages in the treatment of ballast water:

.1 filtration with a 50 μm filter;

.2 production and storage of ANOLYTE;

.3 injection of ANOLYTE into the ballast water to maintain an ORP of +400 mV in the ballast tank. The Group assumed that this to be approximately equal to 1 mg/L TRO; and

.4 dispensing of CATHOLYTE in to the treated ballast tanks.GESAMP-BWWG 11/6 ANNEX 4 Page 3

I:\MEPC\60\2-12.doc 2.2 A simplified schematic representation of th e system showing only the main aspects is shown in the diagram below:

2.3 The Group noted that ANOLYTE is generated on board using electroly tic cells in which a weak solution of sodium chloride in fresh wate r, generated onboard, is treated by electrolysis.

2.4 This process produces:

.1 ANOLYTE hypochlorous acid (HOCL) solution - < 158.4 mg/L ozone (O 3 ) - < 1.4 mg/L hydrogen peroxide (H 2 O 2 ) - < 0.5 % (wt) various positive ions - <0.5 %

pH 5.5 - 7.0 ORP 850 ± 150 mV Stable for 48 h

.2 CATHOLYTE water - 99.87% w/v hydroxyl ion - <170 mg/L sodium hydroxide - <230 mg/L sodium chloride - <630 mg/L hydrogen - 4 ml/L Filter Ballast tank ANOLYTE storage tank

Ballast water uptake

Ballast water

discharge Fresh water supply Salt storage tank

ANOLYTE generator CATHOLYTE (may also be discharged otherwise )GESAMP-BWWG 11/6 ANNEX 4 Page 4

I:\MEPC\60\2-12.doc 2.5 The Group noted that chemical compositi on both of ANOLYTE and CATHOLYTE is likely to be constant because it was made from salted water, not from natural seawater with associated variable constituents

2.6 The Group also noted that, in the pro cess of generating ANOLYTE, CATHOLYTE is also generated, which is ~0.1% sodium hydroxide (NaOH) solution with a pH of ~11 and an ORP of -850 ± 150 mV.

2.7 The Group noted that the system is intende d to maintain an ANOLYTE concentration in the ballast tanks to achieve an ORP of +400mV. This will require the further addition of oxidant to the tank throughout the holding time. As the system does not incorporat e a neutralization step prior to discharge, this will result in the discharge of an undetermined TRO concentration.

2.8 The Group noted that this type of treatment has been used for several years for the sterilization of animal and huma n feedstuff, for disinfecting sewa ge water and potable water as well as disinfecting swimming pools and aqua riums where no significant adverse effects on humans, animals and aquatic life have been observed.

2.9 However, it was noted that the use of this process on board ship was conceptual at the time of application and that all reported data we re obtained from non ballast water applications. In particular, efficacy test results and chemical analyses of treated water were reported from sewage treated with a similar technology.

3 CHEMICALS ASSOCIATED WITH THE SYSTEM

3.1 The Group noted that the following chemicals had been identified, by the applicant, as being anticipated chemicals of ballast water treated with this system:

Composition of ANOLYTE/CATHOLYTE Chemical Name CAS Number Concentration Type Hypochlorous acid 7790-92-3 < 158.4 mg/L AS Ozone 10028-15-6 < 1.4 mg/L AS Hydrogen Peroxide 7722-84-1 < 0.5 % (wt) AS Chlorine Dioxide 10049-04-4 < 2.5 mg/L AS Hydrogen 1333-74-0 < 4 mL/L RC Sodium Hydroxide 1310-73-2 < 230 mg/L RC

List of potential by-products produced in ballast water

Chemical Name CAS Number Concentration Biodegradation Half-life Chlorite (Sodium Hypochlorite) 7681-52-9 Assumed < 2.5 mg/L 35 h Bromate (Potassium Bromate) 7758-01-2 Assumed < 10 μ g/L 12 h Trichloro Methane 67-66-3 4.0 μ g/L – mean value < 48 h Bromodichloromethane 75-27-4 0.6 μ g/L – mean value 1.6 h (River Water) Dibromochloromethane 124-48-1 0.04 μ g/L – mean value ~ 1 d (Surface Water) Tribromomethane 75-25-2 0.1 μ g/L – mean value 2.6 d (Surface Water) Halo-acetic acids No available informationGESAMP-BWWG 11/6 ANNEX 4 Page 5

I:\MEPC\60\2-12.doc 3.2 Data associated with each of the chemical s associated with the treated ballast water

3.2.1 The data, provided by the applicant and used by the Group in the Risk Assessment are shown for:

.1 hypochlorous acid and sodium hypochlorite (appendix 1);

.2 potassium bromate (appendix 2);

.3 ozone (appendix 3);

.4 hydrogen peroxide (appendix 4);

.5 trihalomethanes (appendix 5);

.6 hydrogen (appendix 6); and

.7 sodium hydroxide (appendix 7).

4 QUESTIONS PUT TO THE APPLI CANT WITH RESPONSES AND THE GROUP’S REACTIONS

4.1 The following part of this section shows the qu estions put to the applicant by the Group, the applicant’s responses and the Group’s reactions.

Question 1:

The submission indicates that, in the case of organism re-growth, additional ANOLYTE is to be dosed. Please could you explain more clearly how re-growth is to be determined?

Response 1:

.1 It has been observed in the applica tion of the technology that the ORP will decrease significantly, when re-growth a ppears. Therefore, each of the ballast tanks will be equipped with a stationa ry ORP probe. The exact ORP potential reached, when re-growth may appear is yet to be determined – but it appears to be about 400 mV.

Reaction: The Group was not satisfied with this response as the dose to be used was still not clear.GESAMP-BWWG 11/6 ANNEX 4 Page 6

I:\MEPC\60\2-12.doc Question 2:

The Group considered that the possibility of tr ansferring the full contents of one ballast tank to another is extremely small due to st resses imposed on the ship. Please could you indicate how this is to be achieved?

Response 2:

.1 We do not intend to move water between the ballast tanks. In case of re-growth detected, according to our comments in paragraph 1, the ballast water intake ANOLYTE injection point is used for forced injection of an amount corresponding to the amount of ballast water in the tank in ques tion. The resulting “plug” of ANOLYTE is then forced by the ballast pump for the corresponding water intake line and is dispersed in the tank.

Reaction: The Group was satisfied with the answer.

Question 3:

The submission indicates that the CATHOLYTE is to be dosed into the ballast tanks when produced. Please could you indicate how this is to be achieved, i.e. how is the CATHOLYTE to be directed to the individual ballast tanks as needed?

Response 3:

.1 When discharging the CATHOLYTE to the ballast water, we anticipate that fixed pipes to one or two ballast tanks cl osest to the ANOLYTE generator will discharge all CATHOLYTE produced.

.2 According to Lloyds, the CATHOLYTE led to any of the balla st tanks will have any influence on the stability of the ship.

Reaction: The Group was satisfied with the answer.

Question 4:

In a previous response, it was indicated th at there is a possibility that the CATHOLYTE may be directed to “Grey” or “Black” water ta nks. What will be the effect of adding CATHOLYTE to either of these waste streams, pa rticularly the effect on standard marine sewage treatment plant reactions?

Response 4:

.1 The CATHOLYTE is a very weak solution (<0,1%) of NaOH, which is not anticipated to create any problems in sewage plants, which will have to cope with substantially higher co ncentrations of soap solutions, etc.

Reaction: The Group was satisfied with the answer.GESAMP-BWWG 11/6 ANNEX 4 Page 7

I:\MEPC\60\2-12.doc Question 5:

Is there any different effect or re action with the use of this treatment with marine water rather than fresh water as usually experienced with shore-based sewage treatment plants?

Response 5:

.1 There does not appear to be reasons, w hy the salt water should behave differently in connection with ANOLYTE, than expe rienced in the previous tests on land.

Reaction: The Group was not satisfied with th e answer as it believed that the resulting chemistry from the electrolytic chlorination is different in natural seawater due to variations in the concentrations of bromated ions, POC, and TSS.

Question 6:

Recognizing that this question has already b een addressed, please could you confirm and clarify the apparent anomaly between the fo recast degradation rate of ANOLYTE, i.e. “up to 48 hours stability” and “excess of two weeks” plus “4-5 weeks”. What is the actual situation?

Response 6:

.1 “Up to 48 hours” is a guaranteed period, where the ANOLYTE maintains the performance. For the last month, we ha ve stored samples of ANOLYTE with ORP of initially 900 mV – 1000 mV. For exampl e, the ORP does not appear to degrade more than 50 mV during four weeks, when stored in darkness at room temperature.

Reaction: The Group was satisfied with the answer.

Question 7:

No PEC values have been calculated and concentrations for Active Substances and Relevant Chemicals have not been identified under ballast water treatment conditions. However, there are data from a different matrix (sewage) in a system operating under presumably different conditions fr om ballast water treatment sy stem (flow rate, filter size and type). The Group kindly requests you to cl arify the expected PECs after ballast water treatment and relate to ecotoxicologically relevan t criteria such as PNEC rather that solely drinking water and bathing water criteria, which may not be protective of the environment.

Response 7:

.1 No modelling (using e.g. MAMPEC software) has yet be en carried ou t – but is anticipated in a next phase – and th erefore no PEC/PNEC ratios have been evaluated.

Reaction: The Group noted the answer.GESAMP-BWWG 11/6 ANNEX 4 Page 8

I:\MEPC\60\2-12.doc Question 8:

The ballast water concentrations given in table on p10 of annex of confid ential material lists THMs of with an average value of 4.74 ug/L from MOOSBURG test s. In section 1.5.1.3 of MEPC 60/2 a value of 9.0 ppm (mg/L) is mentioned, but in the report of IWB from MOOSBURG, a value of 9.0 ug/L is given (presumably the latter is correct). Kindly, clarify the proper range and average values from the 13 tests used for the application (MEPC 60/2, page 7).

Response 8:

.1 This is an error on our part. The measurements in MOOSBURG report 1,6 to 9,0 μ g/liter THM (and not as our section 1.5. 1.3 states “mg/liter”). Also in that paragraph we write that the drinking water limiting value (Germany) is 50 mg/liter – naturally, this should also be 50 μ g/liter.

Reaction: The Group was satisfied with the answer.

Question 9:

The chemical analysis performed in addendum 3 does not provide the information for chemical characterization of control water an d treated water, such as salinity, temperature, bromated ion, pH, DOC, POC an d TSS. Could you provide th e additional information for that? Also are there any actual measurements of TRO of treated water during these 13 series? The Group cannot evaluate th e statement without such information that the levels of by-products are compatible wi th drinking water requirement, so that no further risk assessment would be needed.

Response 9:

.1 In connection with a later phase, these data are anticipated. In our application (section 1.4.4), the sterilizat ion is anticipated finali zed within two minutes – however, the exact level (apart from compatibility with drinking water regulations) of Residual Ox idant is not known. During th e several years of using the ANOLYTE for disinfection of swimming pools, waste effluent and treatment of human foods for salmone lla, campylobactor, etc., the TRO level is considered to be very low.

Reaction: The Group was not satisfied with th e answer as it believed that the resulting chemistry from the electrolytic chlorination is different in natural seawater with variations in the concentrations of bromate ions, POC, and TSS.

Question 10:

The Group considers that the system described in Addendum 3 appears to be different from the system proposed in this dossier. Is the same filtration component used as in the former case, with Amiad filter unit? Is it in tended that the filter with 50μm diameter can eliminate all other organisms, rather than indi cator microbes? If the answer is positive, can the filtration system be scaled up to 1000 m 3 /h (indicated in you r non-confidential application) from 26 m^3/h (described in addendum 3)?GESAMP-BWWG 11/6 ANNEX 4 Page 9

I:\MEPC\60\2-12.doc Response 10:

.1 Initially, we anticipated using the AM IAD filter unit (like the system used by SINCERUS) or a similar system from the company BOLLFILTER. These are both mechanically based filters, where we consider that the potential for failure is present. In our present configuration, we are considering a ceramic porous filter developed by the company COMETAS. We have tested this filter (tests are still in progress) using very dirty and “slimy” ha rbour water during th e late summer. We have found, that we can maintain a 30 μ m capacity when using a cyclic (PLC controlled) with pressure drop across the filters of 0,2 bar. When pressure drop increases to 0,4 bar across the indivi dual units flushing is carried out (we further have an alarm at 0,6 bar pressure drop). The capacity is 160 m3/h per filter unit. The system is highly modular and consists of modul es approximately 500 x 500 mm cross-section and length 2000mm – weighing each about 95 kg.

Reaction: The Group was satisfied with the answer.

Question 11:

The application states that the CATHOLY TE will be applied to ballast tank for sterilization. Are there any ac tual measurements of TRO ch anges before and after adding the CATHOLYTE to treated ballast water by ANOLYTE?

Response 11:

.1 Such measurements have not been carri ed out. As mentioned in paragraph 3, the effect on the ballast water is anticipated to be minimal – due to the very low addition rate. It should be noticed that there is no oxidant in the CATHOLYTE. However, as mentioned in paragraph 4, we favour the solution with discharge to the “grey/black water” sewage system.

Reaction: The Group was satisfied with the answer.

Question12:

In the section of “chemical hazards” in par agraph 3.2.1, it is stated that the ventilation could remove the chlorite and bromated ions and THMs. Could you provide more detailed explanation for this statement? The concentr ation of these chemicals in ballast water can be removed by aeration, however, ventilation fo r headspace of ballast tank is completely a different matter, we need clarification of this.

Response 12:

.1 Ventilation in the ballast tanks will only be required in case of manual inspection and work carried out in the tanks at sea.

Reaction: The Group was satisfied with the answer.GESAMP-BWWG 11/6 ANNEX 4 Page 10

I:\MEPC\60\2-12.doc Question 13: You propose to maintain an ORP level of +400 mV in the tank. Please could you identify what TRO dosage concentration this ORP co rresponds to? Please could you provide the anticipated and/or measured TRO dosage con centration of the system when operated on ballasting.

Response 13:

.1 In the ASI Electrolytic Cells, we pro duce ANOLYTE with a Free Active Chlorine (FAC) of 250 mg/Litre – 400 mg/Litre and acidity pH = 6,5 – 7,0 and because of the internal membrane system (which effectively separates the ANOLYTE and CATHOLYTE and prevents mutual neutra lization with regard to electrical activity) we can maintain an ORP in excess of +900 mV.

.2 Thereby, the biocidal activity of the Hypochlorous acid in the ANOLYTE has been found to be about 300 times more active than the S odium hypochlorite generated in earlier systems (as stated by Professor T. E. Cloete, Department of Microbiology and Plant Pathology, Univer sity of Pretoria, South Africa).

.3 Immediately after injection (dilut ion 1:250 to 1:500) the ABTS achieves a concentration of about 1 mg /Litre of Hypochlorous acid in the ballast water, which has proven to terminate all micro-or ganic life within about two minutes in previous land based application.

.4 After the disinfection has been carried out, the ANOLYTE will be degraded into compounds normally present in seawater and only the trace contaminants of by-products as mentioned in our appli cation (paragraph 3.0) are anticipated.

.5 The presence of bulkheads and frames in real ballast tanks are not (as far as we know) realistically simulated in the tanks used for land-based testing (like NIVA, NIOZ, etc.) and this is the reason that we want a countermeasure against possible re-growth by using as indicator the leve l of electrical activity – after consulting with our Cell sub-supplier ASI selected as an ORP of +400mV.

.6 As mentioned above, we do not anticipate any TRO in the ballast water at that time but, as stated previously, we will use this as a signal for administering an extra dose of ANOLYTE to the offending tank.

.7 However, the precise way of carrying out this process and determining the ORP “trip point” would be part of full-scale tests.

Reaction: The Group did not agree with the a pplicant’s conclusion that no TRO will be anticipated in the ballast water since, according to published literature, 400mV roughly corresponds to 1 mg/L TRO as Cl 2 . The Group accepted this as the initial and maintained treatm ent concentration in this system.GESAMP-BWWG 11/6 ANNEX 4 Page 11

I:\MEPC\60\2-12.doc Question 14:

The Group has not been able to localize Whole Effluent Toxicity test ing of the proposed system that has been carried out. Are such tests as per Procedure (G9), paragraph 5.3.2, and is the Methodology 6.2.1.1 available?

Response 14:

.1 All toxicity data used in the application were derived from the open literature and from information provided by SINCERUS (Germany) and ASI (UK), who have marketed the electrolytic cells fo r production of ANOLYTE for many years.

.2 All these data are related to effect s of the individual relevant active and by-product substances (Hypochlorous Acid, Bromate Ion, Ozone, Hydrogen Peroxide, Trihalomethanes, Hydrogen and Sodium Hydroxide). No whole effluent effects for real or simulated ballast water have b een studied and we appreciate that this may be necessary in relationship to a Final Approval.

.3 However, in view of the previous widespread approved use of ANOLYTE for disinfection in connection with swimmi ng pools, aquariums, human food and animal feed preservation and even medici nal use, the study on combined effluent influence on a marine environment was not considered crucial at the present stage.

.4 Furthermore, the company ASI (our el ectrolytic cell partner) worked with this technology for several years while a resident of South Africa.

.5 Also, the system from Resource Ballast Water (South Africa) uses as part of the BWMS process an earlier version of our technology and was previously granted Basic Approval by the GESAMP-BWWG (MEPC 57, annex 5). Another South Africa Company Radical Waters ) also uses the basic electrolytic process commercially and several studies by Dr . Eugene Cloete (Department of Microbiology and Plant Pathology, Universi ty of Pretoria, South Africa) on the safety and efficiency of ANOLYTE ar e available in the open literature.

.6 Finally, we would like to draw your at tention to the meeting in the European Commission – “32nd meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC” (9 February 2009) – where our technology was evaluated to be “not covered by the EU Biocide Directive”. This was considered by the Danish Environmental Agency to be an indication that the conc ept is harmless to humans and the environment.

Reaction: The Group was not able to substantia te the applicant’s last point. The Group noted the answer of the applicant and co ncluded that the tests required were not available.GESAMP-BWWG 11/6 ANNEX 4 Page 12

I:\MEPC\60\2-12.doc 5 HUMAN HEALTH ASSESSMENT

5.1 The Group noted that, whilst the ANOLYTE is ge nerated onboard, it is also stored in a tank prior to treatment of the incoming ballast water.

5.2 The Group noted the various chemicals id entified in the ANOLYTE or CATHOLYTE (see section 3.1) and agreed that these presented the following potential hazards to the crew:

.1 Free Active Chlorine (FAC) - (hypochlorous acid, sodi um hypochlorite, chlorine and chlorine dioxide) is:

.1 a skin and eye irritant; and

.2 may be corrosive at high concentrations.

.2 Ozone is:

.1 toxic when inhaled and, even at low doses;

.2 can be harmful to the uppe r respiratory tract and lungs; and

.3 irritating to the eyes.

.3 Hydrogen peroxide is:

.1 irritating to the eyes.

.4 Hydrogen :

.1 can cause dizziness, headach e, nausea and unconsciousness in concentrations from 8-10% and upwards; and

.2 is [explosive][flammable] in concentrations from 4%-74%.

.5 Sodium hydroxide is:

.1 very corrosive to skin and eyes; and

.2 harmful in contact with skin; and

.3 harmful via inhalation.

5.3 In addition to those chemicals produced and/ or stored onboard, the Gr oup recognized that the following chemicals in the ballast water after treatment by the system have potential hazards as follows:

.1 Chlorite (sodium hypochlorite) is:

.1 a skin and eye irritant.GESAMP-BWWG 11/6 ANNEX 4 Page 13

I:\MEPC\60\2-12.doc .2 Potassium bromate is:

.1 toxic when ingested;

.2 irritant to skin, eyes a nd the respiratory system and;

.3 a probable human carcinogen.

.3 Trihalomethanes and in particular bromoform are:

.1 toxic by inhalation;

.2 harmful if swallowed;

.3 irritating to the skin and eyes; and

.4 a probable human carcinogen.

6 RISKS TO THE SAFETY OF THE SH IP, ITS CREW AND THE GENERAL PUBLIC

6.1 The Group noted that the applicant had recognized that the ANOLYTE and CATHOLYTE concentrations are potentially corro sive, however, the app licant concludes that, since the exposure times are short, no increase in corrosion rates are anticipa ted. As no data were provided to validate the applicant’s assumption, the Group was not satisfied with the provided information. The Group recommended that co mprehensive testing be conducted in accordance with 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 particular, the appli cant should address the relatively high concentration of oxidants in the ANOLYTE st orage tank and the downstream piping should provide data regardi ng the corrosiveness in that area.

6.2 The Group noted that it was proposed to di rect the output from a Fresh Water Generator directly to the electrolys is unit producing ANOLYTE and CATHOLYTE. The Group recognized that the Fresh Water Generator is no rmally used for producing potable water on the ship and that it is not usually permitted to use this plant in coastal waters due to the possibility of contamination with bacteria. The Group considered th at this aspect ha s yet to be fully considered.

6.3 The Group noted that the ANOLYTE is to be stored on board prior to use and that a stainless steel tank is to be used for this storag e. It was also noted th at the ANOLYTE has a high concentration of chlorine with a significant ozone content and th at the usually expected safety consideration associated with such storage such as tank ventilation, inspection and maintenance had not been specifically id entified and addressed.

6.4 The Group noted, in the applicant’s respons es, that, depending upon residual levels of chemicals in the ballast tank, it was also intende d to inject more ANOLYTE into the ballast tank following the initial dose on uptake. It was also noted that the a dditional dosing was to be made by forcing a “plug of ANOLYTE” through the ballast water main to the tank by the ballast water pump. No indication of how this “plug of AN OLYTE” was to be metered was given. It was considered relevant to note that it is usual to f ill a ballast tank to capacity to avoid “free surfaceGESAMP-BWWG 11/6 ANNEX 4 Page 14

I:\MEPC\60\2-12.doc effect” on stability and therefore the availabil ity of space for such dosing may be limited. Furthermore, the corrosive effect of trans it of “a plug of ANOLYTE”, with a very high concentration of chlorine, thr ough the ballast main appears not to have been identified. The Group considered that such basic operational aspects of this system had not been given sufficient consideration in this application.

6.5 The Group noted that no attempt had been made to quantify the risks to the crew or the general public from chemicals either used or being produced in the proposed system (Ref: Methodology, paragraph 2.3.1, BWM.2/Circ.13).

6.6 The Group noted the applicant ha d stated that the concentra tions of chemicals found in sewage treated with this system were regarded as good/excellent according to the EU Directive on bathing water. In addition, it was recalled that the Group had previously recommended that Basic Approval be granted to a system which pro duced greater concentrations of chlorine (AOX) than cited above. However, since the Group ha d not received sufficient information on the differences between the sewage treatment system and the proposed system , it was not possible to evaluate the inherent risks.

6.7 The Group noted that the applicant did not provide information regarding the identification and description of the unit operations associated with this system where crew exposure could take place (e.g. production, st orage and dosing of ANOLYTE/CATHOLYTE). Therefore, the Group considered that there was significant uncer tainty regardi ng the potential exposure to chemicals which may be experienced by the ships’ crews.

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

7.1.1 Although the applicant did not provide all of the informati on to indicate whether the byproducts in the treated ballas t water would meet the PBT cr iteria, the Group agreed on the following information based on data pr ovided in previous applications.

Chemical Persistence (P) Yes/No Bioaccumulation (B) Yes/No Toxicity (T) Yes/No Bromoform Yes No No Chloroform Yes No No Bromodichloromethane Yes No No Dibromochloromethane Yes No No Sodium hypochlorite No No No Potassium bromate Yes No No Haloacetic acids Yes No No

7.2 Calculation of Predicted Envi ronmental Concentration (PEC)

7.2.1 The Group noted that the applicant had not provided any PEC values for those chemicals identified in the treated ballast water. Furthe rmore, the chemical concentrations provided were from treated sewage which the Group considered may not be representative of those anticipated in treated ballast water.GESAMP-BWWG 11/6 ANNEX 4 Page 15

I:\MEPC\60\2-12.doc 7.2.2 The Group concluded that it was not possible to perform an appropriate environmental risk assessment.

8 CONCLUSIONS AND RECOMMENDATIONS

8.1 The Group considered that, due to the lack of information and data, the dossier presented and reviewed did not demonstrate the necessary confidence that a sa fe and consistent application of the proposed system could be assured.

8.2 The Group recommended that the comprehe nsive corrosion testin g be conducted in accordance with the guidance provided in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG” contained in MEPC 59/2/16.

8.3 The Group recommended that information rega rding the identificati on and description of the unit operations associated with this system and the Human Exposure Scenario (MEPC 56/2/2, annex 9) should be fully supported and documented.

8.4 The Group concluded that it was not possible to perform an appropriate human risk

assessment.

8.5 The Group concluded that it was not possible to perform an appropriate environmental risk assessment.

8.6 Due to the lack of required data, the Group was unable to ca rry out any meaningful risk assessment and so did not recommend that this system be granted Basic Approval.

* * *GESAMP-BWWG 11/6 ANNEX 4 Page 16

I:\MEPC\60\2-12.doc APPENDIX 1

DATA ASSOCIATED WITH HYPOCHLORO US ACID, SODIUM HYPOCHLORITE AND CHLORINE/CHLORINE DIOXIDE

1 Acute aquatic toxicity

1.1 Data on the acute aquatic toxicity from th e US EPA [REF 3] da tabase are reproduced below for representatives of four taxono mic groups (fish, mollusks, crustaceans and phytoplankton).

Chemical Organism Scientific Name & Common Name Development Stage Toxicity Endpoint Effect Measure Exposure Duration Toxic Dose ( μ g/L) Salvenius fontinalis Brook Trout 110-150 mm LC 100 Mortality 9 h 350 Fish

Marone saxatilis Striped Bass ~ 1.0 g LC 50 Mortality 6 h 610

Crassostrea gigas Pacific Oyster Larvae/Velige

r LC 50 Mortality 1 h 556 Mollusks

Mercenaria mercenaria Hard Clam Larvae LC 50 Mortality 48 h 5

Acellus aquaticus Aquatic Sowbug Mature, Nonreproducing LC 50 Mortality 24 h 754 Crustacea

ns Calinectus sapidus Blue Crab Adult LC 50 Mortality 48 h 750 Cl 2

Algae Chlorophyceae Green Algae Several species Abundanc

e 24 h 100

Fish Ciupea pallasii Pacific Herring Juvenile LC 50 Mortality 96 h 65

Leopomis macrochirus Bluegill Juvenile LC 50 Mortality 96 h 580

Dreissena polymorpha Zebra Mussel Adult LC 95 Mortality 17.7 h 90

Crassostrea virginica American Oyster 7 day Larvae LC 50 Mortality 0.5 h 120

Ciibanarius humilis Hermit Crab Several species LC 50 Mortality 96 h 2500 Mollusks

Hemigrapsus nudus Shore Crab Adult LC 50 Mortality 96 h 1418

Chlorella sorokiniana Green Algae 225 cells/mL Mortality 20 h 200 HOCl

Crustacea

Plankton Various LC 50 Mortality 96 h 90

1.2 Endocrine disruption

No information was found on endocrine disruption by chlorine.GESAMP-BWWG 11/6 ANNEX 4 Page 17

I:\MEPC\60\2-12.doc 1.3 Sediment toxicity

Chlorine may react with soil a nd sediment components to form chlorides, which, depending on their water solubility, are easily washed out (US EPA database - [REF 3]).

1.4 Bioavailability/biomagnification/bioconcentration

There is no potential for the bioaccumula tion or bioconcentra tion of chlorine.

1.5 Food web/population effects

As there is no potential for bioconcentration of chlorine, animals higher in the food chain will not be affected.

1.6 Data on mammalian toxicity

Sodium hypochlorite solution causes moderate muco sal irritation, the extent of which depends on the volume ingested, the concentration of the pr eparation and the duration of the contact. When swallowed it may cause gastrointestinal irri tation, with nausea, vomiting and diarrhea.

1.6.1 Acute toxicity

In humans, oral doses of 2.5 mg chlorine/d, ha d no adverse effects for prolonged periods and no adverse effects were noted in persons ingestin g water containing 50 ppm - 90 ppm of chlorine (~1.4 to 2.6 mg Cl/kg/d) for a short period of time. Drinking water concentrations of >90ppm chlorine caused irritation of membranes of thro at and mouth in some studies and concentrations of chlorine in drinking water in excess of 25 ppm make the drinking water unpalatable.

1.6.2 Effects on skin and eye

1.6.2.1 Free active chlorine can cause mild skin ir ritation to corrosive injury depending on the duration of the contact, concentration and pH of the solution. An 8% sodium hypochlorite solution has been shown to not cause skin irrita tion. Mild eye irritation to corrosive injury can also be caused depending on the concentration and pH of the solution and the duration of contact.

1.6.2.2 Chlorine itself is considered a primary irritant to the mucous membranes of the eyes, nose, and throat and to the linings of the entire re spiratory tract. The extent of acute injury to humans depends on the concentration and duration of exposure as well as the water content of the tissue involved.

1.6.2.3 Mild irritation is noticed at 1 ppm – 3 ppm, chest pains, vomiting and coughing at 30 ppm and death at 430 ppm for 30 minutes and at 1000 ppm for a few minutes. For animals (small rodents, cats, etc.) doses above 3000 ppm for more than 1 hour ar e considered critical.

1.6.3 Repeated-dose toxicity

See chronic toxicity.GESAMP-BWWG 11/6 ANNEX 4 Page 18

I:\MEPC\60\2-12.doc 1.6.4 Chronic toxicity

1.6.4.1 The major target organs for the sub-chronic/ chronic toxicity of chlorine in humans are the respiratory tract and the blood. The major target organs for the sub-ch ronic/chronic toxicity of chlorine in animals are the immune system , the blood, the cardiovascular system and the respiratory tract. The US EPA [REF 3] has derive d an oral reference dose (RD) of 0.1 mg/kg/d for chlorine, based on a no-observe d-adverse-effect level (NOAEL) of 14.4 mg/kg/d in a chronic drinking water study in rats.

1.6.4.2 As an example 55 workers exposed to a bout 1.0 ppm of chlorine, 8 h/day for at least 90 days exhibited asthma, chronic bronc hitis, tuberculosis, and emphysema. The concentration of 1 ppm is roughly equivalent to 0.415 mg/kg/d (i.e., 4 times the above stated RD of 0.1 mg/kg/day).

1.6.4.3 Groups of 70 male and female rats were given drinking water c ontaining up to 275 ppm of chlorine (14.4 mg/kg/d) for two years. No abnor malities were detected at interim sacrifices or at the end of the study (EPA to state the abovementioned RD used these results).

1.6.4.4 Similar experiments have been carried ou t using rhesus monkeys, cats, hamsters and mice.

1.6.5 Developmental and reproductive toxicity

No conclusion on the developmenta l/reproductive toxicity of chlo rine can be made based on the limited information available from human and animal studies.

1.6.5.1 Humans – No information was found in the secondary sources searched to indicate that chlorine is a developmental/re productive toxicant in humans.

1.6.5.2 Animals

1.6.5.2.1 Female rats were given chlorine c oncentrations of 0 mg /L, 1.0 mg/L, 10 mg/L, or 100 mg/L in the drinking water (as HOCl) for two-and-a-half months prior to conception and throughout gestation. They were killed on gest ation day 20, and the fetuses were examined.

1.6.5.2.2 Fetuses in the 100 mg/L group had soft ti ssue defects, including improper orientation of the heart and adrenal agenesis, and a slightly increased incidence of skeletal variants, such as incompletely ossified or missing sternebrae or rudimentary ribs.

1.6.5.2.3 In other studies, chlorine administ ered to pregnant mice was not found for reproductive and teratogenic eff ects when given in drinking water as 10-13 ppm of sodium hypochlorite and hydrochloric acid (to maintain water pH of 2.5) or when given in heavily chlorinated municipal drinking water (US EPA – [REF 3]).

1.6.6 Mutagenicity/genotoxicity

In a US EPA [REF 3] investigation, chlorine was mutagenic in Salmonella typhimurium strains TA1530 and TA100, without metabolic activation; produced chromo some aberrations in human lymphocytes and other mammalian cells (at 20 pp m); interacted with DNA in E. coli test (as sodium hypochlorite); and was negative for the induction of eryt hrocyte micronuclei orGESAMP-BWWG 11/6 ANNEX 4 Page 19

I:\MEPC\60\2-12.doc chromosome aberrations of bone marrow cells of mice (up to 8 mg /kg/day of NaOCl) for up to five days.

1.6.7 Toxicokinetics

No additional information is available on toxicokinetics for chlorine.

1.7 Data on environmental fate and eff ects under aerobic and anaerobic conditions

1.7.1 Modes of degradation (biotic; abiotic)

1.7.1.1 Chlorine hydrolyzes very rapidly in wate r (half-life in natural waters, 0.005 s). In fresh and wastewaters at pH >6, complete hydrolysis occurs forming Hypochlor ous acid (HOCl) and chloride ion (Cl

– ). The Hypochlorous acid ionizes to hydrogen ion (H+) and hypochlorite ion (OCl

– ). At pH >5, OCl

– predominates; at pH <5, HOCl predominates. Free chlorine (Cl 2 , HOCl, and OCl

– ) reacts rapidly with inorganic material such as bromide and more slowly with organic material present in natural waters.

1.7.1.2 These reactions yield chloride, oxidi zed organics, chloro ganics (including trihalomethanes), oxygen, nitrogen, ch lorate, bromate and bromoorganics.

1.7.2 Bioaccumulation, octanol/water partition coefficient

There is no potential for the bioaccumula tion or bioconcentra tion of chlorine.

1.7.3 Reaction with organic matter

Chlorine will react slowly with organic material present in natural waters. These reactions yield chloride, oxidized organics, chloroganics (inclu ding trihalomethanes), oxy gen, nitrogen, chlorate, bromate and bromoorganics.

1.7.4 Potential physical effects on wildlife and benthic habitats

1.7.4.1 Chlorine has been shown to have high acute toxicity to many organisms. Low-level chlorination (0.05 to 0.15 mg/L) results in significan t shifts in the species composition of marine phytoplankton communities. Chlorine is phytotoxic but is also essential to plant growth; crops need around 5 pounds or more of chlorine per acre.

1.7.4.2 Acute toxicity to plants is characteri zed by defoliation with no leaf symptoms and, in higher plant forms, by spotti ng of the leaves (at 1.5 mg/m 3 ) and marginal injury (at 150 mg/m 3 to 300 mg/m 3 ). No data were found regarding the toxici ty of chlorine to terrestrial animals; however, the data from experimental studies indicat e that injury to animals would occur only in the presence of high concentrations of chlori ne, either in drinking water or the ambient atmosphere.

1.7.4.3 As chlorine and chlorine compounds do not persist in sediments it is not expected to affect benthic habitats unless direc tly applied in high concentrations.GESAMP-BWWG 11/6 ANNEX 4 Page 20

I:\MEPC\60\2-12.doc 1.7.5 Potential residues in seafood

As there is no potential for the bioaccumulation or bioconcentration of chlo rine, there is no risk of potential resi dues in seafood.

1.7.6 Any known interactive effects

No other effects have been identified.

* * *GESAMP-BWWG 11/6 ANNEX 4 Page 21

I:\MEPC\60\2-12.doc APPENDIX 2

DATA ASSOCIATED WITH POTASSIUM BROMATE

1 Introduction

1.1 Ozone reacts with bromide in seaw ater to form the Bromate ion (BrO 3 – ). The half-life of the Bromate ion is approximately 12 hours. Fr esh water typically contains a very low concentration of the bromide i on and therefore the production of the Bromate ion does not occur in fresh water.

1.2 It was noted that the data presented applies to Potassium Bromate for which compound data were more available.

2 Acute aquatic toxicity

2.1 The PAN (Pesticide Action Network) pestic ides database includes data on the acute toxicity of Bromate to aquatic organisms. Eff ects of Bromate (in seawater) on representatives of three different taxonomic groups (fish, mollusks, and Crustaceans) are summarizedin the table below [REF 4]:

Organism Scientific Name and Common Name Development Stage Toxicity Endpoint Effect Measure Exposure Duration Toxic Dose ( μ g/L) Cymatogaster aggregata

Shiner Perch 25 – 60

mm LC 100 Mortality 72 h 880000 Fish

Onchorhynchus keta

Chum Salmon ~ 30 mm LC 50 Mortality 96 h 512000

Crassostrea gigas Pacific Oyster Larvae EC 50 Mortality 48 h 30000 Mollusks

Macoma inquinata Bent-nosed Clam 20 - 30

mm LC 100 Mortality 72 h 880000

Pandalus danae Coon Stripe Shrimp 40 - 50

mm LC 100 Mortality 72 h 880000 Crustaceans

Neomysis awatschensis Opossum Shrimp 1.5 - 3.0 g LC 50 Mortality 24 h 176000

3 Endocrine disruption

No examples have been reported for the endoc rine disruptive properties of Bromate ions.GESAMP-BWWG 11/6 ANNEX 4 Page 22

I:\MEPC\60\2-12.doc 4 Sediment toxicity

4.1 The soil absorption factor of Bromate ion is estimated as follows from the relation with the octanol/water partition coefficient, P ow : K oc = 0.41 · log P ow (– 7.18) 8 = 2.7 · 10 – 8 L/kg

4.2 This estimate of K oc is below the value of anticipated toxicity to benthic organisms and therefore no risk of toxicity to benthic organisms is foreseen.

5 Bioavailability/biomagnification/bioconcentration

5.1 The octanol/water partition co efficient log value of Bromat e ion is -7.18 (see above). Therefore the Bromate is not considered havi ng a risk of concentration in organisms.

6 Food web/population effects

6.1 The bromate ion does not accumulate and ther efore will not affect organisms at higher levels in the food chain.

7 Data on mammalian toxicity

7.1 The toxicity of the Bromate ion to mammals is based on th e strong oxidizing properties. Bromate ions may affect skin and eyes by expos ure and cause coughing, pharynx pain, nausea, vomiting, abdominal pain, diarrh ea or central nervous system disturbance if taken orally.

7.2 Acute toxicity

7.2.1 Experiments on rats have shown a single dos e of Potassium Bromate of concentration LD 50 300 - 350 mg/kg bodyweight given or ally is lethal [REF 5].

7.3 Effects on skin and eye

7.3.1 Bromate ions will cause skin and eye inflammation and pain.

7.4 Repeated-dose toxicity

7.4.1 The exposure of rats to Bromate for 15 weeks demonstrated a NOAEL (No Observed Adverse Effect Level) of 30.0 mg/kg bw/d.

7.5 Chronic toxicity

7.5.1 The issue has been intensively discussed in the reports from other ballast water Basic Approval processes, wher e several experiments are record ed (e.g. previously mentioned IARC monograph 73) using mice, rats and hamsters . The results appear to be, that when oral intake exceeds about 2 mg/kg bodyweight per day tumors are beginning to develop after typically 100 days of experiments.

7.5.2 In the ABTS, a maximum concentration of Bromate ion below 10 μ g/L is anticipated in the ballast water. This implies, that a risk could be present at an oral in take of 200 L/kg bw/d of ballast water – which is unlikely to happen. Furt hermore, the halftime of Bromate ion decay isGESAMP-BWWG 11/6 ANNEX 4 Page 23

I:\MEPC\60\2-12.doc about 12 hours, where indeed the toxic processes ar e desired. Therefore, ch ronic toxicity is not considered relevant for mammalian toxicity hazards at these low concentrations.

7.6 Developmental and reproductive toxicity

7.6.1 The issue has been intensively discussed in the reports from other ballast water Basic Approval processes and it was noted, that only limited data are available on the reproductive or developmental effects of Bromate by oral intake or by inhalation.

7.6.2 The few results (for rats) indicated that Sodium Bromate treatment did not produce any adverse signs of general toxicity in any of the dose levels tested (which ranged from 0 mg/kg to about 25 mg/kg bodyweight). With reference to the ch ronic toxicity data a bove, such large intake is improbable.

7.7 Mutagenicity/genotoxicity

7.7.1 The issue has been intensively discussed in the reports from other ballast water Basic Approval processes and it was noted that severa l experiments have be en conducted (typically over 80 weeks).

7.7.2 Under the conditions of the study, Potassium Bromate single doses (corresponding to a Bromate ion dose of 154 mg/kg bw by injection) had no potent ial for carcinogenic damage in newborn male or female rats or mice, even using a higher singl e dose (corresponding to orally 231 mg/kg bw of Bromate ion) does not initiate renal tumors within a 104-week of treatment over 104 weeks (oral daily dose 32.3/kg bw Bromate ion dose) that resulted in renal Aden carcinomas in 15% and renal adenomas in 30% of the rats. However, with reference to the chronic toxicity data above, su ch large intake is improbable.

7.8 Toxicokinetics

7.8.1 Bromate may be converted into hypobromic acid by hypochloric acid in the stomach. Liver and kidney tissues may degrade Bromate to bromide by a proces s involving glutathione, although only a small amount appears to be reduced in this way.

7.8.2 Bromate is excreted mainly by urine as faeces may also eliminate Bromate and bromide. Bromate concentrations in urin e peaks after about 1 hour, and Br omate is not detectable in plasma after 2 hours.

8 Data on environmental fate and eff ects under aerobic and anaerobic conditions

8.1 Modes of degradation (biotic; abiotic)

8.1.1 Bromine is reportedly removed from seawater by several mechanisms.

8.1.2 HOBr/OBr – reacts with natural organic ma tter to form Bromoform (CHBr 3 ) by the Haloform reaction. Also, in th e presence of ammonia, HOBr/OBr – will react rapidly to form monobromamine which can subseque ntly disproportionate to NHBr 2 and NH 3 or with excess HOBr/OBr

- it can react further to form N 2 and bromide. The rate of th ese reactions varies light incidence and water salinity.GESAMP-BWWG 11/6 ANNEX 4 Page 24

I:\MEPC\60\2-12.doc 8.2 Bioaccumulation, octanol/water partition coefficient

8.2.1 Small amounts of bromine (1-2 ppm) were dete cted in the adipose (fat-storing) tissues of mice, but not of rats, fed bread treated with Potassium Bromate in a lifetime study.

8.3 Reaction with organic matter

8.3.1 Bromate will not volatilize and is only sligh tly adsorbed onto soil or sediment. Because it is a strong oxidant, its most likely fate is reacti on with organic matter, lead ing to the formation of bromide ion. Potassium bromide is also reportedly harmful if ingested in large amounts and may cause skin and eye irritations.

8.4 Potential physical effects on wildlife and benthic habitats

8.4.1 As noted previously, the half-life of the Brom ate ion in seawater is fairly short (~12 h) and its estimated absorption coeffi cient is very low (about 2.7 · 10 – 8 L/kg). Therefore, no potential of effects on benthic organisms is pr obable. Furthermore, the Bromate ion is not accumulated and therefore will not affect high-order organisms in a food chain.

