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\2-19.doc

INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION

COMMITTEE

59th session Agenda item 2 MEPC 59/2/19 5 May 2009 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

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

Note by the Secretariat

SUMMARY

Executive summary: This document contains the re port of the ninth meeting of the GESAMP-Ballast Water Working Group (GESAMP-BWWG)

and includes the evaluation of proposals submitted for approval by Japan, the Netherlands and Ge rmany. Following the decision of MEPC 58, only the main body of the GESAMP-BWWG’s reports

is translated in all the 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 6

Related document: GESAMP-BWWG 9/6 (attached)

Introduction

1 The ninth meeting of the GESAMP-Ba llast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters from 23 to 27 March 2009 and its report is attached to this

document as GESAMP-BWWG 9/6.

2 The main purpose of this meeting was to revi ew the proposals for approval of ballast water management systems that make use of Active Substa nces to treat ballast water prior to discharge into the marine environment. The findings of th e Group are contained in annexes 4 to 6 of the attached report.

3 Due to the limited time between two consecutiv e sessions of the MEPC, the GESAMP-BWWG could only meet twice (GESAMP-BWWG 8 and GESAMP-BWWG 9) and was able to evaluate eight proposals for appr oval in their chronological order of submission. With a view to facilitating the consideration of as many ballast water management systems asMEPC 59/2/19 - 2 -

I:\MEPC\59\2-19.doc possible by the MEPC and in anticipation of an increasing workload for year 2010, the Group agreed to hold an extraordinary meeting (GESAMP-BWWG 10), te ntatively scheduled from 14 to 18 September 2009, to evaluate the remaining four proposals submitted by the deadline of 19 December 2008 and report to MEPC 60.

4 Since MEPC 60 will be held in March 2010, the Group agreed to te ntatively schedule its next regular meeting (GESAMP-BWWG 11) from 19 to 23 October 2009, subject to submission of relevant documents and application dossiers by Member Governments. In accordance with the approved timetable for activities related to GESAMP-BWWG meetings, the deadline for submission of proposals to be considered by MEPC 60 is 28 August 2009.

5 Recognizing the possibility that more than four proposals may be submitted for its review and approval by MEPC 60, the Group expressed its av ailability to have an additional meeting, in December 2009, to accommodate as many proposals as possible provided that all necessary conditions for organizing such a meeting are met.

Action requested of the Committee

6 The Committee is invited to:

.1 agree that Final Approval is given to the Hitachi Ballast Water Purification System (ClearBallast) submitted by Japan in document MEPC 59/2/5 (see annex 4);

.2 agree that Final Approval is given to the Greenship Sedinox Ballast Water Management System submitted by the Netherlands in document MEPC 59/2/6 (see annex 5);

.3 agree that Basic Approval is given to the AquaTriComb TM Ballast Water Treatment System submitted by Ge rmany in document MEPC 59/2/8 (see annex 6);

.4 note that the Group had agreed to hold an extraordinary meeting (GESAMP-BWWG 10), tentatively schedul ed from 14 to 18 September 2009, to evaluate the remaining four proposals s ubmitted by the deadline of 19 December 2008 and report to MEPC 60;

.5 note the suggested time schedule for th e eleventh meeting of the GESAMP-BWWG (19 to 23 October 2009) and invite Members to submit their proposals for approval (application dossiers) and the non-confid ential description of their ballast water management systems to MEPC 60 , as soon as possible but not later than 28 August 2009; and

.6 approve the report in general.

***I:\MEPC\59\2-19.doc GESAMP-BALLAST WATER WORKING GROUP (GESAMP-BWWG) Agenda item 9 GESAMP-BWWG 9/6

27 March 2009 Original: ENGLISH

REPORT OF THE NINTH 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 ................. 8GESAMP-BWWG 9/6 - 2 -

I:\MEPC\59\2-19.doc ANNEXES

Annex 1 List of members who attended the Ninth Meeting of the GESAMP-BWWG

Annex 2 Agenda for the Ninth Meeting of the GESAMP-BWWG

Annex 3 Terms of referen ce for the Technical Group

Annex 4 Review of proposals for approval of ba llast water management systems that make use of Active Substances – Hitachi Ballast Water Purification System (ClearBallast) (Japan)

Annex 5 Review of proposals for approval of ba llast water management systems that make use of Active Substances – Greenship Se dinox Ballast Water Management System (the Netherlands)

Annex 6 Review of proposals for approval of ba llast water management systems that make use of Active Substances – AquaTriComb TM Ballast Water Treatment System (Germany)- 3 - GESAMP-BWWG 9/6

