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\59\2-16.DOC

INTERNATIONAL MARITIME ORGANIZATION

IMO 

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MARINE ENVIRONMENT PROTECTION COMMITTEE 59th session Agenda item 2 MEPC 59/2/16 8 April 2009 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

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

Note by the Secretariat

SUMMARY

Executive summary: This document contains the re port of the eighth meeting of the GESAMP-Ballast Water Working Group (GESAMP-BWWG) and includes the evaluation of prop osals submitted for approval by Japan, Germany, the Republic of Korea and China. Following the decision of MEPC 58, only the main body of the GESAMP-BWWG’s reports is translated in all th e three working languages with the annexes in English only.

Strategic direction: 7.1

High-level action: 7.1.2

Planned output: 7.1.2.4

Action to be taken: Paragraph 3

Related document: GESAMP-BWWG 8/6 (attached)

Introduction

1 The eighth meeting of the GESAMP-Ba llast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters from 16 to 21 Febr uary 2009 and its report is attached to this document as GESAMP-BWWG 8/6.

2 The main purpose of this mee ting was to review the proposal s for approval of ballast water management systems that make use of Active Substa nces to treat ballast wa ter prior to discharge into the marine environment. The findings of th e Group are contained in annexes 4 to 8 of the attached report.GESAMP-BWWG 8/6 - 2 -

I:\MEPC\59\2-16.DOC Action requested of the Committee

3 The Committee is invited to:

.1 agree that Final Approval is not given to the Special Pipe Hybrid Ballast Water Management System (combined with Ozone treatment) submitted by Japan in document MEPC 58/2/1 (see annex 4 * );

.2 agree that Final Approval is given to the RWO Ballast Water Management System (CleanBallast) submitted by Germany in document MEPC 59/2 (see annex 5);

.3 agree that Final Approval is given to the NK-O3 BlueBallast System (Ozone) submitted by the Republic of Korea in document MEPC 59/2/3 (see annex 6);

.4 agree that Basic Approval is given to the Blue Ocean Shield Ballast Water Management System submitted by China in document MEPC 59/2/2 (see annex 7);

.5 agree that Basic Approval is given to the HHI Ballast Water Management System (EcoBallast) submitted by the Republic of Korea in document MEPC 59/2/4 (see annex 8);

.6 note the opinion of the GESAMP-BWWG that the application related to the HHI Ballast Water Management System (EcoBallast) also fulfilled the requirements of Procedure (G9) for Final Approval (see section 4.7 and annex 8);

.7 agree that ballast water manageme nt systems which employ UV light should also be reviewed in accordance with the requirements of Procedure (G9) (see paragraphs 4.2.2 and 4.2.3);

.8 urge Administrations to thoroughly eval uate the application dossiers and confirm that they are satisfactory and complete before submitting their proposals to the Organization in accordance with Proce dure (G9) (see para graphs 4.2.4 to 4.2.7);

.9 consider changing references to “Toxici ty” in section 5 of Procedure (G9) to “Ecotoxicity” in order to remove any suggestion that mammalian toxicity studies need to be performed on treated ball ast water (see annex 6, section 4.7);

.10 note the Group’s recommendations for corro sion testing contai ned in section 5.1 of the report and invite Member a nd observers to submit their further contributions with a view to endorsing th ese recommendations and their inclusion in the Methodology at MEPC 60; and

.11 approve the report in general.

***

* Paragraphs and annexes referred to in this section are those of document GESAMP-BWWG 8/6.I:\MEPC\59\2-16.DOC INTERNATIONAL MARITIME ORGANIZATION

IMO 

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GESAMP-BALLAST WATER WORKING GROUP (GESAMP-BWWG) 8th session Agenda item 6 GESAMP-BWWG 8/6 21 February 2009 Original: ENGLISH

REPORT OF THE EIGHT MEETING OF THE GESAMP-BALLAST WATER WORKING GROUP (GESAMP-BWWG)

Table of Contents

Section Page Nos.

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 ........................................................... 5

5 ANY OTHER BUSINESS.................................................. 7

6 CONSIDERATION AND ADOPTION OF THE REPORT .......... 10GESAMP-BWWG 8/6 - 2 -

I:\MEPC\59\2-16.DOC ANNEXES

ANNEX 1 List of members attending th e eighth session of the GESAMP-BWWG

ANNEX 2 Agenda for the eighth session of the GESAMP-BWWG

ANNEX 3 Terms of reference and time frame for the GESAMP-BWWG

ANNEX 4 Review of proposals for approval of ba llast water management systems that make use of Active Substances – Special Pipe Hybrid Ballast Water Management System (combined with Ozone treatment) also re ferred to as the SP-Hybrid BWMS Ozone version (Japan)

ANNEX 5 Review of proposals for approval of ba llast water management systems that make use of Active Substances – RWO Ballast Water Management System, CleanBallast (Germany)

ANNEX 6 Review of proposals for approval of ba llast water management systems that make use of Active Substances – NK-O3 Blue Ballast System (Republic of Korea)

ANNEX 7 Review of proposals for approval of ba llast water management systems that make use of Active Substances –Blue Ocean Shield Ballast Water Management System (China)

ANNEX 8 Review of proposals for approval of ba llast water management systems that make use of Active Substances – HHI BWMS , EcoBallast (Republic of Korea)- 3 - GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC 1 INTRODUCTION

1.1 The eighth GESAMP-Ballast Water Wo rking Group (GESAMP-BWWG) meeting was held at IMO Headquarters, London, from 16 to 21 February 2009, under the chairmanship of Mr. Jan Linders. A list of members attendi ng 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. Miguel Paloma res, Director of Marine Environment Division, who informed the Group that 12 proposals for approval had been submitted for consideration by MEPC 59 in accordance with the agreed deadline of 19 December 2008. Mr. Palomares expressed his appreciation for the effort made by the members of the GESAMP-BWWG to have an additional meetin g (the ninth meeting) in March 2009, and to extend the eighth meeting over the weekend in an attempt to evaluate as many proposals as possible. He drew the atten tion of the Group to the importa nce 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 should be noted, in this context, that the outcomes of GESAMP-BWWG (8) and (9) will both be reported to MEPC 59.

1.3 Mr. Palomares noted that, in view of the rapidly increasing workload for the Group and the importance and need for timely review of th e proposals for approval, IMO would take all the possible actions to increase the effectiveness and efficiency of the Group in the common effort to respond to the increased number of proposals for approval. In this respect, Mr. Palomares expressed his appreciation for the productive st ocktaking meeting of the Group in January and pledged IMO’s support for furthe r developing the new tools identified during the workshop, including the adapted MAMPEC computer model and the hazard classification of the most frequently occurring chemicals in ballast water treatments. He welcomed the collaboration with GESAMP WG 1 (the GESAMP-EHS Group) and encouraged furt her co-operation in the GESAMP family.

1.4 Finally, Mr. Palomares expressed his a ppreciation for the effort made by the two IMO consultants, Mr. John Crayford and Dr . Andrew Craven, for their hard work in preparing this meeting and for reviewing a large amount of docum entation in a relatively short period of time.

1.5 Mr. Dandu Pughiuc, Head of the Marine Biosafety Section, Marine Environment Division, reported on the contractual arrangements and informed the Group on the logistics of the meeting. He also informed the Group that, at the request of Dr. Stephan Gollasch, arrangements had been made for him to be excused when th e proposal for approval of the RWO Ballast Water Management System (Germany) is reviewed, due to his involvement in the development of this technology. Dr. Gollasch took no part in this ev aluation and his contract was consequently reduced to ten working days.

2 ISSUES OF CONFIDENTIALITY

2.1 Two proposals for Basic Approva l of ballast water manageme nt systems that make use of Active Substances had been submitted by China (MEPC 59/2/2) and the Republic of Korea (MEPC 59/2/4) and one proposal for Fina l Approval had been submitted by Japan (MEPC 59/2/1). In addition, the Republic of Korea (MEPC 59/2/3) and Germany (MEPC 59/2) had re-submitted their proposals for Final Approval. All five submissions contained confidential supporting data.GESAMP-BWWG 8/6 - 4 -

I:\MEPC\59\2-16.DOC 2.2 The confidential natu re of the information was recognized by the Group and was treated as such in order to protect the commercial interests of the manufacturers concerned. In order to ensure that the report did not contain any confidential information, the Group noted that the Secretariat would liaise with the relevant Administrations prior to su bmitting the repo rt 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 conf idential. In this respect, all the members of the Group and the Consultants 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.

2.5 The submissions (dossiers) were deposited in a safe place in the IMO Headquarters and made available to the Consulta nts, at their request , during the working hours. They were available for consultation by the members of the Group for the dur ation of the meeting in the meeting room and returned to the Organizati on’s designated room afte r 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 agreed to continue to be guided by the Terms of Reference approved by 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, includin g 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 appr oval of the report by GESAMP

(1 week) Administrations confirm that no c onfidential data are contained in the report (1 week) Produce the final report addressing the comments by GESAMP

13 weeks before MEPC Submission of the report of the meeting of the GESAMP-BWWG in accordance with the 13 weeks’ deadline for MEPC- 5 - GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC 3.3 The Group reconfirmed that its next meeti ng will take place from 23 to 27 March 2009 to review as many as possible the remain ing proposals received before the deadline of 19 December 2008. The Group ag reed that, due to the large number of proposals received before the above-mentioned deadline, any proposals for approval that could not be reviewed in the next meeting, would be reviewed at subs equent meetings of the Group after MEPC 59 and will be reported to MEPC 60.

4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS

4.1 Organisation of work

4.1.1 The Group noted that MEPC 59 had received 12 submissions for either Basic Approval or Final Approval.

4.1.2 In an attempt to deal with this heavy workload, the Group concentrated its efforts on reviewing applications at this meeting and so did not have any sign ificant discussions on the Methodology which it had done in previous meetings.

4.1.3 As a result and with an additional working day, the Group was able to review three submissions for Final Approval a nd two submissions for Basic Approval.

4.2 General observations resulting from review of the submissions

4.2.1 Having reviewed all of the submissions, th e Group agreed that there are a number of points arising which it wished to bring to the attention of MEPC. These are addressed in the rest of this section.

4.2.2 Whilst previously, there had been some suggestions that systems employing U.V. light to treat ballast water might not produce chemical disinfection by-pr oducts, it is now considered that this might not be the case as some effects we re shown in one of the systems reviewed. The Group considered that such finding emphasized the need to carry out ecotoxicological tests on the treated ballast water.

4.2.3 As a result, the Group requested ME PC to agree that systems employing U.V. light to treat ballast water should also be consider ed as candidates for review in accordance with Procedure (G9).

4.2.4 The Group agreed that each applicant should make a clear reference to the Methodology version being followed in the prep aration of their application.

4.2.5 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 incomplete or, more commonly, the information provided was unclear , so slowing down the evaluation process.

4.2.6 In this context, the Group invited MEPC to note that tim e spent evaluating inadequate dossiers prevented it from evaluating those that were complete and likely to be recommended for approval.GESAMP-BWWG 8/6 - 6 -

I:\MEPC\59\2-16.DOC 4.2.7 As a result, the Group reiterat ed its request to MEPC to urge each Administration to check that all technical descrip tions and specifications of the BWMS and, in particular, those related to the operating conditions are included with each application. Equally important, all data pertaining to the safety of the ship and crew, human health and environmental exposure and risk need to be submitted with each application. Every applicatio n has to be fully evaluated by the Group and, whether it is recommende d for approval or not, it take s the same amount of time. An application that is not recommended for approval may, therefore, deny another potential applicant the chance of an early and possibly successful evaluation.

4.3 Detailed review of the submissions

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

Annex BWMS Administration

4 Special Pipe Hybrid Ballast Water Management System (combined with Ozone treatment) also referred to as the SP-Hybrid BWMS Ozone version Japan

5 RWO Ballast Water Management System (CleanBallast) Germany

6 NK-O3 BlueBallast System (Ozone) Republic of Korea 7 Blue Ocean Shield Ballast Water Management System China 8 HHI Ballast Water Management Syst em (EcoBallast) Republic of Korea

4.3.2 With regard to the criteria associated w ith Procedure (G9), having reviewed all of the information associated with these submissions, the Group recommended that:

.1 Final Approval be not given for Specia l Pipe Hybrid Ballast Water Management System (combined with Ozone treatment) also referred to as the SP-Hybrid BWMS Ozone version;

.2 Final Approval be given to RWO Ballast Water Management System (CleanBallast);

.3 Final Approval be given to NK- O3 BlueBallast System (Ozone);

.4 Basic Approval be given to Blue O cean Shield Ballast Water Management System; and

.5 Basic Approval be given to HHI Ballas t Water Management System (EcoBallast).

4.4 Specific comments related to Special Pi pe Hybrid Ballast Water Management System (combined with ozone treatment)

4.4.1 After consultation with the applicant, the Group noted that the ballast water management system requires a minimum salinit y of 17 PSU. Consequently, the system cannot be used to treat freshwater or lower salinity brackish waters.- 7 - GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC 4.5 Specific comments relat ed to CleanBallast

4.5.1 The Group noted, with appreciation, the s ubmission of Germany (MEPC 59/2) with respect to the evaluation of corrosion eff ects for ballast water management systems utilizing Active Substances and was of the view that this provided a framework, with additions and revision, for future evaluations to asse ss corrosion effects. Specifically, the Group recommends that corrosion effects should be ev aluated through long-term testing (>6 months) of relevant materials at the maximum treatment or exposure concentration with the test conditions and evaluations as further point ed out in section 5.1 below.

4.5.2 As a consequence of reviewing this app lication, the Group made further observations related to corrosivity testi ng which are described under A ny Other Business (Section 5).

4.6 Specific comments related to Blue Ocean Shield Balla st Water Management System

4.6.1 In recommending that Basic Approval be gi ven to Blue Ocean Shield Ballast Water Management System, the Group would like to point out that the documentation of this application was poorly presented and lacked some information. However, it was agreed that sufficient aspects of this system were presented to allow the Group to be satisfied that further large-scale testing could be carri ed out without significant risk to the crew, the ship and the environment.

4.6.2 As a result, the applicant is advised to re view the requirements of Procedure (G9) and ensure that all of these are met when making th e application for Final Approval, taking note of the remarks in the evaluation (Annex 7).

4.7 Specific comments related to HHI Ballast Water Management System (EcoBallast)

4.7.1 The Group noted that the eco-toxicity tes ting had been performed as a full-scale land-based test in accordance with the requireme nts of Procedure (G9) for Final Approval.

4.7.2 In evaluating the application for Basic Appr oval, the Group noted th at the required tests had been performed correctly an d that the results demonstrated that the system met the requirements of Procedure (G9) to allow it to be recommended for Final Approval.

5 ANY OTHER BUSINESS

5.1 Recommendations for corrosion testing

5.1.1 Having reviewed the application for CleanBallast, the Group recommended that applicants should take account of the following points relate d to corrosivity testing:

.1 testing should include uncoated subs trates and marine epoxy coated steel; Coatings should be in accordance with the IMO Performance standard for protective coatings for dedica ted seawater ballast tanks in all types of ships and double-side skin spaces of bulk carriers (MSC.215(82));

.2 substrates should include low carbon steel and other metals (e.g., stainless steel, Cu alloys and Ni alloys) and non-metals (e.g., gasket and seal materials) as may be found in a ships seawater piping, fittings and structures which will be exposed to the Active Substance, Relevant Chemicals or Disinfection By-products;GESAMP-BWWG 8/6 - 8 -

I:\MEPC\59\2-16.DOC .3 in the case that passive materials are exposed to the Active Substances, Relevant Chemicals or Disinfection By-p roducts, these should be examined for localized corrosion resist ance by immersion with spec imen configurations as defined in ASTM G78 Standard Gu ide for Crevice Corrosion Testing of Iron-Base and Nickel-Base Stainle ss Alloys in Seawater and Other Chloride-Containing Aqueous Environments. As an additional evaluation, short term laboratory tests should be conducted in accordance with ASTM G61 – 86(2003) e1 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Meas urements for Localized Corrosion Susceptibility of Iron-, Nickel -, or Cobalt-Based Alloys;

.4 testing of coated substrates should be conducted using IS O 2812-2:2007 Paints and varnishes – Determination of resistan ce to liquids – Part 2: Water immersion method as guidance;

.5 testing should be conduct ed with controls (untreated ) and treated effluents under continuous exposure and also, if appr opriate, intermittent exposure of the specimens at the maximum treatment concentration of the ballast water management system ASTM G31 – 72(2004) Standard Practice for Laboratory Immersion Corrosion Testing of Metals can be used as a guide for such testing. As a minimum, testing source waters should be conducted using full strength, once-through (not refreshed) natural seawater. If appr opriate, testing should also include testing in fres h or brackish water;

.6 test duration should not be less than 6 months;

.7 subsequent evaluation of uncoated mate rials should include an evaluation of the corrosion rate, by weight loss, and the de pth and density of localized corrosion (i.e. pitting or crevice attack). These ev aluations may be made with the assistance of ISO 11463 Corrosion of Metals and All oys – Evaluation of Pitting Corrosion and ASTM G 46 Guide for Examination and Evaluation of Pitting Corrosion;

.8 subsequent evaluation of coated materi als and coating propert ies of both controls and samples exposed to treatment conditions should include:

.1 coatings adhesion according to ISO 4624 Paints and Varnishes – Pull-Off Test for Adhesion;

.2 degree of blistering according to ISO 4628-2 Paints and Varnishes – Evaluation of Degradation of Coatings – Designation of Quantity and Size of Defects, and of Intensity of Uniform Changes In Appearance – Part 2: Assessment of Degree of Blistering;

.3 degree of rusting according to ISO 4628-3 Paints And Varnishes – Evaluation of Degradation of Coatings – Designation Of Quantity And Size of Defects, and of Intensity of Uniform Changes in Appearance – Part 3: Assessment of Degree of Rusting;

.4 degree of cracking according to ISO 4628-4 Paints and Varnishes – Evaluation of Degradation of Coatings – Designation of Quantity And Size of Defects, and of Intensity of Uniform Changes in Appearance – Part 4: Assessment of Degree of Cracking;- 9 - GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC .5 degree of flaking according to ISO 4628-5 Paints And Varnishes – Evaluation of Degradation of Coatings – Designation of Quantity and Size of Defects, and of Intensity of Uniform Changes In Appearance – Part 5: Assessment of Degree of Flaking; and

.6 degree of delamination around a sc ribe according to ISO 4628-8 Paints and Varnishes – Evaluation of Degrada tion of Coatings – Designation of Quantity and Size Of Defects, and of Intensity of Uniform Changes in Appearance – Part 8: Assessment of Degree of Delamination and Corrosion Around a Scribe.

5.2 Next Stocktaking Workshop

5.2.1 The Group agreed that it would be very us eful to hold a second stocktaking workshop, in the autumn of 2009, in order to di scuss general problems arising from the review of applications for approval. In addition, it was thought necessa ry to continue developing those aspects of the Methodology which would assist the appli cants in preparing dossiers and the Group for reviewing applications.

5.2.2 The Group agreed that the following issues should be included in the workshop:

.1 Comparison of TRO in different systems – In this context, the Group had become aware that TRO is expressed in different ways by applicants and that, to achieve some consistency whilst making the reporti ng meaningful, it w ould be necessary to discuss the issue in depth prior to making recommendations;

.2 Check list for BA and FA – The Group agr eed that it would be useful to develop a checklist, for reference by applicants and Administrations when generating dossiers for the Group to review;

.3 Human Exposure Scenario – The Group recognized that the HES still required significant development before it can be used properly by the applicant and reviewed by the Group;

.4 Modelling of Predicted Environmenta l Concentrations – The Group recognized the need to finalize the input parameters that would be most usefully employed by the MAMPEC model for calculating environm ental concentrations of disinfectant by-products;

.5 Testing of volatile chemical by-pro ducts – Recognizing th at GESAMP–WG 1 has developed protocols for the ecotoxico logical testing of volatile compounds, the Group agreed that it would be useful to discuss the relevance of this to the testing of treated ballast water;

.6 Consideration of systems producing DBP – The Group agreed that further consideration needs to be given to the disinfecta nt by-products generated by generic types of systems, e.g., U. V. light and electrolysis; and

.7 Development of a model application – R ecognizing that most of the applications are not well presented, it was agreed th at it would be useful to develop a model dossier for applicants to follow when submitting documentation of their systems for review by the Group.GESAMP-BWWG 8/6 - 10 -

I:\MEPC\59\2-16.DOC 6 CONSIDERATION AND ADOPTION OF THE REPORT

6.1 A draft report of the ei ghth meeting of the GESAMP-BWWG was produced on 21 February 2009 and, after a paragraph-by-para graph review, the Group agreed on the final text and requested the Secretariat to make the n ecessary 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 8/6

I:\MEPC\59\2-16.DOC ANNEX 1

LIST OF MEMBERS WHO ATTENDED THE EIGHTH SESSION 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 : jan.linders@rivm.nl Tel : +31 30 274 3164
Fax : +31 30 274 4401

Ms Teresa Borges Senior Technical Officer Avenida Rio de Jane iro, no 58, 3o dto 1700-338 Lisbon Portugal E-mail : tborges@dgs.pt Tel : +351 2 1843 0599 Mobile : +351 9 1779 8048

Dr. Stephan Gollasch GoConsult Grosse Brunnenstr. 61 22763 Hamburg Germany E-mail : sgollasch@aol.com Tel : +49 40 390 54 60 Mobile : +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 : s-hanayama@sof.or.jp Tel : +81 3 3502 1886
Fax : +81 3 3502 2033 Mobile : +44 791 213 2909

Ms Annette Kronborg Director Adalia Toxicology Consultants Runslingan 3E SE-187 72 TÄBY
Sweden E-mail : annette.kronborg@adalia.se Tel : +46 8 510 149 36
Fax : +46 8 510 126 02 Mobile : +46 70 483 11 23

Mr. Edward Lemieux Section Head, Corrosion Engineering, Code 6136 Center for Corrosion Science & Engineering Naval Research Laboratory Key West, Florida USA E-mail : edward.lemieux@nrl.navy.mil Tel : +1-305-293-4214
Fax : +1-305-293-4213 Mobile : +1-240-475-6918GESAMP-BWWG 8/6
ANNEX 1 Page 2

I:\MEPC\59\2-16.DOC Dr. Kitae Rhie, Professor of Biology Department Kyung Hee University #1 Hoe-ki Dong Dong-dae-moon Ku Seoul 130-701 Republic of Korea E-mail : rhiekt@khu.ac.kr Tel : +82 2 961-0720 : +82 2 961-0603 (Lab)
Fax : +82 2 961 0244 Mobile : +82 16 9343 3860

Dr. Frank Stuer-Lauridsen LITEHAUZ ApS Diplomvej 381 DK 2800 Lyngby Denmark E-mail : fsl@litehauz.dk Tel : +45 8870 8675 Mobile : +45 2023 0202

IMO-GESAMP CONSULTANTS

Dr. Andrew Craven 23 Wenlock Drive Escrick York YO19 6JB United Kingdom E-mail : andrew.craven7@btinternet.com Mobile : +44 (0) 7849 070 668 Fax : +44 (0) 1904 728 428 (H)

Mr. John Crayford 2 Dunmow Hill Fleet Hampshire GU51 3AN United Kingdom E-mail (home) : j.crayford@ntlworld.com E-mail (work) : j.crayfor@imo .org Tel : +44 (0)1252 672245GESAMP-BWWG 8/6
ANNEX 1 Page 3

I:\MEPC\59\2-16.DOC GESAMP

Mr. Martin Soderberg GESAMP Officer Marine Environment Division International Maritime Organization 4 Albert Embankment, London SE1 7SR United Kingdom E-mail : msoderbe@imo.org Tel : +44 (0)20 7463 4139 Fax : +44 (0)20 7587 3210 Mobile : 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 : mpalomares@imo.org Tel : +44 (0)20 7587 3218 Fax : +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 : rcoenen@imo.org Tel : +44 (0)20 7587 3239 Fax : +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 : dpughiuc@imo.org Tel : +44 (0)20 7587 3247 (Direct) Fax : +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 : thuang@imo.org Tel : +44 (0)20 7463 4198 Fax : +44 (0)20 7587 3261

***GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC ANNEX 2

PROVISIONAL AGENDA FOR THE EIGHTH MEETING OF THE GESAMP-BALLAST WATER WORKING GROUP

1 Introduction

2 Issues of confidentiality

3 Terms of reference and time frame

4 Review of proposals for the a pproval of Active Substances

.1 Special Pipe Hybrid BWMS – comb ined with ozone treatment (Japan)

.2 CleanBallast (Germany)

.3 NK-O3 BlueBallast System (Ozone) (Republic of Korea)

.4 Blue Ocean Shield BWMS (China)

.5 HHI BWMS (EcoBallast) (Republic of Korea)

5 Any other business

6 Consideration and adoption of the report

***GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC ANNEX 3

TERMS OF REFERENCE FOR THE TECHNICAL GROUP

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 59.

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 st orage, handling and application 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 8/6

I:\MEPC\59\2-16.DOC ANNEX 4

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

Special Pipe Hybrid Ballast Water Manageme nt System (combined with Ozone treatment) also referred to as the SP-H ybrid BWMS Ozone version

Submitted for Final Approval by Japan as MEPC 59/2/1

0 SUMMARY

0.1 Having considered the responses of the appl icant to the concerns expressed during the evaluation of the system for Basic Approval and the additional information provided, the Group agreed to recommend that the Special Pipe Hybr id Ballast Water Management System (combined with Ozone treatment) should not be given Final Approval.

0.2 Reasons for not recommending that Final Approval be given:

.1 the level of maximum discharge concentration;

.1 the applicant submits that the maximum discharge concentration, after adjustment of background concentrations, of TRO is 0.69 mg/L as O 3 (1.02 mg/L as Cl 2 ) and the Group considered this an unacceptably high level of TRO for mari ne environmentally safet y. The Group is of the position that even if 1.02 mg/L as Cl 2 was partly caused by natural background levels (ca. 0.02 mg O 3 /L), which could be measured only around the test facility, the authority or Administration of another port with lower TRO levels could not accept such ballast discharge as usual operation;

.2 the confirmation of the performance by Discharge Water Treatment Tank (DWTT) to ensure maximum discharge concentration;

.1 the Group noted that the treatme nt of the discharg e is done through passage of the DWTT which is noted to alarm at a TRO of 0.15 mg/L (as O 3 ) and an automatic shutdown at 0.2 mg/L (as O 3 ). Despite this the Group was concerned that the a pplicant did not ad equately show that DWTT, used to regulate TRO, was capable of removing high dosages of TRO;

.2 also the Group noted that the appl icant should provide more information and evidence to ensure DWTT had sufficient absorption capacity for the recommended 2070 hours’ maintenance period;

.3 after further communication with th e applicant, the Group concluded that this component of the system has not yet been developed or tested in an operational system; andGESAMP-BWWG 8/6
ANNEX 4 Page 2

I:\MEPC\59\2-16.DOC .4 further, the requirement of the DW TT or other neutraliz ing system should be to lower the TRO sufficiently for th e entire discharge, not just that portion which is deemed a result of th e treatment system as these effects are likely inseparable;

.3 the Group noted that the testing conducte d by the applicant was with natural waters having a background concentration of 0.21 to 1.21 mg/L TRO as O 3 . The Group considers such testing inappropriate and recommends that full-scale testing conducted for the purposes of submitting data for Basic or Final Approval be conducted in natural waters with TRO less than 0.02 mg/L as Cl 2 . Also, the Group noted that the analytical method for m easurement of TRO, which the applicant applied during ecotoxicity testing and perf ormance test of DWTT, only ensures the detection level of 0.15 mg/L as O 3 (0.22 mg/L as Cl 2 ). The Group was of the opinion that this detection level is t oo high to evaluate the concentration after DWTT. (See 5.5); and

.4 corrosivity – the Group noted that the applicant attempted to evaluate long-term performance based on the inspection of in-service shipboard tanks, piping and pumping systems, but the Group agreed th at visual examination of such broad areas was insufficient, alone, without usage history or tank pre-condition, to characterize corrosion impact, as conclude d previously in document MEPC 58/2/7 GESAMP-BWWG 6/9, annex 7, paragra ph 4.7.5. Though the Group encourages the inspection of shipboard systems subject ed to the Active Substances to be certain that no obvious or extensive failures have occurred as a result of use with the treatment system, these should not be considered a sufficient replacement for long-term studies on both uniform and local ized corrosion rates at the anticipated treatment concentration of Active Substances (See 5.4).

0.3 In making this recommendation, the Group also expressed the following concerns:

.1 TRO measurements – With regard s to the measurement of TRO, TRO measurements for all scales of testing and for each type of test (i.e. acute toxicity, chronic toxicity, lon- term DWTT perfor mance, etc.) were made on discrete samples collected at the test facility and transported to the laboratory. These measurements were conducted the next day allowing significant time (>12 hours) for oxidant decay and so were likely unde restimate the actual TRO in any given sample. Further concern was evident in the TRO measurements as a significant concentration of oxidant was measured in the raw seawater with up to 1.21 mg TRO /L (as O 3 ). These are very high concentrations of oxidant in natural waters and likely compromises the vali dity of these tests (See 5.7);

.2 Functioning of the DWTT – The DWTT wa s tested for 230 hours at small scale with a flow rate of 20 m 3 /h with no reduction in TR O removal and only some reduction in bromoform removal over th e test period. Finally, the applicant suggested that the DWTT activated carbon should be refreshed at 2070 hours for ships up to 1400 m 3 /h (See 5.9);

.1 The Group was concerned with th e DWTT discharge treatment system since activated carbon removal of the Active Substances, Relevant Chemicals and disinfection by-products will be related to flow rate and total volume treated. The applicant only test ed the system at <0.2% of theGESAMP-BWWG 8/6
ANNEX 4 Page 3

I:\MEPC\59\2-16.DOC suggested total volume capacity and anticipated flow rate for the recommended exchange cycle of the DWTT. Moreover, since the DWTT is arranged to automatically shutdown the discharge in the event of excessive TRO and since the DWTT cannot be refreshed during ship operations, this scenario could reasona bly be expected to result in the inability to discharge pollutant free treated discharge water. With respect to the TRO of the discharge, the appli cant notes that the system is designed to automatically shutdown if the TRO exceeds 0.2 mg/L, yet the discharges reported in Section 6.5 are as high as 0.46 mg/L (as O 3 ). It is not clear whether the proposed TRO control deducts the background concentration to make its analysis or whether the TRO monitoring system was not employed during this or the other testing (See 5.5);

.3 Residual toxicity in treated ballast water – The Group noted that the various required tests were conducted at different scales. Specifically, the acute toxicity testing was conducted at a full-scale land -based test facil ity in accordance with Guidelines (G8) at 200 m 3 /h. The Group noted that whilst the TOC values were in accordance with Guidelines (G8), the DOC values were less than half the required value. The chronic toxicity te sts were conducted at a small-scale test facility not in accordance with Guide lines (G8) at a flow rate of 20 m 3 /h and only at one salinity (seawater). Finally, th e long-term performa nce of the DWTT was conducted at 20 m 3 /h and was neither tested at full scale nor with the proposed integrated TRO sensor (See 5.6); and

.4 The Group recalled that in the dossier on the SP-Hybrid BWMS the substance ozone was defined as an Active Substance with a half life of about 5 s. Therefore, the Group did not consider that ozone wa s of any concern to the environment;

.1 In performing the calculations with the model MAMPEC, the applicant used TRO expressed as O 3 as a Relevant Chemical and defined a worst case estimation of TRO as O 3 of 4.5 d. This may l ead to confusion with the concept of ozone being of no rele vance to the environment. The Group advises the applicant to use a defi nition of TRO that expresses the concerns for the remaining residual oxydant more appropriately.

0.4 Notwithstanding these remarks, the Group also made the following observations:

.1 The Group was satisfied that the risks to the crew from exposure to ozone and bromate could be mitigated by adequate engineering control measures and use of Personal Protective Equipment a nd Respiratory Protective Equipment (PPE/RPE).

.2 The Group also recognized that the App licant made a good attempt to build up the various human exposure scen ario (HES) concerning occupational (e.g., inspection of ballast water tank as well as tank cleaning) and general public exposure (swimming and eating fish from the area) to bromoform.

.3 The overall conclusion is: there is no reason for concern with regards to human exposure to this relevant chemical in the concentrations as generated by the system. However, some aspects in the HE S ought to be further elaborated by the applicant (allocation of appr opriate assessment factors).GESAMP-BWWG 8/6
ANNEX 4 Page 4

I:\MEPC\59\2-16.DOC .4 After consultation with the applicant the Group noted that the BWMS requires a minimum salinity of 17 PSU for it to func tion and so its application should be limited accordingly.

1 INTRODUCTION

1.1 It was recalled that the SP-Hybrid BW MS Ozone version had been recommended for Basic Approval at the second meeting of the Group as the Special Pipe Ballast Water Management System (combined with Ozone tr eatment). This was given Basic Approval by MEPC 55.

1.2 The data used to evaluate the SP-Hybrid BWMS Ozone version were extracted from the Japanese submission to the fifty-ninth session of MEPC as document MEPC 59/2/1.

2 COMPLETENESS OF THE DOSSIER

2.1 Whilst recognizing that ther e were some omissions from the submission, the Group agreed that such omissions were eith er justified or of minor significance.

3 DESCRIPTION OF THE SYSTEM

3.1 Overview

3.1.1 The Group noted that the system being cons idered for Final Approval was the same as that which had been given Basic A pproval with the following exceptions:

.1 the name had been changed and the refere nce to ozone is important to differentiate it from another system being developed which uses different Active Substances to ozone; and

.2 the post-treatment DWTT is applied to all ballast water discharge so that there is no need to specify the storage time of tr eated ballast water in the tank to reduce the level of ozone present; and

.3 the applicant for Basic Approval was th e Japan Association of Marine Safety whilst the applicant for Final Approval is Mitsui Engineering & Shipbuilding Co. However, in both cases, the applicati ons were submitted to MEPC from the Japanese Government.

3.1.2 Noting these exceptions, the Group recalle d that the ballast water treatment and disinfecting system comprises of four main sections as follows:

.1 the first being a pre-treatment filtration unit;

.2 the second contains a mechanical trea tment element and a chemical treatment element where ozone generated on board is injected into the ballast water;GESAMP-BWWG 8/6
ANNEX 4 Page 5

I:\MEPC\59\2-16.DOC .3 the third is a gas/liquid separation un it where undissolved oz one is removed and then destroyed; and

.4 the fourth and final section is a pos t-treatment unit designed to control the concentration of oxidants rema ining in the ballast water.

A schematic representation of th is system is shown below:

Figure 1 – Configuration of SP- Hybrid BWMS Ozone version

3.1.3 In addition, it was recalled th at the applicant had indicated that the treatment system is fully automated with the controls intended to be integrated in the ships ballasting consol. The in-line main treatment unit allows the disinf ection treatment to be applied during uptake of ballast water.

3.1.4 It was further recalled that ozone will be gene rated ‘on demand’ and will be injected into the ballast water to a maximum le vel of 4 mg Ozone/litre ballast water. The system includes a ballast water discharge conditioning unit to treat oxidants remaining in the ballast water at discharge.

3.1.5 It was also recalled that ther e is no need to store ozone on board ship and the previous submission identified the intended safety measures to be put in place that will reduce the risk of crew exposure to ozone.

S.C. Gas/Liquid Separation Control Panel

Pre

- Filter Gas/Liquid Separation Tank To ballast tank O.B.

Waste Ozone Destruction Unit

Special Pipe

( Slit plate ) Ballast Water Treatment Control Panel

Ballast Pump Ballast Control Panel

Ozone Generator Oxygen Generator
Discharge Water Treatment Tank From ballast tank Inactivation Unit

Gas/Liquid Separation Unit Flow Meter Ozone Generator Module

Ozone Injector Flow of Ozone

Electric Control Wire

Ballast Line

TRO Sensor Post

- Treatment Unit Flow of Ozone (low concentration)

Flow of Oxygen

S.C. Gas/Liquid Separation Control Panel

Pre

- Filter Gas/Liquid Separation Tank To ballast tank O.B.

Waste Ozone Destruction Unit

Special Pipe

( Slit plate ) Ballast Water Treatment Control Panel

Ballast Pump Ballast Control Panel

Ozone Generator Oxygen Generator
Discharge Water Treatment Tank From ballast tank Inactivation Unit

Gas/Liquid Separation Unit Flow Meter Ozone Generator Module

Ozone Injector Flow of Ozone

Electric Control Wire

Ballast Line

TRO Sensor Post

- Treatment Unit Flow of Ozone (low concentration)

Flow of OxygenGESAMP-BWWG 8/6
ANNEX 4 Page 6

I:\MEPC\59\2-16.DOC 3.1.6 The Group noted that application for Fina l Approval of the SP- Hybrid BWMS Ozone version was made on the understanding that it was for use under the following conditions:

.1 Ballast water required for treatment

Sea and brackish water containing brom ide ion. Fresh water containing no bromide ion is not includ ed in this application.

.2 Times of ballast water treatment

It is treated only once on ballasting.

.3 Concentration of Active Substance (Ozone) when in use

Ozone as Active Substance is injected on ballasting in such manner to achieve the concentration of 3 mg/L in the ballasting water.

.4 Holding time

Holding time following ballast water treatment is not specified. Ballast water can be discharged immediately after treatment.

.5 Use of DWTT

At the time of ballast water discharge, the Relevant Chemicals should be removed by the DWTT.

.6 The maximum allowable discharge concentration of Relevant Chemicals

The concentration of relevant chemicals at the time of discharge following removal by the DWTT is less than 0.07 mg/L for Bromate ion, less than 0.19 mg/L for Bromoform and less than 0.2 mg/L for TRO (as O 3 ).

3.2 Active Substances (AS), Relevant Chem icals (RC) and Other Chemicals (OC)

3.2.1 The Group recognized ozone as the Active Substance for this system which reacts with the components in seawater to produce the following Relevant Chemicals:

.1 bromate ions;

.2 bromoform; and

.3 Total Residual Oxidants (TRO) which is a term commonly used to describe all of the oxidants in the seawater resulting from treatment by the system concerned. In the case of ozone treatment, TRO is r ecognized as including ozone, bromate ion and hypobromous acid.

3.2.2 The Group noted the following maximum concen trations of by-products reported in the ballast water treated by this system:

.1 bromate ions : 70 μg/L;GESAMP-BWWG 8/6
ANNEX 4 Page 7

I:\MEPC\59\2-16.DOC .2 bromoform : 18 μg/L;

.3 TRO : 1180 μg/L (including background levels). 690 μg/L (after subtraction of background levels).

3.2.3 Whilst noting that the maximum concentr ation of TRO generated by this system was 690 μg/L the Group also noted that th e applicant argued that, for the purposes of Risk Assessment, 200 μg/L should be used as, following treatment with ozone (4/mg/L) and its almost simultaneous removal in the DWTT:

.1 45% of measurements were <150 μg/L (detection limit);

.2 6% of measurements were 140 μg/L to 200 μg/L;

.3 45% of measurements were 200 μg/L to 300 μg/L; and

.4 3% of measurements were 300 μg/L to 690 μg/L.

3.2.4 In addition, the Group noted that the applicant argued further that the maximum concentration of ozone which will be actually used is 3 mg/L (c.f. the above figures were obtained following 4 mg/L treatme nt) and the above measurements were obtained without any detention time, the realistic operational va lues of TRO could be taken as 200 μg/L.

3.2.5 Whilst recognizing the argumentation proposed by the applicant, in the absence of measurements generated from the treatment of ba llast water at 3 mg/L, the Group considered that a TRO concentration of 0.69 mg/L as O 3 should be used for the purposes of Risk Assessment.

3.3 Data associated with each of the chemical by-products

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

.1 ozone appendix 1 (as a surrogate for TRO)

.2 bromate appendix 2;

.3 bromoform appendix 3; and

.4 treated ballast water appendix 4

4 CONSIDERATION OF CONCERNS EX PRESSED BY THE GROUP DURING ITS PREVIOUS REVIEW FOR BASIC APPROVAL

4.1 The Group recalled that, as part of its evaluati on of the system for Basic Approval, it had raised the following points:

.1 due consideration should be given to the fact that the risk assessment currently performed has been based upon an incomple te data set and therefore the risk assessment should be considered as indi cative only. A complete data set may result in a different conclusion;GESAMP-BWWG 8/6
ANNEX 4 Page 8

I:\MEPC\59\2-16.DOC .2 due consideration should be given to the fact that the information on the substance bromoform as a possible Relevant Chemical is considered insufficient for a risk assessment on this chemical on all topics, therefore, additional information should be provided on this substance;

.3 the discharge from the “waste ozone dest ruction unit” should be suitably sited and included in the Ozone monitoring and alarm system;

.4 it should be confirmed that the levels of THM and free Ozone in the ballast tanks remain acceptable. Additional safety precau tions should be put in place until such confirmation is obtained;

.5 it should be confirmed that the noise levels when the system is in operation remain within permitted levels for machinery spaces (MEPC 55/2/16, annex 5, paragraph 10.4.2.5);

.6 it should be confirmed that the initial assessment that the corrosion effect will be limited is correct and that there is no additional corrosion effect on ballast piping, ballast tanks or degradation of protective coatings resulting from the use of the system; and

.7 the apparent discrepancy between the m easured chronic toxicity of the treated ballast water and the assessment of brom ate should be investigated further. Awaiting the results of such investigations , the discharge of ba llast water treated with Ozone during further development a nd testing should only take place under controlled conditions and into an environment where a sufficient dilution can be assured for avoiding unreasonable ri sks to the aquatic environment.

4.2 The Group noted that, in response to these concerns, the applica tion for Final Approval included the following:

.1 acute toxicity tests of treated ballast water from the land-based test facility (See Table 4.3.23);

.2 repetition of chronic toxic ity test (See Table 4.3.23);

.3 degradation test for generated Relevant Chemicals (See Table 4.3.21);

.4 removal test for generated Rele vant Chemicals (See Table 4.3.21);

.5 long-term performance test of DWTT (See Table 4.3.3);

.6 inspection for hull corrosion in full-s cale shipboard system (See Table 4.3.14);

.7 analysis for volatile Bromoform fr om ballast tank (See Table 4.3.14); and

.8 noise measurement test in full-scale shipboard system (See Table 4.3.5).GESAMP-BWWG 8/6
ANNEX 4 Page 9

I:\MEPC\59\2-16.DOC 4.3 A summary of the specific c oncerns made by the Group and th e response of the applicant with references to the information provided in addition to the non-confidential submission to MEPC is shown in the table below:

No Comments of GESAMP-BWWG Response in application for Final Approval Reference inFolder ‘Nonconfidential, confidential and appendices

.1 The risk assessment should be considered based on a complete data set. Data set was improved and risk assessment was provided again. 2, 3, 4, 5, 6, 7

.2 Additional information should be provided on Bromoform as Relevant Chemical for a risk
assessment. Information on Bromoform was added to the data set. Risk assessment was provided based on the concentration of Bromoform which was measured in the various tests. 2, 3, 4, 5, 6, 7

.3 The discharge from the “waste Ozone destruction unit” should be suitably sited and monitored in the Ozone monitoring and alarm system. Concentration of Ozone discharged from the waste Ozone destruction unit was confirmed with both the land-based and shipboard systems and safety measures were established. 3.2.5.6.3.6.1, 3.2.7.1.5, 7.1.4.2.5

.4 Confirm that the THM and free Ozone in the ballast tanks remain acceptable. Concentration of THM and Ozone in the ballast tanks was confirmed with shipboard system. The concentration was acceptable. 3.2.5.6.3.5.1, 7.1.4

.5 Confirm that the noise of the system remain within permitted levels for machinery space. Operation noise was measured with the shipboard system. The noise in the engine room remained within the permitted level. 7.1.5, App 12

.6 Confirm the initial assessment that the corrosion effect will be limited, and that there is no additional corrosion effect from use of the system. It was confirmed that corrosion of the full-scale shipboard system after operation for a certain term was acceptable. There are no additional corrosion effects. 7.1.1.1

.7 The apparent discrepancy between the measured chronic toxicity of the treated ballast water and the assessment of Bromate should be investigated further. The discharge of ballast water should only take place under controlled conditions. Concentration of Bromate ion was measured in the repetition of the chronic toxicity test. Treated ballast water is discharged with post treatment each time to avoid risks. 2, 4, 5, 6, 7

.8 Quantitative data on Hypobromous acid ion or Hypobromous acid might have been useful. Hypobromous acid ion and Hypobromous acid generated by the reaction of seawater and Ozone is described in 2.1 Identification of Substance or Preparation. 2.1, App 1-1GESAMP-BWWG 8/6
ANNEX 4 Page 10

I:\MEPC\59\2-16.DOC

No Comments of GESAMP-BWWG Response in application for Final Approval Reference inFolder ‘Nonconfidential, confidential and appendices

.9 Sampling and analysis for other chemicals such as Bromoform should be included in the further testing. Such data should be submitted in the application for Final Approval. Information on the other chemicals that may be formed was investigated by open literature recommended by GESAMP. (Amy D et al. 2001, Gunten

v, et al. 1994, Fabbricino et al. 2005) Sampling and analysis of Bromoform, other THM’s and chlorophenols were included in various developments and tests. Bromoform was confirmed to be generated. A data set of Bromoform was added to the application of Final Approval. 2, 6.2, 6.3

.10 It should be noted that the dashes indicate “data not required” which might not be strictly correct. If it is not applicable or Relevant then, perhaps this should be indicated and the reason given. The reason for non-applicability or nonrelevance was described. 2

.11 Justification for non-submission of oral and dermal toxicity data for Ozone and absence of inhalation and dermal toxicity data for Bromate should be presented. Reasons such as difference of main exposure route etc. were described. 2.3

.12 It is highly recommended that strict mitigation measures to avoid human inhalation and exposure to Ozone during the process should be applied. Excellent separation of Ozone from ballast water in Gas/Liquid Separation Tank and excellent removal of Ozone in Waste Ozone Destruction Unit were obtained. Further, Ozone Leak Monitors were installed. If a leakage should be detected, there is a visible and audible alarm and the system performs an emergency stop. Since there is possibility of contact with Residual Oxidant in ballast tanks, safety measures require the wearing of protective equipment. These were tested in the full-scale land-based system and in the full-scale shipboard system. 3, 7.1, 7.2

.13 The exposure to Bromate should be totally avoided. Possibility of exposure to Bromate is limited to internal inspections of the ballast tank. Exposure in internal inspections is completely avoided with protective clothing, mask, goggles, gloves, etc. 7.2.2.2GESAMP-BWWG 8/6
ANNEX 4 Page 11

I:\MEPC\59\2-16.DOC

No Comments of GESAMP-BWWG Response in application for Final Approval Reference inFolder ‘Nonconfidential, confidential and appendices

.14 Bromoform and other brominated DBP: as highly reactive compounds capable of bioaccumulating, exposure to these in the long-term should be minimized. There is no probability of long term exposure to Bromoform, etc. However, these chemicals may remain in the ballast tank. During tank internal inspections, exposure is completely avoided by protective clothing, mask, goggles, gloves, etc. 3.2.7.1.6, 7.2.2.3.1

.15 The potential for cumulative toxicological effects of the mixture of chemicals generated by the system should be taken into account. Sampling and analysis of THM were performed in the course of various developments and tests including the land-based and shipboard system were performed. Analysis of chlorophenols was performed in the chronic toxicity test, to check for generation of compounds which may exert influence. 2.1, 6.2, 6.3, 6.4, 6.5, 6.6

.16 It is recommended that placards giving additional warnings of the hazards related to the inhalation of Ozone be provided on board to promote a general awareness. An Ozone Leak Monitor is placed at the required location and measures were taken so that if a leakage should be detected, there is a visible and audible alarm and the system performs an emergency stop. A caution plate is posted at the place where there is a possibility of inhalation of Ozone by shipboard personnel. 3.2.5.4, 3.2.7, 7.1.4

.17 The THM levels in the ballast tank should be regularly measured during the further prototype development and testing period. Precautionary measures to mitigate any risk to the crew from contact with THM are put in place until it can be demonstrated that the risk is negligible. Sampling and analysis of THM were performed in various developments and tests including the land-based and shipboard system. In the tank internal inspections where there is possibility to contact with THM by shipboard personnel, exposure is completely avoided by protective clothing, mask, goggles, gloves, etc. 2.1, 3.2.7.1.6, 6.2, 6.3, 6.4, 6.5, 6.6, 7.2.2.3.1

.18 The reaction of Ozone with seawater should be analysed further. Sampling and analysis of treated ballast water were performed in various developments and tests including the land-based and shipboard system. Analysis of chlorophenols was also performed in the second chronic toxicity test to confirm generated quantity. Using additional information obtained from various documents, the reaction of Ozone and seawater was re-analysed. 2.1, 6.2, 6.3, 6.4, 6.5, 6.6, APPENDIX 1- 1GESAMP-BWWG 8/6
ANNEX 4 Page 12

I:\MEPC\59\2-16.DOC

No Comments of GESAMP-BWWG Response in application for Final Approval Reference inFolder ‘Nonconfidential, confidential and appendices

.19 Specify the analysis method of Bromate. The analysis method for Bromate ion applied in various tests was specified. 2.6, 6.2, 6.3, 6.4, 6.5, 6.6, APPENDIX 2,3,9

.20 It is recommended that toxicity data and degradation data found in analyses of the treated ballast water are related to TRO and not only to the concentration of Bromate ion. In various developments and tests including the land-based and shipboard system, THM such as Bromoform were analysed in addition to Bromate ion and TRO. In the second chronic toxicity test, chlorophenols were analysed. 2.1, 6.2, 6.3, 6.4, 6.5, 6,6, APPENDIX 2,3,9

.21 The group noted that the dossier did not include any information about degradation rates in sediment and freshwater for Bromate ions or TRO. Information on the degradation rates of Bromoform as Relevant Chemical in addition to Bromate ion and TRO in the sediment and freshwater was added. 2.4.1

.22 As the group accepts the minor role of Ozone after the treatment of the ballast water the risk assessment has been focused on Bromate ion. Therefore only for Bromate the PNEC has been derived. The acute toxicity data presented in the Table T8.1 is considered complete for Bromate but Table T8.2 does not show a complete data set for the chronic toxicity of Bromate. Bromate, Bromoform and TRO were measured in the toxicity tests of treated ballast water. A complete data set of each chemical was added. 2.2.2, 6.2 6.3

.23 However, the group considered that there was a discrepancy between the toxicity data available on Bromate (see Tables T8.1 and T8.2), which result in a derived PNEC for Bromate of 0.26 μ g/L, and the concentration of Bromate in treated ballast water at 0.16 mg/L, which causes no effect in the chronic toxicity tests with treated ballast
water. In the second chronic toxicity test, Bromate ion, TRO, Bromoform and other THM were analysed and consistency with the toxicity data was verified and used for the final evaluation. 2.2.2, 6.3GESAMP-BWWG 8/6
ANNEX 4 Page 13

I:\MEPC\59\2-16.DOC

No Comments of GESAMP-BWWG Response in application for Final Approval Reference inFolder ‘Nonconfidential, confidential and appendices

.24 Under normal operating conditions it is expected that the discharge concentration of TRO will be about 0.16 mg/L as TRO. Since the derived PNEC for Bromate is 0.26 μ g/L, a dilution of more than 500 times would be required before long-term toxicity can be avoided. The Group was not aware of information that allows an evaluation of whether this can be obtained under realistic and representative conditions. TRO concentration of discharged ballast water and concentration of Relevant Chemicals were analysed and re-evaluated in various developments and tests including the full-scale land-based and shipboard systems. Post treatment is conducted with the Discharge Water Treatment Tank in all cases. Relevant Chemicals were re-evaluated under such conditions. These results and decomposition rate of Relevant chemicals were used for the re-evaluation. 6.2, 6.3, 6.4, 6.5, 6.6, 6.9, 6.12, 7.2, APPENDIX 2,3,9GESAMP-BWWG 8/6
ANNEX 4 Page 14

I:\MEPC\59\2-16.DOC 5 OTHER CONCERNS ARISING DURING THE REVIEW

5.1 The Group noted that the applicant submitted that the maximum discharge concentration, after adjustment of background concen trations, of TRO is 0.69 mg/L as O 3 (1.02 mg/L as Cl 2 ) and the Group considered this an unacceptably high level of TRO for environmentally safety.