8.5 Potential residues in seafood

8.5.1 The Bromate ion is not accumulated and ther efore there will be no potential residues in seafood.

8.6 Any known interactive effects

8.6.1 Under normal environmental conditions, it is difficult for the Bromate ion to be reduced. However, it may be reduced to the bromide ion in the presence of ferrous ions, activated carbon or other carbonaceous substances.

* * *GESAMP-BWWG 11/6 ANNEX 4 Page 25

I:\MEPC\60\2-12.doc APPENDIX 3

DATA ASSOCIATED WITH OZONE

1 Background

1.1 Ozone is an unstable gas that cannot be stor ed. In pure (fresh) water Ozone has a half-life of 10-30 minutes. In seawater th e half-life is reduced to 5.3 s econds. Ozone decomposition rate increases in accordance with the increase of temper ature and pH. The rate increases fast in the neutral to alkaline range at any temperature. This tendency accelerates with the increase of temperature. The pH value of ballast water is generally between 5 and 8, in which range the decomposition of Ozone progresses quickly. Therefor e, it is highly unlikely that Ozone will have an effect on any ecosystem by the tim e the ballast water is discharged.

1.2 Basic Approval has previously been recommended by the GESAMP-Ballast Water Working Group for use of systems designed for the treatment of ballast wa ter with considerable higher content of ozone and several of the data below are retrieved from the documents of these processes [ADD. 4].

2 Acute aquatic toxicity

2.1 The PAN (Pesticide Action Network - [REF 6]) pesticides database was used to obtain data on the acute toxicity of Oz one to aquatic organisms. The e ffect of Ozone on representatives of two taxonomic groups (fish and mo lluscs) is reproduced below.

Organism Scientific Name & Common Name Development Stage Toxicity Endpoint Effect Measure Exposure Duration Toxic Dose ( μ g/L) Lepomis macrochirus Bluegill 3.82 g LC 50 Mortality 24 h 60

Morone saxatilis Striped Bass Larvae 20

mm LC 50 Mortality 6 h 150 Fish

Pimephales promelas Fathead Minnow Larvae LC 50 Mortality 0.03 h 100

Molluscs Dreissena polymorpha Zebra Mussel Adult LC 50 Mortality 5.78 h 520 - 530

3 Chronic toxicity

3.1 There are only limited data on the ch ronic aquatic toxicity of Ozone.

3.2 It is reported that the concentr ation of Ozone will break down to <11 μ g/L within 40 seconds in seawater and within 3.5 hours in fresh water, and to <0.14 μ g/L (which is considered as the natural bac kground level) within 75 seconds in seawat er and 6.5 hours in fresh water. Therefore, it ma y be assumed that Ozone has no chronic aquatic toxicity.

4 Endocrine disruption

4.1 There have been no documented studies on th e endocrine disruptive properties of Ozone. Due to its rapid dissolution (see above), it is considered not to be an endocrine disruptor.GESAMP-BWWG 11/6 ANNEX 4 Page 26

I:\MEPC\60\2-12.doc 5 Sediment toxicity

5.1 The decomposition rate of Ozone is high enough so that there is no c oncern of toxicity to benthic organisms (see above).

6 Bioavailability/biomagnification/bioconcentration

6.1 Ozone decomposes very rapidly in natural wa ter. Therefore there is no risk that Ozone may become concentrated in organisms.

7 Food web/population effects

7.1 Ozone does not persist or con centrate in organisms therefore there is no concern of effect on any animal higher up the food chain.

8 Data on mammalian toxicity

8.0 The toxicity of Ozone to mammals is ba sed on its strong oxidizing property. Ozone causes irritation to the eyes a nd to the pharynx, trachea, bronchi and bronchiole when inhaled.

8.1 Acute toxicity

8.1.1 Acute toxicity data for Ozone is available from test conducted on mice (CHEMINFO-Canadian Center for Occupational Health and Safety [REF 7]). Data have been submitted for inhalation only and not for oral and dermal toxicity as Ozone is a gas and thus inhalation is the main e xposure route of concern.

8.1.2 The acute toxicity of Ozone (4 hours, LD 50 ) is 5.9 ppm - 6.8 ppm.

8.2 Effects on skin and eye

8.2.1 Ozone gives no effect to the skin but causes ir ritation to the eyes at levels of 2 ppm or more when exposed for several minutes.

8.3 Repeated-dose toxicity See chronic toxicity.

8.4 Chronic toxicity

8.4.1 In a series of studies, mice and rats exposed to 0.01 mg/kg -0.02 mg/kg bw/d for 105 weeks to 130 weeks displayed increased inciden ce of non-carcinogenic le sions of the nose and lungs. Several studies also examined the effect s of long-term exposure to monkeys. Exposures ranging from 0.003 mg/kg – 0.013 mg/kg bw/d for 3-18 months consis tently showed significant structural alterations to lungs. Many of the change s seemed irreversible six months after exposure had stopped.

8.5 Developmental and reproductive toxicity

8.5.1 A study on offspring of rats continuously exposed to 0.020 mg/kg or 0.03 mg/kg bw/d for four days during middle or late pregnancy produced reduced growth rates after birth and delayed behavioral development. Matern al toxicity was not reported.GESAMP-BWWG 11/6 ANNEX 4 Page 27

I:\MEPC\60\2-12.doc 8.5.2 Another study reported a decrease in fetal body weight gain in the offspring of mice exposed to 0.024 mg/kg but not to 0.008 mg/kg or 0.016 mg/kg bw/d, on days 7 to 17 of pregnancy. Signs of maternal toxicity were observed.

8.5.3 Embryo toxicity in the form of increased resorption was observed in rats exposed to 0.03 mg/ and 0.04 mg/ bw/d, but not 0.013 mg/kg -0.025 mg/kg bw/d. Maternal toxicity was not reported.

8.5.4 Continuous exposure of mice from six days prio r to mating to postnatal day 22 resulted in reduced body weight and slight effects in neurobehavioral development of the offspring.

8.5.5 Maternal toxicity was not evaluated. No effects on reproductive pe rformance (proportion of successful pregnancies, litter size, offs pring viability and sex ratio) were noted.

8.6 Mutagenicity/genotoxicity

8.6.1 From a study with rats and mice expos ed to 0.0021 mg/kg, 0.01 mg/kg and 0.02 mg/kg bw/d of Ozone for 105 weeks -130 weeks, there was no evidence of carcinogenicity in male and female rats, inconclusive evidence in male mice and some evidence in female mice. Ozone showed no tumor promoter pr operties in these studies.

8.6.2 There are a number of studies, which examin e the potential for mutage nicity of Ozone in humans but due to some deficiencies not all of them seem to be conclusive.

8.6.3 However cytogenetic aberrations have been observed in the lymphocytes of hamsters exposed to 0.0048 mg/kg - 0.086 mg/kg bw for 5 hour s and in the macrophages of female rats exposed to 0.0024 mg/kg - 0.016 mg/kg bw for 6 hours. Several studies have also shown that Ozone is mutagenic in bacteria and in human and mammalian cells in vitro following inhalation exposure.

8.7 Toxicokinetics

8.7.1 Ozone is absorbed in both th e upper and lower respiratory tract. It is a potent oxidant that reacts with protein and lipids, particularly within biological membranes. A small amount of Ozone is absorbed into the blood. The extr eme reactivity of Ozone limits its ability to accumulate.

9 Data on environmental fate and effect s under aerobic and anaerobic conditions

9.1 Ozone reacts with both orga nic and inorganic compounds wh en present in the ballast water. The Ozone molecule is an unstable s ubstance and higher temperatures and higher pH promote its decomposition in water. In seawater, Ozone degradates as mentioned previously with a half-life of between 5 seconds and 30 seconds. It is finally decomposed to oxygen and water.

9.2 Therefore, it will not be possible to find Ozone in the ballast water when discharged – normally several days after the ABTS treatment.GESAMP-BWWG 11/6 ANNEX 4 Page 28

I:\MEPC\60\2-12.doc 9.3 Modes of degradation (biotic; abiotic)

9.3.1 Because of the rapid disintegra tion, this issue is not important.

9.3.2 Bioaccumulation, octanol/water partition coefficient

9.3.1 Because of the rapid disintegra tion, this issue is not important.

9.4 Reaction with organic matter

9.4.1 Because of the rapid disintegra tion, this issue is not important.

9.5 Potential physical effects on wildlife and benthic habitats

9.5.1 Because of the rapid disintegra tion, this issue is not important.

9.6 Potential residues in seafood

9.6.1 Because of the rapid disintegra tion, this issue is not important.

9.7 Any known interactive effects

9.7.1 Ozone produces oxygen when decomposed in wa ter. As a result, it increases the amount of oxygen dissolved in the water, which helps aquatic organisms. In a closed system, such as a seawater aquaculture system, Ozone removes nitroge n in the form of ammonia that is discharged from fish.

* * *GESAMP-BWWG 11/6 ANNEX 4 Page 29

I:\MEPC\60\2-12.doc APPENDIX 4

DATA ASSOCIATED WITH HYDROGEN PEROXIDE

1 Background

1.1 Hydrogen Peroxide is a known oxidant, which is normally us ed in considerable higher concentrations (generally 3% or higher in household applications for wound treatment and general disinfection and typical in 20% - 40% solution for various industrial appl ications) than anticipated in the ballast water (less than 0.5 %) immediately after a ddition of the ANOLYTE by the ABTS, considered in this proposal. No Material Safety Data Sheets (MSDS) appears to be available for the low concentration, considered here but an MSDS for a considerably higher concentration (30%) is reproduced in [ADD. 5]. Furthermore, the concentration will be substantially reduced after a few hours interacti on with the organic material contained in the ballast water. When discharged (after a few da ys), the concentration of Hydrogen Peroxide will be close to zero.

1.2 From several sources the half-life is lis ted as typically 8 hours in fresh water (up to 20 days in chemically clean water). It is further stated, that half-life decreases to a range from a few minutes to a few hours in soil de pending upon microbiological activity and metal contaminants. No information was found for degr adation in biologically contaminated seawater.

1.3 Therefore, even if Hydrogen Peroxide is re latively unimportant with relation to (medium, long-term) ecological hazards, so me data will be provided.

2 Acute aquatic toxicity

2.1 The PAN [REF 6] pesticides database was us ed to obtain data on the acute toxicity of Hydrogen Peroxide to aquatic organisms and the effects of Hydrogen Per oxide on representatives of four taxonomic groups (fish, mollusks, crustaceans and phyt oplankton) are listed below:

Organism Scientific Name and Common Name Development Stage Toxicity Endpoint Effect Measure Exposure Duration Toxic Dose ( μ g/L) Lepomis macrochirus Bluegill Juvenile LC 50 Mortality 96 h 26700 Fish

Salmo salar Atlantic Salmon 107 g LC 50 Mortality 0.33 h 1230000

Mollusks Dreissena polymorpha Zebra Mussel Adult > 20

mm Mortality 0.50 h 29600

Crustaceans Lepeophtheirus salmonis Salmon Louse Different Stages Mortality 0.41 h 1500000

Phytoplankton Oscillatoria rubescens Blue-Green Algae Mixed Species Mortality < 12 h 1750GESAMP-BWWG 11/6 ANNEX 4 Page 30

I:\MEPC\60\2-12.doc Furthermore, the MSDS (from PAN) st ate the following Ecotoxical data:

Channel catfish 96-hour LC 50 = 37.4 mg/L Fathead minnow 96-hour LC 50 = 16.4 mg/L Daphnia magna 24-hour EC 50 = 7.7 mg/L Daphnia pulex 48-hour LC 50 = 2.4 mg/L Fresh water snail 96-hour LC 50 = 17.7 mg/L

However, Hydrogen Peroxide is generally rated as “Not acutely toxic” and “Slightly toxic”.

3 Endocrine disruption – No information has been available.

4 Sediment toxicity

4.1 No information has been found, but materials in the sediments woul d quickly degrade the small amounts, which might reach them. Therefor e, there is no concern of toxicity to benthic organisms.

5 Bioavailability/biomagnification/bioconcentration

5.1 Because of the short half -life, there is no danger th at Hydrogen Peroxide might concentrate in organisms.

6 Food web/population effects

6.1 Hydrogen Peroxide does not persist or concen trate in organisms, therefore, there is no concern of effect on any animal higher up the food chain.

7 Data on mammalian toxicity

7.1 Background

7.1.1 Toxicity of Hydrogen Peroxide is generall y not considered at the low concentration (< 0.5%) in the ANOLYTE produced by the ABTS. Ho wever, for higher aqua concentrations (20% - 40% solution), some information is available.

7.2 Acute toxicity

7.2.1 Because Hydrogen Peroxide is classified as “Not acutely toxic” and “Slightly toxic”, this does not need to be considered.

7.3 Effects on skin and eye

7.3.1 Hydrogen Peroxide will not affect the skin (at low concen trations), but ma y irritate the eyes if exposed for several minutes.

7.4 Repeated-dose toxicity – See chronic toxicity.GESAMP-BWWG 11/6 ANNEX 4 Page 31

I:\MEPC\60\2-12.doc 7.5 Chronic toxicity

7.5.1 In the PAN MSDS [REF 6], Hydrogen Peroxide has been classified as not carcinogenic to humans, but as confirmed carcinogenic to smaller mammals. However, at the small concentrations (in the ABTS AN OLYTE) and the short half-life, this needs hardly to be considered.

7.6 Developmental and repr oductive toxicity – No information was available.

7.7 Mutagenicity/genotoxicity – No information was available.

7.8 Toxicokinetics

7.8.1 Hydrogen Peroxide reacts quick ly and for this reason the abili ty to accumulate is limited.

7.9 Data on environmental fate and eff ects under aerobic and anaerobic conditions

7.9.1 Modes of degradation (biotic; abiotic)

7.9.1.1 Because of the rapid disintegration of Hydrogen Peroxide, its short half-life and its limited concentration, this issue is not important.

7.9.2 Bioaccumulation, octanol/water partition coefficient

7.9.2.1 Because of the rapid disintegration of Hydrogen Peroxide, its short half-life and its limited concentration, this issue is not important.

7.9.3 Reaction with organic matter

7.9.3.1 Because of the rapid disintegration of Hydrogen Peroxide, its short half-life and its limited concentration, this issue is not important.

7.9.4 Potential physical effects on wildlife and benthic habitats

7.9.4.1 Because of the rapid disintegration of Hydrogen Peroxide, its short half-life and its limited concentration, this issue is not important.

7.9.5 Potential residues in seafood

7.9.5.1 Because of the rapid disintegration of Hydrogen Peroxide, its short half-life and its limited concentration, this issue is not important.

7.9.6 Any known interactive effects

7.9.6.1 Hydrogen Peroxide produces oxygen whendecomposed in water. As a result, it increases the amount of oxygen dissolved in the water, which helps aquatic organisms. In a closed system, such as a seawat er aquaculture system, Hydrogen Peroxide removes nitrogen in the form of ammonia that is discharged from fish.

* * *GESAMP-BWWG 11/6 ANNEX 4 Page 32

I:\MEPC\60\2-12.doc APPENDIX 5

DATA ASSOCIATED WITH TRIHALOMETHANES

1 Background

1.1 The chemicals treated here are the so-called Trihalometha nes, which are formed, when three of the Hydrogen atoms of methane are exchanged with halogen atoms. The relevant compounds are:

.1 Tribromomethane (bromoform) CHBr 3 .2 Trichloromethane (chloroform) CHCl 3

.3 Bromodichloromethane CHBrCl 2

.4 Dibromochloromethane CHBr 2 Cl

1.2 The Trihalomethanes are by-products generate d through the interac tion of Ozone with organic material contained in the water. The production is fairly limited for ABTS and well within the limits allowed for international standards for potable water.

1.3 Basic Approval has previously been recommended by the GESAMP-Ballast Water Working Group for use of similar systems designed for the treatment of ballast water that also produce these compounds and several of the data below are retrieved from the documents of these processes [ADD. 4].

2 Acute aquatic toxicity

2.1 The PAN [REF 6] pesticides database was us ed to obtain data on th e acute toxicity of Bromoform to aquatic organisms and the effect s of Bromoform on representatives of four taxonomic groups (fish, mollusks, crustacean s and phytoplankton) are listed below:

Organism Scientific Name and Common Name Development Stage Toxicity Endpoint Effect Measure Exposure Duration Toxic Dose ( μ g/L) Brevoortia tyrannus Atlantic Menhaden Mortality 96 h 9000

Cyprinodon varigatis Sheepshead Minnow 8 - 15 mm LC 50 Mortality 48 h 16000 Fish

Leopomis Macrochirus Bluegill 0.32 - 1.2 g LC 50 Mortality 24 h 33000

Crassostrea Virginica American Oyster 75 g LC 50 Mortality 96 h 40000 Mollusks

Mercenaria mercenaria Hard Clam 141 g Mortality 96 h 140000

Crustaceans Penaeus aztecus Brown Shrimp 3.3 g Mortality 96 h 20000

Phytoplankton Selenastrum capricornutum Green Algae EC 50 Chlorophyll 24 h 18700GESAMP-BWWG 11/6 ANNEX 4 Page 33

I:\MEPC\60\2-12.doc 2.2 Endocrine disruption

No information is available on disruption of e ndocrine functions by Br omoform or the other Trihalomethanes.

2.3 Sediment toxicity

2.3.1 Bromoform and Dibromochloromethane have a minor tendency to be adsorbed by soils and sediments. Calculated and measured values of Koc (the organic carbon/water partition coefficient, an index of the relative mobility of a material in water-soil systems) for Bromoform range from 62 to 126 [REF 8]. These relatively low values imply that Bromoform will exhibit only a minor affinity for soil materials and will tend to be highly mobile [REF 9]. This low tendency for adsorption to soil has been confirmed in laboratory studies and in field studies.

2.4 Bioavailability/biomagnification/bioconcentration

2.4.1 Bioaccumulation potential of the trihalometha nes appears to be low, compared to many chlorinated organic compounds. A test of 28 days’ uptake a nd depuration were conducted on five commercially and recreationa lly important species. These included three species of Penaeid shrimp and one species of fish. It was found that both uptake and depurati on were rapid, with an equilibrium reached after 24 hours. Biocon centration factors were relatively low (between <1 and 10 times the water concentra tion). Experiments usi ng the marine oyster Crassostrea virginica have shown that exposure to 90 μ g/L Bromoform for 24 hours resulted in a bioconcentration factor of 7.6. Up take and depuration of Bromofor m were both ra pid, both being essentially completed after 24 hours – 48 hours. However, it was concluded that the rate of uptake and depuration was dependen t on the individual, the species and the concentration of Bromoform in the water.

2.5 Food web/population effects

2.5.1 There is no evidence as to whether Bromofor m is concentrated upwar ds in the food chain but it appears unlikely that Bromoform persists in organisms. The same may be assumed for the other Trihalomethanes mentioned.

2.6 Data on mammalian toxicity

2.6.1 Background

2.6.1.1 Bromoform has been considered to be a m oderately toxic chemical that can be absorbed through the lungs, gastrointestinal tract, and skin. The oral LD 50 value for Tribromomethane is 1,400 mg/kg and 1,550 mg/kg in male and fe male mice and 1,388 mg/kg and 1,147 mg/kg in male and female rats.

2.6.1.2 Tribromomethane was slightly less acute ly toxic than Chloroform, Bromodichloromethane, or Chlorodibromomethane in rats and mice.

2.6.1.3 Exposure to bromoform vapours may cause irritation to th e respiratory tract, lacrimation, and liver damage. The liver and kidney have been identified as target organs of trihalomethane toxicity in singl e exposure and short-term studies . Liver changes, described as variation in size of hepatocytes and vesiculation of biliary epithelial nuclei, were observed inGESAMP-BWWG 11/6 ANNEX 4 Page 34

I:\MEPC\60\2-12.doc female rats that survived a single oral dose of Tribromome thane (1,071 mg/kg bodyweight or higher. Kidney changes were observed in rats that survived single oral doses of chloroform, Bromodichloro-methane, or Chlorodibromometha ne, however, these changes were not observed in rats exposed to Tribromomethane.

2.6.1.4 No pathologic changes were observed in rats exposed to Tribromomethane at 5 ppm, 50 ppm, or 500 ppm (which is equiva lent to 0.13 mg, 1.5 mg, and 14 mg per rat per day, respectively) in drinking water for 28 days.

2.6.2 Acute toxicity

2.6.2.1 Oral LD 50 values for Bromoform are 1,388 mg/kg and 1,147 mg/kg for male and female rats, respectively, and 1,400 mg/kg and 1,550 mg/kg for male and fe male mice, respectively. The principal cause of death in th e laboratory animals following acu te oral exposure is Central Nervous System failure. Clinical signs recorded for rats were e.g. hypothermia and enlargement of the livers and kidneys.

2.6.2.2 At doses of 1,000 mg/kg bw, ataxia, seda tion, and anesthesia o ccurred in mice within 60 minutes, with seda tion persisting for about 4 hours. In rats, a single dose of 1,000 mg/kg bodyweight produced reductions in liv er cytochrome and increases in porphyrin content, suggesting disturbances in hepatic heme metabolism.

2.6.3 Effects on skin and eye

2.6.3.1 Direct contact with Bromoform in liquid form causes redness and pain and may also be absorbed.

2.6.4 Repeated-dose toxicity

2.6.4.1 In a force-feeding study, rats and mi ce were treated 5 times weekly for 13 weeks with Bromoform at doses:

Rats: 0, 12, 25, 50, 100, 200 mg/kg bw

Mice: 0, 25, 50, 100, 200, 400 mg/kg bw

2.6.4.2 All male rats treated with 100 mg/kg or 200 mg/kg/d and all female rats treated with 200 mg/kg mg/kg/d were lethargic. Bromofor m was administered to male and female mice by force-feeding at daily doses of 50 mg /kg, 125 mg/kg, or 250 mg/kg/d for 14 days.

2.6.4.3 Liver weights and serum glutamate oxalo acetate transaminase (SGOT) levels were increased and serum glucose and blood urea nitroge n (BUN) levels were d ecreased in the highdose animals. In a similar study, 72 mg/kg, 145 mg/ kg, or 289 mg/kg/d of bromoform was fed by force-feeding to mice for 14 days. BUN levels a nd serum creatinine values were not altered, but serum glutamate-pyruvate transaminase (SGPT) levels were elevated in high-dose animals.

2.6.4.4 Histological changes were seen in the kidneys and liver in the mid and high-dose groups and included hyperplasia of tubular epithelial cells, and hypertrophy and degene rative changes of the glomeruli in the kidney, and centrilobular cytoplasmic pallor a nd slight focal inflammation of the liver.GESAMP-BWWG 11/6 ANNEX 4 Page 35

I:\MEPC\60\2-12.doc 2.6.5 Chronic toxicity

2.6.5.1 Rats were exposed to Tribromomethan e at 5 ppm, 50 ppm, 500 ppm or 2,500 ppm in drinking water for 90 days. Liver lesions were observed and the severity was increased in male rats dosed with 2500 ppm Tribromo Methane and in female rats dosed with 500 ppm or 2,500 ppm Tribromo Methane.

2.6.5.2 Tribromo Methane was force-fed to mi ce for 14 days at doses of 0 mg/kg, 72 mg/kg, 145 mg/kg or 289 mg/kg/d. Blood urea nitrogen (B UN) and serum creatinine levels were not altered, however, active uptake of p-aminohippurate into renal cortical slices was reduced, and serum glutamate-pyruvate transaminase (SGPT) leve ls were elevated in the high dose animals. Similar effects were observed in animals admi nistered Chloroform, Bromodichloromethane, or Chlorodibromo-methane.

2.6.5.3 Histopathologic changes in the kidney ( hyperplasia of tubular epithelial cells and hypertrophy and degenerative changes in the gl omerular mesangium) and liver (centrilobular cytoplasmic pallor and slight focal inflammatio n) were observed in the mid dose and high dose

groups.

2.6.6 Developmental and reproductive toxicity

2.6.6.1 Teratology studies (on birt h defects) of organic concentr ates were prepared from the drinking water of five cities in the United St ates. In addition, because low molecular weight organohalides may be lost during the concentrati on procedure, a synthetic mixture was prepared based on the EPA monitoring survey [REF 3] of the concentrations of these compounds in 110 cities in the United States. The latter mixture contained 68. 9% Chloroform, 16.4% Bromodichloromethane, 10.0% Chlorodibromo-methane, and 3.6% Tribromomethane. Each of these preparations, dissolved in dimethyl sulfoxi de, was administered by force-feeding to groups of pregnant mice on gestation peri od of 7 days - 14 days at dos e levels equivalent to 300, 1,000, and 3,000 times the anticipated human exposure.

2.6.6.2 The mice that were administered th e synthetic mixture at 3,000 times the human exposure level received 10.3 mg organohalide/ kg bw/d (the Tribromomethane dose level was 0.37 mg/kg/d). No effects on fetal weight, morta lity, or the occurrence of skeletal or visceral anomalies were observed in any of the exposed groups.

2.6.6.3 Chloroform was administered to pregnant rats by force-feeding from day 6 to day 15 of gestation at doses of 100 mg/kg, 200 mg/kg, or 400 mg/kg bw/d and Tribromomethane, Bromodichloro-methane and Chlorodibromomet hane at doses of 50 mg/kg, 100 mg/kg, or 200 mg/kg bw/d. Corn oil was used as the ve hicle for all studies. Only Tribromomethane did not have an effect on maternal body weight gain . No histopathologic cha nges were observed for any of the four Trihalomethanes in any of the dams or fetuses, nor were there any changes in the number of fetuses per dam, average fetal we ight, or occurrence of visceral anomalies.

2.6.7 Mutagenicity/genotoxicity

Human data are considered inadequate in providing evidence of cancer by exposure to bromoform, while animal data indicate that long-te rm oral exposure can caus e liver and intestinal tumors. Bromoform has been classified as a Group B2, probable human carcinogen.GESAMP-BWWG 11/6 ANNEX 4 Page 36

I:\MEPC\60\2-12.doc 2.6.8 Toxicokinetics

2.6.8.1 Inhalation, ingestion and dermal r outes of exposure can absorb Bromoform and Dibromo-chloromethane and in humans and laboratory animals, Bromoform is generally absorbed quickly.

2.6.8.2 Although Bromoform and Dibromochlorometha ne are lipophilic, th ey do not appear to accumulate in adipose tissue.

2.6.8.3 Bromoform and Dibromochloromethane are believed to metabo lize by at least two route-independent pathways: Oxidation by cyto chrome mixed function oxidase system and conjugation via glutathione S-transf erase. Bromoform is primarily excreted via exhalation as the parent compound or carbon dioxide.

3 Data on environmental fate and eff ects under aerobic and anaerobic conditions

3.1 Modes of degradation (biotic; abiotic)

3.1.1 Bromoform tends to volatilize from water when exposed to the air, where it is relatively stable with a half-lif e of 1 month - 2 months

. Most measurements of the concentration of bromoform in air indicate that levels are quite low (<10 ppm).

3.2 Bioaccumulation, octanol/water partition coefficient

3.2.1 Bromoform may be slightly bioconcentrated by aquatic organisms. The octanol/water partition coefficient (K ow ) (an index of the partitioning of a compound between octanol and water) is approximately 2.38 for bromoform [REF 10]. The magnit udes of these values suggest that the chemicals will tend to partition to fat tissues of aquatic organisms.

3.3 Reaction with organic matter

Trihalomethanes such as Bromoform are formed as a by-product when chlorine or bromine is used to treat ballast water. They result from the reaction of chlorine and/or bromine with organic matter in the water being treated. However, once the Bromoform is formed it does not appear to have any further reactions with organic matter.

3.4 Potential physical effects on wildlife and benthic habitats

No information is available on the effects of Bromoform on wildlife or benthic habitats.

3.5 Potential residues in seafood

No information is available on Bromoform residues in seafood.

3.6 Any known interactive effects

No other effects have been identified.

* * *GESAMP-BWWG 11/6 ANNEX 4 Page 37

I:\MEPC\60\2-12.doc APPENDIX 6

DATA ASSOCIATED WITH HYDROGEN

1 Background

1.1 Hydrogen gas is produced in the electrolyt ic cells of the ABTS as a by-product of hydroxyl radicals. Basic Approval has previously been recommended by the GESAMP-Ballast Water Working Group for use of similar electrolytic systems designed for the treatment of ballast water that also produce hydrogen gas. Also, some of the following data or iginates from these proposal processes [ADD. 4].

1.2 Most of the hydrogen gas will be ventilated directly from the electrolytic cell modules during production of ANOLYTE. A very small frac tion of the hydrogen gas will be present as micro-bubbles is the treated ballas t water and will eventually be vented from the ballast tanks.

2 Acute aquatic toxicity – No data on acute aquatic toxicity of hydrogen have been found.

3 Endocrine disruption – None of the available data indica te toxicity for exposures of any duration.

4 Sediment toxicity – There is no data on sediment toxicity of hydrogen.

5 Bioavailability/biomagnification/bioconcentration – Hydrogen does not bioconcentrate in the tissues of organisms.

6 Food web/population effects

6.1 Hydrogen does not bioconcentrate or accumulates in the tissues of organisms. Therefore, no risk to organisms upwards in the food chain is present.

7 Data on mammalian toxicity

7.1 Acute toxicity

High concentrations of hydrogen in the air can cause a deficiency of oxygen with risk of unconsciousness or death. Ingestion is not an obse rved route of exposure to gaseous hazardous materials. Exposure to moderate concentratio ns may cause dizziness, headache, nausea and unconsciousness - probably related to oxygen deficiency.

7.2 Effects on skin and eye

7.2.1 No detrimental effects of skin or eye cont act have been reported. However, when ignited a risk of thermal burns is present.

7.3 Repeated-dose toxicity

7.3.1 None of the available data indicate toxicity for exposures of any duration.GESAMP-BWWG 11/6 ANNEX 4 Page 38

I:\MEPC\60\2-12.doc 7.4 Chronic toxicity

7.4.1 None of the available data indicate toxicity for exposures of any duration.

7.5 Developmental and reproductive toxicity

7.5.1 None of the available data indicate toxicity for exposures of any duration.

7.6 Mutagenicity/genotoxicity

None of the available data indicate to xicity for exposures of any duration.

7.7 Toxicokinetics

None of the available data indicate to xicity for exposures of any duration.

8 Data on environmental fate and eff ects under aerobic and anaerobic conditions

8.1 Modes of degradation (biotic; abiotic)

8.1.1 Hydrogen exists as a natural compound in th e atmosphere and will be dissipated rapidly in well-ventilated areas.

8.2 Bioaccumulation, octanol/water partition coefficient

8.2.1 Hydrogen will dissipate rapidly so there is no bioaccumulation.

8.3 Reaction with organic matter

8.3 Hydrogen has not been reported to react with organic matter.

8.4 Potential physical effects on wildlife and benthic habitats

8.4.1 No adverse ecological effects are anticipat ed. Hydrogen does not contain any Class I or Class II ozone depleting chemicals and no listing as a marine pollutant has been identified.

8.5 Potential residues in seafood

Hydrogen does not bioaccumulate so there is no risk of hydrogen re sidues in seafood.

8.6 Any known interactive effects

No other effects have been identified.

* * *GESAMP-BWWG 11/6 ANNEX 4 Page 39

I:\MEPC\60\2-12.doc APPENDIX 7

DATA ASSOCIATED WITH SODIUM HYDROXIDE

1 Background

1.1 Sodium Hydroxide is present in the CATHOLYTE produced in the ABTS at an extremely low concentration (< 230 ppm). The concentration considered here is substantially lower, than considered in available Material Safety Data Sheets – however, a representative MSDS for concentrated NaOH is shown in [ADD. 6].

1.2 The Sodium Hydroxide solution does not itself participate in the disinfection process but is produced in a quantity which is discharged to the ballast ta nks after the disinfection with ANOLYTE has been carried out an d will increase the ballast wa ter pH value to normal level (about 7 - 8). After this, the Sodium Hydroxide will also attack remaining organic material (and possible surviving organisms) and thereby reduce the amount of sludge in the tanks.

2 Acute aquatic toxicity

2.1 Sodium Hydroxide is a toxi c material, which is listed by PAN as a “Bad Actor” – implying, that it has probable carcinogenic properti es. The PAN [REF 6] pe sticides database was used to obtain data on the acute toxicity of Sodium Hydroxide to aquatic organisms and the effects of Bromoform on repres entatives of four taxonomic groups (fish, mollusks, crustaceans and plankton) are listed below:

Organism Scientific Name and Common Name Development Stage Toxicity Endpoint Effect Measure Exposure Duration Toxic Dose ( μ g/L) Notropis sp

. Shiner Mortality 120 h 100000

Lepomis macrochirus Bluegill 30 mm – 60 mm Mortality > 7 d 50000 Fish

Agonis cataphractus Hooknose Adult LC 50 Mortality 48 h 33000 – 100000

Mollusks Cerastoderma edule Cockle Adult LC 50 Mortality 48 h 330000 – 1000000

Crangon crangon Common Shrimp Adult LC 50 Mortality 48 h 33000 – 100000 Crustaceans

Palaemon adspersus Baltic Prawn 200 mg – 360 mg Mortality 30 d 10000 – 100000

Zooplankton Ceriodaphnia dubia Water Flea EC 50 Mortality 48 h 100000GESAMP-BWWG 11/6 ANNEX 4 Page 40

I:\MEPC\60\2-12.doc 3 Endocrine disruption – No information was found.

4 Sediment toxicity – No information was found and not considered important because of the weak solution involved.

5 Bioavailability/biomagnification/bioconcentration

5.1 The Sodium Hydroxide will not concentrate in the organisms.

6 Food web/population effects

6.1 Sodium Hydroxide does not persist or concentr ate in organisms and there is no concern of effects higher up in the food chain.

7 Data on mammalian toxicity

7.1 Acute toxicity

7.1.1 The Sodium Hydroxide MSDS re ports an acute dermal dose (LD 50 ) for rabbits of 1,350 mg/kg bw.

7.2 Effects on skin and eye

7.2.1 From the MSDS it is observed, that even weak solutions of S odium Hydroxide will irritate the eyes and that a 0.04 % solution (co rresponding to about 20 time s the concentration in the CATHOLYTE, before diluted in the ballast wa ter. Therefore, the effects on skin and eye are not considered important.

7.3 Repeated-dose toxicity – No information on effects was found.

7.4 Chronic toxicity – No information on effects was found.

7.5 Developmental and repr oductive toxicity – No information on effects was found.

7.6 Mutagenicity/genotoxicity – No information on effects was found.

7.7 Toxicokinetics

7.7.1 Sodium Hydroxide is absorbed in the resp iratory tract and through the skin and reacts with both protein and lipids. The effects are limited to the description previously.

8 Data on environmental fate and eff ects under aerobic and anaerobic conditions

8.1 Background

8.1.1 Sodium Hydroxide is strongly alkaline. If released to surface water, this compound will cause the pH to increase dependent on the buffering capacity of the water body. Aquatic organisms become increasingly stressed as pH exceeds 9, with many aquatic species being intolerant of pH in excess of 10.GESAMP-BWWG 11/6 ANNEX 4 Page 41

I:\MEPC\60\2-12.doc 8.2 Modes of degradation (biotic; abiotic)

8.2.1 The pH of the water body will locally increa se only slightly (because of the weak solution) and the Hydrogen Peroxide will quickly be dispersed.

8.3 Bioaccumulation, octanol/water partition coefficient – No bioaccumulation is possible in organisms.

8.4 Reaction with organic matter

8.4.1 Sodium Hydroxide reacts primarily with pr oteins and lipids, but – because of the low concentration from a ballast water discharge – this will give no concerns.

8.5 Potential physical effects on wildlife and benthic habitats – No information was available.

8.6 Potential residues in seafood

8.6.1 Because Sodium Hydroxide does not bioa ccumulate, it will not appear in seafood.

8.7 Any known interactive effects No other information was available.

***GESAMP-BWWG 11/6

I:\MEPC\60\2-12.doc ANNEX 5

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

JFE Ballast Water Management System (JFE-BWM S) that makes use of TG Ballastcleaner and TG Environmentalguard

Submitted by Japan for Final Approval

0 SUMMARY

0.1 Having reviewed the application details related to all aspect s of the JFE-BWMS, the Group recommended that this Ballast Wate r Management System (BWMS) should be granted Final Approval.

0.2 The Group concurred with the applicant fo llowing the use of the model MAMPEC to achieve the Predicted Environmental Concentrations (PECs) that the resu lting concentrations, in the scenario defined by the applicant, would not result in any unacceptable risks for the environment.

0.3 The Group recognized that th e risk to the crew and ge neral public was adequately assessed by using EUSES model 2.1.

0.4 The recommendation that Final Approval be gr anted to the JFE-BWMS is subject to the Administration verifying that all the followi ng recommendations have been fully addressed prior to issuance of a T ype Approval Certificate:

.1 the neutralization step described by the manufacturer when using TG Environmentalguard should always be applied during discharge. The Group considered this step of gr eat importance to ensure the safety of the marine environment, recognizing the importance of the neutralization process as an environmental risk mitigation measure;

.2 the maximum allowable dosage of Activ e Substances (TG Ballastcleaner) should be 20 mg/L as Cl 2 , expressed as the maximum injec tion rate. This injection rate and the relevant parameters needed for th e calculation of the dosage rate should be monitored and recorded whenthe BWMS is in use. In addition, the actual TRO concentration monitored by adequately maintained TRO sensors should be recorded during ballasting;

.3 the maximum allowable discharge c oncentration of Relevant Substances (TG Environmentalguard) should not exceed 22 mg/L as sodium sulfite, which is expressed as maximum residual concentra tion after consumed in neutralization. The dosage and relevant parameters s hould be continuously monitored and recorded during discharge;

.4 the maximum allowable discharge c oncentrations of Active Substances (the concentration of TRO after neutra lization) should be kept to the level proposed by the applicant, that is not exceeding 0.03 mg/L under any circumstances, as monitored by a suitably high sensitivity TRO sensor which is to be adequately maintained. This paramete r should be continuously recorded during ballast water discharge; andGESAMP-BWWG 11/6 ANNEX 5 Page 2

I:\MEPC\60\2-12.doc .5 having reviewed the information provide d on corrosive effects, the Group did not agree with the applicant’s conclusions. The Group recommended that all of the corrosivity and coating degradation testi ng be repeated with adequate control throughout the testing to ma intain the TRO concentr ations between 15 mg/L and 20 mg/L. Furthermore, the Group i nvited the applicant to consider the guidance provided in section 5.1 of the “Report of the eight h meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

1 INTRODUCTION

1.1 The Group recalled that, at its sixth meeting, it had recommended that Basic Approval be granted to TG Ballastcleaner and TG Environmen talguard and that MEPC 58 had granted such approval.

1.2 Data used to evaluate this system were extracted from MEPC 60/2/2 (Japan) and were supplemented by additional info rmation provided to the Group.

2 DESCRIPTION OF THE SYSTEM

2.1 The Group noted that the JFE-BWMS comprised:

.1 a 50 μm filter which is backflushed into the sea at point of uptake; and

.2 chemical treatment with TG Ballastcleaner, which is thoroughly mixed with the ballast water in a Venturi device.

2.2 It was also noted that a surplus of TG Ballastcleaner remains in the ballast tanks following the initial treatment in order to prevent re-growth and hatching of any eggs associated with marine organisms. When the ballast water is discharged during loading in port, the TRO in the treated ballast water is neutra lized using TG Environmentalguard.

2.3 It was noted that the applican t claimed that this ensured that the ballast water is always non-toxic when discharged.

2.4 It was also noted that, in the applicati on for Basic Approval, the maximum chemical dosage rate proposed was 30mg/L TRO as Cl 2 . However, in the application for Final Approval, the applicant indicated that the maxi mum dosage rate has been reduced to 20 mg/L .

2.5 The Group noted that the actual TRO measur ed after 5 days remained above 15 mg/L, shown as in the table below, the treated ballas t water would have significant risks to marine ecosystem, if it were discharged without neutralization.GESAMP-BWWG 11/6 ANNEX 5 Page 3

I:\MEPC\60\2-12.doc TRO concentration (mg/L Cl 2 ) in ballast water at land-based test after 5 days’ holding time

Test cycle Measured date Salinity TRO concentration Measured by sensor (mg/L) TRO concentration Measured by sensor (mg/L) after neutralization Cycle1 1st Dec 33.5 15.52 -0.200 Cycle2 8th Dec 21.0 17.70 -0.200 Cycle3 19th Jan 20.9 16.94 -0.200 Cycle4 26th Jan 21.5 17.55 -0.200 Cycle5 2nd Feb 20.5 17.96 -0.200 Cycle6 9th Feb 21.3 17.89 -0.200 Cycle7 16th Feb 32.2 18.06 -0.200 Cycle8 23rd Feb 32.5 18.04 -0.200 Cycle9 2nd Mar 32.4 17.87 -0.200 Cycle10 9th Mar 32.3 17.97 -0.200

2.5.1 In the documentation provided to the Group, it was noted that the TRO measured by the two methods was significantly different on on e occasion. It was recommended that the appropriate QA/QC procedures of the land-based test facility shoul d be reviewed to ensure that inconsistencies do not occur.

2.6 The Group confirmed that the MADC of TRO after neutralization was maintained at the level of ND (or excess neutralizer was maintained). Considering that potential risk by neutralizer (sulfite) was in the level of acceptable level ev en with maximum discharge concentration (22 mg/L), the Group conclude d that the neutralization process and scheme was ac ceptably reliable to mitigate the risk to environment cause d by a high concentration of TRO.

2.7 A schematic diagram of the JFE-BW MS is shown below which shows:

.1 TG Ballastcleaner is injected into th e incoming filtered seawater at the lowest possible level to be effectiv e with the amount of Free Av ailable Chlori ne (FAC) to be not greater than 20 mg/L. Should this level be exceeded, the system is shut down;

.2 mixing takes place in a Venturi tube th at causes rapid agitation and mixing which facilitates the effect of the Activ e Substance on the organisms; and

.3 in situations where the Active Substan ces have not had sufficient time to decay, the treated ballast water is treated with TG Environmentalguard during discharge. The TG Environmentalguard is dosed prior to the ballast pump used for discharge to ensure complete mixing. The amount of TRO present in the ballast water is measured and used to determine the amount of TG Environmen talguard necessary to neutralize/reduce the TRO.GESAMP-BWWG 11/6 ANNEX 5 Page 4

I:\MEPC\60\2-12.doc Simplified schematic representation of the JFE Ballast Water Management System

3 CHEMICALS ASSOCIATED WITH THE SYSTEM

3.1 The Group noted that the di sinfectant/biocidal agent (trade name: TG Ballastcleaner ® ), which is used in JFE-BWMS, is an aqueous solution of sodium hypochlorite.

3.2 In addition, it was noted that TG Ballastcleaner can have a Free Available Chlorine (FAC) content of either 5% to 10%, or 10% to 13%.

3.3 Also, the Group noted that the TG Environmentalguard ® , can be either an aqueous solution with a concentration of 10% to 13% , or a solid form of sodium sulphite.