I:\MEPC\59\2-19.doc 1 INTRODUCTION

1.1 The ninth GESAMP-Ballast Water Wo rking Group (GESAMP-BWWG) meeting was held at IMO Headquarters, London, from 23 to 27 March 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. Dandu Pughi uc, Head, Marine Bi osafety Section, who conveyed the appreciation of the Di rector of Marine Environment Division for the effort made by the members of the GESAMP-BWWG to have this additional meeting before MEPC 59 in an attempt to review as many as possible of the remaining proposals which had been submitted

before the deadline established for MEPC 59 (i.e. 19 December 2008). Mr. Pughiuc informed that, in view of the rapidly increasing worki ng load for the Group and the importance and need for timely review of the proposals for approval, IM O is prepared to take all the possible actions to maximize the effectiveness and efficiency of the Group in the common effort to respond to the growing number of proposals for approval. Al so on this subject, Mr. Pughiuc emphasized the need to continue the work on adapting the MAMP EC model to the specificity of ballast water discharges and invited the members of the Gr oup advice on the next step s in this respect.

1.3 The Group was also inform ed a new link for approved ballast water management systems on the IMO’s website and agreed that a clear di stinction between systems that have undergone evaluations according to Procedure (G9) and system s approved in accordance with Guidelines (G8)

needs to be made.

1.4 Mr. Pughiuc expressed his appreciation fo r the effort made by the IMO consultant, Dr. Andrew Craven, for his hard work in prep aring this meeting and for reviewing a large amount of documentation in a relatively short period of time.

1.5 Finally, Mr. Dandu Pughiuc re ported on the contractual a rrangements 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 the proposal for approval of the AquaTriComb TM Ballast Water Treatment System (Germany) is reviewed, due to his involvement in the development of this technology. Dr. Gollasch took no part in this

evaluation and his contract was conse quently reduced to ten working days.

2 ISSUES OF CONFIDENTIALITY

2.1 One proposal for Basic Approval of ballast water management systems that make use of Active Substances had been submitted by Germany (MEPC 59/2/8) and two proposals for Final Approval had been submitted by Ja pan (MEPC 59/2/5) and the Netherlands (MEPC 59/2/6). All three submissions contained confidential supporting data.

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

the Secretariat would liaise with the relevant Administrations prior to submitting the report

to MEPC.

2.3 Pursuant to paragraphs 4.2.2, 8.1.1 and 8.1.2.7 of the “Procedure for approval of ballast water management systems that make use of Activ e Substances (G9)”, all information gathered, materials, notes and reports obtained or ma de out during the work of the GESAMP-BWWG,GESAMP-BWWG 9/6 - 4 -

I:\MEPC\59\2-19.doc were, and will be, treated as confidential. 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 Consultant, at his request, during the working hours. They were available for consultation by the members of the Group for the duration of the meeting in the meeting room and returned to the Organization’s designated room after the working hours.

2.6 On completion of the work, the Chairman of the GESAMP-BWWG obtained from the other members all the documents, drafts and any other associated records and reports, which

were transmitted to the Technica l Secretary of the GESAMP-BWWG for retention in confidence.

All electronic records and data held on personal computers/laptops were destroyed when they were no longer necessary for the work of the GESAMP-BWWG.

3 TERMS OF REFERENCE AND TIME FRAME

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

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

TIMETABLE FOR ACTIVITIES RELA TED TO GESAMP-BWWG MEETINGS

Timeline Activity

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

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

20 weeks before MEPC GESAMP-BWWG Meeting

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

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

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

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

13 weeks before MEPC Submission of the report of the meeting of the GESAMP-BWWG in

accordance with the 13-week deadli ne (bulk documents) for MEPC- 5 - GESAMP-BWWG 9/6

I:\MEPC\59\2-19.doc 3.3 Due to the limited time betw een two consecutive se ssions of the MEPC, the Group could only meet twice (GESAMP-BWWG 8 and GESAMP-B WWG 9) and was able to evaluate eight proposals for approval in their ch ronological order of submission. W ith a view to facilitating the consideration of as many balla st water management systems as possible by the MEPC and in anticipation of an increasing wo rkload for year 2010, the Group agr eed to hold an extraordinary meeting (GESAMP-BWWG 10), tentatively sc heduled from 14 to 18 September 2009, to evaluate the remaining four proposals subm itted by the deadline of 19 December 2008 and to report to MEPC 60.

3.4 Since MEPC 60 will be held in March 2010 , the Group noted that the deadline for submission of proposals for approval to be considered by MEPC 60 is 28 august 2009 and agreed to tentatively schedule its elev enth meeting for 19 to 23 Octobe r 2009, subject to submission of relevant documents and application dossiers by Member Governments. The Group will review the application dossiers received before 28 August 2009 and will further develop its “Methodology for information gathering and the conduct of work” as necessary.