5.2 The Group noted that the treatment of the discharge is done through passage of the DWTT which was noted to alar m at a TRO of 0.15 mg/L (as O 3 ) and an automatic shutdown at 0.2 mg/L as O 3 . Despite this the Group was concerned that the applicant did not adequately show that the Discharge Water Treatment Tank (D WTT), used to regulate TRO, was capable of removing high dosages of TRO or that the DWTT had sufficient absorption capacity for the recommended 2070 hours maintenance period. The Group recommended that the applicant either show that the DWTT or a neutralizing agent can reduce the TRO (due to treatment and background) to <0.2 mg/L as Cl 2 as a minimum.

5.3 The Group noted that the testing conducted by the applicant was with natural waters having a concentration of 0.21 to 1.21 mg TRO /L as O 3 . The Group considers such testing to be inappropriate and recommended that full scale te sting conducted for the purposes of submitting data for Basic or Final Approva l be conducted in natural waters with TRO less than 0.02 mg/L as Cl 2 . Furthermore, the requirem ent of the DWTT or other neut ralizing system should be to lower the TRO sufficiently for the entire discharge, not just that portion wh ich is deemed a result of the treatment system as thes e effects are likely inseparable.

5.4 The Group noted that the appli cant attempted to evaluate lo ng term performance based on the inspection of in-service sh ipboard tanks, piping and pumping systems, but the Group agreed that visual examination of such broad areas was insufficient, without usage history or tank pre-condition, to characterize corrosion imp act, as concluded previously in document MEPC 58/2/7, GESAMP-BWWG 6/9, annex 7, paragraph 4.7.5.

5.5 The Group was concerned with the DWTT di scharge treatment syst em since activated carbon removal of the AS, RC and disinfection by-products will be related to flow rate and total volume treated. The applicant only tested the system at <0.2% of the suggested total volume capacity and anticipated flow rate for th e recommended exchange cycle of the DWTT. Moreover, since the DWTT is arranged to automati cally shutdown the discha rge in the event of excessive TRO and since the DWTT cannot be refr eshed during ship operations, this scenario could reasonably be expected to result in th e inability to discharge pollutant free treated discharge water. With respect to the TRO of the discharge, the applicant noted that the system is designed to automatically shutdown if the TRO exceeds 0.2 mg/L, yet the discharges reported in section 6.5 are as hi gh as 0.46 mg/L both as O 3 . It is not clear wh ether the proposed TRO control deducts the background concentration to make its analysis or whether the TRO monitoring system was not employed during this or the other testing.

5.6 The Group noted that the various required te st were conducted at different scales. Specifically, the acute toxicity testing was conduc ted at a full scale land-based test facility in accordance with Guidelines (G8) at 200 m 3 /h. The Group noted that whilst the TOC values were in accordance with Guidelines (G8), the DOC values were less than half the required value. The chronic toxicity tests were conducted at a small scale test facili ty not in accordance with Guidelines (G8) at a flow rate of 20 m 3 /h and only at one salinity (seawater). Finally the long term performance of the DWTT was conducted at 20 m 3 /h and was never tested at full scale or with the proposed integrated TRO sensor.GESAMP-BWWG 8/6
ANNEX 4 Page 15

I:\MEPC\59\2-16.DOC 5.7 The Group noted that TRO measurements for all scales of testing and for each type of test (i.e. acute toxicity, chro nic toxicity, long term DWTT performa nce, etc.) were made on discrete samples collected at the test facility and tran sported to the lab. These measurements were conducted the next day allowing significant time (>12 hours) for oxidant decay, as such these measurements likely underestimate the actual TRO in any given sample . Further concern was evident in the TRO measurements as a significant concentration of oxidant was measured in the raw seawater with up to 1.21 mg TRO /L as O 3. These are very high conc entrations of oxidant in natural waters and likely compromise the validity of these tests.

5.8 As a result, the Group concl uded that due to th e high background TRO of the raw intake waters and the potential underestimation of TRO measurements caused by delaying analysis until the day following sampling that all such tests should be repeated.

5.9 The Group concluded that the testing of the DWTT was insufficient in treated volume capacity and flow rates relative to the propose d shipboard treatment volume and flow rate. Additionally, the Group expressed c oncern that the testing did not sufficiently evaluate the long term performance of the DWTT as the recommended exchange cycle is 2070 hours, but the system was only tested for 230 hours. The Group noted that no evaluations of the DWTT with the integrated TRO control system were presen ted and that discharge concentrations of TRO exceeded 0.2 mg/L (as O 3 ).

5.10 The Group recommended that the applicant repeat testing, as appropriate, of the complete, integrated ballast water manage ment system be conducted in accordance with Guidelines (G8) and to insure that the te sts are conducted at a test facility whose natural waters have a TRO <0.2 mg/L (as Cl 2 ) and that all measurements of TRO should be completed immediately following sample acqui sition, to the extent possible.

5.11 The Group recommended that the applican t demonstrate, either by calculation or experimentation, the anticipated ex change frequency requir ed relative to both treated volume and flow rates. Further, the applicant should de monstrate that the DWTT tested as part of the G8 testing (i.e. at 200 m 3 /h) sufficiently reduces the Active Substances and Relevant Chemicals.

6 HUMAN HEALTH ASSESSMENT

6.1 Based on the data provided by the applicant in its submissions for both Basic Approval and Final Approval, the Group agreed that the hazards to human health posed by this system could be described in association with the chemicals produced as shown below:

.1 Ozone

.1.1 Ozone is toxic when inhaled and even at low doses can be harmful to the upper respiratory tract and lungs as well as being irritating to the eyes.

.1.2 Long term exposure to low doses can cause non-carcinogenic lesions in the nose and lungs.

.1.3 Exposure during pregnancy can affect foetal development.GESAMP-BWWG 8/6
ANNEX 4 Page 16

I:\MEPC\59\2-16.DOC .2 Bromate

.2.1 Bromate is toxic when ingested.

.2.2 It is irritant to skin, eyes and respiratory system.

.2.3 It may be a human carcinogen.

.3 Bromoform

.3.1 Bromoform is toxic by inhala tion and harmful if swallowed.

.3.2 It is irritating to the skin and eyes.

.3.3 It may also be a human carcinogen.

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

7.1 Risks associated with exposure of the crew to the Active Substance (Ozone)

7.1.1 The Group recognized that the oz one used by this system is generated on board and so there will not be any risks associated with the storage of chemicals.

7.1.2 As a result, the Group agreed that the only risk to the crew from exposure to ozone would be from leakages in the pipe-work.

7.1.3 However, the Group noted that the system is equipped with ozone leak monitors located at the ozone generator, near the ozone injector and near the waste oz one destruction unit. On detection of an ozone leak, visible and audi ble alarms are raised, the ozone generation is stopped and evacuation of the cr ew from the area is urged.

7.1.4 In addition, the applicant indicated that porta ble ozone monitors are provided for use as appropriate.

7.1.5 Whilst recognizing that ozone ha s a short half-life in seawater , the Group considered that exposure of the crew to ozone might occur when entering the ballast tank e.g., during inspection. Therefore, the Group recommended the use of PPE and RPE.

7.1.6 The Group was satisfied that the risks to the crew from exposur e to ozone could be mitigated by adequate engineering control measures and the use of PPE/RPE.

7.2 Risks to the safety of the ship

7.2.1 The Group recalled that, previ ously, it had expressed concer ns related to the potential corrosivity of ozone on the materials of construc tion. The Group noted that, in response to these concerns, the applicant had provi ded the following information:

.1 The applicant indicated that ozone is a strong oxidizer and therefore provisions for corrosion resistant materials of constructi on in the treatment system components is necessary. The applicant recommended the use of stainless steel for all system components and delivery systems. The type and grade of stainless steel is not identified; andGESAMP-BWWG 8/6
ANNEX 4 Page 17

I:\MEPC\59\2-16.DOC .2 The applicant conducted a visual assessm ent of the corrosion condition of barge ballast tanks, system components and pu mping systems subsequent to 8 months operation with the installed system. The applicant provided no details regarding the frequency or conditions of operation or pre-existing material conditions. The applicant notes the absence of corrosi on in both the ballast tank, where the corrosion-control measures were judged not to be necessary at the application of Basic Approval, and in the equipmen t, where the corrosion-control measures were required due to contact with a high concentration of Ozone.

7.2.2 The Group determined that this conclusi on could not be accepted since it contradicts known and published data regarding increased local ized corrosion of stai nless steel and other passive metals in ozonated seawater. Furthermor e, the Group noted that the applicant attempted to evaluate long term performance based on the inspection of in-service shipboard tanks, piping and pumping systems, but the Group agreed that visual examination of such broad areas was insufficient, alone, without usage history or tank pre-condition, to characte rize corrosion impact, as concluded previously in document MEPC 58/2/7, GESAMP-BWWG 6/9, annex 7, paragraph 4.7.5. Though the Group en courages the inspect ion of shipboard systems subjected to the Active Substances to be certain that no obvious or extensive failures have occurred as a result of use with the treatment system, these should not be consider a sufficient replacement for long term studies on both uniform and localized co rrosion rates at the anticipated treatment concentration of Active Substances.

7.2.3 The Group recommended that long-term studies, as appr opriate, be carried out or otherwise documented from literature to qua ntify, at the treatment and possible exposure concentrations, resultant balla st tank coatings de gradation and the e xpected uniform and localized corrosion rates on typical marine vesse l metallic (e.g., steel, galvanized steel, zinc, stainless steel, etc.) and non-metallic material s (e.g., EPDM rubber) materi als used for ballast tanks, fixtures and piping.

7.3 Risks associated with exposure of the crew to Relevant Chemicals

7.3.1 The Group recognized the argumentation proposed by the applicant that the risk to the crew from bromate can occur when entering balla st water tanks e.g., during inspection. Bromate is classified as a probable human carcinogen (IARC, 1999; EPA, 2001) and IPCS (2000) has recommended a TDI of 1 μ g/kg bw/d based on a NOAEL for the formation of renal tumours in rats at 1.3 mg/kg bw/d using an AF 1000. Therefore the Group recommended the use of personal protective equipment (PPE ) and respiratory protec tive equipment (RPE).

7.3.2 In considering the risks associated with poten tial acute inhalation e xposure of the crew to bromoform during tank cleaning operations, th e Group noted the following argumentation:

.1 Maximum concentration of bromoform in ballast water = 0.19 mg/L

.2 Assuming t 1/2 for bromoform is 185 d and using the Mackay model level III, thenGESAMP-BWWG 8/6
ANNEX 4 Page 18

I:\MEPC\59\2-16.DOC .2.1 Proportion expected to partition into the atmosphere = 3.25%

.3 Assume the volume of ballastwater taken on board = 15000 m 3

.3.1 Assume the headspace in the tank = 5000 m 3

.4 Then the concentration of bromofor m in the airspace of the ballast tank =

3

3 3 / 0185

. 0 / 0185

. 0 5000 15000 0325

. 0 / 19

. 0 m g L mg
m m L mg air of Volume water of Volume air in ion Concentrat = = × × = ×

.5 Assuming the concentration of brom oform is not dilute d around the ship (not likely), then the crew would be exposed to 0.0185 g/m 3

.5.1 Assume: a crew member works for 5 h, once/month in the tank a crew member weighs 60 kg a crew member breaths 10 m 3 in 5 h

.6 The exposure to bromoform during this activity would be:

kg mg kg m mg m member Crew of Weight air in bromoform of ion Concentrat breathed air of Volume / 09

. 3 60 / 5

. 18 10 3 3

=

×

= ×

.7 The Oral LD 50 of rats is 1147 mg/kg

.8 The Margin of Safety is calculated as 1147/3.09 = 371

7.3.3 According to the applicant the risks associ ated with acute exposur e to bromoform were concluded to be of lower concern. However, the Group has the following considerations to make:

.1 generally speaking, the use of LD50 as a critical thre shold value to derive an acute MOS is not the most appropriate one because this type of toxicity test addresses mortality as an endpoint and not acute adverse effects;

.2 considering the maximum concentration of bromoform in air space of the BWT of 0.0185 g/m 3 (18.5 mg/m 3 ) as calculated by the applicant using Mackay level III model and comparing this va lue with the Japanese OEL of 10.3mg/m 3

, and taking into consideration that this will be a worst case scenario (no dilution was assumed), the Group considered that acute exposure to bromoform volatized in the BWT will not represen t a risk to the crew; and

.3 the Group wanted also to highlight that as a general rule the different MOS have to be refined with the appropriated assessment fact ors (AF) in order to address uncertainties related to extrapolation from animal toxi city data to the e xposed human population.GESAMP-BWWG 8/6
ANNEX 4 Page 19

I:\MEPC\59\2-16.DOC 7.3.4 In addition, the Group noted the argumentation, proposed by the applicant, associated with the potential long-ter m exposure to bromoform as a result of tank washing.

.1 Take the No Observed Adverse E ffect Level (NOAEL) as 25 mg/kg/d

.2 The Chronic Exposure associated with working in the tank for 5 h once a month would be:

3.09 mg/kg/30d = 0.103 mg/kg/d

.3 Therefore, the MOS is 25/0.103=243 and so the risks associated with chronic exposure of the crew in tank clean ing is regarded as minimal.

7.3.5 According to the applicant the risk associat ed with long-term exposure to bromoform as a result of tank cleaning was c oncluded to be of lower concer n. However, the Group had the following considerations to make:

.1 considering the maximum concentration of bromoform in air space of the BWT of 0.0185 g/m 3 (18.5 mg/m 3 ) as calculated by the applicant’s model and comparing this value with the Japanese OEL of 10.3mg/m 3 , and taking into consideration that this will be a worst case scenario (no dilution was assumed), the Group considered that long-term exposure to bromoform volatized in the BWT from tank washing operations will not represent a risk to the crew;

.2 the Group noted that th e relevant NOAEL (25 mg/kg bw/d) for MOS derivation was adequately chosen by the applicant; and

.3 however, the MOS for long-term exposure needs to be refined with the appropriate assessment factors (AF) in or der to address uncertainties related to extrapolation from animal toxicity data to the exposed human population.

7.3.6 With regard to the potential exposure of th e crew to bromoform in their living spaces, the Group noted the following arguments proposed by the applicant:

.1 Assume the living space is about 1600 m 3 ;

.2 assume the living space has a direct conn ection to the BWT (a totally unrealistic worst case scenario);

.3 then, the concentration of bromoform above the ballast water would be diluted by the living space to 75% of the balla st water tank head space, i.e.:

(5000 x 0.0185)/(5000+1600) = 0.014 g/m 3

.
.4 Assume the living space is continuously ventilated at 78 m 3 /min;

.5 therefore, the air is replaced every 20 min ( i.e. 1600 m 3 /78 m 3 ) and the bromoform concentration is diluted 72 times/day.

.6 Assume exposure of a 60 kg crew is 24 h/d;GESAMP-BWWG 8/6
ANNEX 4 Page 20

I:\MEPC\59\2-16.DOC .7 then the crew me mber would breath 20 m 3 /d;

.8 then the crew member would be exposed to:

.9 0.014 g/m 3 x 1/72 x 20 m 3 x 1/60 kg = 0.064 mg/kg bw/d (390 times less than the NOAE L of 25 mg/kg/13 weeks);

.10 As a result, the risks to the crew from long-term exposure to bromoform would be minimal.

7.3.7 The Group agreed with the assumptions used by the applicant to develop HES for the living space and refer to the considerations made in the previous paragraph regarding the use of AF for MOS derivation, until a more final HES will be developed by the Group.

7.4 Risks to the general public from potentia l exposure to bromoform in the atmosphere

7.4.1 The Group noted that, using similar calculations to those described above, the applicant argued that the concentration in the a tmosphere of bromoform would be 0.367 μg/m 3 . The Group agreed that this would not lead to unacceptable risks.

7.5 Risks to the general public from pote ntial exposure to bromoform via seafood

7.5.1 Based on the properties of bromoform and th e predicted levels in the environment, the Group agreed that the risks to the general public from inge stion of bromoform from seafood was minimal.

7.6 Risks to the general public from potential exposure to bromoform whilst bathing in
the sea

7.6.1 Having noted that the calculated PEC for bromoform would be 0.0113 μg/L (see below at paragraph 8.2.2) and the NOAEL has been reporte d as 25mg/kg/d, the Group agreed that the risks associated with exposure to bromoform by swimming in the sea would be minimal.

7.6.2 The Group agreed with the arguments made by the applicant concerning the assessment of general public exposu re via environment and the conclu sions achieved. In cases where a combined exposure may occur (e.g., swimming in the water and eating fish from the area), the Group also suggested that the TDI approach c ould be integrated in th e iterative process and the predicted daily uptake considering all upt ake routes simultaneously taken into account (Guidelines for drinking-wat er quality, WHO, 2006).GESAMP-BWWG 8/6
ANNEX 4 Page 21

I:\MEPC\59\2-16.DOC 8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Assessment of Persistence (P), Bioa ccumulation (B) and Toxicity (T)

Chemical Persistence (P) (Yes/No) Bioaccumulation (B) (Yes/No) Toxicity (T) (Yes/No)
Ozone No (1⁄2 life ~ 5 sec No (Log Pow <1) Yes (NOEC 0.002mg/L/90d)
Bromate Yes (1⁄2 life > 40d) No (Log Pow -7.18) No (NOEC >0.13 mg/L/7d)
Bromoform Yes (1⁄2 life 185 d) No (BCF 21) No (NOEC 10 mg/L/4d)

8.2 Calculation of Predicted Envi ronmental Concentrations (PEC)

8.2.1 The Group noted that the MAMPEC model ver. 2.0 had been used to calculate the Predicted Environmental Concentrations (PEC) of the Active S ubstance and Relevant Chemical associated with this system, usi ng the Port of Tokyo as the model harbour.

8.2.2 The resultant PECs are shown in the table belo w, together with the chosen toxicity data that define the lowest value and the applicable assessment factor. Finally, this leads to the presented PEC/PNEC-ratio.

Chemical Conc. In BW (μg/L) PEC (μg/L) Toxicity (μg/L) Assessment
Factor PNEC (μg/L) PEC/PNEC

TRO (as O 3 ) 690 0.0432
Bromate 70 0.00517 30000 1000 30 0.000172 Bromoform 190 0.0113 7100 1000 7.1 0.00159

8.2.3 The Group recalled that in the review of the dossier on the SP-Hybrid BWMS the substance ozone was defined as an Active Substan ce with a half life of a bout 5 s. Therefore, the Group does not consider ozone as a substance of any concern to the envi ronment. Therefore, no PEC/PNEC for ozone has been calculated.

8.2.4 In performing the calculations with th e model MAMPEC, the applicant used TRO expressed as O 3 as a Relevant Chemical and defined a worst case estimation of half-life TRO as O 3 of 4.5 days. This may lead to confusion with the concept of ozone be ing of no relevance to the environment. The Group advised the use of a definition of TRO that expresses the concerns for the remaining residual oxygen in a more appropriate way.

8.2.5 As the Group defined a standard emissi on environment and a GESAMP-BWWG standard harbour during the stocktaking workshop in Ja nuary 2009, the Group performed some additional calculations using the estimated PECs in the disc harged ballast water of the applicant and the standard harbour and standard emission environmen t. It should be noted that the applicant was not able to perform these calculations because at the time of submission these standard conditions were not yet defined. Therefor e, the calculations presented be low only show a comparison with the results obtained by the applicant. The results are used to validate the results of the standard environment definition.GESAMP-BWWG 8/6
ANNEX 4 Page 22

I:\MEPC\59\2-16.DOC Results of risk assessment using the estima ted load of the applicant and the standard environment as defined by the Group.

Chemical Conc. In BW (μg/L) PEC (μg/L) Toxicity (μg/L) Assessment
Factor PNEC (μg/L) PEC/PNEC

TRO (as O 3 ) 690 0.117
Bromate 70 0.0311 30000 1000 30 0.00104 Bromoform 190 0.0346 7100 1000 7.1 0.0048

In the above table, the results are presented of the calculation us ing the emission load estimated by the Group based on the conc entration established by the applicant in the standard environment.

Results of risk assessment using the load ba sed on the ballast water concentration of the applicant and the standard environment as defined by the Group

Chemical Conc. In BW (μg/L) PEC (μg/L) Toxicity (μg/L) Assessment
Factor PNEC (μg/L) PEC/PNEC

TRO (as O 3 ) 690 12.4
Bromate 70 3.3 30000 1000 30 0.11 Bromoform 190 3.67 7100 1000 7.1 0.52

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risk to the safety of the ship

9.1.1 The Group concluded that visual examination of exposed ship structures and systems was insufficient, alone and without usage history or tank pre-condition, to characterize corrosion impact, as concluded previously in docum ent MEPC 58/2/7, GESAMP-BWWG 6/9, annex 7, paragraph 4.7.5. The Group further concluded that visual assessment of corrosion should not be considered a sufficient replacement for long term studies on both uniform and localized corrosion rates at the anticipated treatment concentration of Active Substances.

9.1.2 The Group recommends that long-term studies, as appropriate, be carried out or otherwise documented from literature to quantify, at the treatment and possible exposure concentrations, resultant ballast tank coatings degradation and th e expected uniform and localized corrosion rates on typical marine vessel metallic (e.g., steel, galvan ized steel, zinc, stainless steel, etc.) and non-metallic materials (e.g., EPDM rubber) materials used for ballast tanks, fixtures and piping.

9.2 Risk to crew and general public

9.2.1 The Group considered that the HES would n eed to be allocated with the appropriate assessment factors (AF) in order to address the uncertainties de riving from the extrapolation of results from animal toxicity testing to human exposure. However, the Group is also in favour that for Final Approval and in order to address th e risk to the crew from inhalation exposure to disinfectant by-products, the applicant could us e the Occupational Expos ure Level (OEL) in order to avoid the uncertainty related to route- to-route extrapolation from oral to inhalation.GESAMP-BWWG 8/6
ANNEX 4 Page 23

I:\MEPC\59\2-16.DOC 9.2.2 In addition, the Group would like to sugge st that in what concerns general public exposure (by swimming and eating fish from the ar ea), the TDI approach c ould be integrated in the iterative process and the predicted daily upt ake considering all uptake routes simultaneously taken into account (Guidelines fo r drinking-water quality, WHO, 2006).

9.3 Risks to the environment

9.3.1 The Group agreed that due to the high level of TRO generated by this syst em and the lack of adequate performance of the DWWT , the potential risks to the envi ronment were unacceptably high.

9.3.2 In this context, the Group also expressed c oncern that the natural sea water used in the various tests also had such high levels of TRO as to make environmental testing very difficult and so recommended that more suitable seawater was used for future testing.

9.4 Conclusions

9.4.1 Having reviewed all of the data, the Group agreed that it could not recommend this system for Final Approval at this stage and recommended that the applicant develop its neutralization as well as carrying out fu ture tests under more suitable conditions.

* * *GESAMP-BWWG 8/6
ANNEX 4 Page 24

I:\MEPC\59\2-16.DOC Appendix 1

Basic Data on Ozone

1 CHEMICAL IDENTIFICATION

Chemical Name Molar

mass Structural formula CAS Number Concentration in discharge ballast water, after treatment of the DWTT (Bio) degradationrate or halflife AS, RC or OC

Ozone 48.00 10028- 15-6 N/A 5.8 Sec AS

TRO (as O 3 ) N/A N/A N/A 0.21 - 1.18mg/L (<0.15 - 0.69mg/L) 0.75-4.5 day RC

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity

Species LC 50 (mg/L) Reference/Comments

Morone saxatilis , SW 0.08 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Morone americana

, SW 0.2 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Oncorhynchus mykiss , FW 0.0093 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Fish

Ictalurus punctatus

, FW 0.03 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a)

Crustacea N/A N/A ECOTOX data base (U.S. EPA, 2007a) Other literature was not available for data.

Molluscs Dreissena polymorpha, FW 0.53 (5.8-h LC 50 ) Harrington et al. (1997)

Algae N/A N/A ECOTOX data base (U.S. EPA, 2007a). Othe r literature was not available for data.

2.2 Chronic Aquatic Toxicity

Species NOEC (mg/L) Reference/Comments

Fish Oncorhynchus mykiss 0.002 (90 day) Wedemeyer et al ., 1979

Crustacea N/A N/A ECOTOX data base (U.S. EPA, 2007a). Data were not available in other literature.
Algae N/A N/A ECOTOX data base (U.S. EPA, 2007a). Data were not available in other literatureGESAMP-BWWG 8/6
ANNEX 4 Page 25

I:\MEPC\59\2-16.DOC 2.3 Information on Endocrine Disruption Not Available

2.4 Sediment Toxicity Due to short half-life (~ 5.8 s), it is unlikely to adhere to or accumulated in sediment.

2.5 Bioavailability/Biomagnification/Bioconcentration

Chemical

name logPow/BCF information Cause for

concern (Yes/No) Reference/Comments/ Justification for missing data

logPow N/A

Ozone BCF N/A No Due to Ozone being an inorganic compound and having a short half life in the environment, there is no need for it to be considered. logPow N/A TRO BCF N/A No Due to the short half life of the TRO, there is no need for it to be considered.

2.6 Food web/population effects

2.6.1 Due to it short half-life, it is anticipated th at the potential for bioaccumulation in the food chain would be minimal.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

3.1.1 It was recognized that it is not possible to determine the oral and dermal toxicities of gases. However, the Group r ecognized that the inhalation LC 50 of ozone is 0.012 mg/L/4h.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) decomposes very rapidly to form oxygen.

4.2 Partition Coefficients

Log Pow N/A BCF N/A

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 With a short half-life (5.8 s), ozone is not regarded as persistent.

4.4 Reaction with Organic Matter not considered required.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats not considered required.

4.6 Potential Residues in Seafood not considered required.GESAMP-BWWG 8/6
ANNEX 4 Page 26

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPERTIES

Property Value Reference/Comments/ Justification for missing data

CAS number 10028-15-6 Ullmann’s Encyclopedia of Industrial Chemistry 6th Ed,2001 Molecule weight 48.0 ISCS 1993

Liquid density 1358 g/L (at -112oC) Ullmann’s Encyclopedia of Industrial Chemistry 6th Ed,2001

Evaporation heat 15.2kJ/moL Ullmann’s Encyclopedia of Industrial Chemistry 6th Ed,2001 Melting point -193oC ISCS 1993 Boiling point -112oC ISCS 1993

Flammability Noncombustible but promotes burning of other substances. No inflammability to liquid. ISCS 1993

Density (20 oC ) 2.144g/L(N.T.P) (at 0oC,101kPa) Ullmann’s Encyclopedia of Industrial Chemistry 6th Ed,2001 Vapour pressure (20 oC ) >1 atm ISCS 1993 Vapour density (air=1) 1.6 (air=1) ISCS 1993 Water solubility 0.1g/100mL (at 0oC) ISCS 1993 pH in solution N/A Exits as a gas
Dissociation constant N/A Not applicable since Ozone is a gas.

Oxidation reduction potential 2.07V Ullmann’s Encyclopedia of Industrial Chemistry 6th Ed, Section 2.Physical Properties P.39-P.40 June-2001

Corrosivity to Material Yes Ozone reacts with inorganic compounds including metals and organic compounds. See section 2.1, APPENDIX 1-1 (confidential dossier).

Reactivity to container material Yes Ozone reacts with inorganic compounds including metals and organic compounds. See section 2.1,
APPENDIX 1-1.

Auto ignition temperature ( oC ) Non-combustible but promotes burning of other substances. Various reactions may cause a fire or explosion. Ozone reacts with inorganic compounds including metals and organic compounds. See section 2.1,
APPENDIX 1-1.

Explosive Properties May cause a fire or explosion when heated or coming in contact with a combustible material (alkene, ether). ISCS 1993

Oxidizing properties Yes ISCS 1993

Surface tension 3.84×10 -2 N/mm (at -183oC) Refer to section 2.1 and APPENDIX 1-1

Viscosity 1.57×10 -3 Pa.s(at -183oC) Ullmann’s Encyclopedia of Industrial Chemistry 6th Ed,2001 Thermal stability and breakdown product Oxygen Ullmann’s Encyclopedia of Industrial Chemistry 6th Ed,2001 Other physical and chemical properties N/A Refer to section 2.1 and APPENDIX 1-1

* * *GESAMP-BWWG 8/6
ANNEX 4 Page 27

I:\MEPC\59\2-16.DOC Appendix 2

Data on Bromate

1 CHEMICAL IDENTIFICATION

Chemical Name Empirical Formula Molar

mass Struc-tural formula CAS Number AS, RC or Other

Bromate ion BrO 3 - 127.9 15541-45-4 RC

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity

Species LC 50 and EC 50 (mg/L) Reference/Comments/ Justification for missing data

Fish Oncorhynchus keta , SW 512 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a)

Crustacea Neomysis awatschensis

, SW 176 (24-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a)
Crassostrea gigas , SW 30 (96-h EC 50 ) ECOTOX data base (U.S. EPA, 2007a) Molluscs Crassostrea gigas , SW 170 (24-h EC 50 ) ECOTOX data base (U.S. EPA, 2007a)

Algae N/A N/A ECOTOX data base (U.S. EPA, 2007a) Other literature was not available for data.

2.2 Chronic Aquatic Toxicity

Species NOEC (mg/L) Reference/Comments/Justification for missing data

Fish N/A N/A ECOTOX data base U.S. EPA, 2007a). Data were not available in other literature.

Crustacea N/A N/A ECOTOX data base (U.S. EPA, 2007a). Data were not available in other literature.
Algae Skeletonema

costatum , SW >0.125 (7 days) Erickson and Freeman, 1978

2.3 Information on Endocrine Disruption Not Available, but not considered required.

2.4 Sediment Toxicity Not thought to be applicable due to its water solubility.GESAMP-BWWG 8/6
ANNEX 4 Page 28

I:\MEPC\59\2-16.DOC 2.5 Bioavailability/Biomagnification/Bioconcentration

Chemical

name logPow/BCF information Cause for

concern (Yes/No) Reference/Comments/ Justification for missing data
logPow -7.18 Bromate ion BCF N/A No SRC, 2007

2.6 Food web/population effects

2.6.1 The Log Pow of Bromate suggests that its bioaccumulation in the food chain would be minimal.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Exposure Route Value Species Reference Oral LD 50 280 mg/kg Rat GESAMP-BWWG 3/9, annex 6

3.2 Corrosion/Irritation

Species Results Reference
Skin Human Irritant RTECS & EEC Classification R36/37/38 Eyes Human Irritant RTECS & EEC Classification R36/37/38
Inhalation Not specified Irritant EEC Classification R36/37/38

3.3 Sensitization

3.3.1 Assumed not to be a sensitizer as EEC Classification does not include R43.

3.4 Repeated Dose Toxicity

3.4.1 Exposure of rats to 30 mg/kg/d for 15 w eeks produced significant increases in blood serum parameters indicative of live and ki dney toxicity (GESAMP-BWWG 3/9, annex 6).

3.4.2 NOAEL and LOAEL reported as 30 mg/kg/d.

3.5 Development and Reproductive Toxicity

3.5.1 Exposure of rats to 30 mg/kg/d for five and eight generations did not produce any observable developmental or reproductive toxicity.

3.6 Carcinogenicity

Species Method Results Reference Carcinogenicity Rat Possible human carcinogen IARC Gp 2B Mutagenicity Bacteria
Hamster Ames Mutagenic MutagenicGESAMP-BWWG 8/6
ANNEX 4 Page 29

I:\MEPC\59\2-16.DOC 4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) bromate ions are converted into bromide ions by microbial degradation under anaerobic conditions.

4.2 Partition Coefficients

Log Pow -7.18 BCF N/A

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 With a half-life of > 40 d, bromate i ons are considered to be persistent.

5 PHYSICAL AND CHEMICAL PROPERTIES

Property Value Reference/Comments CAS number 7758-01-2 WHO, 2005 Molecule weight 167.01 WHO, 2005 Liquid density N/A Not liquid but solid
Evaporation heat Not considered to be a fire hazard MSDS(APPENDIX 7-1-2)

Melting point 350 o C WHO, 2005 Boiling point 370 o C( decomposes WHO, 2005 Flammability Yes ICSC, 2003 Density (20 o C) 3.27g/m 3 WHO, 2005 Vapour pressure (20 o C) N/A MSDS(APPENDIX 7-1-2) Vapour density(air=1) N/A MSDS(APPENDIX 7-1-2)

Water solubility 70g/L(20 o C ) 133g/L(40 o C ) 498g/L(100 o C ) HydroChem Industrial Services,Inc.

pH in solution Not Found MSDS(APPENDIX 7-1-2) Dissociation constant Not Found WHO, 2005 Oxidation reduction potential 1.05V NTP 2008a Corrosivity to Material Yes NTP 2008a Reactivity to container material Yes MEPC 55/2

Auto ignition temperature ( o C) No MEPC 55/2

Explosive Properties Risk of fire and explosion on contact with combustible, organic or other easily oxidizable materials. MEPC 55/2

Oxidizing properties Oxidizer HydroChem Industrial Services,Inc.

Surface tension Not Found Material Safety Data Sheet of Potassium Bromate Viscosity No ICSC, 2003GESAMP-BWWG 8/6
ANNEX 4 Page 30

I:\MEPC\59\2-16.DOC Thermal stability and breakdown product No HydroChem Industrial Services,Inc.

Other physical and chemical properties contact with combustible materials may cause fire. Incompatible with combustible material, organics, reducing agents, aluminium, finely powdered metals. The substance decomposes on heating or on burning producing toxic and corr osive fumes including bromine, and oxygen, which increases fire hazard. The substance is a strong oxidant and reacts violently with combustible and reducing materials, metal powder, fats, carbon, sulphur, phosphorus, ammonium salts, and metal sulphides causing fire and explosion hazard http://physchem. ox.ac.uk/MSDS/ PO/potassium_B romate.html http://www.itcilo .it/english/actrav/ telearn/osh/ic/77 58012.htm

* * *GESAMP-BWWG 8/6
ANNEX 4 Page 31

I:\MEPC\59\2-16.DOC Appendix 3

Data on Bromoform

1 CHEMICAL IDENTIFICATION

Chemical Name Empirical Formula Molar

mass Structural formula CAS Number AS, RC or Other

Bromoform CHBr 3 252.7 75-25-2 RC

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity

Species LC 50 (mg/L) or EC 50 (mg/L) Reference/Comments/ Justification for missing data Cyprinodon variegatus , SW 7.1 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Brevoortia tyrannus

, SW 12 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Fish Lepomis macrochirus

, FW 29 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Americamysis bahia

, SW 24.4 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Penaeus aztecus , SW 26 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Daphnia magna , FW 46 (48-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Crustacea

Daphnia pulex , FW 44 (96-h LC 50 ) ECOTOX data base (U.S. EPA, 2007a) Skeletonema

costatum , SW 12.3 (96-h EC 50 ) ECOTOX data base (U.S. EPA, 2007a) Pseudokirchneriella subcapitata , FW 42 (72-h EC 50 ) ECOTOX data base (U.S. EPA, 2007a) Algae

Pseudokirchneriella subcapitata , FW 40.1 (96-h EC 50 ) ECOTOX data base (U.S. EPA, 2007a)

2.2 Chronic Aquatic Toxicity

Species MATC (mg/L) or NOEC(mg/L) Reference/Comments/ Justification for missing data

Fish Cyprinodon variegatus MATC; 4.8 (28 d) Ward et al ., 1981

Crustacea N/A N/A ECOTOX data base (U.S. EPA, 2007a). Data were not available in other literature.
Algae Pseudokirchneriella subcapitata , FW NOEC;10 (96 h) ECOTOX data base (U.S. EPA, 2007a)GESAMP-BWWG 8/6
ANNEX 4 Page 32

I:\MEPC\59\2-16.DOC 2.3 Information on Endocrine Disruption

Not Available, but not considered required.

2.4 Sediment Toxicity

As log Pow is <3 it is not expe cted to cause sediment toxicity.

2.5 Bioavailability/Biomagnification/Bioconcentration

Chemical

name logPow/BCF information Cause for

concern (Yes/No) Reference/Comments/ Justification for missing data
logPow 2.4

Bromoform BCF 0.1mg/L: 7.1-21 0.01 mg/L: 7.7-19 No NITE, 2007

2.6 Food web/population effects

The BCF of bromoform suggests that its potential to bioaccumulate in the food chain would be minimal.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Exposure Route Value Species Reference Oral LD 50 707-1550 mg/kg
933-2440 Mouse
Rat Dermal LD 50 Inhalation LC 50 7000 μg/L/4h Dog

3.2 Corrosion/Irritation

Route Species Results Reference Skin Human Irritant GESAMP-BWWG 3/9, annex 6 Eye Human Irritant GESAMP-BWWG 3/9, annex 6 Inhalation Human Irritant GESAMP-BWWG 3/9, annex 6

3.3 Sensitization

Not thought to be a sensitizer.GESAMP-BWWG 8/6
ANNEX 4 Page 33

I:\MEPC\59\2-16.DOC 3.4 Repeated Dose Toxicity

3.4.1 A summary of the repeated toxicity data evaluated by the Group fo r bromoform is shown in the table below:

Exposure Route Oral Exposure Duration 13 weeks Exposure dose Missing Species Rats and Mouse
NOAEL 25mg/kg/d (rat), 100mg/kg/d(Mouse)

NOEL

3.4.2 The Group noted a 13-week study, performed in rats, where a NOAEL of 25mg/kg bw/d could be derived on the basis of the absence of liver lesions whereas in the study in mice was 100mg/kg bw/d (NTP, 1989).

3.4.3 A summary of the chronic toxicity data evaluated by the Group for bromoform is shown in the table below:

Exposure Route Oral Exposure Duration 2 years Exposure dose 100 and 200 mg/kg/d Species Rat
Method
Results Small increase in tumours of the large intestine
NOAEL

NOEL
Reference/Comments/ Justification for missing
data EHC 216(2000)

3.4.4 The Group noted that no neoplasic effects were associated with the exposure of mice to bromoform. However, adenocarcinomas of the col on or rectum were observed in 3/50 male rats dosed with 200mg/kg and 1/50 female rats dosed with 100mg/kg and 8/50 female rats dosed with 200mg/kg (c.f. 0/48 in female control rats).GESAMP-BWWG 8/6
ANNEX 4 Page 34

I:\MEPC\59\2-16.DOC 3.5 Development and Reproductive Toxicity

3.5.1 A summary of the development and reproductiv e toxicity data evaluated by the Group for bromoform is shown in the table below:

Exposure Route Oral Oral Exposure Duration At days 6-15 of gestation 105 days Exposure dose 50, 100 and 200 mg/kg/d Species Rat Rats (male and female pairs)
Method
Results Evidence of foetotoxic response. No foetal malformations observed No detectable effect on fertility, litters/pair, live pups/litter, proportion of pups born alive, sex or body weights
NOAEL

NOEL
Reference/Comments/ Justification for missing
data EHC 216 (2000) EHC 216 (2000)

3.5.2 It was noted that Ruddick et al. (1983) had conducted a terato logical investigation in Sprague-Dawley rats, where bromoform was ad ministered by gavage at dose of 50, 100 or 200mg/kg bw/d on gestation days 6-15. Evid ence of foetotoxic res ponse was observed, but there were no foetal malformations. This stud y was used to examine effects on fertility and reproduction in Swiss CD-1 female rats. There were no detectable eff ects of bromoform on reproduction function. Bromoform was found to i nduce resorption in F344 pregnant rats, at higher doses (150 and 200mg/kg bw/d).

3.6 Carcinogenicity

3.6.1 A summary of the carcinogenicity and mutage nicity data, evaluated by the Group for bromoform, is shown in the table below:

Species Method Details Results Reference/Comments/ Justification for

missing data Carcinogenicity Rats 5 days exposure/week for 2 years No evidence observed NTP, 1989a

Mutagenicity Bacteria
Not identified (Ames test)
In vivo Mutagenic Inconclusive

3.6.2 The Group noted that IARC had evaluated car cinogenicity of bromoform and concluded that there is inadequate eviden ce for its carcinogenicity in humans and limited evidence for its carcinogenicity in experimental animals. IARC classified bromoform in Group 3 (not classifiable as to its ca rcinogenicity to humans). EPA (2005) classified bromoform as possible human carcinogen (Group 2B).GESAMP-BWWG 8/6
ANNEX 4 Page 35

I:\MEPC\59\2-16.DOC 3.6.3 In addition, the Group noted that bromoform is largely positive in bacterial assays of mutagenicity and appeared to be more potent than the other brominated THMs. In vivo studies have given contradictory results.

3.6.4 The Group noted that the applicant had not su bmitted any data relate d to mutagenicity. However, it was agreed that, with the developm ent, reprotoxicity and car cinogenicity data, this additional information was not essential.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

4.2 Partition Coefficients

Log Pow 2.4
BCF 7.1 – 21

4.3 Persistence and Identifica tion of Main Metabolites

With a half-life of 32 – 185 d, brom oform is regarded as persistent.

4.4 Reaction with Organic Matter

Not considered required.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

Not considered required.

4.6 Potential Residues in Seafood

Not considered required.GESAMP-BWWG 8/6
ANNEX 4 Page 36

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPERTIES

Physical property Value Reference/Comments/ Justification for missing data CAS number 75-25-2 U.S. EPA 2005 Molecule weight 252.77 U.S. EPA 2005 Liquid density 2.899 g/mL (20 o C) U.S. EPA 2005 Evaporation heat 46.05 kJ/mol ATSDR 2005 Melting point 8 o C U.S. EPA 2005 Boiling point 149-150 o C U.S. EPA 2005 Flammability No ATSDR 2005 Density (20 o C ) 2.899 g/mL ATSDR 2005 Vapour pressure (20 o C ) 667 Pa NTP 2008b Vapour density (air=1) 8.7 NTP 2008b Water solubility 3190mg/L(30 o C) U.S. EPA 2005 pH in solution N/A Not hydrolyzed
Dissociation constant N/A No dissociable groupOxidationreduction potential N/A No ionization

Corrosivity to Material Yes ATSDR 2005

Reactivity to container material Yes ATSDR 2005

Auto ignition temperature ( o C ) - N/A

Explosive Properties Not considered to be an explosion hazard MSDS(APPENDIX 7-1-2)

Oxidizing properties N/A MSDS(APPENDIX 7-1-2) Surface tension 41.50mN/m (20 o C) NTP 2008b Viscosity 1.8 cP NTP 2008b
Thermal stability and breakdown product May form toxic fumes of bromides when heated to degradation MSDS(APPENDIX 7-1-2)

Other physical and chemical properties Volatilize ATSDR 2005

* * *GESAMP-BWWG 8/6
ANNEX 4 Page 37

I:\MEPC\59\2-16.DOC Appendix 4

Data on Treated Ballast Water

1 CHEMICAL IDENTIFICATION Treated Ballast Water

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity

2.2 Chronic Aquatic Toxicity

Test water Max. concentration of Relevant Chemicals in No Observed Effect Test Water Case (mg/L) Fish: Oryzias javanicus (28d-NOEC) Crustacea: Hyale barbicornis (21d-NOEC) Algae: Skeletonema

costatum (78h-NOEC) Bromate ion 0.03 Bromoform: 0.0093 TRO (as O 3 ) 0.96 Sea water Generated TRO by Ozone Treatment (mg/L as O 3 ) 0.69 Before PT;10% After PT;100% Before PT;10% After PT;100% Before PT;10% After PT;100%

2.3 Information on Endocrine Disruption

Not Available, but not considered required.

2.4 Sediment Toxicity

Not considered required.

2.5 Bioavailability/Biomagnification/Bioconcentration

Not considered required.

*** Test water Max. concentration of Relevant Chemicals (mg/L) Fish: Oryzias javanicus Crustacea: Hyale barbicornis (96h-LC 50 ) Al g ae: Skeletonema

costatum (72h-ECr 50 ) Bromate ion 0.07 Bromoform: 0.0023 TRO (as O 3 ) 0.85 Sea water Generated TRO by Ozone Treatment ( m g /L as O 3 ) <0.15 >100% >100% >100%

Bromate ion 0.04 Bromoform: 0.015 TRO (as O 3 ) <1.18 Brackish

water Generated TRO by Ozone Treatment ( m g /L as O 3 ) <0.15 >100% 71% >100%GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC ANNEX 5

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

RWO Ballast Water Management System (CleanBallast)

Submitted by Germany

0 SUMMARY

0.1 Having reviewed all the information provi ded by the applicant, the Group agreed to recommend to the MEPC that Final Approval be given to the RWO Ballast Water Management System (CleanBallast), subject to the Admi nistration verifying that all the following recommendations have been fully addressed prior to issuance of a Type Approval Certificate:

.1 the neutralization step should always be employed prior to 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.

.1 the maximum allowable dosage of Active Substances (TRO) should be 2.5 mg/L as Cl 2 for the first treatment at intake and 1.5 mg/L as Cl 2 for the second treatment at discharge, if required. These parameters should be monitored by TRO sensors adequately maintained, and also recorded during when the BWMS in use; and

.2 the maximum allowable discharge concen trations of Active Substances

– the concentration of TRO after neutralization should be kept to a level not exceeding the range of 0.1-0.2 mg/L. During the Type Approval procedure by the Administration, the applicant s hould finalize the maximum allowable discharge concentrations of TRO in the range of 0.1-0.2 mg/L as Cl 2 and validated by the Administration. This parameter should be monitored and recorded during discharge.

0.2 In addition to the above recommendati on, the Group made the following observations:

.1 it was noted that the applicant ha d used the model calculations using the MAMPEC-model and the model MIKE to generate estimations of the PECs for different Relevant Chemicals;

.2 it was also noted that the results used were only based on the MAMPEC results. Although the attempt of the applicant was appreciated the Group found some difficulties in reproducing the results of the applicant as the documentation did not include a listing of the input values used. The results ob tained by the Group were too high by a factor of about 100 fo r the commercial harbour and a factor of about 50 for the OECD-EU commercial harbour. However, the Group did consider these results as i ndicative as a standard scen ario has not been endorsed yet. It is recommended that applicants deliver all the input and output data used in the modelling; andGESAMP-BWWG 8/6
ANNEX 5 Page 2

I:\MEPC\59\2-16.DOC .3 the Group noted the thorough evaluation of corrosion of both unc oated and marine epoxy coated steel. The applicant conclude d, from these tests, that CleanBallast was compatible with epoxy based ballast water tank coating systems as certified by Germanischer Lloyd (GL). However, the corrosion evaluation of uncoated steel was insufficient due to the low e xposure dose through th e majority of the exposure evaluation. This was not c onsidered a reason influencing the FA recommendation.

1 INTRODUCTION

1.1 The Group noted that the EctoSys TM system had been recommended to MEPC for Basic Approval at its second session in May 2006.

1.2 It was also noted that Final Approval for the CleanBallast system, which employed the Basic Approved Ectosys technology, had not been recommended to MEPC due to a number of perceived shortcomings.

1.3 The data used to evaluate the CleanBallast system for Final Approva l were extracted from the German submission to the fifty-ninth session of MEPC as document MEPC 59/2.

2 COMPLETENESS OF THE DOSSIER

2.1 The Group noted that the development of the CleanBallast system started in 2003 and that different treatment devices for mechanical sepa ration and disinfection (i ncluding the advanced EctoSys ® electrolysis) had been tested in parall el, achieving a direct comparison of their performance at the naturally changing inlet water quality.

2.2 It was also noted that the EctoSys ® electrolysis system had received Basic Approval of Active Substances at the MEPC 55 and that RWO GmbH had purchased the EctoSys ® technology from the former owner Permascand (S weden) including all rights (BWM.2/Circ.11).

3 DESCRIPTION OF THE SYSTEM

3.1 Overview

3.1.1 The Group noted that the CleanBallast system comprised:

.1 a filtration process employing 50μm filters; followed by;

.2 electrochemical oxidation to produce disi nfection at uptake and discharge using an algae monitor to measure the concentrati on of algae which relates to the current applied to the electrolysis cell; and, if required; and

.3 a neutralization system to lower the TR O concentration in high salinity seawater.