3.4 A list of chemical identification of the a bove Active Substances, other components and Relevant Chemicals is shown in Table 2.5.1. Filter

Ballast tank TG

Ballastcleaner Ballast water uptake

Ballast water

discharge

TG EnvironmentalguardGESAMP-BWWG 11/6 ANNEX 5 Page 5

I:\MEPC\60\2-12.doc List of Chemical Identification

Name of chemical substance IUPAC CAS No. Molecular weight Chemical formula Structural formula

Active Substances

AS Sodium hypochlorite Sodium hypochlorite 7681-52-9 74.45 NaClO Na-Cl-O

Other Components

OC1 Sodium hydroxide Sodium hydroxide 1310-73-2 40.00 NaOH NaOH

OC2 Sodium chloride Sodium chloride 7647-14-5 58.44 NaCl NaCl

OC3 Sodium sulfite Sodium sulfite 7757-83-7 126.06 Na 2 SO 3 NaO NaO

S O

OC4 Sodium sulfate Sodium sulfate 7757-82-6 142.04 Na 2 SO 4 S O

O ONa NaO

Relevant Chemicals

RC1 Hypochlorous acid Hypochlorous acid 7790-92-3 84.64 HClO H-O-Cl

RC2 Chloroform Trichloromethane 67-66-3 119.4 CHCl 3 C H Cl

Cl

Cl

RC3 Dichlorobromomethane Dichlorobromomethane 75-27-4 163.82 CHBrCl 2 C Cl

Br H Cl

RC4 Dibromochloromethane Dibromochloromethane 124-48-1 208.27 CHBr 2 Cl C Cl

Br

Br H

RC5 Bromoform Tribromomethane 75-25-2 252.7 CHBr 3 C Br H

Br Br

RC6 Hydrobromous acid Hypobromous acid 13517-11- 8 96.91 HBrO H-O-Br

RC7 Sodium hypobromite Sodium hypobromite 13824-96- 9 118.89 NaBrO Na-O-BrGESAMP-BWWG 11/6 ANNEX 5 Page 6

I:\MEPC\60\2-12.doc Name of chemical substance IUPAC CAS No. Molecular weight Chemical formula Structural formula

RC8 Bromate ions (see sodium bromate.) Bromate 7789-38-0 150.9 NaBrO 3 Br O

O NaO

RC9 Monochloro acetic acid Monochloroacetic acid 79-11-8 94.5 CH2ClC OOH C O

Cl C OH H

H

RC 10 Dichloro acetic acid Dichloroacetic acid 79-43-6 128.9 CHCl 2 C OOH C O

Cl C OH H Cl

RC 11 Trichloroacetic acid Trichloroacetic acid 76-03-9 163.4 CCl 3 CO OH C O Cl

Cl Cl C OH

RC 12 Bromochloroacetic acid Bromochloroacetic acid 5589-96-8 173.39 CBrClH COOH C O

C OH H Cl

Br

RC 13 Bromodichloroacetic acid Bromodichloroacetic acid 71133-14- 7 207.84 CBrCl 2 C OOH C O

C OH Cl

Cl

Br

RC 14 Dibromochloroacetic acid Dibromochloroacetic acid 5278-95-5 138.95 Br 2 ClCC OOH C O

C OH Br

Cl

Br

RC 15 Monobromoacetic acid Monobromoacetic acid 79-08-3 138.95 BrCH 2 C OOH C O

C OH H

H

Br

RC 16 Dibromoacetic acid Dibromoacetic acid 631-64-1 217.84 CHBr 2 C OOH C O

C OH Br

H

Br

RC 17 Tribromoacetic acid Tribromoacetic acid 75-96-7 296.74 Br 3 CCO OH C O

C OH Br

Br

Br

RC 18 Chloroacetonitrile Chloroacetonitrile 107-14-2 75.47 CH 2 ClC N C C H Cl

N

H

RC 19 Dichloroacetonitrile Dichloroacetonitrile 3018-12-0 109.94 CHCl 2 C N C

Cl C H Cl

NGESAMP-BWWG 11/6 ANNEX 5 Page 7

I:\MEPC\60\2-12.doc Name of chemical substance IUPAC CAS No. Molecular weight Chemical formula Structural formula

RC 20 Trichloroacetonitrile Trichloroacetonitrile 545-06-2 154.39 CCl 3 CN C

Cl C Cl

N Cl

RC 21 Dibromoacetonitrile Dibromoacetonitrile 3252-43-5 198.84 CHBr 2 C N C C H N

Br Br

RC 22 Bromochloroacetonitrile Bromochloroacetonitrile 83463-62- 1 154.39 CHBrCl CN C C H Cl

N

Br

RC 23 Monochloramine Chloramide 10599-90- 3 51.48 NH 2 Cl N H Cl HGESAMP-BWWG 11/6 ANNEX 5 Page 8

I:\MEPC\60\2-12.doc 3.5 The Group also noted the followi ng results of chemical anal ysis for these chemicals in both treated brackish ballast water and sea ballast water:

Analytical values of Relevant Ch emicals in the land-based test

maximum

value mean value standard deviation maximum value mean value standard deviation μg/l μg/l μg/l μg/l μg/l μg/l μg/l

RC2 Chloroform 0.1 LT.DL.* LT.DL LT.DL. - LT.DL. LT.DL. LT.DL. -
RC3 Bromodichloromethane 0.1 0.88 0.81 0.08 3,4,5,6 0.70 0.33 0.25 7,8,9,10 RC4 Dibromochloromethane 0.1 16.00 13.00 2.16 3,4,5,6 6.60 4.50 1.45 7,8,9,10 RC5 Bromoform 0.1 330.00 310.00 21.60 3,4,5,6 180.00 122.50 38.62 7,8,9,10 RC6 Hydrobromous acid - - RC7 Sodium hypobromate - - RC8 Bromate ion 1.0 18.00 12.00 7.62 3,4,6 46.00 34.00 14.45 7,8,9,10 RC9 Monochloroacetic acid 0.5 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -
RC10 Dichloroacetic acid 0.3 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. - RC11 Trichloroacetic acid 0.2 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -
RC12 Bromochloroacetic acid 0.1 0.47 0.39 0.08 3,4,5,6 0.43 0.24 0.17 9,10 RC13 Bromodichloroacetic acid 0.1 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -
RC14 Dibromochloroacetic acid 0.1 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -
RC15 Bromoacetic acid 0.2 LT.DL. LT.DL. LT.DL. - 5.70 1.58 2.75 7 RC16 Dibromoacetic acid 0.1 47.00 23.98 19.06 3,4,5,6 8.70 5.80 2.97 7,8,9,10 RC17 Tribromoacetic acid 0.1 LT.DL. LT.DL. LT.DL. - 0.10 0.10 0.00 9,10 RC18 Chloroacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -
RC19 Dichloroacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -
RC20 Trichloroacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. - RC21 Dibromoacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. -
RC22 Bromochloroacetonitrile 1.0 LT.DL. LT.DL. LT.DL. - LT.DL. LT.DL. LT.DL. - RC23 Monochloroamine - - * : LT.DL.. = less than detection limit Bold character indicate the measured maximum value Detected substances are indicated in the shaded cells Measured as TROHaloacetic acidsHalo-acetonitriles

Measured as TRO Measured as TRORelevant ChemicalsTrihalomethanesBromate Measured as TRODetectionLimit. Brackish Water Seawater

Test Cycle 3,4,5,6 Detected Test Cycle Test Cycle 7,8,9,10 Detected Test CycleClass No. Name of chemical species

3.6 Chemical, physical and biol ogical properties associated w ith pertinent chemicals and treated ballast water are shown in:

.1 appendix 1 – Treated ballast water;

.2 appendix 2 – Aquatic toxicity of Active Substances, Relevant Chemicals and Other Chemicals; and

.3 appendix 3 – Mammalian toxicity of Ac tive Substances, Relevant Chemicals and Other Chemicals.GESAMP-BWWG 11/6 ANNEX 5 Page 9

I:\MEPC\60\2-12.doc 4 CONSIDERATION OF CONCERNS EX PRESSED BY THE GROUP DURING ITS PREVIOUS REVIEW FOR BASIC APPROVAL AND SUBSEQUENT QUESTIONS PUT TO THE APPLICANT

4.1 Concerns expressed during the applicat ion for Basic Approval and reactions of the Group to the applicant’s responses

Original Concern Applicant’s Response Group’s Reaction

1 Considering corrosion, the Group agreed that the applicant’s response was insufficient to quantitatively assess the corrosion impact to relevant metallic and non-metallic materials likely to be used in ballast water tanks, piping and fixtures.

For non-metallic gasket materials, the applicant responded that tests were not started since they have sufficient information for suitable materials but no details or data were provide. The data are stated briefly in 7.1.1.5 of this summary, and additional corrosion tests necessary for evaluation were performed. (The detailed data are given in the confidential part of the assessment report.) The Group noted the response, but did not concur with the applicant’s conclusions

2 The applicant should provide appropriate QAs and QCs and indicate why there are different detection limits for the same substance being analysed. In order to ensure Quality Assurance/Quality Control for chemical experiments and chemical analyses when applying for Final Approval, a decision was made to organize a Quality Assurance Committee including members of all related companies, and to carry out all drafting and implementation of plans and reporting and verification of the results in accordance with a Quality Assurance Project Plan (QAPP) audited and approved by the Committee.

Regarding detection limits, these were unified simultaneously with the improvement of making lower detection limits. When some substances have different limit values, the reason for this is described separately. The Group was satisfied with the applicant’s statement.GESAMP-BWWG 11/6 ANNEX 5 Page 10

I:\MEPC\60\2-12.doc Original Concern Applicant’s Response Group’s Reaction

3 Further measurement and analysis of discharge concentration of THMs and HAAs with adequate QA/QC should be taken during the full-scale land-based test before the submission for Final Approval. As mentioned in .2 above, for the application for Final Approval, appropriate Quality Assurance/Quality Control were performed in accordance with the QAPP, and this obligation was also imposed in commissioned tests (e.g., test contracted out to Ballast Tech –NIVA AS).

Standard Operation Procedures (SOP) which are capable of assuring quality were prepared for all tests, and audits as to whether the test were carried out as specified in the SOP were carried out in accordance with the quality assurance system. The Group was satisfied with the applicant’s statement.

4 The chemical analyses for THMs were not performed under adequate QAPPs and so recommended that all chemical measurement and analyses should be performed under QAPPs. As mentioned in .2 and .3 above for the application for Final Approval, measurements and analyses of all chemical substances were conducted based on the QAPP. The Group was satisfied with the applicant’s statement.

5 Final Approval submission should provide full details of the dosing control arrangements so as to ensure certainty of maintaining specified dosage levels of Active Substances. During ballasting, injection control of TG Ballastcleaner® is performed. Regarding TG Ballastcleaner® injection control, at a set after the start of operation of the JFE-BWMS, a set amount of TG Ballastcleaner® corresponding to a free available chlorine (FAC) concentration of 20 mg/L is injected. Thereafter, the TG Ballastcleaner® supply rate is controlled so that the value of the residual chlorine concentration in The Group was satisfied with the additional responses provided during the evaluation for Final Approval.GESAMP-BWWG 11/6 ANNEX 5 Page 11

I:\MEPC\60\2-12.doc Original Concern Applicant’s Response Group’s Reaction the ballast water will fall within a target range of residual chlorine concentrations which has been set in advance.

On the other hand, during deballasting, discharge neutralization control is performed using the chemical TG Environmentalguard ®

. In discharge neutralization control using TG Environmentalguard ® at a set time after the start ofoperation of the JFEBWMS, a set amount of TG Environmentalguard ®

, which will neutralize the 20 mg/L FAC concentration of TG Ballastcleaner ® that was supplied during ballasting, is injected. Thereafter, the supply rate of TG Environmentalguard ® necessary for neutralization is calculated and adjusted based on the residual chlorine concentration value in the ballast water at the outlet of the ballast tank, and the ballast water is discharged into the sea after neutralization/reduction

treatment.

Those are brief explanation of control system and more details of the control system are explained in 2.2.3 above.GESAMP-BWWG 11/6 ANNEX 5 Page 12

I:\MEPC\60\2-12.doc Original Concern Applicant’s Response Group’s Reaction

6 The Group was satisfied that the flow diagram provided was suitable for Basic Approval. It is appreciated that further details for evaluation be supplied for review during any Final Approval. The piping system diagram, system composition diagram, single line diagram (skeleton diagram), control flowchart, and protective interlock diagram of the JFE-BWMS and the operational procedure of the JFE-BWMS are described in the confidential part of the assessment report. The Group was satisfied with the information provided.

7 The applicant indicated to continue gathering information related to the two chemicals, bromochloroacetic acid and bromodichloroacetic acid and, if no additional data were to be found, they would carry out further algal tests as required. As data on dibromochloroacetic acid and bromodichloroacetic acid were required in the the GESAMP-BWWG report (MEPC 58/2/7, annex 5, paragraph 2.10), a toxicity test (Algal Growth Inhibition Test) was performed, and NOEC was obtained. The test results were added to the confidential part of the assessment report. The Group was satisfied with the information provided.

8 The Group was satisfied that the applicant had given due preliminary consideration to the concerns concerning temperature control put forward but requested that these safety mitigation measures and requirements should be fully detailed in the operating manual presented for any Final Approval. In order to prevent selfdegradation of TG Ballastcleaner ® , it is necessary to control the temperature to 20°C or less. In onboard tests, the TG Ballastcleaner ® tank was covered with thermal insulation, and external heat inputs were prevented as much as possible. The very small amount of input heat which was transmitted through the insulation was radiated to the outside by a water cooling method through cooling tubes arranged between the tank wall and the insulation using an independently controlled electric chiller. The Group was satisfied that the concerns had been addressed.GESAMP-BWWG 11/6 ANNEX 5 Page 13

I:\MEPC\60\2-12.doc Original Concern Applicant’s Response Group’s Reaction Regarding the temperature control procedure with this chiller, temperature control is performed automatically when the power is turned on, the set temperature is inputted, and operation begins. In the temperature control, cooling operation begins when the temperature exceeds the set temperature by 1°C and ends when the temperature of 1°C lower than the set temperature, is reached.

As another possible method, the tank can be installed in an area where it is air-conditioned to 20°C or less.

9 Whilst recognizing the validity of the pressure monitoring/control, the Group considered that further verification of this should be made during the ship board testing and included in the documentation for Final Approval. PV(Pressure-vacuum) valves are provided in the chemical storage tanks. When the tank internal pressure exceeds the external atmospheric pressure by 100 mmAq, PV valve opens and reduces the pressure, and when the internal pressure decreases to 100 mmAq less than the external atmospheric pressure, PV valve opens and increases the pressure.

In onboard tests, the internal pressure increased and decreased due to the loading and use of the chemicals, respectively. It was confirmed that the PV valves operated normally, and the tank internal pressure was kept within the set range.

Normal operation of the level gauges and high level alarms was also confirmed in shipboard experiments. The Group was satisfied that the concerns had been addressed.GESAMP-BWWG 11/6 ANNEX 5 Page 14

I:\MEPC\60\2-12.doc Original Concern Applicant’s Response Group’s Reaction

10 The Group is of the opinion that the acute toxicity testing for treated ballast water and the information for acute toxicity testing by simulated ballast water in a laboratory scale and full-scale land-based system are needed for evaluation.

In addition, the Group requested that quantification analysis and degradation rates of sodium sulphite in various conditions should be carried out for the submission for Final Approval. These were performed in land-based tests carried out by Ballast Tech-NIVA. The evaluation is described in Chapter 3. The Group was satisfied with the applicant’s statement.

11 The Group recommended that the following human exposure information related to TG BallastCleaner ® should be addressed:

.1 in advance identification of all leaking points; these are to be considered critical points for the HSE (due to the corrosive properties of the preparation);

.2 foreseen safety measures for spills/leaks in the wastewater collection tank;

.3 manual handheld (residual chlorine meter) measurements of residual chlorine concentration in the waste water tank. All locations where leaks can be expected were designated in advance, and those positions were indicated on the piping system diagram.

Because the periphery of the tank is surrounded by a coaming, there will be no effect on the surrounding area in the unlikely event of a leak. It should also be noted that the collected wastewater is discharged immediately after confirming with a simple sensor that it does not contain residual chlorine, and is not stored in the tank. The operation procedure for the portable residual chlorine meter was attached to the appendix of the assessment report. The Group was satisfied that the concerns had been addressed.

4.1.1 Having considered each of the above resp onses, the Group still had the following

concern:

.1 the evaluations of the degradation of epoxy paints, non-metallic seal materials and the corrosion rate of bare steels were considered insufficient since the TRO concentration of the treated test waters were below 0.05 mg/L at the conclusion of the test period and not comparable to the results of the land-based testing in which discharge TRO concentrations above 15 mg/L were realized prior to neutralization.GESAMP-BWWG 11/6 ANNEX 5 Page 15

I:\MEPC\60\2-12.doc 4.2 Questions put to the applicant during evaluation for Final Approval

Question 1:

Please could you provide an electronic vers ion of the EUSES 2.1 spreadsheets with the input values used in th e assessment of the specific exposu re scenarios for crew and general public?

Response 1: List of the EUSES 2.1 spreadsheets

.1 Health risk to crew of ballast water (primary treatment water) left in ballast tank (Table 7-2-7)

No. Test substance Word file name AS Sodium hypochlorite STUDY_AS(Crew).doc RC3 Bromodichloromethane STUDY_ RC3 (Crew).doc RC4 Dibromochloromethane STUDY_ RC4 (Crew).doc RC5 Bromoform STUDY_ RC5 (Crew).doc RC8 Bromate ion STUDY_ RC8 (Crew).doc RC12 Bromochloroacetic acid STUDY_ RC12 (Crew).doc RC15 Monobromoacetic acid STUDY_ RC15 (Crew).doc RC16 Dibromoacetic acid STUDY_ RC16 (Crew).doc RC17 Tribromoacetic acid STUDY_ RC17 (Crew).doc

.2 Health risk to general public of discharged ballast water (secondary treatment water) (Table 7-2-8)

No. Test substance Word file name RC3 Bromodichloromethane STUDY_ RC3 (General Public).doc RC4 Dibromochloromethane STUD Y_ RC4 (General Public).doc RC5 Bromoform STUDY_ RC5 (General Public).doc RC8 Bromate ion STUDY_ RC8 (General Public).doc RC12 Bromochloroacetic acid STUD Y_ RC12 (General Public).doc RC15 Monobromoacetic acid STUDY_ RC15 (General Public).doc RC16 Dibromoacetic acid STUDY_ RC16 (General Public).doc RC17 Tribromoacetic acid STUDY_ RC17 (General Public).doc

Reaction: The Group noted the response which enabled it to verify the findings of the applicant.GESAMP-BWWG 11/6 ANNEX 5 Page 16

I:\MEPC\60\2-12.doc Question 2 :

Please could you clarify if, fo r the crew exposure assessment a worst case scenario was used and, if so, could you provide details?

Response 2: (Answer to Question 2, please see a ttached file, “Answer number 2”. [3] Answer to Questions related to JFE BWMS – 2. Clarification of the worst case scen ario of the crew exposure assessment)

.1 The crew exposure scenarios are shown in the Table 7-2-1 of the application for the Final Approval. Because the exposures to “A, Chemicals (TG Ballastcleaner, TG Environmentalguard)” are avoided with personal protective equipment (PPE), as stated in paragraph 7.2.4.3, the exposures to “B, Treated ballast water stored in ballast tanks before neutralization (prima ry treatment water)” were investigated.

.2 There are two scenarios related with crew which are shown in Table 7-2-1:

(a) Normal operation (ballasting); and

(e) Maintenance of ballast tanks and equipment.

.1 Descriptions of the Exposure

(a) Normal operation (ballasting) – During ballasting (uptake of ballast water to ballast tanks) the air in the headspace of ballast tank is released from the air vent and this ai r contains vapors of Active Substance and Relevant Chemicals in B, primary treatment water. The concentrations of Relevant Chemicals in the air de pend on the duration of time after the air is taken into the ballast tank, how ever, the maximum concentrations are saturated condition and are used fo r the HES assessment for the crew.

(e) Maintenance of ballast tanks and equipment – During the operation of ships, the internal surface of all ballast tanks is visually inspected periodically by crews. The pur pose of this inspection is to check the soundness of the struct ure and the amount of sl udge accumulated in the ballast tanks. The visual inspection is to check the protective coating and dent. This inspection is normally conducted about twice a year in many large shipping companies and this interv al of 6 month is considered as the most frequent case. With confirmation to shipping companies the following assumption was made:

The inspection of a ballast tank requires 2 hours. Four tanks are inspected each month.

In total, the exposure to the air in the headspace of th e ballast tanks is calculated as: 2 hours x 4 times/month = 8 hours/month.

.2 Clarification of Worst Case Scenario

In the application for the Final A pproval, the exposure shown in (e) is described as the worst case scenario after both assessment results of exposure (a) and (e) were compared a nd MOS/MOSref values in (e) were tabulated in Table 7-2-7.GESAMP-BWWG 11/6 ANNEX 5 Page 17

I:\MEPC\60\2-12.doc After submission of the application, we had a lot of discussions with shipping companies and we recognized th at this exposure is avoided in the ordinary procedures in the ship oper ation. For the safety of the crews, whenever a crew enters into ballas t tanks, the concentration of oxygen in the tank is checked and in most cases th e fresh air is blown into the tank to replace the air to secure the crew’s respiration. We consider that this operation of air exchange decreases the crew’s risk of exposure and decide this air exchange as a mandatory pr ocedure for the ballast tank inspection. This worst case scenario of exposure (e) is avoided in practical operation. Therefore, exposure (a), the second wors t case scenario is described below.

. 3 Details of Exposure (a) During Balla sting, Second Worst Case Scenario

During ballasting, the headspace air in the ballast tank of the same amount of loaded ballast water is released through air ve nts to the deck. It is assumed that the air is saturated with Relevant Chemicals in the equilibrium with the concentrations in the primary treated ballast water. The air released from air vents are diffused into the atmosphere and the concentration at the accommodations wh ere crews are staying most of the time on their duty and off duty were calculated.

The diffusion was calculated with the Puff Model and the Plume Model which are broadly used in environmental effect assessments. The Puff Model was used for the condition without wind and the Plume Model was used for the condition with wind.

.3.1 Simulation Model

(1) Ship Model

A large ship of 200,000 DWT is assumed with the following configurations:

Length: 300 m Breadth: 50 m Number of ballast tanks: 5 on each side x 2 : 10 Size of ballast tanks: 50 m long x 20 m wide Location of air vents: x, y coordinates Two air vents on each ballast tanks are assumed

BWT No. No. 5 BWT (P) No. 4 BWT (P) No. 3 BWT (P) No. 2 BWT (P) No. 1 BWT (P) Loc. of Vent Aft Fore Aft Fore Aft Fo re Aft Fore Aft Fore

x (m) 5 45 55 95 105 145 155 195 205 245 y (m) 15 15 15 15 15 15 15 15 15 15GESAMP-BWWG 11/6 ANNEX 5 Page 18

I:\MEPC\60\2-12.doc BWT No. No. 5 BWT (S) No. 4 BWT (S) No. 3 BWT (S) No. 2 BWT (S) No. 1 BWT (S) Loc. of Vent Aft Fore Aft Fore Aft Fo re Aft Fore Aft Fore

x (m) 5 45 55 95 105 145 155 195 205 245 y (m) -15 -15 -15 -15 -15 -15 -15 -15 -15 -15 (P): Port side, (S): Starboard side

(2) Calculation

During ballasting, a pair of ballast ta nk on port side and starboard side are loaded at the same time, therefore, the nearest ballast tanks of No. 5 are considered producing highest exposure. The simulations were conducted under the conditions without wind and with wind at speed of 1 m/sec from bow to aft.

Exposure of 24 hours a day on 365 days in a year was assessed by dividing NOAEL with each concentration obtained by the simulation and MOS was calculated.

.3.2 Calculation results

The simulations were conducted on Sodium hypochlorite as an Active Substance and eight Relevant Chemicals and the calculated MOS and MOS/MOSref are shown in the following tables. Air vents of ballast tanks Accomodation

Point of exposure assessment  x y

No. 5 BWT AccommodationGESAMP-BWWG 11/6 ANNEX 5 Page 19

I:\MEPC\60\2-12.doc Table 1 : Health risk to crew of balla st water (primary treatment water) in ballast tank, no wind

No. Test substance MOS MOSref RCR(MOS/MOSref) AS Sodium hypochlorite 2181 100 22 RC3 Bromodichloromethane 2.356x10 4 100 236 RC4 Dibromochloromethane 2.064x10 4 100 206 RC5 Bromoform 3.678x10 4 100 368 RC8 Bromate ion 6.293x10 4 100 629 RC12 Bromochloroacetic acid 4.128x10 9 100 4.128x10 7

RC15 Monobromoacetic acid 1.159x10 9 100 1.159x10 7

RC16 Dibromoacetic acid 2.073x10 8 100 2.073x10 6

RC17 Tribromoacetic acid 1.289x10 11 100 1.289x10 9

Note: For the atmosphere stability coefficient in the Plume Model, the value at stable condition which yields higher concentration was used.

Table 2 : Health risk to crew of ballast water (primary treatment water), with wind of 1 m/sec

No. Test substance MOS MOSref RCR(MOS/MOSref) AS Sodium hypochlorite 1.182x10 4 100 118 RC3 Bromodichloromethane 1.276x10 5 100 1276 RC4 Dibromochloromethane 1.118x10 5 100 1118 RC5 Bromoform 1.993x10 5 100 1993 RC8 Bromate ion 3.409x10 5 100 3409 RC12 Bromochloroacetic acid 2.236x10 10 100 2.236x10 8

RC15 Monobromoacetic acid 6.278x10 9 100 6.278x10 7

RC16 Dibromoacetic acid 1.123x10 9 100 1.123x10 7

RC17 Tribromoacetic acid 6.986x10 11 100 6.986x10 9

Note: According to these results, all RCR (MOS/MOS ref) are greater than 1 and it is confirmed that there are no health risk to crew of ballast water (primary treatment water) in ballast tank.

.3 Additional assessment during voyage

Although it is not included in the single operation conditions in GESAMP-BWWG 6/9, annex 52.15.1(A), the health risk of ballast water (primary treatment water) in ballast tank during voyage was also assessed in addition to Table 7-2-1.

Although there are no active exchange of ai r in ballast tanks, diffusion through air vents were considered. The amount of diff usion is calculated for a tank without a cover, which is very conservative though, by multiplying the (mass) transfer coefficients with ballast water surface ar ea in ballast tanks. In this calculation contributions of all ten ballast tanks we re considered. The ship speed of 15 knots (7.717 m/sec) was assumed and the Plume Model is used. Even with this over estimation, the calculation re sults shown in Table 3 ar e far less than those in Tables 1 and 2 and the safety during voyage is confirmed.GESAMP-BWWG 11/6 ANNEX 5 Page 20

I:\MEPC\60\2-12.doc Table 3 : Health risk to crew of ba llast water (primary treatment water) during voyage at 15 knots

No. Test substance MOS MOSref RCR(MOS/MOSref) AS Sodium hypochlorite 4.547x10 5 100 4547 RC3 Bromodichloromethane 4.911x10 6 100 4.911x10 4

RC4 Dibromochloromethane 4.303x10 6 100 4.303x10 4

RC5 Bromoform 7.667x10 6 100 7.667x10 4

RC8 Bromate ion 1.312x10 7 100 1.312x10 5

RC12 Bromochloroacetic acid 8.604x10 11 100 8.604x10 9

RC15 Monobromoacetic acid 2.416x10 11 100 2.416x10 9

RC16 Dibromoacetic acid 4.321x10 10 100 4.321x10 8

RC17 Tribromoacetic acid 2.688x10 13 100 2.688x10 11

Reaction: The Group was sati sfied with this response.

Question 3:

In paragraph 3.1.1.2, it is stated that “a larger amount of TG Environmentalguard than what is stoichiometrically need ed is injected to neutralize TRO completely”. Could you kindly provide the factor of Environmentalg uard injection from the stoichiometrical amount calculated from TRO concen tration monitored by the sensor?

Response 3:

.1 In this system, 1.6 times the stoichiome trical amount of TG Environmentalguard for the TRO measured by the sensor is injected. The Summary, paragraph 3.1.1.2, states that “a larg er amount of TG Environmen talguard than what is stoichiometrically needed is injected to neutralize TRO completely” because this value is considered know-how, and as such, we wish to maintain its confidentiality. This value is stated in the application for the Final Approval on page 2.4-28(3).

.2 In the application for the Basic Approval 1.2 times the stoichiometrical amount was described to be injected, however, it was changed because 1.6 times of the stoichiometrical amount was required in the neutralization which was recognized in the experiments using JFE-BWMS equipment later.

Reaction: The Group was satisfied with this answer.

Question 4:

In Table 6.1.3 among pargraph 6.1.5, the m aximum discharge concentration of Sodium sulfite is set as 22 mg/L (same as the input in Basic Approval). Is it the calculated value theoretically introduced from the factor above and TRO maximum condition or maximum dosage value limited from th e capacity of injector?GESAMP-BWWG 11/6 ANNEX 5 Page 21

I:\MEPC\60\2-12.doc Response 4:

.1 As you pointed out, the maximum concen tration of sodium sulfite shown in Table 6.1.3 is the calculated value an d not the actual measured value.

.2 After sodium hypochlorite is injected, a nd the concentration of TRO in the treated ballast water reaches 20 mg/L, which is the maximum dosage, the amount of injected sodium sulfite is 1.6 times rela tive to the theoretical amount required to neutralize TRO (20 mg/L). Accordingly, th e maximum detected concentration of sodium sulfite in the ballast water after neutralization is considered to be equal to the 0.6 times relative to th e theoretical amount which does not react with TRO. This concentration was obtained by using the following equation:

20 mg/L / 71 x 0.6 x 126.06 = 21.3 Æ 22 mg/L 71: Molecular weight of chlorine 126.06: Molecular weig ht of sodium sulfite

.3 In the application for the Basic Approva l, the same concentration of 22 mg/L was described for the dosage of sodium h ypochlorite in the following assumption:

.1 The concentration of TRO at th e dosage of 30 mg/L is decreased to 10 mg/L in the treated ballast water.

.2 In order for the remaining TRO in the ballast water sodium sulfite of 1.6 times relative to the theoretical amount required to neutralize TRO, which is calculated as 22 mg/L in concen tration, in the following equation:

10mg/l / 71 x 1.2 x 126.06 = 21.3 Æ 22 mg/L

Therefore, we consider that the logic used in the application for the Final Approval is more rational, although the concentration values in both applications coincide incidentally.

Reaction: The Group was satisfied with this answer.

Question 5:

In relation to question 2, are th ere any possibility that only Sodium sulfite will be discharged to receiving water? In that case, not only direct toxic effect bu t also reduction of DO should be assessed, could you provi de the worst case scenario, which will cause such high sulfite ion discharge and the assessment for DO reduction ar ound the discharge point regarding with self distraction of sulfite ion (paragraph 3.1.1.2 only stat ed the result)?

Response 5:

.1 Because an excess amount of sodium sulf ite is injected as a neutralizing agent, there may be cases in which only sodi um sulfite is discharged into the environmental water.

.2 Because the amount of addition is cont rolled, the maximum concentration in the case mentioned above can be estimated at 22 mg/L. This is the worst case of discharge into environmental water as mentioned in A2.

.3 Sodium sulfite changes rapidly to sodium sulfate as a result of reaction with the dissolved oxygen in the water. For this re ason, “chronic toxicity” of sodium sulfite is not considered possible.GESAMP-BWWG 11/6 ANNEX 5 Page 22

I:\MEPC\60\2-12.doc .4 Sodium sulfate is one of the main natura l components of seawater. Therefore, it is judged that the increased amount due to oxi dation of sodium sulfite is not toxic, and is not a problem.

.5 Due to the speed with which sodium sulf ite changes to sodium sulfate in seawater, the calculation using the MAMPEC model gave a dilution fact or of 442,656 (see the application for the Final Approval, 6.1.3).

.6 On the other hand, the theoretical and experimental results showed that the amount of dissolved oxygen (DO) consum ed in the process of change from sodium sulfite to sodium sulfate is not large.

.7 Theoretically, the change in these substan ces in water can be expressed as follows:

2Na 2 SO 3 + O 2 Æ 2Na 2 SO 4

The molar mass of Na 2 SO 3 is 126.06 g/mol. Therefore, the amount of oxygen consumed by one mol of Na 2 SO 3 is a half mol of oxygen, representing a decrease of 16g in DO.

Accordingly, for example, assuming 10 mg/L of sodium sulfite reacts completely in water, 1.27 mg/L of oxygen is consumed.

If sodium sulfite is discharged at its maximum discharge rate of 22 mg/L in seawater without dilution, the reduction in oxygen will be 2.79 mg/L. However, assuming the discharged water is diluted off-board the ship, DO is not reduced to a level that would a ffect marine life.

.8 Experiments were also conducted in orde r to verify these points. For example, when the DO of test water was measured over time with test water adjusted to Na 2 SO 3 43 mg/L, using coastal seawater c ontaining no TRO, a DO reduction of from 7.0 mg/L to 4.8 mg/L was confirmed.

.9 In the land-based test, DO was measured at various stages. The decrease in the DO of the discharged water before dilution (i.e., 100% discharged water) was on the order of 20% at maximum, and as a measur ed value, the effect was judged to be small. (The value of approximately 10% shown in the Summary, paragraph 3.1.1.2 was the result of the land-based test.) A detailed explanation was presented in the application for the Fi nal Approval, 2.4.1.4(3).

Reaction: The Group was satisfied with this answer.

Question 6:

The Group considered that the discharge concen tration of Bromoform from this system was higher than that from other BWMS which used oxidant as an Active Substance. In the application for Final Approval, th e value was set at 330 ug/L, ho wever, the Group noted in the Basic Approval report that the maximum co ncentration of bromoform was 460 ug/L. Additionally, in append ix 25, the applicant stated that measured TRO concentration, using seawater from Nagoya Port , reached 390 ug/L. Co uld you clarify which va lue is representative as a “worst case maximum co ncentration” for bromofrom?

Response 6:

.1 The maximum concentration of bromoform in the Basic Approval was 460 μ g/L. This value is observed under the inject ed TRO concentration of 30 mg/L. The value of 330 μ g/L in this Final Approval is observed under the injected TRO concentration of 20 mg/L. (The maximu m value of the TRO concentration wasGESAMP-BWWG 11/6 ANNEX 5 Page 23

I:\MEPC\60\2-12.doc set at 20 mg/L, which is lower than the 30 mg/L in the Basic Approval, in order to reduce the concentration of system by-pr oducts, considering the fact that the concentration of 20 mg/L is a condition whic h can also satisfy the D2 standard.)

.2 The value of 390 μ g/L obtained with seawater from Nagoya Port was the result of a laboratory test. We consider that the maximum value obtained in 10 cycles of the land-based test, 330 μ g/L, in which a continuous treatment test was performed at the treatment capacity of 350 m 3 /h, is the value of th e “worst case maximum concentration” of bromof orm with the JFE-BWMS.

Reaction: The Group was satisfied with this answer.

Question 7:

The PEC calculation in dossiers shows a different “dilution ra tio” against the same substances. For example, 418 in the main re port (Table 6.1.3) and 145 in appendix 25 (Table 4) was calculated as the ratios for br omoform, respectively. Could you clarify which parameter settings for MAMPEC would be representative for Final Approval?

Response 7:

.1 Regarding the diffe rent dilution ratios, according to the MAMP EC calculations, the maximum value in harbour of bromoform for a discharge concentration of 330 μ g/L was 2.28 μ g/L, and the average va lue in harbour was 0.789 μ g/L. The abovementioned figures of 145 and 418 were obtained by dividi ng the discharge concentration of 330 μ g/L by these values, respectively.

.2 We are attaching the parameters and input/output data used in this MAMPEC simulation. (Please see the attached file, 330 μ g/L (1998data) Bromoform V4 to Default commercial harbor.rtf.)

.3 The dilution ratio using the maximum value in harbour was listed in Table 4 of appendix 25. The reason for using the maximum value here is to maintain the compatibility with the application for th e Basic Approval in which the maximum values were provided in the supplementary data.

Reaction: The Group was satisfied with this answer.

Question 8:

Because the TRO concentration remains higher th an 15 mg/L even after 5 days’ tank holding time, the reliability of neutralization process is the key for preventing environmental risks to aquatic ecosystem. The Group considers that the feedback loop for Environmentalguard injection by TRO sensors is a key component for the neutralizat ion process. Could you provide the algorithm for controling Environmentalg uard injection, when TRO sensors have malfunctioned? If the fail-safe setting is to fix the dose of Environmentalguard injection as maximum rate and it does not cause significant concerns, what is the advantage of choosing a feedback loop for Environmentalgua rd injection by TRO sensors?

Response 8:

.1 In discharge control in the JFE-BWMS, the TRO value at the outlet of the ballast tank is measured with a TRO meter (1), and an amount of TG Environmentalguard capable of neutralization treatment of that TRO is injected.GESAMP-BWWG 11/6 ANNEX 5 Page 24

I:\MEPC\60\2-12.doc .2 In addition, neutralizat ion/reduction of the TRO in the ballast water at the discharge outlet is confirmed by m easurement with a high sensitive TRO sensor (2).

.3 Regarding detection of malfunctions of the TRO sensors, over-scale reading values and hunting are judged by a control device (PLC), and a warning is displayed.

.4 In case injection of TG Environmentalguard is in adequate due to reduced sensitivity of TRO sensor (1), and the reading value of TRO sensor (2) becomes positive, the amount of TG Environmentalguard is controlled so that injection is automatically increased.

.5 If the reading of TRO (2) does not become a minus value as a result of this action, the system is designed so that the device is auto matically stopped.

.6 This protective safety interlock circuit is described in item 2 of the “Explanation of safety interlock circuit” in appendix 11 (see below).

.7 These control functions we re selected by considering to minimize the effect to the environment by avoiding over use of chemicals.

Reaction: The Group was satisfied with this answer and the other information related achieved from the applicant.

Question 9:

Could you kindly provide the relation between the TRO concentration monitored by high sensitive sensor and that by manually meas urement with “high resolution analytical method”, such as calibration curve under high salinity, brackish and fresh water condition (laboratory measurement could be acceptable) ? This information would be needed for evaluation of reliability for TRO sensors. Also are there any data for long-term degradation of sensors sensitivities during onboard testing?

Response 9:

.1 We do not have calibration data between the TRO concentration monitored by high sensitive sensor and that by manually meas urement with “high resolution analytical method”. The purpose of measuring by “high re solution analytical me thod” is to prove that the TRO concentration of treated ballast water after neutralization is lower than the detection limit of Hach DPD, which is 0.02mg/L.

.2 On the other hand, high sensitive sensor (TRO sensor) is used to confirm that ter is in reduction condition when the reading value is negative, while the positive reading value shows the concentration of TRO.

.3 In the land-based test, the concentrati on of the TRO in the neutralized seawater and brackish water is measured with Hi gh Resolution analyti cal method and High Sensitive sensor (TRO sensor). The results obtained show that when the reading value of High sensitive sensor (TRO senso r) is negative, which shows that water is in reduction condition, all the measured values of High Resolution analytical method are less than 0.02mg/L.

.4 These data is shown in the Table 2- 4-18 “Result of the immediate analysis of TRO” in section 2.4.1.4 and appendix-15 “T RO monitoring trend data for test cycle 1-11 during Deballasting” of the application for the Final Approval.GESAMP-BWWG 11/6 ANNEX 5 Page 25

I:\MEPC\60\2-12.doc .5 The TRO meters used in the JFE-BWMS have an extens ive record of practical use in waterworks and other a pplications, and were also used for approximately 6 months in the shipboard test with no problems.

.6 Regarding maintenance of the TRO meters, as mentioned in the I nstruction Manual of Tro Meter in appendix 6, the 0-30 mg/L TRO meter sensor is to be exchanged at a cycle of approximately 300 hours (however, because no current passes through when the BWMS is not in use, 300 hours actually refer to the total time when ballast water is being treated) . The recommended exchange cycle of the 0-3 mg/L TRO meter sensor is approximately one year.

Reaction: The Group was not satisfied with this answer. However, the applicant provided additional information (see be low) which with the above answer, satisfied the Group.

Question 10:

Is there an option and/or plan to set each TRO sensors in pa rallel to ensure the system’s reliability with redundancy?

Response 10:

.1 As an option, installation of ORP meter or additional TRO sensor is also available.

.2 As explained in the reply to question 6, discharge control in the JFE-BWMS is performed by an automatic control f unction which increases the supply of TG Environmentalguard when a TRO meter malf unctions, and in parallel with this, also includes a protective safety interlock ci rcuit which stops the BWMS if abnormal conditions occur. This is considered to provide the fail-safe characteristics.

Reaction: The Group was satisfied with this answer.

Question 11:

In their corrosion analysis given in appendix 14, they show that the TRO dosage decays from 20 ppm at the start to some lower value over the course of the seven-day exposure. Can you provide quantitative information on th e level of TRO over the course of the sevenday immersion?

Response 11:

.1 TRO decay data including start, e nd and intermediate value are shown in “Durability Test of Paint Film with Si mulated Defect” and “Dew Condensation.