3.5 Recognizing the possibility that more than four proposals may be submitted for its review and approval by MEPC 60, the Group expressed its availab ility to have an a dditional meeting to accommodate as many proposals as possible provided that all necessary conditions for organizing such a meeting are met.

4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER

MANAGEMENT SYSTEMS

4.1 General review of the submissions

4.1.1 The Group noted that submissions for Fina l Approval had been received from Japan

and the Netherlands whilst a submission for Basi c Approval had been received from Germany.

4.1.2 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 atte ntion of the MEPC. These are addressed in the

rest of this section.

4.1.3 During a general discussion on the possibility of requesting the manufacturers to address additional aspects to the ones id entified during the evaluation fo r Basic Approval, the Group was of the view that aspects posing a risk to the environment or hu man health not raised during the

initial evaluations could still be questioned, particularly when the systems or the Methodology have changed.

4.1.4 The Group recommended that Administrations, before submitti ng a Final Approval dossier to MEPC, should check and confirm whether or not the ecotoxicity testing required by Procedure (G9) is performed as part of the Type Approval testing in accordance with the requirements for the whole effluent tests, as this has implications fo r the dossier review required under Procedure (G9).

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

4.1.6 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.GESAMP-BWWG 9/6 - 6 -

I:\MEPC\59\2-19.doc 4.1.7 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.

4.2 Detailed review of the submissions

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

Annex BWMS Administration

4 Hitachi Ballast Water Purificati on System (ClearBallast) Japan

5 Greenship Sedinox Ballast Water Management System the Netherlands

6 AquaTriComb TM Ballast Water Treatment System Germany

4.2.2 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 given to the Hitachi Ballast Water Purification System (ClearBallast) (Japan);

.2 Final Approval be given to the Gr eenship Sedinox Ballast Water Management System (the Netherlands); and

.3 Basic Approval be given to the AquaTriComb TM Ballast Water Treatment System (Germany).

4.3 Specific comments related to the Hitachi Ballast Water Management System (ClearBallast)

4.3.1 The Group noted that the Hitachi Ballast Wa ter Management System (ClearBallast) is a system consisting of coagulation and magnetic separation, with rem oval of the resulting

flocculated material from the ballast water.

4.3.2 The Group recommended to MEPC that Fina l Approval be given to the Hitachi BWMS (ClearBallast) provided that the concerns and issu es raised in the review are addressed by the Applicant and this is confirmed by the Admini stration during Type Approval procedures under Guidelines (G8).

4.3.3 The Group, having reviewed the dossier an d additional responses requested of the applicant, was of the opinion that although generally safe, this system remains under development. The Group agreed that when this BWMS is correctly operated it will present no unacceptable risks to the environment, and when a ll the risk mitigation measures that have been identified as necessary in this review are develope d in detail and implemented, the ClearBallast BWMS will present no unacceptable ri sks to the safety of the ship, its crew or human health. To this end, the Group st rongly recommended that the MEPC requests the Administration undertaking th e Type Approval testing under Guidelines (G8) to inform

the Committee that all issues and concerns have been addressed prior to issuing a Type Approval Certificate for this system.- 7 - GESAMP-BWWG 9/6

I:\MEPC\59\2-19.doc 4.4 Specific comments related to the Greensh ip Sedinox Ballast Water Management System

4.4.1 The Group noted that the Greenship Sedinox Co mbined Ballast Water Management System

consists of sediment removal and in situ electrolysis using seawater to produce Active Substance

for biocidal treatment of ballast water.

4.4.2 The Group noted that in response to th e comment of the GESAMP-BWWG that the system needed refinement (MEPC 58/2/7, a nnex 6, paragraph 2.1.9), the Applicant had significantly refined the sy stem without changing the principles of the treatment. The refinement consisted of three main adjustments: (1 ) lowering the maximum dose concentration of Active Substance at uptake, (2 ) removal of the disi nfection at ballast wa ter discharge and (3) installing online continuous mon itoring of Active Substance during uptake with continuous feedback to the electrolytic cells to maintain an optimum dose concentration of Active Substance. The Group reviewed these modifications in detail and noted that significa nt improvements to the BWMS have resulted, and in view of all the info rmation now received from the Applicant on this refined system, the Group was satisfied with th e completeness of the dossier received from the Applicant.