3.1.2 The Group noted that electrochemical oxidati on process employed a controlled current to ensure that the maximum dose of disinfectant pr oduced is proportional to the ballast water uptake flow rate resulting in a maximum of 2 mg/L of Total Residual Oxidant (TRO). The current is regulated in proportion to the con centration of alg ae in the ballast water which is monitored using an algae monitor.GESAMP-BWWG 8/6
ANNEX 5 Page 3

I:\MEPC\59\2-16.DOC 3.1.3 Furthermore, the Group noted that the system is capable of functioning in both saline (sea water) and fresh (river water).

3.2 Active Substances (AS), Relevant Chem icals (RC) and Other Chemicals (OC)

3.2.1 The Group recognized the following chemi cal reactions that take place during electrolysis:

.1 H 2 O → OH * + H + + e - primary reaction in fresh water;

.2 2 Cl - → Cl 2 + 2 e -

.3 Cl 2 + H 2 O → HCl + HOCl

.4 HOCl + Br - → HOBr + Cl 3.2.2 The Group agreed with the applicant that the following chemicals should be regarded as Active Substances:

.1 Hydroxyl Radicals (OH * ) which have very short half-lives (10 -9 s) and so analysis and toxicity testing were neither necessary nor appropriate; and

.2 Free Active Chlorine as hypochloric acid (HOCl) and hypochlorite ion (OCl - ) which react to form hypobromite.

3.2.3 Recognizing that the Active Substances produc ed by the electrolysis of seawater react with naturally occurring organic and inorgani c compounds, the Group al so agreed that the following chemicals should be regarded as Relevant Chemicals:

.1 Free Active Bromine as hypobromic acid (HOBr) and hypobromite ion (OBr - )

.2 Dibromochloromethane (CHBr 2 Cl);

.3 Tribromomethane (Bromoform) (CHBr 3 );

.4 Dichloroacetic acid;

.5 Trichloroacetic acid;

.6 Dibromoacetic acid;

.7 1,2,3-trichloropropane;

.8 Bromate; and

.9 Hydrogen.GESAMP-BWWG 8/6
ANNEX 5 Page 4

I:\MEPC\59\2-16.DOC 3.2.4 Other Chemicals (OC) recognized by the Group as by-products of the process were:

.1 Oxygen;

.2 Adsorbable Organic Halogens (AOX); and

.3 Extractable Organic Halogens (EOX).

3.2.5 Key data for the Active Substances, as supplied by the applicant, can be found in the following appendices to this annex:

.1 sodium hypochlorite appendix 1;

.2 sodium bromate appendix 2;

.3 tribromomethane appendix 3;

.4 dibromochloromethane appendix 4;

.5 dibromoacetic acid appendix 5; and

.6 trichloropropane appendix 6.

4 CONSIDERATION OF THOSE CONCERNS EXPRESSED ABOUT THE PREVIOUS SUBMISSION FOR FINAL APPROVAL

4.1 The Group recalled that, in considering the previous submission for Final Approval of this system, a number of concerns had been rais ed. It was noted that these concerns had been addressed by the applicant in this submission and so the Group considered each one as reported in the rest of this section.

4.2 The Group recalled that, previously, it had re commended that a number of the chemicals identified by the applicant, inter alia, hydroxyl radicals, chlorine gas and hydrogen gas should be regarded as Active Substances and that a numbe r of Disinfectant By-Products (DBPs), which had also been identified, should be regarded as Relevant Chemicals.GESAMP-BWWG 8/6
ANNEX 5 Page 5

I:\MEPC\59\2-16.DOC 4.2.1 It was noted that the applican t had, subsequently, identified and quantitatively analysed the whole-effluent samples of treated water of severa l qualities (e.g., fresh, brackish and full salinity) as shown below:

FreshWater BrackishWater SeaWater Chemical Units DL BW Control BW Control BW Contro
l Trichloromethane μg/L 0.3 0.38 0.32 <0.50 <0.50 <0.50 <0.50 Dichlorobromomethane μg/L 0.1 0.38 <0.1 <0.50 <0.50 <0.50 <0.50 Dibromochloromethane μg/L 0.1 0.82 <0.1 6 <0.50 5.3 <0.50 Tribromomethane μg/L 0.1 1.44 <0.1 147 1.05 135 <1.43 THM μg/L 3.02 <155 <6 <141 <2.9 Monochloroacetic acid μg/L 0.1 0.21 <0.1 <0.50 <0.50 <0.50 <0.50 Dichloroacetic acid μg/L 0.1 0.87 0.14 <0.30 <0.30 <0.30 <0.30 Trichloroacetic acid μg/L 0.05 0.5 0.08 <0.20 <0.20 <0.20 <0.20 Monobromoacetic acid μg/L 0.1 0.15 <0.1 <0.20 <0.20 <0.20 <0.20 Dibromoacetic acid μg/L 0.1 1.28 <0.1 22 <0.47 5.0 <0.22 Bromochloroacetic acid μg/L 0.1 1.07 <0.1 <0.6 <0.10 <0.17 <0.10 HAA μg/L 4.08 <8.8 <1.74 <6.4 <1.52 Bromate μg/L 1 2.6 <1 26 <1.0 9.9 <1.0 AOX (as Cl 2 ) mg/L 0.02/0.0
1 0.14 0.1 0.06 <0.010 0.05 <0.012

EOX (as Cl 2 ) mg/L 0.01 0.01 <0.010 0.03 <0.010 TRO (mean) mg/L 0.22 0.12 0.4 0.06 1.10 0.08

AOX = Adsorbable Organic Halogens: Include s chlorinated and brominated adsorbable organic compounds e.g., trihalomethanes.

EOX = Extractable Organic Hal ogens: i.e. the sum of all the organically bound halogens which can be extracted from solids.

TRO = Total Residual Oxidants (HOCl and OCl - ) which react in sea water to form sodium hypobromite).

Note : As both AOX and EOX comprise indi vidual disinfectant by-products, which have been processed separately, they are not treated as Relevant Chemicals.

4.2.2 The Group noted this additional information and was satisfied.

4.3 The Group recalled that, as the previous app lication had indicated that the maximum TRO in seawater was 2 mg/L and as no levels had be en reported for fresh wate r, the Group had agreed that 2 mg/L should be treated as both th e Maximum Dosage and the Maximum Allowable Discharge Concentration in accordance with Procedure (G9).

4.3.1 The Group noted that the applicant had indicated that, in fresh water, the only Active Substance generated is the hydroxyl ra dical which has an extremely short half-life and would not enter the aquatic e nvironment with the discharged ba llast water. As a result, the applicant had indicated that TRO could not be detected above the natural background level.GESAMP-BWWG 8/6
ANNEX 5 Page 6

I:\MEPC\59\2-16.DOC 4.3.2 As a result, the Group accepted the applicant’s argu ment that Maximum Dosage and Maximum Allowable Discharge Concentration were not relevant for this system when used with fresh water.

4.4 The Group recalled that, previously, the appl icant had explained th at high levels of disinfection by-products such as THM were due to the fact that the EctoSys ® system was run differently in the land-based tests than it will be in normal operation on board ships. The Group had then considered that a full chemical character ization of water treated by that system run in normal mode should be provide d together with toxicity tests with the same water

4.4.1 The Group noted that the applicant had st ated that in its previous submission for Final Approval, the CleanBallast system was operated taking a worst case approach, i.e., the maximum current was applied to th e electrodes, consequently gene rating concentrations close to the maximum TRO limit of 2 mg/L in marine wate rs at all times. This had been done both at ballasting and at deballas ting treatment in order to allow a wo rst case approach in the subsequent risk assessment. This procedure was applied regardless of the actual need for such a high maximum concentration to achieve the biologic al efficiency define d by Guidelines (G8).

4.4.2 The Group also noted that the applicant had clarified this point by stressing that 2 mg TRO /L had originally been reported as the result of running the system at a high rate even though this was unnecessary. The applicant had then explained that the purpose of the algae monitor, used during treatment at discharge, was to determine the amount of current needed to effect disinfection. This part of the system ensures that such high levels of TRO are not produced during the discharge of treated ballas t water (ref: email from applicant 15/12/08).

4.4.3 However, the Group noted that in the cu rrent application, the CleanBallast system including the EctoSys ® electrolysis had been run under normal operating conditions, causing the TRO concentration/current applied at deballas ting treatment to be minimized whilst fulfilling the performance criteria specified under the Guidelines (G8).

4.4.4 It was noted that the same fu ll-scale land-based test water tr eated by the CleanBallast system was used to provide the chemical analysis and carry out toxicity studies. It was noted that, under these conditions, both the concentrations of disinfection by-products and toxi city values were lower than had previously been reported under a worst-case scenario. It was also noted that such values were lower than had been reported under the application for Basic Approval.

4.4.5 The Group noted that the applicant included the option of a neutra lization system, though the system is not described in the non-confid ential dossier, the system manual or system description and that without it the system is capable of up to 2 mg TRO /L (as Cl 2 ) discharge.

4.4.6 Whilst the included algal monitor is intended to mitigate this, the possibility of treatment in large concentrations of algae, and thus high di scharges of TRO are possible. In fact, since the discharge sensor limit is 2 mg/L as Cl 2 , it is assumed that this is the practical limit of TRO discharge. The Group also note d that, during a land-based treat ment test, a malfunction of the online TRO control unit upon discharge re sulted in a TRO >2 mg/L (as Cl 2 ) despite the Algal Monitor. In addition, in all land-based tests in both brackish and seawater conditions without neutralization the resultant disc harge TRO was 0.76-1.42 and ~0.4 mg/L (as Cl 2 ), respectively. However, when neutralization wa s applied the TRO discha rge was undetectable. The Group recommended that Final Approval of this system should be conditional on the inclusion of the neutralization step in all cases.GESAMP-BWWG 8/6
ANNEX 5 Page 7

I:\MEPC\59\2-16.DOC 4.5 The Group recalled that, previously it had not ed that no detailed information about the control system which could ensure that the ma ximum designed TRO-concentration is maintained had been included in the CleanBallast system. In this context, it had also been noted that an algae monitor sensor was to be included in the i ndustrialized version of th e system installed on board ships. As this sensor had been under deve lopment at the time of the previous application, the Group had expressed its concern that a proper control system had not been fully developed and so could not be fully evaluated.

4.5.1 The Group noted that the applicant ha d indicated that the Maximum Dosage Concentration of 2 mg/L TRO in marine waters is ensured by restricting the current distributed from the rectifier to th e electrodes depending on th e flow rate and conductiv ity. Thus, it is not linked to the function or opera tion of the Algae Monitor.

4.5.2 In addition, the recommendation of GESAMP-BWWG on maintaining the maximum TRO concentration had been considered and an additional TRO online sensor included in the CleanBallast system for monitoring and controlling the produced TRO concentration in marine waters.

4.5.3 The applicant also indicated that the Algae Monitor is not used for the measurement of the chemical properties of the effluent such as TR O levels but is used to continuously analyse the direct effect of the treatment on phytoplankton and, by a feed-back loop to the disinfection unit operation system (EctoSys ® ), to minimize the use of Active S ubstances at concentrations below the Maximum Dosage of 2 mg/L TRO. The Al gae Monitor is a mitigation measure for the second EctoSys ® treatment, reducing disinfection at de ballasting only to a level needed for achieving the G8 efficiency.

4.5.4 The Group was satisfied with this explanation.

4.6 The Group recalled that it had been satisfied w ith the risks associated with the generation of hydrogen as a by-product of this system but had expressed concern that the formation of oxygen in a full-scale test ha s not been investigated.

4.6.1 It was noted that the app licant had indicated that, besides the measurements of the dissolved oxygen concentration in water, an addi tional oxygen gas analyser had been installed in the de-aeration pipe in the testing for the Fina l Approval. A slight in crease of the dissolved oxygen concentration had been measured in the e ffluent water of the CleanBallast system, which was in the range of the dissolved oxygen saturati on concentration. In accordance with the still low dissolved oxygen concentration, the measured oxygen gas concentr ations were in the normal range of 20% Vol.

4.6.2 In addition, it was noted that both the hydrogen gas and the oxygen gas by-products are removed by the de-aerator through the chimney di rectly to the ambient air well above the main deck or through the deck with the pipe ending well above the height of a human.

4.6.3 The Group was satisfied with this explanation.GESAMP-BWWG 8/6
ANNEX 5 Page 8

I:\MEPC\59\2-16.DOC 4.7 The Group recalled that, previ ously, it had noted that the long-term corrosion testing, which had been advised in the Basic approval ev aluation, had not commenced and so the level of potential risk of accelerated corrosion to th e ballast water piping could not be assessed.

4.7.1 The Group noted that the applicant had indica ted that corrosion studies had been started. The applicant also indicated that the result show ed that the CleanBallast system did not have any negative influence on the tested coating systems, which are intended for the use in seawater ballast tanks on ships. As a result, a “Certific ate on compatibility of the CleanBallast system with epoxy based ballast water tank coating syst ems” for use on board ships has been issued.

4.7.2 However, the Group noted that the applicant re ported that the corrosi on rate of steel was increased in high concentrations of the oxidizer . Whilst the Group agrees with this evaluation, the Group noted that since the exposure concen tration of approximately 0.5 mg/L for 80 of the 100 day exposure. The Group concluded that thes e data are insufficient to fully characterize the anticipated corrosion effects of the CleanBallast system on uncoated steel. It is expected that the corrosion rate of uncoated steel would be significantly higher if the TRO had been maintained >1 mg/L (as Cl 2 ), as documented in literature.

4.7.3 The Group was not satisfied that this c oncern had been adequately addressed and recommended that the exposure and subsequent corrosion rate analysis be repeated by the applicant at the worst case e xposure dosage anticipated from th e CleanBallast system through the entirety of the test. This ev aluation should include uncoated steel and any other metals (i.e. brass, stainless steel, etc...) or non-metallic materials (i.e. EPDM rubber, fluoropolymers, etc.) within the shipboard piping, pumping or structure which may be exposed to the Active Substances or Relevant Chemicals. Th e Group noted that in the case that passive or oxide forming materials are exposed in service, evaluations of the localized corrosion resistance of these materials should also be conducted.

4.8 The Group recalled that, previously, it had noted that chronic aquatic toxicity studies had not been carried out in a land-base d installation as required by Pr ocedure (G9), but in a lab-based installation. Whilst the a pplicant had indicated that it is the TRO concentr ation which is relevant in relation to the toxicity of the treated water and not the scale of the installation, the Group considered that both the level of TRO and organi c matter which leads to the level of halogenated by-products (DBP) and so to the t oxicity of the treated water. For this reason the Group had expressed the view that toxicity tests with water samples from the land-based efficacy tests as required by Guidelines (G8) and Pr ocedure (G9) would ensure that adequate levels of TRO and organic matter are used in all tests and the chemical characterization of treated water.

4.8.1 The Group noted that the applicant had indica ted that acute and chronic aquatic toxicity studies with six different species on three trophic levels and five phyla ha d been carried out using water treated in the full-scale Cl eanBallast system during land-base d type approval testing. The tests and equipment fulfilled the criteria under the G8 guideline, as required by the G9 procedure. Water quality also fulfilled the inlet criteria. The full-scale land-based CleanBallast unit was operated according to normal procedures, similar as on board a ship. The treatment efficiency fulfilled the D-2 standard criteria.

4.8.2 Having considered these additi onal data the Group was satisfie d that the appropriate tests had been carried out an d concluded that no negative influen ce on the coating system had been identified.GESAMP-BWWG 8/6
ANNEX 5 Page 9

I:\MEPC\59\2-16.DOC 4.9 The Group recalled that, previously, it had e xpressed the view that brominated DBPs (Disinfection By-Products) are to xicologically relevant compounds generated by the process. As the applicant had not provided informati on concerning the Human Exposure Scenario an adequate conclusion as to the outcome of the Human Risk Assessment could not be achieved. Therefore, the Group had recommended that hu man exposure, when handling ballast water treatment operations, should be restricted and RMM put in place

.
4.9.1 The Group noted that the appl icant had indicated that Hu man Exposure Scenarios (HES) of Active Substances and Relevant Chemicals, including brominated disinfection by-products, originating from treated ballast water had be en evaluated according to guidelines given by the Group and elaborated from templates and principles used in the available TGD (Technical Guidance Document, issued by the EU Commission) as well as reflecting the recommendations given by the Group concerning HE S. Occupational as well as exposures via the environment have been addressed and inhalati on, dermal route and oral exposures have been evaluated.

4.9.2 The Group noted that the applicant had stated that, during normal ba llast water operations on board the ship such as ball asting, ballast water storage and ballast water discharge, there would be no dermal or oral exposure route of Active Substances or Rele vant Chemicals to the crew, due to the EctoSys ® cell being installed in the main ballast pipe.

4.9.3 The applicant also indicated that, as the inhalation route had raised concern, since brominated and other disinfection by-products mi ght enter into the gas phase, special attention had been given to this potential risk when deve loping the HES. The application stated that HES concludes that the predicted concentratio n in the air for inhalation is far below existing OEL-values and so no risk to the crew on the ships is e xpected. Also, as the predicted daily uptake considering all uptake routes simu ltaneously is far below existing TDI values, no risk to the public from the TRO, its degradati on products or by-products is expected from the environment.

4.9.4 In case of damage to any equipment carryi ng treated ballast water (e.g., the ballast water piping), the CleanBallast system is automatica lly shut-down although it wa s recognized that any leakage might lead to exposure. The applicant stated that th e Maximum Dosage Concentration of 2 mg/L Active Substances will never be exceeded in any step of the process, thus the acute toxicity of treated water is evaluated to have no dermal effect on humans, should there be a direct exposure outside normal operation, i.e. leakag e. The potential exposure dose, duration and frequency of such events were assessed as pro ducing negligible risk. Having considered the additional information provided, the Group conc urred with the views of the applicant.

4.10 The Group recalled that, prev iously, based on information provided in the application for Basic Approval, a PEC/PNEC ratio of discharged ballast wa ter in Rotterdam harbour could be calculated to 0.85. Based on this ratio the Gr oup concluded that, under the conditions of the test, there would be low risk for the environment. For a final risk assessment to the environment the Group indicated that it needed a better explanation of the pr esence and performance of the algae monitor and information on the validity and a pplicability of the model used. For reference reasons, the Group had recommended that calcula tions with the MAMPEC-model use as many of the same parameter values as possible.GESAMP-BWWG 8/6
ANNEX 5 Page 10

I:\MEPC\59\2-16.DOC 4.11 The Group recalled that such recommendati ons had been made in order that more confidence in the applied tools and methods coul d be given to support the assumptions of the applicant there seems no risk for the environment.

4.11.1 The Group noted that the applicant had subsequently used MAMPEC (ver.2) in addition to previous custom-made simulatio ns to assess conservative PEC TRO values for large commercial harbours comparable to Rotterdam . Using (as far as possible) the same input parameters (i.e. standard commercial har bour EU OECD commercial harbour) as for previous evaluations, the PEC/PNEC ratios for TRO as derived by MAMPEC for discharge concentrations relevant for normal operation of the CleanBallast operated in natural waters were reported as <1. The risk characterization is further based on input para meters varying over the whole range from the unrealistically conservative defa ult assumptions on e.g., discharge quantities to a more balanced assessment of the discharge into the receiving environment.

4.11.2 In addition to calculating predicted stea dy-state concentrations, the Group noted that plume modelling had been adopted to examin e the acute exposure of receiving waters to Active Substances and Relevant Chemicals. Properly defined real case harbours had been used in order to simplify future comparisons. Immediate exposure during discharge as well as dilution/diffusion over time had been considered. The results had been compared to the outcome of the acute toxicity studies, calculated NOEC of the most sensitive species and literature references.

4.11.3 Having considered the additional data provi ded, the Group was satisf ied with the results provided.

5 HUMAN HEALTH ASSESSMENT

5.1 Occupational exposure of the crew

5.1.1 The Group noted that the applicant had de veloped a human exposure assessment from which it concluded that occupational exposure to TRC and its degradation products may occur in the following two situations:

.1 sampling from the system. However, samp ling is expected only to be carried out by RWO technicians and thus no exposure to the crew on the ship due to sampling is expected; and

.2 on the loading of the ballast tanks with wa ter, the excessive air of the ballast tanks arising as air is replaced w ith water in the ballast tanks will be exhausted on board and humans on board may inhale some of this air.GESAMP-BWWG 8/6
ANNEX 5 Page 11

I:\MEPC\59\2-16.DOC 5.1.2 The Group noted that, initiall y, the concentration in air (C air ) was calculated assuming equilibrium between the substances found in water and air:

water air C RT H C

⋅ =

Where:

C air is the concentration in air (mg/m 3 ) H is the Henry’s law constant (Pa m 3 /mole) R is the Gas constant (8.314 Pa m 3 /(mole K) T is the absolute temperature (K) C water is the concentration in ballast water (μg/L)

5.1.3 The Group also noted that if the substance was not detecte d, the concentration in water was assumed to be equal to the detection limit.

5.1.4 The predicted concentration in air were than compared wi th the OEL values assigned by various countries when it was f ound that the predicted c oncentrations in air were well below the various OEL values, with the exception of dibromom ethane which was slightly above the Dutch OEL value.

5.1.5 However, further modelling showed that the required dilution of at least two fold is obtained for all ship sizes consid ered and so it was concluded by the applicant th at exposure of the crew to dibromomethane by inhala tion did not present a significant risk.

5.2 Exposure via the environment

5.2.1 The Group agreed that human exposure to TRO in the treated ballast water could

occur as:

.1 oral intake due to bioaccumulation of the substance in the food chain; or

.2 oral, inhalational or dermal exposure dur ing bathing in areas close to the ballast water outlet.

5.2.2 The Group agreed with the applicant that the concentration in fish and bivalves may be calculated from:

MAMPEC fish PEC BCF PEC

⋅ =GESAMP-BWWG 8/6
ANNEX 5 Page 12

I:\MEPC\59\2-16.DOC Where:

PEC fish is the concentration in fish (mg/kg) PEC MAMPEC is the concentration in the water co lumn calculated by the MAMPEC model BCF is the bioconcentration factor.

Assuming that people are only eating fish fr om the area (very conservative), the daily intake via eating fish and biva lves is then calculated as:

U oral,fish = M fish × PEC Fish × BIO oral = M fish × BCF × PEC MAMPEC × BIO oral

Where:

U oral,fish is the amount chemical uptake by eating fish

M fish is the amount fish eaten per day per person. It is set to the default value given in the ECHA TGD of 115 g/d (reference).

BIO oral is the bioavailability for oral intake (set to 1)

5.2.3 The Group considered that the input values should be shown in the U oral,fish formula in order to understand its contribu tion to the overall exposure values (Table 5.4. - Appendix K of the confidential dossier). Howeve r, the Group agreed with the a pplicant that dermal, oral and inhalation exposure to humans coul d occur during swimming and that the total uptake during this activity could be estimated as:

U tot,swimming = I skin,swimming per day,pot × BIO dermal + I inhalation,swimming per day,pot × BIO inhal + I oral,swimming × BIO oral

Where:

U tot,swimming is the total amount of chemi cal potential uptake during swimming

BIO der is the bioavailability for dermal uptake (set to 1)

BIO inh is the bioavailability fo r inhalation (set to 1)

BIO oral is the bioavailability for oral intake (set to 1)

I skin,swimming per day,pot is the potential dermal uptake of substance (mg/kg/d)

I inhalation,swimming per day,pot is the inhalatory intake of substance (mg/kg/d)

I oral,swimming oral intake (mg/kg/d)GESAMP-BWWG 8/6
ANNEX 5 Page 13

I:\MEPC\59\2-16.DOC The skin uptake is calculated from so-calle d Dermal A model from the TGD on Information Requirements and Chemical Safety Assessment, (ECHA, 2008)):

I skin,swimming per day,pot = AREA skin × n swim × TH dermal × PEC MAM-PEC /BW

Where:

I skin,swimming per day,pot is the amount of chemical uptake via the skin during swimming (mg.kg/d)

TH dermal is the thickness of produc t layer on skin (default 10 -4 m)

AREA skin is the area of the body exposed to the water (m 2 )

BW is the body weight (kg)

n swim mean number of events per day (d -1 )

The TH dermal in the above equation may be replaced by:

TH dermal = K p ·T contact

Where:

K p is the permeability coefficient (-) and can be estimated from

log Kp (cm/h) = -2.72 + 0.71·log K OW – 0.0061·MW. (US EPA(2000): DERWIN v1.43 model)

The Group considered that the input values should be shown in the U tot,swimming formula in order to understand its cont ribution to the overall e xposure values (Table 5.4. – Appendix K of the confidential dossier).

5.2.4 The Group noted that a comparative calculation showed that for all relevant substances, the default value of 10 -4 m resulted in a higher dermal uptake than using the log K p equation. The only exception was 1,2,3-trichloropropane, which re sulted in slightly higher dermal uptake.

5.2.5 However, for this substance, the dermal upt ake is orders of magnitude lower than the uptake via inhalation and eating fish. So overall , it was concluded that using the dermal model for calculating skin uptake, the contribution to the total uptake is negligible.

5.2.6 Similarly, the Group agreed with the applic ant that the oral uptake due to swimming, could be calculated from (TGD, ECHA) as:

I oral , swimming = W·n swim × C W /BW

Where:

I oral , swimming is the total potential upta ke during swimming (mg/kg bw/d) W is the volume water swallowed per event (m 3 )GESAMP-BWWG 8/6
ANNEX 5 Page 14

I:\MEPC\59\2-16.DOC 5.2.7 The Group considered that the input values should be shown in the I oral , swimming formula in order to understand its contribu tion to the overall exposure valu es (Table 5.4. -Appendix K of the confidential dossier).

5.2.8 Having considered the applicant’s Human Ex posure Assessment and table of results, shown in appendix 8, the Group agreed that there wa s an acceptable risk to the crew or general public as a result of by-products produced by this ballast water treatment system.

5.2.9 In addition and in what concerns the occupa tional scenario of sampling from the system identifying the technicians as the target populati on, the Group considered that the appropriate risk mitigation measures have to be put in place in order to minimize the exposure of operating technicians e.g., use of PPE/PRE.

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

6.1 Based on the data described in section 5 of this report , the Group agreed that the by-products of this system do not pose a significant risk to either the crew or the general public.

7 ENVIRONMENTAL RISK ASSESSMENT

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

7.1.1 The Group agreed that the following classifi cations could be made on the by-products of this system.

By-product Persistence (P) (Yes or No) Bioaccumulation (B) (Yes or No) Toxicity (T) (Yes or No) Sodium hypochlorite No (Log Kow=-3.4) No (Chronic NOEC=0.04) Sodium bromate Yes No (Log Kow=-7.2) No

Tribromomethane Yes 1 No (BCF=14) No

Dibromochloromethane Yes Dibromoacetic acid Trichloropropane

Note: the applicant states 1⁄2-life <60days but data evaluated in previous applications show 1⁄2-life >60 days

7.2 Estimations of Predicted No Effect Con centrations (PNEC) of Active Substances (AS) and Relevant Chemicals (RC)

7.2.1 The Group recalled that its previous consider ation for Final Approval had indicated that in order to estimate the PNEC TRO-saltwater value, the corresponding value for TRC in sea water of 0.3 μg/L had been taken, including a safety fact or of 10. This value had been derived from the dilution of the effluent, plus the degradation of TRO in natural water to result in a PEC.GESAMP-BWWG 8/6
ANNEX 5 Page 15

I:\MEPC\59\2-16.DOC 7.2.2 It was noted that the LOEC of three marine organisms under long-term exposure conditions to the whole effluent had been 1% e ffluent v/v. Therefore, the PNEC for the whole effluent would be 0.14 μg/L according to the Basic Approval dossier.

7.2.3 The Group noted the relevant eco-toxicity va lues for sodium hypochl orite provided by the applicant and used to deri ve the associated PNEC va lues, as shown below:

Specie Endpoint Result Reference/Justification of missing data
Fish Leiostomus xanthurus 96 h LC50 0.09 mg/L Bellanca & Bailey (1977)
Fish Oncorhynchus kisutch 96 h LC 50 0.032 mg/L Thatcher (1978)
Crustacea Crangon nigricauda 96 h LC 50 0.134 mg/L Thatcher (1978) Algae Thalassiosira pseudonana 24 h LC 50 0.075 mg/L Gentile (1976)

Mollusc Crassostrea virginica 48 h EC 50 0.026 mg/L Robert & Gleeson (1978)
Fish Menidia peninsulae 28 d NOEC 0.04 mg/L Goodman et al. (1983)
Mollusc Crassostrea virginica 15 d NOEC 0.007 mg/L (TRC) Liden et al. (1980)

Note: Shaded area in the above table represents the applicants proposed acu te toxicity values for sodium chlorite at three trophic levels.

7.2.4 Using the NOEC of 40 μg/L and an Asse ssment Factor of 1000, the Group considered that the PNEC should be 0.04 μg/L.GESAMP-BWWG 8/6
ANNEX 5 Page 16

I:\MEPC\59\2-16.DOC 7.2.5 The Group noted the following ap plicants proposals for the estimation of PNEC values shown in the table below (ref applicant dossier M1, App. A, table A1) for the disinfectant by-products potentially associated with the system. The Group agreed with these proposals.

Substance name Shortterm

conc. μg/L Longterm

conc. μg/L No data - Short

-term No data - Long

term Assessment factor (fresh water) Assessment factor

(ma-rine

water) PNEC (fresh water) μg/L PNEC (ma-rine

water) μg/L Tribromomethane 7,100 3,394 3 3 50 50 68 68
Dibromochloromethan

e 2900 63 3 2 50 500 1.26 0.126

Sodium bromate 13,600 3 1,000 10,000 14 1.4

Dichloroacetic acid 23,000 1,485,0 00 3 1 1,000 10,000 23 2

Dibromoacetic acid 62,000 3 1,000 10,000 62 6 1,2,3-trichloropropane 4,136 5,000 3 1 100 1,000 50 5
Dichlorobromomethan

e 6,400 800 3 3 10 100 640 64

Monobromoacetic acid 200 1,600 3 1,000 10,000 0.2 0.02
Bromochloroacetic acid
Dichlorobromoacetic acid
Dibromochloroacetic acid

Tribromoacetic acid 279,00 0 3 1,000 10,000 279 27.9

Bromoacetonitrile 326,00 0 3 1,000 10,000 326 32.6

Dibromoacetonitrile 550 3 1,000 10,000 0.55 0.055
Bromochloroacetonitri le Bromophenol 3,300 3 1,000 10,000 3.3 0.33 p-bromophenol 2,000 300 3 3 10 100 30 3 m-bromophenol 1,242 3 1,000 10,000 1.242 0.1242 o-bromophenol 900 3 1,000 10,000 0.9 0.09 2,4-dibromophenol 2,780 3 1,000 10,000 2.78 0.278 2,6-dibromophenol 3,150 3 1,000 10,000 3.15 0.315 2,4,6-tribromophenol 220 100 3 2 50 500 2 0.2

1,1-dibromoethane 150,00 0 3 1,000 10,000 150 15

1,2-dibromoethane 142,80 8 3 1,000 10,000 142.808 14.2808

1,2-dibromo-3- chloropropane 19,000 1,600 3 2 50 500 32 3.2

2-chlorotoluene 700 140 3 2 50 500 2.8 0.28 4-chlorotoluene 9,000 3,400 3 1 100 1,000 34 3.4 1,2,3-tribromobenzeneGESAMP-BWWG 8/6
ANNEX 5 Page 17

I:\MEPC\59\2-16.DOC 7.3 Calculation of Predicted Environmental Con centrations (PEC) of Active Substances (AS) and Relevant Chemicals (RC)

7.3.1 The Group noted that PEC values for Activ e Substances and Relevant Chemicals had been derived for two generic cases in MAMP EC ver. 2.0, namely the “Commercial harbour scenario” and the “OECD-EU Commercial harbour”.

7.3.2 The Group also noted that because the “c ommercial harbour” sc enario of MAMPEC, which is based on the Rotterdam harbour in the Netherlands, has a lower salinity than sea water i.e. MAMPEC assumes a salinity of 34 psu for Ro tterdam harbour whilst the salinity range is actually in the range of 0.3-28.6 psu. It was al so noted that, over 1.5 m onth observations period, salinities had been identified in the range of:

.1 5-25 psu in the Hook of Holland;

.2 0-18 psu at Botlek Harbour (16 km up th e estuary of the Hook of Holland); and

.3 0-10 psu at Lek Harbour (25 km up the estuary of the Hook of Holland).

7.3.3 As a result, the applicant had proposed that the maximum discharge concentration of TRO should be:

.1 <1200 μg/L in seawater;

.2 <500 μg/L in brackish water; and

.3 no higher than background levels in fresh water,

rather than the 2000 μg/L reported in previous su bmissions. It was noted that these differences were due to differences in the PSU of the untreated ballast water.

7.3.4 The Group also noted that a second mode lling system (MIKE 3 + ECOLAB) had been employed to calculate the PEC values of those ch emicals identified in the treated ballast water.

7.3.5 In this context, the Group noted the fo llowing PEC levels of Active Substances and Relevant Chemicals genera ted by the MAMPEC model.

Original table provided by applicant:

Sea Water Concentration (μg/L) Fresh water Concentration (μg/L)

Name Treated
sea water
at discharge Commercial
Harbour OECD-EU Commercial

Harbour treated fresh
water OECD-EU Commercial

Harbour
2000 0.23 0.222 0 ---
1200 0.135 0.133 0 ---
500 0.056 0.055 0 --- Sodium Hypochlorite

200 0.023 0.022 0 ---
2000 0.23 0.222 0 ---
1200 0.135 0.133 0 ---
500 0.056 0.055 0 --- Sodium Hypobromite

200 0.023 0.022 0 ---GESAMP-BWWG 8/6
ANNEX 5 Page 18

I:\MEPC\59\2-16.DOC Sea Water Concentration (μg/L) Fresh water Concentration (μg/L)

Name Treated
sea water
at discharge Commercial
Harbour OECD-EU Commercial

Harbour treated fresh
water OECD-EU Commercial

Harbour
Dibromochloromethane 8.2 0.05 0.030 1.1 0.0039
Tribromomethane 190 1.25 0.708 3 0.0112
Bromate 19 0.47 0.136 4.4 0.0314
Dichloroacetic Acid 0.97 0.00 0.005 1.4 0.0085
Trichloroacetic Acid 0.28 0.01 0.003 2 0.0141
Dibromoacetic Acid 9.3 0.17 0.062 2.2 0.0145
Bromochloroacetic Acid 0.43 0.01 0.003 1.6 0.0105 1,2,3-Trichloropropane 1 0.01 0.005 0 0.0000

7.3.6 It was further noted by the Group that the a pplicant did not use the results obtained with the plume modelling system (MIKE-ECOLAB) and focused on the MAMPEC results. The Group agreed with this approach.

7.3.7 The Group appreciated the attempt of the applican t but found some diffic ulties in reproducing the results of the applicant as the documentation did not include a listing of the input values used. The results obtained by the Group were a factor of abou t 100 for the commercial harbour and a factor of about 50 for the OECD-EU commercial harbour higher. However, the Group did consider these results as indicative as not yet a standard scenario has been endorsed. It is recommended that the applicant delivers all the data obtain ed in the use of modelling.

Table constructed by the Group:

Toxicity AF PNEC (μg/l) PEC(μg/l )* PEC/PNEC
Chemical by-Product μg/l (fw ) (sw) (fw ) (sw ) (fw) (sw) (fw) (sw)

75 (ac) - ? - ? Sodium hypochlorite 40 (ch) - 1000 - 0.04 0.0 0.13
5 3.38

Sodium hypobromite 0.0 0.13
5 2900 (ac) Dibromochloromethane 63 (ch) 50 500 1.3 0.13 0.003 9 0.05 0.0039/1.3= 0.003 0.05/0.13= 0.04

7100 (ac) 100 0 7.1 Bromoform 3394 (ch) 50 50 68 68 0.011
2 1.25
0.0112/68= 0.0002 1.25/68= 0.02

Bromate 13600(ac) 100 0 1000 0 13. 6 1.36 0.031
4 0.47 0.0314/13.6= 0.002 (Applicant val 0.01) 0.47/1.36= 0.35

23000 (ac) 100 0 1000 0 23 2.3 0.0085/23= 0.0004 0.005/2.3= 0.002 Dichloroacetic acid 1485000(ch) 0.008
5 0.00
5

Trichloroacetic acid 0.014
1 0.01

62000 100 0 1000 0 62 6.2 0.0145/62= 0.0002 0.17/6.2= 0.027 Dibromoacetic acid 0.014
5 0.17

Bromochloroacetic acid 0.010
5 0.01

4136 (ac) 0.01/1000= 0.00
001 Trichloropropane 5000 (ch) 100 1000 50 5 0.000 0 0.01GESAMP-BWWG 8/6
ANNEX 5 Page 19

I:\MEPC\59\2-16.DOC 7.3.8 The Group also noted the following PEC/PNEC ratios of Active Substance and Relevant Chemicals calculated from various initial concentrations measured in treated ballast water, both fresh and marine.

PEC/PNEC PEC/PNEC

Name Initial concentrations in discharged marine water, μg/l Commercial (Marine)
Harbour OECD-EU Commercial

(marine)
Harbour Initial concentrations in discharged fresh water, μg/l OECD-EU Commercial (fresh water)

Harbour
2000 5.64 5.54 0 ---
1200 3.39 3.32 0 ---
500 1.41 1.39 0 --- Sodium Hypochlorite

200 0.56 0.55 0 ---
2000 5.64 5.54 0 ---
1200 3.39 3.32 0 ---
500 1.41 1.39 0 --- Sodium Hypobromite

200 0.56 0.55 0 ---
Dibromochloromethane 8.2 0.51 0.30 1.1 0.004
Tribromomethane 190 0.02 0.01 3 0.000
Bromate 19 0.34 0.10 4.4 0.010
Dichloroacetic Acid 0.97 0.00 0.00 1.4 0.000
Trichloroacetic Acid 0.28 0.29 0.14 2 0.071
Dibromoacetic Acid 9.3 0.03 0.01 2.2 0.000
Bromochloroacetic Acid 0.43 0.003 0.001 1.6 0.00027 1,2,3-Trichloropropane 1 0.00 0.00 0 0.000

7.3.9 The Group noted that some of the asse ssment factors used for deriving PNECs (50 and 500) are not foreseen in Procedure (G9). The applicant provided a clarification regarding their use of assessment factors from draft EU Risk Assessment Reports on chlorine and sodium hypochlorite.

7.3.10 The Group noted that as a result of th e use of assessment factors as foreseen in Procedure (G9) (100 and 1000) raises the PNEC s a factor of two for five compounds, and one recalculated value leads to a PEC/PNEC n ear 1 (dibromochloromethane = 1.02) in the standard Commercial (Marine) Harbour and to a value of 0.6 in the OECD-EU Commercial (Marine) Harbour scenarios based on the PE C of Relevant Chemicals calculated by MAMPEC v.2.0.

7.3.11 The Group is satisfied with the clarificat ions provided by Applicant and it is the opinion of the Group that the MAMPEC scenarios are suffici ently conservative and that the discharge of treated ballast water should not raise c oncern regarding dibromodichloromethane.

7.3.12 Considering these findings the Group is of the opinion that the application of CleanBallast as a ballast water management system would not result in unacceptable risks for the aquatic organisms in the receiving environment.GESAMP-BWWG 8/6
ANNEX 5 Page 20

I:\MEPC\59\2-16.DOC 8 CONCLUSIONS AND RECOMMENDATIONS

8.1 Risk to the safety of the ship

8.1.1 The Group noted the thorough evaluation of co rrosion of both uncoate d and marine epoxy coated steel. The applicant concluded from th ese tests that CleanBallast was compatible with epoxy based ballast water tank coating systems as certified by Germanischer Lloyd (GL). However, the corrosion evaluation of uncoated steel was insufficient du e to the low exposure dose through the majority of the exposure evaluation.

8.1.2 The Group recommended that the exposure an d subsequent corrosion rate analysis be repeated by the applicant at the worst case ex posure dosage anticipated from the CleanBallast system through the entirety of the test. This evaluation shoul d include uncoated steel and any other metals (i.e. brass, stai nless steel, etc...) or non-metallic materials (i.e. EPDM rubber, fluoropolymers, etc...) within th e shipboard piping, pumping or st ructure which may be exposed to the Active Substances or Relevant Chemicals. The Group notes that in the case that passive or oxide forming materials are exposed in service, evaluati ons of the localized corrosion resistance of these materials should also be conducted.

8.1.3 Despite the above-mentioned criticism the Gr oup agreed that these deficiencies should not hamper a Final Approval recommendation

8.2 Risks to crew and general public

8.2.1 The Group recognized that the methodology used by the applicant to develop HES associated with CleanBallast ballast water ma nagement system adequately addressed the potential risks of human exposur e deriving from this system. The applicant has identified the relevant human exposure assessments regard ing 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 fr om the area). The Group agreed that the risk was acceptable to the crew and general public.

8.3 Risks to the environment

8.3.1 Having reviewed all of the data, the Group agreed that the risks to the environment caused by this system would be acceptable.

8.4 Conclusion

8.4.1 The Group agreed to recommend Final Approv al be given to the German application CleanBallast Ballast Water Management System by MEPC.

8.4.2 The Group concluded that base d on the information presente d no unacceptable effects be expected upon the application of the Clean Ballast Ballast Water Management System.

* * *GESAMP-BWWG 8/6
ANNEX 5 Page 21

I:\MEPC\59\2-16.DOC Appendix 1

Data for Sodium hypochlorite

1 Acute Aquatic Toxicity Data

Species LC50 (mg/L) Reference/Comments

Fish Leiostomus xanthurus 0.09 96h Bellanca & Bailey (1977)
Crustacea Crangon nigricauda 0.134 96h Thatcher (1978) Algae Thalassiosira pseudonana 0.075 24h Gentile (1976)

2 Chronic Aquatic Toxicity Data

Species NOEC (mg/L) Reference/Comments

Fish* Menidia peninsulae 0.04 (28d) Goodman et al. (1983)
Crustacea Crassostrea virginica 0.11 (60d) Scott et al. (1979) Algae N/A N/A Supp. Info: MEPC 55/2/4

* Used to generate PNEC for RA (re f: email from applicant 09/01/09).

3 Information on Endocrine Disruption

Endocrine disruption have been screened and as sessed based on information provided in MSDS. Information on endocrine disruption considered not relevant for this substance due to its chemical structure and other chemical/ physical properties, e.g., vapour pressure.

4 Sediment Toxicity

No toxicity data available for sediment organisms, but not considered required.

5 Bioavailability/Biomagnification/Bioconcentration

Non adequate – an oxidizing, disinfect ant and inorganic substance BCF <100.

6 MAMMALIAN TOXICITY

6.1 Acute mammalian Toxicity

No available data for the pure substance. Indicative values for commercial 5% solution (MEPC 55/2/4).

Value Species Reference/Comments/

Oral LD50 (mg/kg) 13000 Rat MSDS Dermal LD50 (mg/kg) > 3000 Rat MSDSGESAMP-BWWG 8/6
ANNEX 5 Page 22

I:\MEPC\59\2-16.DOC 6.2 Corrosion/Irritation

No available data for the pure substance. In dicative values for commercial 5% solution. Inhalation of fumes or mists causes respiratory tract irritation and irritation of mucous membranes.

6.3 Sensitization

Chronic hand dermatitis related to sens itization to sodium hypochlorite reported (Habets et al. 2006)

6.4 Repeated-Dose Toxicity

Exposure Route Drinking water Exposure Duration 12 months Exposure dose 1, 10, 100 mg/L Species Rat
Method ---

Results Decrease of blood gluthatione with 10 or 100mg/L, increase of osmotic fragility after 6 months. In animals exposed for 3 months, the 3H-thymidine incorporation into nuclei of rat kidney and testes in the 100mg/L group was increased
Reference/Comments Abdel-Rahman, M.S. Et. al 1984 (MEPC 57/2

6.5 Carcinogenicity

No available data for the pure s ubstance. Indicative va lues can be found for commercial solutions of different concentrations. Sodium hypochlor ite is not considered to be a carcinogen by the US National Toxicology Program, the Internat ional Agency for Research of Cancer, or the Occupational Safety a nd Health Administration.

7 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

7.1 Modes of degradation

.1 Abiotic route: Reduction

.2 Photodegradation: Decompose to form chloride

7.2 Partition Coefficients

Log Kow -3.42 log Koc 1.16

7.3 Persistence and Identifica tion of Main Metabolites

Not persistent, due to the rapid degradation.GESAMP-BWWG 8/6
ANNEX 5 Page 23

I:\MEPC\59\2-16.DOC 7.4 Reaction with Organic Matter

Oxidating agent, not considered required.

7.5 Potential Physical Effects on Wildlife and Benthic Habitats

Fully miscible to water and thus potentially a ffecting physical wildlife and benthic habitats.

7.6 Potential Residues in Seafood

Low risk for residues in sea food – see further HES evaluation.

7.7 Any Known Interactive Effects

No.

8 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property Value Reference/Comments/ Justification for missing data Melting point (°C) -25 IUCLID Boiling point (°C) 96-99 IUCLID Flammability (flash point for liquids; °C) Non-flammable IUCLID Density (20°C; kg/m3) 1.21-1.23 IUCLID Vapour pressure (20°C; Pa) 17.4-20hPa IUCLID Vapour density (air = 1) N/A

Water solubility pH; mg/l) (temp; effect of 79.9g/100g
H 2 O IUCLID

pH in solution N/A Not applicable Dissociation constant (pKa) N/A Not applicable Oxidation-reduction potential N/A Not applicable Corrosivity to material or equipment corrosive Chemical data base Reactivity to container material corrosive Chemical data base Auto-ignition temperature(°C) Non flammable Explosive properties explosive

Oxidizing properties E0: 1.7V Strong oxidizer, ECB RA (2997)
Surface tension N/A Not applicable DynamicViscosity 2.6mPa.s IUCLID Thermal stability and identity of breakdown products N/A

Other physical or chemical properties N/A

* * *GESAMP-BWWG 8/6
ANNEX 5 Page 24

I:\MEPC\59\2-16.DOC Appendix 2

Data for sodium bromate

1 EFFECTS OF AQUATIC ORGANISMS

1.1 Acute Aquatic Toxicity

Species LC50 (mg/L) Reference/Comments
Fish (Various Marine) 427 to 512 (96h) Hutchinson et al. (1997)
Crustacea Daphnia magna 179 (48h) Hutchinson et al. (1997) Algae N/A N/A N/A
Turbellaria Polycelis nigra 2258 (48h) Hutchinson et al. (1997)

In conclusion, a number of studies provide evid ence for the acute toxi city of bromate to invertebrates and fish in th e lowest region of 30 mg BrO 3 - /L (Hutchinson et al. (1997)).

1.2 Chronic Aquatic Toxicity

Species LC50 or EC50 (mg/L) Reference/Comments

Fish (marine) 279 (10day LC50) Hutchinson et al. (1997)
Crustacea N/A N/A N/A Algae* 4 marine phytoplankton >13.6 (m ulti-generation EC50 Hutchinson et al. (1997)

* Data added from email of applicant (09/01/09) – used by applicant to generate PNEC for RA

Applying the factor of 10 used to extrapolate from acute to potential chronic toxicity, the available data suggest that to protect aquatic organisms from long-term adverse effects, concentrations should not exceed approximately 3.0 mg BrO 3 - /L (Hutchinson et al. (1997))

1.3 Information on Endocrine Disruption

Not listed as endocrine disruptor (e.g., Europ ean Union (EU) Prioritization List etc.).

1.4 Sediment Toxicity

Very low risk for sediment toxicity due to lo w Log Pow and Koc values respectively. Bromate does not volatilize and adsorbs only slightly to soil or sediment.

1.5 Bioavailability/Biomagnification/Bioconcentration

Log Pow Reference/Comments/Justification for missing data
-7.18GESAMP-BWWG 8/6
ANNEX 5 Page 25

I:\MEPC\59\2-16.DOC 2 MAMMALIAN TOXICITY

2.1 Acute mammalian Toxicity

Value Species Reference/Comments/ Justification for Oral LD50 (mg/kg) 140 Mouse MSDS

2.2 Corrosion/Irritation

May be harmful by inhalation, inge stion, or skin absorption. Caus es eye and skin irritation. (MSDS).

2.3 Sensitization

Not known.

2.4 Repeated-Dose Toxicity

No data.

2.5 Development and Reproductive Toxicity

No data.

2.6 Carcinogenicity

“Possible human” carcinogen Group 2B carcinogen (WHO).

3 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

3.1 Modes of degradation (biotic and abiotic)

Not readily biodegradable, 1/2-Life: ∞ (DHI).

3.2 Partition Coefficients

Results
Log Pow -7.18
Koc 2.7exp-8

3.3 Persistence and Identifica tion of Main Metabolites

Persistent (half-life >60days). Degrades to bromide ions.GESAMP-BWWG 8/6
ANNEX 5 Page 26

I:\MEPC\59\2-16.DOC 3.4 Reaction with Organic Matter

Oxidation – ultimately leading to formation back to Bromide ion.

3.5 Potential Physical Effects on Wildlife and Benthic Habitats

Solubility in water implies possible effects.

3.6 Potential Residues in Seafood

Very unlikely.

3.7 Any Known Interactive Effects

No.

4 PHYSICAL AND CHEMICAL PROPERTIES

Relevant Chemical: Bromate (Sodiumbromate)

Property Value Reference/Comments Melting point (°C) 314 DHI Boiling point (°C) 718 DHI Flammability (flash point for liquids; °C) Non-flammable

Density (17°C; kg/m3) 3339 US EPA Toxreview(2001) Vapour pressure (20°C; Pa) 2.3 kPa (highest) MSDS Vapour density (air = 1) N/A Water solubility of pH; mg/L) (temp; effect 275 g/L at 0°C 909 g/L at 100°C US EPA Toxreview (2001) pH in solution N/A Oxidation-reduction potential N/A Corrosivity to material or equipment No

Reactivity to container material No

Oxidizing properties strong oxidant -

* * *GESAMP-BWWG 8/6
ANNEX 5 Page 27

I:\MEPC\59\2-16.DOC Appendix 3

Data for tribromomethane

1 Chemical Identification

Concentration in BW,
Chemical Name CAS Number max (μg/l) AS, RC or Other
Tribromomethane 75-25-2 190 RC

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC50 (mg/L) Reference/Comments

Fish Cyprinodon variegates 18 (96h LC 50 ) Boccafusco et al. (1981)
Fish* Cyprinodon variegates 7.1 (96h LC 50 ) US EPA Aquire
Crustacea Penaeus aztecus 20 (4d LC 50 ) Gibson et al. (1981) Algae Selenastrum capricornutum 40 (96h EC 50 ) US EPA(1978) * Data reported by email from applicant on 09/01/09 as used to derive PNEC for RA.