.2 Test” of appendix 14. Data of other tests are shown in attached data sheet in page 2 but unfortunately we have only the data fo r start and 7 days after. Only the data for “Test (Accelerating Test) of Syntheti c Rubber” were conducted under constant TRO concentration at 20 ppm.GESAMP-BWWG 11/6 ANNEX 5 Page 26

I:\MEPC\60\2-12.doc Table 1 : Table of TRO decay data for all corrosion tests

Report name TRO Data

Durability Test of Paint Film with Simu lated Defect Shown in Table10 on pages 25 and 26 Dew Condensation Test Shown in Table10 on page 24 Corrosion Test on uncoated steel pl ate See attached data sheet Cathodic Protection Performance Test on Zi nc Anode See attached data sheet Test of Durability of Piping P acking See attached data sheet Corrosion Check Test of Butterfly Valve Components See attached data sheet Test (Accelerating Test) of Synthetic Rubber TRO was kept at about 20 ppm during whole test period.GESAMP-BWWG 11/6ANNEX 5Page 27I:\MEPC\60\2-12.docTest of Durabilityof PipingPackingStart7daysStart7daysStart7daysStart7daysStart7daysStart7daysStart7daysStart7daysStart7days21.00.32 20.00.18 21.0<0.05 21.0 0.1020.0 0.07 20.0 0.07 21.0 0.06 19.0 <0.05 20.0 0.08Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days19.0 <0.05 19.0 <0.05 19.0<0.0521.0<0.0521.0<0.0520.0<0.0520.0 0.08 20.0 0.09 20.0 0.06Corrosion Test on uncoated steelplateStart7daysStart7daysStart7daysStart7daysStart7daysStart7daysStart7daysStart7daysStart7days21.0 <0.0521.0<0.05 20.0 <0.0521.0<0.05 20.0 <0.05 20.0 <0.05 19.0 <0.05 20.0 <0.05 20.0 <0.05Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days20.0 <0.05 21.0 <0.05 19.0 <0.05 20.0 <0.05 21.0 <0.05 21.0 <0.05 20.0 0.06 20.0 <0.05 20.0 <0.05Cathodic Protection Performance Test on Zinc AnodeTest Specimen No.Start 7daysNo.6 20.0 2.06No.7 20.0 0.57No.8 20.0 1.63No.9 20.0 0.33No.10 20.0 2.01Corrosion Check Test of ButterflyValve ComponentsStart 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7daysSCS13 19.0 0.16 19.0 0.14 20.0 0.14 21.0 0.11 21.0 0.1 19.0 0.16 21.0 0.13 21.0 0.12 21.0 0.12SUS403 19.0 0.15 19.0 0.09 20.0 0.13 21.0 0.11 21.0 0.09 19.0 0.15 21.0 0.11 21.0 0.16 21.0 0.17S25C 19.0 <0.05 19.0 <0.05 20.0 <0.05 21.0 <0.05 21.0 <0.05 19.0 <0.05 21.0 <0.05 21.0 0.06 21.0 0.06FC250 19.0 <0.05 19.0 0.05 20.0 <0.05 21.0 <0.05 21.0 <0.05 19.0 <0.05 21.0 <0.05 21.0 0.05 21.0 <0.05Painted Specimen(S25C)19.0 0.09 19.0 0.09 20.0 0.0621.0 <0.0521.0 <0.05 19.0 0.0621.0 0.05 21.0 0.0521.0 0.06Painted Specimen(FC250)19.0 0.0619.0 0.0520.0 0.0521.0 <0.0521.0 <0.05 19.0 0.07 21.0 0.06 21.0 0.07 21.0 0.06Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7days Start 7daysSCS13 20.0 0.12 20.0 0.14 21.0 0.12 19.0 0.09 20.0 0.13 21.0 0.13 20.0 0.1 20.0 0.10 19.0 0.14SUS403 20.0 0.11 20.0 0.10 21.0 0.05 19.0 0.08 20.0 0.10 21.0 0.1 20.0 <0.05 20.0 0.1 19.0 0.11S25C 20.0 <0.05 20.0 <0.05 21.0 <0.05 19.0 <0.05 20.0 <0.05 21.0 <0.05 20.0 <0.05 20.0 <0.05 19.0 <0.05FC250 20.0 <0.05 20.0 <0.05 21.0 <0.05 19.0 <0.05 20.0 <0.05 21.0 <0.05 20.0<0.05 20.0 <0.05 19.0 <0.05Painted Specimen(S25C)20.0 <0.05 20.0 <0.05 21.0 <0.05 19.0 <0.0520.0 <0.05 21.0 0.0520.0 <0.0520.0 <0.05 19.0 0.05Painted Specimen(FC250)20.0 0.0520.0 0.0521.0 <0.05 19.0 <0.0520.0 <0.05 21.0 <0.05 20.0 <0.0520.0 <0.05 19.0 <0.058989Kind ofTest Specimen12345671718Kind ofTest Specimen123456789Natural Seawater+ 20ppmNaClO101112131415161718Test cycle123456789Natural Seawater+ 20ppmNaClO101112131415164567Test cycle123GESAMP-BWWG 11/6 ANNEX 5 Page 28

I:\MEPC\60\2-12.doc Reaction: The Group was satisfied with this response.

Question 12:

Please could you provide the EUSES spread sheets which could not be found in the confidential section.

Response 12:

.1 We believe that the 17 spreadsheets in Word file which we sent in reply to the first question have the full contents of inform ation including all manually input data such as characteristics and NOAELs of each chemical species and calculated output data.

.2 If “the confidential section” means “??” in the spreadsheets, that show no default values in the system when no data are inputted we presume. If our understanding is wrong, will you kindly let us know “the confidential section”. For reference, we attach the exported files of EUSES 2.1.

Reaction: The Group was sati sfied with this response.

5 HUMAN HEALTH ASSESSMENT

5.1 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 TG Ballastcleaner) is:

.1 corrosive at concentrations above 10%*;

.2 irritant to skin and eyes at concentrations from 5-10%*

________________ * The classification according to GHS (CLP, 1272/2008/EC, in Europe) will change the current classification of sodium hypochlo rite. According to CLP concentrations ≥ 5% will lead to a classification as Sk in Corrosive Category 1B (H 314; Causes severe skin burns and eye damage). The specific concentration limits (5% ≤ conc < 10% and conc ≥ 10%) have been removed from the harmonized classification and are no longer applicable.

.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.GESAMP-BWWG 11/6 ANNEX 5 Page 29

I:\MEPC\60\2-12.doc .3 Halo-acetic acids and in particular dibromoacetic acid are:

.1 acutely toxic if swallowed;

.2 acutely toxic if inhaled;

.3 acutely toxic in contact with skin; and

.4 corrosive to skin.

6 RISKS TO THE SAFETY OF THE SH IP, ITS CREW AND THE GENERAL PUBLIC

6.1 Risk associated with exposure of th e crew to the Active Substances, Relevant Chemicals and Other Chemicals

6.1.1 The Group agreed that the risks to the crew from this system were primarily associated with:

.1 chemical storage on board (TG Ballastcleaner ® , TG Environmentalguard ® );

.2 leakage during the chemicals dosage operations and mainte nance of the BWMS;

.3 ballast water which has been treated by the BWMS and is stored in the ballast tanks before neutralization (p rimary treatment water); and

.4 treated ballast water which has been withdrawn from the ba llast tanks and is discharged from the ship after neutra lization (secondary treatment water).

6.1.2 The Group noted that the applicant had iden tified the following exposure scenarios for personnel:

.1 persons on onboard (crew, 8 hours/ day x 5 days/week). Exposure routes: respiration and dermal contact ; and

.2 general public (persons in port while ship is at anchor, persons in area near shore). Exposure routes: Oral ingestion, re spiration and dermal contact.

6.1.3 The Group recommended that the scenarios fo r occupational exposure assessment to be considered were the following (MEPC 58/2/7, annex 5, paragraph 2.15.1 (A)):

.1 Resupply of chemicals

.2 Ballasting (taking on ballast water)

.3 Deballasting (discharging ballast water)

.4 Inspection and maintenance of equipment and chemical tanks

.5 Inspection and maintenance of ballast tanks

.6 Trouble and emergency states (this assume s breakdowns of the system and accidents)GESAMP-BWWG 11/6 ANNEX 5 Page 30

I:\MEPC\60\2-12.doc 6.1.4 The following individual un it operations to ad dress crew exposure were proposed by the applicant for Final Approval:

Individual operations for crew exposure assessment

Crew General public

(a) Normal operation (ballasting) B -- (a) Normal operation (deballasting) -- C (b) Resupply of chemicals A -- (c) Equipment breakdown A -- (d) Ship accident or other emergency A -- (e) Maintenance of ballast tanks and equipment A and B --

Here, A: Chemicals (TG Ballastcleaner ® , TG Environmentalguard ® ) B: Treated ballast water store in ballast tanks before neutralization C: Treated ballast water discharged from ship after neutralization

6.1.5 The Group noted that the applicant consid ered that the exposur es to “A, Chemicals (TG Ballastcleaner, TG Environm entalguard)” are minimized by using PPE (personal protective equipment) and therefore do not need to be consid ered further. On the other hand, the exposures to “B, Treated ballast water stored in ballast tanks before neutralization (primary treatment water)” were investigated.

6.1.6 The Group also noted that the applicant in itially identified two s cenarios as worst-case scenarios to address crew expos ure associated with B: (a) Normal operation (ballasting) and (e) Maintenance of ballast tanks and equipment. Furthermore, the applicant considered this scenario as non-applicable during ordinary procedures in the ship operation due to mitigation measures put in place when crew entering the balla st tanks. Therefore the only scenario to be developed was (a).

6.1.7 The Group noted that the a pplicant, in order to address a), assumed the crew being exposed to the air released from air vents during their duty and off duty time. The diffusion in to the atmosphere was calculated with the Puff Model (Table 1 – Condition without wind) and the Plume Model (Table 2 – Condition with wind).

6.1.8 The Group noted that the a pplicant had used EUSES 2.1 to estimate crew exposure levels and risks. Oral NOAELs values were extra polated to inhalation NOAELs by using conversion default values according to EUSES 2.1 Back ground Report, Model Calculation assuming a worker respiration rate of 10 m 3 /d (eight hour exposure).GESAMP-BWWG 11/6 ANNEX 5 Page 31

I:\MEPC\60\2-12.doc Table 1 : Health risk to crew of ballast wat er (primary treatment water) in ballast tank, no wind (Puff model)

No. Test substance MOS MOSref RCR(MOS/MOSref) AS Sodium hypochlorite 2181 100 22 RC3 Bromodichloromethane 2.356x10 4 100 236 RC4 Dibromochloromethane 2.064x10 4 100 206 RC5 Bromoform 3.678x10 4 100 368 RC8 Bromate ion 6.293x10 4 100 629 RC12 Bromochloroacetic acid 4.128x10 9 100 4.128x10 7

RC15 Monobromoacetic acid 1.159x10 9 100 1.159x10 7

RC16 Dibromoacetic acid 2.073x10 8 100 2.073x10 6

RC17 Tribromoacetic acid 1.289x10 11 100 1.289x10 9

Table 2 : Health risk to crew of balla st water (primary treatment water), with wind of 1 m/sec

No. Test substance MOS MOSref RCR(MOS/MOSref) AS Sodium hypochlorite 1.182x10 4 100 118 RC3 Bromodichloromethane 1.276x10 5 100 1276 RC4 Dibromochloromethane 1.118x10 5 100 1118 RC5 Bromoform 1.993x10 5 100 1993 RC8 Bromate ion 3.409x10 5 100 3409 RC12 Bromochloroacetic acid 2.236x10 10 100 2.236x10 8

RC15 Monobromoacetic acid 6.278x10 9 100 6.278x10 7

RC16 Dibromoacetic acid 1.123x10 9 100 1.123x10 7

RC17 Tribromoacetic acid 6.986x10 11 100 6.986x10 9

6.1.9 The Group concurred with the applicant’s vi ew that calculated results of the obtained RCR (Risk Characterization Ratio = MOS/MOSref) ar e larger than 1 and judged that there is no health risk to humans, and it is not necessary for the crew to we ar additional personal protective equipment (PPE) as a routine when working on deck.

6.4 Risks to the general public from pote ntial exposure to Relevant Chemicals

6.4.1 It was noted that a EUSES 2.1 simulation had been performed to estimate the exposure of the general public to bromoform, bromate ion, bromochloroacetic acid, monobromoacetic acid, and dibromoacetic acid which are com ponents of the treated ballast water.

6.4.2 The calculated results of the obtained Risk Characterization Ratio (RCR) = MOS/MOSref) are shown in the table belo w. As the risk char acterization are larger than 1, it can be judged that there is no unacceptable risk to the general public.GESAMP-BWWG 11/6 ANNEX 5 Page 32

I:\MEPC\60\2-12.doc Health risk to general public of discharged ballast water

Risk Characterization Ratio (MOS/MOSref) Local Regional No. Chemical substance Inhalatory Total Exposure Inhalatory Total Exposure RC3 Dichlorobromomethane 9.16 x10 6 5.92 x10 6 9.48 x10 6 6.55x10 6

RC4 Dibromochloromethane 1.27x10 7 3.01 x10 6 1.29 x10 7 3.38x10 6

RC5 Tribromomethane 4.89x10 5 9.85x10 4 4.96x10 5 1.11x10 5

RC8 Bromate ion 1.58x10 10 9.41x10 4 6.24x10 12 1.06x10 5

RC12 Bromochloroacetic acid 1.50x10 9 1.32x10 7 1.58x10 9 1.46x10 7

RC15 Monobromoacetic acid 1.85x10 8 1.87x10 5 2.01x10 8 1.89x10 5

RC16 Dibromoacetic acid 1.20x10 6 1.56x10 5 1.25x10 8 1.79x10 5

RC17 Tribromoacetic acid 5.60x10 12 5.60x10 7 9.66x10 12 6.11x10 7

6.5 Risks to the safety of the ship

6.5.1 The Group noted that the applicant had indicate d that tanks and pipes must be coated or lined with chlorine and salt water resistant epox y resins when exposed to TG Ballastcleaner. The Group recommended that this is considered pr ior to fitting this BWMS on the ship.

6.5.2 The Group noted that the applicant carried out a comprehensive corrosion evaluation of epoxy-coated steel, bare steel, galvanized steel and non-metallic seals. In addition, two alloys of stainless steel were evaluated for suscepti bility to crevice co rrosion. The testing included 18 exposures to a 10-day cycle whic h was comprised of an initial seven days’ immersion, followed by three days in air. The tr eatment solutions included both natural seawater and seawater dosed with 20 ppm of sodium hypoc hlorite (TG Ballast Clea ner). The applicant indicated that the actual TRO concentration du ring the seven-day immersion decays from the initial dosage of 20 ppm to less than 0.05 ppm at the end of the immersion period, in most cases. The evaluations of coated steels included an examination coating hardness and adhesion. Galvanized steel and uncoated steel was evaluate d on the basis of weight loss and the resulting uniform corrosion rate. Crevice corrosion was ev aluated using the depth of penetration and the number of incidences. Non-meta llic degradation was evaluated on the basis of visual appearance and percent elongation. The applicant concluded from these test that:

.1 the effect of sodium hypochlorite on the epoxy painted specimens was limited to slight discoloration with no significant difference in coating physical properties compared to natural seawater;

.2 regarding the Zn-coated specimens (g alvanized), no effect due to sodium hypochlorite addition was found;

.3 for uncoated steel exposures, the av erage corrosion rate was 0.059 mm/year in seawater dosed with 20 ppm sodium hypochlorite vs. 0.052 mm/year in natural seawater; and

.4 the effect of sodium hypochlorite on seal materials had not been determined as the testing is incomplete.GESAMP-BWWG 11/6 ANNEX 5 Page 33

I:\MEPC\60\2-12.doc 6.5.3 The Group could not agree with the applicant’ s conclusions regardi ng the corrosivity of natural seawater dosed to an initial TRO concen tration of 20 mg/L. While the Group considered that the test results showed no difference betwee n treated and natural seaw ater, the experimental procedure is in question. Specifically, the Group noted, from the data set provided by the applicant that the TRO concentration in the discharge from the land-based testing prior to neutralization was 15 mg/L . This is significantly higher than the <0.05 mg/L TRO concentration at the end of the experiments for the evaluation of corrosion. As a result, the Group did not agree with the applicant’s conclusion that the testin g indicates that no significant difference in the corrosion rate of bare steel, non-m etallics or the degradation of epoxy paints versus exposure to natural seawater. The Group recommended that a ll of the corrosivity and coating degradation testing be repeated with adequate contro l throughout the testing to maintain the TRO concentrations between 15 mg/L and 20 mg/L. Fu rthermore, the Group i nvited the applicant to consider the guidance provided in section 5.1 of the “Report of th e eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

6.5.4 The Group noted that the use of PPE is recommended as a risk mitigation measure for personnel performing specific tasks in the operati on and maintenance of the BWMS. The ship specific operational manual should contain clear in structions as to where and when the use of PPE is required.

6.5.5 The Group noted that the applicant had id entified risk mitigation measures to be incorporated in the system together with routin e procedures for risk mitigation. Such measures and procedures should be clearly id entified in the operational manual.

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

PBT criteria for 8 chemical substances

Object chemical substances of PBT criteria Persistence P (Yes or No) Bioaccumulation B (Yes or No) Toxicity T (Yes or No)

OC Sodium hypochlorite No No No RC3 Dichlorobromomethane Yes No No RC4 Dibromochloromethane Yes No No RC5 Bromoform Yes No No RC8 Sodium bromate Yes No No RC12 Bromochloroacetic acid Yes No No RC15 Monobromoacetic acid Yes No No RC16 Dibromoacetic acid Yes No No RC17 Triibromoacetic acid Yes No No

7.1.1 Substances which are evaluated “Yes” for a ll of the items Persis tence, Bioaccumulation, and Toxicity in this table are identified as PBT substances.

7.1.2 The Group agreed with the applicant that, as shown in the table, none of the chemicals are PBT substances. However, for chemical subs tances which are eval uated as displaying persistence, PEC/PNEC values were calculated in order to evaluate the effects on the aquatic environment, and this evaluation was made.GESAMP-BWWG 11/6 ANNEX 5 Page 34

I:\MEPC\60\2-12.doc 7.2 Calculation of Predicted En vironmental Concentration (PEC)

7.2.1 The MAMPEC Model was used to calculate the degree of dilu tion of ballast water in the port. The input data used in MAMPEC Model a ssumes higher ballast water amount so as not to underestimate actually discharged ballast wa ter in a year in the Rotterdam port.

7.2.2 The Group noted that the applicant used wo rst-case assumptions as no degradation of Relevant Chemicals had been taken into account except for sodium sulfite, as this substance is assumed to be converted very quickly to sodium sulfate.

7.3 Calculation of PEC/PNEC Ratios

7.3.1 The Group noted that, because the acute toxicity values we re used, the factor 1000 was taken from Table 2 in the Methodology (BWM.2/Circ.13, 10 June 2008) and was selected as the assessment factor for use in the calculations.

7.3.2 An average GRT in the table is recalculated for daily basis to generate 1,067 kt/day for the number of arriving ships, which is then mu ltiplied by 0.5 for a ratio of the ballast water discharging ship for evaluation, re sulting in a GRT of 533.5 kt/day. Using the above, calculation results in 280.1 kt/day for the amount of ballast water per day.

7.3.3 The Group noted that to estimate the emission into the receiving waters, the applicant used an estimation of the ballast water based on the port of Rotterdam in the years 1996-1997 and the results of the concen tration of the WET tests.

PEC/PNEC values Yes: Effect on aquatic organism, No: No effect on aquatic organism

Test substance Species Maximum measured value PEC PNEC PEC/ PNEC Evaluation

(mg/L) (mg/L) (mg/L)

RC3 Dichlorobromo
-methane Other life forms (Ciliates) ( Tetrahymena pyriformis ) 0.88×10 -3 0.00232

×10 -3 240×10 -3 9.7

×10 -6 No

RC4 Dibromochloro
-methane Other life forms (Ciliates) ( Tetrahymena pyriformis ) 16×10 -3 0.0344

×10 -3 65×10 -3 5.3

×10 -4 No

RC5 Bromoform Fish (acclimatization to seawater) Sheepshead
minnow ( Cyprinodon variegatus ) 330×10 -3 0.789

×10 -3 7.1×10 -3 0.111 No

RC8 Sodium
bromate Mollusks Pacific oyster ( Crassostrea gigas ) 46×10 -3 0.250

×10 -3 25.4×10 -3 0.0098 NoGESAMP-BWWG 11/6 ANNEX 5 Page 35

I:\MEPC\60\2-12.doc

Test substance Species Maximum measured value PEC PNEC PEC/ PNEC Evaluation

(mg/L) (mg/L) (mg/L)

RC12Bromochloroacetic acid Not possible to
obtain data.
Based on
structure, substituted with high toxicity
bromodichloroace
tic acid. 0.47×10 -3 0.00258

×10 -3 53×10 -3 4.9

×10 -5 No

RC15Monobromoacetic acid Aquatic plant (algae) Green algae ( Scenedesmus subspicatus ) 5.7×10 -3 0.0313

x10 -3 1.4

x10 -3 0.022 No

RC16 Dibromoacetic
acid Fish
Fathead minnow ( Pimephales

promelas ) 47×10 -3 0.258

×10 -3 69

×10 -3 3.74

×10 -3 No

RC17 Tribromoacetic
acid Fish
Java medaka ( Oryzias javanicus ) 0.1×10 -3 0.55x10

-6 101x10 -3 5.4x10 -6 No

OC3 Sodium sulfite Aquatic plant (algae) Green algae ( Chlamydomonas reinhardtii,

Chlorella vigaris, Scenedemus

basiliensis ) 22 0.0497 ×10 -3 63 ×10 -3

*1 0.00080 (Short term) No

Note: 1 : Method of calculating PNEC for sodium sulfite. PNEC: The most sensitive species used for s odium hypochlorite is Aquatic plant (algae) ( Chlamydomonas reinhardtii

, Chlorella vulgaris

, Scenedesmus basiliensis ), EC 50 , 6.4 h-8.9 h, 16-32 mg/L (as SO 3 -S). Accordingly, the value is 40 mg/L (=(16 x 80)/32) as SO3, that is, 63 mg/L (=(16 x 126)/32) as sodium sulfite. PNEC is obtained by dividi ng this value by the above-mentioned assessment factor of 1000, the result being PNEC=63 μg/L.

7.3.5 The Group noted that the applicant used a scen ario for the establishment of the PECs that is not adopted by the Group as the relevant emission scenario. Howe ver, this did not affect the conclusions reached.

7.3.6 As a result, all of the substa nces to be designated as evalua tion object were determined as having no unacceptable risk on aquatic organisms.GESAMP-BWWG 11/6 ANNEX 5 Page 36

I:\MEPC\60\2-12.doc 8 CONCLUSIONS AND RECOMMENDATIONS

8.1 The Group concurred with the applicant’s view that calculat ed results of the obtained RCR (Risk Characterization Ratio = MOS/ MOSref) were greater than 1 and judged that there is no unacceptable health risk to humans, a nd it is not necessary for the crew to wear additional personal protective equipment ( PPE) as a routine when working on deck.

8.2 The calculated results of the obtaine d Risk Characterization Ratio (RCR) = MOS/MOSref) were deemed acceptable and it can be judged that there is no unacceptable risk to the general public.

8.3 Whilst not agreeing with all of the PBT assignments to th e chemical by-products found in the treated ballast wate r, the Group agreed th at none of these chemi cals met the required PBT criteria that would result in the system not being recommended for Final Approval.

8.4 Based on the PEC/PNEC ratio values shown in paragraph 7.3.4, the Group agreed that the chemicals produced in the treated water did no t present a significant effect on the marine environment.

8.5 The Group confirmed, from the results of onboard and land-based tests, that the treated ballast water, after neutraliza tion, had no unacceptable effects on the aquatic environment. The maximum allowable discharge concentrations of Active Substances (the concentration of TRO after neutralization) sh ould be kept to the level propos ed by the applicant, i.e. not exceeding 0.03 mg/L as monitored by high sensitivit y TRO sensor when adequately maintained. This parameter should be continuously r ecorded during ballast water discharge.

8.6 Having considered the corrosion informa tion, provided by the applicant, the Group agreed with the applicant’s recommendation to provide epoxy-lined/coated piping and tank structures which are exposed to Active Substance and Relevant Chemicals to prevent elevated corrosion rates. The Group noted that the applican t’s testing did not rev eal significantly higher corrosion rates for uncoated steel natural seawater with 20 mg/L sodium hypochlorite. However, the applicant’s experiments were conducted with only 18 cycles of intermittent exposures to 20 mg/L sodium hypochlorite with a rapid decay in TRO, which may not be indicative of the long-term conditions or provide an adequate prediction of long-term corrosion rates.

8.7 As a result, the Group did not agree with the a pplicant’s conclusion that the testing indicates that no si gnificant difference in th e corrosion rate of bare steel, non-metallics or the degradation of epoxy paints versus exposure to natural seawater. The Group recommended that all of the corrosivity and coating degradation testing be repeated with adequate control throughout the testing to maintain the TRO c oncentrations between 15 mg/L and 20 mg/L. Furthermore, the Group invited the applicant to c onsider the guidance provi ded in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

8.8 As a result, the Group agreed that the sy stem should be recomme nded for Final Approval provided that all recommendations contained w ithin this assessment report are taken into

account.

* * *GESAMP-BWWG 11/6 ANNEX 5 Page 37

I:\MEPC\60\2-12.doc APPENDIX 1

DATA ASSOCIATED WITH TREATED BALLAST WATER

1 Results of the growth inhibi tion test on marine algae ( Skeletonema costatum )

The following table shows the values of EC 10 and EC 50 obtained from the growth inhibition test.

These results indicate that the ef fect on growth inhibition was not seen except in the case of 66% of EC 10 on Day 5 during the test cycle 1 and 100% of EC 10 on Day 5 during the test cycle 2.

Results of the growth inhibiti on test on marine algae ( Skeletonema costatum )

Test cycle Test water Day No. Water condition EC10 (%) EC50 (%)

0 Immediately after TGBC injection 2.0 2.3 1 Seawater 5 After TGEG neutralization 66 >100 0 Immediately after TGBC injection 1.0 1.4 2 Brackish

water 5 After TGEG neutralization 100 >100 0 Immediately after TGBC injection 1.9 1.8 3 Brackish

water 5 After TGEG neutralization >100 >100 0 Immediately after TGBC injection 3.1 3.4 4 Brackish

water 5 After TGEG neutralization >100 >100 0 Immediately after TGBC injection 3.7 4.4 5 Brackish

water 5 After TGEG neutralization >100 >100 0 Immediately after TGBC injection 1.5 1.7 6 Brackish

water 5 After TGEG neutralization >100 >100 0 Immediately after TGBC injection 0.98 0.95 7 Seawater 5 After TGEG neutralization >100 >100 0 Immediately after TGBC injection 0.15 0.27 8 Seawater 5 After TGEG neutralization >100 >100 0 Immediately after TGBC injection >1.8 >1.8 9 Seawater 5 After TGEG neutralization >100 >100 0 Immediately after TGBC injection 0.42 0.70 10 Seawater 5 After TGEG neutralization >100 >100 0 Immediately after TGBC injection 1.9 1.7 11 Brackish

water 5 After TGEG neutralization >100 >100

Note : (“>100%” means that no effect was seen in th e test using the raw wa ter for the secondary treated ballast water.)GESAMP-BWWG 11/6 ANNEX 5 Page 38

I:\MEPC\60\2-12.doc 2 Results of the acute toxicity test to marine copepods ( Acartia tonsa )

Acute toxicity test on Acartia tonsa , a type of marine copepods

Acute toxicity test on invertebrate ( Acartia tonsa )

Test cycle Test water Collection date Test result 48h-NOEC % Comment

8 Seawater 2009.02.25 >100 % The death rate was zero in all test concentrations up to the 100% concentration of the secondary treated water.

3 Reproduction toxicity (chronic toxicity) to Nitocra spinipes , a type of marine copepods

Results of the chroni c toxicity test on Nitocra spinipes , a type of marine copepods

Results of reproducible toxicity test (chronic toxicity test) on Nitocra spinipes , a type of marine copepods Test cycle Test water Collection date Test result 14d-NOEC % Comment

3, 4 Brackish

water 2009.01.19 2009.01.26 >100 % No significant effect was seen on reproducibility.

4 Oyster embryo

Table 3.1.5 : Results of the chroni c toxicity test on oyster embryo

5 Acute toxicity to juvenile turbot ( Scophthalmus maximus )

Results of the acute toxicity test on fish

Results of the acute toxicity te st on fish (juvenile turbot)

Test cycle Test water Collection date Test result 96h-NOEC (%) Comment

6 Brackish

water 2009.02.09 >100 % The limit test showed no effect

7 Seawater 2009.02.16 >100 % Th e limit test showed no effect Results of the chronic toxi city test on oyster embryo

Test cycle Test water Collection date Test result 48h-LC 50 (%) Test result 48h-NOEC (%) Comment

3 Brackish

water 2009.01.19 >100 % ≥ 100 % No effect was seen at all concentrations.

7 Seawater 2009.02.16 >100 % ≥ 100 % DittoGESAMP-BWWG 11/6 ANNEX 5 Page 39

I:\MEPC\60\2-12.doc 6 Chronic toxicity to juvenile turbot ( Scophthalmus maximus )

Results of the chronic t oxicity test on fish

Results of the acute toxicity test on fish (juvenile fish) Test cycle Test water Collection date Test result 28d-NOEC (%) Comment

3-6 Brackish

water 2009.01.19 -2009.02.17 >100 % The limit test showed no effect. Lack of weight increase at controlled section.

7-10 Seawater 2009.02.16 -2009.03.17 >100 % The limit test showed no effect.

7 Chronic toxicity on Brachiomus plicatilis using a reproduction test

Results of the chronic toxicity test on marine rotatoria

Reproduction test using marine rotatoria ( Brachiomus plicatilis )(chronic toxicity)

Test cycle Test water Collection date Test result LC 50 (%) Test result NOEC (%) Comment

5 Brackish

water 2009.01.26 >100 % ≥ 100 % No effect was seen at all concentrations.

10 Seawater 2009.03.09 >100 % ≥ 100 % No effect was seen at all concentrations,

The following conclusion was obtained from the results of these toxicity tests:

In the growth inhibitory experiments using Skeletonema costatum , only two out f 11 cases exhibited minor effects as measured utilizing EC 10 . No effects were observed in other organisms and in other test conditi ons. These results demonstrate ballast water after neutralization/reduction treatment in the present system has no effect against aquatic organisms.

* * *GESAMP-BWWG 11/6 ANNEX 5 Page 40

I:\MEPC\60\2-12.doc APPENDIX 2

AQUATIC TOXICITY OF ACTIVE SUBS TANCES, RELEVANT CHEMICALS AND OTHER CHEMICALS

1 ACUTE AQUATIC TOXICITY

1.1 Active Substances - Sodium hypochlorite (main component of TG Ballastcleaner)

Because the sodium hypochlorite (NaC lO) contained in TG Ballastcleaner ® partially forms hypochlorous acid (HClO) in ballast water, the acute toxicity value for the most sensitive species in free chlorine is for the Water flea ( Ceriodaphnia dubia ), which shows LC 50 24 h with a concentration of 0.005 mg/L 1 . The acute toxicity of ma ny life forms is between 0.01 and 0.1 mg/L.

1.2 Other components

1

. 2.1 The other components are so dium hydroxide (NaOH), sodium chloride (NaCl), sodium sulfite (Na 2 SO 3 ) and sodium sulfate (Na 2 SO 4 ). Sodium chloride is th e main component of ballast water (seawater) and as sodium hydroxide exists only in a trace amount, sodium hydroxide does not cause changes in the pH of seawater. Ther efore, these two substances were excluded from the scope of study in this section. Sodium sulfite, which is the main component of TG Environmentalguard ® , and sodium sulfate were cons idered as object substances.

1.2.2 The acute toxicity for aquatic organisms is described as follows: the most sensitive species of aquatic life for sodium sulfite at 16-32 mg/L (as SO 3 -S) are Green algae ( Chlamydomonas reinhardtii ) EC 50 8.9 h, ( Chlorella vulgaris ) EC 50 6.4 h, and ( Scenedesmus basiliensis ) EC 50 8.2 h. On the other hand, the most sensit ive species for sodium sulfate is the aquatic plant Diatom ( Nitzschia linearis ), which showed TLm 120 h = 1,900 mg/L.

1.3 Relevant Chemicals

1

. 3.1 Substances in this summary are limited to ei ght types of Relevant Chemicals detected in the land-based test, among which most sensitive species from the acute toxicity test are described. Other Relevant Chemical s are described in the full text or in appendix 1 (Key Data).

1

. 3.2 Data on the toxity of RC12-bromochloroacetic acid is not available and was substituted by the data of dibromochloroacetic acid which has hi gher toxicity based on the chemical structure.GESAMP-BWWG 11/6 ANNEX 5 Page 41

I:\MEPC\60\2-12.doc Acute toxicity of most sensitive sp ecies for Relevant Chemicals by class

Class Species End point Period Concentration (mg/L) Reference

RC3 Dichlorobromomethane

Other life forms (ciliates) ( Tetrahymena pyriformis ) EC 50 Growth rate 24h 240 Y.Yoshioka et al. (1985)

RC4 Dibromochloromethane

Other organisms (ciliates) Ciliate ( Tetrahymena pyriformis ) EC 50 24h (Growth

rate) 65 Y.Yoshioka et al. (1985) RC5 Bromoform (tribromomethane)

Fish (seawater

acclimation) Sheepshead minnow ( Cyprinodon variegatus ) LC 50 96h 7.1 G.S.Ward et al. (1981)

RC8 Sodium bromate Invertebrate (molluscan) Pacific Oyster (Crassostrea gigas) LC 50 96h >30 E. A. Crecelius

RC12 Bromochloroacetic acid - - - - No data RC15 Monobromoacetic acid

Aquatic plants (algae) Green algae ( Scenedesmus

subspicatus ) E μ C 50 Growth rate 72h 1.4 R. Kuhn et al.

. (1990)

RC16 Dibromoacetic acid

Fish Fathead minnow ( Pimephales promelas ) LC 50 96h 69 M. A. Mayes et al. (1985) RC17 Tribromoacetic acid

Fish Java medaka ( Oryzias javanicus ) LC 50 96h 101 Appendix 13 9

2 Chronic aquatic toxicity

2.1 Active Substances - Sodium hypochlorite

2.1.1 Because the sodium hypochlorite contained in TG Ballastcleaner ® partially forms hypochlorous acid (HClO) in ballast water, the ch ronic toxicity results for the most sensitive species in free chlorine was Cladoceran ( Daphnia magna ), NOEC 14d = 2-4 μg/L. Thus, other genera, not limited to the water flea, showed toxicity values on the order of 10 μg/L.

2.2 Other components

2.2.1 Although a search of the literature was carried out, chronic toxicity values for sodium sulfite and sodium sulfate could not be obtained.GESAMP-BWWG 11/6 ANNEX 5 Page 42

I:\MEPC\60\2-12.doc 2.2.2 Sodium sulfite, which is the main component of TG Environmentalguard ® , changes to sodium sulfate, and the second main compone nt of seawater, in a short period of time (15 minutes: materials were submitted at time of Basic Approval). Therefore, it is judged that no chronic toxicity exists.

2.3 Relevant Chemicals

2.3.1 It was not possible to find chronic toxi city data for RC3-bromodichloromethane, RC4-dibromochloromethane, RC8-bromate ion, RC12-bromochloroacetic acid, and RC17 tricbromoacetic acid. The evaluations of the chronic toxicities of bromodichloromethane and dibromochloromethane were performed usi ng data for bromoform, based its structural relationship with the aforementioned substances.

2.3.2 The chronic toxicity values for bromate ion, bromochloroacetic acid, and tribromoacetic acid were evaluated considering a safety factor in the acute toxicity values.

Chronic toxicity of most sensitive aqua tic life in Relevant Chemicals by class

Class Species End point Period Concentration ( mg/L ) Reference

RC5 Bromoform (tribormomethane)

Fish Sheepshead minnow ( Cyprinodon

variegatus ) NOEC 4d 2.9 P.T. Heitmuller et al. (1981) RC15 Monobromoacetic acid Invertebrate (crustaceans) Water flea (Daphnia magna) NOEC 21d 3.2 R.Kuhn et al. (1989)

3 ENDOCRINE DISRUPTION

3.1 The applicant confirmed that the Active S ubstances, four other chemical substances, and 23 Relevant Substances related to TG Ballastcleaner ® and TG Environmentalguard ® are not included in the Candidate list of 553 substances in the EC report, “Towards the establishment of a priority list of substances for further eval uation of their role in endocrine disruption”.

3.1.1 In submitting this proposal, the applicant also confirmed that there have been no changes in the contents of the above-mentioned report from the time of Basic Approval.

4 SEDIMENT TOXICITY

4.1 For substances which have the potential pr operty of accumulating or adsorbing in large quantity in sediments, toxicity with respect to organisms inhabiting sedime nts will be evaluated.

4.2 As the evaluation standard, Log Kow has been adopted in accordance with the Methodology for information gathering and conduct of work of the GESAMP-BWWG (BMW. 2/Circ.13, 10 June, 2008), by referring Hazardous Substances Data Bank (HSDB), a database of the National Library of Medicine’s TOXNET system ( http://toxnet.nlm.nih.gov/ ) and Syracuse Research Corporation’s database ( http://www.srcinc.com/what-we- do/databaseforms.aspx?id=385 ).GESAMP-BWWG 11/6 ANNEX 5 Page 43

I:\MEPC\60\2-12.doc 5 BIOAVAILABILITY, BIOMAGNIFI CATION, AND BIOCONCENTRATION

5.1 Evaluation criteria are the bioconcentr ation factor (BCF) >2000 obtained in the experiment Methodology (BMW.2/Circ.13, 10 June. 2008).

5.2 Therefore, these values are cited from HS DB and the Syracuse Research Corporation database.

6 FOOD WEB AND POPULATION EFFECTS

Because no data are available, it was evaluated by using the BCF values.

* * *GESAMP-BWWG 11/6 ANNEX 5 Page 44

I:\MEPC\60\2-12.doc APPENDIX 3

MAMMALIAN TOXICITY OF ACTIVE SUBSTANCES, RELEVANT CHEMICALS AND OTHER CHEMICALS

1 ACUTE TOXICITY

1.1 Acute toxicity of Active Substances

Acute toxicity and LD 50 of Active Substances in mammals

Value Species Reference/Comments/Justification for missing data AS Sodium hypochlorite Oral LD 50 (mg/L) 1.23-1.46g/kg 12.5% FAC Rat Proposal for the Health Classification and Labelling of the ESR substance Sodium Hypochlorite,ECBI/14/05 Dermal LD 50 (mg/L) No data Inhalation LC 50 (mg/L/4h) >10.5mg/L air rate 10 L/min Rat IUCLID P.61 (95)

1.2 Acute toxicity of Relevant Chemicals

Acute toxicity and LD50 of bromoform in mammals

Value Species Reference/Comments/Justification for missing data RC5 Bromoform Oral LD 50 (mg/L) 1147 mg/kg Rat female HSDB(2005) Dermal LD 50 (mg/L) No Data Inhalation LC 50 (mg/L/4h) No Data Can be substituted with data for chloroform, which displays high volatility.

2 EFFECTS ON SKIN AND EYE

2.1 Effects of Active Substances on skin and eye

2.1.1 Skin and eye irritation

2.1.1.1 The Group noted that, according to RAR EC (2007), with respect to corrosivity data from animal studies, it has been shown that 12.7% of hypochlorite solu tion produced severely irritant or corrosive effects to the eye. Howeve r, the same concentration applied to rabbit skin does not show corrosive effects, only moderate irritation was observed. Sodium hypochlorite aerosols may be an irritant to the respiratory tract.GESAMP-BWWG 11/6 ANNEX 5 Page 45

I:\MEPC\60\2-12.doc 2.1.2 Skin sensitization

2.1.2.1 Skin sensitization was not found in an anim al test with an 8% hypochlorite solution according to a standard sensitization procedure. There are a few reports on cases of allergic contact dermatitis caused by skin sensitization to the hypochlorite and conclusive agreement has not been reached yet. No skin sensitization of sodium hypochlorite has been proposed based on these collected data.

2.2 Effects of Other Components on skin and eye

2.2.1 Irritation of the skin and eyes by sodium hydroxide is extremely strong.

2.2.2 Regarding irritation of the skin and eyes by sodium sulfite, although based on limited study, the results have shown that this substance is not a strong irritant. Descriptions of the skin sensitization of sodium sulfite we re not found in IUCLID or HSDB.

2.2.3 With sodium sulfate, no irritation was obs erved, even when 500 mg was applied in a rabbit test. Regarding irritation of the eyes, the description states that this chemical causes very slight irritation in cases where it actually pene trates the eyes, but the affected part recovers. Although no direct data were availa ble for sensitization by sodium su lfate, as noted in the table, OECD SIDS has rejected the possibility that sodium sulfate causes increased sensitization.

2.3 Effects of Relevant Chemicals on skin and eye

Effects of bromoform on skin and eye

Species Method Results (including scores where available) Reference/Comments/ Justification for missing data RC5 Bromoform Skin Rabbit Single doses of 2, 000mg/kg under a cuff on the intact skin of rabbits were survived by two rabbits treated with undiluted bromoform. HSDB(2005)

Eye Rabbit The undiluted liquid was moderately irritating to rabbit eyes. Healing appeared complete in 1 to 2 days. HSDB(2005)

3 REPEATED DOSE TOXICITY TESTS

3.1 Repeated dose toxicity of Active Substances

Repeated dose toxicity of the Active Substances in mammals was not available in the data listed in NOAEL.GESAMP-BWWG 11/6 ANNEX 5 Page 46

I:\MEPC\60\2-12.doc 3.2 Repeated dose toxici ty of Relevant Chemicals

Repeated dose of RC3-Dichlorobromomethane

Exposure Route Oral administration Exposure Duration 102 weeks Exposure dose 0, 25, or 50 mg/kg/d Species 50 male B6C3F1 mice

Method Gavage

Results renal cytomegaly in male mice, an effect considered minimal in the absence of data demonstrating renal functional impairment

NOAEL 1.79 mg/kg/d = LOAEL 17.9 mg/kg/d (25 mg/kg/d x 5 days/7 days) x 0.1 NOEL No description Reference/Comments/ Justification for missing data EPA IRIS (2008)

Repeated dose of RC4-Dibromochloromethane

Exposure Route Oral administration Exposure Duration 13 weeks Exposure dose 0, 15, 30, 60, 125, or 250 mg/kg Species Fischer-344 rats and B6C3F1 mice

Method Fischer-344 rats and B6C3F1 mice were administered 0, 15, 30, 60, 125, or 250 mg/kg chlorodibromomethane for 13 weeks by gavage. Results A Fisher Exact test showed that incide nces of these liver lesions at doses of 60 mg/kg/d or above were elevated relative to the vehicle controls, thus 30 mg/kg/d is the NOEL. NOAEL 21.4mg/kg/d

NOEL No description

Reference/Comments/ Justification for missing data EPA IRIS (2008)

Repeated dose of RC5-Bromoform

Exposure Route Oral Exposure Duration 13w Exposure dose 0, 12, 25, 50, 100, 200 mg/kg/d (5 days/week) Species Rat Method Gavage Bioassy Results Hepatocellular vacuolization was observed in most male rats (10/l0 at 200 mg/kg, 8/10 at 100 mg/kg, 8/10 at 50 mg/kg, 5/10 at 25 mg/kg, 6/10 at 12 mg/kg, and 3/10 vehicle controls). NOAEL 17.9mg/kg/d (converted from 25mg/kg/d) NOEL No description Reference/Comments/ Justification for missing data EPA IRIS (2008)GESAMP-BWWG 11/6 ANNEX 5 Page 47

I:\MEPC\60\2-12.doc Repeated dose of RC16-Dibromoacetic acid

Exposure Route Oral (Gavage) Exposure Duration 2 to 79days Exposure dose No description Species Rats Method Rats were gavaged daily for 2 to 79 d with a by-product of water disinfection, dibromoacetic acid (DBAA). Results No abnormalities were detected at the dosage of 2 mg/kg. The changes suggest that the testicular effects of DBAA are sequel ae to structural and/or functional changes in the Sertoli cell. NOAEL 2mg/kg/d NOEL No description Reference/Comments/ Justification for missing data HSDB(2009)

4 CHRONIC TOXICITY

4.1 Chronic toxicity of Active Substances

Chronic toxicity of AS-Sodium hypochlorite

Exposure Route Oral Exposure Duration 2 years Exposure dose 0, 70, 140, 275 mg/L Species F344 rats

Method Drinking water

Results No effects seen at 14 and 66 weeks.