4.4.3 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 Greenship Sedinox BWMS, subject to the Administration verifying that these two re commendations have been fully addressed prior to issuance of a Type Approval Certificate:

.1 maximum allowable dosage of Active Substance at FAC of 1.0 mg/L as Cl 2 is monitored by FAC sensor adequately ca librated and maintained. FAC should be recorded during uptake; and

.2 maximum allowable discharge con centration of Active Substance The concentration of FAC at discharge shoul d be kept to a leve l not exceeding the range of 0.01-0.20 mg/L as Cl 2 even after a short leg. During the Type Approval procedure by the Administration, the A pplicant should decide on the maximum allowable discharge concentration of TRO in the range of 0.01-0.20 mg/L as Cl 2 and this value should be approved by th e Administration. This parameter should be monitored by FAC sensor adequately calibrated and maintained.

4.5 Specific comments related to the AquaTriComb TM Ballast Water Management System

4.5.1 The Group noted that the AquaTriComb system is a Ballast Water Management System consisting of filtration and disinfection by low- pressure ultraviolet-light and low-frequency ultrasound. The Group noted that the low-pressu re UV technology in the system makes use of electromagnetic radiation (photons) and the lo w-frequency ultrasound technology makes use of

ultrasonic oscillation and cavitati on effects to treat the ballast water and for cleaning purposes.

5 ANY OTHER BUSINESS

No action was taken unde r this agenda item.GESAMP-BWWG 9/6 - 8 -

I:\MEPC\59\2-19.doc 6 CONSIDERATION AND ADOPTION OF THE REPORT

6.1 A draft report of the ninth meeting of the GESAMP-BWW G was produced on 27 March 2009 and, after a paragraph-by-paragra ph review, the Group agreed on the final text and requested the Secretariat to make the nece ssary 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 9/6

I:\MEPC\59\2-19.doc ANNEX 1

LIST OF MEMBERS WHO ATTENDED THE NINTH MEETING

OF THE GESAMP-BWWG

Mr. Jan Linders (Chairman)

Senior Risk Assessor

National Institute for Public Health and Environment Expert Centre on Substances

Anthonie van Leeuwenhoeklaan 9

RIVM-SEC

P.O. Box 1

NL-3720 BA Bilthoven

The Netherlands E-mail:

Tel:

Fax: jan.linders@rivm.nl

+31 30 274 3164

+31 30 274 4401

Ms Teresa Borges

Senior Technical Officer

Avenida Rio de Jane iro, no 58, 3o dto

1700-338 Lisbon Portugal E-mail:

Tel:

Mobile: tborges@dgs.pt

+351 2 1843 0599

+351 9 1779 8048

Dr. Stephan Gollasch

GoConsult

Grosse Brunnenstr. 61

22763 Hamburg Germany E-mail:

Tel:

Mobile : sgollasch@aol.com

+49 40 390 54 60

+49 177 590 54 60

Mr. Shinichi Hanayama

Senior Research Fellow Maritime Technology Department Ocean Policy Research Foundation

1-15-16 Toranomon

Minato-ku Tokyo 105-0001 Japan E-mail:

Tel:

Fax: s-hanayama@sof.or.jp

+81 3 3502 1886

+81 3 3502 2033

Ms Annette Kronborg

Director Adalia Toxicology Consultants Runslingan 3E SE-187 72 TÄBY

Sweden E-mail:

Tel:

Fax:

Mobile: annette.kronborg@adalia.se

+46 8 510 149 36

+46 8 510 126 02

+46 70 483 11 23GESAMP-BWWG 9/6

ANNEX 1 Page 2

I:\MEPC\59\2-19.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-mails:

Tels:

Fax:

Mobile: rhiekt@khu.ac.kr alga0720@hotmail.com +82 (2) 961-0720 (Univ.) (2) 961-0603 (Lab.) +82 (2) 961 0244 (Univ.)

+82 16 9343 3860

Dr. Frank Stuer-Lauridsen LITEHAUZ ApS Diplomvej 381 DK 2800 Lyngby

Denmark E-mail:

Tel:

Mobile: fsl@litehauz.dk

+45 8870 8675

+45 2023 0202

Mr. David Tongue Marine Manager International Chamber of Shipping

12 Carthusian Street

London EC1M 6EZ United Kingdom E-mail:

Tel:

Fax:

Mobile: david.tongue@marisec.org

+44 20 7417 2860

+44 20 7417 8877

+44 78 5539 1258

IMO-GESAMP CONSULTANT

Dr. Andrew Craven

23 Wenlock Drive

Escrick

York YO19 6JB United Kingdom E-mail:

Tel:

Fax: andrew.craven7@btinternet.com +44 (0) 7849 070 668 (Mobile) +44 (0) 1904 728 428 (H)