2.2 Chronic Aquatic Toxicity Data

Species LC50/NOEC/MATC (mg/L) Reference/Comments

Fish Cyprinodon variegatus LC50:4.8-8.5/28d Ward et al. (1981)
Fish Cyprinodon variegatus MATC 3.394/28d US EPA Aquire
Crustacea Penaeus aztecus LC50: 0.03-0.29/28d Gibson et al. (1981) Algae Selenastrum capricornutum NOEC: 10/96h US EPA (1978) * Data reported by email from applicant on 09/01/09 as used to derive PNEC for RA. MATC=Maximum Acceptable Toxi c Concentration: For a given ecological effects test, the range (or geometric mean) between the No Obse rvable Adverse Effect Level and the Lowest Observable Adverse Effects Level.

2.3 Information on Endocrine Disruption

2.3.1 Endocrine disruption have been screened and assessed based on information provided in Toxprofile/MSDS.

2.3.2 Information on endocrine disruption considered not relevant for this substance due to its chemical structure and other chemical/ physical properties, e.g., vapour pressure.

2.4 Sediment Toxicity

2.4.1 Very low risk for sediment toxicity due to low Log Pow and Koc values respectively.

Bromoform will exhibit only a minor affinity for so il materials and will tend to be highly mobile (Roy and Griffin 1985).GESAMP-BWWG 8/6
ANNEX 5 Page 28

I:\MEPC\59\2-16.DOC 2.5 Bioavailability/Biomagnification/Bioconcentration

Log Pow Reference/Comments

BCF<100, 2.4 DHI, CITI (1992)

(“DHI” = report “Theoretical evaluation of the fa te and effect of disi nfection by-products”).

3 MAMMALIAN TOXICITY

3.1 Acute mammalian Toxicity

Value Species Reference/Comments/Justif ication for missing data Oral LD50 (mg/L) 1-day: 1147 (Fem Rat (SpragueDawley) Toxprofile (Chu et al. (1982))

3.2 Corrosion/Irritation

Skin Contact: Causes skin irritation.

Skin Absorption: May be harmfu l if absorbed through the skin.

Eye Contact: Causes eye irritation.

Inhalation: Toxic if inhaled. Material may be irritating to mucous membranes and upper respiratory tract.

Ingestion: Harmful if swallowed. (MSDS).

3.3 Carcinogenicity

3.3.1 Carcinogenic effects have been observe d in animals exposed to bromoform.

3.3.2 Chronic oral exposure to bromoform resulted in increases in the occurrence of intestinal tumors in female rats. The International US Agency for Research on Cancer (IARC) concluded that there were inadequate human data and limited animal data and assigned bromoform to weight of evidence category 3, not classifiable as to carcinogenici ty in humans. EPA classified bromoform as a probable human carcinogen, group B2.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation

Abiotic: FotolysisGESAMP-BWWG 8/6
ANNEX 5 Page 29

I:\MEPC\59\2-16.DOC 4.2 Partition Coefficients

Results Reference/Comments

Log Pow 2.4 Toxprofile

Koc 35.04 Toxprofile, DHI

(“DHI” = report “Theoretical evaluation of the fate and effect of disinfection byproducts”).

4.3 Persistence

Half-life <60 days --> non persistent

4.4 Reaction with Organic Matter

Low.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

Slightly soluble and thus posing a small potential threat to benthic habitats.

4.6 Potential Residues in Seafood

Bromoform do not appear to concen trate in fish. (Toxprofile p.3).

4.7 Any Known Interactive Effects

No.

5 PHYSICAL AND CHEMICAL PROPERTIES

Property Value Reference/Comments Melting point (°C) 8.0 Toxprofile (Lide 2000) Boiling point (°C) 149.1 Toxprofile (Lide 2000) Flammability (flash point for liquids; °C) Non-flammable Toxprofile (HSDB 2004a, 2004b))

Density (20°C; kg/m3) 2.899 Toxprofile (Lide 2000) Vapour pressure (20°C; mmHg) 5 Toxprofile (Mabey et al. 1982) Vapour density (air = 1) 8.7 Toxprofile (Mabey et al. 1982) Water solubility pH; mg/L) 3100 (25°C) Toxprofile (Horvath 1982)

* * *GESAMP-BWWG 8/6
ANNEX 5 Page 30

I:\MEPC\59\2-16.DOC Appendix 4

Data for Dibromochloromethane

1 EFFECTS ON AQUATIC ORGANISMS

1.1 Acute Aquatic Toxicity Data

Species LC50 (mg/L) Reference/Comments

Fish Cyprinus carpio 52/0.75h Trns. Am. Fish. Soc.
Crustacea

--- --- No data found Algae Tetrahymena pyriformis 65/24h Sci. Total. Environm.

Algae* ? NOEC 2.9/72h Japanese ministry of environment * Data reported by e-mail from applicant on 09/01/09 as used to derive PNEC for RA.

1.2 Chronic Aquatic Toxicity Data

Species LC50(mg/L) or NOEC(mg/L) Reference/Comments

Fish Cyprinus carpio LC50: 34 /days Trns. Am. Fish. Soc.
Crustacea Daphnia magna NOEC 0.0063/21 d Japanese ministry of environment Algae Tetrahymena pyriformis LC50: 65 /24h Sci. Total. Environm.

* Data reported by email from applicant on 09/01/09 as used to derive PNEC for RA.

1.3 Information on Endocrine Disruption

Endocrine disruption have been screened and assessed ba sed on information provided in Toxprofile/MSDS. Information on endocrine disruption considered not relevant for this substance due to its chemical structure and other chemical/physical properties.

1.4 Sediment Toxicity

1.4.1 Very low risk for sediment toxicity due to low Log Pow and Koc values, respectively.

1.4.2 No toxicity data availabl e for sediment organisms.

1.5 Bioavailability/Biomagnification/Bioconcentration

BCF Reference/Comments

<100 DHI, Sangster (1994)GESAMP-BWWG 8/6
ANNEX 5 Page 31

I:\MEPC\59\2-16.DOC 2 MAMMALIAN TOXICITY

2.1 Acute mammalian Toxicity

Value Species Reference

Oral LD50 (mg/kg) 848-1186 Rat Chu I et al. (1980)

2.2 Corrosion/Irritation/sensitization

Causes eye irritation. Causes skin irritation.

Harmful if swallowed. May cause i rritation of the digestive tract.

Inhalation of high concentrations may cause central nervous system effects (MSDS).

2.3 Carcinogenicity

2.3.1 Carcinogenic effects have been observed in animals exposed to dibromochloromethane. Dibromochloromethane induced liver tumors in male and female mice.

2.3.2 The US Department of Health and Huma n Services (DHHS) has not categorized the human carcinogenic potential of dibromochloromet hane. The International Agency for Research on Cancer (IARC) concluded that there were inadequate human data and limited animal data and assigned dibromochloromethane to weight of evidence category 3, not classifiable as to carcinogenicity in humans. EPA classified dibromochloromethane as a possible human carcinogen, group C

3 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

3.1 Modes of degradation

Photolysis. 1/2 life: 19d.

Anaerobic:(groundwater, Bouwer et al. 1981) half-lives estimated to be between 21 and 42 days (Bouwer and McCarty 1984).

3.2 Partition Coefficients

Results Reference/Comment

Log Pow 2.16 Sangster (1994)

Koc 83.17 Mabey et al. (1982)GESAMP-BWWG 8/6
ANNEX 5 Page 32

I:\MEPC\59\2-16.DOC 3.3 Persistence

Half-life <60 days --> non persistent.

3.4 Reaction with Organic Matter

Low

3.5 Potential Physical Effects on Wildlife and Benthic Habitats

Slightly soluble and thus posing a small potential threat to benthic habitats.

3.6 Potential Residues in Seafood

Dibromochloromethane do not appear to concen trate in fish. (Toxprofile p.3) Low risk for residues in sea food.

3.7 Any Known Interactive Effects

No

4 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property Value Reference/Comments
Melting point (°C) -20 Toxprofile, Lide (2000) Boiling point (°C) 120 Toxprofile, Lide (2000) Flammability (flash point for liquids; °C) Non-flammable Toxprofile

Density (20°C; kg/m3) 2.899 Toxprofile, Lide (2000)

Vapour pressure mmHg (20°C); 76 Toxprofile (Mabey et al. 1982) Vapour density (air = 1) N/A ---- Water solubility of pH; mg/L (temp; effect) 2700 mg/L (20°C) Toxprofile (Heikes 1987)

* * *GESAMP-BWWG 8/6
ANNEX 5 Page 33

I:\MEPC\59\2-16.DOC Appendix 5

Data for dibromoacetic acid

1 CHEMICAL IDENTIFICATION

Chemical Name CAS Number Concentration in BW, max (μg/l) AS, RC or Other Dibromoacetic acid (DBAA) 631-64-1 9.3 RC

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

.1 Very few data could be retrieved, th us PNEC assessment factor set to 10000.

.2 Only fish in US ECOTOX. Danish EPA QSAR: LC50 (fish, cr ust) > 1000 mg/L

.3 Danish EPA QSAR: LC50 Algae: 419 mg/L

2.3 Information on Endocrine Disruption

Not identified as endocrine disruptor. Endocri ne disruption properties unlikely due to e.g., molecular structure.

2.4 Sediment Toxicity

Adsorbs poorly to to sediment particles and is relatively rapidly degraded, thus potential for sediment accumulation is considered very low.

2.5 Bioavailability/Biomagnification/Bioconcentration

BCF Reference/Comments/Justific ation for missing data
3.162

3 MAMMALIAN TOXICITY

3.1 Acute mammalian Toxicity

Value Specie

s Reference/Comments/Justification for missing data Oral LD50 (mg/kg) 1737 Rat MSDS

3.2 Corrosion/Irritation

Skin/eye contact: causes burns.

Harmful if inhaled.

Harmful if swallowed.GESAMP-BWWG 8/6
ANNEX 5 Page 34

I:\MEPC\59\2-16.DOC 3.3 Sensitization

Not identified as sensitizer.

3.4 Repeated-Dose Toxicity

No data.

3.5 Development and Reproductive Toxicity

No data.

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

Effects fertility in rats: pre-impl antation mortality, litter size (MSDS).

Not found to be carcinogenic/mutagenetic.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Half-life: 29d (DHI), not bioaccumulative.

4.2 Partition Coefficients

Results Reference/Comments/Justif ication for missing data Log Pow 0.7
Koc 1.895

4.3 Persistence

Not persistent (half-life <60d).

4.4 Reaction with Organic Matter

Oxidation.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

Solubility in water implies possible effects.

4.6 Potential Residues in SeafoodGESAMP-BWWG 8/6
ANNEX 5 Page 35

I:\MEPC\59\2-16.DOC Evaluated in HES (DHI), assessing no risk of hazardous levels of residues in seafood.

4.7 Any Known Interactive Effects

No.

5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property Value Reference/Comments

Melting point (°C) 54 DHI Boiling point (°C) 243 DHI

Flammability (flash point for liquids; °C) Non-flammable

Density (20°C; kg/m3) N/A Vapour pressure (20°C; Pa) 3.1 Vapour density (air = 1) N/A Water solubility (temp; effect of pH; mg/L) 22140 (20°C) DHI Oxidation-reduction potential E0: 2.926V DHI Corrosivity to material or equipment corrosive MSDS Reactivity to container material not expected Oxidizing properties oxidizing agent DHI

“DHI” = report “Theoretical evaluation of the fate and effect of disinfect ion by-products” (2008).

* * *GESAMP-BWWG 8/6
ANNEX 5 Page 36

I:\MEPC\59\2-16.DOC Appendix 6

Data for 1,2,3-Trichloropropane

1 EFFECTS ON AQUATIC ORGANISMS

1.1 Acute Aquatic Toxicty Data

Species LC50 (mg/L) Reference

Fish Pimephales promelas 66.5 (96h) USGS
Crustacea Daphnia magna 20 (48h EC50) MSDS
Crustacea* Ceriodaphnia dubia 4.136 (2d immobilisation) US EPA Algae N/A N/A N/A * Data reported by e-mail from applicant on 09/01/09 as used to derive PNEC for RA.

1.2 Chronic Aquatic Toxicity Data

Species NOEC (mg/L) Reference/Comments/ Justification for missing data

Fish N/A N/A Toxprofile = U.S. Public Health Service (1992)

Crustacea N/A N/A Toxprofile = U.S. Public Health Service (1992)
Crustacea* Daphnia magna 5 (21 d reproduction) IUCLID

Algae N/A N/A Toxprofile = U.S. Public Health Service (1992) * Data reported by e-mail from applicant on 09/01/09 as used to derive PNEC for RA.

1.3 Information on Endocrine Disruption

Not identified as an endocrine disruptor.

1.4 Sediment Toxicity

Very low risk for sediment toxicity due to low Log Pow and Koc values, respectively (see section 4.2).

1.5 Bioavailability/Biomagnification/Bioconcentration

Bioaccumulation Reference/Comments

Log Pow 1.98 Toxprofile
BCF 9 IUCLIDGESAMP-BWWG 8/6
ANNEX 5 Page 37

I:\MEPC\59\2-16.DOC 2 MAMMALIAN TOXICITY

2.1 Acute mammalian Toxicity

Value Species Reference/Comments

Oral LD50 (mg/kg) 369 Mouse MSDS Inhalation LC50 (mg/m3) 3400 Mouse MSDS

2.2 Corrosion/Irritation

Skin, Rabbit, 0.5ml/24h: Mild irritation effect.

Readily absorbed through skin. Ha rmful if absorbed through skin.

2.3 Sensitization

No data.

2.4 Repeated-Dose Toxicity

No data.

2.5 Development and Reproductive Toxicity

No studies were located rega rding developmental/reproductiv e effects in humans after inhalation/dermal/oral exposure to 1,2,3-trichloropropane. Furt her information: Toxprofile chapter 2).

2.6 Carcinogenicity

Carcinogen (IARC Group 2A).

3 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

3.1 Modes of degradation (biotic and abiotic)

Degradation mainly in gas-phase , radical mediated fotolysis.

Nothing definitive is known about the biodegradability of the compound (Toxprofile).

3.2 Partition Coefficients

Results Reference/Comments

Log Pow 1.98 Toxprofile
Koc 131.8 DHIGESAMP-BWWG 8/6
ANNEX 5 Page 38

I:\MEPC\59\2-16.DOC 3.3 Persistence Persistent (half-life > 60days)

3.4 Reaction with Organic Matter No data. 3.5 Potential Physical Effects on Wildlife and Benthic Habitats

Solubility in water implies possible effects.

3.6 Potential Residues in Seafood

Low risk: Available data in dicates that 1,2,3-trichloropropa ne would not significantly bioconcentrate in plants, aquatic orga nisms, or animals (EPA 1988b; Lyman et al. 1982).

3.7 Any Known Interactive Effects

No.

4 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property Value Reference/Comments Melting point (°C) -47 DHI Boiling point (°C) 162 DHI Flammability (flash point for liquids; °C) 82.2 Toxprofile (Hawley 1981)

Density (20°C; kg/m3) 1389 Toxprofile Vapour pressure (25°C; mmHg) 3.1 Toxprofile Water solubility (temp; effect of pH; mg/L) 1750 (20°C) Toxprofile

Corrosivity to material or equipment No Reactivity to container material No Auto-ignition temperature(°C) 304 Toxprofile (Hawley 1981) Explosive properties No data Toxprofile Oxidizing properties E0: 1.583 DHI

* * *GESAMP-BWWG 8/6
ANNEX 5 Page 39

I:\MEPC\59\2-16.DOC Appendix 7

Aquatic Toxicity of Treated Ballast Water

1 Introduction

The Group noted that the applicant had carried out aquatic toxicity testing using the land-based treated ballast water discharge. All toxicity data disclosed were obtained at land-based type approval test cycles meeting Performance Standa rd D-2 concerning biological efficiency. Tests were carried out with water from several consecu tive cycles and the most conservative values are reported in the summary tables below.

2 Acute Aquatic Toxicity Test s in Fresh water (0.4 psu)

The acute aquatic acute toxicity results from tr eated fresh water ballast are shown in the table below:

Species Endpoint Result Reference/Justification of missing data
Fish Danio rerio LC50 n.r.* DIN 38415-T6
Crustacea Daphnia magna EC50 n.r.* DIN 38412-L30 Algae Scenedesmus sp. EC50 n.r.* DIN 38412-L33
Other Vibrio fischeri (Microtox © ) EC50 n.r.* ISO 11348-2

* n.r. = not reached.

3 Acute Aquatic Toxicity Tests in Brackish water (22 psu)

The acute aquatic acute toxicity results from treated brackish water ballast are shown in the table below:

Specie Endpoint Result (%) Reference/Justification of missing data
Fish Scophthalmus maximus LC50, %* >100 OECD 203
Crustacea Acartia tonsa LC50, %* >100 ISO 14669 Algae Skeletonema costatum EC10, %* EC50, %* 61 >100 ISO 10253

(* percentage of treated ballast water diluted in control water.)

4 Acute Aquatic Toxicity Test s in Sea water (32-35 psu)

The acute aquatic acute toxicity results from treated sea water ballast are shown in the table below:

Specie Endpoint Result (%) Reference/Justification of missing data
Fish Scophthalmus maximus LC50 74 OECD 203
Crustacea Acartia tonsa LC50 60.5 ISO 14669 Algae Skeletonema costatum EC10 EC50 14 19 ISO 10253

(* percentage of treated ballast water diluted in control water.)GESAMP-BWWG 8/6
ANNEX 5 Page 40

I:\MEPC\59\2-16.DOC 5 Chronic Aquatic Toxicity Test s in Brackish water (22 psu)

The chronic aquatic toxicity results from treated brackish water are show n in the table below:

Specie Endpoint Result (%) Reference/Justification of missing data
Fish Scophthalmus
maximus NOEC 56 OECD 215

Crustacea Nitocra spinipes NOEC >32* Danish standard reproduction test Algae Skeletonema

costatum EC10 EC50 61 > 100 ISO 10253

Other Brachionus plicatilis EC50 NOEC > 100 > 100 ISO/DC 20666 Chronic rotifer test

6 Chronic Aquatic Toxicity Test s in Brackish water (22 psu)

The chronic aquatic toxicity results from treated brackish water are show n in the table below:

Specie Endpoint Result (%) Reference/Justification of missing data
Fish Scopthalmus
maximus NOEC 56 OECD 215

Crustacea Nitocra spinipes NOEC >32* Danish standa rd reproduction test Algae Skeletonema

costatum EC10 EC50 14 19 ISO 10253

Bivalve Crassostrea gigas LC50 NOEC 62 46 ASTM E724 Chronic oyster embryo test
Rotifer Brachionus plicatilis EC50 NOEC > 100 56 ISO/DC 20666 Chronic rotifer test

* * *GESAMP-BWWG 8/6ANNEX 5Page 41I:\MEPC\59\2-16.DOCAppendix 8Calculated total uptakeTotal Daily Intake and Risk QuotientsSubstanceTDI(μg/kgbw/d)Exposure(μg/kgbw/d)Exposure(μg/kgbw/d)Exposure(μg/kgbw/d)RQ (-)RQ (-)RQ (-)Exposure(μg/kgbw/d)Exposure(μg/kgbw/d)Exposure(μg/kgbw/d)RQ (-)RQ (-)RQ (-)ManFemaleChildManFemaleChildManFemaleChildManFemaleChildSodium hypochlorite 3241.9·10-3 32.1·10-35.2·10-30.0000.0000.000------------Sodium hypobromite 5181.9·10-2.1·10-35.2·10-30.0000.0000.000------Trichloromethane CHCl310------------Dichlorobromomethane CHBrCl22.10------------Dibromochloromethane CHBr2Cl 307.7·10-17.3·10-13.70.0260.0240.1226.0·10-25.7·10-22.9·10-10.0020.0020.010Tribromomethane CHBr3251.41.46.60.0570.0540.2641.3·10-21.2·10-25.9·10-20.0010.0000.002Bromate 1.003.8·10-34.3·10-31.1·10-20.0040.0040.0112.5·10-42.8·10-47.1·10-40.0000.0000.001Sodium bromate (BrO3) 1.174.5·10-35.0·10-31.2·10-20.0040.0040.0113.0·10-43.3·10-48.3·10-40.0000.0000.001Calcium bromate (BrO3) 1.535.0·10-35.5·10-31.4·10-20.0030.0040.0093.3·10-43.7·10-49.2·10-40.0000.0000.001Potassium bromate (BrO3) 2.185.4·10-36.1·10-31.5·10-20.0020.0030.0073.6·10-44.1·10-41.0·10-30.0000.0000.000Monochloroacetic acid (MCAA) 3.50------------Dichloroacetic acid (DCAA)4.1·10-54.6·10-51.1·10-40.0000.0000.0006.9·10-57.7·10-51.9·10-40.0000.0000.000Trichloroacetic acid (TCAA) 406.3·10-56.9·10-51.8·10-40.0000.0000.0008.8·10-59.7·10-52.6·10-40.0000.0000.000Monobromoacetic acid (MBAA)------------Dibromoacetic acid (DBAA) 201.5·10-31.6·10-34.3·10-30.0000.0000.0001.3·10-41.4·10-43.7·10-40.0000.0000.000Bromochloroacetic acid (BCAA)9.6·10-51.0·10-42.9·10-4---1.0·10-41.1·10-43.1·10-4---Dichlorobromoacetic acid(DCBAA)1.8·10-41.9·10-46.3·10-4---------Dibromochloroacetic acid(DBCAA)1.4·10-41.6·10-44.5·10-4---------Tribromoacetic acid (TBAA)------------Bromoacetonitrile------------Monobromoacetonitrile 3.50------------Dibromoacetonitrile 233.5·10-53.5·10-51.4·10-40.0000.0000.000------Bromochloroacetonitrile 0.0571.1·10-51.3·10-53.2·10-50.0000.0000.001------Bromophenol------------p-bromophenol------------m-bromophenol------------o-bromophenol------------GESAMP-BWWG 8/6ANNEX 5Page 42I:\MEPC\59\2-16.DOCMED JVC jwSubstanceTDI(μg/kgbw/d)Exposure(μg/kgbw/d)Exposure(μg/kgbw/d)Exposure(μg/kgbw/d)RQ (-)RQ (-)RQ (-)Exposure(μg/kgbw/d)Exposure(μg/kgbw/d)Exposure(μg/kgbw/d)RQ (-)RQ (-)RQ (-)2,4-dibromophenol------------2,6-dibromophenol------------2,4,6-tribromophenol------------------------Dibromoethane 1.14·10-2------------1,1-dibromoethane 1.14·101,2-dibromoethane 1.14·10-2------------------------1,2-dibromo-3-chloropropane - 2.86·10-2-----------1,2,3-trichloropropane6.3·10-3-6.0·10-3-2.9·10-2--------2-chlorotoluene-----------4-chlorotoluene------------1,2,3-tribromobenzene------------***GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC ANNEX 6

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

NK-O3 BlueBallast System (Ozone)

Submitted by the Republic of Korea

0 SUMMARY

0.1 Having considered the submission by th e Republic of Korea and the responses provided by the applicant to the concerns e xpressed during the previous evaluations of the NK-03 BlueBallast system (Ozone), the Gr oup agreed to recommend that Final Approval should be given to this proposal.

0.2 The Group noted that the proposed system a pplies on board ozone generation without any chemicals carried on board the ship . A maximum dosage of 2.5 mg O 3 /L (7.5 mg/L as TRO) is then injected into the incoming ballast water for treatment. The Group also noted that TRO is classified as Active Substances for this system.

0.3 The applicant stated that dosage of ozone is monitored and controlle d automatically with a TRO sensor in the ballast water line after inj ection of ozone controlling the flow of injected ozone gas. With optimized side injector, the injected ozone ga s is efficiently converted to dissolved oxidants, mainly hypobromous and hypobromide ion. The Group noted that the maximum TRO measurement following 2.5 mg O 3 /L ozone treatment (7.5 mg/L as TRO) was 6.160 mg/L, in which the utili zation of ozone gas was up to 80%. The app licant provided improved a control scheme of ozone gas injectio n, and the Group noted that the results of TRO measured with fresh, brackish and seawater i ndicated the adequate relia bility of the control mechanism.

0.4 During review at its seventh meeting, the Gr oup noted that no report of the results of chemical analyses had been available in the dossi er. However, in the revised dossier for this meeting the applicant had carried out chemical analysis on the full-scale land-based treated ballast water. The Group was satisfied with the information provided for TRO and Relevant Chemicals analysis which was accompanied with appropriate indications of the limits of quantification, quality assuran ce and quality control (QC) and quality assurance (QA).

0.5 The Group also noted that the applicant prov ided the information of additional toxicity testing in the Whole Effluent Test (WET) using both seawater and brackish water with five species. The results of th ese tests showed that none of the samples showed a ny difference in toxicity between treated an d untreated ballast water. However, the Group noted that some of these toxicity tests needed improved QC in accordance with interna tionally recogniz ed guidelines.

0.6 The Group was pleased that, according to resu lts of their assessment for TRO degradation rate in short voyage, the appl icant decided to introduce the neutralization pr ocess by sodium thiosulphate for redu ction of residual TRO and some Relevant Chemicals. The Group reco gnized the importance of the neutralization process as an environmental risk mitigation measure.GESAMP-BWWG 8/6
ANNEX 6 Page 2

I:\MEPC\59\2-16.DOC 0.7 The Group noted the applicant had concluded, fr om fifteen cycles of treated and untreated ballast cycles of coated and uncoated steel that co ating tests that there we re no significant effects of fifteen 100 hour cycles of trea ted ballast water on th e ballast tank coatings and that corrosion rates were reduced in the case of uncoated samples installed in the treatment tank relative to those in the control.

0.8 The Group considered that the actual exposure time for the treatment dose was insufficient for long term corrosion rates and that these data are insufficient to characterize long term corrosion rates of steel subjected to th e treatment system accurately. Furthermore, the Group noted that such a conclusion would st rongly conflict with pub lished literature which indicate increased corrosion ra tes for TRO >1.0 mg/L as Cl 2 (2.2 mg/L as Br 2 ).

0.9 The Group considered that, with the various mitigation measures put in place by the applicant, the occupational exposure risks to th e Active Substances gene rated by the system would be acceptable.

0.10 However the Group also recogni zed that the risk of handlin g the neutralization unit by the crew, namely in mixing and load ing operations should be furthe r elaborated by the applicant when fully operating the BWTS.

0.11 The Group appreciated the efforts of the applicant to apply the model MAMPEC to generate estimations of the Rele vant Chemicals in the system, a lthough the results were achieved with an old version of the model, versi on 1.02 instead of the latest version (2.1).

0.12 The Group was therefore not able to reproduc e the results presente d by the applicant. Nevertheless, the results were considered ac ceptable as currently no recommended model and scenario has been adopted.

0.13 In conclusion, having reviewed all the info rmation provided by the applicant, the Group agreed to recommend to the MEPC that Final Approval be given to the NK-O3 BlueBallast System subject to the Administration verifying that all the recommendations have been fully addressed prior to issuance of a Type Approval Certificate:

.1 maximum allowable dosage of Active Substances at 2.5 mg/L O 3 in control scheme of ozone gas flow, and TRO of 7.5 mg/L as Br 2 is monitored by TRO sensors adequately maintained. Both these parameters should be monitored and recorded during uptake; and

.2 maximum allowable discharge concen trations of Active Substances at TRO of 0.2 mg/L as Cl 2 has been used as a reference valu e. In the current situation the applicant has shown that a TRO value of 0.08 mg/L as Cl 2 was achievable under normal operational conditions based on the Maximum Detection Limits (MDL). This parameter should be monitored and recorded during discharge.GESAMP-BWWG 8/6
ANNEX 6 Page 3

I:\MEPC\59\2-16.DOC 1 INTRODUCTION

1.1 It was noted that the NK-O3 BlueBallast System had, originally, been submitted to the Group at its second session for Basic Approval which was not recommended. However, it was recommended for Basic Approv al during its third session.

1.2 It was also noted that this system had not been recommended for Final Approval following consideration by the Gr oup during its seventh session.

2 COMPLETENESS OF THE DOSSIER

2.1 The Group agreed that all of the data neces sary to carry out a full review of this application for Final Approval had been provided by the applicant. Furthermore, the presentation of these data had made it relatively easy for the Group to examine specific aspects as needed.

3 DESCRIPTION OF THE SYSTEM

3.1 Overview

3.1.1 The Group recalled that the NK-O3 BlueBallast System uses a shipboard oxygen generator which takes ambient air and strips away the nitrogen leaving an oxygen rich mixture. This is then passed through a hi gh frequency electrical field to produce ozone which is injected into the incoming ballast water.

3.1.2 The five integrated modules of the system were noted as:

.1 an oxygen generator;

.2 an ozone generator;

.3 an ozone injector;

.4 a monitoring and control system; and

.5 a neutralizer.

3.1.3 The Group also noted that ancillary equipm ent associated with this system which includes:

.1 a Power Supply Unit (PSU) to provide overall power to the system;

.2 a compressor to feed air to the oxygen ge nerator (in some cases this can be based on the ship’s existing air compressors);

.3 a Refrigerated Dryer (RD) to de-humidify air being fed to the oxygen generator;

.4 a Chiller for the Closed Loop Cooli ng System (CLCS), which keeps the Ozone Generator cool; and

.5 an Ozone Destruct System (ODS) to convert any unused Ozone back to oxygen before release to the atmosphere.GESAMP-BWWG 8/6
ANNEX 6 Page 4

I:\MEPC\59\2-16.DOC 3.1.4 A schematic representation of the system is shown below:

Figure 1 – Scheme of the NK-O3 BlueBallast system.

3.2 Ozone Dosage and Control

3.2.1 The Group noted that the ozone dosage and cont rol is integrated into the ballast water management system which will be controlled fr om the bridge and/or cargo control room. It comprises the following aspects:

.1 activation, priming and st abilization – establishes a st able oxygen supply pressure and flow to the ozone generator;

.2 start of ballast water uptake triggers the ballast water treatment system to commence ozonation; and

.3 measurement of TRO levels in the treat ed influent which causes the amount of ozonation to be reduced if the levels of TRO reach 7.0 mg/L.

3.2.2 A maximum dosage of 2.5 mg O 3 /L is then injected into the incoming ballast water for treatment. The applicant indicated that th e dosage of ozone is monitored and controlled automatically using a TRO sensor in the ballast water line after injection of ozone. With an optimized side injector, the injected ozone gas is efficiently converted to dissolved oxidants, mainly hypobromous and hypobromide ion.

3.2.3 The Group noted that the theoretical TRO for natural seawater could be limited to <7.0 mg/L. However, it is possible to prod uce much higher TRO con centration in treating fresh water. Therefore, the Group recognized that the maximum dose concentration of TRO (as Br 2 ) to be 7.5 mg/L.

3.2.4 The applicant provided details of an impr oved and simplified control scheme for ozone gas injection, and the Group noted that the result s of TRO levels measured in fresh, brackish and seawater indicated the adequate reliability of the control system. The Group also noted that the maximum TRO measurement of balla st water treated with 2.5 mg O 3 /L (theoretically TRO 7.5 mg/L as Br 2 ) was 6.2 mg/L.GESAMP-BWWG 8/6
ANNEX 6 Page 5

I:\MEPC\59\2-16.DOC 3.3 Neutralization System

3.3.1 It was noted that, on discharge of the treated ballast water, the BWMS monitors the TRO levels and that discharge does not start until th e sensors are operational a nd the neutralizer feed system is functional.

3.3.2 If the TRO levels exceed 0.1 mg/L then neut ralization is activated with the neutralizer dose being calculated from the concentration of TRO monitored just before the neutralizer injection point, to offset all TRO still remains. The other set of TRO sensors is located after injection to confirm that neutralization is completed. However, if additional sensors, located after the neutralizing stage, detect leve ls >0.1 mg/L, the system is shut down.

3.3.3 The Group noted that the applicant had reporte d that the sensors had recorded levels of TRO down to 0.02 mg/L during their testing. Howe ver, the TRO sensor used for neutralization had a sensitivity limit, specified by the manufacturer, of 0.08 mg/L.

3.3.4 The Group noted that the applicant had indicat ed the need to replenish reagents used by the sensors which is to be done as part of the ma intenance schedule. It was also noted that the detectors are set up in pairs so that, should one of the pair fail, the other sensor would allow the system to continue to function properly. In such an event, the system would also indicate the need for maintenance. In the event that both systems should fail, the system shuts down.

3.4 Active Substances (AS), Relevant Chem icals (RC) and Other Chemicals (OC)

3.4.1 The Group noted that the Active Sustances (ozone) was generated in situ in this system and so there were no hazards associated with the storage of this chemical.

3.4.2 The Group recognized the followi ng reactions anticipated as taking place in ballast water treated with ozone:

O 3 + Br - O 2 + OBr - k = 160 ± 20 M -1 s -1

O 2 + OBr - 2O 2 + Br - k = 330 ± 60 M -1 s -1

OBr - + H 3 O + HOBr + H 2 O k = 2.09 10 9 M -1 s -1

HOBr + H 2 O OBr - + H 3 O + pKa = 8.8 ~ 9.0 2O 3 +OBr - 2O 2 + BrO 3 - k = 100 ± 20 M -1 s -1

HOBr + NH 3 NH 2 Br + H 2 O k = 7.5 10 7 M -1 s -1

where O 3 and OBr - are considered the real actives a nd k is the reacti on rate constant. In the figure 2 these main reactions of the chemistry of ozone are depicted.

Figure 2 – Main reaction scheme for ozone.GESAMP-BWWG 8/6
ANNEX 6 Page 6

I:\MEPC\59\2-16.DOC 3.4.3 Recognizing these reactions, the Group agreed with the applicant that ozone produced oxidants can be measured as Total Residual Oxid ants (TRO). The Group also agreed that the oxidation of bromide ions by chlorine ( hypochlorous acid/hypochl orite ion (HOCl/OCl - )) will result in the formation of oxidized bromide ion (bromine) which is the residual oxidant most likely to exist for any extended period of time in concentrations potentia lly harmful to marine organisms. Bromine rapidly forms hypobromous acid (HOBr) in equilibrium with hypobromite ion (OBr - ).

3.4.4 Furthermore, it was recognized that ozonatio n of hypobromite ion resu lts in bromate ion which, in turn, reacts with natu rally occurring organic matter to form haloacetic acids (HAA) and trihalomethanes (THM).

3.4.5 The Group noted the following highest leve ls of Active Substances and Relevant Chemicals recorded, by the applicant, during tests for Basic Approva l and Final Approval.

Additional tests 08 Additional tests 08 (Neutralization ) Chemical Basic Approva
l tests 07 Final Approva
l tests 07 0 days 2 days 5 days Before After

μ g/L
Ozone 2,500 2,350 2,500 - - 2,500 -
TRO 7,500 4,840 6,160 840 190 - 100
Bromate ion <2.00 <2.00 < 0.004 3 <0.004 3 <0.004 3 <0.004 3 <0.004 3
Bromoform 255 28.40 24.3 145 152 25.4 19.0
Bromochloroacetic acid - 11.90 <0.02 <0.02 <0.02 <0.02 <0.02

Dibromoacetic acid - 8.05 7.43 11.6 14.1 4.41 1.35
Monochloroacetic acid - <2.13 11.4 4.11 4.45 2.97 1.04

Dichloroacetic acid - 0.85 <0.14 1.1 <0.14 <0.14 <0.14
Trichloroacetic acid - 0.70 43 51.4 50.1 <0.04 <0.04 Sodium thiosulphate - - - - - - 5,290GESAMP-BWWG 8/6
ANNEX 6 Page 7

I:\MEPC\59\2-16.DOC 3.4.6 Additional information on the AS, RC and OC were provided by the applicant as shown below:

Component Chemical Name AS,RC,OC CAS
Number Concentration (bio)degradation rate or half-life Ozone (Triatomic Oxygen) AS 10028-15-6 2.50 mg/L 5 sec hypobromous acid TRO hypobromite ion AS 13517-11-8 7.50 mg/L

Bromate ion RC 15541-45-4 0.0020 mg/L 12 hours Tribromomethane (TBM) RC 75-25-2 0.2550 mg/L 38 days

Bromochloroacetic acid (BCA) RC 5589-96-8 0.0119 mg/L 15 days

Dibromoacetic acid (DBA) RC 631-64-1 0.0141 mg/L 15 days

Monochloroacetic acid (MCA) RC 79-11-8 0.0114 mg/L 3.36 days

Dichloroacetic acid (DCA) RC 79-43-6 0.0011 mg/L 15 days Trichloroacetic acid (TCA) RC 76-03-9 0.0514 mg/L 38 days Sodium thiosulphate OC 7772-98-7 5.29 mg/L

3.4.7 The Group noted the comprehensive set of da ta associated with each of the above chemicals and included in a ppendices 1-10 of this Annex.

4 CONSIDERATION OF CONCERNS EX PRESSED BY THE GROUP DURING ITS PREVIOUS REVIEW FOR FINAL APPROVAL

4.1 Overview

4.1.1 It was noted that the appli cant had provided the following sp ecific responses to concerns expressed by the Group related to the previous application for Final A pproval of this system.

4.2 Ozone monitoring and control ( MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, paragraph 0.3)

4.2.1 The Group recalled that it had ex pressed the view that it woul d be necessary to have an improved ozone injection control system in order to ensure the correct dosing.

4.2.2 In response to this observa tion, the Group noted th at the applicant ha d provided a more detailed description of the ozone dosage cont rol system which uses TRO sensors. Further evaluation of the TRO sensors had been undertake n, the results of which were shown in annex 2 of the supplementary information provided by the applicant.

4.2.3 Having reviewed this information, the Group agreed that the monitoring and control system associated with the ozone injection should ensure that the correct dose is applied without any undue excess.GESAMP-BWWG 8/6
ANNEX 6 Page 8

I:\MEPC\59\2-16.DOC 4.2.4 It was also noted that, in order to ensure th at there is no undue excess ozone injected into the ballast water which could l ead to the production of chemi cal by-products, the applicant had also included a TRO neutralizer (thiosulphate) as pa rt of the standard desi gn of the system which, it was claimed, is effective at keeping TRO levels in treated ballast water discharge below the PNEC level of 0.1 mg/L.

4.2.5 The Group was satisfied that this additional information removed their concerns about the monitoring and control of th e ozone injection system.

4.3 Results of Chemical Analyses ( MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, paragraph 0.4)

4.3.1 The Group recalled that, previously, it ha d expressed concern about the lack of information related to the chemical analyses of the treated ballast water i.e. lack of data, how and where analysis had been performed and l ack of adequate quality control reports.

4.3.2 In response to this concern, the Group noted that the applicant had now provided all the necessary information (supplementary data, annex 1). The information provided showed that few or no residual chemicals were detected in sa mples from land-based and ship-board tests.

4.3.3 Additional analyses of chemical residues in th e treated ballast water were also carried out (supplementary data, annex 3) which show ed small amounts of monochloracetic acid, dichloroacetic acid, trichloroacetic acid, dibromoacetic acid and tribromomethane.

4.3.4 Having reviewed this information, the Group was satisfied that it no longer had any concerns regarding this issue.

4.4 Degradation time of TRO vs holding time of NK-O3 treated ballast water (MEPC 58/2/8, GESAMP-BWWG 7/9, Annex 6, paragraph 0.5)

4.4.1 The Group recalled that it had, previously, noted that, the land-based G8 test showed that most of the TRO had been degrad ed in the ballast wate r after forty-eight hour s and so this time had been proposed as a holding ti me for treated ballast water.

4.4.2 However, the Group recalled that it had not been satisfied with this proposal as no ecotoxicity tests had been carried out af ter this proposed holding time and no exact measurements of the remaining TRO had been presented. Furthe rmore the dossier had included information which indicated that TRO levels we re well above detectable levels after 48 h.

4.4.3 The Group noted that the applicant had, subs equently, carried out additional ecotoxicity testing and TRO analyses at 0, 2 and 5 d intervals after treatment , the results, of which, were shown in annexes 2 and 3 of the supplementary information provided.

4.4.4 The Group noted that at time 0, the treated ballast water had some toxicity whilst at 2 d and 5 d there was none. However, it was also noted that the observed toxicity was less than that previously recorded fr om tests carried out on the test ba rge. The Group ag reed with the applicant that this was probably due to the effects of mixing, e xposure to sunlight and elapsed time.GESAMP-BWWG 8/6
ANNEX 6 Page 9

I:\MEPC\59\2-16.DOC 4.4.5 In addition, it was noted that TRO levels we re above detection limits after 2 d but were below toxic levels.

4.4.6 Having reviewed the additional information, the Group was satisfied that treated ballast water could be discharged immediately afte r treatment provided th at neutralization was employed.

4.5 Reported Degradation Rate of TRO (MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, paragraph 0.6)

4.5.1 The Group recalled that it had, previously, ex pressed concerns regarding the apparent discrepancies between the applicant’s reported ha lf-life of TRO in wate r with a high organic content and that of other BWMS:

– one BWMS, using ozonation had reported a half-life for TRO of 15 h resulting in concentrations of TRO of 160 μg/L after 5 d; and

– the applicant had reported a half-life of 1-2 d in its application for Basic Approval leading to a concentration of TRO of 130 μg/L after 5 d.

4.5.2 In response to this observation, the Gr oup noted that the applicant had undertaken additional measurements of TRO degradation, the results, of wh ich, were shown in annex 2 of the supplementary information.

4.5.3 In addition, should there still be concerns, the Group noted that the applicant had included a TRO neutralizer as part of the NK-O3 system.

4.5.4 Having reviewed the additional information, the Group was satisfied with it.

4.6 Whole Effluent Toxicity (WET) test ing and QA procedures (MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, paragraph 0.7)

4.6.1 The Group recalled that it had, previously, ex pressed concern, that the reports of the samples taken for ecotoxicity testing after 5 d holding time had inconsistencies in the reported dates of tests and samples received at the laborat ory. As a result, the Group was uncertain about the QA procedures employed in this activity.

4.6.2 In response to these concerns, the Group noted that the applicant shared such concerns which might have been due to the involvement of two separate test facilities, one for the on-barge testing and one carrying out the necessary anal yses. It appeared that the error was an administrative one related to recording of dates because of a delay to the start of the on-barge testing which meant that the WET te sting was done 4 d after treatment.

4.6.3 However, it was noted that extra vigilan ce had been taken when further tests were carried out.

4.6.4 The Group was satisfied with this explan ation and accepted the reported results.GESAMP-BWWG 8/6
ANNEX 6 Page 10

I:\MEPC\59\2-16.DOC 4.7 Disapproval of using animals to carry out new toxicity testing on Whole Effluent Toxicity (MEPC 58/2/8, GESAMP-BWWG 7/9, annex 6, paragraph 0.9)

4.7.1 The Group recalled that it had expressed disapp roval of animal testing for the purpose of generating new data which is not required for WET testing.

4.7.2 The Group noted that the University concerne d was trying to comply with Procedure (G9) which was of the opinion that mammalian toxicity should be determined using standard test methods.

4.7.3 Whilst the Group recognized that paragraph 5.2 of Procedure (G9) states that “Toxicity testing is necessary for treated ballast water di scharge as covered in this section”, the Group considered that, in the context of section 5 of Procedure (G9), this refers to ecotoxicity testing of fish, crustacean and algae.

4.7.4 Nevertheless, the Group recognized th e potential ambiguity of section 5.2 of Procedure (G9) which it request s MEPC to consider with a vi ew to changing references to “Toxicity” in section 5 of Pro cedure (G9) to “Ecotoxicity”.

4.8 Duration of corrosion tests (MEP C 58/2/8, GESAMP-BWWG 7/9, annex 6, paragraph 0.10)

4.8.1 The Group recalled that, previously, it had r ecommended that corrosion tests longer than the reported 100 h used by the applicant should be carried out using both coated and uncoated samples in order to verify the corrosive effect to steel and that the effect of using this BWTS on epoxy coated ballast tanks remains acceptable.

4.8.2 In response to this request, the Group noted that the corrosion tests were just over 100 h for each ballast test cycle and, with a total of 12 test cycles, this gave a total exposure time for each test coupon of 1200 h. However, the Group not ed that whilst the tests had been extended the time of exposure at the intended treatment dose of 7 mg TRO /L (as Br 2 ) was minimal and that these tests would be insuffi cient to predict the long term corrosion rate of uncoated steel.

4.8.3 Nevertheless, the applicant i ndicated that additional tests had been undertaken which are still ongoing although an interim report had b een provided (annex 4 of the supplementary application).

4.8.4 The Group noted that the appli cant concluded from the interim results that there were no significant effects of fifteen 100 hou r cycles of treated ballast wate r on the ballas t tank coatings and that corrosion rates were re duced in the case of uncoated samples installed in the treatment tank relative to those in the cont rol. As indicated previousl y, the Group considered that the actual exposure time at the treatment dose was insufficient for long term corrosion rates. Furthermore, the Group noted that such a conc lusion would conflict w ith published literature which indicates increased corrosion rates for TRO > 1 mg/L as Cl 2 (2.2 mg/L as Br 2 ).

4.8.5 Having considered this inform ation, the Group agreed that th e applicant should repeat the evaluation of uncoated steel substrates, in addi tion to other exposed metals and non-metallics to quantify, the effects on ballast tank coatings and other materials of construction. Such effects should include degradation as well as uniform and localized corrosion rates on typical marine vessel metallic (e.g., steel, galvanized steel, zinc, stainless steel, etc...) and non-metallic materials (e.g., EPDM rubber) materials used for ballast ta nks, fixtures and piping. Additionally, suchGESAMP-BWWG 8/6
ANNEX 6 Page 11

I:\MEPC\59\2-16.DOC testing should be conducted for both continuous and intermittent exposure at the treatment concentration. Hoewever, this wa s not considered a reason infl uencing the FA recommendation.

5 WHOLE EFFLUENT TESTING (WET) RESULTS

5.1 The Group noted that WET tes ting had been carried out on a mobile ba rge fitted with the NK-O3 system and two simu lated ballast tanks of 312.5 m 3 . Tests were carried out at two different sites so that sea water a nd brackish water media could be used.

5.2 It was noted that samples of treated ballast water were taken immediately after treatment and two days and five days later. Ozone and TRO levels were measured immediately on site whilst other tests were carried out in the laboratories.

5.3 The Group noted that th e treated ballast water did not show any signs of t oxicity two days and five days after treatment. However, so me toxicity was observed in the ballast water immediately after treatment, th e results of which are shown in the following two tables.

Toxicity of treated, high salinity, ba llast water immediately after treatment

Species NOEC LOEC EC50 Notes

Microalgae Phaeodactylum
tricornutum 50% 75% 83% Growth rate, 96 h

Dunaliella tertiolecta 50% 75% 81% Growth rate, 96 h

Rotifer Brachionus plicatilis > 100% > 100% > 100% Survival, 24 h

Brachionus plicatilis 25% 50% > 100% Growth rate, 96 h

Fish Cyprinodon variegatus > 100% > 100% > 100% Survival, 96 h

Cyprinodon variegatus > 100% > 100% > 100% Growth weight, 7 d

Amphipod Monocorophium acherusicum > 100% > 100% > 100% Survival, 10 d

Toxicity of treated, medium salinity, ba llast water immediately after treatment

Species NOEC LOEC EC50 Notes

Microalgae Phaeodactylum
tricornutum 50% 75% > 100% Growth rate, 96 h

Dunaliella tertiolecta 50% 75% > 100% Growth rate, 96 h

Rotifer Brachionus plicatilis > 100% > 100% > 100% Survival, 24 h

Brachionus plicatilis > 100% > 100% > 100% Growth rate, 96 h

Fish Cyprinodon variegatus > 100% > 100% > 100% Survival, 96 hGESAMP-BWWG 8/6
ANNEX 6 Page 12

I:\MEPC\59\2-16.DOC Cyprinodon variegatus > 100% > 100% > 100% Growth weight, 7 d

Amphipod Monocorophium acherusicum > 100% > 100% > 100% Survival, 10 d

5.4 Based on this information, the Group agreed that, even immediately following treatment, the treated ballast water was only slightly toxic. However, the Group also concurred with the views of the applicant th at ozone-produced oxidants may pers ist for one to two days at toxic concentrations in treated ballast water.

5.5 The Group also agreed with the decision of the applicant to include the sodium thiosulphate neutralizer as a standard part of the system.

6 HUMAN HEALTH ASSESSMENT

6.1 The Group recalled that, at its seventh session, it had reviewed the potential human health problems associated with this system during which the following obs ervations were made:

.1 relevant toxicological data had been submitted by the applicant for ozone, TRO and disinfection by-products (DBP) in the confidential version (3.4). Additionally, the Whole Effluent Toxici ty (WET) had been tested in new in vivo studies for the endpoints of acute toxici ty and genotoxicity/mutagenicity. Though the Group recognized that some ambiguity may exist regarding the requirements of toxicity testing under paragraph 5.2 of Procedure (G9) which states that “Toxicity testing is necessary for treated ballast water discharge as covered in this section”, the Group considers that this refers to toxicity testing of fish, crustacean and algae and not the use of animals for mammalian toxicity testing therefore disapproving it;

.2 it was noted that MSDSs for ozone, bromoform, bromochloroacetic acid, dibromoacetic acid had been provided and that risk concerni ng crew exposure to the chemicals generated by the system the human exposure assessment had been elaborated by the applicant;

.3 it had been noted that safety systems had been foreseen by the applicant to prevent contact of ship personnel to ozone in the vicinity of the NK-O3 System;

.4 concerns had previously been expresse d about the possibility of free ozone gas being present in the ship’s ballast tanks when they are emptied and that personnel may be exposed when entering the tanks for inspection and maintenance purposes, and also about the possibility of gaseous ozone being emitted from the ballast tank air vents during ballasting. However, the a pplicant had explained that it is highly improbable that ballast tanks would ever be opened and entered within a short time after the NK-O3 System having been operated, whic h occurs during ballasting. Ballast tanks need to be emptied prior to entr y, giving more than sufficient time for the breakdown of ozone. To address the perceived concern of the Group, safety procedures had been s upplemented to recommend an exclusion zone of 1 meter, to be pa inted on the ship’s deck around each ballast tank air vent with clear notice for personnel to keep out of these zones during ballasting. This will be included in crew induction and safety trainingGESAMP-BWWG 8/6
ANNEX 6 Page 13

I:\MEPC\59\2-16.DOC in ships fitted with the NK-O3 System, as reflected in the updated Operation and Maintenance Manual and Safety Manual for ozone system; and

.5 the applicant had proposed risk mitigation measures concerning bromoform, which could include periodic sampling of sy stem effluent as pa rt of port State control compliance procedures.