NOAEL 14.4mg/kg/d

NOEL No description
Reference/Comments/ Justification for missing data Proposal for the Health Classification and Labelling of the ESR substance Sodium Hypochlorite,ECBI/14/05

4.2 Chronic toxicity of Relevant Chemicals

Chronic toxicity of RC8-Bromate ion

Exposure Route Oral Exposure Duration 100 weeks Exposure dose 0, 1.1, 6.1, 12.9, and 28.7 mg BrO 3 - /kg/d Species F344 rat male Method Drinking water Results Nonneoplastic kidney lesions were observed in rats. Although the severity of chronic nephropathy was comparable between control and treated rats, there was a signific ant dose-dependent increase in the incidence of urothelial hyperplasia in rats in dose groups of 6.1 mg/kg-d and higher. NOAEL 1.1 mg BrO 3 - /kg/d (converted from 1.5 mg KBrO 3 /kg/d) NOEL No description Reference/Comments/ Justification for missing data EPA IRIS (2001)GESAMP-BWWG 11/6 ANNEX 5 Page 48

I:\MEPC\60\2-12.doc 5 DEVELOPMENTAL AND REPR ODUCTIVE TOXICITY

5.1 Developmental and reproductive toxicity of Ac tive Substances

Data on developmental and reprodu ctive toxicity of sodium hypochl orite is limited, but there is no direct evidence to indicate the adverse effect of sodium hypochlorite on development and reproduction. Similarly, there is no evidence of adverse effect in an epidemiological study on people drinking chlorinated water. These studies indicate sodium hypoc hlorite should not be classified into the substances adversely affecting reproduction.

5.2 Developmental and reproductive toxicity of Re levant Chemicals

Developmental and reproductive toxicity of RC5-bromoform

Exposure Route Injection Exposure Duration 10 days Exposure dose 100-200 mg/kg/d Species Guinea pig Method Injection of 100-200 mg/kg/d to Guinea pig for 10 days Results Pathological change in kidney and liver NOAEL No description NOEL No description Reference/Comments/ Justification for missing data HSDB (2005)

6 CARCINOGENICITY

6.1 Carcinogenicity of Active Substances

In a study on carcinogenicity of the drinking wate r in rats and mice, ther e was no evidence to demonstrate the incidence of tumor increase by Ac tive Substances. Available data do not indicate that sodium hypochlorite has to be classified as carcinogenic. International Agency for Research on Cancer (IARC) presumes sodium hypochlorite belongs to Group 3 (not classifiable as carcinogenic to human). Sodium hypochlorit e is therefore not tr eated as carcinogenic.

6.2 Carcinogenicity of Relevant Chemicals

Carcinogenicity of RC5-Bromoform

Species Method Details Results Reference/Comments/ Justification for

missing data

F344/N

rats 2 year gavage studies There was no evidence of carcinogenic activity for male B6C3F1 mice given 50 or 100 mg/kg bromoform or for female B6C3F1 mice given 100 or 200 mg/kg; male mice might have been able to tolerate a higher dose. Survival of female mice was reduced, partly due to a utero-ovarian infection HSDB(2005)GESAMP-BWWG 11/6 ANNEX 5 Page 49

I:\MEPC\60\2-12.doc 7 MUTAGENICITY AND GENOTOXICITY

7.1 Mutagenicity and genotoxi city of Active Substances

7.1.1 There was some data indica ting in vitro mutagenic activity of sodium hypochlorite, but a detailed in vivo study using mice indicates this substanc e has no mutagenic activity (Hayashi et al.

, 1988). Other in vivo study also showed no mutagenic effect of this substance. These data related to genetic toxicity of sodium hypochlorite did no t indicate the final conc lusion, but further data would not be required based on no effects on car cinogenicity. Data obtained indicate sodium hypochlorite does not exhibit mutagenic ity so that this substance is not classified as mutagenic.

7.2 Mutagenicity and genotoxi city of Relevant Chemicals

Mutagenicity and genotoxicity of bromoform

Species Method Details Results Reference/ Comments/ Justification for

missing dataAroclorinduced rat liver S9 fraction Based on preliminary bacterial toxicity determinations, bromoform was evaluated for mutagenicity at concentrations of 5, 10, 50, 100, 500, and 1000 ug/plate using the direct plate incorporation method. The mutagenicity of bromoform was also tested for mutagenicity in Salmonella tester strains TA98, TA100 and TA1535, both with and without metabolic activation at dose levels of 0.02, 0.05, 0.1, and 0.2 ml/dessicator. In this study, bromoform caused a reproducible positive response in all three strains. HSDB(2005)

8 TOXICOKINETICS

8.1 Toxicokinetics of Active Substances

No data existed.

8.2 Toxicokinetics of Relevant Chemicals

Toxicokinetics of RC5-Bromoform

Species Observation/Remarks Reference/ Comments/ Justification for

missing data No description Bromoform metabolized to carbon monoxide by hepatic microsomal mixed function oxidases. HSDB(2005)

***GESAMP-BWWG 11/6

I:\MEPC\60\2-12.doc ANNEX 6

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

Sunrui Ballast Water Management System

Submitted by China for Basic Approval

0 SUMMARY

0.1 Having reviewed all of the data provided by the applicant, the Group recommended that the Sunrui Ballast Water Management Syst em (BWMS) be granted Basic Approval.

0.2 Notwithstanding this recommendation, the Gro up recognized that th e risk to general public (HES via seafood consumption) was ade quately assessed by using EUSES model 2.1. However, the HES for the general public via aggr egated exposure (oral, skin and inhalation) when bathing in the areas close to the disc harged ballast water had not been provided by the applicant.

0.3 The Group also noted that the applicant did not provid e information regarding the identification and description of the unit operations associated with this system. The Group also noted that information regarding the Human Expo sure Scenario (MEPC 56/2/2, annex 9) had not been provided. The Group proposed that this information should be fully supported and documented so that it can be taken into account if the system has to be reviewed for Final Approval.

0.4 The Group concluded that based on the risk assessment performed for the environment, it is not expected that the Sunrui BWMS woul d cause unacceptable risks for the environment.

0.5 However, the Group considered that the syst em should not cause any unacceptable risk to the crew or the general public provided that th e standard risk mitigation measures are applied.

0.6 Furthermore, the Group recommended that the risks to the general public during recreational activities (s wimming) should be assessed for c onsideration during Final Approval consideration.

0.7 In addition the Group recommended that the co mprehensive corrosion testing referred to in paragraph 9.6 should be addressed prior to application for Final Approval review.

1 INTRODUCTION

1.1 Data used to evaluate this system we re extracted from MEPC 60/2/3 and were supplemented by additional info rmation provided to the Group.GESAMP-BWWG 11/6 ANNEX 6 Page 2

I:\MEPC\60\2-12.doc 2 DESCRIPTION OF THE SYSTEM

2.1 The Group noted that the Sunrui system comprised:

.1 a filtration process using 50 μ m filter;

.2 electrolyzing seawater to pr oduce disinfection at intake; and

.3 a neutralization system to offset the residual TRO to the level below 0.1 mg/L when de-ballasting.

2.2 The Group noted that, following filtration, a side stream from the ballast line of seawater is subjected to electrolysis whic h generates a solution of sodium hypochlorite. This side stream is then injected back into the main ba llast stream following a de-gassing process.

2.3 It was noted that the TR O level is measured and th e concentration maintained between 8.0 mg/L and 9.5 mg/L by controlling the cu rrent according to the ballast water uptake flow rate and the Group ev aluated this applicatio n based on these levels.

2.4 It was also noted that the applicant stated that , if the salinity of the intake ballast water is below 3 PSU, then salt would be needed to be a dded to the water being subject to electrolysis.

2.5 Schematic representation of the ballasting a nd de-ballasting processes, as provided by the applicant, are shown below:

Schematic representation of the ballasting procedure

Filter Ballast tank Electrolysis

Ballast

water u p take

Ballast

water side stream

NeutralizerGESAMP-BWWG 11/6 ANNEX 6 Page 3

I:\MEPC\60\2-12.doc 2.6 The Group noted the following chemical reac tions which take place as part of the electrolysis process:

Anode: 2Cl - → Cl 2 + 2e

Cathode: 2H 2 O + 2e → 2OH - + H 2 ↑

Chlorine gas can be dissolved in water to produce hypochlorous acid and hydrochloric acid rapidly:

Cl 2 + H 2 O → HOCl + Cl - + H -

So the overall reaction is:

NaCl + H 2 O → NaOCl + H 2 ↑

Hypochlorous acid is a weak acid, which means that it tends to undergo partial dissociation as follows:

HOCl ⇋ H + + OCl -

to produce a hydrogen ion and a hypochlorite ion. In water of pH between 6.5 and 8.5 the reaction is incomplete and both species are pres ent to some degree. The extent of this reaction can be calculated from the equation:

K i = ) ( )

).( (

HOCl OCl H − +

where K i is the ionization constant, varies in magnitude with temperature. The value of the constant ranges from 1.488x10 -8 mole/L at 0 °C to 3.175 x10 -8

mole/L at 30 °C

.

Hypochlorous acid is the most germicidal of all chlorine compounds with the possible exception of chlorine dioxide. Undissociate d HOCl species is a func tion of pH value and temperature.

2.7 In addition to the normal chemical reacti ons, which take place between salt and water under electrolysis, the Group also noted the chemi cal reactions involving bromine and ammonia, as shown below:

Normally, natural seawater contains bromine ions with a density of 50~70 mg/L. The oxidation reaction between hypochlorous ac id and bromine ions will produce hypobromous acid:

HOCl + Br - → HOBr + Cl -GESAMP-BWWG 11/6 ANNEX 6 Page 4

I:\MEPC\60\2-12.doc Hypobromous acid will dissociate, as does hypochlorous acid depending upon pH, temperature and ionic strength as follows:

K = ) ( ) ( ). (

HOBr OBr H − +

Where K = 2 x 10 -9 at 20 °C

Hypobromous acid is also an effective biocid e more stable than chlorine under alkaline seawater. It is calculated th at at pH 8, the undissociated HOBr is 83 percent versus HOCl of only 28 percent.

In addition, the reaction of hypochlorous ac id and hypobromous acid with ammonia in seawater generate chloramines, including m onochloramine, dichloramine, trichloramine and bromamines (including monobromamine, di bromamine, tribromamine). The reaction equations for generating chloramines are as follows:

HOCl + NH 3 ⎯→

⎯ NH 2 Cl ( monochloramine ) + H 2 O

NH 2 Cl + HOCl ⎯→

⎯ NHCl 2 ( dichloramine ) + H 2 O

NHCl 2 + HOCl ⎯→

⎯ NCl 3 ( trichloramine ) + H 2 O

Chloramines and bromamines are also germicidal agents, and it is generally considered that their bactericidal actions are much weaker than those of HClO/ClO and HOBr/OBr -

. However, recent studies indica ted that if chloramines are allowed contact time of 45–60 minutes they are able to match the efficien cy of free chlorine based upon the destruction of coliform organisms.

In this document, the substances with bactericidal action mentioned above are HClO/ClO

- /Cl 2 , HOBr/OBr - /Br 2 , chloramines and bromamines, which are called by a joint name Total Residual Oxidants (TRO).

3 CHEMICALS ASSOCIATED WITH THE SYSTEM

3.1 The Group noted that the applicant had id entified the following chemical as Active Substance, Relevant Chemicals or Other Chemicals:

Chemicals CAS No. Molecular weight Formula AS/ RC/ OC (bio)degradation rate or half-life

Hypochlorous acid /hypochlorite 7681-52-9 74.44 NaOCl AS 1.4 hour (at pH 8) Hypobromous acid /hypobromite 13824-96-9 118.89 NaOBr AS Biodegrades fast

Chloramines/ Bromamines Not available 51.48 NH 2 Cl AS 9 to 420 hours (as monochloramine)GESAMP-BWWG 11/6 ANNEX 6 Page 5

I:\MEPC\60\2-12.doc Chemicals CAS No. Molecular weight Formula AS/ RC/ OC (bio)degradation rate or half-life

Dibromochloromethane 124-48-1 208.28 CHBr 2 Cl RC Water: 38 days Soil: 75 days Sediment: 340 days Air: 280 days Tribromomethane 75-25-2 252.73 CHBr 3 RC 1.7 years (Fresh water, at an aqueous concentration of 1X10 -17 mole/l hydroxyl radicals) Monobromoacetic acid 79-08-3 167.01 CH 2 BrCOOH RC Half-life: Water: 8.7 days Soil: 17 days Sediment: 78 days Air: 22 days

Bromochloroacetic acid 5589-96-8 138. 95 CHBrClCOOH RC Half-life: Water: 15 days Soil: 30 days Sediment: 140 days Air: 24 days

Dibromoacetic acid 631-64-1 217.86 CHBr 2 COOH RC Half-life: Water: 15 days Soil: 30 days Sediment: 140 days Air: 25 days Dibromochloroacetic acid 5278-95-5 252.36 CClBr 2 COOH RC No data available

Tribromoacetic acid 75-96-7 296.74 CBr 3 COOH RC Half-life: Water: 15 days Soil: 30 days Sediment: 140 days Air: 31 days

Dibromoacetonitrile 3252-43-5 198.86 CHBr 2 CN RC Half-life: Water: 38 days Soil: 75 days Sediment: 340 days Air: 540 days

Bromate 7758-01-2 167.01 KBrO 3 RC Half-life: Seawater: 12 hours Sodium thiosulfite 7772-98-7 158.09 Na 2 S 2 O 3 OC Biodegrades fast

3.2 In addition to the above chemicals, the Group noted that other chemicals are produced by this system including:

.1 hydrogen gas;

.2 oxygen gas;GESAMP-BWWG 11/6 ANNEX 6 Page 6

I:\MEPC\60\2-12.doc .3 hydrogen peroxide; and

.4 ozone.

3.3 However, the Group recognized that bot h hydrogen and oxygen were removed by a degassing process immediately following electrolys is and that hydrogen per oxide and ozone have short half-lives and so need not be cons idered in the risk assessment process.

3.4 Data, supplied by the applicant on those chemi cals shown in the above table are shown in appendices as indicated below:

.1 appendix 1 – Aquatic toxicity data;

.2 appendix 2 – Mammalian toxicity data;

.3 appendix 3 – Environmental fate data;

.4 appendix 4 – Physical and chemical properties data; and

.5 appendix 5 – Chemical analysis of untreated and treated water.

4 QUESTIONS SENT TO APPLICANT DURING EVALUATION WITH ANSWERS AND REACTIONS OF THE GROUP

Question 1:

The Group would like to be clarified in what concerns the application of EUSES 2.1 model to assess human risk – genera l public exposed via environmen t (oral intake of fish)? Therefore, we would like to know what were the assumptions made and the calculations performed by the applicant to set the input parameters fo r exposure assessment/effects assessment/risk characterization process (M RR). We would appreciate that a worst case scenario could be used to illustrate the reasoning.

Response 1:

.1 In assessing human risk – general public exposed via environment (oral intake of fish) by EUSES 2.1 model – it was assume d that when the ballast water is discharged into a port, the chemicals in th e ballast water may accumulate in fishes and affect the health of the people who consume the fishes.

.2 In the application of EUSES 2.1 model, the “man exposed via the environment” and the “local scale” mode was used. And the physico-chemi cal parameters and environmental data are from key data summaries or MAMPEC model calculation. Regarding the input parameters, please refe r to the “Data sheet of EUSES for risk assessment” in appendix 8 in folder 4 of the confidential application dossier.GESAMP-BWWG 11/6 ANNEX 6 Page 7

I:\MEPC\60\2-12.doc .3 The concentrations of the chemicals in fishes were calculated by the equation C fish =BCF fish ·C water , C water is the PEC, which was cal culated by MAMPEC model. Then the human total intake exposure dose (DOSE local ) was calculated, and the MOS man-env was work out by following equation:

MOS man-env = Effects / Exposure= NOAEL/DOSE local

.4 The worst case scenario has been used in the calculation and assessment. The MRR was calculated by the following equation: MRR=MOS man-env /MOS ref ., and according to the worst case scenario, the largest MOS ref value was used to calculate MRR, the smallest MRR value was used to assesse human risk- general public exposed via enviroment (oral intake of fish).

Reaction: The Group was satisfied with the response.

Question 2:

It is noted that the submission informs that in the case of water salinity below 3 psu, salt needs to be added. Please give details, otherw ise, if the required component for addition of salt to the side stream electrolysis line has not been developed yet, is this to be furthered prior to Final Approval?

Response 2:

.1 As for ballasting in water with salinity below 3 PSU, to add salt is one option that is under consideration. It has been noted that a number of similar systems have proposed to add salt when fresh water needs to be treated and this option has been endorsed by the Group.

.2 The other option, as we recommended in our application (see second paragraph of section 2.5 of the confidential application report), might be that if a ship has to ballast in fresh water areas, i.e. sea outfall of fresh water river, the ship in question may retain a certain amount of seawater in the ballast tanks from previous voyage (about 1%~2% of the ballast water needed for the voyage), which can be used as the electrolytic water. We think this method would be more economical and easy in operation.

.3 Investigation and further testing with regard to the above-mentioned two options are undergoing and the results and findings will be provided to the Group when applying for Final Approval.

Reaction: The Group was satisfied with the response.GESAMP-BWWG 11/6 ANNEX 6 Page 8

I:\MEPC\60\2-12.doc Question 3:

The Group needs further explanation about “s ig. of ANOVA” on the bottom of the Tables on pages 13 to 18 at appendix 4–3 to eval uate the results of toxicity test.

Response 3:

.1 “Sig. of ANOVA” means the significan ce of difference be tween every group include treatments and control, using one-w ay analysis of vari ance, the method of analysis of variance.

Reaction: The Group noted the response of the applicant.

5 HUMAN HEALTH ASSESSMENT

5.1 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 corrosive at concentrations above 10%*; and

.2 irritant to skin and eyes at concentrations from 5-10% *

.

Note: * The classification according to GHS (CLP, 1272/2008/EC, in Europe) will change the current cl assification of sodium hypochlorite. According to CLP concentrations ≥ 5 % will lead to a classification as Skin Corrosive Category 1B (H314; Causes seve re skin burns and eye damage). The specific concentration limits (5% ≤ conc < 10% and conc ≥ 10%) have been removed from the harmonised classi fication and are no longer applicable.

.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 are:

.1 acutely toxic if swallowed;

.2 acutely toxic if inhaled;

.3 acutely toxic in contact with skin; and

.4 corrosive to skin.GESAMP-BWWG 11/6 ANNEX 6 Page 9

I:\MEPC\60\2-12.doc 5.2 The Group noted that the applicant consider ed the Human Exposure Scenario (HES) via seafood consumption to be the relevant scen ario for general public risk assessment.

5.3 However, the Group noted that the risks associated with such chemicals had been evaluated using EUSES (version 2.1) the results, of which, showed a MOS/MOS ref of >1 for the general population in local and regional areas. Results from EUSES are shown in the table below which are different from those shown in MEPC 60/2/3 and were corrected following discussion with the applicant a nd, were corrected due to the wrong units for Henry’s constant being used by the applicant:

MRR (MOS/MOS ref ) values

Chemical Name PEC, μg /l BCFfish,

m 3 /kgwwt Cfish, mg/kg MRR

Tribromomethane 1.06E+00 14.00 1.48E-02 7.36E+03 Dibromochloromethane 2.41E-02 1.47 3.54E-05 1.89E+05 Bromoacetic acid 3.03E-02 3.20 9.70E-05 3.14E+05 Dibromoacetic acid 7.03E-01 0.17 1.20E-04 4.76E+05 Tribromoacetic acid 3.81E-01 0.63 2.40E-04 1.01E+05 Bromochloroacetic acid 1.96E-01 3.20 6.27E-04 1.94E+04 Dibromochloroacetic acid 4.94E-02 3.16 1.56E-04 2.93E+05 Dibromoacetonitrile 1.01E-01 3.00 3.03E-04 1.99E+03 Sodium thiosulfite 7.89E+00 3.16 2.49E-02 1.34E+04

5.4 The Group tentatively assessed the risk to th e crew by using the HES – crew entering the ballast tank as a worst case scenario. Th e risk was found to be acceptable taking into consideration the concentration of tribromomethan e (as being the critical relevant chemical in terms of human health risk) in the head space of the ballast ta nk and by comparing it with the OEL set for this substance.

5.5 The Group noted that the applicant considered that the only chem ical substance being handled and mixed by crew is sodium thiosulfate. Th e applicant stated that it is required that the operators should wear protective gl oves, clean body-covering clothi ng and safety glasses. Safety procedure for handling of sodium thiosulfate is detailed in Technical Specification and Manual, in appendix 9 of the full application dossier.

5.6 However, the Group noted that the applicant had not provided information regarding the identification and description of the unit operations associated with this system. Also, the Group noted that information regarding the Human Expo sure Scenario (MEPC 56/2/2, annex 9) had not been provided. The Group proposed that this information should be fully supported and documented so that it can be taken into account if the system is to be reviewed for Final Approval.GESAMP-BWWG 11/6 ANNEX 6 Page 10

I:\MEPC\60\2-12.doc 6 EVALUATION OF TR EATED BALLAST WATER

6.1 The Group noted that the applicant had carried out the following aquatic toxicity tests with the results shown below:

Type Organism Test Result

A Skeleonema costatum Acute and Chronic 96 h Growth Inhibition (static condition) NOAEC > 100%

Neomysis awatschenis Acute 96 h mortalities (static condition) NOEC > 100% LOEC > 100%

C

Neomysis awatschenis Chronic 7 d mortalities (semistatic condition renewal all volume everyday) NOEC > 100% LOEC > 100%

Ctenogobius gymnauchen Acute 96h mortalities (static condition) NOEC > 100% LOEC > 100%

F

Ctenogobius gymnauchen Chronic 7d mortalities (semistatic condition, renewal 85%-90% volume everyday) NOEC > 100% LOEC > 100%

6.2 The Group noted that this WET testing used the simulated ballast water with 48 h tank holding time and the neutralization process after this holding time.

6.3 The Group noted that the results of these testing show that all the ecotoxicity of discharged ballast water is in the range of acceptable level.

7 RISKS TO THE SAFETY OF THE SHIP

7.1 Flooding

7.1.1 The Group noted that the system is designed to shut down automatically in the event of any failure.

7.2 Corrosion

7.2.1 The Group noted that the applicant cites corro sivity evaluations for ballast water treated by electrolysis which were repor ted by previous applicants and concluded that no significant increase in corrosion compared to natural seawater would result, and even less in some cases. In particular, the applicant noted that doc ument MEPC 58/2/7, (GESAMP-BWWG 6, annex 7, paragraph 4.7.2) indicated an el ectrolysis system with an initial TRO concentration up to 10 mg/L did not have increased corrosion eff ect. However, the Group does not agree with the applicant’s inference as the full consider ation and recommendations of the Group in these citations was not accounted for by the applicant. In all cases, and specifically in MEPC 58/2/7, (GESAMP-BWWG 6, annex 7, paragraph 4.7.4), the Group considered these conclusions to be insufficient and in conflict with published litera ture discussing the increased corrosion rates of steel in seawater with a TRO concentration >2 mg/L.GESAMP-BWWG 11/6 ANNEX 6 Page 11

I:\MEPC\60\2-12.doc 7.2.2 The Group recommended that the comprehensiv e testing be conducted in accordance with the guidance provided in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG” contained in MEPC 59/2/16. Where intermitte nt exposures are utilized to predict long-term corrosion rates, as proposed by th e applicant, the TRO in the sample containers should be recorded and reported over the peri od of the exposure. In addition, the Group recommended that some indication, with supporting data, of the long-term corrosion rates under a constant level of TRO at the maximum allowable dosage concentr ation should be provided to assess the potential impact on exposed ship systems more realistically.

7.3 Hydrogen and Chlorine gases

7.3.1 It was noted that hydrogen is generate d during electrolysis and at 9.5 mg/L TRO as Cl 2 133.8 mols (267.6 g) of hydrogen gas is gene rated when treating 1000 tons of ballast

water.

7.3.2 However, it was also noted that the hydrogen gas is separated from the water in a degas tank and diluted, by air blowers, to a level belo w the Lower Explosive Level (LEL) after which it is vented overboard. There is a spark arrestor fitted to the discharge end of the vent pipe.

7.3.3 It was also noted that the level of hydrogen gas in the air discharge from the degas unit was monitored and, should unsafe levels of hydrogen concentration arise, then the system is shut down.

7.3.4 The Group noted that, during te sts, no chlorine gas had been detected in the area around the electrolytic unit and the chlorine gas concentr ations in the headspace of the tank holding the treated ballast water were <0.3 mg/L.

7.3.5 It was also noted that the system had both chlorine gas and hydrogen gas sensors to be arranged in the spaces containing the treatment system to detect any leakage and alarms are triggered when the concentration of hydrogen ex ceeds 2% or the concentration of chlorine exceeds 0.4 mg/L. Furthermore, if levels dete cted exceed 3% or 0.55 mg/L respectively, the electrolytic units will be shut down automaticall y. The Group consequently considered that the risk mitigation measures to be put in place in this regard as sufficient to permit further development of this system.

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

Chemical Persistenc (Y/N) Bioaccumulation (Y/N) Toxicity (Y/N) HOCl(NaClO) No Half-life:1.4 hour (at pH 8) No BCF: -2.19 Log Pow: -3.42 Yes 134 d NOEC:0.005 mg/L/

HOBr(NaBrO) No Biodegrades fast No BCF: 1.24 Log Pow: -1.03 N. A.

Monochloramine No Abiotic Degradation: Chloramine half-lives ranging from 9 to 420 hours N. A. N. A.GESAMP-BWWG 11/6 ANNEX 6 Page 12

I:\MEPC\60\2-12.doc Chemical Persistenc (Y/N) Bioaccumulation (Y/N) Toxicity (Y/N) Tribromomethane Yes Fresh water, Half-life: 1.7 years (at an aqueous concentration of 1X10 -17 mole/l hydroxyl radicals) No BCF: 14 Log Pow: 2.4 No 28 d NOEC: 4.8 mg/L

Dibromochloro methane Yes Half-life: Water: 38 days

Soil: 75 days Sediment: 340 days Air: 280 days No BCF: 0.74-1.47 L/kg Log Pow: 2.24 No 21 d NOEC: 3.2mg/L

Bromoacetic acid No Half-life: Water: 8.7 days

Soil: 17 days Sediment: 78 days Air: 22 days No BCF: 3.2 Log Pow: 0.41 No 21 d NOEC: 1.6 mg/L

Dibromoacetic acid No Half-life: Water: 15 days

Soil: 30 days Sediment: 140 days Air: 25 days No BCF: 0.17 Log Pow: 0.70 No PBT Profiler

Tribromoacetic acid No Half-life: Water: 15 days

Soil: 30 days Sediment: 140 days Air: 31 days No BCF: 0.63 Log Pow: 1.71 No PBT Profiler

Bromochloro acetic acid No Hal- life: Water: 15 days

Soil: 30 days Sediment: 140 days Air: 24 days No BCF: 3.2 Log Pow: 0.61 No PBT Profiler

Dibromochloro acetic acid No Activated sludge: 100%(aerobic), 28 days No Log Pow: 1.62 N. A.

Dibromoacetonitrile No Half-life: Water: 38 days

Soil: 75 days Sediment: 340 days Air: 540 days No BCF: 3 Log Pow: 0.47 No PBT Profiler

Bromate No Half-life: Seawater: 12 hours No BCF: 3.7×10 -7 Log Pow: -7.18 No 7 d NOEC:8 mg/L

Sodium thiosulfite No Biodegrades fast No BCF: 3.162 Log Pow: -4.53 No 18 m NOEC:600mg/L

8.1.1 The value of 134 d NOEC of 0.005 mg/L, in the table above, should possibly be substituted by a NOEC of 0.003 mg/L (Cairns 1990 in table 4-2 in MEPC 60/2/3) based on TRC measurement. However, the Group decided not to pursue this since it has no practical consequence for the PBT classificatio n or the PEC/PNEC calculations.GESAMP-BWWG 11/6 ANNEX 6 Page 13

I:\MEPC\60\2-12.doc 8.1.2 The Group agreed with the applicant that none of the above chemicals are classified as PBT substances

8.2 Calculation of Predicted En vironmental Concentration (PEC)

8.2.1 The Group noted that the applicant had used the MAMPEC m odel (version 2.0) to calculate the PEC for chemicals employing:

.1 the OECD-EU commercial harbour;

.2 the physico-chemical properties for each chemical as shown in the appendices (assuming that the chemicals w ill not decay in the water);

.3 the concentrations of each chemical an alysed in the treated ballast water; and

.4 and a ballast water discharge rate of 100,000 m 3 /day.

8.2.2 The results are shown in the table below:

Chemicals Background conc

μ g/L BW Concentration

μ g/L Max PEC

μ g/L HOCl(NaOCl) 0 0 0

HOBr(NaOBr) 0 0 0

Chloramine 0 0 0

Tribromomethane 0.19 157.98 1.06E+00

Dibromochloromethane 0 4.32 2.41E-02 Monobromoacetic acid 0 3.31 3.03E-02 Dibromoacetic acid 0.52 19.98 7.03E-01 Tribromoacetic acid 0 41.63 3.81E-01 Bromochloroacetic acid 0.19 0.61 1.96E-01 Dibromochloroacetic acid 0 5.4 4.94E-02 Dibromoacetonitrile 0 11.09 1.01E-01
Bromate 0 0 0 Sodium thiosulphite 0 862 7.89E+00

Note : The above table shows results corrected after consu ltation with the applicant. The original results, reported in MEPC 60/2/3 were calculated using the wrong Henry’s Law Constant.

8.2.3 The Group concurred with the applicant, ha ving used the MAMPEC model to achieve the Predicted Environmental Concentrations (PECs), th at the resulting concentrations in the scenario defined by the applicant would not result in any unacceptable risks for the environment.GESAMP-BWWG 11/6 ANNEX 6 Page 14

I:\MEPC\60\2-12.doc 8.3 Calculation of PEC/PNEC ratios

8.3.1 The Group agreed with the ap plicant’s assessment of PEC/ PNEC ratios, after correction from the original results shown in MEPC 60/2/3 as shown below:

Chemical name Toxicity (mg/L) Information factor PNEC (μg/L) PEC (μg/L) PEC/PNEC

HOCl(NaOCl) 0.003 Lowest L(E)C50 from a fish, crustacean and alga and lowest NOEC from a algae, crustaceans and fish 100 0.03 0

Chloramine 0.012 Lowest LC50 from a fish and

crustacean 1000 0.012 0

Tribromomethane 4.8 Lowest L(E)C50 from a fish, crustacean and alga and Lowest NOEC from a algae and fish 100 48 1.06 0.02

Dibromochloromethane 3.2 Lowest L(E)C50 from a fish, crustacean and alga and Lowest NOEC from fish 100 32 .0241 0.0008

Monobromoacetic acid 0.2 Lowest L(E)C50 from a crustacean and alga and Lowest NOEC from

crustacean 1000 0.2 .0303 0.15

Dibromoacetic acid 6.9 Lowest LC50 from a fish 1000 6.9 .703 0.1

Tribromoacetic acid 6.9 PNEC was assumed to be the same value as that for dibromoacetic acid 1000 6.9 .381 0.06

Bromochloroacetic acid 6.9 PNEC was assumed to be the same value as that for dibromoacetic acid 1000 6.9 .196 0.03

Dibromochloroacetic acid 6.9 PNEC was assumed to be the same value as that for dibromoacetic acid 1000 6.9 .0494 0.007

Dibromoacetonitrile 0.55 Lowest L(E)C50 from a fish, crustacean and alga 1000 0.55 .102 0.18

Bromate 8 Lowest L(E)C50 from a fish, crustacean and alga and Lowest NOEC from fish and alga 100 80 0

Sodium thiosulphate 64 Lowest L(E)C50 from a fish and alga and Lowest NOEC from fish 1000 64 7.62 0.1

8.3.2 The Group agreed with the applicant that, as all of the above PEC/PNEC ratios were <1, the system has a low potential risk for the aquatic environment.

8.4 Effects on sediment

8.4.1 The Group concurred with the applicant th at, as the Koc values for the Relevant Chemicals were all <500 L/kg, thes e products would not readily part ition into the sediment and so are not likely to be a signifi cant risk to benthic organisms.GESAMP-BWWG 11/6 ANNEX 6 Page 15

I:\MEPC\60\2-12.doc 8.5 Estimation of Risks to the Environment

8.5.1 Based on the PEC/PNEC ratios and the PBT properties of those ch emicals associated with the system, the Group agreed that this sy stem should not present any undue risks to the environment.

8.5.2 This view was supported by th e results of the W hole Effluent Testing (WET) where no ecotoxicological effects were seen in 100% treated ballast water in both acute and chronic tests.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Based on the PEC/PNEC ratios and the PBT properties of those ch emicals associated with the system, the Group agreed that this system did not present any undue risks to the environment.

9.2 This view was supported by th e results of the W hole Effluent Testing (WET) where no ecotoxicological effects were seen in treated ballast water in both acu te and chronic tests.

9.3 The Group also agreed that the Sunrui Ballast Water Ma nagement System should not cause any unacceptable risks to the crew, the ge neral public (HES via seafood consumption) or the safety of the ship, providing that sta ndard risk mitigation measures are applied.

9.4 The Group recommended that the HES general public via aggregated exposure (oral, skin and inhalation) when bathing in the areas clos e to the discharged ballast water should be provided by the applicant if the system is to be reviewed for Final Approval. The applicant should also identify and describe the unit operations associated wi th this system and information regarding the Human Exposure S cenario (MEPC 56/2/2 Annex 9).

9.5 The Group recommended that the comprehe nsive corrosion testin g be conducted in accordance with the guidance provided in secti on 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG” contained in MEPC 59/2/16. Where intermittent exposures are utilized to predict long-term corrosion ra tes, as proposed by the applicant, the TRO in the sample containers should be recorded and reported over the period of the exposure. In addition, the Group recommended that some indication, with supporting data, of the long-term corrosion rates under a constant level of TRO at the ma ximum allowable dosage concentration should be provided to allow the potential impact on exposed ship systems to be assessed.

9.6 The Group recommended that the neutraliz ation system should include appropriate monitoring and control to ensure efficient reduction of TRO in the ballast water discharge and this should be fully described in an application for Final Approval.

9.7 The Group, therefore, concluded that the system should be recommended for Basic Approval. For Final Approval, th e Group recommended that all comments and recommendations made in this eval uation should be taken into account.

* * *GESAMP-BWWG 11/6 ANNEX 6 Page 16

I:\MEPC\60\2-12.doc APPENDIX 1

AQUATIC TOXICITY DATA FOR ACTIVE SUBSTANCES, RELEVANT CHEMICAL AND OTHER CHEMICALS

1 ACUTE AQUATIC TOXICITY

F C Test Substance A Species Test Type LC50/EC50 mg/L (duration) NOEC mg/L Reference/ Comments

Active Substances Fresh

water Oncorhynch

us gorbuscha 0.023-0.052 mg/L (96h) ECB, IUCLID, 2000 F

Salt

water Oncorhynch us kisutch 0.032 mg/L (96h) (as TRO) ECB, IUCLID, 2000

Fresh

water Ceriodaphni a dubia 0.005 mg/L (24h) for HOCl(pH 7) Flowthrough tests (without food) Taylor, 1993 C

Salt

water B. plicatilis 0.01mg/L (30- 60min) The thermal stress Capuzzo, 1976, ECB, IUCLID, 2000 HOCl (NaOCl)

A Saltw

ater Thalassiosir a guilardii EC50:0.075 mg/L (24h) Gentile et al. , 1976

F No data found in literature C No data found in literature HOBr(NaOBr)

A No data found in literature F Notropis atherinoides (Emerald shiner) 0.63 mg/L 40 min exposures at 5 h intervals for 24 h, 10 °C ; 0.51 mg/L, 20 °C ; 0.35 mg/L, 30 °C HSDB, 2009

C Ceriodaphni a dubia (Water flea) 0.012 mg/L (24 h) Taylor PA, 1993 Chloramine

A No data found in literature Relevant Chemicals F Cyprinodon variegatus 7.1 mg/L (96h) Ward et al. , 1981

C Daphnia magna 46 mg/L (48 h) LeBlanc G.A, 1980 Tribromo methane

A Skeletonema

costatum 12.3mg/L (96h) (EC50) U.S. EPA 1978

F Cyprinus carpio 34mg/L (72 to 120h) Mattice et al. , 1981 C N.A. 27mg/L (48h) MEPC 58/2 Dibromochloro methane

A Selenastrum caprocornutum 6.1mg/L (72h) MEPC 58/2

F No data found in literature Monobromo acetic acid C Daphnia magna (Water flea) EC50 : 65 mg/L for 24 h HSDB, 2009GESAMP-BWWG 11/6 ANNEX 6 Page 17

I:\MEPC\60\2-12.doc A Scenedesmus subspicatus (Green algae, log growth phase) EC50 : 0.2 mg/L for 72 h Kuehn R and Pattard M, 1990

F Pimephales promelas 6.9 mg/L (96 h) Mayes et al. , 1985 C No data found in literature Dibromoacetic acid

A No data found in literature F No data found in literature C No data found in literature Tribromoacetic acid

A No data found in literature F No data found in literature C No data found in literature Bromochloro acetic acid

A No data found in literature F No data found in literature C No data found in literature Dibromochloro acetic acid

A No data found in literature F Pimephales promelas 0.55 mg/L (96 h) Mayes MA et al.

, 1985 C Daphnia magna 3,897.8mg/L (48h) ECOSAR Dibromoaceto nitrile

A green algae 2,231.3mg/L (96h) ECOSAR

F Morone

s axatilis 31mg/L (96h) Richardson et al., 1981 C Neomysis awatschnsis Opossum shrimp 176mg/L/ (24h) Crecelius, 1979 Bromate

A three seawater species EC50: 13.6mg/L (72h) Thomas H., 1997

Other chemicals F Gambusia affinis (fresh water) Ca. 24000 mg/L (96h) ECB, IUCLID, 2000

C No data found in literature Sodium thiosulphate

A Ankistrodesmus falcatus Ca. 64mg/L 1h Wodzinski R. S. et al , 1978 F = Fish; C = Crustacean; A = Algae.GESAMP-BWWG 11/6 ANNEX 6 Page 18

I:\MEPC\60\2-12.doc 2 CHRONIC AQUATIC TOXICITY

F C Test Substance A Species Test Type LC50/ EC50 mg/L NOEC mg/L (duration) Reference Comments

Active Substances Fresh

water Ictaluru

s punctatu

s NOEC:0.005 mg/L (133d) Hermanutz et al., 1990 F

Salt

water Menidia peninsul

ae NOEC:0.04 mg CPO/L CPO=Chlorineproduced oxidants Goodman et al. , 1983

C Pandalu s danae (Saltwat er) NOEC:0.05 mg/L FREE Active Chlorine Gibson et al.

, 1976 HOCl (NaOCl)

A algal biomass NOEC:0.003 mg TRC/L Cairns, 1990

F No data found in literature C No data found in literature HOBr (NaOBr)

A No data found in literature F No data found in literature C No data found in literature Chloramine

A No data found in literature Relevant Chemicals F sheepshead minnows ( Cyprinodon variegatus ) NOEC 4.8 mg/L (28d) Ward et al.

, 1981

C No data found in literature Tribromomethane

A Selenastrum

c apricornutum NOEC:10 mg/L /96h U.S. EPA 1978

F Oryzias latipes 3.2mg/L/21da

y IMO, MEPC 58/2 C No data found in literature Dibromochloro methane

A No data found in literatureGESAMP-BWWG 11/6 ANNEX 6 Page 19

I:\MEPC\60\2-12.doc F No data found in literature C Daphnia magna NOEC=1.6 (mg/L/21days) MEPC 58/2/7GESAMPBWWG 6/9, annex 7 Monobromoacetic acid

A No data found in literature F No data found in literature C No data found in literature Dibromoacetic acid

A No data found in literature F No data found in literature C No data found in literature Tribromoacetic acid

A No data found in literature F No data found in literature C No data found in literature Bromochloro acetic acid

A No data found in literature F No data found in literature C No data found in literature Dibromochloro acetic acid

A No data found in literature F No data found in literature C No data found in literature Dibromoaceto nitrile

A No data found in literature F Morone saxatilis LC50:(93) mg/L (10d), NOEC:(50) mg/L (10d) Richardson et al. ,1981

C No data found in literature Bromate

A Isochrysis galbana NOEC:8 mg/L (7d) Erickson and Freeman, 1978 Other chemicalsGESAMP-BWWG 11/6 ANNEX 6 Page 20

I:\MEPC\60\2-12.doc F Oncorhynchus mykiss 600mg/L 18 month In/with FW: NO MORTALITY, Temp:15 °C pH :7.82-7.92 ECB, IUCLID, 2000

C No data found in literature Sodium thiosulphite

A No data found in literature

F = Fish; C = Crustacean; A = Algae.

3 ENDOCRINE DISRUPTION

No reports were found, showing that the Active Substances might have any endocrine effects on aquatic organisms. Likewise, no reports were f ound, indicating the relevant chemicals and other chemicals identified might have any endoc rine effects on aquatic organisms.

4 SEDIMENT TOXICITY

Chemical Koc (L/kg) Reference

Active Substances

HOCl(NaOCl) 14.3 MEPC 58/2/7, GESAMP-BWWG 6/9, annex 6 HOBr(NaOBr) 14.3 MEPC 58/2/7, GESAMP-BWWG 6/9, annex 6 Chloramine

Relevant Chemicals

Tribromomethane 35.04 HSDB, 2009

Dibromochloromethane 95-468 MEPC 59/2/11

Monobromoacetic acid 39.8 HSDB, 2009

Dibromoacetic acid 1.5 HSDB, 2009

Tribromoacetic acid 5.3 HSDB, 2009

Bromochloroacetic acid 1.9 HSDB, 2009

Dibromochloroacetic acid Dibromoacetonitrile 13 HSDB, 2009 Bromate 2.7×10 -8 MEPC 58/2/7, GESAMP-BWWG 6/9, annex 5 Other Substances Sodium thiosulphiteGESAMP-BWWG 11/6 ANNEX 6 Page 21

I:\MEPC\60\2-12.doc 5 BIOAVAILABILITY/BIOMAGNIFICATION/BIOCONCENTRATION

Chemical Log Pow BCF (L/kg) Reference Active Substances HOCl(NaOCl) -3.42 -2.19 MEPC 58/2/7, GESAMP-BWWG 6/9, annex 6 EPI SUIT (2007) HOBr(NaOBr) -1.03 1.24 MEPC 58/2/7, GESAMP-BWWG 6/9, annex 7 Chloramine Relevant Chemicals Tribromomethane 2.4 14 HSDB, 2009 Dibromochloromethane 2.24 0.74-1.47 MEPC 59/2/11 Monobromoacetic acid 0.41 3.2 HSDB, 2009 Dibromoacetic acid 0.70 0.17 HSDB, 2009

Tribromoacetic acid 1.71 0.63 HSDB, 2009

Bromochloroacetic acid 0.61 3.2 HSDB, 2009 Dibromochloroacetic acid 1.62 HSDB, 2009 Dibromoacetonitrile 0.47 3 HSDB, 2009 Bromate -7.18 3.7×10 -7 MEPC 58/2/7, GESAMP-BWWG 6/9, annex 5 Other chemicals Sodium thiosulphate -4.53 3.162 MEPC 58/2

6 FOOD WEB/POPULATION EFFECTS

6.1 Based on the low Kocs and Log Pows, little biomagnification and persistence in aquatic and mammalian food webs is anticipated from th e Active Substances, Relevant Chemicals and other chemicals. All of the Kocs for the Ac tive Substances, Relevant Chemicals and other chemicals are <500 L/kg, which indicate that the ch emicals would not readily be absorbed into sediments so that they would not be of concern to benthic populations and their food webs.

6.2 All the chemicals have established Bio-C oncentration Factors (BCFs). The BCFs show that little bioconcentration/bioaccumulation will occur in aquatic organisms. Little biomagnification occurs in aquatic food we bs and bird/mammalian food webs since the chemicals are not readily bioconcentrated/bioaccumulated.

* * *GESAMP-BWWG 11/6 ANNEX 6 Page 22

I:\MEPC\60\2-12.doc APPENDIX 2

MAMMALIAN TOXICITY DATA FOR ACTIVE SUBSTANCES, RELEVANT CHEMICAL AND OTHER CHEMICALS

1 ACUTE MAMMALIAN TOXICITY

Chemical Exposure Route Species Value Range Reference/Comments

a. Oral LD 50 (mg/L) b. Oral LD 50 (mg/L) a. Mouse b. Rat a. 880 mg/kg bw b. >5000 mg/kg bw ECB, IUCLID, 2000

Dermal LD 50 rabbit >10000 mg/kg bw ECB, IUCLID, 2000 HOCl(NaOCl)

Inhalation LC 50 (mg/L/4h) Rat >10.5mg/L (1h) ECB, IUCLID, 2000

HOBr(NaOBr) No data available; this compound is thought to be similar in toxicity to chlorinated analogue. Chloramine a.Oral LD 50

b.Oral LD 50 a. Rabbits: under 3 wk of age; older than 3 wk b. Rat a.LD:40-50 mg/kg; 60-70 mg/kg, respectively b. 935mg/kg a. HSDB, 2009 b. Mallinkrodt Baker, 2006

a. Oral LD 50 b. Oral LD 50 a.Male mice/female mice b. Male rats/ female rats a. 1,400 mg/kg/ 1,550 mg/kg b. 1388 mg/kg 1147 mg/kg a. Bowman et al. , 1978 b. Chu et al. , 1980Tribromomethane

Inhalation LC 50 a. Dog b. Mouse a. 7 mg/L (4 h) b. 12.1mg/L (2h) RTECS, 2006

Dibromochloro methane a. Oral LD 50 b. Oral LD 50 a.Male mice/female mice b. Male rats/ female rats a. 800 mg/kg/ 1,200 mg/kg b. 1186 mg/kg/ 848 mg/kg IPCS, 2000

Oral LD 50 rat 50mg/kg RTECS, 2008 Dermal LD 50 rabbit 59.9mg/kg RTECS, 2008 Monobromo acetic acid

Inhalation LC 50 rat lowest publishedlethal concentration: 114 gm/m 3 /30 minute RTECS, 2008

Dibromoacetic acid Oral LD 50 Rat 1737 mg/kg Linder et al ., 1994

Tribromoacetic acid No data available; this compound is thought to be similar in toxicity to chlorinated analogue.GESAMP-BWWG 11/6 ANNEX 6 Page 23

I:\MEPC\60\2-12.doc Chemical Exposure Route Species Value Range Reference/Comments

Bromochloroacetic acid No data found in literature Dibromochloro acetic acid

Oral LD 50 Rat 245 mg/kg for male

rats 361 mg/kg female rats Hayes JR et al. , 1986 Dibromo- acetonitrile

Inhalation LC 50 Rat 10g/m 3 /h IMO, MEPC 58/2

Bromate a. Oral LD 50 b. Oral LD 50 a. Rat b. Mouse a. 157mg/kg b. 289mg/kg RTECS, 2007

Sodium thiosulphite a. Oral LD 50 b. Oral LD 50 a. Rat (males and females combined) b. rat a. >5,050 mg/kg b. 2,500mg/kg to 5,000mg/kg a. EPA Federal Register Sodium thiosulfite, 2001 b. RTECS, 2006

2 EFFECTS ON SKIN AND EYE, AND SENSITIZATION EFFECTS

Chemical Skin Eye Sensitiz ation Reference/Comments HOCl(NaOCl) Irritation to the skin Irritation to the eye 225 patients tested with sodium hypochlorite in patch test, 3 showed positive tractions (1.3%) ECB, IUCLID, 2000

HOBr(NaOBr) No data available; this compound is thought to be similar in toxicity to chlorinated analogue. Chloramine Did not produce hyperplasia of the skin Irritation to the eye Did not produce hyperplasia of the skin. WHO, 2000 HSDB, 2009

Tribromomethane Irritation to the skin. Repeated or prolonged contact may

cause dermatitis. Irritation to the eye. Repeated or prolonged contact may

cause dermatitis. Skin : Y (Redness.) Inhalation : Y ( Re ddening of the face.Salivation. Disturbance of

movements. Convulsions. Cough. Dizziness. Headache. HSDB, 2009 ICSC, 0108

Dibromochloromethane Irritation to the skin Irritation to the eye Aldrich Chemical MSDSGESAMP-BWWG 11/6 ANNEX 6 Page 24

I:\MEPC\60\2-12.doc Chemical Skin Eye Sensitiz ation Reference/Comments

Monobromoacetic acid Cause severe burns Cause severe burns HSDB, 2009

Dibromoacetic acid Cause burns Cause burns Inhalation may result in spasm, inflammation and edema of the larynx and bronchi, chemical pneumonitis, and pulmonary edema. Sigma-Aldrich, 2006, MSDS

Tribromoacetic acid Irritating to the skin Irritating to the eye Inhalation may result in spasm, inflammation and edema of the larynx and bronchi, chemical pneumonitis, and pulmonary edema Fisher Scientific MSDS HSDB, 2009

Bromochloroacetic acid Extremely destructive to shin Extremely destructive to

eye Sigma-Aldrich, MSDS 2006

Dibromochloro acetic acid Extremely destructive to shin Extremely destructive to

eye Inhalation may result in spasm, inflammation and edema of the larynxand bronchi, chemical pneumonitis, and pulmonary edema. is extremely destructive to tissue of the mucous membranes and upper respiratory

tract. HSDB, 2009

Dibromoacetonitrile May cause skin irritation Cause eye irritation HSDB, 2009

Bromate May cause skin irritation Cause moderate eye irritation. May cause transient corneal injury. May cause skin irritation. May cause respiratory tract irritation. The chemical database

Sodium thiosulphite May cause skin irritation May cause eye irritation and possible burns May cause skin irritation. May cause respiratory tract irritation. The chemical databaseGESAMP-BWWG 11/6 ANNEX 6 Page 25

I:\MEPC\60\2-12.doc 3 REPEATED-DOSE TOXICITY

Chemical Exposure Route Species Value Range Reference/ Comments HOCl(NaOCl) a. Oral, 13 weeks b. Oral, 90days a. F344 rats b. Mouse a. Significant suppression of body weight (as a result of decreased consumption of water and food) occurred at 0.2% and above. Slight damage to the liver as indicated by increased levels of serum enzymes (not specified) at 0.2% and 0.4% sodium hypochlorite in both sexes. No evidence of treatment-related pathology was observed in this study. b.NOAEL 50mg/L (10-12mg/kg/d) a. Hasegawa R, et al. , 1986 b. Daniel et al. , 1991

HOBr(NaOBr) No data available; this compound is thought to be similar in toxicity to chlorinated analogue. Chloramine a. Oral, 90-day(drinkingwater) b. Oral, 90- day(drinkingwater) a. SpragueDawley

rats b. B6C3F1 mice a. NOAEL: 100mg/L, equivalent to 5.8 mg/kg bw/d. b. NOAEL: 50 mg/L, equivalent to 8.6 mg/kg bw/d. WHO, 2000

Tribromomethane a. Oral Gavage 5 days/week for 13 weeks b. Oral Gavage 5 days/week for 13 weeks a. F344/N rats/sex b. B6C3F1 mice a. LOAEL: 50 mg/kg/day (converted to 35.7 mg/kg/d) NOEL: 25 mg/kg/day (converted to 17.9 mg/kg/d) b. LOAEL: 50 mg/kg/day(converted to 35.7 mg/kg/d) NOEL: 25 mg/kg/d (converted to 17.9 mg/kg/d) NTP 1989

Dibromochloromethane a. Gavage, 13 weeks b. Gavage, 90 days a. Rats and mice b. Rats a. NOAEL:30 mg/kg/d b. Kidney damage at 50 and 100 mg/kg/d IPCS, 2000

Monobromoacetic acid Oral pig Damage to the liver, heart, kidney, lung and skeletal muscle was found in pigs which died and movement disorders occurred in those that survived. HSDB, 2009GESAMP-BWWG 11/6 ANNEX 6 Page 26

I:\MEPC\60\2-12.doc Chemical Exposure Route Species Value Range Reference/ Comments Dibromoacetic acid a. Oral, 28d b. Oral, 3 months a. Mouse b. Mouse a. NOAEL: 38 mg/kg/d b. No deaths but various effects seen at >500 mg/L WHO, 2004

Tribromoacetic acid No data found in literature

Bromochloroacetic acid a. oral, 3 months b. oral, 3 months a. B6C3F 1 Mice b. F344/N Rats a. Mean body weight gains of females exposed to 250 mg/L or greater were significantly decreased. Liver weights of 1000 mg/L males and all exposed groups of females were significantly increased. All males and females exposed to 500 or 1000 mg/L had periportal cytoplasmic vacuolization. In the spleen, there were increased incidences of hematopoietic cell proliferation in 62.5, 125 and 250 mg/L males and 125 and 1000 mg/L females. b. Liver weights of 500 and 1000 mg/L males and females and kidney weights of 1000 mg/L males were significantly increased. In the liver, there were significantly increased incidences of cytoplasmic vacuolization in 10000 mg/L males and females. HSDB, 2009

Dibromochloroacetic acid No data found in literatureDibromoacetonitrile Oral, 13 weeks SpragueDawley

rats NOAEL: 10 mg/kg/d, equivalent to 1.11 and 1.21 mg/kg/d in the males and females, respectively Poon R et al.

, 2003

Bromate Oral, 13 weeks Rats Liver toxicity at higher doses IPCS, 2000

Sodium thiosulphate No data found in literature

4 CHRONIC TOXICITY

Chemical Exposure Route Species Value Range Reference/ Comments HOCl(NaOCl) Oral 2 years Rat and Mouse NOAEL: 14.4mg/kg/d NTP, 1992

HOBr(NaOBr) No data available; this compound is thought to be similar in toxicity to chlorinated analogue.GESAMP-BWWG 11/6 ANNEX 6 Page 27

I:\MEPC\60\2-12.doc Chemical Exposure Route Species Value Range Reference/ Comments

Chloramine Oral (drinking water) 2-year F344/N rats and B6C3F1 mice There was a decrease in mean body weight in high-dose rats. The high-dose group had decreases in organ weights and increases in organ-to-body weight ratios at 14- or 66-week evaluations. There was also a dose-related decrease in mean body weights of dosed male and female mice throughout the study. There were decreases in organ weights and increases in organ-to-body weight ratios observed in high-dose mice at 15- or 66-week evaluations. EPA, 1994

Tribromomethane a. gavage 5 days/week for 2 years b. gavage 5 days/week for 2 years a. F344/N

rats b. B6C3F1 mice a. NOAEL: 17.9 mg/kg/d b. NOAEL: 17.9 mg/kg/d NTP 1989.

Dibromochloromethane Gavage, 2

years Mice and

rats Kidney and liver effects noted at all doses IPCS, 2000

Monobromoacetic acid No data found in literature Dibromoacetic acid a. Oral, 2

years b. Oral, 2

years a. Mouse b. Rat a. Increased body weights at 50 and 500 mg/L in males only b. Decrease body weights at 500and 1000 mg/L NTP, 2007

Tribromoacetic acid No data found in literatureBromochloroacetic acid a. oral, 2

years b. oral, 2

years a. B6C3F 1 Mice b. F344/N Rats a. Survival of 1000 mg/L males was significantly less than that of the control group. Mean body weight of 1,000 mg/L males were 12% less than the control group after week 97, and those of 1,000 mg/L females were 8% less than the control group after week 21. b. Mean body weights of 500 mg/L males were 8% less than the control group after week 81, and those of 1000 mg/L males were 10% less than the control group after week 69. Mean body weights of 1000 mg/L females were 10% less than the control group after week 85. HSDB, 2009GESAMP-BWWG 11/6 ANNEX 6 Page 28

I:\MEPC\60\2-12.doc Chemical Exposure Route Species Value Range Reference/ Comments

Dibromochloroacetic acid No data found in literatureDibromoacetonitrile drinking

water 2-year Mice and Rat there was clear evidence of carcinogenic activity of dibromoacetonitrile in male rats based on increased incidences of squamous cell papillomas or carcinomas of the oral cavity; adenomas in the glandular stomach of male rats were alsoconsidered to be exposurerelated. There was some evidence of carcinogenic activity of dibromoacetonitrile in female rats based on an increased incidence of squamous cell papillomas of the oral cavity; increased incidences of basal cell or squamous cell neoplasms of the skin in female rats may have been related to dibromoacetonitrile exposure. There was clear evidence of carcinogenic activity of dibromoacetonitrile in male and female mice based on increased incidences of squamous cell papillomas or carcinomas of the forestomach. Increased incidences of neoplasms in the liver of male mice may have been related to dibromoacetonitrile exposure. Exposure to dibromoacetonitrile for 2 years caused increased incidences of epithelial hyperkeratosis in the esophagus of male and female rats, ectasia of the glandular stomach and squamous epithelial hyperplasia of the tongue in female rats, and squamous epithelial hyperplasia of the forestomach in male mice. NTP/NIEHS, 2008

Bromate a. Drinking water, 100 weeks b. Drinking water, 100 weeks a. Male, B6C3F1 mice b. Male F344 rats a. NOAEL: 800mg/L b. NOAEL: 20mg/L WHO, 2005

Sodium thiosulphite No data found in literatureGESAMP-BWWG 11/6 ANNEX 6 Page 29

I:\MEPC\60\2-12.doc 5 DEVELOPMENTAL AND REPR ODUCTIVE TOXICITY

Chemical Exposure Route Species Effects Reference/ Comments HOCl(NaOCl) Oral Rat NOAEL: 14.4 mg/kg/d Druckrey, 1968

HOBr(NaOBr) No data available; this compound is thought to be similar in toxicity to chlorinated analogue. Chloramine Gavage, 66-76 days male (12/dose) and female (24/dose) Long-Evans

rats NOAEL:10 mg/kg/d Carlton et al. 1986

Tribromomethane a. gavage, 105 days b. Gavage, days 6-15 a. mice b. rat a. No effect on fertility or offsping. b. An increased incidence of minor skeletal abnormalities, including appearance of a 14th rib, intraparietal deviations, and delayed ossification of sternebrae, was seen in developing fetuses at 100 and 200 mg/kg. a. WHO, EHC216 (2000) b. Ruddick, et al. 1983

Dibromochloromethane exposed individuall y in 5 ml of embryo rearing solution, 15 days Medaka embryos at stage 10 (N= 60 per concentratio n) Embryos were evaluated daily for mortality and cardiovascular abnormalities. The heartbeat count was made for one full minute from day 3-10. The earliest lesion observed was the tubular heart on day 4 of exposure. Lack or incomplete chambe rs formation often began on day 5. Diathesis or pooling of blood in various tissues began to appear staring on day 5 of exposure, followed by slowing of blood flow and complete stasis usually on day 10. At this time pericardial edema began to develop and progressed to other organs and interfered with hatching which resulted in partial hatching. In addition, low incidence ofthe following lesions was observed: nondevelopment of heart, absence or reduced numbers of vitelline vessels, reduced numbers of blood cells, and ruptured blood vessels. Palit S et al. (2004)

Monobromoacetic acid a. Oral intubation b. N.A. a. pregnant Long Evans

rats b. rats a. These results suggest that bromoacetic acid is developmentally toxic at 100 mg/kg/d. b. Did not affect parameters related to male reproductive function a. Randall JL et al. , 1991 b. Environmental Health Criteria 216GESAMP-BWWG 11/6 ANNEX 6 Page 30

I:\MEPC\60\2-12.doc Chemical Exposure Route Species Effects Reference/ Comments Dibromoacetic acid Oral Rat NOAEL:125 mg/kg/d Cummings et al . ,1998Tribromoacetic acid gavage rat Tribromoacetic acid at up to 400 ppm marginally reduced water consumption and did not affect reproductive function or produce general toxicity. TBA is not a reproductive toxicant in males or females at doses up to 400 ppm. NTP, 1998

Bromochloroacetic acid gavage SpragueDawley rats There were no clinical signs of general toxicity noted at any dose level. There were no treatment-related effects on body weights or feed consumption. Water consumption was decreased by 21-34% at many of the intervals for the 600 ppm rats. The overall calculated consumption of BCA for Groups 2-4 was 7, 20, and 50 mg/kg/d, respectively. Clinical chemistry and hematology endpoints at necropsy were unaffected by BCA treatment except for a 16% increase in the albumin to globulin ratio in the 600 ppm A males; decreases of 15 and 20% in the alanine aminotransferase parameter in the 200 and 600 ppm A males, respectively; and increases of 5 and 9% in albumin in the 60 and 600 ppm A males, respectively. The increases in albumin to globulin ratio and albumin represent a small but possible biologically significant indicator of dehydration, probably attributable to decreased fluid consumption. The decreases in alanine aminotransferase are of little toxicological significance. Results of this study indicate that BCA at doses of 600 ppm produced a consistent decrease in water consumption in both sexes and affected reproductive function in females at a dose of 600 ppm. From these data, BCA is taste-aversive and a general toxicant in both sexes at 600 ppm and also a female reproductive toxicant at 600 ppm. NTP, 1998

Dibromochloroacetic acid drinking

water rats The first range-finding study was conducted at concentrations of 0, 30, 100, 300, and 500 ppm of DBCA in the drinking water for two weeks, with no significant test-article related effects observed at any dose level including 500 ppm. Following two HSDB, 2009GESAMP-BWWG 11/6 ANNEX 6 Page 31

I:\MEPC\60\2-12.doc Chemical Exposure Route Species Effects Reference/ Comments weeks of a wash-out period, the second range-finding study was conducted at concentrations of 0, 750, 1000, and 1500 ppm of DBCA in the drinking water for two weeks. During the treatment period, all animals survived to the scheduled necropsy. Body weights were 10-14% less than controls in the 1500 ppm A and C females. Water consumption was decreased at several of the intervals for the 1000 and 1500 ppm dose groups. Water consumption was decreased by 12-49% at 1000 and 1500 ppm in both males and females throughout the course of the study. Results of this study indicate that DBCA at doses at and above 1000 ppm produced consistent decreases in food and water consumption in both sexes, but did not result in any female reproductive toxicity or any visceral malformation or variations in any pups. In the male reproductive data, a decrease of 11% in the male sperm velocity samples and in the male ALH max were observed in the 1500 ppm A male; no changes in fertility were noted.Dibromoacetonitrile gavage Long-Evans

rats Four of the 26 dams treated with dibromoacetonitrile died. There was a significant decrease in maternal weight gain during the period of treatment. Litter weight at the time of birth was lower than in the controls, and weight gain to lactation day 4 was significantly decreased. There was no significant effect on the percentages of pregnant females or resorptions and no effect on neonatal survival after birth. HSDB, 2009

Bromate Oral rat NOAEL: 7.7 mg/kg/d NOEL: 22 mg/kg/d WHO, 2005

Sodium thiosulphite a. Oral b. Oral a. Mouse b. Rat a. There was no indication of any effect on maternal or fetal survival, or in incidences of visceral or skeletal abnormalities. b. There was no indication of any effect on maternal or fetal survival, or in incidences of visceral or skeletal abnormalities. EPA Federal Register Sodium thiosulfate, 2001.GESAMP-BWWG 11/6 ANNEX 6 Page 32

I:\MEPC\60\2-12.doc 6 CARCINOGENICITY

Chemical Carcinogen Classification Description Reference/ Comments HOCl(NaOCl) Not carcinogenic NTP, 1992

HOBr(NaOBr) No data available; this compound is thought to be similar in toxicity to chlorinated analogue.

Chloramine IARC Group 3-not classifiable as to its carcinogenicity to humans. Negative Inadequate evidence in humans and sufficient evidence in experimental animals. MOUSE, B6C3F1/male and female Oral, 0; 50; 100; 200 ppm in buffered, charcoal-filtered, deionized water for 104 wk (study duration: 2 yr) IARC,2004 CCRIS,1993

Tribromomethane IARC Group 3- not classifiable as to carcinogenicity to humans WHO, EHC216 (2000)

Dibromochloromethane Group 3-not classifiable as to its carcinogenicity IPCS, 2000

Monobromoacetic acid No data available;

Dibromoacetic acid Carcinogenic (tumours/cancers observed) Mouse and Rat NTP, 2007

Tribromoacetic acid No data available;GESAMP-BWWG 11/6 ANNEX 6 Page 33

I:\MEPC\60\2-12.doc Chemical Carcinogen Classification Description Reference/ Comments There was clear evidence of carcinogenic activity in male F344/N rats based on increased incidences of malignant mesotheliomas and adenomas of the large intestine. There was clear evidence of carcinogenic activity in female F344/N rats based on increased incidences of adenomas of the large intestine; increased incidences of multiple fibroadenomas of the mammary gland in female rats were also considered to be exposure related. Increased incidences of pancreatic islet adenomas in male rats and of hepatocellular adenomas in male and female rats may have been related to bromochloroacetic acid

exposure. F344/N rats HSDB, 2009

Bromochloroacetic acid

There was clear evidence of carcinogenic activity in male and female B6C3F1 mice based on increased incidences of hepatocellular neoplasms and hepatoblastoma (males only). Exposure to bromochloroacetic acid for 2 years resulted in increased incidences of nonneoplastic lesions in the liver of male rats, liver and lung of female rats, and liver of male and female mice. B6C3F1 mice HSDB, 2009

Dibromochloroacetic acid No data available;

Dibromoacetonitrile Group 3-not classifiable as to its carcinogenicity to humans Inadequate evidence in humans and sufficient evidence in experimental animals. HSDB, 2009

Bromate IARC Group 2B- possibly carcinogenic to humans. Inadequate evidence in humans and sufficient evidence in experimental animals IPSC, 2000

Sodium thiosulphite No data available;GESAMP-BWWG 11/6 ANNEX 6 Page 34

I:\MEPC\60\2-12.doc 7 MUTAGENICITY/GENOTOXICITY

Chemical Study Results Reference/Comments HOCl(NaOCl) Mice Not mutagenic Hayashi, 1988 Meier et al. , 1985 HOBr(NaOBr) No data available; this compound is thought to be similar in toxicity to chlorinated analogue. Chloramine Mice No evidence of any significant effects in any of the tests. USEPA, 1994

Salmonella typhimurium, in vitro, Positive Simmon et al. 1977; Simmon and Tardiff 1978 Salmonella typhimurium, in vitro

, Negative Rapson et al. 1980; Varma et al. 1988 Kubo et al. 2002 human lymphocytes, in vitro, Increase in sister chromatid exchange Morimoto and Koizumi 1983 rat erythroblastic leukemia K3D, in vitro

, Increase in sister chromatid exchange Fujie et al. 1993 Tribromomethane

Chinese hamster ovary cells in vitro , No increase in sister chromatid exchange Galloway et al. 1985

Dibromochloromethane Positive mutagenicity results in several in vitro and in vivo assays. IPCS, 2000

Monobromoacetic acid Salmonella typhimurium strains TA98, TA100, and RSJ100 +/- S9, Positive Kargalioglu Y et al. ,2002

Dibromoacetic acid Salmonella typhimurium, Ames test, Positive at 10 mg/L Giller et al. , 1997

Tribromoacetic acid Positive with metabolic activation in the Ames assay IPCS, 2000

Salmonella typhimurium strain TA100, in vitro, Positive in tests conducted with and without exogenous metabolic activation enzymes (S9) HSDB, 2009 Bromochloroacetic acid

Salmonella typhimurium strain TA98 or Escherichia coli WP2 uvrA/pKM101, in vitro, no mutagenicity was detected with or without S9 HSDB, 2009

Dibromochloroacetic acid No data available; Dibromoacetonitrile Rat intestinal epithelial cells, may trigger various forms of imbalance to intestinal mucosa and its functions USEPA. 2000.

Bromate Weakly mutagenic in Ames assay with metabolic activation, caused chromosomal aberrations in Chinese hamster cell lines at high concentrations IPSC, 2000

Sodium thiosulphite sodium thiosulfite was found to cause no mutagenic effects. EPA Federal Register Sodium thiosulfite, 2001.GESAMP-BWWG 11/6 ANNEX 6 Page 35

I:\MEPC\60\2-12.doc 8 TOXICOKINETICS

Chemical Study Results Reference/ Comments HOCl(NaOCl) Free chlorine is consumed upon contacting with living tissues, making measurement of biodegradation impossible and unnecessary. The chloride ion is actively transported by most fresh water and marine organisms, typically being concentrated in fresh water sp ecies and diluted in saltwater forms including some hyperosmotic and isotonic groups such as chondrichthys (sharks, rays etc). Free chlorine is very toxic to biodegrading micro-organisms and may interfere with the biodegradation of other materials at levels of greater than or equal to 0.01 mg/L. ECB, IUCLID, 2000

HOBr(NaOBr) No data available; this compound is thought to be similar in toxicity to chlorinated analogue. Chloramine Information on the absorption of inorganic chloramines is extremely limited. In one study Abdel-Rahman et al. (1983) calculated an absorption rate constant for 36 Cl at 0.278 mg/hour (after 8 hours) with an absorpti on half-life of 2.5 hours after male Sprague-Dawley rats were ad ministered a single oral dose of 4.6 mg/kg/day. After 48 hours the radiolabel was eliminated from the plasma with a half-life of 38.8 hours and a rate constant of 0.018 mg/hour. Absorption rates with respect to various dosage media and different routes of exposure were not available. The distribution of ra diolabeled chlorine in the subfractions of rat liver homogenates, in or gans, tissues and fluids was similar (120 hours) after oral administration of either 36Cl (200 mg/L as Na 36 Cl) or NH 2 36 Cl (370 mg/L NH 2 Cl). Plasma contained the highest concentrations of 36 Cl radioactivity for NH 36 Cl followed by whole blood sk in, testes, packed cells, bone marrow, kidney, lung, stomach, thyroid, thymus, duodenum, spleen, carcass, liver, ileum and fat. Abdel-Rahman et al. 1983; Suh and Abdel-Rahman,1983

Tribromomethane The metabolism of bromoform, dibromochloromethane, and other trihalomethanes has been investigated by Anders and colleagues. The first step in the metabolism of trihalomethanes is oxidation by the cytochrome P-450 mixed function oxidized system of liver. This has been demonstrated in vitro using isolated rat liver microsomes, an d in vivo, where the rate of metabolism is increased by cytochrome P-450 inducers (phenobarbital) and decreased by cytochrome P-450 inhibitors (SKF-525A). The product of this reaction is presumed to be trihalomethanol, which then d ecomposes by loss of hydrogen and halide ions to yield the dihalocarbonyl. Although this intermediate has not been isol ated, its formation has been inferred by the detection of 2-oxothiazolidine-4-carboxylic acid (OZT) in an in vitro microsomal system metabolizing bromoform in the presence of cysteine. The dihalocarbonyl molecule (an analogue of phosgene) is highly reactive, and may undergo a number of reactions, including: (a) direct reaction with cellular nucleophil es to yield covalent adducts; (b) reaction with two moles of glutathione (GSH) to yield ATSDR, 2005GESAMP-BWWG 11/6 ANNEX 6 Page 36

I:\MEPC\60\2-12.doc Chemical Study Results Reference/ Comments carbon monoxide and oxidized glutathione (GSSG); and (c) hydrolysis to yield CO 2 . The amount of trihalomethane metabolized by each of these pathways has not been studied in detail, but it appears that conversion to CO2 is the main route. However, this depends on the species, the trihalomethane being metabolized and metabolic conditions (cellular glutathione levels). Mink et al. (1986) found that mice oxidized 72% of an oral dose of dibromochloromethane and 40% of an oral dose of bromoform to CO 2 . In contrast, rats oxidized only 18% of dibromochloromethane and 4% of bromoform to CO 2 . The fraction of the dose converted to carbon monoxide has not been quantified, but dramatically increased levels of carboxyhemoglobin have been reported following oral exposure of rats to bromoform. Mink et al. (1986) reported that.about 10% of a dose of br omoform was present in blood in mice; the form of the label was not investigated, but it may have been carboxyhemoglobin.Dibromochloromethane Oral dosing in rats and mice show ed that less than 2% of the dose was excreted in the urine in both species. Half-lives of DBCM in rats and mice were es timated to be 1.2 h and 2.5 h, respectively. IPCS, 2000

Monobromoacetic acid No data available;

Dibromoacetic acid di-HAAs are nearly completely eliminated by metabolism and exhibit poor renal elimination. FPTC, 2006

Tribromoacetic acid brominated tri-HAAs exhibit both moderate renal and metabolic elimination. FPTC, 2006

Bromochloroacetic acid di-HAAs are nearly completely eliminated by metabolism and exhibit poor renal elimination. FPTC, 2006

Dibromochloroacetic acid No data available

Dibromoacetonitrile Urinary thiocyanate accounted for 2.25–12.8% of a single gavage dose of bromochloroacetonitrile, dibromoacetonitrile, dichloroacetonitrile or trichloroacetonitrile during th e 24-h period following dosing of male rats. The cyanide carbon group is more readily excreted in the urine, whereas the halomethyl carbon group is excreted nearly equally in enhaled air and in urine; excretion in faeces is low. WHO, 2004

Bromate Bromate may be converted into hypobromic acid by hypochloric acid in the stomach. Liver and kidney tissues may degrade bromate to bromide by a process involving glutathione, although only a small amount appears to be reduced in this way. Bromate is excreted mainly by urine as bromate and bromide and some may also be eliminated by faeces. Bromate concentrationsin urine peak at about 1 hour, and bromate is not detectable in plasma after 2 hours4. MEPC 58/2/7, GESAMP-BWWG 6/9, annex 5

Sodium thiosulphite Sodium thiosulfite is poorly absorbed from bowel and thiosulfite ion distributes itself in extracellular fluid. HSDB, 2009

* * *GESAMP-BWWG 11/6 ANNEX 6 Page 37

I:\MEPC\60\2-12.doc APPENDIX 3

ENVIRONMENTAL FATE DA TA FOR ACTIVE SUBSTANCES, RELEVANT CHEMICAL AND OTHER CHEMICALS

1 MODES OF DEGRADATION (biotic; abiotic)

1.1 The degradation information of the Active Substances, Relevant Chemicals and other chemicals are presented in Tables 4-13, 4-14 and 4- 15. The results show that the half-lives of the chemicals are ranging from hours to years. For ex ample, the half-lives of HOCl are 0.8 hour (at pH 7) and 1.4 hour (at pH 8). Chloramine half- lives are ranging from 9 to 420 hours. . Half-life of tribromomethane in fresh water is 1.7 years a nd the half-life of monobromoacetic acid in water is 8.7 days, in soil: 17 days, in sediment: 78 days and in air: 22 days.

Aerobic degradation for the Chemicals

Chemical Aerobic Degradation Reference/Comments HOCl(NaOCl) No data found

HOBr(NaOBr) No data found

Chloramine No data found

Tribromomethane 0% biodegradation in 4 weeks at 30 mg/L and the Japanese MITI test HSDB, 2009

Dibromochloromethane 25-39% loss in 28 days; HSDB, 2006

Monobromoacetic acid Fresh water Mineralized in river water with 73% conversion to carbon dioxide in 8-10 days at 29oC. FPTC, 2006

Dibromoacetic acid Probability of Biodegradability =1.000, due to probability of biodegradability is greater than 0.7, dibromoacetic acid may be capable to biodegradation. MEPC 58/2

Tribromoacetic acid Probability of Rapid Biodegradation: Biowin 1(Linear model)-0.3565

Biowin 2(Non-linear model)-0.0000 Expert Survey Biodegradation

Results: Biowin3 (Ultimate survey model) -2.7827 weeks Biowin4 (Primary survey model)-3.7579 days MEPC 58/2

Bromochloroacetic acid activated sludge

, 65% loss in 21 days activated sludge

, 100% loss in 28 days ECB, IUCLID, 2000

Dibromochloroacetic acid activated sludge

, 65% loss in 21 days activated sludge

, 100% loss in 28 days ECB, IUCLID, 2000GESAMP-BWWG 11/6 ANNEX 6 Page 38

I:\MEPC\60\2-12.doc Chemical Aerobic Degradation Reference/Comments Dibromoacetonitrile No data found Bromate No data found Sodium thiosulphite No data found

Anaerobic degradation for the Chemicals

Chemical Anaerobic Degradation Reference/Comments HOCl(NaOCl) No data found

HOBr(NaOBr) No data found

Chloramine No data found

Approximately 20% of the initial concentration of 57 ug/L underwent biodegradation after 6.25 hours; approximately 30% biodegraded after 25 hours. Wookeun B et al. ,1990

Greater than 99% of the initial concentration of 18 ug/L was removed under methanogenic, denitrification and sulfate reducing conditions after 2.5 days Bouwer EJ and Wright JP, 1988 Tribromomethane

Greater than 99% reduction, initially present at 132-177 ug/L was observed after 1.5 hours Cobb GD and Bouwer EJ, 1991

Dibromochloromethane 100% loss in 2 weeks; mixed methanogenic bacterial culture HSDB, 2006

Monobromoacetic acid No data found Dibromoacetic acid No data found Tribromoacetic acid No data found Bromochloroacetic acid Bacteria

, 100% loss in 2 days ECB, IUCLID, 2000

Dibromochloroacetic acid Bacteria

, 100% loss in 2 days ECB, IUCLID, 2000 Dibromoacetonitrile No data found Bromate No data found Sodium thiosulphite No data foundGESAMP-BWWG 11/6 ANNEX 6 Page 39

I:\MEPC\60\2-12.doc The Half-lives of the Chemicals

Chemical Half-life Reference/Comments HOCl(NaOCl) Half-life:1.4 hour(at pH 8) Taylor, 1993

HOBr(NaOBr) Biodegrades fast MEPC 59/2/16 GESAMP-BWWG 8/6, annex 6

Chloramine Chloramine half-lives ranging from 9 to 420 hours HSDB, 2009

Tribromomethane Half-life (fresh water):1.7 years HSDB, 2009 Dibromochloromethane Half-life: Water: 38 days Soil: 75 days Sediment: 340 days Air: 280 days PBT Profiler

Monobromoacetic acid Half-life: Water: 8.7 days Soil: 17 days Sediment: 78 days Air: 22 days PBT Profiler

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

Tribromoacetic acid Half-life: Water: 15 days Soil: 30 days Sediment: 140 days Air: 31 days PBT Profiler

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

Dibromochloroacetic acid No data found

Dibromoacetonitrile Half-life: Water: 38 days Soil: 75 days Sediment: 340 days Air: 540 days PBT Profiler

Bromate Seawater: 12 hours MEPC 57/2/10 GESAMP-BWWG 5/9, annex 5

Sodium thiosulphite Biodegrades fast MEPC 59/2/16 GESAMP-BWWG 8/6, annex 6GESAMP-BWWG 11/6 ANNEX 6 Page 40

I:\MEPC\60\2-12.doc 2 BIOACCUMULATION, PARTITION COEFFICIENT, OCTANOL/WATER PARTITION COEFFICIENT

2.1 The octanol/water partition coefficients (P ows) and bioaccumulation factors (BCFs) for the Active Substances

, Relevant Chemicals and other chemicals are given above in section 4.1.5. The adsorption coefficients (Kocs) for the Active Substances

, Relevant Chemicals and other chemicals ar e given in section 4.1.4.

3 PERSISTENCE AND IDENTIFICATION OF THE MAIN METABOLITES IN THE RELEVANT MEDIA (BALLAST WATE R, MARINE AND FRESH WATERS)

3.1 Active Substances have low Log Pow (range from -3.42 to -1.03) and BCF values and, therefore, it is expected they are not considered to be bioaccum ulation on aquatic organisms and to be main metabolites. For Relevant Chemical s and other chemicals, there is no food chain concentration potential. Due to low Log Pows and BCF values, it is unlikely that these will be accumulated through the aquatic organisms and metabolites.

4 REACTION WITH ORGANIC MATTER

4.1 HOCl (NaOCl) reacts with organic matte r in water forming by-products such as halomethanes and halogenated acetic acids.

4.2 For most of Relevant Chemicals, there is no accumulation through aquatic organisms and there is no available information on reaction with organic matter by Relevant Chemicals.

5 POTENTIAL PHYSICAL EFFECTS ON WILDLIFE AND BENTHIC HABITATS

5.1 No data were found, indicating that the Active Substances

, Relevant Chemicals and other chemicals could cause potenti al physical effects to wildlife.

6 POTENTIAL RESIDUES IN SEAFOOD

6.1 Based on the low log Pows and BCFs of th e Active Substances, Relevant Chemicals and other chemicals, there is little possibility for significant residues to accumulate in tissues which could impact the consumption of seafood

7 ANY KNOWN INTERACTIVE EFFECTS

7.1 No interactive effects of the Active Substa nces, Relevant Chemical s and other chemicals have been identified.

* * *GESAMP-BWWG 11/6 ANNEX 6 Page 41

I:\MEPC\60\2-12.doc APPENDIX 4

PHYSICAL PROPERTIES FOR ACTIVE SUBSTANCES, RELEVANT CHEMICAL AND OTHER CHEMICALS

1 PHYSICAL AND CHEMICAL PROPER TIES FOR ACTIVE SUBSTANCES

1.1 Hypochlorous acid/hypochlorite

Property Value Reference/Comments/ Justification for missing data Melting point (°C) - 20 to -30° C ECB, Risk Assessment Report for Sodium hypochlorite, 2007

Boiling point (°C) 96 – 120 °C ECB, Risk Assessment Report for Sodium hypochlorite, 2007

Flammability (flash point for liquids; °C) Non flammable solution Th e chemical data base

Density (20 °C; kg/m 3 ) 1.23 g/cm3 at 25°C ECB, Risk Assessment Report for Sodium hypochlorite, 2007 Vapour pressure (20 °C; Pa) 17.4 - 20 hPa at 20°C ECB, Risk Assessment Report for Sodium hypochlorite, 2007 Vapour density (air = 1) N. A Water solubility (temp; effect of pH; mg/L) Miscible [29.3 g/100 g (0 deg C) in water] ECB, Risk Assessment Report for Sodium hypochlorite, 2007 pH in solution >11@20°C Approx. 11 ECB, IUCLID, 2000

Dissociation constant (pKa) N. A Oxidation-reduction potential N. A Corrosivity to material or equipment Contact with metals may evolve flammable hydrogen

gas The chemical data base

Reactivity to container material Contact with metals may evolve flammable hydrogen

gas The chemical data base

Auto-ignition temperature (°C) Non flamma ble solution The chem ical data base Explosive properties Anhydrous sodium hypochlorite is very explosive. ECB, Risk Assessment Report for Sodium hypochlorite, 2007

Oxidizing properties Strong oxidizing agent usually stored and used insolution ECB, Risk Assessment Report for Sodium hypochlorite, 2007

Surface tension N. A Viscosity N. A Thermal stability and identity of breakdown products N. A

Other physical or chemical properties N. AGESAMP-BWWG 11/6 ANNEX 6 Page 42

I:\MEPC\60\2-12.doc 1.2 Hypobromous acid/hypobromite

Property Value Reference/Comments/ Justification for missing data Melting point (°C) -7.2 The Chemical Database Boiling point (°C) -58.7 The Chemical Database Flammability (flash point for liquids; °C) Non flammability ICSC: 0107

Density (20 °C; kg/m 3 ) 3.121g/cm 3 The Chemical Database Vapour pressure (20 °C; Pa) 190mmHg (25°C) The Chemical Database Vapour density (air = 1) 5.5 The Chemical Database Water solubility (temp; effect of pH; mg/L) Insoluble The Chemical Database

pH in solution N. A Dissociation constant (pKa) N. A Oxidation-reduction potential N. A Corrosivity to material or equipment Corrosiveness: Atta cks all metals and organic tissues of pl astics, only those which are fluorinate d resist bromine attack. ECB, IUCLD, 2000

Reactivity to container material Corrosiveness: Atta cks all metals and organic tissues of pl astics, only those which are fluorinate d resist bromine attack. ECB, IUCLD, 2000

Auto-ignition temperature (°C) Flash point: -18°C The Chemical Database

Explosive properties Not ex plosive ECB, IUCLD, 2000 Oxidizing properties A very power ful oxidizer ECB, IUCLD, 2000 Surface tension 40.9g/s 2 (25°C) The Chemical Database Viscosity 0.314sq mm/s The Chemical Database Thermal stability and identity of breakdown products Producing hydrogen bromide The Chemical Database

Other physical or chemical properties N.A.