6.2 The Group was satisfied that, with the vari ous mitigation measures put in place by the applicant, the occupational risk resulting from exposure to the Active Substance generated by the system showed to be acceptable.

6.3 However, the Group also identified a point to be considered by the applicant when fully operating the ballast water management system:

.1 as thiosulphate is an irritant, the risks associated with the handling of the neutralization unit by the cr ew during mixing and loadin g operations need to be brought to the attention of the crew.

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

7.1 Risks to the safety of the ship

7.1.1 The Group recalled that, during its previous evaluation for Fi nal Approval, it had noted the following safety precautions which had been put in place to prevent exposure of the ships

crew to ozone:

.1 the use of materials and construction that is designed to prevent any possible leakage of ozone from the system;

.2 a gas separation unit togeth er with a waste ozone destru ction unit placed after the treatment unit, to destroy ozone produced during start up and testing of the ozone and convert it back to oxygen prio r to release to the atmosphere;

.3 an ozone densitometer to detect any po ssible accidental leakag e from the system;

.4 recommended inspection and maintenance procedures and clearl y outlined safety procedures as contained in suppor ting operating manuals for personnel;

.5 an automatic alarm and shut-down system linked to the ozone densitometer. This is designed to trigger if ozone levels in th e vicinity of the system exceed 0.2 mg/L (the recommended safe level is 0.1 mg/L); and

.6 other events that will shut down the system immediat ely, close all valves and stop, all pumps are high ambient o xygen concentration (25%), no Volumetric Oxygen Deficit (VOD) availa ble, emergency stop push button pressed and fire alarm.GESAMP-BWWG 8/6
ANNEX 6 Page 14

I:\MEPC\59\2-16.DOC 7.1.2 It was also noted that an additional extended corrosivi ty test had been conducted on coated and uncoated test samples as previously suggested by the Group. Having reviewed the results of this test, the Group was satisfied that the risks to the safety of the ship would be minimal.

8 RISKS TO TH E ENVIRONMENT

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

8.1.1 The Group noted the following information rela ted to the disinfection by-products of the Ballast Water Management System as supplied by the applicant:

Chemical Persistence (y/n) Bioaccumulation (y/n) Toxicity (y/n)

Ozone No Half-life: 5 sec No Log Pow: -0.87 No Chronic NOEC = n/a

TRO No Biodegrades Fast No BCF: 3.162 Log Pow: -0.78 No Chronic NOEC = n/a

Bromate ion No Half-life: Sea water: 12 hours No BCF: 3.162 Log Pow: 0.63 No NOEC = 32 mg/L/24h LC50 = 93 mg/L/10d

Bromoform Yes 185 days Half-life: Water: 38 days(applicant’s data Soil: 75 days No BCF: 14.06 Log Pow: 2.40 No NOEC=2.9 mg/L/96h =4.8 mg/L/28d

Bromochloroacetic acid No Half-life: Water: 15 days No BCF: 3.162 Log Pow: 0.61 No Chronic NOEC = n/a

Dibromoacetic acid No Half-life: Water: 15 days No BCF: 3.162 Log Pow: 0.70 No LC50 = 69 mg/L/96h

Monochloroacetic acid No Half-life: Water: 3.36 days No BCF: 3.162 Log Pow: 0.22 No LOEC = 25 mg/L/28d NOEC = 32 mg/L/21d

Dichloroacetic acid No Half-life: Water: 15 days No BCF: 3.162 Log Pow: 0.92 No LC50 = 23 mg/L/96h

Trichloroacetic acid No (Applicant said Yes) Half-life: Water: 38 days Soil: 75 days No BCF: 3.162 Log Pow: 1.33 No LC50 = 0.3 mg/L/14d

Sodium thiosulfate No Biowin1 (Linear Model Prediction):Biodegrades Fast Biowin2 (Non-Linear Model Prediction): Biodegrades Fast No BCF: 3.162 Log Pow: -4.53 No LETC = 520 mg/L/48h

8.1.2 Based on the data in the above table, the Group agreed that none of the chemical by-products, produced by this system , would be classified as PBT.GESAMP-BWWG 8/6
ANNEX 6 Page 15

I:\MEPC\59\2-16.DOC 8.2 Calculation of PEC/PNEC Ratios

8.2.1 The Group agreed with the applicant’s propos als for the estimation of the Predicted No Effect Concentrations (PNECs) for the various chemicals associated with this system as shown in the table below:

Chemical name Toxicity (mg/L) Information Assess.
Factor PNEC ( μ g/l)

Ozone 0.0081 Lowest short-term L(E)C50 from freshwater species representing three trophic levels 1,000 0.0081

TRO 0.080 Lowest short-term L(E)C50 from marine species; representing three trophic levels 1,000 0.080

Bromate ion 21.0 Lowest short-term L(E)C50 from marine species; representing three trophic levels 1,000 21.0

Bromoform 4.60 Lowest short-term L(E)C50 from marine species; representing three trophic levels 1,000 4.60

Bromochloroacetic acid 0.033 Lowest short-term L(E)C50 from freshwater species representing three trophic levels(Refer to Monochloroacetic acid) 1,000 0.033

Dibromoacetic acid 62.0 One lowest short-term L(E)C50 from freshwater; 1,000 62.0

Monochloroacetic acid 0.033 Lowest short-term L(E)C50 from freshwater species representing three trophic levels 1,000 0.033

Dichloroacetic acid 21.0 Lowest short-term L(E)C50 from marine species; representing three trophic levels 1,000 21.0

Trichloroacetic acid 0.30 Lowest short-term L(E)C50 from freshwater species representing three trophic levels 1,000 0.30

Sodium thiosulfate 805 Lowest short-term L(E)C50 from freshwater species representing three trophic levels 1,000 805GESAMP-BWWG 8/6
ANNEX 6 Page 16

I:\MEPC\59\2-16.DOC 8.2.2 The Group noted that the applicant had used tw o scenarios, associated with Busan Port, to calculate the Predicted Environm ental Concentration of the va rious chemical by-products as shown below:

Scenario 1

Emission
Conc. Emission PEC Assessment factor Endpoint PNEC PEC /
PNEC Chemical

(mg/L) (g/d) (μg/L) ( - ) (mg/L) (μg/L) ( - ) TRO (not neut) 7.5000 2,105,953 0.2560 1,000 0.0800 0.0800 3.2000
TRO (neut) 0.1000 28,079 0.0034 1,000 0.0800 0.0800 0.0426
Bromoform 0.2550 71,602 0.5540 1,000 4.6000 4.6000 0.1204
BCAA 0.0119 3,341 0.0297 1,000 0.0330 0.0330 0.9000
DBAA 0.0141 3,959 0.0352 1,000 62.0000 62.0000 0.0006
MCAA 0.0114 3,201 0.0231 1,000 0.0330 0.0330 0.7000
DCAA 0.0011 309 0.0027 1,000 21.0000 21.0000 0.0001
TCAA 0.0514 14,433 0.1340 1,000 0.3000 0.3000 0.4467
Sodium thiosulfate 5.2900 1,485,399 14.100 1,000 805.0000 805.0000 0.0175

Scenario 2

Emission
Conc. Emission PEC Assessment factor Endpoint PNEC PEC /
PNEC Chemical

(mg/L) (g/d) (μg/L) ( - ) (mg/L) (μg/L) ( - ) TRO (not neut) 7.5000 700,493 0.0852 1,000 0.0800 0.0800 1.0644
TRO (neut) 0.1000 9,340 0.0011 1,000 0.0800 0.0800 0.0142
Bromoform 0.2550 23,817 0.1843 1,000 4.6000 4.6000 0.0401
BCAA 0.0119 1,111 0.0099 1,000 0.0330 0.0330 0.2994
DBAA 0.0141 1,317 0.0117 1,000 62.0000 62.0000 0.0002
MCAA 0.0114 1,065 0.0077 1,000 0.0330 0.0330 0.2328
DCAA 0.0011 103 0.0009 1,000 21.0000 21.0000 0.0000
TCAA 0.0514 4,801 0.0446 1,000 0.3000 0.3000 0.1486
Sodium thiosulfate 5.2900 494,081 4.6900 1,000 805.0000 805.0000 0.0058

8.2.3 Based on these data, the Group agreed that th e PEC/PNEC ratios for each of the chemical by-products are expected to be less than 1 assu ming that neutralization of TRO is carried out during discharge.

8.2.4 Although the Group appreciated the attempts of the applicant to perform these calculations, the Group was not able to reproduce th e results achieved. It was not clear what the reason for this deviation is except that the version used by the applicant is MAMPEC 1.02, whilst the version available to the Group is MAMPEC 2.1.GESAMP-BWWG 8/6
ANNEX 6 Page 17

I:\MEPC\59\2-16.DOC 8.2.5 Nevertheless, the Group accepted the results of the modelling in general as that no environmental risk is expected from the appli cation of the NK-O3 system, also as there is currently not an accepted modelling approach available. The Group recommended that the applicant apply the more recent version of the model in any future applications.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risk to the safety of the ship

9.1.1 The Group considered that the actual exposur e time at the treatment dose was insufficient to characterize the long term corrosion rates of st eel subjected to the trea tment system accurately.

9.1.2 As a result, the Group agreed that the applicant should rep eat the evaluation of uncoated steel substrates, in addition to other exposed me tals and non-metallics to quantify, the effects on ballast tank coatings and other materials of construction.

9.1.3 Nevertheless, the Group did not consider that this shortcoming was sufficient for it to recommend that Final Approval should not be given.

9.2 Risks to crew and the general public

9.2.1 The Group recognized that some ambiguity may exist regarding the requirements of toxicity testing under paragraph 5. 2 of Procedure (G9) which stat es that “Toxicity testing is necessary for treated ballast wa ter discharge as covered in th is section” however the Group considers that this refers to toxicity testing of fish, crustacean and algae and not the use of animals for mammalian toxicity te sting therefore disapproving it.

9.2.2 The Group was satisfied that, with the vari ous mitigation measures put in place by the applicant, the occupational exposur e risk to the active substance generated by the system showed to be acceptable. However the Group also identif ied the following point to be further elaborated by the applicant when fully operating the ballast water management system:

.1 the risk of handling the neutralization unit by the crew namely in what mixing and loading operations are concerned as the ne utralizer thio-sulfate has irritative properties;

9.3 Risks to the environment

9.3.1 Having reviewed all of the data, the Group agreed that the risks to the environment caused by this system would be acceptable.

9.4 Conclusions

9.4.1 Notwithstanding the comments made in sect ions 9.1 to 9.3, the Group was satisfied with the response of the applicant to the questions posed to them afte r the earlier evaluation of the system.

9.4.2 Having considered all of the data submitte d for Final Approval, the Group agreed to recommend to MEPC that Final A pproval be given to this system.

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 18

I:\MEPC\59\2-16.DOC Appendix 1

Data on Ozone

1 CHEMICAL NAME: Ozone

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 (mg/L) Reference/Comments/ Justification for

missing data
Morone Americana White perch 0.20 (0.181 - 0.223) / 96h / Mortality Flow through / Salt water Richardson et al. (1983)

Lepomis macrochirus Bluegill 0.06 (0.05 - 0.06) / 24h / Mortality Flow though / Fresh water Paller and Heidinger (1979)

L. macrochirus Bluegill 0.02 / 24h / Mortality (NRZERO) Flow through / Fresh water Paller and Heidinger (1980)

Alosa sapidissima American shad 0.39 (0.28 - 0.58) / 3h / Mortality Static / Fresh water Coler and Asbury (1980)
Catostomus
commersoni White sucker 1.43 (0.97 - 1.92) / 1.33h / Mortality Flow through / Fresh water Coler and Asbury (1980)

Ictalurus punctatus Channel catfish 0.03 / 96h / Mortality Flow through / Fresh water Hammond and Bishop (1979)
Morone saxatilis Striped bass 0.06 (0.03 - 0.12) / 12h / Mortality Flow through / Fresh water Hall et al. (1981)

M. saxatilis Striped bass 0.08 (0.05 - 0.11) / 96h / Mortality Flow through / Salt water Hall et al. (1981)

Notropis hudsonius Spottail shiner 1.22 (1.06 - 1.4) / 3h / Mortality Static / Fresh water Coler and Asbury (1980) Oncorhynchus mykiss Rainbow trout 0.0093 (0.0081 - 0.0106) / 96h Mortality / Flow through / Fresh

water Wedemeyer et al. (1979)

Perca flavescens Yellow perch 0.06 (0.05 - 0.07) / 0.017h / Mortality Flow through / Fresh water Coler and Asbury (1980) Fish

Pimephales promelas Fathead minnow 0.1 / 0.008h / Mortality Flow through / Fresh water Coler and Asbury (1980)
Nannochloris sp. Green algae 0.45 a / 24h / Biomass Static Toner et al. (1975) Algae

Nannochloris sp. Green algae 0.45 b / 72h / Biomass Static Toner et al . (1975)GESAMP-BWWG 8/6
ANNEX 6 Page 19

I:\MEPC\59\2-16.DOC Species LC 50 (mg/L) Reference/Comments/ Justification for

missing data Monochrysis lutheri Dinoflagellate 1.00 c / 48h / Biomass Static Toner et al. (1975)

Skeletonema costatum Diatom 0.10 d / 24h / Biomass Static Toner et al. (1975)

Dreissena polymorpha Zebra mussel 0.35 - 0.42 / 1.83h / Mortality (LT 50 ) Flow through / Fresh water Harrington et al. (1997) Molluscs

D. polymorpha Zebra mussel 0.26 - 0.36 / 1.18h / Mortality (LT 95 ) Flow through / Fresh water Harrington et al. (1997)

Amphibians Pleurodeles sp. Newt 1.6 - 1.8 / 12d / Hematological parameters, Biochemistry Fresh water Jaylet et al. (1989)

a: severe biomass decrease in 24 h after 10-15min. exposure. b: severe biomass decrease in ca. 72 hr after 5 min. exposure, then recovers. c: severe biomass decrease in ca. 48 h after 5 min. exposure. d: complete biomass depletion in 24 h after 5 min. exposure. LT: time to % mortality of organisms NR-ZERO: 0% mortality or 100% survival of organisms

2.2 Chronic aquatic toxicity

No data was found on the chronic aquatic toxicity of ozone because of its short half-life.

2.3 Endocrine disruption

No data was found on the endocrine disruption potential of ozone be cause of its short half-life.

2.4 Sediment toxicity

No data was found on sediment toxicity of ozone because of it s short half-life.

2.5 Bioavailability/biomagnification/bioconcentration

Log Pow BCF Cause for concern (yes/no) Reference/Comments/Justification for missing data - 0.87 3.162 no US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67, BCFWIN TM

v.2.17

Ozone decomposes very rapidly in both seawater and freshwater. Therefore there is no risk that ozone may concentrate in organisms.GESAMP-BWWG 8/6
ANNEX 6 Page 20

I:\MEPC\59\2-16.DOC 2.6 Food web/population effects

Ozone decomposes very rapidly in both seawater and freshwater. Th erefore, there is no risk that ozone may cause food-web/population effects.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Value Species Reference/Comments/Justification for missing data
Oral LD 50 (mg/L) n/a
Dermal LD 50 (mg/L) n/a
Inhalation LC 50 (mg/L/4h) 0.015 - 0.016 0.012 - 0.014 0.032 Rat
Mouse
Hamster CCOHS(Canadian Center for Occupational Health and Safety)

n/a: not applicable.

3.2 Corrosion/Irritation

Species Method Results Reference/Comments/ Justification for missing data
Skin human Not irritant CCOHS Eyes human Irritant (>0.04 mg/for several minutes) CCOHS

3.3 Sensitization

The standard skin sensitization tests are not possible for gases a nd so there were no laboratory data available for this property. There are no data to suggest that ozone might be a sensitizer and it is not classified as such by the EEC.

3.4 Repeated-Dose Toxicity

From the available information, it was not possi ble to address the dose -response effects in relation to repeated inhalation e xposure (sub-chronic, 90 days) to ozone. However, it can be expected that similar effects on the lungs of humans and other mammals even at low concentration. In addition, the se verity of the respiratory res ponses to ozone becomes reduced following repeated daily exposures. This func tional adaptation to the effects of ozone may persist for several days after e xposure stops. Decreases in resp iratory function do not appear to be more pronounced in cigarette smokers or pe ople with pre-existing lung disorders (CCOHS).GESAMP-BWWG 8/6
ANNEX 6 Page 21

I:\MEPC\59\2-16.DOC 3.4.1 Chronic and Long-term Toxicity

Exposure Route Inhalation Exposure Duration 105 - 130 weeks Exposure dose 0.01 - 0.02 mg/kg/d Species rats and mice
Method
Results Increased incidence of non-carcinogenic lesions of the nose and lungs.
NOAEL
NOEL
Reference/Comments CCOHS

Exposure Route Inhalation Exposure Duration 3 - 18 months Exposure dose 0.003 - 0.013 mg/kg/d Species monkeys
Method
Results Significant structural alterations to lungs.
NOAEL
NOEL
Reference/Comments CCOHS

3.5 Developmental and Reproductive Toxicity

Exposure Route Inhalation Exposure Duration 4 days in middle or late pregnancy Exposure dose 0.02 or 0.03 mg/kg/d Species rats (offspring)
Method
Results Reduced growth rates after birth and delayed behavioural development. No maternal toxicity.
NOAEL
NOEL
Reference/Comments CCOHS

Exposure Route Inhalation Exposure Duration days 7 - 17 of pregnancy Exposure dose 0.008, 0.016 or 0.024 mg/kg/d Species mice (offspring)
Method
Results Decreased foetal body weight gain. Maternal toxicity.
NOAEL 0.016 mg/kg/d
NOEL
Reference/Comments CCOHS

Exposure Route Inhalation Exposure Duration Exposure dose 0.013, 0.025, 0.03 or 0.04 mg/kg/d Species ratsGESAMP-BWWG 8/6
ANNEX 6 Page 22

I:\MEPC\59\2-16.DOC Method
Results Embryotoxicity (increased resorptions) No Maternal toxicity.
NOAEL 0.025 mg/kg/d
NOEL
Reference/Comments CCOHS

Exposure Route Inhalation Exposure Duration 6 days prior to mating to postnatal day 22 Exposure dose Species mice
Method
Results Reduced body weight and slight effect s in neurobehavioral development of the offspring. No Maternal toxicity.
NOAEL
NOEL
Reference/Comments CCOHS

3.6 Carcinogenicity

Species Method Details Results Reference/Comments Rats 0.0024, 0.01 and 0.02 mg/kg/d 105-130 weeks No evidence for carcinogenicity in male and female rats. NTP,1994

Mice 0.0024, 0.01 and 0.02 mg/kg/d 105-130 weeks Inconclusive evidence(male) Some evidence (female) No evidence as tumor promoter NTP,1994

3.7 Mutagenicity/Genotoxicity

Species Method Details Results Reference/Comments/ lymphocytes of hamsters 0.0048-0.0086 mg/kg/d for 5 h Cytogenetic aberrations Victorin k. (1992) NTP (1994) lung macrophages of female rats 0.0024-0.016 mg/kg/d for 6 h Cytogenetic aberrations Victorin k. (1992) NTP (1994) bacteria, mammalian and human cells
in vitro Evidence for mutagenicity Victorin k. (1992) NTP (1994)GESAMP-BWWG 8/6
ANNEX 6 Page 23

I:\MEPC\59\2-16.DOC 4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Seawater or
Fresh water Test Duration Results Breakdown products Reference/Comments/ Justification for

missing data Hydrolysis (pH 5) Seawater ≤ 5 sec O 2 Hydrolysis (pH 7) Seawater Fresh water ≤ 5 sec 200 sec O 2

Hydrolysis (pH 9) Seawater Fresh water ≤ 5 sec 20 sec O 2

Biodegradation n/a
1/2 - Life Pure water Fresh water Seawater Air not recorded 20 min 10sec~2min
≤ 5 sec 1 h O 2

Baba S. et al . (2002)
n/a: not available

4.2 Partition Coefficients

Method Results Reference/Comments/Justification for missing data Log P OW Estimated -0.87 US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67
K OC Estimated 23.74 US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference /Comments/Justification for missing data
Persistence Estimated No US EPA Estimation Program Interface (EPI) Suite v.3.20, BIOWIN TM v.4.10GESAMP-BWWG 8/6
ANNEX 6 Page 24

I:\MEPC\59\2-16.DOC 4.4 Reaction with organic matter

4.4.1 In theory ozone can oxidi ze organic pollutants to carbon di oxide and water. In practice this does not happen, as it would take too long. The oxidation reactio ns usually attack C-C double bonds or aromatic groups in humic molecules, and aliphatic side chai ns or fatty acids by hydrogen atom abstraction. It will al so oxidize complexed metal ions.

4.4.2 Care needs to be taken when using ozone for reversible oxidations, for example the removal of color from dye waste. If the trea ted waste comes into contact with a reducing environment the molecule may convert to its previous form. This is not im portant for irreversible reactions.

4.5 Potential physical effects on wildlife and benthic habitats

4.5.1 The extremely short half-life of ozone in s eawater (five seconds) precludes the possibility of such impacts.

4.6 Potential residues in seafood

4.6.1 The extremely short half-life of ozone in s eawater (five seconds) precludes the possibility of such impacts.

4.7 Any known interactive effects

Forms bromine and related compounds in s eawater as addressed in this report.GESAMP-BWWG 8/6
ANNEX 6 Page 25

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property(with units and reference) Value Reference/Comments

Melting point (°C) -193°C

-192.5°C SRC PhysProp Database CHEMINFO Boiling point (°C) -111.9°C

-111.9°C SRC PhysProp Database CHEMINFO Flammability (flash point for liquids; °C) Non-flammable (does not burn) CHEMINFO

Density (20°C; kg/m 3 ) 1.5 (-183°C) 2.14 (0°C, 1013 mbar ) Vapour pressure (20°C; Pa) 5,460kPa Not applicable (gas) > 7,000kPa (estimated, 50°C) CHEMINFO

Vapour density (air = 1) 1.7
1.66 CHEMINFO Water solubility (temp; effect of pH; mg/L 3 1,100 (0°C), 600 (20°C) CHEMINFO pH in solution 6~9 Not applicable CHEMINFO Dissociation constant (pKa) Not available Oxidation- reduction potential 2.07 E 0 (V) Corrosivity to material or equipment Corrosive 1)

Reactivity to container material Ozone attacks rubber. It can be used with glass, stainless steel, aluminum, Teflon, Tygon, Hypalon, polyvinyl chloride and polyethylene. CHEMINFO

Auto-ignition Temperature (°C) Not applicable CHEMINFO

Explosive properties Explosive when heated or in contact with combustible material 2) Oxidizing properties Powerful oxidizer Surface tension 48.4 dyne/cm Viscosity 1.55 cP (-183°C) Thermal stability and identity of breakdown products Thermal oxidative decomposition will produce oxygen 3) Other physical or chemical Properties Colorless/blue gas, Characteristic odour (freshly mown hay) CHEMINFOGESAMP-BWWG 8/6
ANNEX 6 Page 26

I:\MEPC\59\2-16.DOC 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method Indigo Colorimetric Method Applicability Water Sensitivity 0.01 mg/L
Reference/Comments Standard Method 4500-O 3

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data
No No No PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 27

I:\MEPC\59\2-16.DOC Appendix 2

Data for Hypobromous acid/Hypobromite ion

1 CHEMICAL NAME: TRO (Hypobromous acid/Hypobromite ion)

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 (mg/L) Reference/Comments/ Justification for

missing data
Chlorella sorokiniana Green algae 0.2 - 0.6 / 20h / Mo rtality (N/R) Renewal / Fresh water Kott and Edlis (1969)

C. sorokiniana Green algae 0.2 - 0.6 / 20h / Mo rtality (N/R) Static / Fresh water Kott and Edlis (1969)

C. sorokiniana Green algae 1 / 18h / Population change, general (N/R) Static / Fresh water Kott and Edlis (1969)

Cladophora sp

. Green algae 1 - 5 / 0.5 - 24h / Chlorophyll, (N/R) / Static / Salt water Betzer and Kott (1969) Algae

Cladophora sp

. Green algae 20 - 100 / 24h / Cell changes (N/R) Static / Salt water Betzer and Kott (1969)

N/R: Endpoint was not reported.

2.2 Chronic aquatic toxicity

No information on the chronic aquatic toxi city of TRO was found in the literature.

2.3 Endocrine disruption

No information on the endocrine disruption potentia l of TRO was found in the literature. Their short half-lives present an extremely low risk of such.

2.4 Sediment toxicity

No information on the sediment toxicity of TRO wa s found in the literature. Their short half-lives present an extremely low risk of such.

2.5 Bioavailability/biomagnification/bioconcentration

Log Pow BCF Cause for concern (yes/no) Reference/Comments/Justification for missing data - 0.78 3.162 no US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67, BCFWIN TM

v.2.17GESAMP-BWWG 8/6
ANNEX 6 Page 28

I:\MEPC\59\2-16.DOC The octanol/water partition coefficient log va lue of hypobromous acid is -0.78 and is therefore considered not to pose a risk of concentration in organisms.

2.6 Food web/population effects

No information on the food web/population effect s of TRO was found in the literature. Their short half-lives present an extremely low risk of such.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

No information on the acute mammalian toxi city of hypobromous acid/hypobromite ion was found in the literature.

3.2 Corrosion/Irritation

No information on the acute mammalian corros ion/irritation of hypobr omous acid/hypobromite ion was found in the literature.

3.3 Sensitization

No information on the acute mammalian sensiti zation of hypobromous acid/hypobromite ion was found in the literature.

3.4 Repeated-Dose Toxicity

No information on the acute mammalian repeated dose toxicity of hypobromous acid/hypobromite ion was found in the literature.

3.4.1 Chronic and Long-term Toxicity

No information on the chronic and long- term mammalian toxicity of hypobromous acid/hypobromite ion was found in the literature.

3.5 Developmental and Reproductive Toxicity

No information on the acute mammalian deve lopmental and reproductive toxicity of hypobromous acid/hypobromite ion was found in the literature.

3.6 Carcinogenicity

No information on the mammalian carcinogeni city of hypobromous acid/hypobromite ion was found in the literature.

3.7 Mutagenicity/genotoxicity

No information on the mammalian mutagenic ity/genotoxicity of hypobromous acid/hypobromite ion was found in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 29

I:\MEPC\59\2-16.DOC 4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Seawater

or Fresh
water Test Duration Results Breakdown products Reference/Comments/ Justification for

missing data

Hydrolysis (pH 5) n/a Hydrolysis (pH 7) n/a Hydrolysis (pH 9) n/a Biodegradation n/a
1/2 – Life n/a
n/a: not available

4.2 Partition Coefficients

Method Results Reference/Comments/ Justification for missing data Log P OW Estimated -0.87 US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67
K OC Estimated 23.74 US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference/C omments/ Justification for missing data
Persistence Estimated No US EPA Estimation Program Interface (EPI) Suite v.3.20, BIOWIN TM v.4.10

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.

4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

No potential residues indicated in the literature.

4.7 Any known interactive effects

No potential effects indicat ed in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 30

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPERTIES

Property(with units and reference) Value Reference/Comments/ Justification for missing data Melting point (°C) 208.57 EPI Suite, v.3.20;
MPBPWIN TM v.1.42 Boiling point (°C) 527.32 EPI Suite, v.3.20;
MPBPWIN TM v.1.42 Flammability(flash point for liquids; °C) Not available

Density (20°C; kg/m 3 ) Not available Vapour pressure (20°C; Pa) 3.06x10 -13 mmHg(25°C) EPI Suite, v.3.20;
MPBPWIN TM v.1.42 Vapour density (air = 1) Not available Water solubility (temp; effect of pH; mg/L) 1.0x10 6 EPI Suite, v.3.20; WSKOWWIN TM v.1.41

pH in solution Not available Dissociation constant (pKa) 8.8 Perrins et al. (2006) Oxidation- reduction potential Not available Corrosivity to material or equipment Not available

Reactivity to container material Not available Auto-ignition Temperature (°C) Not available

Explosive properties Not available Oxidizing properties Not available
Surface tension Not available Viscosity Not available Thermal stability and identity of breakdown products Not available

Other physical or chemical properties Not available

6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method DPD Colorimetric Method Applicability Water Sensitivity 0.02 mg/L
Reference/Comments Standard Method 4500-CL GGESAMP-BWWG 8/6
ANNEX 6 Page 31

I:\MEPC\59\2-16.DOC 6.2 Material Safety Data Sheet provided: No.

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data
No No No PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 32

I:\MEPC\59\2-16.DOC Appendix 3

Data on Bromate ion

1 CHEMICAL NAME: Bromate ion

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 (mg/L) Reference/Comments/ Justification for

missing data Cymatogaster aggregate, Shiner perch 880 / 72h / Mortality (LC 100 ) Static / Salt water Crecelius E.A. (1979)

Leiostomus xanthurus Spot 399 (304 - 590) / 6d Salt water Richardson et al

. (1981)
Morone saxatilis Striped bass 230 (200 - 271) / 6d Salt water Richardson et al. (1981)
M. saxatilis Striped bass 31 (21 - 40) / 96h / EC 50 Salt water Richardson et al. (1981) Oncorhynchus keta Chum salmon 512 / 96h / Mortality Static / Salt water Crecelius E.A. (1979) Fish

Cyprinus carpio Common carp 397 / 40h / Mortality (NRLETH) Gavage / Fresh water Loeb and Kelly (1963)

Neomysis awatschensis Opossum shrimp 176 / 24h / Mortality Static / Salt water Crecelius E.A. (1979)

Pandalus danae Coon stripe shrimp 880 / 72h / Mortality (LC 100 ) Static / Salt water Crecelius E.A. (1979)

Daphnia magna Water flea 179 / 48h Fresh water Anderson B.G. (1946) Crustacea

D. magna Water flea 210 / 48h / Immobile, Intoxication (LETC) / Fresh water Anderson B.G. (1946)

Chilomonas paramecium Cryptomonad 38 / Population growth rate (N/R) Fresh water Bringmann and Kuhn (1981)

Glenodinium halli Dinoflagellate 16 / 7d / Population changes, general (N/R) / Salt water Erikson and Freeman (1978)

Isochrysis galbana Haptophyte 8 - 16 / 7d / Population changes, general (N/R) / Salt water Erikson and Freeman (1978) Algae

Skeletonema costatum Diatom 0.125 - 16 / 7d / Population changes, general (N/R) / Salt

water Erikson and Freeman (1978)GESAMP-BWWG 8/6
ANNEX 6 Page 33

I:\MEPC\59\2-16.DOC Species LC 50 (mg/L) Reference/Comments/ Justification for

missing data
Thalassiosira pseudonana, Diatom 16 / 7d / Population changes, general (N/R) / Salt water Erikson and Freeman (1978)

Crassostrea gigas Pacific oyster 170 (105 - 303) / 24h / Abnormal, Development (EC 50 ) Static / Salt water Brixham Environmental Laboratory (1995)

C. gigas Pacific oyster 30 / 48h / Developmental changes, general (EC 50 ) Static / Salt water Crecelius E.A. (1979)

C. gigas Pacific oyster 56 / 24h / Abnormal, Development (LOEC) Static / Salt water Brixham Environmental Laboratory (1995)

C. gigas Pacific oyster 32 / 24h / Abnormal, Development (NOEC) Static / Salt water Brixham Environmental Laboratory (1995)

Macoma inquinata Bent-nosed clam 880 / 72h / Mortality (LC 100 ) Static / Salt water Crecelius E.A. (1979) Molluscs

Protothaca staminea Littleneck clam 880 / 72 h / Mortality (LC 100 ) Static / Salt water Crecelius E.A. (1979)

Worms Polycelis nigra Planarian 2,258 / 48h / Mortality (LT 50 ) Static / Fresh water Jones J.R.E. (1941)

N/R: Endpoint was not reported NR-LETH: 100% mortality or 0% survival of organism LETC: Lethal threshold concentration

2.2 Chronic aquatic toxicity

Species LC 50 (mg/L) or NOEC

(mg/L) Reference/Comments/ Justification for

missing data
Leiostomus xanthurus Spot 279 (244 - 317) / 10d / Mortality Salt water Richardson et al. (1981) Fish

Morone saxatilis Striped bass 93 / 10d / Mortality Salt water Richardson et al. (1981)

2.3 Endocrine disruption

No information on the endocrine disruption poten tial of bromate ion was found in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 34

I:\MEPC\59\2-16.DOC 2.4 Sediment toxicity

No information on the chronic sediment toxicity of bromate ion was found in the literature.

2.5 Bioavailability/biomagnification/bioconcentration

Log Pow BCF Cause for concern (yes/no) Reference/Comments/Justification for missing data 0.63 3.162 no US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67, BCFWIN TM

v.2.17

The octanol/water partition coefficient log va lue of bromate ion is 0.63 and is therefore considered not to pose a risk of concentration in organisms.

2.6 Food web/population effects

The EPI Suite estimates that bromate ion is no t expected to bioaccumu late in the food chain because it does not exceed the BCF criteria.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Value Species Reference/Comments/ Justification for missing data
Oral LD 50 (mg/kg) 280 - 495 rats, mice and hamsters Kurokawa et al. (1990)

Oral LOAEL (6h) 385 rats Fujie et al. (1988)
Dermal LD 50 (mg/kg) n/a a
Inhalation LC 50 (mg/L/4h) n/a b

n/a a : not available. Refer to chronic and long-term dermal toxicity data. n/a b : not applicable.

3.2 Corrosion/Irritation

Species Method Results (including scores where available) Reference/Comments/Justification for missing data

Skin Not specified human Irritant MSDS Eyes Not specified human Irritant MSDS

3.3 Sensitization

EEC Classification for bromate ions did not include R43 (May cause sensitization by skin contact).GESAMP-BWWG 8/6
ANNEX 6 Page 35

I:\MEPC\59\2-16.DOC 3.4 Repeated-Dose Toxicity

Exposure Route Oral Exposure Duration 2 weeks Exposure Dose 0, 10.8, 54, 108, 270 or 540 mg/kg/d Species mice
Method
Results Based on changes in enzyme activities.
NOAEL 108
NOEL
Reference/Comments Kawana et al. (1991)

Exposure Route Oral Exposure Duration 13 weeks Exposure Dose 0, 16, 32, 63, 140, 270, 540 or 1,080 mg/kg/d Species rats
Method
Results Died within 7 weeks ( ≥ 270 mg/kg/d). Significant inhibition of body weight gain ( ≥ 63 mg/kg/d). Significant increases of serum parameters (63 mg/kg/d). 63 mg/kg/d (an adverse effect level).
NOAEL
NOEL
Reference/Comments Kurokawa et al. (1990)GESAMP-BWWG 8/6
ANNEX 6 Page 36

I:\MEPC\59\2-16.DOC 3.4.1 Chronic and Long-term Toxicity

Exposure Route Dermal (shaven dorsal skin) Exposure Duration twice weekly for 51 weeks Exposure Dose 0.2 ml of a potassium bromate solution in acetone (40mg/ml) Species mice
Method
Results No skin tumours were seen in the test group or control group.
NOAEL
NOEL
Reference/Comments Kurokawa et al. (1984)

Exposure Route Oral Exposure Duration 15 months Exposure Dose 30 mg/kg/d Species rats
Method
Results Inhibition of body weight gain and renal effects.
NOAEL
LOAEL 30
NOEL
Reference/Comments Nakano et al. (1989)

Exposure Route Oral Exposure Duration 100 weeks Exposure Dose 0, 1.1, 6.1, 12.9 or 28.7 mg/kg/d Species rats
Method
Results Based on kidney effects.
NOAEL 1.1
NOEL
Reference/Comments DeAngelo et al. (1998)

Exposure Route Oral Exposure Duration 100 weeks Exposure Dose 0, 6.9, 32.5 or 59.6 mg/kg/d Species mice
Method
Results No effects on survival, body weight, organ weights, serum chemistry or the incidence of non-neoplasic lesions were observed.
NOAEL 59.6
NOEL
Reference/Comments DeAngelo et al. (1998)GESAMP-BWWG 8/6
ANNEX 6 Page 37

I:\MEPC\59\2-16.DOC 3.5 Developmental and Reproductive Toxicity

Exposure Route Oral Exposure Duration 35 days Exposure Dose 2.2, 7.7 or 22 mg/kg/ds Species rats
Method
Results Significant decrease (18%) in epididymal sperm density (treated males in the 250-ppm (22 mg/kg/d) dosed group). Female reproductive function was not adversely affected. There were no treatment related gross or microscopic changes in the kidney,

liver, spleen, testis, or epididymis. No indication of the developmental e ndpoints or any effects were observed.
NOAEL 7.7
LOAEL 22
NOEL
Reference/Comments Wolf and Kaiser (1996)

3.6 Carcinogenicity

Species Method Details Results Reference/Comments/ Rats 0, 0.7, 1.3, 2.5, 5.6, 12 or 33 mg/kg/d 104 weeks (Drinking water) Significantly increased renal adenomas and carcinomas

( ≥ 5.6 mg/kg/d). Significantly increased dysplastic foci in the kidney

( ≥ 1.3 mg/kg/d). Increased incidence of follicular tumours of thyroid gland and of peritoneal mesotheliomas

(33 mg/kg/d). Kurokawa et al. (1986b)

Rats 0 or 32.3 mg/kg/d 104 weeks (Drinking water) Increased dysplastic foci and renal adenomas, adenocarcinomas, follicular adenomas and adenocarcinomas of the thyroid gland. Kurokawa et al. (1987)

Mice 0, 6.9, 32.5 or 59.6 mg/kg/d 100 weeks (Drinking water) Increased renal adenomas and carcinomas (6.9 mg/kg/d). Not increased renal tumours

(32.5 or 59.6 mg/kg/d). DeAngelo et al. (1998)GESAMP-BWWG 8/6
ANNEX 6 Page 38

I:\MEPC\59\2-16.DOC 3.7 Mutagenicity/Genotoxicity

Species Method Details Results Reference/Comments/ Justification for

missing data
Chinese hamster fibroblasts Chromosomal aberration

assay Increase in the frequency of exchange-type aberrations. Ishidate et al. (1984)

Mouse bone

marrow cells Micronucleus

test Increased micronuclei. Hayashi et al. (1988)

V79 Chinese hamster cells Cytotoxicity, micronucleus, chromosome aberration, HPRT gene mutation, and comet assays Cytotoxic, increased the frequency of cells with micronuclei, increased the number of chromosome aberrations, and increased DNA migration, increased levels of 8- oxodeoxyguanosine, induced gene mutations at the HPRT locus. Speit et al. (1999)

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Seawater or
Fresh water Test Duration Results Breakdown products Reference/Comments/ Justification for

missing data Hydrolysis (pH 5) n/a Hydrolysis (pH 7) n/a Hydrolysis (pH 9) n/a Biodegradation n/a
1/2 - Life Sea water 12 hours GESAMP-BWWG 5/9, annex 5 (p22)
n/a: not available

4.2 Partition Coefficients

Method Results Reference/C omments/ Justification for missing data Log P OW Estimated 0.63

-7.18 (NaBrO 3 ) US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67 SRC PhysProp Database

K OC Estimated 14.3 US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66GESAMP-BWWG 8/6
ANNEX 6 Page 39

I:\MEPC\59\2-16.DOC 4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference /Comments/Justification for missing data
Persistence Estimated No US EPA Estimation Program Interface (EPI) Suite v.3.20, BIOWIN TM v.4.10

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.

4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

No potential residues indicated in the literature.

4.7 Any known interactive effects

No potential effects indicat ed in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 40

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPERTIES

Property(with units and reference) Value Reference/Comments/

Melting point (°C) 38 (bromate ion) 381 (Sodium bromate) WHO (2005) Boiling point (°C) 1,390 MSDS-FisherScientific Flammability Non-flammable (Not applicable) MSDS-SienceLab Density (20°C; kg/m 3 ) 3,339 3,340 U.S. EPA(2001) NIOSH-ICSC Vapour pressure (20°C; Pa) 5.6x10 -16 (25°C) SRC PhysProp Database Vapour density (air = 1) 5.2 MSDS-FisherScientific Water solubility (temp; effect of pH; mg/L) 3.64x10 5 (20°C) NIOSH-ICSC

pH in solution 5.0~9.0 MSDS-SigmaAldrich
Dissociation constant (pKa) Not available MSDS-SienceLab

Oxidation- reduction potential Not available

Corrosivity to material or equipment Non corrosive (Neutral in aqueous solution) MSDS-SienceLab HSDB Reactivity to container material Avoid contact with strong reducers, finely powdered metals, alcohols, strong acids, ammonium compounds, combustible materials. MSDS-FlinnScientific

Auto-ignition Temperature (°C) Not applicable MSDS-SienceLab

Explosive properties Risk of fi re and explosion on contact with combustible substances and reducing agents. NIOSH-ICSC

Oxidizing properties Strong oxi dizer MSDS-FlinnScientific Surface tension Not available MSDS-SigmaAldrich Viscosity Not available Not applicable MSDS-SigmaAldrich MSDS-FisherScientific Thermal stability and identity of breakdown products Stable When heated to decomposition, emits toxic fumes of bromides. MSDS-SienceLab MSDS-FlinnScientific

Other physical or chemical properties Colorless or White, odorless crystals or powder MSDS-FlinnScientific MSDS-FisherScientificGESAMP-BWWG 8/6
ANNEX 6 Page 41

I:\MEPC\59\2-16.DOC 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method Ion chromatographic Method Applicability Water Sensitivity 0.0043 μ g/L
Reference/Comments/Justification for missing data EPA Method 300.0

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data
No No No PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 42

I:\MEPC\59\2-16.DOC Appendix 4

Data on Tribromomethanes

1 CHEMICAL NAME: Tribromomethane (Bromoform)

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 (mg/L) Reference/Comments/ Justification for

missing data Brevoortia tyrannus Atlantic menhaden 12 (9 - 15) / 96h / Mortality Flow through / Salt water Anderson et al. (1979) Gibson et al. (1981) Cyprinodon variegatus Sheepshead minnow 7.1 (4.6 - 11) / 96h / Mortality Flow through / Salt water Ward et al. (1981)

C. variegatus Sheepshead minnow 2.9 (NOEC) / 96h / Mortality Static / Salt water Heitmuller et al. (1981)

Cyprinus carpio Common carp 52 (50 - 54) / 3-5d / Mortality Renewal / Fresh water Mattice et al. (1981) Fish

Lepomis macrochirus Bluegill 29 (24 - 36) / 96h / Mortality Static / Fresh water Buccafusco et al. (1981) Daphnia magna Water flea 46 (42 - 51) / 48h / Mortality Static / Fresh water LeBlanc, G.A. (1980)

Daphnia pulex Water flea 44 / 96h / Mortality Renewal / Fresh water Trabalka et al. (1978)

Americamysis bahia Opossum shrimp 24.4 / 96h / Mortality Salt water U.S. EPA (1978) Crustacea

Penaeus aztecus Brown shrimp 26 (20 - 30) / 96h / Mortality Flow through / Salt water Anderson et al. (1979)

Selenastrumcapricornutum, Green algae 38.6 (26.1 - 53.8) / 96h / Chlorophyll (EC 50 ) / Fresh water U.S. EPA (1978)

S. capricornutum Green algae 10 / 96h / Chlorophyll / NOEC Fresh water U.S. EPA (1978)

Skeletonema costatum Diatom 12.3 / 96h / Photosynthesis(EC 50 ) Fresh water U.S. EPA (1978) Algae

Protothaca staminea Littleneck clam 7 / 28d / Mortality (LC 0 ) Flow through / Salt water Gibson et al. (1981)GESAMP-BWWG 8/6
ANNEX 6 Page 43

I:\MEPC\59\2-16.DOC 2.2 Chronic aquatic toxicity

Species NOEC/IC50 (mg/L) Reference/Comments/ Justification for

missing data Cyprinodon variegatus Sheepshead minnow 4.8 / 28d / Mortality (NOEC) Flow through / Salt water Ward et al. (1981) Fish

C. variegatus Sheepshead minnow 8.5 / 28d / Mortality (LOEC) Flow through / Salt water Ward et al. (1981)

Glenodinium halli Dinoflagellate > 32 / 7d / Population changes, general (IC 50 ) / Salt water Erickson et al. (1978)

Isochrysis galbana Haptophyte 32 (8 - 32) / 7d / Population changes, general (IC 50 ) / Salt water Erickson et al. (1978)

Skeletonema costatum Diatom 32 (2 - 32) / 7d / Population changes, general (IC 50 ) / Salt water Erickson et al. (1978) Algae

Thalassiosira pseudonana, Diatom 32 (1 - 32) / 7d / Population changes, general (IC 50 ) / Salt

water Erickson et al. (1978)

2.3 Endocrine disruption

No information on the endocrine disruption poten tial of bromoform was f ound in the literature.

2.4 Sediment toxicity

Tribromomethane is relatively stable in the air, bu t reactions with other ch emicals in the air cause them to break down slowly (about 50% in 1 or 2 months). Tribromomethane in water or soil may also be broken down by bacteria, but the speed of this process is not known.

According to CITI (1992) and Sangster (1994), the value of Log Pow is 2.4, which is smaller than the indicated value of bioaccumulation which is 3. And Koc value from EPI Suit V 3.20 is 35.04 and it is smaller than 500l/kg. Therefore, it is considered to have low possibility of sediment toxicity.

2.5 Bioavailability/biomagnification/bioconcentration

Log Pow BCF Cause for concern (yes/no) Reference/Comments/Justification for missing data 2.40 14.06 no US EPA (2005) US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67, BCFWIN TM

v.2.17

The bioaccumulative potential of an organic chemi cal reflects the tendency of a chemical to be taken up and retained by an aquatic organi sm, both from water and through food, which then results in higher concentration of that chemical in an organism th an in its environment. Log Pow is a common term to classify chemicals as bioaccumulative.GESAMP-BWWG 8/6
ANNEX 6 Page 44

I:\MEPC\59\2-16.DOC The value of Log Pow is 2.4 and this value is sma ller than 3 which is used as a rough indication for bioaccumulation and the BCF-value using th e method of regression-based extrapolation was 14.06 which is smaller than the value of 2000. The substance is considered to be not bioaccumulative.

2.6 Food web/population effects

The PBT Profiler estimates that tribromomethane (bromoform) is not expected to bioaccumulate in the food chain because it doe s not exceed the BCF criteria.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Value Species Reference/Comments/ Justification for missing data
Oral LD 50 (mg/kg) 933 - 1,388 707 - 1,550 rats mice EPA, EHC 216 (2000)

Dermal LD 50 (mg/kg) 2,000 rabbits Torkelson (1994)

Inhalation LC 50 (mg/L/4h) 4,500 mg/m 3 (LC LO )
≥ 7,000 ppm 1,070 - 1,260 ppm rats dogs rabbits ACGIH (1991) ACGIH (1991) Dykan (1964)

3.2 Corrosion/Irritation

Species Method Results Reference/Comments/ Justification for missing data
Skin human Irritant (Redness).

Prolonged or repeated contact causes defatting and cracking of the skin. International Chemical Safety Cards (WHO/IPCS/ILO)
MSDS

Eyes human Irritant (Redness, Pain).