1.3 Chloramine

Property Value Reference/Comments/ Justification for missing data Melting point (°C) -66 °C HSDB, 2009 Boiling point (°C) N. A Flammability (flash point for liquids; °C) N. A

Density (20 °C; kg/m 3 ) N. A Vapour pressure (20 °C; Pa) N. A Vapour density (air = 1) N. AGESAMP-BWWG 11/6 ANNEX 6 Page 43

I:\MEPC\60\2-12.doc Property Value Reference/Comments/ Justification for missing data Water solubility (temp; effect of pH; mg/L) Soluble in water, alcohol and ether HSDB, 2009

pH in solution N. A Dissociation constant (pKa) N. A Oxidation-reduction potential N. A Corrosivity to material or equipment N. A

Reactivity to container material N. A

Auto-ignition temperature (°C) N. A Explosive properties N. A Oxidizing properties N. A Surface tension N. A Viscosity N. A Thermal stability and identity of breakdown products It may decompose violently above -66 °C , When heated to decomposition it emits very toxic fumes of /nitrogenoxides, ammonia, and hydrogen chloride/. HSDB, 2009

Other physical or chemical properties Sensitive to light, temperature and pH change. Reacts with oxidizing materials. The chemical database

2 PHYSICAL AND CHEMICAL PROPERTI ES FOR THE RELEVANT CHEMICALS

2.1 Tribromomethane

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 9.2 The chemical database Boiling point (°C) 149.5 The chemical database Flammability (flash point for liquids; °C) 83 The chemical database

Density (20 °C; kg/m3) 2.8912 g/cm3 (20 C) The chemical database

Vapour pressure (20 °C; Pa) 700 ICSC 0108

Vapour density (air = 1) 8.7 The chemical database

Water solubility (temp; effect of pH; mg/L) 0.1 g/100 g water at 20 °C HSDB, 2009

pH in solution N.A. Dissociation constant (pKa) N.A. Oxidation-reduction potential N.A.GESAMP-BWWG 11/6 ANNEX 6 Page 44

I:\MEPC\60\2-12.doc Property Value Reference/Comments/ Justification for missing data Corrosivity to material or equipment Keep away from metals. Liquid bromoform will attack some forms of plastics, rubber, and coatings The chemical database HSDB, 2009

Reactivity to container material Do not store in metal containers. The chemical database

Autoignition temperature (°C) N.A.

Explosive properties N.A. Oxidizing properties Strong oxidizing agents, The chemical database

Surface tension 41.53 dynes/cm at 20 °C HSDB, 2009 Viscosity 1.73 cp (35 C) The chemical database

Thermal stability and identity of breakdown products Stable at room temperature in closed containers under normal storage and handling conditions. Carbon monoxide, irritating and toxic fumes and gases, carbon dioxide, hydrogen bromide. The chemical database

Other physical or chemical properties Colorless liquid, with characteristic odour. Turns yellow exposure on light and air. ICSC 0108

2.2 Dibromochloromethane

Property Value Reference/Comments/ Justification for missing data Melting point (°C) -20 °C HSDB, 2006 Boiling point (°C) 121.3-121.8°C HSDB, 2006 Flammability (flash point for liquids; °C) 20 °C The chemical database

Density (20 °C; kg/m 3 ) 2.38 HSDB, 2006 Vapour pressure (20 °C; Pa) 5.54 mm Hg at 25 deg C (est) HSDB, 2006

Vapour density (air = 1) 7.1 The chemical database Water solubility (tem p; effect of pH; mg/L) 2.07×10 3 mg/L at 20°C HSDB, 2006

pH in solution N.A. Dissociation constant (pKa) N.A. Oxidation-reduction potential N.A. Corrosivity to material or equipment N.A.

Reactivity to container material N.A. Auto-ignition temperature (°C) N.A. Explosive properties N.A. Oxidizing properties N.A. Surface tension N.A.GESAMP-BWWG 11/6 ANNEX 6 Page 45

I:\MEPC\60\2-12.doc Property Value Reference/Comments/ Justification for missing data Viscosity N.A. Thermal stability and identity of breakdown products N.A.

Other physical or chemical properties Enthalpy of formation at 25°C: -5.0 kcal/mole (gas); Gibbs free energy of formation at 25°C: -4. 50 kcal/mole (gas); entropy at 25°C: 78.31 cal/mole (gas) HSDB, 2006

2.3 Monobromoacetic acid

Property Value Reference /Comments/Justification for missing data Melting point (°C) 49 HSDB, 2009 Boiling point (°C) 208 HSDB, 2009 Flammability (flash point for liquids; °C) 113 Sigma-Aldrich, MSDS, 2006

Density (20 °C; kg/m 3 ) 1.9335 g/cm 3 The Chemical Database,2009 Vapour pressure (20 °C; Pa) 0.09 mmHg (25 °C ) The Chemical Database,2009

Vapour density (air = 1) N.A. Water solubility (tem p; effect of pH; mg/L) Miscible The Chemical Database,2009

pH in solution N.A. Dissociation constant (pKa) 2.72 The Chemical Database, 2009 Oxidation-reduction potential N.A. Corrosivity to material or equipment N.A.

Reactivity to container material N.A. Auto-ignition temperature (°C) N.A. Explosive properties N.A. Oxidizing properties N.A. Surface tension 40.3 g/s 2 (55 °C ) The Chemical Database,2009

Viscosity 3.65 cp (50 °C ) The Chemical Database,2009

Thermal stability and identity of breakdown products Stable under normal temperatures and

pressures. The Chemical Database,2009

Other physical or chemical properties When heated to decomposition it emits toxic fumes HSDB, 2009GESAMP-BWWG 11/6 ANNEX 6 Page 46

I:\MEPC\60\2-12.doc 2.4 Dibromoacetic acid

Property Value Reference /Comments/Justification for missing data Melting point (°C) 48°C HSDB, 2009 Boiling point (°C) 232-234°C HSDB, 2009 Flammability (flash point for liquids; °C) 94°C The Chemical Database

Density (20 °C; kg/m 3 ) N.A. Vapour pressure (25 °C; Pa) 2.3×10-2 mm Hg HSDB, 2009

Vapour density (air = 1) N.A. Water solubility (temp; effect of pH; mg/L) Very soluble The Chemical Database

pH in solution N.A Dissociation constant (pKa) 1.47(pKa) The Chemical Database Oxidation-reduction potential N.A Corrosivity to material or equipment N.A Reactivity to container material N.A Auto-ignition temperature (°C) N.A Explosive properties N.A Oxidizing properties N.A Surface tension N.A Viscosity N.A Thermal stability and identity of breakdown products N.A

Other physical or chemi cal properties N.A

2.5 Tribromoacetic acid

Property Value Reference/C omments/Justification for missing data Melting point (°C) 135°C The Chemical Database Boiling point (°C) 245°C The Chemical Database Flammability (flash point for liquids; °C) N.A. Density (20 °C; kg/m 3 ) N.A. Vapour pressure (20 °C; Pa) 0.00028 mmHg at 25°C HSDB, 2009

Vapour density (air = 1) N.A Water solubility (temp; effect of pH; mg/L) 20000 mg/L HSDB, 2009

pH in solution N.A Dissociation constant (pKa) 0.72 at 25°C HSDB, 2009 Oxidation-reduction potential N.A. Corrosivity to material or equipment N.A. Reactivity to container material N.A.GESAMP-BWWG 11/6 ANNEX 6 Page 47

I:\MEPC\60\2-12.doc Property Value Reference/Comments/Justification for missing data Auto-ignition temperature (°C) N.A. Explosive properties N.A. Oxidizing properties N.A. Surface tension N.A. Viscosity N.A. Thermal stability and identity of breakdown products N.A.

Other physical or chemical properties N.A.

2.6 Bromochloroacetic acid

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 38 The chemical database Boiling point (°C) 201 The chemical database Flammability (flash point for liquids; °C) 110 Sigma-Aldrich, MSDS 2006 Density (20 °C; kg/m 3 ) 1.9848 g/cm 3 (31 °C) HSDB, 2009 Vapour pressure (20 °C; Pa) 1.4×10 -1 mmHg at 25 °C HSDB, 2009 Vapour density (air = 1) N.A. Water solubility (tem p; effect of pH; mg/L) 2.5×10 +5 mg/L at 25 deg C HSDB, 2009

pH in solution N.A. Dissociation constant (pKa) 1.40 HSDB, 2009 Oxidation-reduction potential N.A. Corrosivity to material or equipment N.A. Reactivity to container material N.A. Auto-ignition temperature (°C) N.A. Explosive properties N.A. Oxidizing properties N.A. Surface tension N.A. Viscosity N.A. Thermal stability and identity of breakdown products N.A.

Other physical or chemical properties Henry’s Law constant=2.2×10-8 atm-cu m/mole at 25 deg C HSDB, 2009GESAMP-BWWG 11/6 ANNEX 6 Page 48

I:\MEPC\60\2-12.doc 2.7 Dibromochloroacetic acid

Property Value Reference/Comments/ Justification for missing data Melting point (°C) N. A Boiling point (°C) N. A Flammability (flash point for liquids; °C) N. A Density (20 °C; kg/m 3 ) N. A Vapour pressure (20 °C; Pa) 5.2×10 -3 mm Hg at 25 deg C (est) HSDB, 2009

Vapour density (air = 1) Water solubility (tem p; effect of pH; mg/L) In water, 2.4×10 3 mg/L at 25°C HSDB, 2009

pH in solution N.A. Dissociation constant (pKa) 0.03 HSDB, 2009 Oxidation-reduction potential N. A Corrosivity to material or equipment N. A Reactivity to container material N. A Auto-ignition temperature (°C) N. A Explosive properties N. A Oxidizing properties N. A Surface tension N. A Viscosity N. A Thermal stability and identity of breakdown products N. A

Other physical or chemical prope rties Henry's Law constant = 2.6×10 -9 atm-cu m/mole at 25 °C HSDB, 2009

2.8 Dibromoacetonitrile

Property Value Reference/C omments/Justification for missing data Melting point (°C) 6.98°C MEPC 58/2 Boiling point (°C) 67°C The chemical database Flammability (flash point for liquids; °C) Non flammability (37°C) The chemical database

Density (20 °C; kg/m 3 ) 2.369 g/cm 3 (20°C) The chemical database

Vapour pressure (20 °C; Pa) 2 mmHg The chemical database Vapour density (air = 1) 6.86 The chemical database Water solubility (tem p; effect of pH; mg/L) Slightly soluble The chemical database

pH in solution N.A. Dissociation constant (pKa) N.A. Oxidation-reduction potential N.A.GESAMP-BWWG 11/6 ANNEX 6 Page 49

I:\MEPC\60\2-12.doc Property Value Reference/Co mments/Justification for missing data Corrosivity to material or equipment N.A. Reactivity to container material N.A. Auto-ignition temperature (°C) N.A. Explosive properties N.A. Oxidizing properties N.A. Surface tension N.A. Viscosity N.A. Thermal stability and identity of breakdown products N.A.

Other physical or chemical properties N.A.

2.9 Bromate

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 350 The chemical database Boiling point (°C) Decomposition point: 370°C The chemical database

Flammability (flash point for liquids; °C) N.A. Density (20 °C; kg/m 3 ) 3.218 g/cm 3 The chemical database Vapour pressure (20 °C; Pa) N.A. Vapour density (air = 1) 5.8 Water solubility (temp; effect of pH; mg/L) 75 g/L pH in solution N. A Dissociation constant (pKa) N. A Oxidation-reduction potential N. A Corrosivity to material or equipment N. A Reactivity to container material N. A Auto-ignition temperature (°C) N. A Explosive properties N. A Oxidizing properties Oxidizer The chemical database Surface tension N. A Viscosity N. A Thermal stability and identity of breakdown products N. A

Other physical or chemical properties N.A.GESAMP-BWWG 11/6 ANNEX 6 Page 50

I:\MEPC\60\2-12.doc 3 PHYSICAL AND CHEMICAL PROPERTIES FOR THE OTHER CHEMICALS

3.1 Sodium thiosulphate

Property Value Reference/Comments/ Justification for missing data Melting point (°C) 48 The chemical database Boiling point (°C) 100 The chemical database Flammability (flash point for liquids; °C) Non flammable ECB, IUCLID, 2000

Density (20 °C; kg/m 3 ) 1740 kg/m 3 ECB, IUCLID, 2000 Vapour pressure (20 °C; Pa) N. A Vapour density (air = 1) N. A Water solubility (tem p; effect of pH; mg/L) 701g/l at 20 °C pH : Ca. 6.5-9 at 100g/l and 25°C ECB, IUCLID, 2000

pH in solution N. A Dissociation constant (pKa) N. A Oxidation-reduction potential N. A Corrosivity to material or equipment N. A Reactivity to container material N. A Auto-ignition temperature (°C) N. A Explosive properties Not explosive ECB, IUCLID, 2000 Oxidizing properties No oxidizing properties ECB, IUCLID, 2000 Surface tension N. A Viscosity N. A Thermal stability and identity of breakdown products Stable under normal temperatures and pressures. Decomposition: Oxides of sulfur, hydrogen sulfide, sodium oxide. ECB, IUCLID, 2000

Other physical or chemical properties N.A.

4 PHYSICAL AND CHEMICAL PROPERTI ES OF THE TREATED AND UNTREATED SEAWATER

Property Untreated seawater Treated seawater Melting point (°C) N.A. N.A. Boiling point (°C) N.A. N.A. Flammability (flash point for liquids; °C) N.A. N.A.

Density (20 °C; kg/m 3 ) 1.0235 1.0235. Vapour pressure (20 °C; Pa) N.A. N.A. Vapour density (air = 1) N.A. N.A. Water solubility (tem p; effect of pH; mg/L) N.A. N.A.GESAMP-BWWG 11/6 ANNEX 6 Page 51

I:\MEPC\60\2-12.doc Property Untreated seawater Treated seawater pH in solution 8.23 8.09 Dissociation constant (pKa) N.A. N.A. Oxidation-reduction potential 283 287 Corrosivity to material or equipment / / Reactivity to container material N.A. N.A. Auto-ignition temperature (°C) N.A. N.A. Explosive properties N.A. N.A. Oxidizing properties N.A. N.A. Surface tension N.A. N.A. Viscosity N.A. N.A. Thermal stability and identity of breakdown products N.A. N.A.

Salinity 30.13 29.74 TOC, % particulate matter 1.90 3.21 DOC, % particulate matter 1.75 2.89 Other physical or chemical properties N.A. N.A.

* * *GESAMP-BWWG 11/6 ANNEX 6 Page 52

I:\MEPC\60\2-12.doc APPENDIX 5

WATER PROPERTIES AMONG TEST WATERS USED FOR ECOTOXICITY TESTING AND CHEMICAL ANALYSIS

Chemicals Control 0h after treatment Without neutralization 24h after treatment Without neutralization 48h after treatment

With neutralization 120h after treatment With neutralization

Sampling date April 14 April 14 April 15 April 16 April 19 Temperature 10.0 10.0 10.5 11.0 12.0

Salinity 30.13 30.09 29.81 29.74 30.19

TSS mg/l 2.6 6.6 8.2 4.4 1.2

DO mg/l 9.92 10.73 10.51 8.97 8.79

pH 8.23 8.22 8.22 8.09 8.04 Turbidity 1.4 1.4 1.5 1.5 1.4

DOC mg/l 1.75 1.55 1.66 2.89 1.66

POC mg/l 0.15 0.12 0.09 0.32 0.26

Eh mV 283 272 281 287 292

Relative density 1.0235 1.0235 1.0235 1.0235 1.0235

Chemical analysis of untreated and treated water

Chemicals Control 0h after treatment Without neutralization 24h after treatment Without neutralization 48h after treatment

With neutralization 120h after treatment

With neutralization Quantification

limit

Hypochlorous acid

/hypochlorite ND 980 115 ND ND 40

Hypobromous acid

/hypobromite ND 7310 2005 ND ND 6

Chloramines/ Bromamines ND 410 280 ND ND 40

Trichoromethane 0.08 0.06 0.05 0.05 0.03 0.02Bromodichloromethane 0.05 0.05 0.04 0.05 0.04 0.02

Dibromochloromethane 0.06 0.07 0.11 0.10 ND 0.03

Tribromomethane ND 1.96 5.08 4.32 2.40 0.02

Dibromoacetic acid 0.19 74.87 200.34 157.98 129.78 0.03

Bromochloroacetic acid 0.19 0.23 0.60 0.58 0.61 0.03

Dibromoacetic acid 0.52 12.09 20.30 19.98 17.74 0.03

Dibromochloroacetic acid ND 5.12 6.60 5.40 5.23 0.03

Tribromoacetic acid ND 45.62 55.25 41.63 40.99 0.03

Dibromoacetonitrile ND 5.05 11.89 11.09 7.72 0.01

Bromate ND 34.3 20.1 ND ND 0.4 Sodium thiosulfite ND ND ND 862 529 20

***GESAMP-BWWG 11/6

I:\MEPC\60\2-12.doc ANNEX 7

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

DESMI Ocean Guard Ballast Water Management System

Submitted by Denmark for Basic Approval

0 SUMMARY

0.1 Having considered all of the information provided by the applicant, the Group, agreed that the DESMI Ocean Guard Ballast Water Ma nagement System (BWMS) be recommended for Basic Approval subject to all the comments and r ecommendations of this report being taken into

account.

0.2 The Group agreed that the DESMI Ocean Guard Ballast Water Management System should not cause any unacceptable risk to the marine environment.

0.3 Recognizing that, based on the informati on provided by the applicant, ballast water treated with the DESMI Ocean Guard Ballast Wa ter Management System should not cause any unacceptable risk to the marine environment. Ne ither should it cause any unacceptable risk to human health or the structure of the ship.

0.4 The Group recognized that the applicant ha s identified the relevant human exposure scenarios regarding occupational and general public by using an OEL to address inhalation risk in the workplace and TDI to address the risk resulting from combined exposures (swimming and eating fish from the area). The Group agreed that the risk was not unacceptable to the crew and general public.

1 INTRODUCTION

1.1 Data used to evaluate this system we re extracted from ME PC 60/2/4 and were supplemented by additional info rmation provided to the Group.

2 DESCRIPTION OF THE SYSTEM

2.1 The Group noted that the DESMI Ocean Guard BWMS proposed treatment at both uptake and discharge of ballast water. Th e main components of the system are:

.1 an automatic backflushing filtration unit (either a 20 μm gravity fed-free flow filter or a 40 μm pressurized unit);

.2 an ozone-generating component;

.3 a venturi injector system for introduc ing the generated ozone with the ballast water;

.4 an ozone reactor which incl udes a de-aeration function; and

.5 a UVC radiation treatment phase.GESAMP-BWWG 11/6 ANNEX 7 Page 2

I:\MEPC\60\2-12.doc 2.2 It was noted that the filtra tion stage is to be by-passed when the treatment is applied during discharge of ballast water.

2.3 It was noted that generated ozone is injected into the water flow wh ere it reacts with the ballast water in the ozone reacto r that uses a pre-determined holding time to ensure efficient treatment. Any excess gaseous ozone is exhauste d from the ozone reactor and destroyed and any remaining dissolved ozone is decomposed during the following UV treatment.

2.4 Furthermore, it was noted that the applican t claimed that the system did not produce any persistent oxidants in the treated ballast water.

2.5 The Group recalled that it had evaluated simila r systems, which employed high pressure (HP) or medium pressure (MP) UV light , but that this system used lo w pressure (LP) UV generation to create UV-C light which has a narrower wavelengt h range (primarily 254 nm) than other systems.GESAMP-BWWG 11/6 ANNEX 7 Page 3

I:\MEPC\60\2-12.doc 2.6 A simplified flow diagram of the complete system, supplied by the applicant is shown below:GESAMP-BWWG 11/6 ANNEX 7 Page 4

I:\MEPC\60\2-12.doc 2.7 The Group noted that the applicant was proposing two versions of this system:

.1 an open pressureless filter systems, for situations where space is not a limiting factor, such as on new-build ships. These will use filters of 20μm and the water will flow by gravity through the filter to a combined filter housing/buffer tank; or

.2 a standard pressurized filter (40μm) prim arily for retrofits wher e space might be at a premium.

2.8 The Group noted that filtration is only inte nded during uptake of ballast water but that during ballasting and de-ballasting ozone is injected into the wate r which is then allowed a period of approximately 30 seconds to react pr ior to entering the UV treatment section.

2.9 The Group noted that the ozone dose was 0.8 mg/L as O 3 in ambient air. This followed by a UV dose in the range of 150 mJ/cm 2 – 250 mJ/cm 2 . The applicant indicated that this UV dose will both disinfect the ball ast water and degrade the TRO con centration of the treated water to below 0.04 mg/L as Cl 2 . In this context, the Group reco mmended that the applicant provide data to confirm the TRO concentration following the total treatment on uptake and during discharge.

2.10 With the additional information provided by the applicant, the Group noted that maximum dose concentration of ozone is 0.4 mg/L (as O 3 ) and the dose can be controlled according to water conditions. The Group strongly recommended that the applicant should clarify, in detail, the application of the ozon e dose and its control in its application for Final Approval.

3 CHEMICALS ASSOCIATED WITH THE SYSTEM

3.1 The Group noted that the primary disinfective moiety in this system is the photon which is the particle form of the wave/particle duality concept of light. The UVC spectrum (100-280 nm) employed by this system has germicid al properties in a pro cess referred to as photolysis which disrupts chemical bonds particul arly in the DNA of micro-organisms. The dual chromatic lamps used in this system emit light at 185 nm and 254 nm.

3.2 The Group noted that the applicant had iden tified the following Active Substances (AS) associated with this system:

.1 ozone, which is generated in situ but has a short half-life (<30 min) and will not enter the environment in the treated ballast water; and

.2 hydroxyl radicals, have a half-life of milliseconds only and so will not enter the environment in the treated ballast water.GESAMP-BWWG 11/6 ANNEX 7 Page 5

I:\MEPC\60\2-12.doc 3.3 Recognizing that the Active Substances reac t with organic components contained in the ballast water, the app licant provided analysis results for the most likely chemical by-products anticipated in the treated ballast wa ter with the results shown below:

Parameter Fresh water before treatment Fresh water after treatment Marine water before treatment Marine water after treatment

Sum parameters and nitrite (mg/L) Nitrite (NO 2 ), mg/L 0.28 0.33 <0.005 <0.005 AOX, mg/L 0.05 0.04 0.17 <0.01 EOX, mg/L < 0.001 < 0.001 < 0.001 < 0.001 TRO mg Cl 2 /L < 0.04 < 0.04 0.35 < 0.04 VOC, mg/L 0.09 0.1 0.04 0.03 NVOC, mg/L 15 15 3.3 3.3 Suspended matter, mg/L 5.2 3.1 4.8 3.3 Trihalomethanes (THM) Trichloromethane CHCl 3 (chloroform) < 0.05 < 0.06 < 0.07 < 0.08 Tribromomethane CHBr 3 (bromoform) < 0.02 < 0.02 < 0.02 < 0.02 Dibromochloromethane CHClBr 2 < 0.02 < 0.02 < 0.02 < 0.02 Dichlorobromomethane CHBrCl 2 < 0.02 < 0.02 < 0.02 < 0.02 Highly volatile halogenated hydrocarbons (LHKW) 1,2-dibromoethane < 0.02 < 0.02 < 0.02 < 0.02 1,2,3-trichloropropane < 0.02 < 0.02 < 0.02 < 0.02 2-chlorotoluene < 0.02 < 0.02 < 0.02 < 0.02 4-chlorotoluene < 0.02 < 0.02 < 0.02 < 0.02 1,2-dibromo-3-chloropropane < 0.02 < 0.02 < 0.02 < 0.02 1,2,3-tribromobenzene < 0.05 < 0.05 < 0.05 < 0.05 1,1,1-Trichloroethane < 0.02 < 0.02 < 0.02 < 0.02 Carbon tetrachloride < 0.02 < 0.02 < 0.02 < 0.02 Tetrachlorethene < 0.02 < 0.02 < 0.02 < 0.02 Haloacetic Acids (HAA) (μg/L) Monochloroacetic acid (MCAA) < 1.0 < 1.0 < 1.0 < 1.0 Dichloroacetic acid (DCAA) < 1.0 < 1.0 < 1.0 < 1.0 Trichloroacetic acid (TCAA) < 1.0 < 1.0 < 1.0 < 1.0 Monobromoacetic acid (MBAA) < 1.0 < 1.0 < 1.0 < 1.0 Dibromoacetic acid (DBAA) < 1.0 < 1.0 < 1.0 < 1.0 Tribromoacetic acid (TBAA) < 1.0 < 1.0 < 1.0 < 1.0 Bromochloroacetic acid (BCAA) < 1.0 < 1.0 < 1.0 < 1.0 Dibromochloroacetic acid (DBCAA) < 1.0 < 1.0 < 1.0 < 1.0 Dichlorobromoacetic acid (DCBAA) < 1.0 < 1.0 < 1.0 < 1.0 Bromophenols (μg/L) 2,4-dibromophenol <0.01 <0.01 <0.01 <0.01 2,6-dibromophenol <0.02 <0.02 <0.02 <0.02 2,4,6-tribromophenol <0.04 <0.04 <0.04 <0.04 Acetonitrils (μg/L) Dibromoacetonitrile < 1. 0 < 1.0 < 1.0 < 1.0 Bromochloroacetonitrile < 1.0 < 1.0 < 1.0 < 1.0

3.4 Properties of the above products used in environmental fate modelling are shown in appendix 1.

3.5 The Group noted that, during this sampling, th e TRO sensor after UV sterilizer had not yet been installed. The Group considered that the chemical analysis, above, was only the measured data for discharged concentration of TRO. The Group recommended that chemicalGESAMP-BWWG 11/6 ANNEX 7 Page 6

I:\MEPC\60\2-12.doc analysis, including TRO discharge concentration, should be repeated with adequate QA/QC in accordance with Guidelines in (G9).

3.6 Furthermore, the Group recommended that, in order to confirm the efficacy of the TRO removal, by UV irradiation, the TRO concentra tion should be measured both upstream and downstream of the UV sterilizer for evaluation during consid eration for Final Approval.

4 QUESTIONS PUT TO THE APPL ICANT DURING EVALUATION WITH ANSWERS AND THE GROUP’S REACTION

Question 1:

The dossier indicates that the residence time in the ozone reactor is between 30 – 120 seconds. For a 1500 m 3 per hour system this would appe ar to require the ozone reactor to have a minimum sizing between 12.5 m 3 and 50 m 3 . Please could you indicate the actual size of the ozone reactor which is planned for full-scale ship use?

Response 1:

.1 You are right about the calculated oz one reactor volumes for 1500 m3/h ballast water flow.

.2 The planned reactor volume is based on 30 seconds residence time corresponding to 12.5 m3 for 1500 m3/h flow.

.3 This is also the residence time used in our scaled set-up from which the reported data originates.

.4 The reason for writing 30-120 seconds is that we have discussed the possibility to use, as an alternative option, a ballast wa ter tank as the ozone reaction chamber.

.5 If it turns out to be technically safe (especially consider ing the corrosion and safety issues) it might be in teresting. Since ballast water tanks have different sizes we will have different residence times.

Reaction: The Group agreed with the response , however, if the alternative option is pursued, then this system would have to be assessed under a new application.

Question 2:

Please could you provide the actual dosing rate of ozone used to generate the data in your application?

Response 2:

.1 The dosing rates calculated for the tests was approximately 0.4 mg O3/l. Rates are calculated using measured ozone concentratio ns in the gas going in and out of the ozone reactor. It is difficult to measure the initial ozone concentrations in the water due to the very fast ozone reactions. Ozone dosi ng is therefore determined using indirect measures (t he gas concentrations).GESAMP-BWWG 11/6 ANNEX 7 Page 7

I:\MEPC\60\2-12.doc .2 The ozone concentration in the water leaving the ozone reactor (before UV-radiation) will very much depend on the ozone “consumption” by the treated water. If the treated water is ve ry clean (no oxidizabl e substances), it is possible to reach high ozone concentrati ons in the ozone reactor outlet. The dissolved ozone sensor (see figure 2, Syst em Flow Diagram) will be used to control ozone gas production so that the ozone reactor outlet concentration at any time will be less than 0.25 mgO3/l. This maximum value guarantees that the UV-system will be able to destru ct residual ozone at any time.

Reaction: The Group was satisfied with the response.

Question 3:

What is the measure TRO value just after tr eatment by ozone/UV i.e.at the place on your flow diagram where the TRO sensor is indicated.

Response 3:

.1 The measured TRO values after ozone/ UV treatment was <0.04 mg/L (as Cl2) for both fresh and marine water. Please see ta ble 3, row 6 in the application. The term “Oxidizing substances” is e quivalent to total residual oxidants (TRO). We should have used “TRO” as this is commonly us ed to express the co llection of residual oxidizing species such as chlorine, bromine etc.

.2 Samples were taken immediately after UV- treatment. Therefore, at the same place as the TRO, sensor will be installed in the final system.

Reaction: The Group was satisfied with the response.

Question 4:

What is the difference between the dissolved ozone sensor, the DO sensor and the TRO sensor? Could you kindly provide the measur ement principle of “dissolved ozone sensor”?

Response 4:

.1 Dissolved ozone sensor – It is designed to be ve ry sensitive to ozone in comparison to other substances; this is primarily due to the membrane and the electrolyte.

.2 DO sensor – A dissolved oxygen sensor follows the same principle as the ozone sensor, but it measures the oxygen concentration in the water.

.3 TRO sensor – The total residual oxidant sensor me asures all substances that have an oxidation potential. This means bot h the ozone and the by-products of an ozone reaction like, for instance, bromate.GESAMP-BWWG 11/6 ANNEX 7 Page 8

I:\MEPC\60\2-12.doc .4 A method for measuring dissolved ozone is an electrochemical ozone sensor with a porous membrane that allows ozone to diffuse into a cel l containing liquid electrolyte and electrodes. When the dissolved gas comes into contact with the electrolyte, a change in electrochemi cal potential between the electrodes is produced. This change is proportional to the dissolved ozone concentration.

Reaction: The Group noted the respons e. The Group recommended that, for Final Approval, the detailed methods and any applicable standards be provided together with data sheets for these sensors.

Question 5:

During the two tests for chemical analysis and ecotoxicity testing, the TRO sensor, after the UV sterilizer, had not been installed yet. As a result, the chemical analysis at the test laboratory only the measured data for th e discharged concentration of TRO. For confirmation, do you accept the statement above? If not, could you provide other real time TRO measurement data?

Response 5:

.1 Yes.

Reaction: The Group was satisfied with the response.

Question 6:

Re clarification of the date of TRO measurement – In paragraph 4.1 of the application, it is stated that sampling for these ch emical analysis was done on 2 July 2009 and carried to test laboratory (Teknologik Insitut, Arhus) on same day. However, the report from the test laboratory in confidential version, stated that the chemical analysis was performed from 6 to 23 July.

It appears that the TRO concentration was me asured at least 4 days after the sampling timing. As the application states that the fa te of TRO in natural seawater and fresh water is very short, TRO could easily react wi th organic compounds and so be reduced significantly in 4 days. Could you please cl arify and confirm the timing between sampling and TRO measurement at test lab?

Response 6:

.1 All samples were either analysed or conserved for later an alysis on the day of sampling. Teknologisk Institut, Arhus, st ated a wrong date in their report.

Reaction: The Group noted this response.GESAMP-BWWG 11/6 ANNEX 7 Page 9

I:\MEPC\60\2-12.doc 5 WHOLE EFFLUENT TESTING (WET)

5.1 The Group noted that the applicant had carri ed out the following tests on both treated fresh water and treated seawater:

.1 growth inhibition test w ith the fresh water microalga Pseudokirchneriella subcapitata;

.2 growth inhibition test with the marine microalga Skeletonema costatum;

.3 acute toxicity test wi th fresh water crustacean Daphnia magna;

.4 acute toxicity test with the marine crustacean Acartia tonsa; and

.5 acute toxicity test with zebra fish ( Danio rerio ) – fresh water.

5.2 The results of such tests are shown below:

Test organism Sample NOEC LOEC L(E)C10 L(E)C50 Fresh water samples Pseudokirchneriella subcapitata Treated fresh water 80% 80% 80% 80% Daphnia magna Treated fresh water 100% 100% Zebra fish (Danio rerio) Treated fresh water 100% 100% Marine water samples

Skeletonema costatum Treated marine

water 80% 80% 80% 80%

Acartia tonsa Treated marine

water 100% 100%

6 RISKS TO THE SAFETY OF THE SH IP, ITS CREW AND THE GENERAL PUBLIC

6.1 Risks associated with exposure of th e crew to potential chemical by-products

6.1.1 The Group concurred with the applicant’s view that crew exposure to Active Substances and their degradation products could happen in some situations and agreed with the HES chosen by the applicant to address occupational exposure: (a) sampling from the system; and (b) on the loading of the ballast tanks with water.

6.1.2 The Group noted that the appli cant considered the HES (b) as the worst case scenario for crew exposure assessment as chem icals that are partitioned out of the water into the air space above the treated ballast water can be exha usted on board and be inhaled by the crew.

6.1.3 The Group noted that the applicant had used the predicted concentrations in the treated ballast water of the substances and potential chem ical by-products to calculate the concentrations in air at equilibrium in the head space of the ballast tank and then compared these results with the OEL values found for the various substances for various countries. Whenever the substance was not detected in the treated ballast water, the concentration was assumed equal to the detection limit.GESAMP-BWWG 11/6 ANNEX 7 Page 10

I:\MEPC\60\2-12.doc 6.1.4 The Group agreed that no unacceptable risk was expected for crew exposure to this system as the calculated values (with the excep tion of dibromoethane) were below the OELs.

6.2 Risks to the safety of the ship

6.2.1 The Group noted that the applicant had indica ted that ballast wate r treated with this system did not contain any detectable chemicals likely to cause corrosion.

6.2.2 As a result, the Group agreed that the risk to the ship from corrosion resulting from the use of this system would be minimal.

6.2.3 The Group was also satisfied that the risk s of fire, explosion or flooding would be no greater than with any other installation deemed acceptable by the national authorities.

6.3 Risks to the general public from pote ntial exposure during recreational activities

6.3.1 The Group noted that the applicant in orde r to assess general pub lic exposure to the treated ballast water considered the HES (a) oral intake due to bioaccumulation of the substances in seafood and HES b) oral, inhalative and dermal exposure during bathing in areas close to the ballast water outlet. The estimated calculated va lues for the daily uptake via eating fish and swimming in the harbour were found to be below the Tolerable Daily Inta ke (TDI) values for each substance (except for 1,2-dibromoethane for a child who swims twice a day and inhaling air from the area).

6.3.2 Taking the above results into consideration and the overall information, the Group agreed with the applicant that there is no unacceptable risk to the general public when exposed via the environment to this system i.e. due to eating th e fish from the harbour area and due to swimming in the harbour.

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

7.1 Whilst recognizing that none of the potential chemical by-pr oducts had been detected in the treated ballast water, the Group also recognized that neither did these chemicals meet the PBT criteria as shown in the table below:

Substance Persistent (P) Y/N Bioaccumulative (B) Y/N Toxic (T) Y/N Hydrogen peroxide N (1/2-life 15 h) N BCF <100) N Ozone N (1/2-life 28 h) N (BCF <100) N Nitrite N (1/2-life 0.5 h) N (BCF <100) N Sodium hypochlorite N (1/2 -life 0.5 h) N (BCF <100) N Sodium hypobromite N (1/2-life 0.5 h) N (BCF <100) N Trichloromethane N (1/2-life 19 h) N (BCF <100) N Dichlorobromomethane N (1/2-life 19 h) N (BCF <100) NGESAMP-BWWG 11/6 ANNEX 7 Page 11

I:\MEPC\60\2-12.doc Substance Persistent (P) Y/N Bioaccumulative (B) Y/N Toxic (T) Y/N Dibromochloromethane N (1/2 -life 19 h) N (BCF <100) N Tribromomethane N (1/2-life 19 h) N (BCF <100) N Monochloroacetic acid N (1/2-life 15 h) N (BCF <100) N Dichloroacetic acid N (1/2-life 15 h) N (BCF <100) N Trichloroacetic acid Y (1/2-life 147 h) N (BCF <100) N Monobromoacetic acid N (1/2-l ife 15 h) N (BCF <100) N Dibromoacetic acid N (1/2-life 29 h) N (BCF <100) N Bromochloroacetic acid N (1/2 -life 29 h) N (BCF <100) N Dichlorobromoacetic acid Y (1/2-life 147 h) N (BCF <100) N Dibromochloroacetic Y (1/2-life 147 h) N (BCF <100) N Tribromoacetic acid N (1/2-life 29 h) N (BCF <100) N Dibromoacetonitrile Y (1/2-life 147 h) N (BCF <100) N Bromochloroacetonitrile Y (1/2-life 147 h) N (BCF <100) N 2,4-dibromophenol Y (1/2-life 147 h) N (BCF <100) N 2,6-dibromophenol Y (1/2-life 147 h) N (BCF <100) N 2,4,6-tribromophenol N (1/2-life 15 h) N (BCF <100) N 1,2-dibromo-3-chloropropane Y (1 /2-life 29 h) N (BCF <100) N 1,2,3-trichloropropane Y (1/2-l ife 146 h) N (BCF <100) N 2-chlorotoluene Y (1/2-life 147 h) N (BCF <100) N 4-chlorotoluene Y (1/2-life 147 h) N (BCF <100) N

7.3 Calculation of Predicted En vironmental Concentration (PEC)

7.3.1 The Group noted that the appl icant had used the MAMPEC model to estimate the PECs for those potential by-products of the system using:

.1 the detection limits for each chemical as the maximum amount likely to be found in treated ballast water; and

.2 the OECD-EU commercial harbour with a fresh water (FW) and a seawater (SW) scenario.

7.3.2 The results obtained, by the applicant, from running this model are shown below:

CAS No. Substance PEC-SW ( μg/L) PEC-FW ( μg/L)

7632-00-0 Nitrite (NO 2 ) 0.038 0.001 7722-84-1 Hydrogen peroxide (H 2 O 2 ) 0.042 0.027 10028-15-6 Ozone 0.025 0.025 7681-52-9 HOCl/OCl - 0.004 0.004 13824-96-9 HOBr/OBr - 0.004 0.004 79-11-8 Monochloroacetic acid (MCAA) 0.006 0.006GESAMP-BWWG 11/6 ANNEX 7 Page 12

I:\MEPC\60\2-12.doc CAS No. Substance PEC-SW (μg/L) PEC-FW (μg/L) 76-03-9 Trichloroacetic acid (TCAA) 0.007 0.007 79-08-3 Monobromoacetic acid (MBAA) 0.006 0.006 5278-95-5 Dibromochloroacetic acid (DBCAA) 0.007 0.007 71133-14-7 Dichlorobromoacetic acid (DCBAA) 0.007 0.007 3252-43-5 Dibromoacetonitrile 0.007 0.007 83463-62-2 Bromochloroacetonitrile 0.007 0.007

7.3.3 The Group was not able to recalculate these cal culations as the necessa ry input data were not provided.

7.4 Calculation of PEC/PNEC ratios

7.4.1 The Group noted the PNEC values for various potential chemical by-products, as shown in appendix 4, and agreed with the d ecision process used to derive them.

7.4.2 The Group noted the applicant’ s assessment of the PEC/PNEC ratios, as shown below.

Substance Conc. in treated SW (μg/L) PEC-SW (μg/L) PNEC-SW (μg/L) PEC/PNEC Hydrogen peroxide (H 2 O 2 ) 40 0.04 1.2 0.03 Ozone 10 0.025 0.007 3.6 HOCl/OCl - 40 0.004 0.04 0.11 HOBr/OBr - 40 0.004 0.04 0.11 Monochloroacetic acid 1 0.006 0.058 0.11 Trichloroacetic acid 1 0.007 0.02 0.36 Monobromoacetic acid 1 0.006 0.02 0.31 Dibromochloroacetic acid 1 0.007 0.03 0.24 Dichlorobromoacetic acid 1 0.007 0.03 0.24 Dibromoacetonitrile 1 0.007 0.055 0.13 Bromochloroacetonitrile 1 0.007 0.04 0.17

7.4.3 The Group was not able to recalculate these cal culations as the necessa ry input data were not provided. The PEC/PNEC ratio of 3.6 for ozone could, therefore, not be substantiated but it was noted that this was a worst case situation beca use of the detection lim it for ozone being used to calculate the PEC.

7.5 Estimation of Risks to the Environment

7.5.1 The Group agreed that, from the results of the preliminary Whole Effluent Testing (WET) presented, no unacceptable risk would be expected but , in the application for Final Approval, this would need confirmation.

8 CONCLUSIONS AND RECOMMENDATIONS

8.1 The Group agreed that the DESMI Ocean Guard Ballast Water Management System should not cause any unacceptable risk to the marine environment.GESAMP-BWWG 11/6 ANNEX 7 Page 13

I:\MEPC\60\2-12.doc 8.2 The Group noted that the applicant used the MAMPEC model to calculate Predicted Environmental Concentrations (P EC). The Group also noted the applicant’s assessment of the PEC/PNEC ratios. However, the data provided di d not allow recalculation of the concentrations in detail and recommended that clear input data are provided for such model calculation for Final Approval.

8.3 The Group recognized that the methodology used by the applicant to develop HES associated with DESMI Ocean Guard Ballast Wa ter Management System adequately addressed the potential risks of human exposure deriving from this system. The applicant has identified the relevant human exposure scenarios regarding o ccupational and general public by using an OEL to address the inhalation risk in the workpl ace and TDI to address the risk resulting from combined exposures (swimming and eating fish fr om the area). The Group agreed that the risk was not unacceptable to the crew and general public.

8.4 Therefore, the Group concluded that the DESMI Ocean Guard Ballast Water Management System should be recommended for Basic Approval subject to all the comments and recommendations of this report are taken into account.