Contact with eyes causes irritation and may be painful. International Chemical Safety Cards (WHO/IPCS/ILO)
MSDS

3.3 Sensitization

EEC Classification for bromoform did not include R43 (May cause sensiti zation by skin contact).GESAMP-BWWG 8/6
ANNEX 6 Page 45

I:\MEPC\59\2-16.DOC 3.4 Repeated-Dose Toxicity

Exposure Route Oral Exposure Duration 90 days Exposure Dose 0, 0.65, 6.1, 57 or 218 mg/kg/d (male) 0, 0.64, 6.9, 55 or 283 mg/kg/d (female) Species rats
Method
Results Decreased lymphocyte counts. Decrease in LDH in both males and females at the high dose. Increased hepatic lesions (increased cytoplasmic volume and vacuolation

due to fatty infiltration). Increased thyroid lesion (decreased folli cular size and colloid density and

occasional focal collapse of follicles).
NOAEL 57 (male), 55 (female)
LOAEL 218 (male), 283 (female)
NOEL
Reference/Comments/ Justification for

missing data Chu et al. (1982b)

Exposure Route Oral Exposure Duration 13 weeks (5days per week) Exposure Dose 0, 25, 50, 100 or 200 mg/kg/d (rats) 0, 25, 50, 100, 200 or 400 mg/kg/d (mice) Species rats and mice
Method
Results The only significant finding, hepatic vac uolation, was observed in male rats ( ≥ 50 mg/kg/d) and male mice ( ≥ 200 mg/kg/d).
NOAEL 25 (rats), 100 (mice)
NOEL
Reference/Comments/ Justification for

missing data NTP (1989a)

3.4.1 Chronic and long-term toxicity

Exposure Route Oral (diet) Exposure Duration 24 months Exposure dose 0, 22, 90 or 364 mg/kg/d (male) 0, 38, 152 or 619 mg/kg/d (females) Species rats
Method
Results Enzyme changes and altered liver appearance at necropsy.
NOAEL 22 (male), 38 (female)
LOAEL 90 (male), 152 (female)
NOEL
Reference/Comments/ Justification for

missing data Tobe et al. (1982)GESAMP-BWWG 8/6
ANNEX 6 Page 46

I:\MEPC\59\2-16.DOC Exposure Route Oral Exposure Duration 103 weeks (5 days per week) Exposure dose 0, 100 or 200 mg/kg/d Species rats
Method
Results Decreased body weight, lethargy, mild hepatotoxicity.
NOAEL
LOAEL 100
NOEL
Reference/Comments/ Justification for

missing data NTP 1989a

Exposure Route Oral Exposure Duration 103 weeks (5 days per week) Exposure dose 0, 50 or 100 mg/kg (male) 0, 100 or 200 mg/kg (female) Species mice
Method
Results No observed effects on body weight or hepatotoxicity (male). Decreased body weight, minimal to mild fatty changes in liver

(female).
NOAEL 100 (male)
NOEL 100 (female)
Reference/Comments/ Justification for

missing data NTP 1989a

3.5 Developmental and Reproductive Toxicity

Exposure Route Oral (gavage) Exposure Duration At days 6-15 of gestation Exposure dose 0, 50, 100 or 200 mg/kg/d Species rats
Method
Results Evidence of a fetotoxic response. No fetal malformations observed.
NOAEL 50 (developmental), 200 (maternal)
LOAEL 100 (developmental)
NOEL
Reference/Comments/ Justification for

missing data Ruddick et al. (1983)GESAMP-BWWG 8/6
ANNEX 6 Page 47

I:\MEPC\59\2-16.DOC Exposure Route Oral (gavage) Exposure Duration 105 days Exposure dose 0, 50, 100 or 200 mg/kg/d Species mice
Method Continuous breeding reproductive toxicity protocol.
Results No detectable effect on fertility, litters/pair, live pups/litter, proportion of live births, sex of live pups, or pup body weight.
NOAEL 100 (developmental / maternal)
LOAEL 200 (developmental / maternal)
NOEL
Reference/Comments/ Justification for

missing data NTP (1989b)

3.6 Carcinogenicity

Species Method Details Results Reference/Comments Rats 0, 100 or 200 mg/kg/d. 103 weeks (5 days per week) (via gavage in oil) Increased adenomatous polyps or adenocarcinomas. Some evidence for carcinogenic activity

(male) and clear evidence (female). NTP (1989a)

Mice 0, 50 or 100 mg/kg/d (male). 0, 100 or 200 mg/kg/d (female). 103 weeks (5 days per week) (via gavage in oil) No statistically significant increases in the incidence of any neoplastic lesion in any dose group compared to controls. NTP (1989a)

3.7 Mutagenicity/Genotoxicity

Species Method Details Results (with/without

activation) d Reference/Comments

In Vitro Studies Salmonella typhimurium

TA100 a , TA1535 Gene mutation nt/+ Simmon and Tardiff (1978)

TA1535, TA1537 b

, TA100 TA97, TA98 Gene mutation -/- -/± C

± C /- NTP (1989A)

TA100 b Gene mutation -/+ Ishidate et al. (1989a)
TA98 TA100, TA1538 a Gene mutation +/+ -/- Zeiger (1990)

S. typhimurium Ara Gene mutation -/+ c Roldan-Arjona and Pueyo (1993)
RSJ100 Gene mutation nt/+ DeMarini et al. (1997) Mouse lymphoma cells b Gene mutation +/+ NTP (1989a)
Chinese hamster

fibroblasts b Chromosome aberration +/- Ishidate et al. (1982)

Chinese hamster

fibroblasts b Chromosome aberration -/± NTP (1989a)GESAMP-BWWG 8/6
ANNEX 6 Page 48

I:\MEPC\59\2-16.DOC Species Method Details Results (with/without

activation) d Reference/Comments

Human lymphocytes DNA damage nt/+ Landi et al. (1999a) Human lung epithelial

cells DNA damage nt/+ Landi et al. (2003)

Toadfish leukocytes a Sister chromatid exchange nt/- Maddock and Kelly (1980)

Human lymphocytes b Sister chromatid exchange nt/+ Morimoto and Koizumi (1983) Chinese hamster ovary

cells b Sister chromatid exchange -/± NTP (1989a)

Rat liver GGT-foci assay Initiation - Herren-Freund and Pereira (1986)
CCRF-CEM human

lymphoblastic leukemia cells DNA strand breaks nt/+ Geter et al. (2004a)

F344/N primary rat

hepatocytes DNA strand breaks nt/- Geter et al. (2004a)

In Vivo Studies
Mouse bone marrow

cells Micronuclei - Ishidate et al. (1982)

Mouse bone marrow

cells Micronuclei - Hayashi et al. (1988)

Mouse bone marrow

cells Micronuclei - Stocker et al. (1997)

Mouse bone marrow

cells Chromosome aberrations - NTP (1989a)

Rat bone marrow

cells (oral) Rat bone marrow

cells (ip) Chromosome aberrations +

+ Fujie et al. (1990)

Rat renal cells DNA strand breaks - Potter et al. (1996) Rat liver, kidney or

duodenum epithelial cells DNA strand breaks - Geter et al. (2004a)

Mouse bone marrow

cells Sister chromatid exchange + Morimoto and Koizumi (1983)
Mouse bone marrow

cells (ip) Sister chromatid exchange + NTP (1989a)

Drosophila Sex-linked recessive lethal mutations NTP (1989a)

nt: Not tested. a: Assay was conducted in a closed system. b: Authors did not specify whether or not the assay was conducted in a closed system. c: Equivocal results obtained. d: With/without activation applies to in vitro assays only.GESAMP-BWWG 8/6
ANNEX 6 Page 49

I:\MEPC\59\2-16.DOC 4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Seawater
or Fresh

Water Test Duration Results Breakdown products Reference/Comments/ Justification for

missing data Hydrolysis (pH 5) n/a

Hydrolysis (pH 7) n/a

Hydrolysis (pH 9) n/a

Ultimate Biodegradation Survey 2.728 (Weeks to Months ) PBT Profiler (Estimated) Biodegradation

Aerobic: limited biodegradation Anaerobic: readily biodegrade
1/2 - Life Water Soil Sediment Air estimated 38 days 75 days 340 days 380 days PBT Profiler

Photolysis Air: 1~2 months Water: not asignifican t degradation pathway
n/a: not available

4.2 Partition Coefficients

Method Results Reference/C omments/ Justification for missing data Log P OW 2.40 U.S. EPA (2005)

K OC Column, Keweenaw 7 soil; 0.85% OC Estimated 114.8 126

35.04 ATSDR (2005) U.S. EPA (1996)

US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66GESAMP-BWWG 8/6
ANNEX 6 Page 50

I:\MEPC\59\2-16.DOC 4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference/C omments/ Justification for missing data
Persistence Estimated Yes PBT Profiler

The PBT Profiler uses three environmental co mpartments (water, soil, and sediment) to determine the persistence of a chemical in the environment. If released to the environment, Bromoform is expected to be found predominantly in soil. It is also expected to be found in water but not in sediment.

The PBT Profiler has estimated that Bromoform is expected to be found predominantly in soil and its persistence estimate is based on its transformation in this medium. Its half-life in soil, 75 days, exceeds the EPA criteria of ≥ 2 months (and ≤ 6 months). Therefore, Bromoform is estimated to be persistent in the environment.

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.

4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

No potential residues indicated in the literature.

4.7 Any known interactive effects

No potential effects indicat ed in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 51

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES,

PREPARATIONS AND TREATED BA LLAST WATER, IF APPLICABLE

Property(with units and reference) Value Reference/Comments/ Justification for missing data Melting point (°C) 6~7
8.0 8.0~8.5 U.S. EPA(2005) ATSDR(2005) CHEMINFO Boiling point (°C) 149~150
149.1 149.5 U.S. EPA(2005) ATSDR(2005) CHEMINFO Flammability(flash point for liquids; °C) Non-flammable (No data) ATSDR(2005)

Density (20°C; kg/m 3 ) 2.887x10 3

2.899x10 3 U.S. EPA(2005) ATSDR(2005) Vapour pressure (20°C; Pa) 700 (20°C) 747 (25°C) NIOSH-ICSC U.S. EPA(2005) Vapour density (air = 1) 8.7
8.72 ATSDR(2005) CHEMINFO Water solubility (temp; effect of pH; mg/L) 1.0x10 3 (20°C)
3.1x10 3 (25°C)
3.19x10 3 (30°C) NIOSH-ICSC ATSDR(2005) U.S. EPA(2005) pH in solution Not available Dissociation constant (pKa) Not available Oxidation- reduction potential Not available Corrosivity to material or equipment Will attack some forms of plastics, rubber, and coatings 1) ATSDR(2005)

Reactivity to container material Not available

Auto-ignition Temperature (°C) No data ATSDR(2005) Explosive properties Reactive Metal Powders can react explosively. Nitromethane or Cyclic Polyethylene Oxides/Potassium Hydroxide mixtures can explode. CHEMINFO

Oxidizing properties Normally stabilized to prevent oxidation. CHEMINFO

Surface tension 41.53 dynes/cm 46.18 (15°C) ATSDR(2005)

Viscosity 2.15 cP (15°C) 0.74 centistokes(15°C, Estimated) 2.217 cP (10°C) CHEMINFO

Thermal stability and identity of breakdown products Stable under normal conditions. Gradually decomposes on standing, acquiring a yellow colour. 2) CHEMINFO

Other physical or chemical properties Colorless to yellow liquid with a sweet, suffocating, chloroform-like odor 3) CHEMINFOGESAMP-BWWG 8/6
ANNEX 6 Page 52

I:\MEPC\59\2-16.DOC 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method Liquid-Liquid Extraction Gas Chromatographic Method Applicability Water Sensitivity 0.63 μ g/L
Reference/Comments/Justification for missing data Standard Method 8260B

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data
Yes No No PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 53

I:\MEPC\59\2-16.DOC Appendix 5

Data on Bromochloroacetic acid

1 CHEMICAL NAME: Br omochloroacetic acid

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Information on the acute aquatic toxicity of bromochloroacetic acid was not found in the literature.

2.2 Chronic aquatic toxicity

No information on the chronic aquatic toxicity of bromochloroacetic acid was found in the literature.

2.3 Endocrine disruption

No information on the endocrine disruption poten tial of bromochloroacetic acid was found in the literature.

2.4 Sediment toxicity

No information on the sediment toxicity of br omochloroacetic acid was found in the literature.

2.5 Bioavailability/biomagnification/bioconcentration

Log Pow BCF Cause for concern (yes/no) Reference/Comments/Justification for missing data 1.08 3.162 no WHO (2004) US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67, BCFWIN TM

v.2.17

The octanol/water partition coefficient log va lue of bromochloroacetic acid is 1.08 and is therefore considered not to pose a ri sk of concentration in organisms.

2.6 Food web/population effects

The PBT Profiler estimates that bromochloroacetic acid is not expected to bioaccumulate in the food chain because it does not exceed the BCF criteria.

3 MAMMALIAN TOXICITY

3.1 Acute toxicity

No information on the acute toxicity of bromoc hloroacetic acid was f ound in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 54

I:\MEPC\59\2-16.DOC Much more health effects data are available on dichloroacetate and di bromoacetate than on bromochloroacetate. Results of toxicity studi es on dichloroacetate and dibromoacetate are informative of the potential health effects of bromochloroacetate because of qualitative similarities in the metabolism of the chlori nated/brominated dihaloacetates (NTP, 2008).

3.2 Corrosion/Irritation

Species Method Results Reference/Comments/ Justification for missing data
Skin human Causes burn. MSDS Eyes human Destructive to tissue of mucous membrane. MSDS

3.3 Sensitization

No information on mammalian sensitization of bromochloroacetic acid was found in the literature.

3.4 Repeated-dose toxicity

Exposure Route Oral Exposure Duration 2 weeks Exposure Dose 0, 62.5, 125, 250, 500 or 1,000 mg/L (0, 9, 18, 35, 75 or 140 mg/kg/d to male) (0, 8, 17, 35, 70 or 130 mg/kg/d to female) Species rats
Method
Results Increased right kidney weights (the highest dosed male group). No exposure-related gross or hist opathologic lesions were observed.
NOAEL
NOEL
Reference/Comments NTP (2008)

Exposure Route Oral Exposure Duration 2 weeks Exposure Dose 0, 62.5, 125, 250, 500 or 1,000 mg/L (0, 10, 20, 40, 80 or 170 mg/kg/d to male) (0, 9, 17, 40, 75 or 155 mg/kg/d to female) Species mice
Method
Results Increased mean body weights (250 mg/L-dose male group). No exposure-related gross or hist opathologic lesions were observed.
NOAEL
NOEL
Reference/Comments/ Justification for

missing data NTP (2008)GESAMP-BWWG 8/6
ANNEX 6 Page 55

I:\MEPC\59\2-16.DOC Exposure Route Oral Exposure Duration 3 months Exposure Dose 0, 62.5, 125, 250, 500 or 1,000 mg/L (0, 5, 10, 20, 40 or 75 mg/kg/d to male) (0, 5, 10, 20, 40 or 85 mg/kg/d to female) Species rats
Method
Results Increased liver weights ( ≥ 500mg/L). Increased kidney weights (1,0 00 mg/L dosed male group). Increased incidences of cytoplas mic vacuolization (1,000mg/L).
NOAEL
NOEL
Reference/Comments NTP (2008)

Exposure Route Oral Exposure Duration 3 months Exposure Dose 0, 62.5, 125, 250, 500 or 1,000 mg/L (0, 8, 16, 32, 65 or 125 mg/kg/d to male) (0, 8, 17, 35, 70 or 140 mg/kg/d to female) Species mice
Results Decreased body weight gain ( ≥ 250 mg/L dosed female group). Increased liver weights (the highest dosed male group and all exposed

female groups). Periportal cytoplasmic vacuolization (all male groups and females exposed

to 500 and 1,000 mg/L). Increased incidences of hematopoietic cell proliferation (62.5, 125 and

250 mg/L males and 125 and 1,000 mg/L females).
NOAEL
NOEL
Reference/Comments/ NTP (2008)

3.5 Developmental and reproductive toxicity

Exposure Route Oral Exposure Duration 14 days Exposure Dose 0, 24, 72 or 216 mg/kg/d Species rats
Method
Results Decreased epididymal sperm count s, the number of motile sperm. Increased epididymal sperm with mi sshapen heads or tail defects, the

number of atypical residual bodies in seminiferous tubules, the number of Step 19 spermatids retained in Stage X and XI of the spermatogenic cycle.
NOAEL
LOAEL 24
NOEL
Reference/Comments Klinefelter et al. (2002)GESAMP-BWWG 8/6
ANNEX 6 Page 56

I:\MEPC\59\2-16.DOC Exposure Route Oral Exposure Duration 14 days (juvenile mice : postnatal day 8 to day 21) Exposure Dose 0, 8, 24, 72 or 216 mg/kg/d Species juvenile and adult mice
Method
Results Effects on fertility: disruption of spermatid differentiation. Reduced mean number of litters per ma le, the percentage of litters per

female bred and the total number of fetuses per male (at two highest exposure groups). Spermatids with abnormal head morphology and atypical residual bodies. No affect relative testis, epididymal or seminal vesicle weights.
NOAEL 72
LOAEL 24
NOEL
Reference/Comments Tully et al. (2005)

Exposure Route Oral Exposure Duration 14 days Exposure Dose 0, 8, 24, 72 mg/kg/d Species rats
Method
Results Reduced the fertility of cauda epididymal sperm (evaluated by in utero insemination).
ED 50 = 2.7
NOAEL 8
NOEL
Reference/Comments Klinefelter et al. (2002) kaydos et al. (2004)

Exposure Route Oral Exposure Duration during cohabitation and separated after mating. gestation day 6 to onset of birth (pregnant rats) Exposure Dose 0, 60, 200 or 600 ppm (mg/L) (0, 5, 15 or 39 mg/kg/d to male) (0, 6, 19 or 50 mg/kg/d to female) Species rats
Method
Results Reduced implants per litter and live fetuses per litter (at 600 ppm).
NOAEL 19
LOAEL 50
NOEL
Reference/Comments NTP (1998)GESAMP-BWWG 8/6
ANNEX 6 Page 57

I:\MEPC\59\2-16.DOC 3.6 Carcinogenicity

Species Method Details Results Reference/Comments/ Justification for

missing data Rats 0, 250, 500 or 1,000 mg/L. 2 years. Malignant mesothelioma. Adenoma in Large intestine. Fibroadenoma in mammary gland. Clear evidence of carcinogenic activity. NTP (2008)

Mice 0, 250, 500 or 1,000 mg/L. 2 years. Hepatocellular adenoma, hepatocellular carcinoma, hepatocellular adenoma or carcinoma and hepatoplastoma in Liver. Clear evidence of carcinogenic activity. NTP (2008)

3.7 Mutagenicity/genotoxicity

Species Method Details Results Reference/Comments Salmonella typhimurium TA100 Gene mutation Positive, with or without S9 NTP (2008)

S. typhimurium TA98 Gene mutation Negative, with or without S9 NTP (2008)

Escherichia coli strain WP2

uvrA /pKM101 Gene mutation Negative, with or without S9 NTP (2008)

Mouse peripheral blood Chromosomal damage Negative NTP (2008)

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Seawater
or Fresh

Water Test Duration Results Breakdown products Reference/Comments/ Justification for

missing data Hydrolysis (pH 5) n/a Hydrolysis (pH 7) n/a Hydrolysis (pH 9) n/a Biodegradation Ultimate Biodegradati on Survey 3.036 Weeks PBT Profiler (Estimated)

1/2 - Life Water Soil Sediment Air estimated 15 days 30 days 140 days 24 days PBT Profiler

n/a: not availableGESAMP-BWWG 8/6
ANNEX 6 Page 58

I:\MEPC\59\2-16.DOC 4.2 Partition Coefficients

Method Results Reference /Comments/Justification for missing data Log P OW 1.080 WHO (2004)

K OC Estimated 1.895 US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference /Comments/Justification for missing data
Persistence Estimated No PBT Profiler

The PBT Profiler uses three environmental co mpartments (water, soil, and sediment) to determine the persistence of a chemical in the environment. If released to the environment, Bromochloroacetic acid is expected to be found pre dominantly in soil. It is also expected to be found in water, but not in sediment.

The PBT Profiler has estimated that Bromochl oroacetic acid is expected to be found predominantly in soil and its persistence estimate is based on its transformation in this medium. Its half-life in soil, 30 days, does not exceed the EPA criteria. Th erefore, Bromochloroacetic acid is estimated not to be persistent in the environment.

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.

4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

No potential residues indicated in the literature.

4.7 Any known interactive effects

No potential effects indicat ed in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 59

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property(with units and reference) Value Reference/Comments/ Justification for missing data Melting point (°C) 27.5~31.5
36 WHO (2004) PBT Profiler Boiling point (°C) 210~215
215 U.S EPA (2005) SRC PhysProp Database Flammability (flash point for liquids;) Not available

Density (20°C; kg/m 3 ) 1,980 WHO (2004) Vapour pressure (20°C; Pa) 11 (25°C) 18 (25°C) PBT Profiler SRC PhysProp Database Vapour density (air = 1) Not available Water solubility (temp; effect of pH; mg/L) 4.40x10 4 (25°C)
2.46x10 5 (25°C) PBT Profiler SRC PhysProp Database pH in solution Not available Dissociation constant (pKa) 1.30 NTP (2008) Oxidation- reduction potential Not available Corrosivity to material or equipment Not available

Reactivity to container material Not available

Auto-ignition Temperature (°C) Not available

Explosive properties Not available Oxidizing properties Not available
Surface tension Not available Viscosity Not available Thermal stability and identity of breakdown products Not available

Other physical or chemical properties Hygroscopic crystal WHO (2004)GESAMP-BWWG 8/6
ANNEX 6 Page 60

I:\MEPC\59\2-16.DOC 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method Gas Chromatographic Method Applicability Water Sensitivity 0.02 μ g/L
Reference/Comments/Justification for missing data EPA Method 552.2

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data
No No No PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 61

I:\MEPC\59\2-16.DOC Appendix 6

Data on Dibromoacetic acid

1 CHEMICAL NAME: Dibromoacetic acid

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 (mg/L) Reference/Comments

Pimephales promelas Fathead minnow 160 (138 - 1,380) / 24h / Mortality Static / Fresh water Mayes et al. (1985)

P. promelas Fathead minnow 107 (99 - 119) / 48h / Mortality Static / Fresh water Mayes et al. (1985)

P. promelas Fathead minnow 81 (73 - 91) / 72h / Mortality Static / Fresh water Mayes et al. (1985) Fish

P. promelas Fathead minnow 69 (62 - 75) / 96h / Mortality Static / Fresh water Mayes et al. (1985)

2.2 Chronic aquatic toxicity

No information on the chronic toxicity of di bromoacetic acid was f ound in the literature.

2.3 Endocrine disruption

No information on the endocrine disruption pote ntial of dibromoacetic acid was found in the literature.

2.4 Sediment toxicity

No information on the sediment toxicity of di bromoacetic acid was found in the literature.

2.5 Bioavailability/biomagnification/bioconcentration

Log Pow BCF Cause for concern (yes/no) Reference/Comments

1.22 3.162 no WHO (2004) PBT Profiler US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67, BCFWIN TM

v.2.17

The octanol/water partition coefficient log value of dibromoacetic acid is 0.70 and is therefore considered not to pose a risk of concentration in organisms.GESAMP-BWWG 8/6
ANNEX 6 Page 62

I:\MEPC\59\2-16.DOC 2.6 Food web/population effects

The PBT Profiler estimates that dibromoacetic acid is not expected to bioaccumulate in the food chain because it does not exceed the BCF criteria.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Value Species Reference/Comments/ Justification for missing data
Oral LD 50 (mg/kg) 1,737 (1,411-1,952) rats Linder et al. (1994a)

Dermal LD 50 (mg/kg) n/a
Inhalation LC 50 (mg/L/4h) n/a
n/a: not available.

3.2 Corrosion/Irritation

Species Method Results Reference/Comments/ Justification for missing data
Skin human Causes burns. MSDS Eyes human Causes burns. MSDS

3.3 Sensitization

No information on mammalian sensitization of dibromoacetic acid was found in the literature.

3.4 Repeated-Dose Toxicity

Exposure Route Oral Exposure Duration 12 weeks Exposure Dose 0, 300, 1000 or 2000 mg/L Species mice
Method
Results Decreased water consumption and body weight (the highest dose group). Increased liver weight ( ≥ 1000 mg/L) and the total liver

glycogen content (the highest dose group). Decreased serum glucose and serum insulin concentrations

( ≥ 1000 mg/L).
NOAEL
NOEL
Reference/Comments Kato-Weinstein et al. (2001)GESAMP-BWWG 8/6
ANNEX 6 Page 63

I:\MEPC\59\2-16.DOC Exposure Route Oral Exposure Duration 13 weeks Exposure Dose 0, 125, 250, 500, 1000 or 2000 mg/L Species rats and mice
Method
Results Decreased mean body weights and water consumption due to poor palatability (the highest dose group). Increased liver weight in mice ( ≥ 1000 mg/L), in rats ( ≥ 125 mg/L). Increased cytoplasmic vacuolation in hepatocytes (all dose group of mice)

and vacuolization (the highest dose group of rats). Cytoplasmic alteration in the pituita ry glands (high-dose male rats).
NOAEL 500 (mice), 1000 (rats)
NOEL
Reference/Comments/ Justification for

missing data NTP (1999b)

Exposure Route Oral Exposure Duration 6 months Exposure Dose 0, 20, 72 or 161 mg/kg/d Species rats
Method
Results Decreased body weights gain (high-dose group). Neuromuscular toxicity (limb weakness, mild changes in gait and hypotonia)

was revealed (mid- and high-dose). Depressed sensorimotor responses. Decreased activity and chest clasping (the highest dose). Degeneration of spinal cord nerve fibers (mid- and high-dose). Increased neuronal vacuolization of the spinal cord.
NOAEL
NOEL 20
Reference/Comments Moser et al. (2004)

Exposure Route Oral Exposure Duration 42 days Exposure Dose 250 mg/kg/d Species rats
Method
Results Abnormal posturing, light tremor, atypical movement of limbs and difficulty in moving hind limbs.
NOAEL
NOEL
Reference/Comments Linder et al. (1995)GESAMP-BWWG 8/6
ANNEX 6 Page 64

I:\MEPC\59\2-16.DOC Exposure Route Oral Exposure Duration 28 days Exposure Dose 0, 14-20, 33-39, 68-73, 132-150 or 236-285 mg/kg/d Species mice
Method
Results Decreased body weight gain and thymus weights (the highest dose group). Increased liver weights (all dose groups) and kidney weights

(4 highest dose groups). Increased the number of spleen macrophages (3 highest dose groups),

indicative of immunotoxicity, and there was a significant dose-dependent reduction in spleen IgM antibody-forming cell responses to sheep erythrocytes, representing a decrease in humoral immunity.
NOAEL 250 mg/L (33 - 39 mg/kg/d)
LOAEL 500 mg/L (68 - 73 mg/kg/d)
NOEL
Reference/Comments NTP (1999a)

3.5 Developmental and Reproductive Toxicity

Exposure Route Oral (single gavage) Exposure Duration 0 or 1,250 mg/kg Exposure dose Single Species rats (male)
Method
Results Adverse effects on sperm count, morphology and motility.
NOAEL
LOAEL
NOEL
Reference/Comments Linder et al. (1994a)

Exposure Route Oral Exposure Duration 14 days Exposure dose 0, 10, 30, 90 or 270 mg/kg/d Species rats (male)
Method
Results Reduced testis and epididymis weight s and testicular sperm head counts. Decreased cauda sperm count and sperm motility and increased frequency

of abnormal cauda sperm morphology. Decreased caput sperm count and hi stopathological evidence of altered

spermiation, including delayed release of Step 19 spermatids and atypical acrosomal development of Step 15 spermatids ( ≥ 10 mg/kg/d).
LOAEL 10 (equivocal)
NOEL
Reference/Comments Linder et al. (1994b)GESAMP-BWWG 8/6
ANNEX 6 Page 65

I:\MEPC\59\2-16.DOC Exposure Route Oral Exposure Duration the first protocol: 42 days / the second protocol: 79 days Exposure dose the first protocol: 0 or 250 mg/kg/d the second protocol: 0, 2, 10 or 50 mg/kg/d Species Rats
Method
Results Decreased mating and fertility. Histological evidence for changes in sem iniferous tubule staging of altered

spermatid development.
NOAEL 2 (corresponding)
LOAEL 10 (equivocal)
NOEL
Reference/Comments Linder et al. (1995); Linder et al. (1997)

Exposure Route Oral Exposure Duration Gestation day 15 to parturition Exposure dose 0, 0.97, 5.05 or 54.2 mg/kg/d Species rabbits
Method
Results Reduced sperm fertility
NOAEL
LOAEL 0.97
NOEL
Reference/Comments Veeramachaneni et al. (2000)

Exposure Route Oral (single dose) Exposure Duration single Exposure dose 0, 600 or 1,200 mg/kg/d Species
Method
Results No changes in sperm motility, sperm morphology or cell membrane permeability. Mild changes in testes histopathology (the presence of basophilic bodies).
NOAEL
LOAEL 600
NOEL
Reference/Comments Vetter et al. (1998)

Exposure Route Oral Exposure Duration days 1 to 8 of gestation Exposure dose 0, 62.5, 125 or 250 mg/kg/d Species rats (female)
Results No treatment-related changes in body weight, reproductive organ weights, number of implantation sites, number of resorptions, number of corpora lutea, preimplantation losses or serum levels of progesterone and luteinizing hormone. The only effect was a 170% increase in serum 17 β

estradiol (250 mg/kg/d).
NOAEL 125
NOEL
Reference/Comments Cummings and hedge (1998)GESAMP-BWWG 8/6
ANNEX 6 Page 66

I:\MEPC\59\2-16.DOC Exposure Route Oral Exposure Duration beginning 14 days prior to cohabita tion and continuing through gestation and lactation (63-70 days of treatment) Exposure dose 0, 125, 250, 500 or 1,000 ppm (mg/L) Species rats
Method
Results Slight reduction in mating performance (1,000 mg/L group).
NOAEL 66 (male), 60 (female),
NOEL
Reference/Comments Christian et al. (2001)

3.6 Carcinogenicity

Species Method Details Results Reference/Comments/

Rats 0, 50, 500 or 1,000 mg/L. 2 years. Malignant mesothelioma and mononuclear cell leukemia. Some evidence of carcinogenic activity. NTP (2007)

Mice 0, 50, 500 or 1,000 mg/L. 2 years. Hepatocellular adenoma or carcinoma, hepatocellular carcinoma and heptoblastoma in Liver. Alveolar/bronchiolar adenoma or carcinoma in Lung. Clear evidence of carcinogenic activity. NTP (2007)

3.7 Mutagenicity/Genotoxicity

Species Method Details Results (with/without

activation) Reference/Comments

In Vitro Studies Salmonella typhimurium Gene mutation + NTP (2000c) S. typhimurium

TA100 Gene mutation +/+ Giller et al. (1997)

S. typhimurium

TA98, TA100 Gene mutation +/+ Saito et al. (1995)

Micronuclei in Pleurodeles

waltl larvae (newt) erythrocytes Clastogenicity nt/- Giller et al. (1997)

Escherichia coli strain PQ37 SOS chromotest DNA damage +/+ Giller et al. (1997)

In Vivo Studies Mouse liver cell DNA damage + Austin et al. (1996) Mouse liver cell DNA damage + Parrish et al. (1996)
nt: not tested.GESAMP-BWWG 8/6
ANNEX 6 Page 67

I:\MEPC\59\2-16.DOC 4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Seawater
or Fresh

water Test Duration Results Breakdown products Reference/ Comments

Hydrolysis (pH 5) n/a Hydrolysis (pH 7) n/a Hydrolysis (pH 9) n/a Biodegradation n/a
1/2 - Life Water Soil Sediment Air estimated 15 days 30 days 140 days
16.869 days PBT Profiler

EPI Suite v.3.20, AOPWIN TM

v.1.92
n/a: not available

4.2 Partition Coefficients

Method Results Reference/Comments
Log P OW 1.220 WHO (2004)

K OC Estimated 1.895 US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference/Comments

Persistence Estimated No PBT Profiler

The PBT Profiler uses three environmental co mpartments (water, soil, and sediment) to determine the persistence of a chemical in the environment. If released to the environment, dibromoacetic acid is expected to be found predominantly in soil. It is also expected to be found in water, but not in sediment.

The PBT Profiler has estimated that dibromoacetic acid is expected to be found predominantly in soil and its persistence estimate is based on its tr ansformation in this medium. Its half-life in soil, 30 days, does not exceed the EPA criteria. Ther efore, dibromoacetic acid is estimated not to be persistent in the environment.

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 68

I:\MEPC\59\2-16.DOC 4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

No potential residues indicated in the literature.

4.7 Any known interactive effects

No potential effects indicat ed in the literature.

5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property(with units and reference) Value Reference/Comments

Melting point (°C) 49
54 Health Canada.(2006) PBT Profiler Boiling point (°C) 195
233 Health Canada (2006) SRC PhysProp Database Flammability (flash point for liquids; °C) Not available

Density (20°C; kg/m 3 ) Not available Vapour pressure (20°C; Pa ) 3 (25°C) PBT Profiler Vapour density (air = 1) Not available Water solubility (temp; effect of pH; mg/L) 2.11x10 6 (25°C)
2.20x10 4 (25°C) Health Canada (2006) PBT Profiler pH in solution Not available Dissociation constant (pKa) 1.48 (25°C) NTP:ChemIDplus/HSDB Oxidation- reduction potential Not available Corrosivity to material or equipment Not available

Reactivity to container material Not available Auto-ignition Temperature (°C) Not available Explosive properties Not available Oxidizing properties Not available
Surface tension Not available Viscosity Not available Thermal stability and identity of breakdown products Not available

Other physical or chemical properties Hygroscopic crystal WHO(2004)GESAMP-BWWG 8/6
ANNEX 6 Page 69

I:\MEPC\59\2-16.DOC 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method Gas Chromatographic Method Applicability Water Sensitivity 0.02 μ g/L
Reference/Comments/Justification for missing data EPA Method 552.2

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data
No No No PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 70

I:\MEPC\59\2-16.DOC Appendix 7

Data on Monochloroacetic acid

1 CHEMICAL NAME: Monochloroacetic acid

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 (mg/L) Reference/Comments

Brachydanio rerio Zebra fish 370 / 96h / Mortality Static / Fresh water CIT (1998)

Poecilia reticulata Guppy 369 / 96h / Mortality Static / Fresh water Akzo Nobel (1985)

Leuciscus idus melanotus, Golden orfe 100 / 96h / Mortality (LC 0 ) Static / Fresh water Hoechst (1979) Fish

L. idus melanotus, Golden orfe 500 / 96h / Mortality (LC 100 ) Static / Fresh water Hoechst (1979)

Crustacea Daphnia magna Water flea 77 / 48h / Immobile, Intoxication EC 50 / Static / Fresh water K ϋ hn et al. (1989)

Scenedesmussubspicatus, Green algae 0.033 / 72h / Population changes, general (EC 50 ) Static / Fresh water Hoechst (1992) Algae

S. subspicatus Green algae 0.0058 / 72h / Biomass (NOEC) Static / Fresh water Hoechst (1992)

Brachionus calyciflorus Rotifer 68.9 (12 - 94) / 48h / Progeny counts/numbers, Reproduction (EC 50 ) Static / Fresh water Radix (1998) Inverteb-
rates

B. calyciflorus Rotifer 40 / 48h / Progeny counts/numbers, Reproduction (NOEC) Static / Fresh water Radix (1998)GESAMP-BWWG 8/6
ANNEX 6 Page 71

I:\MEPC\59\2-16.DOC 2.2 Chronic Aquatic Toxicity Data

Species NOEC (mg/L) Reference/Comments/

Brachydanio rerio Zebra fish 320 / 12d / NOEC (embryo/larval) Fresh water Akzo Nobel (1985)

B. rerio Zebra fish 560 / 12d / LOEC (embryo/larval) Fresh water Akzo Nobel (1985) Fish

B. rerio Zebra fish 25 / 28d / LOEC (early life stage) Fresh water CIT (1998)

Crustacea Daphnia magna Water flea 32 / 21d / Reproduction, general NOEC / Renewal / Fresh water K ϋ hn et al. (1989)

2.3 Information on Endocrine Disruption

No information on the endocrine disruption poten tial of monochloroacetic acid was found in the literature.

2.4 Sediment Toxicity

No information on the chronic sediment toxici ty of monochloroacetic acid was found in the literature.

2.5 Bioavailability/Biomagnification/Bioconcentration

Results Cause for

concern (yes/no) Reference/Comments/Justification for missing data

Log Pow 0.22 no EU Risk Assessment Report (2005) BCF 3.162 no US EPA Estimation Program Interface (EPI) Suite v.3.20, BCFWIN TM v.2.17

The octanol/water partition coe fficient log value of monochlo roacetic acid is 0.22 and is therefore considered not to pose a ri sk of concentration in organisms.

2.6 Food Web/Population Effects

The PBT Profiler estimates that monochloroacetic acid is not expe cted to bioaccumulate in the food chain because it does not exceed the BCF criteria.GESAMP-BWWG 8/6
ANNEX 6 Page 72

I:\MEPC\59\2-16.DOC 3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Value Species Reference/Comments
Oral LD 50 (mg/kg) 55 (40.4-74.8)
76.2 a (70.7-82.2) 260 (214-316)
165 a
79.8 a (71.8-88.6)
90 a rats

mice

guinea pigs rabbits Maksimov and Dubinina (1974) Woodard et al. (1941) Berardi (1986) Morrison (1946) Woodard et al. (1941) Woodard et al. (1941)
Dermal LD 50 (mg/kg) 305 (242-384)
250 a
178 b 490 (428-562) rats rabbits

mice Hoechst (1979) Hoechst (1979) Hercules (1969) Berardi (1986)
Inhalation LC 50 (mg/L/4h) 180 c (146-221) mg/m 3 rats Maksimov and Dubinina (1974)

a: based on SMCA b: solid MCAA under occlusive patch c: MCAA aerosol

3.2 Corrosion/Irritation

Species Method Results Reference/Comments
Skin rabbits FDA similar to FDA

OECD 404 Induced corrosion and mortality Severe erythema and oedema

No sings of irritation a Hoechst (1979g) Pasquet and Mazuret

(1975) Hoechst (1988b) Eyes rabbits FDA

similar to FDA

OECD 404 Eyelids and mucous membranes discoloured and corroded. Extremely irritant

Moderately irritant a Hoechst (1979g)

Pasquet and Mazuret

(1975) Hoechst (1988b)
a: based on SMCA

3.3 Sensitization

An open epicutaneous test in rabbits did not indicate any skin sensi tizing effects of MCAA (induction: 10 drops of 5% MCAA soln/d to 6 cm 2 skin, challenge: 1 drop of 0.1-50% soln on day 30) (Maksimov and Dubinina, 1974).

None of the Dunkin-Hartley guinea pigs sensitized to ethyl monochloroacetate in a maximization assay, cross-reacted with MCAA in a subsequent challenge (Braun and van der Walle, 1987).GESAMP-BWWG 8/6
ANNEX 6 Page 73

I:\MEPC\59\2-16.DOC 3.4 Repeated-dose Toxicity

Exposure Route oral Exposure Duration 13 weeks (5 days per week) Exposure Dose 0, 25, 50, 100, 150 or 200 mg/kg/d Species mice
Method
Results Increased mortality (at the highest group, mostly in male). Increased absolute and relative liver weights (at the highest group, female) Decreased mean body weight gain (at the highest group, female). Decreased cholinesterase levels (at the two highest group, female).
NOAEL 100
NOEL
Reference/Comments/ Justification for

missing data NTP (1992) Bryant et al. (1992)

Exposure Route oral Exposure Duration 0, 30, 60, 90, 120 or 150 mg/kg/d Exposure Dose 13 weeks (5 days per week) Species rats
Method
Results Almost all animals died ( ≥ 90 mg/kg/d). Decreased relative heart weights (60 mg/kg/d). No microscopic evidence of kidney or liver damage.
NOAEL 30
Reference/Comments NTP (1992) Bryant et al. (1992)

Exposure Route inhalation Exposure Duration exact duration not clearly stated, but probably 4 months Exposure Dose 5.8 and 20.8 mg/m 3 Species rats and guinea pigs
Method
Results Produced only some early functional changes (5.8 mg/m 3 ). Initial body-weight loss in both species. (20.8 mg/m 3 )
NOAEL
NOEL
Reference/Comments/ Justification for

missing data Maksimov and Dubinina (1974)

3.5 Development and Reproductive Toxicity

Exposure Route oral Exposure Duration gestation days 1 to 22 Exposure dose 0 or 1.57 g/L (0 or 193 mg/kg/d) Species rats
MethodGESAMP-BWWG 8/6
ANNEX 6 Page 74

I:\MEPC\59\2-16.DOC Results A significant decrease in body weight gain was observed in exposed dams relative to controls. No adverse reproductive, developmen tal or teratogenic effects were reported
NOAEL 193 (developmental)
LOAEL 193 (maternal)
Reference/Comments/ Justification for

missing data Johnson et al. (1998)

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

Species Method Details Results Reference/Comments Rats 0, 15 or 30 mg/kg/d 2 years No evidence NTP (1992)

Rats 0, 3.5, 26.1 or 59.9 mg/kg/d 2 years No evidence DeAngelo et al. (1997) Carcinogenicity

Mice 0, 50 or 100 mg/kg/d 2 years No evidence NTP (1992)

3.7 Mutagenicity/Reprotoxicity

Species Method Details Results Reference/Comments
In Vitro Assays bacterial gene mutation assays Salmonella typhimurium

strain TA98, TA100, TA1535, TA1537 Histidine reversion no mutagenic activity Mortelmans et al. (1986) NTP (1992) JETOC (1996)
Escherichia coli WP2

uvr A Tryptophan reversion no mutagenic activity JETOC (1996)

mammalian gene mutation assays
Mouse L5178Y/TK +/-

lymphoma cells Trifluorothymidineresistant mutation positive McGregor et al. (1987) NTP (1992) Amacher and Turner (1982) chromosomal aberration assays Chinese hamster ovary (CHO) cells Cytogenetic analysis no clastogenic activity Galloway et al. (1987) NTP (1992) Chinese hamster lung

fibroblast (CHL) cells Cytogenetic analysis no clastogenic activity Sawada et al. (1987)

bacterial primary DNA damage assays
Bacillus subtilis strains 168M, Hcr-9, FB-13 and MC-1 DNA repair no genotoxic activity Elmore et al. (1976)

Escherichia coli strains WP2 and WP100 uvr A -

rec A DNA repair no genotoxic activity Mamber et al. (1983, 1984)

Salmonella typhimurium

strain TA1535/pSK1002 umu test no genotoxic activity Nakamura et al. (1987) Ono et al. (1991)
Escherichia coli strains PQ37 SOS chromotest no genotoxic activity Giller et al. (1997)GESAMP-BWWG 8/6
ANNEX 6 Page 75

I:\MEPC\59\2-16.DOC Species Method Details Results Reference/Comments
Escherichia coli strains
K12 λ lysogen (GY5027) uvr B env A Prophage-induction test (inductest) no genotoxic activity Mamber et al. (1984)

mammalian cell primary DNA damage assays Chinese hamster ovary (CHO) cells Sister chromatid exchange - / + (with/without) Galloway et al. (1987) NTP (1992) Chinese hamster lung fibroblast (CHL) cells Sister chromatid exchange no genotoxic activity Sawada et al. (1987)

F344 rat hepatocytes DNA strand breaks genotoxic activity Chang et al. (1992)

B6C3F1 mouse hepatocytes DNA strand breaks genotoxic activity Chang et al. (1992)

human lymphoblastic CCRF-CEM cells DNA strand breaks no genotoxic activity Chang et al. (1992)

In Vivo Assays
Pleurodeles waltl larvae chromosomal aberration in blood

(micronucleus assay) no clastogenic activity Giller et al. (1997)

male B6C3F1 mice Primary DNA damage (DNA strand breaks) no genotoxic activity Chang et al. (1992)

male B6C3F1 mice Primary DNA damage (DNA strand breaks) no genotoxic activity Chang et al. (1992)

male F344 rat Primary DNA damage (DNA strand breaks) no genotoxic activity Chang et al. (1992)

Drosophila melanogaster

canton-S wild-type male Sex-linked recessive lethal mutation no mutagenic activity / slight and equivocal increase Foureman et al. (1994)

NTP (1992)GESAMP-BWWG 8/6
ANNEX 6 Page 76

I:\MEPC\59\2-16.DOC 4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Sea
water or

Fresh
water Test Duration Results Break-down products Reference/ Comments

Hydrolysis at pH
5 n/a

Hydrolysis at pH
7 n/a

Hydrolysis at pH 9 n/a

Water 2 days 20% SRC Water 8 days 73.5% SRC Water 10 days 72.6% SRC Water 5.5 days 90% SRC Water 5 days 80% SRC Water 6 days 90% SRC Biodegradation

Water 5 days 80% SRC
1/2 - Life Water Soil Sediment Air Neutral soil Acid soil estimated

experimenta l 15 days 30 days 140 days 20 days 66 hour (15°C) 33 days (7°C) PBT-Profiler

ECB, EU Risk
Assessment Report (2005)
n/a: not available.

4.2 Partition Coefficients

Method Results Reference /Comments/Justification for missing data Log P OW 0.22 EU Risk Assessment Report (2005)
K OC Calculated using the QSAR Estimated 4.0

1.201 EU Risk Assessment Report (2005)

US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference /Comments/Justification for missing data
Persistence Estimated No PBT ProfilerGESAMP-BWWG 8/6
ANNEX 6 Page 77

I:\MEPC\59\2-16.DOC The PBT Profiler uses three environmental co mpartments (water, soil, and sediment) to determine the persistence of a chemical in the environment. If released to the environment, monochloroacetic acid is expected to be found pre dominantly in soil. It is also expected to be found in water, but not in sediment.

The PBT Profiler has estimated that monochloroacetic acid is expected to be found predominantly in soil and its persistence estimate is based on its transformation in this medium. Its half-life in soil, 30 days, does not exceed the EPA criteria. Therefore, monochloroacetic acid is estimated not to be persistent in the environment.

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.

4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

The PBT Profiler estimates that monochloroacetic acid is not expe cted to bioaccumulate in the food chain because it does not exceed the BCF criteria.

4.7 Any known interactive effects – No known effects indicated in the literature.

5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property(with units and reference) Value Reference/Comments

Melting point (°C) Commercial form: 61-65

α -form: 62-63 β -form: 55-56

γ -form: 50-51 δ -form: 43.8 ECB IUCLID (2000)

Boiling point (°C) 189 EU Risk Assessment Report (2005) Flammability(flash point for liquids; °C) 126°C (melt) EU Risk Assessment Report (2005) Density (20°C; kg/m 3 ) 1.58x10 3 EU Risk Assessment Report (2005) Vapour pressure (20°C; Pa) < 100 (20°C) 8.7 (25°C) 1,100 (80°C) EU Risk Assessment Report(2005)

Vapour density (air = 1) 3.26 NIOSH-ICSC Water solubility (temp; effect of pH; mg/L) 4.21x10 6 (20°C) EU Risk Assessment Report (2005)

pH in solution 3.2 (100ml/L) EU Risk Assessment Report (2005)GESAMP-BWWG 8/6
ANNEX 6 Page 78

I:\MEPC\59\2-16.DOC Dissociation constant (pKa) 2.85 ( 25°C) EU Risk Assessment Report (2005) Oxidation- reduction potential Corrosivity to material or equipment Non-corrosive in presence of glass. Corrosive to metal MDSD-ScienceLab

Reactivity to container material Auto-ignition Temperature (°C) 470 NIOSH-ICSC

Explosive properties Not explosive EU Risk Assessment Report (2005) Oxidizing properties Not oxidizing EU Risk Assessment Report (2005) Surface tension 35.2mN/m (100°C) EU Risk Assessment Report (2005) Viscosity 2.16 mPa·s, dynamic (70°C) Ullmann (1986) Thermal stability and identity of breakdown products Stable under ordinary conditions of use and storage MSDS-J.T.Baker

Other physical or chemical properties Colorless crystals, Pungent MSDS-ScienceLab

6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method Gas Chromatographic Method Applicability Water Sensitivity 0.14 μ g/L
Reference/Comments/Justification for missing data EPA Method 552.2

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data
no no no PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 79

I:\MEPC\59\2-16.DOC Appendix 8

Data on Dichloroacetic acid

1 CHEMICAL NAME: Dichloroacetic acid

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species L(E)C 50 (mg/L) Reference/Comments/

Fish Cyprinus carpio Common carp 82 - 123 / 96h / Mo rtality (N/R) Gavage / Fresh water Loeb et al. (1963)

Daphnia magna Water flea 106 / 24h / Equilibrium, Behavior (EC 50 ) / Static / Fresh water Trenel et al. (1982) Crustacea

Nitocra spinipes Harpacticoid copepod 23 ( 21 - 25) / 96h / Mortality Static / Salt water Linden et al. (1979)

Algae Scenedesmus subspicatus Green algae 1,485 / 7d / Proliferation (EC 03 ) Static / Fresh water Trenel et al. (1982)

Xenopus laevis African clawed frog 4,060 (3,900 - 5,600) / 96h Mortality / Renewal / Fresh

water Fort et al. (1993)

X. laevis African clawed frog 3,560 (2,400 - 4,680) / 96h Teratogenic measurements (EC 50 ) Renewal / Fresh water Fort et al. (1993)Amphibians

X. laevis African clawed frog 4,680 / 96h / Growth, general (LOEC) / Renewal / Fresh water Fort et al. (1993)

Insects Aeschna umbrosa Dragonfly 0.013 / 8h / Oxygen consumption (N/R) / Flow through / Fresh

water Dominguez et al. (1988)

N/R: Endpoint was not reported.

2.2 Chronic Aquatic Toxicity Data

No information on the chronic aquatic toxicity of dichloroacetic acid wa s found in the literature.

2.3 Information on Endocrine Disruption

No information on the endocrine disruption pote ntial of dichloroacetic acid was found in the literature.

2.4 Sediment Toxicity

No information on the chronic sediment toxic ity of dichloroacetic acid was found in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 80

I:\MEPC\59\2-16.DOC 2.5 Bioavailability/Biomagnification/Bioconcentration

Results Cause for

concern (yes/no) Reference/Comments/

Log Pow 0.92 no WHO (2005)
BCF 3.162 no PBT Profiler US EPA Estimation Program Interface (EPI) Suite v.3.20, BCFWIN TM v.2.17

The octanol/water partition coeffici ent log value of dichloroacetic acid is 0.92 and is therefore considered not to pose a risk of concentration in organisms.

2.6 Food Web/Population Effects

The PBT Profiler estimates that dichloroacetic acid is not expected to bioaccumulate in the food chain because it does not exceed the BCF criteria.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Value Species Reference/Comments
Oral LD 50 (mg/kg) 2,820 4,480 5,520 rats (male)

rats mice Smyth et al. (1951) Woodard et al. (1941) Woodard et al. (1941)
Dermal LD 50 (mg/kg) 795 510 rats (male) Rabbits Smyth et al. (1951) MSDS (Science Lab)
Inhalation LC 50 (mg/L/4h) n/a

n/a: not available.

3.2 Corrosion/Irritation

Species Method Results Reference/Comments/
Skin human Extremely hazardous in case of skin contact (corrosive, irritant) Very hazardous in case of skin contact (permeator) MSDS-ScienceLab

Eyes human Extremely hazardous in case of eye contact (irritant) MSDS-ScienceLab

3.3 Sensitization

EEC Classification for dichloroacetic acid does not include R43 (May cause sensitization by skin contact).GESAMP-BWWG 8/6
ANNEX 6 Page 81

I:\MEPC\59\2-16.DOC 3.4 Repeated-dose Toxicity

Exposure Route oral Exposure Duration 3 months Exposure dose 0, 125, 500 or 2,000 mg/ kg/d (sodium dichloroacetate) Species rats
Method
Results Decreased body weight. Increased liver, kidney and adrenals weight. Brain lesions.
NOAEL
LOAEL 125
NOEL
Reference/Comments Katz et al. (1978; 1981)

Exposure Route oral (by capsule) Exposure Duration 13 weeks Exposure dose 0, 50, 75 or 100 mg/kg/d Species beagle dogs
Method
Results Decreased body weight, mean blood gluc ose, lactate and pyruvate levels. Brain lesions.
NOAEL
LOAEL 50
NOEL
Reference/Comments Katz et al. (1978; 1981)

Exposure Route oral (by capsule) Exposure Duration 90 days Exposure dose 0, 12.5, 39.5 or 72 mg/kg/d Species beagle dogs
Method
Results Dyspnoea, partial paralysis of the hind limbs, and decreased erythrocyte count and haemoglobin levels. Decreased body weight gain. Organ lesions.
NOAEL
LOAEL 12.5
NOEL
Reference/Comments Cicmanec et al. (1991)

3.5 Development and Reproductive Toxicity

Exposure Route oral Exposure Duration gestation days 6 to 15. Exposure dose 0, 14, 140 or 400 mg/kg/d (first study) 0, 900, 1400, 1900 or 2400 mg/kg/d (second study) Species rats
Method Results First study Reduced maternal body weight gain ( ≥ 140 mg/kg/d). Increased dose-related liver weights of dams (at all dose levels). Decreased dose-related fetal growth and increased the total soft tissue malformations ( ≥ 140 mg/kg/d).GESAMP-BWWG 8/6
ANNEX 6 Page 82

I:\MEPC\59\2-16.DOC Second study Occurred dose-related mortality in treated dams ( ≥ 1,400 mg/kg/d). Increased post-implantation losses and reduced the number of live fetuses per litter ( ≥ 900 mg/kg/d).
NOAEL 14 (maternal and developmental)
NOEL
Reference/Comments Smith et al. (1992)

Exposure Route oral Exposure Duration gestation days 6 to 15. Exposure dose from 1,900 to 3,500 mg/kg/d Species rats
Method
Results Reduced fetal body weight in the offspring of dams. (1,900 mg/kg; gestation days 6-8) Fetal cardiac malformations in th e offspring of pregnant dams. (1,900 mg/kg; gestation days 9-11 and 12-15) (2,400 mg/kg; gestation days 10 or 12) (3,500 mg/kg; gestation day 12)
NOAEL
NOEL
Reference/Comments Epstein et al. (1992)

Exposure Route oral Exposure Duration 14 days Exposure dose 0, 18, 54, 160, 480 or 1,440 mg/kg/d Species rats (male)
Results Decreased epididymis weights ( ≥ 480 mg/kg/d). Increased the percentage of abnor mal cauda sperm and decreased the

percentage of motile sperm ( ≥ 160 mg/kg/d). Increased spermatotoxicity ( ≥ 54 mg/kg/d).
NOAEL 18
NOEL
Reference/Comments Linder et al. (1997)

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

Exposure Route oral Exposure Duration 60 and 75 weeks Exposure dose 0, 0.05, 0.5, 3.5 or 5.0 g/L (0, 7.6, 77, 410 or 486 mg/kg/d for 60 weeks) (0, 7.6 or 77 mg/kg/d for 75 weeks) Species mice (male)
Method
Results Decreased body weight. Increased relative liver weight. Significant positive dose-related tre nd in age-adjusted prevalence of liver tumours. Exhibited threshold of at least 500 mg/L (77 mg/kg/d) for tumour response in mice.
NOAEL 7.6GESAMP-BWWG 8/6
ANNEX 6 Page 83

I:\MEPC\59\2-16.DOC NOEL
Reference/Comments DeAngelo et al. (1991)

Exposure Route oral Exposure Duration 104 weeks Exposure dose 500 mg/L (410 mg/kg/d) Species mice (male)
Method
Results No significant treatment-related effects on drinking water consumption, relative body weight gain or relative absolute spleen, kidney or testes weight. Significant increase in the incidence of hepatocellular carcinomas and hepatocellular adenomas (and/or combined).
NOAEL
NOEL
Reference/Comments Daniel et al. (1992)

Exposure Route oral Exposure Duration 90 - 100 weeks Exposure dose 0, 0.05, 0.5, 1, 2 or 3.5 g/L (0, 8, 84, 168, 315 or 429 mg/kg/d) Species mice (male)
Method
Results Significantly decreased mean body weights ( ≥ 315 mg/kg/d). Increased dose-dependent liver weight ( ≥ 84 mg/kg/d). Produced a dose-related increase in the incidence of hepatocellular

carcinoma (not associated with either liver peroxisome or hepatocyte proliferation).
NOAEL
NOEL
Reference/Comments/ DeAngelo et al. (1999)

Exposure Route oral Exposure Duration 100 weeks Exposure dose 0, 0.05, 0.5 or 1.6 g/L (0, 3.6, 40.2 or 139.1 mg/kg/d) Species rats (male)
Method
Results No significant differences in water consumption or survival. Reduced body weights and relative liver and kidney weights (at the highest group). Increased prevalences of hepatoce llular adenoma and hepatocellular carcinoma (and/or combined). Induced hepatocyte peroxisome proliferation.
NOAEL
NOEL 3.6
Reference/Comments DeAngelo et al. (1996)

IARC and IRIS classified it in Group 2B (possibly carcinogenic to humans).

ACGIH classified it as confirmed animal carcinogen with unknown relevance to humans.GESAMP-BWWG 8/6
ANNEX 6 Page 84

I:\MEPC\59\2-16.DOC 3.7 Mutagenicity/Reprotoxicity

Species Method Details Results Reference/Comments
In Vitro Assays bacterial gene mutation assays Salmonella typhimurium

strain TS 24, TA98, TA100, TA1535, TA1537, TA1538 TA1950, TA2322 Histidine reversion negative Waskell L. (1978)
Fox et al. 1996) Herbert et al. (1980)

S. typhimurium strain
TA98 Histidine reversion positive (equivocal) Herbert et al. (1980)

S. typhimurium strain
TA100 Histidine reversion positive DeMarini et al. (1994) Giller et al. (1997) S. typhimurium strain
TA1538 Histidine reversion positive a (equivocal) Herbert et al. (1980)

Escherichia coli WP2 uvr A Tryptophan reversion negative Fox et al. (1996)

mammalian gene mutatin assays
Mouse L5178Y/TK +/- lymphoma cells Thymidine-resistant mutation negative positive b negative c Fox et al. (1996) Harrington-Brock et al. (1998) bacterial primary DNA damage assays
Escherichia coli WP2 Prophage-induction test (inductest) positive DeMarini et al. (1994)

Salmonella typhimurium strain TA1535 umu test negative / positive Ono et al. (1991)

Escherichia coli PQ37 SOS chromotest positive / negative Giller et al. (1997)

mammalian cell primary DNA damage assays
B6C3F1 mouse hepatocytes DNA strand breaks positive d Chang et al. (1992)

F344 rat hepatocytes DNA strand breaks negative Chang et al. (1992) human lymphoblastic CCRF-CEM cells DNA strand breaks negative Chang et al. (1992)

Chinese hamster ovary cells Chromosome aberration negative Fox et al. (1996)

In Vivo Assays mice Micronuclei assay positive negative negative Fuscoe et al. (1996)

Fox et al. (1996) Mouse leukocytes DNA strand breaks negative Fuscoe et al. (1996) Mouse hepatocytes DNA strand breaks positive positive negative Nelson and Bull. (1988) Nelson et al. (1989) Chang et al. (1992) Mouse splenocytes DNA strand breaks negative Chang et al. (1992) Mouse epithelial cells DNA strand breaks negative Chang et al. (1992) Fischer rat hepatocytes DNA strand breaks negative Chang et al. (1992) Sprague-Dawley rat hepatocytes DNA strand breaks positive Nelson and Bull. (1988)GESAMP-BWWG 8/6
ANNEX 6 Page 85

I:\MEPC\59\2-16.DOC (a) The results in TA1538 were positive but did not “exhibit an unequivocal dose-response relationship” (Herbert et al. , 1980). (b) Mutations/chromosome aberrations. (c) Micronuclei induction. (d) Small increase in strand break age (7%) seen after 4-hour exposure, but not at 1 hour; response deemed negligible.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Seawater
or Fresh

water Test Duration Results Breakdown products Reference/Comments

Hydrolysis (pH 5) n/a

Hydrolysis (pH 7) n/a

Hydrolysis (pH 9) n/a

Sea water 3 days 8% HSDB (2005) Fresh water 3 days 14% HSDB (2005) Biodegradation

Activated sludge 14 days 97% HSDB (2005)

1/2 - Life Water Soil Sediment Air estimated

experimental 15 days 30 days 140 days 22 days 22 days PBT-Profiler

HSDB (2005)
n/a: not available.GESAMP-BWWG 8/6
ANNEX 6 Page 86

I:\MEPC\59\2-16.DOC 4.2 Partition Coefficients

Method Results Reference/Comments Log P OW 0.92 WHO (2005)
K OC Estimated Estimated 75 1.895 Science Research Council (SRC) US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference/Comments
Persistence Estimated No PBT Profiler

The PBT Profiler uses three environmental co mpartments (water, soil, and sediment) to determine the persistence of a chemical in the environment. If released to the environment, dichloroacetic acid is expected to be found pred ominantly in soil. It is also expected to be found in water, but not in sediment.

The PBT Profiler has estimated that dichloroacetic acid is expected to be found predominantly in soil and its persistence estimate is based on its tr ansformation in this medium. Its half-life in soil, 30 days, does not exceed the EPA criteria. Ther efore, dichloroacetic acid is estimated not to be persistent in the environment.

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.

4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

The PBT Profiler estimates that dichloroacetic acid is not expected to bioaccumulate in the food chain because it does not exceed the BCF criteria.

4.7 Any known interactive effects

No known effects indicated in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 87

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPERTI ES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property(with units and reference) Value Reference/Comments

Melting point (°C) 10
13.5 MSDS-ScienceLab Lide DR. (1995-1996) Boiling point (°C) 193-194 Budavari et al. (1989) Flammability(flash point for liquids; °C) May be combustible at high temperature. Flash point: 110°C MSDS-ScienceLab

Density (20°C; kg/m 3 ) 1.563x10 3 Budavari et al. (1989) Vapour pressure (20°C; Pa) 19 NIOSH-ICSC Vapour density (air = 1) 4.4 NIOSH-ICSC Water solubility (temp; effect of pH; mg/L) 8.63x10 4

Miscible WHO (2005) Nikolaou et al. (1999)

pH in solution Not available MSDS-ScienceLab Dissociation constant (pKa) 1.26 Maruthamuthu and Huie (1995) Oxidation- reduction potential Not available Corrosivity to material or equipment Highly corrosive liquid that gives off acidic vapors. Gerhartz W. (1985)

Reactivity to container material Auto-ignition Temperature (°C) Not available MSDS-ScienceLab

Explosive properties Not available MSDS-ScienceLab Oxidizing properties Not available
Surface tension Not available Viscosity Not available Thermal stability and identity of breakdown products Not available

Other physical or chemical properties Colorless to slightly yellow liquid with a pungent odor Ashford RD. (1994) Budavari S. (1989)GESAMP-BWWG 8/6
ANNEX 6 Page 88

I:\MEPC\59\2-16.DOC 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method Gas Chromatographic Method Applicability Water Sensitivity 0.14 μ g/L
Reference/Comments/Justification for missing data EPA Method 552.2

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data
no no no PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 89

I:\MEPC\59\2-16.DOC Appendix 9

Data on Trichloroacetic acid

1 CHEMICAL NAME: Trichloroacetic acid

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 /EC 50 (mg/L) Reference/Comments/

Cyprinus carpio Common carp 88 - 336 / 66h / Mortality Gavage / Fresh water Loeb and Kelly (1963)

Leuciscus idus melanotus, Carp 10,000 / 48h / Mortality Fresh water Juhnke et al. (1978)

Pimephales promelas Fathead minnow 2,000 / 96h / Mortality Static / Fresh water Dennis et al. (1979)

Poecilia reticulata Guppy 9,160 / 48h / Mortality Jirasek et al. (1980)

Salmonidae Trout family 1,050 / 96h / Mortality Fresh water Knapek et al. (1974)

Tinca tinca Tench 3,420 / 96h / Mortality Fresh water Knapek et al. (1974) Fish

Ictalurus punctatus a
Channel catfish 2,000 / 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h / Mortality Static / Fresh water Clemens and Sneed (1959)

Daphnia magna Water flea 137 / 1h / Enzyme activity (EC 50 ) Static / Fresh water Janssen et al. (1993)

D. magna Water flea 164 / 24h / Immobile, Intoxication (EC 50 ) / Static / Fresh water Janssen et al. (1993)

D. magna Water flea 146 / 48h / Immobile, Intoxication (EC 50 ) / Static / Fresh water Janssen et al. (1993)

Nitocra spinipes Harpacticoid copepod 4,800 (4,400 - 5,200) / 96h Mortality / Static / Salt water Linden et al. (1979)

Streptocephalusproboscideus , Fairy shrimp 1.2 (1.0 - 1.3) / 24h / Mortality Static / Fresh water Centeno et al. (1993)

S. proboscideus Fairy shrimp 1.5 (1.3 - 1.6) / 24h / Mortality Static / Fresh water Centeno et al. (1993) Crustacea

Thamnocephalus platyurus , Fairy shrimp 16.9 / 24h / Mortality Static / Fresh water Centeno et al. (1995)

Algae a Chlorococcales Green algae order 1,000 / 24h / Assimilation efficiency (EC 10 ) / Static / Fresh water Krebs F. (1991)GESAMP-BWWG 8/6
ANNEX 6 Page 90

I:\MEPC\59\2-16.DOC Species LC 50 /EC 50 (mg/L) Reference/Comments/

Pseudokirchneriella subcapitata , Green algae 10 / 96h / Population growth rate (LOEC) / Static / Fresh water Garten C.T.Jr. (1990)

P. subcapitata Green algae 1 / 96h / Population growth rate (NOEC) / Static / Fresh water Garten C.T.Jr. (1990)

Chlorella pyrenoidosa Green algae 500 / 72h / Chlorophyll (NOEC) Static / Fresh water Huang and Gloyna (1968)

C. vulgaris Green algae 100 / 96h / Population growth

rate (NOEC) / Static / Fresh water Garten C.T.Jr. (1990)

Invertebrates Uronema parduczi Cilicate 435 / 20h / Population growth

rate (N/R) / Fresh water Bringmann and Kuhn (1980)

Xenopus laevis African clawed frog 4,430 (3,800 - 5,120) / 96h Mortality / Renewal / Fresh

water Fort et al. (1993)

X. laevis African clawed frog 1,740 (1,550 - 1,950) / 96h Teratogenic measurements (EC 50 ) Renewal / Fresh water Fort et al. (1993)Amphibians

X. laevis African clawed frog 5,000 / 96h / Growth, general (LOEC) / Renewal / Fresh water Fort et al. (1993)

Insects Aedes aegypti Yellow fever mosquito 5,500 / 96h / Mortality Fresh water Knapek and Lakota (1974)

a: Toxicity studies for trichloroacetic acid, sodium salt

. N/R: Endpoint not reported

2.2 Chronic Aquatic Toxicity Data

Species NOEC (mg/L) Reference/Comments
Fish a Cyprinus carpio Common carp 7 / 63d / Growth, general (N/R) Fresh water Schulz D. (1970a, b)

Anabaena variabilis Blue-green algae 8 / 14d / Population growth rate Static / Fresh water Bednarz T. (1981)

Chlorella pyrenoidosa Green algae 0.3 / 14d / Population growth

rate Static / Fresh water Bednarz T. (1981)

Chlorococcum sp. Green algae 1.2 / 14d / Population growth

rate Static / Fresh water Bednarz T. (1981)

Dictyosphaerium pulchellum , Green algae 7 / 14d / Population growth rate Static / Fresh water Bednarz T. (1981) Algae a

Scenedesmus acutus Green algae 8.8 / 14d / Population growth

rate Static / Fresh water Bednarz T. (1981)GESAMP-BWWG 8/6
ANNEX 6 Page 91

I:\MEPC\59\2-16.DOC Species NOEC (mg/L) Reference/Comments Spirulina platensis Blue-green algae 5 / 14d / Population growth rate Static / Fresh water Bednarz T. (1981)

Stichococcus sp. Green algae 100 / 14d / Popul ation growth

rate Static / Fresh water Bednarz T. (1981)

Aquatic plants Lemna perpusilla Duckweed 1,000 / 7d / Mortality (N/R) Fresh water Nishiuchi Y. (1974)

a: Toxicity studies for trichloroacetic acid, sodium salt

. N/R: Endpoint not reported.

2.3 Information on Endocrine Disruption

No information on the endocrine disruption potential of trichloroacetic acid wa s found in the literature.

2.4 Sediment Toxicity

No information on the chronic sediment toxicity of trichloroacetic acid wa s found in the literature.

2.5 Bioavailability/Biomagnification/Bioconcentration

Results Cause for

concern (yes/no) Reference/Comments

Log Pow 1.33 no WHO (2004)
BCF 0.4-1.0 and
<1.7 3.162 no Hansch et al. (1995), NITE; CHRIP (2007) US EPA Estimation Program Interface (EPI) Suite v.3.20, BCFWIN TM v.2.17

The octanol/water partition coefficient log value of trichloroacetic acid is 1.33 and is therefore considered not to pose a risk of concentration in organisms.

2.6 Food Web/Population Effects

The PBT Profiler estimates that trichloroacetic acid is not expected to bioaccumulate in the food chain because it does not exceed the BCF criteria.GESAMP-BWWG 8/6
ANNEX 6 Page 92

I:\MEPC\59\2-16.DOC 3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Value Species Reference/Comments
Oral LD 50 (mg/kg) 3,320 4,970 rats mice Woodard et al. (1941)

Dermal LD 50 (mg/kg) > 2,000 rats Tomlin (1994) Hoechst AG. (1974)
Inhalation LC 50 (mg/L/4h) n/a

n/a: not available.

3.2 Corrosion/Irritation

Species Method Results Reference/Comments/ Justification for

missing data
Skin human Very hazardous in case of skin contact (irritant). Hazardous in case of skin contact (corrosive). Slightly hazardous in case of skin contact (permeator). MSDS-ScienceLab

Eyes human Hazardous in case of eye contact (corrosive). MSDS-ScienceLab

3.3 Sensitization

Species Method Results Reference/Comments/ Justification for

missing data Guinea pigs Maximization test Not sensitizing ECB IUCLID (2000) mice Ear swelling test Not sensitizing ECB IUCLID (2000)

3.4 Repeated-dose Toxicity

Exposure Route oral Exposure Duration 0, 0.1, 0.5 or 2.0 g/L (0, 25, 125 or 500 mg/kg/d) Exposure dose 3 or 10 weeks Species mice (male)
Method
Results Increased liver weight (in the two highest dose groups).
NOAEL 25
NOEL
Reference/Comments Parrish et al. (1996)GESAMP-BWWG 8/6
ANNEX 6 Page 93

I:\MEPC\59\2-16.DOC Exposure Route oral Exposure Duration 90 days Exposure dose 0, 0.05, 0.5 or 5.0 g/L (0, 4.1, 36.5 or 355 mg/kg/d) Species rats (male)
Method
Results Decreased absolute spleen weight an d increased relative liver and kidney weights (at the two highest dose groups). Focal hepatocellular enlargement, in tracellular hepatic swelling, hepatic

glycogen accumulation and increased hepatiperoxisomal β -oxidation activity (at the highest dose group).
NOAEL 36.5
NOEL
Reference/Comments Mather et al. (1990)

Exposure Route oral Exposure Duration 10 weeks Exposure dose 0 or 0.025 g/L (0 or 3.8 mg/kg/d) Species rats
Method
Results Decreased body weight and kidney glutathione levels. Changed serum markers of lipid and carbohydrate metabolism. Mild liver and kidney histopathology.
NOAEL
LOAEL 3.8
NOEL
Reference/Comments Acharya et al. (1995; 1997)

3.5 Development and Reproductive Toxicity

Exposure Route oral Exposure Duration gestation days 6 to 15 Exposure dose 0, 330, 800, 1200 or 1800 mg/kg/d Species rats
Method
Results Decreased maternal body weight gain, increased maternal spleen and kidney weights and increased resorptions. Reduced fetal weight and length. Increased in the incidence of soft ti ssue malformations, primarily involving

the cardiocascular and renal systems. Skeletal malformations (orbit and hydronephrosis).
NOAEL
LOAEL 330 (maternal and developmental)
NOEL
Reference/Comments Smith et al. (1989)GESAMP-BWWG 8/6
ANNEX 6 Page 94

I:\MEPC\59\2-16.DOC Exposure Route oral Exposure Duration gestation days 1 to 22 Exposure dose 0 or 2.73 g/L (0 or 290 mg/kg/d) Species rats
Method
Results Decreased maternal body weight gain. Increased resorption and cardiac soft tissue malformations.
NOAEL
LOAEL 290 (maternal, reproductive and developmental)
NOEL
Reference/Comments Johnson et al. (1998)

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

Exposure Route oral Exposure Duration 104 weeks Exposure dose 0, 500 or 4500 mg/L (0, 71 or 583 mg/kg/d) Species mice (female)
Method
Results Significantly increased in the incide nce of combined liver tumour (adenomas + carcinomas) in the high-dose group.
NOAEL
LOAEL 71
NOEL
Reference/Comments US EPA (1991)

Exposure Route oral Exposure Duration 2 years Exposure dose 0, 50, 500 or 5000 mg/L (0, 3.6, 32.5 or 364 mg/kg/d) Species rats (male)
Method
Results Significantly decreased body weights and absolute liver weights (in the high-dose group). Increased serum levels of ALT and palmitoyl CoA activity (in the high-dose group).
NOAEL 32.5
NOEL
Reference/Comments DeAngelo and Daniel. (1992) DeAngelo et al. (1997)

IARC classified it in Group 3 (no cl assifiable as to carcinogenicity to humans), IRIS classified it in Group C (possibly carcinogenic to humans) a nd ACGIH classified it as confirmed animal carcinogen with unknown relevance to humans.GESAMP-BWWG 8/6
ANNEX 6 Page 95

I:\MEPC\59\2-16.DOC 3.7 Mutagenicity/Reprotoxicity

Species Method Details Results Reference/Comments/
In Vitro Studies Salmonella typhimurium

strain TA98, TA100, TA1535, TA1538 Histidine reversion negative Bignami et al. (1977)

Salmonella typhimurium

strain TA100 Histidine reversion negative Rapson et al. (1980)
Sato et al. (1985) DeMarini et al. (1994) Salmonella typhimurium

strain TA98, TA100 Histidine reversion negative Waskell (1978)

Mouse L5178Y/TK +/- lymphoma cells Thymidine-resistant mutation positive (weekly) Harrington-Brock. (1985)

Escherichia coli Prophage-induction test (inductest) negative DeMarini et al. (1994)

Salmonella typhimurium

strain TA1535 pSK1002 umu test positive Ono et al. (1991)

In Vivo Studies
Mouse bone marrow cells Chromosomal aberration positive Bhunya and Behera. (1987)

Swiss mice Micronucleus test pos itive Bhunya and Behera. (1987) Swiss mice Sperm head abnormality positive Bhunya and Behera. (1987)

male B6C3F1 mouse hepatocytes DNA strand breaks positive Nelson et al. (1989) Nelson and Bull. (1988) Sprague-Dawley rats hepatocytes DNA strand breaks positive Nelson et al. (1989) Nelson and Bull. (1988)

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Sea water
or Fresh

water Test Duration Results Breakdown products Reference/ Comments

Hydrolysis (pH 5) n/a Hydrolysis (pH 7) n/a Hydrolysis (pH 9) n/a Biodegradation Activated sludge 4 weeks 7 % NITE; CHRIP (2007)

1/2 - Life Water Soil

Sediment Air estimated estimated experimental estimated estimated experimental 38 days 75 days
119.6 days 340 days 31 days 31 days PBT-Profiler PBT-Profiler HSDB (2007) PBT-Profiler PBT-Profiler HSDB (2007)

n/a: not availableGESAMP-BWWG 8/6
ANNEX 6 Page 96

I:\MEPC\59\2-16.DOC 4.2 Partition Coefficients

Method Results Reference/Comments Log P OW 1.33 Hansch et al. (1995) US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67
K OC Estimated Estimated 130 2.738 Science Research Council (SRC) US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference/Comments
Persistence Estimated Yes PBT Profiler

The PBT Profiler uses three environmental co mpartments (water, soil, and sediment) to determine the persistence of a chemical in the environment. If released to the environment, trichloroacetic acid is expected to be found predom inantly in soil. It is also expected to be found in water, but not in sediment.

The PBT Profiler has estimated that trichloroacetic acid is expect ed to be found predominantly in soil and its persistence estimate is based on its tr ansformation in this medium. Its half-life in soil, 75 days, exceeds the EPA criteria of ≥ 2 months (and ≥ 6 months). Therefore, Acetic acid, trichloro- is estimated to be persistent in the environment.

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.

4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

The PBT Profiler estimates that trichloroacetic acid is not expected to bioaccumulate in the food chain because it does not exceed the BCF criteria.

4.7 Any known interactive effects

No known effects indicated in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 97

I:\MEPC\59\2-16.DOC 5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property(with units and reference) Value Reference/Comments

Melting point (°C) 57-58
57.5 56 Budavari et al. (1996) Lide DR. (2005-2006) OECD SIDS Boiling point (°C) 196-197
195.5 197 Budavari et al. (1996) Lide DR. (2005-2006) OECD SIDS Flammability(flash point for liquids; °C) Non flammable Flash point: not applicable MSDS-ScienceLab

Density (20°C; kg/m 3 ) 1.58x10 3 (20°C)
1.62x10 3 (25°C) ECB IUCLID (2000) Budavari et al. (1996) Vapour pressure (20°C; Pa) 8 (6.0x10 -2 mmHg at 25°C) 120 (1.2hPa at 50°C) Perry and Green (1984) ECB IUCLID (2000) Vapour density (air = 1) 5.6 NIOSH-ICSC Water solubility (temp; effect of pH; mg/L) 1.3x10 6 (20°C)
9.0x10 5 (pH <1, 20°C)
5.4x10 4 (25°C) ECB IUCLID (2000)

Yalkowsky et al. (2003) pH in solution 1.2 in 0.1M solution O’Nell MJ. (2001) Dissociation constant (pKa) 0.51

0.512-0.7 0.7 Serjeant and Dempsey (1979) WHO (2004) OECD SIDS Oxidation- reduction potential Not available OECD SIDS Corrosivity to material or equipment Corrosive to iron, zinc and aluminum. Worthing and Walker (1987) Reactivity to container material Not available

Auto-ignition Temperature (°C) Not applicable MSDS-ScienceLab

Explosive properties Not available ECB IUCLID (2000) Oxidizing properties Not available ECB IUCLID (2000) Surface tension 27.8 dynes/cm (80.2°C) ECB IUCLID (2000) Viscosity Not available Thermal stability and identity of breakdown products Not available

Other physical or chemical properties Colorless to white, crystalline solid. White deliquescent crystals. NIOSH-ICSC Morris and Bost. (2005)GESAMP-BWWG 8/6
ANNEX 6 Page 98

I:\MEPC\59\2-16.DOC 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Method Gas Chromatographic Method Applicability Water Sensitivity 0.04 μ g/L
Reference/Comments/Justification for missing data EPA Method 552.2

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments

Yes no no PBT Profiler See table 2, section 2.1.4 in annex 5

* * *GESAMP-BWWG 8/6
ANNEX 6 Page 99

I:\MEPC\59\2-16.DOC Appendix 10

Data on Sodium thiosulphate

1 CHEMICAL NAME: Sodium thiosulphate

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 (mg/L) Reference/Comments

Gambusia affinis Western mosquitofish 24,000 / 96h / Mortality Static / Fresh water Wallen et al. (1957) Fish

Pimephales promelas Fathead minnow 10,000 / > 96h / Mortality (LT 50 ) Static / Fresh water Terhaar et al. (1972)

Daphnia magna Water flea 805 / 4.2d / Mortality Static / Fresh water Dowden and Bennett (1965) Crustacea

D. magna Water flea 520 / 48h / Immobile, Intoxication (LETC) / Fresh water Anderson B.G (1946)

Ankistrodesmus falcatus , Green algae 64 / 1.2h / Photosynthesis (N/R) Static / Fresh water Wodzinski et al. (1978)

Chlamydomonas reinhardtii , Green algae 64 / 1.2h / Photosynthesis (N/R) Static / Fresh water Wodzinski et al. (1978)

Lyngbya sp. Blue-green algae 64 / 1.2h / Photosynthesis (N/R) Static / Fresh water Wodzinski et al. (1978) Algae

Spirulinalabyrinthiformis , Blue-green algae 22 / 1 - 1.5h / Photosynthesis (N/R) Static / Fresh water Castenholz R.W(1977)

Spirostomum ambiguum
Protozoa 1,710 / 24h / Mortality Static / Fresh water Nalecz-Jawecki and Sawicki (1998)Invertebrates

S. ambiguum
Protozoa 1,700 / 24h / Deformation (EC 50 ) Static / Fresh water Nalecz-Jawecki and Sawicki (1998)

N/R: Endpoint not reported. LETC: Lethal threshold concentration.

2.2 Chronic Aquatic Toxicity Data

No information on the chronic aquatic toxicity of sodium thiosulphate was found in the literature.

2.3 Information on Endocrine Disruption

No information on the endocrine disruption poten tial of sodium thiosulphate was found in the literature.GESAMP-BWWG 8/6
ANNEX 6 Page 100

I:\MEPC\59\2-16.DOC 2.4 Sediment Toxicity

No information on the chronic sediment toxic ity of sodium thiosulphate was found in the literature.

2.5 Bioavailability/Biomagnification/Bioconcentration

Results Cause for

concern (yes/no) Reference/Comments

Log Pow -4.53 no WHO (2004) BCF 3.162 no US EPA Estimation Program Interface (EPI) Suite v.3.20, BCFWIN TM v.2.17

The octanol/water partition coeffici ent log value of sodium thiosul phate is -4.53 a nd is therefore considered not to pose a risk of concentration in organisms.

2.6 Food Web/Population Effects

The PBT Profiler estimates that trichloroacetic acid is not expected to bioaccumulate in the food chain because it does not exceed the BCF criteria.

3 MAMMALIAN TOXICITY

3.1 Acute Mammalian Toxicity

Value Species Reference/Comments
Oral LD 50 (mg/kg) >5,050 rats PMEP
Dermal LD 50 (mg/L) n/a Intraperitoneal LD 50 (mg/kg) 5,200 mice MSDS-Oxford University
Inhalation LC 50 (mg/L/4h) n/a

n/a: not available PMEP: Pesticide Management Education Program

3.2 Corrosion/Irritation

Species Method Results Reference/Comments
Skin human Slightly hazardous in case of skin contact (irritant, permeator) MSDS-ScienceLab

Eyes human Hazardous in case of eye contact (irritant) MSDS-ScienceLab

3.3 Sensitization

EEC Classification for sodium thiosulphate does not include R43 (May ca use sensitization by skin contact).GESAMP-BWWG 8/6
ANNEX 6

Page 101

I:\MEPC\59\2-16.DOC 3.4 Repeated-dose Toxicity

No information on the repeated-dos e toxicity of sodium thiosulpha te was found in the literature.

3.5 Development and Reproductive Toxicity

Exposure Route oral Exposure Duration gestation days 6 to 15 Exposure dose 0, 5.5, 25.5, 118 or 550 mg/kg/d Species mice
Method
Results No indication of any effect on maternal or fetal survival. No incidence of visceral or skeletal abnormalities. The male/female ratio at the lowest and highest dose level are lower than

other ratios.
NOAEL
NOEL
Reference/Comments/ PMEP; Pesticide Management Education Program

Exposure Route oral Exposure Duration gestation days 6 to 15 Exposure dose 0, 4, 19, 86 or 400 mg/kg/d Species rats
Method
Results No indication of any effect on maternal or fetal survival. No incidence of visceral or skeletal abnormalities.
NOAEL
NOEL
Reference/Comments PMEP; Pesticide Management Education Program

Exposure Route oral Exposure Duration gestation days 6 to 15 Exposure dose 0, 4, 19, 86 or 400 mg/kg/d Species hamsters
Method
Results No indication of any effect on maternal or fetal survival. No incidence of visceral or skeletal abnormalities. Unusual male/female ratio.
NOAEL
NOEL
Reference/Comments PMEP; Pesticide Management Education Program

Exposure Route oral Exposure Duration gestation days 6 to 18 Exposure dose highest dose level of 580 mg/kg/d Species rabbits
Results No indication of any effect on maternal or fetal survival at the highest dose level (580 mg/kg/d). No incidence of visceral or skeletal abnormalities at the highest dose level (580 mg/kg/d). No incidence of any effect on the male/female ratio of the fetuses.
Reference/Comments PMEP; Pesticide Management Education ProgramGESAMP-BWWG 8/6
ANNEX 6 Page 102

I:\MEPC\59\2-16.DOC 3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

No information on the carcinogenicity of sodi um thiosulphate was found in the literature.

3.7 Mutagenicity/Reprotoxicity

Species Method Details Results (with/without

activation) Reference/Comments

In Vitro Studies Salmonella typhimurium strain TA98, TA100 TA1535, TA1537 TA1538 Ames test negative Prival et al. (1991)

Escherichia coli WP2 negative Prival et al. (1991)

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Sea water or
Fresh water Test Duration Results Break-down products Reference/ Comments Hydrolysis (pH 5) n/a Hydrolysis (pH 7) n/a Hydrolysis (pH 9) n/a Biodegradation n/a
1/2 - Life n/a
n/a: not available

4.2 Partition Coefficients

Method Results Reference/Comments Log P OW Estimated -4.53 US EPA Estimation Program Interface (EPI) Suite v.3.20, KOWWIN TM v.1.67
K OC Estimated 6.124 US EPA Estimation Program Interface (EPI) Suite v.3.20, PCKOCWIN TM v.1.66

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference/Comments
Persistence Estimated n/a PBT Profiler
n/a: not available.

4.4 Reaction with organic matter

No such reactions indicat ed in the literature.GESAMP-BWWG 8/6
ANNEX 6

Page 103

I:\MEPC\59\2-16.DOC 4.5 Potential physical effects on wildlife and benthic habitats

No potential effects indicat ed in the literature.

4.6 Potential residues in seafood

No potential residues indicated in the literature.

4.7 Any known interactive effects

No known effects indicated in the literature.

5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES, PREPARATIONS AND TREATED BALLA ST WATER, IF APPLICABLE

Property(with units and reference) Value Reference/Comments

Melting point (°C) 48 ECB IUCLID (2000) Boiling point (°C) Decomposes 300°C (decomposes below b.p.) ECB IUCLID (2000) NIOSH-ICSC Flammability(flash point for liquids; °C) Non flammable Flash point: Not applicable MSDS-ScienceLab

Density (20°C; kg/m 3 ) 9.1x10 2

1.74x10 3 ECB IUCLID (2000)

Vapour pressure (20°C; Pa) Not applicable MSDS-ScienceLab Vapour density (air = 1) Not available MSDS-ScienceLab Water solubility (temp; effect of pH; mg/L) 2.09x10 5 (20°C)
7.01x10 5 (20°C)
1.0x10 5 (pH 6.5-9 at 25°C) NIOSH-ICSC ECB IUCLID (2000)

pH in solution 7 in 1% solution MSDS-ScienceLab Dissociation constant (pKa) Not available Oxidation- reduction potential Not available Corrosivity to material or equipment Non corrosive in presence of glass. MSDS-ScienceLab

Reactivity to container material Not available

Auto-ignition Temperature (°C) Not applicable MSDS-ScienceLab

Explosive properties Not explosive ECB IUCLID (2000) Oxidizing properties No oxidizing properties ECB IUCLID (2000) Surface tension Not available ECB IUCLID (2000) Viscosity Not available Thermal stability and identity of breakdown products Not available

Other physical or chemical properties Powder. Colorless monoclinic crystals. The Merck Index. (1976) Weast RC. (1976)GESAMP-BWWG 8/6
ANNEX 6 Page 104

I:\MEPC\59\2-16.DOC 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Concentration at environmentally Relevant Concentrations

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments

No no no PBT Profiler See table 2, section 2.1.4 in annex 5

***GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC ANNEX 7

REVIEW OF PROPOSALS FOR APPR OVAL OF ACTIVE SUBSTANCES

Blue Ocean Shield - A Ballast Water Management System Consisting of Sedimentation by Hydrocyclone, Filtration a nd Low Pressure UV Disinfection

Submitted for Basic Approval by China

0 SUMMARY

0.1 Having considered all of the data submitted for Basic Approval, the Group recommended that Blue Ocean Shield be given Basic Approval.

0.2 The Group noted that the Blue Ocean Shield Ballast Water Management System uses a combination of sdimentation by hydrocyclone, filtration and low pressure UV disinfection to treat the ballast water.

0.3 The Group was satisfied that, as the system do es not involve the storage or generation of chemicals to treat ballast water, there were no associated storage safety problems.

0.4 The Group noted that the UV technology in the Blue Ocean Shield System makes use of electromagnetic radiation (photons) in order to treat ballast water. As such, the Group considered that it was neither necessary nor feasible to pr ovide the physical characteristics or toxicological profiles of such photons.

0.5 However, it was recognized that the ra diation (photons) might react with naturally occurring organic molecules in seawater to fo rm by-products with safety and environmental concerns. Half-lives of the photons are expected to be in the order of micro- to milliseconds.

0.6 Based on results from chemical analyses of treated ballast water, the Group concurred with the views of the applican t that it was not necessary to provide toxicological and ecotoxicological data on these by-products and that an evaluation of the possible effects of treated ballast water should suffice to provide a recommendation regarding Basic Approval.

0.7 The Group recognized that the only potenti al for human health risk was related to exposure to UV irradiation from the treatment unit and therefore the Group recommended that appropriate risk mitigation measures be put in place.

0.8 The Group noted that the applicant had provide d some acute aquatic ecotoxicity data for the treated ballast water which demonstrated a la ck of toxicity. Whilst the Group identified some shortcomings associated with these ecotoxicity studies, the data were considered acceptable for Basic Approval. As the applicant had not pr ovided any chronic aquatic ecotoxicity testing on the UV-treated ballast water, the Group emphasized that this should be pr ovided in the dossier for Final Approval.GESAMP-BWWG 8/6
ANNEX 7 Page 2

I:\MEPC\59\2-16.DOC 0.9 The Group noted that Procedure (G9) requires that “Proposed procedures for the use and technical equipment introduced needs to be taken into account”. However, it was also noted that no confirmation that the equipment is suitable fo r use on board a ship had been provided for evaluation by the Group. As a result, the Gr oup proposed that such procedures should be properly documented so that they can be taken into account if the system is to be reviewed for Final Approval in the future.

0.10 The Group noted that a signi ficant proportion of the data, references and information provided in the confidentia l dossier was in Chinese, and that the Group does not possess facilities to assess such material. The Group was inform ed by the Chinese Administration that all the information provided in Chinese wa s also available in English.

0.11 The Group emphasized that if the applicant wishes to present data, references or information to be taken into account when the syst em is to be reviewed for Final Approval in the future, then all such documentati on should be provided in English (or if original documents are in Chinese, then the Group must be provi ded with accompanying English translations).

0.12 The Group noted that, in the Basic Approval do ssier received, not all items were properly addressed. If, according to the opinion of the a pplicant, items from the dossier should be waived on scientific grounds, the applicant should clearly indicate the reason ing for waiving these items. The Group considered it necessary that all the items should be a ddressed by a proper explanation.

0.13 The Group reserved the right to comment in full on the entirety of any future dossier to be submitted for Final Approval. The Group feels able to recommend Basic Approval based on the dossier available, only by relying on the exis ting knowledge and expertise of members of the Group, together with information available from the public literatu re. However, it was agreed that sufficient aspects of this system were presented to a llow the Group to be satisfied that further large scale testing could be carried out w ithout significant risk to the crew, the ship and the environment.

0.14 The applicant is advised to review the require ments of Procedure (G9) and ensure that all of these are fully met when making an application for Final Approval.

0.15 Having reviewed all the information in the non-confidential submission and the information received from the applicant during its meeting, the Group recommended that Blue Ocean Shield be given Basic Approval w ith the following considerations if the system is to be reviewed for Fi nal Approval in the future:

.1 all the topics in this Summary (section 0) have to be carefully addressed by the applicant;

.2 all the topics under section 2 (Completen ess of the Dossier as mentioned below) have to be addressed by the applicant; andGESAMP-BWWG 8/6
ANNEX 7 Page 3

I:\MEPC\59\2-16.DOC .3 The Group considered that the Level of Quantification (LOQ) for the by-products in treated ballast water were too high. Th is may lead to unde rstatement of the potential levels in the treated ballast wa ter. It was noted by the Group that the dossier did not include information about other relevant halogenated chemical by-products that may be produced accord ing to open available literature. The LOQ of the analytical methods used for the potential by-products measured should be at a level that confirms that the poten tial amount of by-products produced by the system is sufficiently lo w and meets the international standards on these substances. It is common to determine these contaminants in natural waters at levels of 0.01 or 0.05 μ g/L. The Group therefore recommended that this uncertainty should be clarified by additiona l analyses during the full scale testing on land and/or on board ships by the applic ant and that these data are submitted in the application for Final Approval.

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted fr om that supplied by China in document MEPC 59/2/2, which was supplemented by additional confidential information provided by the applicant.

2 COMPLETENESS OF DOSSIER

2.1 The Group had the following concerns which it considered should be addressed prior to application for Final Approval:

.1 a more detailed description of the sy stem needs to be provided to include inter alia:

.1 system layout - the Group agreed that the information already provided was acceptable for Basic Approval; and

.2 details of the protection devices a nd failsafe controls incorporated – the Group agreed that the information provided was acceptable for Basic Approval. The Group not ed that the dossier’s system description, operational manual and control methodology was insufficient to assess or insure safe operation of the system.

.2 following application of the BWMS at both ballasting and de ballasting, the Group wanted to know the concentration of potential by-products at the point of discharge of the treat ed ballast water;

.3 the quantification of THM and HAA fo r natural seawater maybe completely different from those obtaine d from fresh water or brack ish water – the applicant indicated that tests ha d been carried out only in natural seawater;

.4 lack of chronic aquatic ecotoxicity testing on the UV-treated ballast water – the Group emphasizes that chroni c testing should be provided in the dossier for Final Approval;GESAMP-BWWG 8/6
ANNEX 7 Page 4

I:\MEPC\59\2-16.DOC .5 the mutagenicity testing as referred to by the applicant (in email correspondence during the GESAMP-BWWG meeting) was no t part of the confidential dossier; the Group wanted to highlight that all info rmation and test data used in the human health risk assessment should be included in the future submission forFinalApproval; and

.6 the Group agreed that the statement sa ying that corrosion was not anticipated should have been supported with evidence.

2.2 The Group also considered that the Level of Quantification (LOQ) associated with the chemical analysis of the potential by-products meas ured in treated ballast water was too high and that much lower detection limits are achievable. Some concern was expressed that some of the chemicals analysed for might still be produced at le vels lower than the detection limits used by the applicant.

2.3 The Group noted that the appl icant did not provid e information concerning the processes and unit operations in which crew exposure may occur and therefore the Group recommends that for Final Approval this information should be included in the submission.

2.4 Whilst no other physico-chemi cal properties, fate and beha viour in the environment and mammalian toxicity data had been provided, the Gr oup agreed that this was not necessary, from the aquatic toxicity perspective, due to the lo w level of possible by-products being produced by the system.

3 DESCRIPTION OF THE SYSTEM

3.1 Working Principles of the Blue Ocea n Shield Ballast Water Management System

3.1.1 The Group noted that the applicant had supp lied the following information on the basic operation of the system. China Ocean Shipping (Group) Company (COSCO) has joined forces with Tsinghua University to develop a m odular ballast water management system (Blue Ocean Shield) that operates in-line during th e uptake and discharge of ballast water. Prior to UV treatment, a filter system specifically designed for ballast water applications will significantly reduce the sediment load of the ballast water, as well as remove some micro-organisms. The filtration system is installed on the discharge side of the ballast water pumps and is fully automatic in terms of its ope ration in cleaning. This does not, however, affect the treatment process and the fl ushing water is returned to the sea. The UV unit employs low-pressure, high output ultra vi olet (LPUV) lamps to destroy li ving micro-organisms present in the ballast water.

3.1.2 Ballast water is treated at intake and once again at discharge. The treatment on intake ensures that a minimal amount of viable organi sms enters the ballast water tanks and reduces sediment built-up in the tanks, which is a potential area for the survival of organisms. The water is treated again at discharge by the UV system onl y, to ensure that the potential re-growth of organisms in the ballast water tanks is decreased as much as possible.GESAMP-BWWG 8/6
ANNEX 7 Page 5

I:\MEPC\59\2-16.DOC 3.2 Overview

3.2.1 The ballast water management system

3.2.1.1 The Group noted that this ballast water ma nagement system consists of four modular functions:

.1 Hydrocyclone : removes most of larger or heavier particles.

The Group noted that the hydrocyc lone is a device used to se parate particles in a liquid suspension based on the density and size of the particles. Hydrocyclones have a cylindrical section at the top, where liquid enters the unit, and a conical base. The particular Blue Ocean Shield hydrocyclone units have three exits: a small one on the bottom (weighty particles, underflow), a smalle r exit at the top (lighter particles, overflow) and a larger exit in the middle (m iddle flow). In the treatment process, centrifugal force moves larger, weighty particles to the bottom exit and light particles to the top.

Parameters of hydrocyclone unit:

Flow rate: 250 m 3 /hr
Working pressure: 0.8 bar
Maximum working pressure: 10 bar

Material: SS 316L

.2 Filter :

The Group noted that the filter is a device us ed to separate solid particles by size. In the Blue Ocean Shield system, multiple element tubular filter units with accessorial filtration are used. The ship’s high-pressure gas can be automatically used by filters on cleaning function, which had more than two filter units installed at the same time in order to meet with uninterrupted water supply. Fi lter impurities from the ship arise through the discharge pipe into the wa ter at the original port.

Parameters of filter unit:

Flow rate: 250 m 3 /hr

Filtration degree: 50 micron

Working pressure: 2.0 bar

Maximum working pressure: 10 bar

Automatic cleaningGESAMP-BWWG 8/6
ANNEX 7 Page 6

I:\MEPC\59\2-16.DOC Material

- Filter housing: SS 316L

- Filter screen: seawater-fast material

.3 UV disinfection :

The Group noted that no substances are ad ded to the process and it removes most micro-organisms and algae smaller than 50 μ m (according to applicant).

Flow rate: 250 m 3 /hr

Low pressure UV lamps

Material: SS 316L

Maximum dose: 300 mJ/cm 2

Automatic washing wiper for quartz sleeves

.4 Control and auxiliary equipment : including sampling points.

The control system and transf ormer control the system a nd supply all co mponents with power. The auxiliary equipment controls the flow and measures di fferent alarm levels.

3.2.1.2 A simplified diagram of the Blue Ocean Shield BWMS is given in Figure 1.

Figure 1. Simplified diagram of the Blue Ocean Shield BWMS.GESAMP-BWWG 8/6
ANNEX 7 Page 7

I:\MEPC\59\2-16.DOC 3.2.1.3 The Group noted that the Applicant stated the Blue Ocean Shield system may be run in different configurations depending on the level of treatment required and th e particular properties of the ballast water. For example:

.1 Hydrocyclone / Filter / UV; or

.2 Filter / UV

3.2.1.4 According to the applicant, the Blue O cean Shield can be viewed as flexible and modular, and can be applied in different configurations for di fferent end user requirements.

3.2.1.5 The Group decided this application for Basic Approval will focus on the UV treatment unit, as this is the only component in volving the use of Active Substance.

3.2.2 Description of pilot scale test system used for Basic Approval

3.2.2.1 The Group noted that in order to confirm and justify th is system, the applicant has developed a pilot scale system and systematic ex periments were performed using “treated water” and raw seawater, as described below.

3.2.2.2 The Group noted that the UV unit employs low-pressure, high- output ultra violet (LPUV) lamps to destroy living micro-organisms present in the liquid being treated. During deballasting, the ballast water is treated agai n by the UV unit to destroy any organisms which may have re-grown in the tanks during the voyage. The BWMS used for the pilot test consisted of a UV unit and a monitoring and control panel. The maximum fl ow rate designed for the pilot system is 2 m 3 /h. The UV doses used for acute toxicity were 100 mJ/cm 2 and 300 mJ/cm 2 . For other tests, the UV dose range was from 37 to 1990 mJ/cm 2

.
3.2.2.3 The stated test strategy of the applicant was as follows:

.1 basic characteristics testing: to investig ate any change in the seawater before and after treatment, the basic characteristics (i .e., ions, TOC, UV absorbance scanning, and SUVA) of seawater are compar ed with the “treated water”;

.2 by-products formation testing: to investig ate the possibility of the formation of harmful halogenated organics and inorganic compounds; and

.3 toxicity testing: to invest igate the acute aquatic ecotoxic ity of sea water before and after UV system treatment.

3.2.2.4 The seawater (DOC=8.1mg/L; SS=7.0 mg/L) transported to the laboratory was treated twice by the model Blue Ocean Shield ballast wa ter treatment system. The control sample was not treated by the water treatment system. Part of control sample and treated water was used for the test immediately.

3.2.2.5 According to the applicant, the results of biological efficacy testing of the BWMS showed that the system met the standard in regul ation D-2 of the Convention in all test cycles.GESAMP-BWWG 8/6
ANNEX 7 Page 8

I:\MEPC\59\2-16.DOC 3.3 Chemical processes involved (provided by the applicant)

3.3.1 The Group noted that according to the applican t, in the Blue Ocean Shield Ballast Water Management System, the UV system produces a “phot on” as the only Active Substance, which is responsible for inactivating all harmful aquatic micro-organisms and pathogens present in the ballast water.

3.3.2 For the Blue Ocean Shield system, “ballast water discharge” is the treated ballast water that has passed the UV unit twice, duri ng ballasting and deba llasting, respectively.

3.3.3 The Blue Ocean Shield Ballast Water Mana gement System does not intentionally add any Preparation besides UV light.

3.3.4 According to the applicant, the Blue Ocean Shield Ballast Water Management System does not produce any Relevant Chemicals.

3.3.5 As a result of the above points, the Group acce pted that chemicals ar e neither required to be stored on board nor generated on demand.