* * *GESAMP-BWWG 11/6ANNEX 7Page 14I:\MEPC\60\2-12.docAPPENDIX 1PROPERTIES OF POTENTIAL BY PRODUCTS FROM THE DESMI SYSTEMCAS No. SubstanceMwg/moleMPoCBPoClogKOWlogKOCSwmg/LPsatPaHPa m3/moleRed.potentialmVRBAbioticdegradationOverallhalf-life (d)BCF7722-84-1 Hydrogen peroxide34 -0.43 152 -1.57 1.2 1,000,000 263 1.7·10-2NoReduction7.8 hr (F)15.6 hr (M)<10010028-15-6 Ozone48 -193 -112 -0.87 1.4 85,201 2.5·10-37.9·103(F)1.8·104(M) NoReduction27.5 hr (F)** (M)<1007632-00-0Nitrite*68 - - -3.7 1.4 82,000 - 0 NoOxidation0.5 hr<1007681-52-9 Sodium hypochlorite 74310 708 -3.42 1.16 1,000,000 1.4·10-111.0·10-15No Reduction 0.5 hr <10013824-96-9 Sodium hypobromite 119 319 728 -3.33 1.16 1,000,000 1.9·10-152.3·10-19No Reduction 0.5 hr <10067-66-3 Trichloromethane 119 -64 61 1.97 1.55 8,000 2.1·1043.1·102-2.754 No Photolysis 19 <10075-27-4 Dichlorobromomethane 164 -56 118 2 1.55 1,287 7.7·1039.7·102-2.632 No Photolysis 19 <100124-48-1 Dibromochloromethane208 -34 143 2.16 1.55 567 2.1·1037.6·102-2.51 No Photolysis 19 <10075-25-2 Tribromomethane 253 -12 167 2.4 1.55 204 7.1·10254 -2.4 No Photolysis 19 <10079-11-8 Monochloroacetic acid 9563 189 0.22 0.08 3,1700,00 8.7 2.6·10-4-3.081 Yes - 15 <10079-43-6 Dichloroacetic acid 129 24 201 0.92 0.28 37,760 8.9·10-13.0·10-3-3.42 No - 15 <10076-03-9 Trichloroacetic acid163 56 197 1.33 0.44 1,300,000 2.5·1013.2·10-3-3.485 No - 147 <10079-08-3 Monobromoacetic acid 139 29 193 0.41 0.08 93,790 1.7·1012.6·10-2-2.903 Yes - 15 <100631-64-1 Dibromoacetic acid 218 54 243 0.7 0.28 22,140 3.1 3.0·10-2-2.926 No - 29 <1005589-96-8 Bromochloroacetic acid 173 36 223 0.61 0.28 44,270 1.8·1017.2·10-2-3.215 No - 29 <10071133-14-7 Dichlorobromoacetic acid 208 48 235 1.53 0.44 4,869 4.8 2.0·10-1-3.368 No - 147 <1005278-95-5 Dibromochloroacetic252 68 264 1.62 0.44 2,353 6.9·10-17.4·10-2-3.329 No - 147 <10075-96-7 Tribromoacetic acid 297 87 290 1.71 0.44 1,102 3.7·10-21.0·10-2-3.342 No - 29 <1003252-43-5 Dibromoacetonitrile 199 7 204 0.47 1.11 9,600 4.0·1018.3·10-1-2.842 No - 147 <10083463-62-1 Bromochloroacetonitrile 154 -15 181 0.38 1.11 18,720 1.2·1020.0 -2.82 No - 147 <100615-58-7 2,4-dibromophenol 252 71 270 3.22 2.86 156 2.1 3.5 -2.732 No - 147 <100608-33-3 2,6-dibromophenol 252 71 270 3.36 2.87 119 5.7·10-11.2 -2.401 No - 147 <100118-79-6 2,4,6-tribromophenol 331 94 244 4.13 3.07 50 4.2·10-22.8·10-1-1.772 No - 15 513106-93-4 1,2-dibromoethane 188 9-10 131 1.96 1.64 4,040 2.1·1049.6·102-2.017 No Hydrolysis 29 <10096-12-8 1,2-dibromo-3-chloropropane 236 -7 197 2.96 2.12 83 5.9·1011.7·102-1.66 No Hydrolysis 146 <10096-18-4 1,2,3-trichloropropane147 -47 162 2.27 2.12 897 3.6·1023.0·101-1.583 No - 147 <10095-49-8 2-chlorotoluene 127 -27 159 3.42 2.65 114 3.6·1023.9·102-3.577 No - 147 <100106-43-4 4-chlorotoluene 127 -27 162 3.33 2.64 136 3.0·1022.8·102-3.61 No - 147 <100608-21-9 1,2,3-tribromobenzene 315 65 264 4.66 2.87 1 4.4·10-11.3·102-2.788 No - 295 <100* * *GESAMP-BWWG 11/6ANNEX 7Page 15I:\MEPC\60\2-12.docAPPENDIX 2PREDICTED CONCENTRATIONS IN AIR COMPARED WITH THE OEL-VALUES FOUNDFOR THE VARIOUS SUBSTANCESFOR VARIOUS COUNTRIESSubstanceCi(M)μg/LCi(F)μg/LCair (M)mg/m3Cair (F)mg/m3 AT BE CZ CH DE DK EE ES EU FI FR GB GR HU IE IS LT LU LV NL NO PL PT RU SE SI SK USReq. dilutionHydrogen peroxide40 40 3.E-04 3.E-041.4 1.4 0.71 0.71 1.4 1.4 1.5 1.4 1.4 1.4-Ozone10 10 8.E+01 3.E+010.2 0.2 0.1 0.2 0.2 0.12 0.15 0.2770Nitrite5 330-Sodium hypochlorite40 40 2.E-17 2.E-17-Sodium hypobromite40 40 4.E-21 4.E-21-Trichloromethane0.05 0.05 7.E-03 7.E-0310 10 10 2.5 10 10 10 10 10 10 9.9 50 10 9.8 10 10 10 10 5 10 8 5 10 10 10-Dichlorobromomethane0.02 0.02 8.E-03 8.E-03-Dibromochloromethane0.02 0.02 6.E-03 6.E-03-Tribromomethane0.02 0.02 5.E-04 5.E-045 5.3 5 5 5.3 5.2 5 5 5 5 5 5 5-Monochloroacetic acid1 1 1.E-07 1.E-074 4 4 1.2 1 4 1 2 4 4-Dichloroacetic acid1 1 1.E-06 1.E-062.7 4 4-Trichloroacetic acid1 1 1.E-06 1.E-065 6.8 1 6.8 5 5 1 5 5-Monobromoacetic acid1 1 1.E-05 1.E-05-Dibromoacetic acid1 1 1.E-05 1.E-05-Bromochloroacetic acid1 1 3.E-05 3.E-05-Dichlorobromoacetic acid1 1 9.E-05 9.E-05-Dibromochloroacetic1 1 3.E-05 3.E-05-Tribromoacetic acid1 1 4.E-06 4.E-06-Dibromoacetonitrile1 1 4.E-04 4.E-04-Bromochloroacetonitrile1 1 0.E+00-2,4-dibromophenol0.01 0.01 1.E-05 1.E-05-2,6-dibromophenol0.02 0.02 1.E-05 1.E-05-2,4,6-tribromophenol0.04 0.04 5.E-06 5.E-06-1,2-dibromoethane0.02 0.02 8.E-03 8.E-030.8 1 1 3.9 0.78 3.9 4 4 10.002 1 0.5 0.8 4.11,2-dibromo-3-chloropropane0.02 0.02 1.E-03 1.E-030.01 0.01-1,2,3-trichloropropane0.02 0.02 3.E-04 3.E-04300 61 0.6 300 18 300 300 60 2 2 0.108 60 7-2-Chlorotoluene0.02 0.02 3.E-03 3.E-03250 263 285 250 264 250 250 250 285 10 125 100-4-Chlorotoluene0.02 0.02 2.E-03 2.E-0310-1,2,3-tribromobenzene0.05 0.05 3.E-03 3.E-03-(M)= Marine Water (F)=Fresh Water* * *GESAMP-BWWG 11/6ANNEX 7Page 16I:\MEPC\60\2-12.docAPPENDIX 3CALCULATED TOTAL DAILY UPTAKE, TDI AND RISK QUOTIENTSMarine FreshExposure(μg/kg bw/day)RQ (-)Exposure(μg/kg bw/day)RQ (-)SubstanceTDI(μg/kg bw/day)Man Female Child Man Female Child Man Female Child Man Female ChildHydrogen peroxide-3.6E-04 4.0E-04 1.0E-03 - - - 2.3E-04 2.6E-04 6.6E-04 - - -Ozone-3.7E+01 3.5E+01 1.8E+02 - - -1.6E+01 1.5E+01 7.7E+01 - - -Nitrite 46 3.2E-04 3.6E-04 8.7E-04 6.9E-06 7.7E-06 1.9E-05 5.8E-06 6.5E-06 1.6E-05 1.3E-07 1.4E-07 3.4E-07Sodium hypochlorite 324 3.7E-05 4.2E-05 1.0E-04 1.2E-07 1.3E-07 3.1E-07 3.7E-05 4.2E-05 1.0E-04 1.2E-07 1.3E-07 3.1E-07Sodium hypobromite 517 3.7E-05 4.2E-05 1.0E-04 7.2E-08 8.0E-08 2.0E-07 3.7E-05 4.2E-05 1.0E-04 7.2E-08 8.0E-08 2.0E-07Trichloromethane Cl3CH 10 3.6E-05 3.4E-05 1.7E-04 3.6E-06 3.4E-06 1.7E-05 3.6E-05 3.4E-05 1.7E-04 3.6E-06 3.4E-06 1.7E-05Dichlorobromomethane CHBrCl2 2.1 4.4E-05 4.2E-05 2.1E-04 2.1E-05 2.0E-05 9.9E-05 4.4E-05 4.2E-05 2.1E-04 2.1E-05 2.0E-05 9.9E-05Dibromochloromethane CHClBr2 30 3.5E-05 3.3E-05 1.6E-04 1.2E-061.1E-06 5.5E-06 3.5E-05 3.3E-05 1.6E-04 1.2E-06 1.1E-06 5.5E-06Tribromomethane Br3CH 25 2.5E-06 2.4E-06 1.2E-05 1.0E-07 9.7E-08 4.7E-07 2.5E-06 2.4E-06 1.2E-05 1.0E-07 9.7E-08 4.7E-07Monochloroacetic acid (MCAA) 3.55.1E-05 5.7E-05 1.4E-04 1.5E-05 1.6E-05 4.0E-05 5.1E-05 5.7E-05 1.4E-04 1.5E-05 1.6E-05 4.0E-05Dichloroacetic acid (DCAA) 40 5.1E-05 5.7E-05 1.4E-04 1.3E-06 1.4E-06 3.5E-06 5.1E-05 5.7E-05 1.4E-04 1.3E-06 1.4E-06 3.5E-06Trichloroacetic acid (TCAA) 40 4.6E-05 5.1E-05 1.3E-04 1.2E-06 1.3E-06 3.3E-06 4.6E-05 5.1E-05 1.3E-04 1.2E-06 1.3E-06 3.3E-06Monobromoacetic acid (MBAA) - 5.4E-05 6.0E-05 1.5E-04 - - - 5.4E-05 6.0E-05 1.5E-04 - - -Dibromoacetic acid (DBAA) 20 5.5E-05 6.0E-05 1.6E-04 2.7E-06 3.0E-06 7.8E-06 5.5E-05 6.0E-05 1.6E-04 2.7E-06 3.0E-06 7.8E-06Bromochloroacetic acid (BCAA) - 6.0E-05 6.5E-05 1.8E-04 - - - 6.0E-05 6.5E-05 1.8E-04 - - -Dichlorobromoacetic acid (DCBAA) - 8.8E-05 9.4E-05 3.0E-04 - - - 8.8E-05 9.4E-05 3.0E-04 - - -Dibromochloroacetic acid (DBCAA) - 6.9E-05 7.6E-05 2.1E-04 - - - 6.9E-05 7.6E-05 2.1E-04 - - -Tribromoacetic acid (TBAA) - 6.0E-05 6.7E-05 1.7E-04 - - - 6.0E-05 6.7E-05 1.7E-04 - - -Dibromoacetonitrile 23 1.7E-04 1.7E-04 7.1E-04 7.6E-06 7.6E-063.1E-05 1.7E-04 1.7E-04 7.1E-04 7.6E-06 7.6E-06 3.1E-05GESAMP-BWWG 11/6ANNEX 7Page 17I:\MEPC\60\2-12.docMarine FreshExposure(μg/kg bw/day)RQ (-)Exposure(μg/kg bw/day)RQ (-)SubstanceTDI(μg/kg bw/day)Man Female Child Man Female Child Man Female Child Man Female ChildBromochloroacetonitrile 0.065.7E-05 6.4E-05 1.6E-04 1.0E-03 1.1E-03 2.7E-03 5.7E-056.4E-05 1.6E-04 1.0E-03 1.1E-03 2.7E-032,4-dibromophenol - 8.1E-06 8.3E-06 3.1E-05 - - - 8.1E-06 8.3E-06 3.1E-05 - - -2,6-dibromophenol - 1.1E-05 1.2E-05 3.4E-05 - - - 1.1E-05 1.2E-05 3.4E-05 - - -2,4,6-tribromophenol - 2.3E-04 2.7E-04 5.5E-04 - - - 2.3E-04 2.7E-04 5.5E-04 - - -1,2-Dibromoethane 0.01 2.7E-03 2.5E-03 1.3E-02 2.4E-01 2.2E-01 1.1E+00 2.7E-03 2.5E-03 1.3E-02 2.4E-01 2.2E-011.1E+001,2-dibromo-3-chloropropane 0.03 4.7E-04 4.4E-04 2.2E-03 1.6E-02 1.6E-02 7.7E-02 4.7E-04 4.4E-04 2.2E-03 1.6E-02 1.6E-02 7.7E-021,2,3-trichloropropane - 8.7E-05 8.3E-05 4.0E-04 - - - 8.7E-05 8.3E-05 4.0E-04 - - -2-chlorotoluene - 1.1E-03 1.1E-03 5.2E-03 - - - 1.1E-03 1.1E-03 5.2E-03 - - -4-chlorotoluene - 7.9E-04 7.5E-04 3.7E-03 - - - 7.9E-04 7.5E-04 3.7E-03 - - -1,2,3-tribromobenzene - 1.4E-03 1.4E-03 5.3E-03 - - - 1.4E-03 1.4E-03 5.3E-03 - - -Trichloroacetic acid (TCAA) - 4.6E-05 5.1E-05 1.3E-04 - - - 2.3E-04 2.6E-04 6.6E-04 - - -* * *GESAMP-BWWG 11/6ANNEX 7Page 18I:\MEPC\60\2-12.docAPPENDIX 4DATA USED FOR THE CALCULATION OF PNECSCAS No.Substance nameShorttermconc.(F)μg/LShorttermconc.(M)μg/LLongtermconc.μg/LNo data- Shortterm(F)No data- Shortterm(M)No data- LongtermAssesssessmentfactor(freshwater)Assesssessmentfactor(marinewater)PNEC(freshwater)μg/LPNEC(marinewater)μg/LCommentsOnly fish and mollucs in USECOTOX. No IUCLID data.No10028-15-6Ozone 70 802 1 0 1000 10000 0.07 0.007data in Danish EPA QSARstates.106-43-4 4-chlorotoluene 2000 10000 320 33 10 100 32 3.2US ECOTOX1,2-di- Data from DK EPA QSARdata106-93-4 bromoethane 15000 6200 7480 31 1 1000 10000 15 1.5 base applied2,4,6-tri- Data from Japanese Minstry of118-79-6 bromophenol 220 100 3 0 2 1000 10000 0.22 0.022 Env.DibromochloromethaneData from Japanese Minstry of124-48-1 CHClBr2 6100 63 3 3 10 100 6 0.6 Env.13824-96-9Sodium hypobromite4 43 3100 1000.04 0.04Values given as TRC. Valueequivalent to 0.04 FAC.GESAMP-BWWG 11/6ANNEX 7Page 19I:\MEPC\60\2-12.docCAS No. Substance name Shorttermconc.(F)μg/LShorttermconc.(M)μg/LLongtermconc.μg/LNo data- Shortterm(F)No data- Shortterm(M)No data- LongtermAssesssessmentfactor(freshwater)Assesssessmentfactor(marinewater)PNEC(freshwater)μg/LPNEC(marinewater)μg/LCommentsFish data in US EPA:LC50=550ug/L. No data in IUCLID. DatafromDibromoace- DK EPA QSAR database:algae:3252-43-5 tonitrile 550 3 0 1000 10000 0.55 0.055 451 mg/L; Crust: 1000 mg/LDibromo-No data in US EPA. No data inDKchloroaceticEPA QSAR database. No datain5278-95-5 acid (DBCAA) 0 0 IUCLIDBromo-No data in US EPA. No data inDKchloroacet icEPA QSAR database. No datain5589-96-8 acid (BC AA) 0 0 IUCLIDNo data in US EPA. No data inDK1,2,3-tribro-EPA QSAR database. No datain608-21-9 mobenzene IUCLID2,6-dibromo- Data from DK EPA QSARdata608-33-3 phenol 3150 3 100010000 3.15 0.315 base applied***GESAMP-BWWG 11/6

I:\MEPC\60\2-12.doc ANNEX 8

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

Blue Ocean Guardian (BOG) Balla st Water Management System

Submitted by the Republic of Korea for Basic Approval

0 SUMMARY

0.1 The Group recommended that the Blue Ocean Guardian (BOG) Ballast Water Management System (BWMS) be granted Ba sic Approval and that the comments and recommendations in this report are taken into account in th e dossier for Final Approval.

0.2 Based on the various concentrations of chem ical by-products found in the treated ballast water, the Group agreed that these should not present any significant effect on the marine environment. This view was supported by the sm all-scale Whole Effluent Test (WET) results presented.

0.3 Due to the fact that none of the potential chemical by-produc ts were found in the treated ballast water at levels greater th an those in the control (untreated ) water, the Group agreed that there would be no unacceptable risks to the crew and general public from chemicals produced by this system.

0.4 The Group agreed that the system should not cause any corrosion, which would be a risk to the safety of the ship as it neither uses any corrosive or aggressive additives nor produces such by-products. However the Group recommended that, for Final Approval, corrosion testing be conducted in accordance with the guidance provided in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

0.5 The Group recognized that risk to operating personnel was inhe rent in the operation of the plasma module and the MPUV module by way of possible electric shock, exposure to UV-light and UV-radiation, heat and handlin g of the UV lamps. However, it was also recognized that appropriate risk mitigation measures and procedures were proposed to mitigate all such risk to an acceptable level, and that such risk control measures and procedures were to be fully described in the safety system for the ship’s crew to be in corporated to the operati ng manual and instructions.

0.6 Due to the fact that none of the potential chemical by-produc ts were found in the treated ballast water at levels greater th an those in the control (untreated ) water, the Group agreed that there would be no unacceptable risks to the environment from chemicals produced by this system.GESAMP-BWWG 11/6 ANNEX 8 Page 2

I:\MEPC\60\2-12.doc 1 INTRODUCTION

1.1 Data used to evaluate this system we re extracted from MEPC 60/2/5 and were supplemented by additional info rmation provided to the Group.

2 DESCRIPTION OF THE SYSTEM

2.1 The Group noted that the B OG BWMS comprised the following modules which are used to treat the incoming ballast water:

.1 filtration module (50 μm);

.2 plasma treatment reactor;

.3 medium pressure ultraviolet (MPUV) light treatment; and

.4 control module.

2.2 It was also noted that only the MPUV phase is employed as a “stand-alone” treatment during deballasting.

2.3 Whilst the Group recalled that it had eval uated systems employing filtration and UV treatment, this was the first system using plasma treatment which it had considered for the disinfection of ballast water.

2.4 It was noted that the treatment of ballast wa ter with plasma involve s the generation of a high voltage current between two electrodes in the reactor which creates an ionization field producing a high energy plasma arc.

2.5 It was noted that this arc causes an extremel y rapid rise in pressure , temperature, density flow and expansion of the ballast water. At this precise moment, high energy plasma produces and intensive pressure shockwave which causes physical damage to the cellular matr ix either by the sudden recoil of cell tissue or by micro-eddies created on the internal cell structure.

2.6 In addition, the plasma discharge generates the following, which helps to render harmless aquatic organisms:

.1 hydroxyl radicals;

.2 ozone;

.3 atomic oxygen;

.4 nitric oxide;

.5 superoxide radicals;

.6 UV-radiation; and

.7 electrical fields.GESAMP-BWWG 11/6 ANNEX 8 Page 3

I:\MEPC\60\2-12.doc 2.7 A schematic representation of the system, as supplied by the applicant, is shown below and it was noted that the filter module was by-pa ssed and the plasma module was not used during de-ballasting:

2.8 A simplified schematic representation of the system, produced by the Group, is shown below:

Filter Ballast tank UV Plasma technologyGESAMP-BWWG 11/6 ANNEX 8 Page 4

I:\MEPC\60\2-12.doc 3 CHEMICALS ASSOCIATED WITH THE SYSTEM

3.1 The Group noted that the system produced th e following Active Substances in the treated ballast water but that such substances we re either short lived or not detectable.

Concentration at Compound CAS number MDL 32 psu 20 psu Superoxide radical(O 2 - ) NN NN NN NN Single oxygen radical (O h ) NN NN NN NN Hydroxyl radical (OH h ) 3352-57-6 NN NN NN Electron ( e - ) NN NN NN NN Ozone (O 3 ) 10028-15-6 0.02 mg/L ND ND NN = Not Necessary ND = Not Detectable

3.2 As a result, the Group agreed that these Ac tive Substances did not pose a risk to the environment, to the ship or to personnel.

3.3 In addition, it was noted that the sy stem produces the following gases:

Analysed at Gas MDL 32 psu 20 psu Hydrogen (%) 0.05 0.09 0.06 Ozone ( μ L/L) 0.2 50.0 18.0 Chlorine ( μ L/L) 0.2 70.0 120

3.4 Furthermore, it was noted that the applicant had analysed the untreat ed and treated ballast water (32 psu) for the following chemicals whic h were assumed to be potential by-products (Relevant Chemicals) of the system:

Sampling time 0 day 1 day 5 day

Sampling point/tank Test

water Control Treated Control Treated Control Beforedeballast Afterdeballast Compounds MDL Active substance (mg/L) TRO 0.20 ND ND ND ND ND ND ND ND FRO 0.05 ND ND ND ND ND ND ND ND Ozone(O 3 ) 0.02 ND ND ND ND ND ND ND ND ClO 2 0.02 ND ND ND ND ND ND ND ND Sulfide(S 2 ) 0.20 ND ND ND ND ND ND ND ND Bromate(BrO 3 - ) ( μ g/L) 0.13 ND ND ND ND ND ND ND ND Bromide(Br - ) 0.01 53.1 52.7 50.6 52.3 50.7 49.6 49.8 50.5GESAMP-BWWG 11/6 ANNEX 8 Page 5

I:\MEPC\60\2-12.doc Sampling time 0 day 1 day 5 day

Sampling point/tank Test

water Control Treated Control Treated Control Beforedeballast Afterdeballast Chlorinated organic compounds (μg/L) 1,1,1-Trichloroethane 0.01 ND ND ND ND ND ND ND ND 1,1,2-Trichloroethane 0.01 ND ND ND ND ND ND ND ND 1,1-Dichloroethane 0.01 ND ND 0.34 ND 0.17 ND 0.11 ND 1,1,2,2- Tetrachloroethane 0.01 0.19 0.18 ND ND ND ND ND ND

1,1,1,2- Tetrachloroethane 0.01 ND ND ND ND ND ND ND ND

1,2,3-Trichlorobenzene 0.01 1.47 1.44 0.45 0.33 0.25 0.19 ND ND 1,2,3-Trichloropropane 0.01 0.25 0.26 ND ND ND ND ND ND 1,2,4-Trichlorobenzene 0.01 1.06 1.01 0.38 0.29 0.23 ND ND ND 1,2-Dibromo-3- chloropropane 0.01 ND ND ND ND ND ND ND ND

1,1-Dichloroethene 0.02 ND ND 0.34 ND 0.29 ND ND 0.03 1,2-Dichloropropane 0.02 0.03 0.03 ND ND ND ND ND ND 2-Chlorotoluene 0.01 0.24 0.21 ND 0.08 ND ND ND ND 4-Chlorotoluene 0.01 0.27 ND ND ND ND ND ND ND Bromobenzene 0.01 0.25 0.23 ND ND ND ND ND ND Bromochloromethane 0.01 ND ND ND ND ND ND ND ND Chlorobenzene 0.01 0.14 0.11 ND ND ND ND ND ND cis-1,2-dichloroethene 0.01 ND ND ND ND ND ND ND ND Dibromochloromethane 0.01 ND ND ND ND ND ND ND ND Dibromomethane 0.01 ND ND ND ND ND ND ND ND Dichlorobromomethane 0.01 ND ND ND ND ND ND ND ND Methylene chloride 0.02 3.12 3.13 3.22 2.56 2.03 ND ND ND Tetrachloroethene 0.01 ND ND ND ND ND ND ND ND Carbon tetrachloride 0.01 ND ND 0.01 ND ND ND ND ND trans-1,2-dichloroethene 0.01 ND ND ND ND ND ND ND ND Chloroform 0.01 0.27 0.26 0.15 0.20 ND 0.18 ND ND Bromoform 0.02 ND ND ND ND ND ND ND ND 1,2,4-Tribromobenzene 0.02 7.94 7.60 4.16 2.99 2.23 1.63 1.23 1.05 1,3,5-Tribromobenzene 0.02 3.59 3.08 1.75 1.21 0.92 0.69 ND ND Toluene 0.01 6.78 6.77 6.07 5.88 5.14 3.42 3.12 1.93 Naphthalene 0.01 3.19 3.36 0.78 0.53 0.39 0.29 0.25 0.21 THMs 0.27 0.26 0.15 0.20 ND 0.18 ND ND Halo-acetonitriles (μg/L) Dibromoacetonitrile 0.004 0.05 0.05 0.04 ND ND ND ND ND Bromochloroacetonitrile 0.003 ND ND ND ND ND ND ND ND Chloropicrin 0.003 ND ND ND ND ND ND ND ND Chloral hydrate 0.002 0.02 0.02 ND 0.02 ND ND ND ND Trichloroacetonitrile 0.001 ND ND ND ND ND ND ND ND Dichloroacetonitrile 0.001 0.04 0.04 0.02 0.01 0.02 ND 0.01 ND Sum of HANs 0.11 0.10 0.07 0.03 0.02 ND 0.01 NDGESAMP-BWWG 11/6 ANNEX 8 Page 6

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water Control Treated Control Treated Control Beforedeballast Afterdeballast Halo-acetic acids (μg/L) 2-mono-chloroacetic acid 0.059 ND ND ND ND ND ND ND ND

2,2-dichloroacetic acid 0.166 ND ND ND ND ND ND ND ND Dalapon acid 0.103 ND ND ND ND ND ND ND ND 2,2,2-trichloroacetic acid 0.02 ND ND ND ND ND ND ND ND

2,2-bromochloroacetic acid 0.035 ND ND ND ND ND ND ND ND

2,2,2- bromodichloroacetic acid 0.014 ND ND ND ND ND ND ND ND

2,2,2-tribromoacetic acid 0.094 ND ND ND ND ND ND ND ND

2-monobromoacetic acid 0.049 ND ND ND ND ND ND ND ND

2,2-dibromoacetic acid 0.022 ND ND ND ND ND ND ND ND Sum of HAAs ND ND ND ND ND ND ND ND Chlorinated Phenols (μg/L) 2-Chlorophenol 0.4 ND ND ND ND ND ND ND ND 3-Chlorophenol 0.2 ND ND ND ND ND ND ND ND 4-Chlorophenol 0.2 ND ND ND ND ND ND ND ND 2,3-Dichlorophenol 0.2 ND ND ND ND ND ND ND ND 2,4-Dichlorophenol 0.5 ND ND ND ND ND ND ND ND 2,5-Dichlorophenol 0.3 ND ND ND ND ND ND ND ND 2,6-Dichlorophenol 0.4 ND ND ND ND ND ND ND ND 3,4-Dichlorophenol 0.2 ND ND ND ND ND ND ND ND 3,5-Dichlorophenol 0.4 ND ND ND ND ND ND ND ND 2,3,4-Trichlorophenol + 3,4,5-Trichlorophenol 0.4 ND ND ND ND ND ND ND ND
2,3,5-Trichlorophenol + 2,4,5-Trichlorophenol 0.6 ND ND ND ND ND ND ND ND
2,3,6-Trichlorophenol 0.2 ND ND ND ND ND ND ND ND 2,4,6-Trichlorophenol 0.3 ND ND ND ND ND ND ND ND 2,3,4,5- Tetrachlorophenol 0.3 ND ND ND ND ND ND ND ND

2,3,4,6- Tetrachlorophenol 0.2 ND ND ND ND ND ND ND ND

2,3,5,6- Tetrachlorophenol 0.3 ND ND ND ND ND ND ND ND
Pentachlorophenol 0.5 ND ND ND ND ND ND ND ND Bromophenols (μg/L) 2,4-Dibromophenol 0.3 ND ND ND ND ND ND ND ND 2,6-Dibromophenol 0.6 ND ND ND ND ND ND ND ND 2,4,6-Tribromophenol 0.8 ND ND ND ND ND ND ND ND Others (mg/L) AOX 0.01 0.35 0.36 0.39 0.31 0.31 0.28 0.29 0.31 DOC 4.65 4.67 4.67 2.09 2.28 2.57 2.40 2.34 POC 0.01 1.35 1.38 1.13 1.31 1.53 0.39 0.39 0.13GESAMP-BWWG 11/6 ANNEX 8 Page 7

I:\MEPC\60\2-12.doc 3.4.1 The Group noted the high concentr ations of 1,2,4-tribromobenzene, 1,3,5-tribromobenzene, tolu ene and naphthalene in the test water. The reasons for the high concentration of these contamin ants were unclear to the Group.

3.5 The following analyses of untr eated and treated ballast water (20 psu) were also noted:

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water Control Treated Cont rol Treated Control Beforedeballast Afterdeballast Compounds MDL Active substance (mg/L) TRO 0.20 ND ND ND ND ND ND ND ND FRO 0.05 ND ND ND ND ND ND ND ND Ozone(O 3 ) 0.02 ND ND ND ND ND ND ND ND ClO 2 0.02 ND ND ND ND ND ND ND ND Sulfide(S 2 ) 0.20 ND ND ND ND ND ND ND ND Bromate(BrO 3 - ) ( μ g/L) 0.13 ND ND ND ND ND ND ND ND Bromide(Br - ) 0.01 36.6 35.0 35.6 34.9 34.4 34.1 34.6 34.7 Chlorinated organic compounds (μg/L) 1,1,1-Trichloroethane 0.01 ND ND ND ND ND ND ND ND 1,1,2-Trichloroethane 0.01 ND ND ND ND ND ND ND ND 1,1-Dichloroethane 0.01 ND ND ND ND ND ND ND ND 1,1,2,2- Tetrachloroethane 0.01 ND ND ND ND ND ND ND ND

1,1,1,2- Tetrachloroethane 0.01 ND ND ND ND ND ND ND ND

1,2,3-Trichlorobenzene 0.01 ND ND ND ND ND ND ND ND 1,2,3-Trichloropropane 0.01 0.03 0.03 0.02 0.02 0.02 ND 0.01 0.01 1,2,4-Trichlorobenzene 0.01 ND ND ND ND ND ND ND ND 1,2-Dibromo-3- chloropropane 0.01 ND ND ND ND ND ND ND ND

1,1-Dichloroethene 0.02 ND ND ND ND ND ND ND ND 1,2-Dichloropropane 0.02 ND ND ND ND ND ND ND ND 2-Chlorotoluene 0.01 ND ND ND ND ND ND ND ND 4-Chlorotoluene 0.01 ND ND ND ND ND ND ND ND Bromobenzene 0.01 ND ND ND ND ND ND ND ND Bromochloromethane 0.01 ND ND ND ND ND ND ND ND Chlorobenzene 0.01 ND ND ND ND ND ND ND ND cis-1,2-dichloroethene 0.01 ND ND ND ND ND ND ND ND Dibromochloromethane 0.01 0.41 0.40 0.27 0.37 0.25 0.29 0.21 ND Dibromomethane 0.01 ND ND ND ND ND ND ND ND Dichlorobromomethane 0.01 1.91 1.85 1.44 1.88 1.29 1.44 1.04 0.90 Methylene chloride 0.02 0.57 0.55 0.54 0.13 0.10 ND ND ND Tetrachloroethene 0.01 ND ND ND ND ND ND ND ND Carbon tetrachloride 0.01 ND ND 0.01 ND ND ND ND ND trans-1,2-dichloroethene 0.01 ND ND ND ND ND ND ND ND Chloroform 0.01 11.7 11.5 8.32 10.5 6.32 5.34 5.62 4.03 Bromoform 0.02 0.92 0.88 ND ND ND ND ND ND 1,2,4-Tribromobenzene 0.02 0.85 0.83 1.08 0.54 0.64 0.39 ND ND 1,3,5-Tribromobenzene 0.02 ND ND ND ND ND ND ND ND Toluene 0.01 2.03 2.12 1.48 1.85 0.54 0.62 1.92 ND Naphthalene 0.01 0.23 0.23 0.19 0.19 0.17 0.17 0.22 0.12 THMs 15.0 14.6 10.0 12.7 7.86 7.07 6.87 4.93GESAMP-BWWG 11/6 ANNEX 8 Page 8

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water Control Treated Cont rol Treated Control Beforedeballast Afterdeballast Halo-acetonitriles (μg/L) Dibromoacetonitrile 0.004 0. 10 0.10 ND ND ND ND ND ND Bromochloroacetonitrile 0.003 0.08 0.03 ND ND ND ND ND ND Chloropicrin 0.003 0.03 0.04 ND 0.10 ND ND ND ND Chloral hydrate 0.002 0.56 0.55 0.41 0.11 0.39 0.04 0.19 0.37 Trichloroacetonitrile 0.001 ND ND ND ND ND ND ND ND Dichloroacetonitrile 0.001 0.71 0.68 0.66 0.09 0.54 0.06 0. 14 0.48 Sum of HANs 1.48 1.44 1.13 0.20 1.03 0.11 0.33 0.85 Halo-acetic acids (μg/L) 2-monochloroacetic acid 0.059 ND ND ND ND ND ND ND ND

2,2-dichloroacetic acid 0.166 ND ND ND ND ND ND ND ND Dalapon acid 0.103 ND ND ND ND ND ND ND ND 2,2,2-trichloroacetic acid 0.02 ND ND ND ND ND ND ND ND

2,2-bromochloroacetic acid 0.035 ND ND ND ND ND ND ND ND

2,2,2- bromodichloroacetic acid 0.014 ND ND ND ND ND ND ND ND

2,2,2-tribromoacetic acid 0.094 ND ND ND ND ND ND ND ND

2-monobromoacetic acid 0.049 ND ND ND ND ND ND ND ND

2,2-dibromoacetic acid 0.022 ND ND ND ND ND ND ND ND Sum of HAAs ND ND ND ND ND ND ND ND Chlorinated Phenols (μg/L) 2-Chlorophenol 0.4 ND ND ND ND ND ND ND 3-Chlorophenol 0.2 ND ND ND ND ND ND ND 4-Chlorophenol 0.2 ND ND ND ND ND ND ND 2,3-Dichlorophenol 0.2 ND ND ND ND ND ND ND 2,4-Dichlorophenol 0.5 ND ND ND ND ND ND ND 2,5-Dichlorophenol 0.3 ND ND ND ND ND ND ND 2,6-Dichlorophenol 0.4 ND ND ND ND ND ND ND 3,4-Dichlorophenol 0.2 ND ND ND ND ND ND ND 3,5-Dichlorophenol 0.4 ND ND ND ND ND ND ND 2,3,4-Trichlorophenol + 3,4,5-Trichlorophenol 0.4 ND ND ND ND ND ND ND
2,3,5-Trichlorophenol + 2,4,5-Trichlorophenol 0.6 ND ND ND ND ND ND ND

2,3,6-Trichlorophenol 0.2 ND ND ND ND ND ND ND 2,4,6-Trichlorophenol 0.3 ND ND ND ND ND ND ND 2,3,4,5- Tetrachlorophenol 0.3 ND ND ND ND ND ND ND

2,3,4,6- Tetrachlorophenol 0.2 ND ND ND ND ND ND ND

2,3,5,6- Tetrachlorophenol 0.3 ND ND ND ND ND ND ND

Pentachlorophenol 0.5 ND ND ND ND ND ND NDGESAMP-BWWG 11/6 ANNEX 8 Page 9

I:\MEPC\60\2-12.doc Sampling time 0 day 1 day 5 day

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water Control Treated Cont rol Treated Control Beforedeballast Afterdeballast Bromophenols (μg/L) 2,4-Dibromophenol 0.3 ND ND ND ND ND ND ND 2,6-Dibromophenol 0.6 ND ND ND ND ND ND ND 2,4,6-Tribromophenol 0.8 ND ND ND ND ND ND ND Others (mg/L) AOX 0.01 0.30 0.29 0.28 0.44 0.31 0.40 0.39 0.46 DOC 0.01 7.31 7.08 8.57 3.17 2.29 4.19 3.34 3.12 POC 0.01 13.3 13.1 10.3 10.3 2.18 0.98 0.12 0.22

3.5.1 The Group noted the relatively high concentrat ions of 1,2,4-tribromobenzene, toluene and naphthalene in the test water, similar to the cas e in seawater with 32 psu. The reasons for the relatively high concentrations of these contaminants were unclear to the Group.

4 QUESTIONS PUT TO THE APPLI CANT, DURING EVALUATION, WITH ANSWERS AND REACTIONS OF THE GROUP

4.1 The following text in this se ction reflects th e questions put to the applicant, the answers received and the reactions of the Group:

Question 1:

The Group recognized that for the dose or irradi ation of UV lamps, the application states in paragraph 2.3.1, that 300mJ/cm 2 (300mW/cm 2 /sec) was set during the test for chemical analysis and toxicity testing. Please could yo u indicate whether you would accept that this value to be set as a maximum dose during the evaluation process, meaning that the values cannot be changed at the Final Approval stage?

Response 1:

.1 The maximum dose of UV lamps for Basic Approval was set at 300 mJ/cm 2 , but the maximum dose during chemical analysis and toxicity testing was 242 mJ/cm 2

. However, it will be increased to (data deemed to be confidential and removed at the request of the submitting Administration) at the Final Approval stage.

Reaction: The Group was satisfied with this response.

Question 2:

Also, could you kindly pr ovide any information for the crite ria of the plasma strength? The Group needs quantitative criteria for evalua ting that the plasma component has no significant changes in the parameters which could affect chemical potential productions. However, the Group considered that electrical power consumption by the component is not adequate for the representati on of this treatment.GESAMP-BWWG 11/6 ANNEX 8 Page 10

I:\MEPC\60\2-12.doc Response 2:

.1 (Data deemed to be confidential and removed at the request of the submitting Administration.)

Reaction: The Group noted the reaction of the applicant.

Question 3:

In the table of paragraph 2.3.1, the application states that the salinity of seawater is 34 psu, however, in table 6 and others, it is mentione d as 32 PSU. Could you clarify what was the actual salinity (PSU) both for seawater and blackish water for chemical analysis and toxicity testing?

Response 3:

.1 32 PSU is the correct number for the act ual salinity of seawater in table 6, but brackish water remains as 20psu. Thus, all numbers that are stated as 34psu in table 2.3.1, must be changed to 32 PSU. However, we would like to let you know that we misspelled brackish wate r in our non-confidential paper.

Reaction: The Group was satisfied with the reaction of the applicant.

5 WHOLE EFFLUENT TESTING (WET)

5.1 The Group noted the following results obtaine d from aquatic toxicity tests on ballast water treated with the BOG BWMS. The Group al so noted that during these WET tests, the BWMS was operated with a flow rate of 125 m 3 /h ballast water which is less than the 200 m 3 /h recommended in Guidelines (G8).GESAMP-BWWG 11/6 ANNEX 8 Page 11

I:\MEPC\60\2-12.doc Acute aquatic toxicity of 32 PSU ballast water treated by the ‘BOG’ BWMS

LC 50 and/or EC 50 Species End point Conc.(%) Reference/Comments/ justification for missing data Algae Skeletonema costatum 72 h EC 50 > 100 Tested (OECD 201)

Crustacean Tigriopus japonicas 48 h EC 50 48 h LC 50 > 100 > 100 Tested (OECD 202)

Fish Paralichthys olivaceus 96 h LC 50 > 100 Tested (OECD 203)

Acute aquatic toxicity of 20 PSU ballast water treated by the ‘BOG’ BWMS

LC 50 and/or EC 50 Species End point Conc.(%) Reference/Comments/ justification for missing data Algae Skeletonema costatum 72 h EC 50 > 100 Tested (OECD 201)

Crustacean Tigriopus japonicas 48 h EC 50 48 h LC 50 > 100 > 100 Tested (OECD 202)

Fish Paralichthys olivaceus 96 h LC 50 > 100 Tested (OECD 203)

5.2 The Group noted that the simulated discha rged water had no unacceptable effects on the aquatic environment according to the results of these tests.

6 HUMAN HEALTH ASSESSMENT

6.1 The Group recognized that none of the poten tial chemical by-products were found in the treated ballast water at levels greater than thos e in the control (untreated) water and so agreed that there was no need to carry out any risk assessment for the environment or for human health.

6.2 The Group, consequently, agreed that the ri sks to the crew and general public from chemicals produced by this system w ould be within acceptable limits.

6.3 The Group noted that in the non-confidential part of the dossier, the a pplicant stated that mammalian toxicity testing had not been perf ormed. The Group emphasized that no animal testing in mammals is encouraged to generate new toxicity data.

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

7.1 Due to the fact that none of the potential chemical by-produc ts were found in the treated ballast water at levels greater th an those in the control (untreated ) water, the Group agreed that there would be no unacceptable risks to the crew and general public from chemicals produced by this system.GESAMP-BWWG 11/6 ANNEX 8 Page 12

I:\MEPC\60\2-12.doc 7.2 The Group recognized that risks to operating personnel was inherent in the operation of the plasma module and the MPUV module by wa y of possible electric shock, exposure to UV-light and UV-radiation, heat and handling of the UV lamps. However, it was also recognized that appropriate risk mitigation meas ures and procedures were proposed to mitigate all such risk to an acceptable leve l, and that such risk control meas ures and procedures were to be fully described in the safety system for the ship’s crew to be incorporated to the operating manual and instructions.

7.3 The Group noted that the dossier states that this BWMS ne ither uses any corrosive or aggressive additives nor produces such by-produc ts. As a result, the Group agreed that the system should not cause any corrosion which would be a risk to the safety of the ship. It was also noted that the applicant intends to carry out a comprehensive corrosion testing program to verify this assumption. The Group recommende d that the corrosion te sting be conducted in accordance with the guidance provided in section 5.1 of the “Report of the eighth meeting of the GESAMP-BWWG”, contained in MEPC 59/2/16.

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 For the reasons cited in paragraphs 5.1 and 6.1, the Group agreed that there would be no unacceptable risk to the environment fr om chemicals produced by this BWMS.

8.2 The Group also agreed that the results of Whole Effluent Testing (WET) supported this view.

8.3 From the fact above, the Group was of the opi nion that there were no needs to perform calculation of PEC/PNEC ratios and analysis particulary for this BWMS.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 The Group agreed that the amounts of gene rated hydrogen, ozone and chlorine gases would not constitute any significant additional risk to the ship or crew.

9.2 Based on the various concentrations of chemical by-products found in the treated ballast water, the Group agreed that these should not present any si gnificant effect on the marine environment. This view was supported by the small-scale Whole Effluent Test (WET) results presented.

9.3 In addition, the Group agreed that there would be no unacceptable risks from the extremely low levels of potential chemical by-products found in the treated ballast water.

9.4 The Group noted that there was some possibility of this BWMS producing an Active Substance and/or Relevant Chemicals, according to the references presented. In this regard, the Group recommended that, for Final Approval, it is confirmed that Active Substance and/or Relevant Chemical concentrations, following treatment, remain at insignificant levels as anticipated. Alternatively, the Group suggested that WET chronic aqua tic toxicity tests be carried out, in accordance with Procedure (G9), to confirm that the treated ballast water does not have any harmful effects.

9.5 The Group recommended that this BWMS be granted Basic Approval and that the comments and recommendations in this repor t are taken into account in the dossier for Final Approval.

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