3.4 Active Substance (AS), Relevant Chem icals (RC) and Other Chemicals (OC)

3.4.1 Active Substance

3.4.1.1 In this LPUV-based system, the Group accepted that photons are the only Active Substance available to kill and inactivate micro-organisms. The definition of “photon” is a particle of electromagnetic radiation that travels at the sp eed of light, used to explain phenomena that require light to behave as particles rather than as waves. Accordingly, as the photons are only available upon turning on the LPUV lam p, there must be no residual photons in both the “ballast water” and “ballast water discharge”.

3.4.1.2 Therefore the Group accepted that the phot on has no chance of exposing aquatic plants, invertebrates, fish, and other bi ota, including sensitive and re presentative micro-organisms. Therefore, all tests for effects on such biot a, are not applicable due to the non-residual characteristics of the photon.

3.4.1.3 Likewise, since the photons generate d in the LPUV reactor are never exposing mammals, all tests for effects on mammals are not applicable.

3.4.1.4 The Applicant has produced a table of the physical and ch emical properties of photons, but all parameters are labelled as not applicable. This has not been reproduced here as it provides no additional information.

3.4.2 Relevant Chemicals

3.4.2.1 Based on the analytical data provide d by the Applicant and general information about UV treatment, the Group concurred with the views of the A pplicant that the Blue Ocean Shield BWMS does not produce any “relevant chemical”.GESAMP-BWWG 8/6
ANNEX 7 Page 9

I:\MEPC\59\2-16.DOC 3.4.3 Other Chemicals

3.4.3.1 It was recognized by the Group that the UV process may react with naturally occurring organic molecules in ballast water to form by-pr oducts with safety and environmental concerns. It was agreed that, it was neither necessary nor practical to provide thei r physical characteristics or toxicological profiles.

3.4.3.2 It was noted that the a pplicant had identified certain chemical by-products as being possible resultant products of the treatment system and had analysed the treated ballast water for

Concentrations of potential chemical by-pro ducts in UV-treated natural seawater samples (provided by applicant)

Parameter/UV dose mJ/cm 2 0 60 97 156 252 406 1234 1990 LOD *

chlorite mg/L 0.4 0.4 0.35 0.24 0.3 0.43 0.42 0.41 0.01
chlorate mg/L 3.19 3.67 2.76 2.68 2.79 3.16 2.7 2.87 0.01
Formaldehyde mg/L ND ND ND ND ND ND ND ND 0.01
Aldehyde mg/L 2.85 4.38 3.5 2.28 2.72 1.88 1.62 2.01 0.01

CHCl 3 μ g/l ND ND 2 2 2 3 5 6 1

CHBr 2 Cl μ g/l ND ND ND ND ND ND ND ND 1

CHBrCl 2 μ g/l ND ND ND ND ND ND ND ND 1

CHBr 3 μ g/l ND ND ND ND ND ND ND ND 1

TTHMs μ g/l ND ND 2 2 2 3 5 6 1

MCAA μ g/l ND ND ND ND ND ND ND ND 2

DCAA μ g/l 2 2 2 2 2 2 2 8 2

MBAA μ g/l 2 2 ND ND ND ND ND 4 2

TCAA μ g/l 2 2 ND ND ND ND ND 4 2

BCAA μ g/l 8 8 8 10 10 8 12 12 2

BDCAA μ g/l 2 2 2 ND ND ND ND 4 2

DBAA μ g/l ND ND ND ND ND ND ND ND 2

CDBAA μ g/l ND ND ND ND ND ND ND ND 2

* ND means not detected
* LOD: Limit of Detection (SD*3.14, n=7) = MDL (method detection limit)

3.4.3.3 The Group considered that the Levels of Quantification (LOQ) fo r the haloacetic acids and trihalomethanes were too high and that this may lead to an underestimation of the levels in the treated ballast water. This uncertainty shou ld be clarified in additional analyses during the full scale testing on land and/or on board ships by the applicant.

3.4.3.4 The results of the chemical tests for the model Blue Ocean Shield Ballast Water Management System showed no significant concentr ation changes before or after UV irradiation when the doses were under 300mJ/cm 2

.GESAMP-BWWG 8/6
ANNEX 7 Page 10

I:\MEPC\59\2-16.DOC 3.4.4 Conclusions

3.4.4.1 Based on these results, the Group concurred w ith the views of the applicant that it was not necessary to provide toxicological and ecotoxi cological data on these by-products and that an evaluation of the effects of tr eated ballast water should suffi ce to provide a recommendation regarding Basic Approval.

3.4.4.2 The Group agreed that it was not necessary to evaluate the properties of any Active Substance or Relevant Chemical asso ciated with this system. Instead, a brief evaluation was carried out on the data generated by the applicant from testing the treated ballast water, the results of which are show n in the appendix to this annex.

4 HUMAN HEALTH ASSESSMENT

4.1 The Group identified that the only potential fo r human health risk wa s related to exposure to UV irradiation from the treatment unit and therefore recommended that appropriate risk mitigation measures be put in place.

4.2 Although the concentrations of the mentioned chemical by-pr oducts were considered to be below LOQ, the Group considered that the LOQ was considerably too high for the quantification of these particular compounds and that the sensitivity of the analytical methods could be improved so as to give satisfactory and c onclusive measurements to be able to evaluate human toxicological effect s produced by the system.

4.3 Pilot testing results indicated that UV did not have a significant impact on most chemicals (table in paragraph 3.3.4.2). The Gr oup noted that for chloroform CHCl 3 and THM (CHCl 3 is a component of THM), there was little incr ease after UV (from undetectable to 3 μ g/L when the UV dose is 406 mJ/cm 2 ). However, this value is we ll below the EPA drinking water regulation safety value of 80 μ g/L (USEPA, 2003) and WHO dri nking water regulation which suggests 300 μ g/L (WHO, 2006).

4.4 The Group also noted that the applicant did not provid e information concerning the processes and unit operations in which crew exposure may. Therefore, the Group recommended that the applicant should supply the above information for Final Approval according to paragraph 7.2.3. of the Me thodology, appendix 2 (G9).

5 RISKS TO SAFETY OF THE SHIP , ITS CREW AND THE GENERAL PUBLIC

5.1 The Group was satisfied that, as the system do es not involve the storage or generation of chemicals to treat ballast water, there were no associated storage safety problems or risks.

5.2 The Group noted that the submi ssion identified a pote ntial risk to the ship and its crew present in the BWMS related to overheating in the treatment unit from the UV lamps. The submission confirmed that these id entified risks had been addressed by system safety measures that ensure there is automatic shut down, in a no flow situation, in order to prevent overheating.GESAMP-BWWG 8/6
ANNEX 7 Page 11

I:\MEPC\59\2-16.DOC 5.3 The submission recognizes that, concerning sh ip and personnel safet y, the G9 procedures require that “Proposed procedures for the use and technical equipment introduced needs to be taken into account”. However no confirmation that the equipment is suitable for use on board a ship had been provided for evaluation by the Group.

5.4 The Group noted that the UV lamps require a warm-up time before the system is ready for use. Full operating and main tenance procedures require to be evaluated to provide all necessary considerations for operators and crew safety.

5.5 The Group noted that the electric power re quirement of the system will not be an insignificant additional ship service demand. It requires to be confirmed that the equipment meets all regulatory standards for equipment to be installed on board a ship, both with regard to construction and prevention of electric shock to personnel.

6 ENVIRONMENTAL RISK ASSESSMENT

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

6.1.1 The Group recognized that it was not possible to evaluate the persistence, bioaccumulation and toxicity of any chemicals e ither within, or produced by, the system, as it does not use any Active Substances or produce a ny Relevant Chemicals. Assessment of the PBT-criteria was, therefore, cons idered to be not applicable.

6.2 Derivation of the Predicted No Effect Concentration (PNEC)

6.2.1 The Group confirmed that the acute aquatic ecotoxicity data provi ded do not indicate a potential risk to the environment and agreed that the derivation of a PNEC is not possible as the nature of the system does not involve the use of chemicals that make the derivation of a PNEC either possible or necessary. The Group noted th at no effects had been observed during ecotoxicity tests, using a 100% concentrati on of UV-treated ballast water (s ee appendix to this annex).

6.2.2 The Group considered that there should be an improvement in Quality Assurance and Quality Controls for any ecotoxicity tests provided for Final Approval, particularly with regard to the following issues:

.1 preparation of water samples and liv ing organisms needs to be described according to the procedures for quality control;

.2 the dilutions of treated balla st water for acute toxicity tests were a serial sequence by the order of 1/2, and the results of the effect at each concentration need to be analysed according to prope r statistical analysis;

.3 according to the acute toxicity test protocol, the LCx is supposed to be presented instead of NOEC;

.4 the number of algal cells for acute toxic ity test at 96 hours after inoculation is supposed to reach to 1.1 x 10 6 cells/mL according to the OECD method which was used for this test. Th e number of algal cells, at given time, were supposed to be analysed with proper statistical methods to provide the level of effect with significant level; and

.5 Procedure (G9) requires the chronic ecot oxicity data for treated ballast water.GESAMP-BWWG 8/6
ANNEX 7 Page 12

I:\MEPC\59\2-16.DOC 6.3 Calculation of the Predicted Environmental Concentration (PEC)

6.3.1 The Group agreed that there would be no point in calcula ting the PEC of the treated ballast water as it was recognized that a 100% concentration of treated ballast water discharge would be acceptable under any situation.

6.4 Calculation of the PEC/PNEC ratios

6.4.1 The Group noted that neither the PEC nor the PNEC had been derived. The Group agreed that it was not necessary to do so as th e PEC/PNEC ratio could be regarded as less than one for all practical purposes.

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to the safety of the ship

8.1.1 Subject to the concerns expr essed above in this Annex, the Group agreed that this system was not likely to cause any concern with regards to the safety of the ship. Certain conditions and requirements have been set above for any future assessment of an application for Final Approval.

7.2 Risks to the crew and the general public

7.2.1 The Group recognized that the levels of pot entially hazardous chemicals (by-products) produced by this system were ge nerally lower than the detection limits of the methods used to analyse for them. However, the Group considered that there might still be some human health concerns and so agreed that human exposur e on board should be avoided until it can be demonstrated that the levels of such chemicals, if produced, are below the threshold limits for any toxicological concerns. Requi rements have been set above fo r assessment of an application for Final Approval.

7.2.2 The Group also noted that the applicant did not provid e information concerning the processes and unit operations in which crew exposure may occu r. Therefore, the Group recommended that the applicant should supply the above information for Final Approval according to paragraph 7.2.3 of the Methodology, appendix 2 (G9).

7.3 Risks to the environment

7.3.1 Having reviewed all of the information subm itted with this application, the Group agreed that this system will not cause any harm to th e environment when carrying out the further work which is necessary to apply for Final Approval.

7.4 Recommendations

7.4.1 Having considered all of the data submitted for Basic Approval, the Group agreed to recommend to MEPC that Basic Ap proval is given to this system.GESAMP-BWWG 8/6
ANNEX 7 Page 13

I:\MEPC\59\2-16.DOC 7.4.2 However, the Group wished to inform MEPC that the following aspects, inter alia , should be given due consideration if the system has to be reviewed for Final Approval in the future:

.1 All the topics addressed under s ection 0 (Summary) and section 2 (Completeness of the Dossier ) have to be addressed by the Applicant carefully.

.2 The Group considered that the Level of Quantification (LOQ) for the haloacetic acids and trihalomethanes were too high. Th is may lead to underestimation of the potential levels in the treated ballast wate r. This uncertainty should be clarified in additional analyses during the full scale testing on land and/or on board ships by the applicant.

* * *GESAMP-BWWG 8/6
ANNEX 7 Page 14

I:\MEPC\59\2-16.DOC Appendix

Properties of Treated Ballast Water

1 PHYSICOCHEMICAL PROPERTIES

The Group recognized that it was both unnecessa ry and irrelevant to report the physical properties of treated ballast water.

2 MAMMALIAN TOXICITY

The Group noted that the applicant had indicated that, as there were no measurable chemical by-products, there was no need to provide any data with rega rds to mammalian toxicity. The Group agrees with this view.

3 ENVIRONMENTAL EFFECTS

The Group noted that some acute aquatic ecotoxici ty tests had been carri ed out by the Applicant using treated ballast water.

3.1 Acute Aquatic Ecotoxicity Data

The following text and Table 2 below summarize the Group’s evaluation of the acute aquatic ecotoxicity of 100% treated ballast water (supplied by Applicant).

Premnas biaculeatus, Artemia salina and Skeletonema costatum were chosen as the challenge organisms for acute toxicity testing. The result s show that no acute to xicity was observed in the 100% treated ballast water.

Premnas biaculeatus , distributed widely in the Indian Ocean and the Pacific Ocean, is the preferred species for toxicity testing to assess possible risks for the envi ronment since it is a sensitive indicator specie s and the bodyweight of Premnas biaculeatus is <3.0 g, which meets the requirement of USEPA test guideline.

Artemia salina belongs to Arthropoda-Crustacea-Branch iopoda-Anostraca, and is distributed widely in high salt water areas all over the world. Artemia salina feeds primarily on zooplankton and phytoplankton and is also consumed by many other aquatic organisms, such as fish. Therefore, Artemia salina plays an important role in the f ood chain of high salt water areas, as well as belonging to the second trophic level animal, a requi rement of Procedure (G9).

Species of algae recommended by USEPA as test or ganisms for the algae acute toxicity test are the freshwater green alga, S.capricornutum (or R. subcapitata ), the marine diatom, S. costatum

, the freshwater diatom, N. pelliculosa , and the blue-green alga or cyanobacterium. In the ballast water acute toxicity test, S. costatum was selected for the test system, meeting the requirement of Procedure (G9) and USEPA test guidelines.GESAMP-BWWG 8/6
ANNEX 7 Page 15

I:\MEPC\59\2-16.DOC Table 2: The acute toxicity testing of the UV-treated ballast water

Results Trophic

level Species Method Endpoint 100 mJ/cm 2 300 mJ/cm 2 Reference

Fish Premnas biaculeatus OECD 202 NOEC/96h 100% 100% (PSEC 2008 report E083420068)

Invertebrates Artemia salina OECD 203 NOEC/96h 100% 100% (PSEC 2008 report E083490078)

Algae Skeletonem

a costatum OECD 201 IrC 50 /96h 100% 100% (PSEC 2008 report E085480018)

3.2 Information on Endocrine Disruption

3.2.1 The Group noted that the endoc rine disruption potential of treated ballast water had not been tested for specifically bu t the applicant reported that no potential endocrine disrupting chemicals had been identified in the treated water.

3.2.2 Based on this information, the Group agreed th at the treated ballast water was unlikely to have any endocrine disrupting effects.

3.3 Sediment Toxicity

The Group noted that the appli cant had indicated that, based on the chemical analysis and toxicity tests of the treated ballast water, ther e would not be any sedime nt toxicity associated with the treated ballast water. The Group agrees with this view.

3.4 Bioavailability/Biomagnification/Bioconcentration

The Group noted that the applicant had indicated that, based on the chemical analysis of the treated ballast water, there was no indication of any chemical by-products that might be bioaccumulative. The Group agrees with this view.

3.5 Food Web/Population Effects

The Group noted that the applicant had indicated that , as the full strength tr eated ballast water did not have any measurable effect on any of the te st species, it would be unlikely for the diluted ballast water to have any negative effects on ec ological communities at environmentally relevant concentrations. The Group agrees with this view.

3.6 Environmental Fate and Behaviour

The Group recognized that there is no chemical Active Substance or any Relevant Chemical produced by the system and so there was no n eed to consider their environmental fate any further. The Group agrees with this view.

***GESAMP-BWWG 8/6

I:\MEPC\59\2-16.DOC ANNEX 8

REVIEW OF PROPOSALS FOR APPR OVAL OF ACTIVE SUBSTANCES

HHI EcoBallast – A Ballast Wa ter Management System Cons isting of Filtration and Disinfection by Medium-Pressure Helix UV Reactor

Submitted for Basic Approval by the Republic of Korea

0 SUMMARY

0.1 Having reviewed all the information receiv ed from the applicant, the Group decided to recommend that Basic Approval be give n to the HHI EcoBallast Ballast Water Management System proposed by the Republic of Korea.

0.2 The Group noted that the HHI EcoBallast Ballast Water Management System uses a combination of Filtration and Medium Pressure UV Disinfection to treat the ballast water.

0.3 The Group was satisfied that, as the sy stem does not involve the storage or generation of chemicals to treat ballast water, there were no associated storage safety problems.

0.4 The Group noted that the Medium Pressure UV technology in the HHI EcoBallast System makes use of electromagnetic radiation (photons) in order to treat ballast water. As such, the Group considered that it was ne ither necessary nor practical to provide the physical characteristics or toxicol ogical profiles of such photons.

0.5 However, it was recognized that the ra diation (photons) might react with naturally occurring organic molecules in seawater to form by-products with safety and environmental concerns. Half lives of the phot ons are expected to be in the order of micro- to milli-seconds.

0.6 Based on results from the chemical anal yses of treated ballast water, the Group concurred with the views of the applicant that it was not nece ssary to provide toxicological and ecotoxicological data on these by-products and that the evaluation of the possible effects of treated ballast water provided in the submitted dossier was sufficient.

0.7 The Group noted that the acute and chroni c aquatic ecotoxicity testing had been performed as a full-scale land-based te st in accordance with the requirements of Procedure (G9) for Final A pproval (MEPC 53/24/Add.1, appendix).

0.8 The Group noted that the potential hazards for human health related to overheating of UV lamps and exposure to UV irradiation resulting from operating this system were sufficiently addressed by the applicant by engi neering control measures put in place and training of operators. Therefore, the Group c oncluded that the risks to the crew from exposure were sufficiently mitigated by the measures put in place.GESAMP-BWWG 8/6
ANNEX 8 Page 2

I:\MEPC\59\2-16.DOC 0.9 In addition, the Group noted that all the disinfection by -products measured in the discharged ballast water were under LOD w ith exception of AOX (Adsorbable Organic Halogens) (0.29mg/L at day 5). The Group considered that th ese chemicals are short-lived and would not pose a toxicological concer n towards the genera l public swimming and eating fish from the area.

0.10 Having reviewed all the information in the non-confidential submission and the information received from the applican t during the GESAMP-BWWG meeting, the Group decided to recommend that Basic Approva l be given to the BWMS submitted by the Republic of Korea.

0.11 Moreover, the Group was satisfied that the required tests ha d been performed correctly and that the results demonstrated that the system met the requirements of Procedure (G9) to allow it to be recomme nded for Final Approval. The Group is of the opinion that this application fulfilled the requirements for Final Approval in accordance with Procedure (G9).

1 INTRODUCTION

1.1 The data used to evaluate this syst em were extracted from that supplied by the Republic of Korea in document MEPC 59/2/4, which was supplemented by additional confidential information pr ovided by the applicant.

2 COMPLETENESS OF DOSSIER

2.1 The Group did not have any concerns wh ich it considered should be addressed for Final Approval as the application contained all the information required to allow it to be reviewed.

3 DESCRIPTION OF THE SYSTEM

3.1 Working Principles of the HHI EcoBa llast Ballast Water Management System

The Group noted that the Applicant had supp lied the following information on the basic operation of the system. The ballast water is treated at intake (ballasting) and again at discharge (de-ballasting). The treatment during intake ensure s that a minimal amount of viable organisms enters into the ballast wate r tanks and reduces sediment build-up in the ballast water tanks, which is a potential area for survival and growth of organisms. The water is treated again during discharge to ensure that any potential re-growth of organisms in the ballast water tanks is preven ted. The working principle is disinfection or destruction of organisms through UV radiati on without addition of chemical compounds.GESAMP-BWWG 8/6
ANNEX 8 Page 3

I:\MEPC\59\2-16.DOC 3.2 Overview

3.2.1 The ballast water management system

3.2.1.1 The Group noted that this ballast wate r management system consists of three separate functions: filt ration; disinfection of marine or ganisms through UV radiation; and controls and auxiliary functions . Accordingly, the system is composed of the following three main units:

.1 a filtration unit;

.2 a UV reactor, and

.3 a control and cleaning unit.

3.2.1.2 The EcoBallast system is illustrated schematically above and includes the following components:

.1 The filtration unit – is composed of a 50 μm filter with automatic back flushing. The filter removes larger part icles and organisms from the water. This filtration reduces the sediment load of the ballast water and hence reduces sediment build-up in the ballast water tanks. The filter is fully automatic in terms of its operation a nd cleaning without affecting the filtration process, and backwashing water is returned into the sea in situ . The filter unit operates only during ballasting; during de-ballas ting, the filter unit is by-passed;

.2 The UV Reactor – which treats the ballast water with UV radiation both during ballasting and again during de-b allasting to destroy any organism which might have re-grown or survived in the ballast water tanks during the

voyage.GESAMP-BWWG 8/6
ANNEX 8 Page 4

I:\MEPC\59\2-16.DOC The Helix type UV reactor of the EcoB allast system has been specially designed for ballast wate r application to reduce space and to maximize its efficiency and it employs a high-intensity, medium-pressure ultra-violet lamp. The helix UV reactor overcomes the limitation of previous UV systems for application to ballast water treatment because the helical lamp structure decreases the probability that water volume segments, including micro-organisms, pass the UV chamber without being exposed to sufficiently high UV doses. Sectors with relatively high velocity and low irradiation flow have been eliminated as far as possible. The helix lamp arrangement ( patent pending ) overcomes the need for additional chemical treatment due to a revolutionary lamp arrangement leading to an extremel y uniform dose distribution at ideal hydraulic conditions. The applied UV dose is ideal and even organisms with very high resistance to UV light can be inactivated definitively.

.3 The control and cleaning system – controls the EcoBallast BWMS and supplies power to all items, and the wate r flow meter and alarms are installed at different levels

3.2.1.3 The Group accepted that this system represents a chemi cal-free disinfection procedure as no chemical compounds are added to the process.

3.2.1.4 The Group decided this application for Basic Approval focussed on the Helix-type UV reactor unit, as it is the only component involving th e use of Active Substance.

3.2.2 Description of pilot scale test system used for Basic Approval

3.2.2.1 The Group noted that, in order to confir m and justify this system, the applicant had developed a pilot scale system and experiment s were performed in accordance with the IMO requirements. The treated ballast water was used for the toxicity tests, corrosivity tests and chemical water analysis. Chemical analysis samples were collected in triplicate at beginning, middle, and end of ballasting and de-b allasting. The corrosivity of UV treated seawater was assessed directly after treatment at the time of ballasting, whilst the acute and chronic aquatic ecotoxicity was measured after fi ve days storage at the time of de-ballasting.GESAMP-BWWG 8/6
ANNEX 8 Page 5

I:\MEPC\59\2-16.DOC 3.2.2.2 The flow diagram of the test facili ty is shown above. It had three 280 m 3 ballast tanks and a 250 m 3 /h ballast pump. All materials for the test facility such as pipes, valves, steel and paints were the same as used in ships. The te st facilities were run under the following conditions:

Flow rate 210 ± 10 m 3 /h; Treatments Two treatments, during ballasting and during de-ballasting; Power consumption 39 ± 1 kW for UV unit Less than 1 kW for Filter Unit Treated volume more than 200 m 3 Salinity 34 PSU (Seawater), 21 PSU (Brackish water)

Note: For test operation, UV transmittance of water was in range be tween 88 and 95%. In this operation, the UV dose was in range between 190 and 350 mWs/cm 2

.
3.2.2.3 The Group noted that, according to the applicant the full scale (200 m 3 /h) performance test was done according to the IMO Guidelines (G8). Test results showed that the EcoBallast system meets the Ballast Water Performance Standard contained in regulation D-2 of the IMO Ballast Water Management Convention.

3.3 Chemical processes involved (provided by the applicant)

3.3.1 The Group noted that according to the applicant, in the HHI EcoBallast BWMS, the UV process produces a photon as the only Active Substance, which is responsible for inactivating all harmful aquatic micro-organisms and pathogens present in the ballast water.

3.3.2 For the HHI EcoBallast system, ballast water discharge is the treated ballast water that has passed the UV unit twice, duri ng ballasting and deba llasting, respectively.

3.3.3 The HHI EcoBallast BWMS does not intentionally a dd any Preparation besides UV light.

3.3.4 According to the Applicant, the HHI EcoBallast BWMS can produce Relevant Chemicals. The UV radiation of EcoBallast can be absorbed by certain molecules, such as nitrate and dissolved organic matter (DOM) in the seawater and cause photo-chemical reactions to produce re active oxygen species such as hyd roxyl radical (OH•). Therefore hydroxyl radical (OH•) is defined by th e Applicant as Relevant Chemicals.

3.3.5 As a result of the above points, the Group accepted that chemicals are neither required to be stored on board nor generated on demand.GESAMP-BWWG 8/6
ANNEX 8 Page 6

I:\MEPC\59\2-16.DOC 3.4 Active Substance (AS), Relevant Chemic als (RC) and Other Chemicals (OC)

3.4.1 Active Substance

3.4.1.1 In this MPUV-based system, the Group accepts that photons are the only Active Substance available to kill and inactivate micro-organisms. The definition of photon is a particle of electromagnetic radiation that travel s at the speed of light, used to explain phenomena that require light to behave as particle s rather than as waves. Accordingly, as the photons are only availabl e upon turning on the MPUV lamp, there must be no residual photons in both the ballast water and ballast water discharge. Half-lives of the photons are expected to be in th e order of micro- to milliseconds.

3.4.1.2 Therefore the Group accepted that th e photon has no chance of exposing aquatic plants, invertebrates, fish, and other biota, including sensitive and representative micro-organisms. Therefore, all tests for effect s on such biota, are “not applicable” due to the non-residual characteristics of the photon.

3.4.1.3 Likewise, since the photons generate d in the MPUV reactor are never exposing mammals, all tests for effects on mammals are not applicable.

3.4.2 Relevant Chemicals

3.4.2.1 The Group noted that the hydroxyl radica l (OH•) is defined by the Applicant as a Relevant Chemical in this BWMS. The Group concurred with the applicant that the extreme reactivity of the hydroxyl radical (OH•) is indicated by its short half-life, typically nanoseconds. Under these circumstances wh ere the hydroxyl radi cal (OH•) can react non-selectively with organic compounds to give possible reaction products, the Group proposed that it was neither necessary nor practi cal to provide the physical characteristics or toxicological profiles of the hydroxyl radical.

3.4.3 Other Chemicals

3.4.3.1 It was recognized that the UV process may react with naturally occurring organic molecules in ballast water to form by-products with safety and envi ronmental concerns. It was agreed that, it was neither necessa ry nor practical to provide their physical characteristics or toxicological profiles.

3.4.3.2 It was noted that the applicant had id entified certain chemical by-products as being possible resultant products of the treatment system and had analysed the treated ballast water for them, as part of the application fo r Basic Approval, with the following results:GESAMP-BWWG 8/6
ANNEX 8 Page 7

I:\MEPC\59\2-16.DOC Concentrations of potential chemical by-products in control and UV-treated brackish water 21 PSU samples (provided by applicant)

Time (day 0) Time (day 1) Time (day 5) Chemical compounds Unit MDL Control Treated Control Treated Control Treated AOX mg/L 0.01 0.45 0.39 0.76 0.36 0.68 0.29 EOX mg/L 0.01 ND ND ND ND ND ND
Bromate μ g/L 0.46 ND ND ND ND ND ND
Trichloromethane μ g/L 0.001 ND ND ND ND ND ND
Dibromochloromethane μ g/L 0.001 ND ND ND ND ND ND
Bromoform μ g/L 0.001 0.003 0.002 0.003 ND 0.004 ND
Dibromomethane μ g/L 0.001 ND ND ND ND ND ND
Dichlorobromomethane μ g/L 0.001 ND ND ND ND ND ND 1,2,3-Trichloropropane μ g/L 0.001 ND ND ND ND ND ND 1,2-Dibromo-3-chloropropane μ g/L 0.001 ND ND ND ND ND ND 2-Chlorophenol μ g/L 0.03 ND ND ND ND ND ND 3-Chlorophenol μ g/L 0.03 ND ND ND ND ND ND 4-Chlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,3-Dichlorophenol μ g/L 0.02 ND ND ND ND ND ND 2,4-Dichlorophenol+ 3,5-Dichlorophenol μ g/L 0.02 ND ND ND ND ND ND

2,5-Dichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,6-Dichlorophenol μ g/L 0.03 ND ND ND ND ND ND 3,4-Dichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,3,4-Trichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,3,5-Trichlorophenol +2,4,5-Trichlorophenol μ g/L 0.02 ND ND ND ND ND ND

2,3,6-Trichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,4,6-Trichlorophenol μ g/L 0.03 ND ND ND ND ND ND 3,4,5-Trichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,3,4,5-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND
2,3,4,6-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND

2,3,5,6-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND

PCP μg/L 0.03 ND ND ND ND ND ND

2-Chlorotoluol μg/L 0.01 ND ND ND ND ND ND

4-Chlorotoluol μg/L 0.01 ND ND ND ND ND ND

1,2,4-Tribromobenzol μg/L 0.001 ND ND ND ND ND ND

1,3,5-Tribromobenzol μg/L 0.001 ND ND ND ND ND ND

Chloral hydrate μg/L 0.02 ND ND ND ND ND ND

Dibromoacetonitrile μg/L 0.01 ND ND ND ND ND ND

Dichloroacetonitrile μg/L 0.01 ND ND ND ND ND ND

Trichloroacetonitrile μg/L 0.02 ND ND ND ND ND ND

Monochloroacetic acid μg/L 0.01 ND ND ND ND ND ND

Dichloroacetic acid μg/L 0.01 ND ND ND ND ND ND

Trichloroacetic acid μg/L 0.01 ND ND ND ND ND ND

Bromochloroacetic acid μg/L 0.01 ND ND ND ND ND ND

Bromoacetic acid μg/L 0.01 ND ND ND ND ND ND

Dibromoacetic acid μg/L 0.01 ND ND ND ND ND ND

Density g/cm 3 0.00001 1.0238 1.0237 1.0237 1.0237 1.0237 1.0237

TRO mg/L 0.02 ND ND ND ND ND ND

DOC mg/L 0.005 11.40 26.30

POC mg/L 0.005 7.95 8.15

TSS mg/L 77.10 79.53GESAMP-BWWG 8/6
ANNEX 8 Page 8

I:\MEPC\59\2-16.DOC Time (day 0) Time (day 1) Time (day 5)

Salinity PSU 20.81
MDL = Method detection limit ND = Not detected

Concentrations of potential chemical by-products in control and UV-treated seawater 34 PSU samples (provided by applicant)

Time (day 0) Time (day 1) Time (day 5) Chemical compounds Unit MDL Control Treated Control Treated Control Treated AOX mg/L 0.01 0.51 0.51 0.45 0.48 0.24 0.29 EOX mg/L 0.01 ND ND ND ND ND ND
Bromate μ g /L 0.46 ND ND ND ND ND ND
Trichloromethane μ g/L 0.001 ND ND ND ND ND ND
Dibromochloromethane μ g/L 0.001 ND ND ND ND ND 0.001
Bromoform μ g/L 0.001 0.015 0.008 0.016 0.008 0.010 0.004
Dibromomethane μ g/L 0.001 ND ND ND ND ND ND
Dichlorobromomethane μ g/L 0.001 ND ND ND ND ND ND 1,2,3-Trichloropropane μ g/L 0.001 ND ND ND ND ND ND 1,2-Dibromo-3-chloropropane μ g/L 0.001 ND ND ND ND ND ND 2-Chlorophenol μ g/L 0.03 ND ND ND ND ND ND 3-Chlorophenol μ g/L 0.03 ND ND ND ND ND ND 4-Chlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,3-Dichlorophenol μ g/L 0.02 ND ND ND ND ND ND 2,4-Dichlorophenol+ 3,5-Dichlorophenol μ g/L 0.02 ND ND ND ND ND ND

2,5-Dichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,6-Dichlorophenol μ g/L 0.03 ND ND ND ND ND ND 3,4-Dichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,3,4-Trichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,3,5-Trichlorophenol +2,4,5-Trichlorophenol μ g/L 0.02 ND ND ND ND ND ND

2,3,6-Trichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,4,6-Trichlorophenol μ g/L 0.03 ND ND ND ND ND ND 3,4,5-Trichlorophenol μ g/L 0.03 ND ND ND ND ND ND 2,3,4,5-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND 2,3,4,6-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND 2,3,5,6-Tetrachlorophenol μg/L 0.03 ND ND ND ND ND ND PCP μg/L 0.03 ND ND ND ND ND ND 2-Chlorotoluol μg/L 0.01 ND ND ND ND ND ND 4-Chlorotoluol μg/L 0.01 ND ND ND ND ND ND 1,2,4-Tribromobenzol μg/L 0.001 ND ND ND ND ND ND 1,3,5-Tribromobenzol μg/L 0.001 ND ND ND ND ND ND Chloral hydrate μg/L 0.02 ND ND ND ND ND ND Dibromoacetonitrile μg/L 0.01 ND ND ND ND ND ND Dichloroacetonitrile μg/L 0.01 ND ND ND ND ND ND Trichloroacetonitrile μg/L 0.02 ND ND ND ND ND ND Monochloroacetic acid μg/L 0. 01 ND ND ND ND ND ND Dichloroacetic acid μg/L 0.01 ND ND ND ND ND ND Trichloroacetic acid μg/L 0.01 ND ND ND ND ND ND Bromochloroacetic acid μg/L 0.01 ND ND ND ND ND ND Bromoacetic acid μg/L 0.01 ND ND ND ND ND ND Dibromoacetic acid μg/L 0.01 ND ND ND ND ND ND Density g/cm 3 0.00001 1.0139 1.0138 1.0138 1.0138 1.0139 1.0137 TRO mg/L 0.02 ND ND ND ND ND ND DOC mg/L 0.005 4.62 4.55 POC mg/L 0.005 2.12 2.20 TSS mg/L 32.50 31.83 Salinity PSU 33.95 MDL = Method detection limit ND = Not detectedGESAMP-BWWG 8/6
ANNEX 8 Page 9

I:\MEPC\59\2-16.DOC 3.4.4 Conclusions

3.4.4.1 Based on these results, the Group concurred with the views of th e applicant that it was not necessary to provide toxicological a nd ecotoxicological data on these by-products and that an evaluation of the effects of treated ballast wate r should suffice to provide a recommendation regarding Basic Approval.

3.4.4.2 The Group agreed that it was not n ecessary to evaluate the properties of any Active Substance or Relevant Chemical asso ciated with this system. Instead, a brief evaluation was carried out on th e data generated by the applicant from testing the treated ballast water, the results of which ar e shown in the Appendix to this Annex.

4 HUMAN HEALTH ASSESSMENT

4.1 The Group noted that the potential hazards for human health related to overheating of UV lamps and exposure to UV irradiation resulting from operating this system were sufficiently addressed by the applicant by engi neering control measures put in place and training of operators. Therefore the Group conc luded that the risk of crew exposure was sufficiently mitigated by the measures put in place.

4.2 In addition the Group noted that all the disinfection by-products measured in the discharged ballast water were under LOD w ith exception of AOX (Adsorbable Organic Halogens) (0.29mg/L at day 5). The Group considered that th ese chemicals are short-lived and would not pose a toxicological concer n towards the genera l public swimming and eating fish from the area. The Group identified that the only potential for human health risk was related to exposure to UV irradiation from the treatment unit a nd therefore recommends that appropriate risk mitigation measures be put in place.

5 RISKS TO SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC

5.1 The Group was satisfied that, as the sy stem does not involve the storage or generation of chemicals to treat ballast water, there were no associated storage safety problems or risks.

5.2 The Group noted that the subm ission identified the only poten tial risk to the ship and its crew present in the BWMS was relate d to UV irradiation and overheating in the treatment unit from the UV lamps. The submission confirmed that these identified risks had been addressed by system safety measures th at ensure that there is no risk of personnel exposure to UV-irradiation and that automatic shut down occurs, in a no-flow situation, in order to prevent overheating.

5.3 The Gr oup noted that the corr osivity of UV-treate d seawater had been tested with the discharged ballast water from the EcoBallast BWMS during about six months. The test results showed no significant changes of th e corrosivity of the discharged seawater compared to raw seawater. The Group concl uded the results indicated that UV-treated seawater, the effluent of EcoBallast, has neglig ible effect on coating performance of ship’s ballast tank, when compared with natural seawater and coating performance will meet the IMO PSPC requirement.GESAMP-BWWG 8/6
ANNEX 8 Page 10

I:\MEPC\59\2-16.DOC 5.4 The Group noted that the applic ant had provided information (during the GESAMP-BWWG meeti ng) about normal maintenan ce procedures to keep the surface of the quartz sleeve in the UV lamps cl ean. This procedure includes frequent cleaning (every 15 hours of operation) using cl eaning solution of of low concentration of biodegradable organic acid. The Group recommends that detailed information for safe use of the cleaning procedure on-board should be supplied during Type Approval and evaluated by the Administration in accordance with Procedure (G8).

6 ENVIRONMENTAL RISK ASSESSMENT

6.1 Assessment of Persistence (p), Bi oaccumulation (B) and Toxicity (T)

6.1 The Group recognized that it was not po ssible to evaluate the persistence, bioaccumulation and toxicity of any chemicals within or produced by the system, as it does not use a chemical active substance or produce any relevant chemical for assessment. Assessment of the PBT-criteria is th erefore considered not applicable.

6.2 Derivation of the Predicted No Effect Concentration (PNEC)

6.2.1 The Group noted that the applicant had provided some acute and chronic aquatic ecotoxicity data for the 100% treated ballast wa ter that demonstrated a complete lack of toxicity in all studies except the chronic test s on Pacific Oyster ELS and Sea Urchin ELS with NOEC values of 12.5% and 6.25% respectively, and LC 25 values of 49% and 18.5% respectively (both LC 50 values were > 100%).

6.2.2 The Group noted that the slight effects seen in the two chronic ecotoxicity tests had not been sufficiently described by the appli cant in the non-confidentia l dossier. In response to a request for further information, the Group was informed that slig ht chronic toxicity effects had been observed in echin oderm and mollusc. However, the LC 50 values of the chronic toxicity effect to echinoderm an d mollusc were greater than 100% of the UV-treated ballast water and there should be no need for holding time in order to prevent adverse effects to the environment upon discharge of the ballas t water. The Group concurred with this view.

6.2.3 The Group agreed that the derivation of a PN EC is not possible as the nature of the system does not involve the use of chemicals that make the derivation of a PNEC either possible or necessary. The Group noted that full results of the ecotoxici ty tests are provided in the Appendix to this annex.

6.3 Calculation of the Predicted Environmental Concentration (PEC)

6.3.1 The Group agreed that there would be no poi nt in calculating the PEC of the treated ballast water, in view of th e absence of any PNEC values.

6.4 Calculation of the PEC/PNEC ratios

6.4.1 The Group noted that neither the PEC nor the PNEC had been de rived. The Group agreed that it was not necessary to do so in the present assessment.GESAMP-BWWG 8/6
ANNEX 8 Page 11

I:\MEPC\59\2-16.DOC 7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to the safety of the ship

7.1.1 Based on the points expressed above in this Annex, the Group agreed that this system was not likely to cause any concern with regards to the safety of the ship.

7.2 Risk to the crew and the general public

7.2.1 The Group agreed that the potential hazards for human health related to overheating of UV lamps and exposure to UV irradiation resulting from operating this system were sufficiently addressed by the applicant by engi neering control measures put in place and training of operators. Therefore the Group conc luded that the risk of crew exposure was sufficiently mitigated by the measures put in place.

7.2.2 In addition the Group noted that all the disinfection by-products measured in the discharged ballast water were under LOD w ith exception of AOX (Adsorbable Organic Halogens) (0.29mg/L at day 5). The Group considered that th ese chemicals are short-lived and would not pose a toxicological concer n towards the genera l public swimming and eating fish from the area. The Group agreed that the only potential for human health risk was related to exposure to UV irradiation from the treatment unit a nd therefore recommends that appropriate risk mitigation measures be put in place.

7.3 Risks to the environment

7.3.1 Based on the acute and chronic aquatic eco toxicity tests carried out on the treated ballast water, the Group agreed that this system was not likely to cause any concern with regards to the environment.

7.4 Recommendations

7.4.1 Having considered all of the data submitted for Basic Approval, the Group agreed to recommend that Basic Approval be given to this system.

7.4.2 Moreover, the Group was satisfied that the required tests ha d been performed correctly and that the results demonstrated that the system met the requirements of Procedure (G9) to allow it to be recommended for Final Approval. The Group was of the opinion that this application fulfils the requi rements for consideration for Final Approval.

* * *GESAMP-BWWG 8/6
ANNEX 8 Page 12

I:\MEPC\59\2-16.DOC Appendix

Properties of Treated Ballast Water

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group recognized that it was both unn ecessary and irrelevant to report the physical properties of treated ballast water.

2 MAMMALIAN TOXICITY

The Group noted that the applicant had indi cated that, as there were no measurable chemical by-products, there was no need to pr ovide any data with regards to mammalian toxicity. The Group agr ees with this view.

3 ENVIRONMENTAL EFFECTS

The Group noted that some acute and chronic a quatic ecotoxicity tests had been carried out by the Applicant using 100% treated ballast wa ter, both seawater (34 psu) and brackish water (21 psu). Results of the tests and c onclusions of the Group are presented below.

3.1 Acute Aquatic Ecotoxicity Data

3.1.1 The following text below summarizes the Group’s evaluation of the acute aquatic ecotoxicity of 100% treated ballast water, the detailed results of which are presented below in Tables 3 and 4 (supplied by Applicant). A ll acute tests showed no significant effects and all results were > 100% ba llast water concentration.

.1 Algae: For the study to assess the effects of the UV-treated ballast water on the diatom, Skeletonema costatum , during 72 hours

, NOEC and LOEC values based on the cell densities at the end of the experiment were calculated for both 34 psu and 21 psu treated ballast water.

.2 Crustacean: For the study to assess the effect s of the UV-treated ballast water on the copepod, Tigriopus japonicus, during 48 hours, EC 50 , and LC 50 values based on mobilization and survival data at the end of the experiment were calculated for both 34 psu and 21 psu UV-treated ballast water.

.3 Fish: For the study to assess the effects of the UV-treated ballast water on flounder, Paralichthys olivaceus , during 96 hours, and LC 50 values based on survival data at the end of the expe riment were calculated for both 34 psu and 21 psu treated ballast water.

.4 Echinoderms: For the study to assess the eff ects of the UV-treated ballast water on sea urchin, Anthocidaris crassispina , during 48 hours, EC 50 , and LC 50 values based on mobilization and survival data at the end of the experiment were calculated for 34 psu treated ballast water.GESAMP-BWWG 8/6
ANNEX 8 Page 13

I:\MEPC\59\2-16.DOC .5 Mollusc: For the study to assess the effect s of the UV-treated ballast water on pacific oyster, Crassostrea gigas , during 48 hours, EC 50 , and LC 50 values based on mobilization and survival data at the end of the experiment were calculated for 34 psu treated ballast water.

Table 3: Acute aquatic toxicity of UV-tr eated 34 psu ballast water

LC 50 and/or EC 50 Species End point Conc.(%) Guideline Reference

Algae Skeletonema costatum EC 50 72 h > 100 OECD 201

Crustacean Tigriopus japonicus EC 50 48 h
LC 50 48 h > 100 > 100 OECD 202

Fish Paralichthys olivaceus LC 50 96 h > 100 OECD 203

Echinoderm Anthocidaris crassispina EC 50 48 h
LC 50 48 h > 100 > 100 OECD 202

Mollusc Crassostrea gigas EC 50 48 h
LC 50 48 h > 100 > 100 OECD 202

Table 4: Acute aquatic toxicity of UV-tr eated 21 psu ballast water

LC 50 and/or EC 50 Species End point Conc.(%) Guideline Reference

Algae Skeletonema costatum EC 50 72 h > 100 OECD 201

Crustacean Tigriopus japonicus EC 50 48 h
LC 50 48 h > 100 > 100 OECD 202

Fish Paralichthys olivaceus LC 50 96 h > 100 OECD 203

3.2 Chronic Aquatic Ecotoxicity Data

3.2.1 The following text below summarizes the Group’s evaluation of the chronic aquatic ecotoxicity of 100% treated ballast water, the detailed results of which are presented below in Tables 5 and 6 (supplied by Applicant). The algae and fish chronic studies showed no significant effects and these results were equi valent to 100% ballast water concentration. However the two chronic st udies on mollusc (Pacific Oyster ELS) and echinoderm (Sea Urchin ELS) showed some significant e ffects with NOEC values of 12.5% and 6.25%, respectively, (both LC50 values were > 100%).

.1 Algae: For the study to assess the effects of the UV treated ballast water on the diatom, Skeletonema costatum, during 96 hours, NOEC and LOEC values based on cell densities at the end of th e experiment were calculated for both 34 psu and 21 psu treated ballast water.

.2 Fish: For the study to assess the effects of the UV treated ballast water on olive flounder, Paralichthys olivaceus , during seven or eight days, NOEC and LOEC values based on number of li ving organisms at the end of the experiment were calculated for 34 ps u and 21 psu treated ballast water.GESAMP-BWWG 8/6
ANNEX 8 Page 14

I:\MEPC\59\2-16.DOC .3 Echinoderms: For the study to assess the eff ects of the UV treated ballast water on the sea urchin, Anthocidaris crassispina , during 14 days, NOEC and LOEC values based on the living or ganisms at the end of the experiment were calculated for 34 psu treated ballast water.

.4 Mollusc: For the study to assess the effects of the UV treated ballast water on pacific oyster, Crassostrea gigas , during 10 days, NOEC and LOEC values based on the living organisms at the end of the experiment were calculated for 34 psu treated ballast water.

Table 5: Chronic aquatic toxicity of UV- treated 34 psu ballast water

LC 50 , LOEC, and/or
NOEC Species End point Conc.(%) Guideline Reference

Algae Skeletonema costatum NOEC 96 h 100 OECD 201

Fish Paralichthys olivaceus NOEC 8 d 100 OECD 212

Echinoderm Anthocidaris crassispina NOEC 14 d LOEC 14 d
LC 50 14 d 6.25 12.50 > 100 OECD 210

Mollusc Crassostrea gigas NOEC 10 d LOEC 10 d
LC 50 10 d 12.50 25.00 > 100 OECD 210

Table 6: Chronic aquatic toxicity of UV- treated 21 psu ballast water

NOEC Species End point Conc.(%) Guideline Reference

Algae Skeletonema costatum NOEC 96 h 100 OECD 201

Fish Paralichthys olivaceus NOEC 7 d 100 OECD 212

3.2.2 The Group noted the variability observed in the data sets on the two tests showing low levels of chronic toxicity, in partic ular with respect to the mollusc test.

3.2.3 The Group was satisfied with the response from the applicant regarding a revised text in the MEPC 59/2/4:

.1 Page 22 in MEPC 59/2/4

.1 From: “No chronic toxicity was observed; see report in Appendix III. Section 3.2”GESAMP-BWWG 8/6
ANNEX 8 Page 15

I:\MEPC\59\2-16.DOC .2 To: “No chronic toxicity was obs erved in algae and fish, however, slight chronic toxicity was observe d in echinoderm and mollusc; see report in Appendix III. Section 3.2”

.2 Page 30 and page 31 in document MEPC 59/2/4

.1 From: “5.2 Toxicity testing of the treated ballas t water Acute and chronic ecotoxicity tests with “E coBallast” treated seawater and brackish water covering multiple test species (a fish, an invertebrate and a plant) indicated no acute or chronic toxicity to any test organisms at any effluent concentrations as tested. Even the full strength effluent (100%) did not sh ow any deleterious effects on any of the test species. Consequently, th e effluent can be expected to be non-toxic to aquatic organisms as well as to the marine environment in general (Appendix III). The ac tual NOEC of “EcoBallast” treated seawater and brackish water was not measurable; the statistically determined NOEC was 100%. (Appendix III). Since the free radicals have a very short lifetim e and no significant toxic effects to aquatic organisms have been observed, and the NOEC has been shown to be 100%, there should be no need for holding time in order to observe further adverse effects upon discharge.”

.2 To: “5.2 Toxicity testing of the treated ballast water Acute and chronic ecotoxicity tests with “E coBallast” treated seawater and brackish water covering multiple test species (a fish, an invertebrate and a plant) indicated no significant acute or chronic toxicity to test organisms. Only slight chronic toxicity effect was observed in echinoderm and mollusc. However, LC50 values of the chronic toxicity effect to echinoderm and mollusc were greater than 100%. Even the full strength effluent (100%) did not show deleterious effects on the test species. Since the free radicals have a very short lifetime and no significant acute and chronic toxic effects to aquatic organisms have been observed, th ere should be no need for holding time in order to observe further adverse effects upon discharge.”

3.2.4 The Group concluded that these results may reflect low resi dual toxicity in discharged water, but they are considered to have minor potential for environmental impact and did not require any further action.

3.3 Information on Endocrine Disruption

3.3.1 The Group noted that the endoc rine disruption potential of treated ballast water had not been tested for specifically but the app licant reported that no potential endocrine disrupting chemicals had been identified in the treated water.

3.3.2 Based on this information, the Group agr eed that the treated ballast water was unlikely to have any endocrine disrupting effects.GESAMP-BWWG 8/6
ANNEX 8 Page 16

I:\MEPC\59\2-16.DOC 3.4 Sediment Toxicity

3.4.1 The Group noted that the applicant had indicated that, base d on the chemical analysis and toxicity tests of the treated ba llast water, there would not be any sediment toxicity associated with th e treated ballast water. The Group agrees with this view.

3.5 Bioavailability/Biomagnification/Bioconcentration

3.5.1 The Group noted that the applicant had indicated that, base d on the chemical analysis of the treated ballast water, ther e was no indication of a ny chemical by-products that might be bioaccumulative. The Group agrees with this view.

3.6 Food Web/Population Effects

3.6.1 The Group noted that the applicant had indi cated that, taking into account the 100% treated ballast water had been used to measur e any effects on the test species, it would be unlikely for the diluted ballast water to have any significant negative effects on ecological communities at environmentally relevant concen trations. The Group agrees with this view.

3.7 Environmental Fate and Behaviour

3.7.1 The Group recognized that there is no chemical Active Substance or any assessable Relevant Chemical produced by the sy stem and so there was no need to consider their environmental fate any further.

___________