GESAMP

Mr. Martin Soderberg

GESAMP Officer

Marine Environment Division International Maritime Organization 4 Albert Embankment, London SE1 7SR United Kingdom E-mail:

Tel:

Fax

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

0755 269 9604GESAMP-BWWG 9/6

ANNEX 1 Page 3

I:\MEPC\59\2-19.doc MED DP TH jw IMO SECRETARIAT

Mr. Miguel Palomares

Director

Marine Environment Division International Maritime Organization

4 Albert Embankment

London SE1 7SR United Kingdom E-mail:

Tel:

Fax: mpalomares@imo.org +44 (0)20 7587 3218 +44 (0)20 7587 3210

Mr. René Coenen IMO Technical Secretary to GESAMP

Marine Environment Division International Maritime Organization

4 Albert Embankment

London SE1 7SR United Kingdom E-mail:

Tel:

Fax: rcoenen@imo.org +44 (0)20 7587 3239 +44 (0)20 7587 3261

Mr. Dandu Pughiuc IMO Technical Secretary to GESAMP-BWWG

Marine Environment Division International Maritime Organization

4 Albert Embankment

London SE1 7SR United Kingdom E-mail:

Tel:

Fax: dpughiuc@imo.org +44 (0)20 7587 3247 (Direct) +44 (0)20 7587 3261

Mr. Huang Tianbing Technical Officer, Marine Biosafety Section

Marine Environment Division International Maritime Organization

4 Albert Embankment

London SE1 7SR United Kingdom E-mail:

Tel:

Fax: thuang@imo.org +44 (0)20 7463 4198 (Direct) +44 (0)20 7587 3261

***GESAMP-BWWG 9/6

I:\MEPC\59\2-19.doc ANNEX 2

AGENDA FOR THE NINTH MEETI NG OF THE GESAMP-BWWG

1 Introduction

2 Issues of confidentiality

3 Terms of reference and time frame

4 Review of proposals for the a pproval of Active Substances

– Hitachi Ballast Water Purification Syst em (ClearBallast)) for Final Approval

– Greenship Sedinox Ballast Water Management System for Final Approval

– AquaTriComb TM Ballast Water Treatment System for Basic Approval

5 Any other business

6 Consideration and adoption of the report

***GESAMP-BWWG 9/6

I:\MEPC\59\2-19.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-s et 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 applic ation of the Activ e Substance (see paragraph 6.3 of Procedure (G9));

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

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

.6 scientific recommendations on whether th e proposal has demonstrated a potential for unreasonable risk to the environment, human health, property or resources (see paragraph 8.1.2.8 of Procedure (G9)); and

.7 preparation of a report a ddressing the above-mentioned aspects for consideration by MEPC (see paragraph 8.1.2.10 of Procedure (G9)).

3 For Final Approval, the Gr oup should review the discharg e testing (field) data and

confirm that the residual toxi city of the discharge conforms to the evaluation undertaken for Basic Approval and that the previous eval uation of the risks to the ship and personnel including consideration of the storage, handling and applicat ion of the Active Substance remains valid. The evaluation will be reported to the MEPC (see paragraph 8.2 of Procedure (G9)).

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

***GESAMP-BWWG 9/6

I:\MEPC\59\2-19.doc ANNEX 4

REVIEW OF PROPOSALS FOR APPRO VAL OF BALLAST WATER MANAGEMENT

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

Hitachi Ballast Water Purifica tion System (ClearBallast)

Submitted for Final Approval by Japan

0 SUMMARY

0.1 Having reviewed all the data and informa tion submitted by Japan with the application for Final Approval and the information receive d from the applicant during the GESAMP-BWWG meeting, the Group recommended to MEPC that Fi nal Approval be given to the Hitachi BWMS (ClearBallast) provided that the concerns and issues raised in this review are addressed by the applicant to the satisfaction of the Admini stration. To avoid unr easonable risk to the environment, human health, property or resour ces the system should be operated with the following restrictions:

.1 M aximum allowable dosages of Active Substances – The maximum dose for

these Active Substances should be set as follows:

5 mg/L of PAC (as Al) 30 mg/L of triir on tetraoxide (Fe 3 O 4 ) 1 mg/L of PASA; and

.2 M aximum allowable discharge concentr ations of Active Substances – The system should ensure a maximum discha rge concentration of all the Active Substances and Relevant Chemicals, if the separation and filtering process are functionally operated. To ensure these processes, the water level in these components should be recorded during ballast water intake.

.3 PASA needs to be strictly controlled by adequate selection of the suppliers in order to keep the concentration of acrylamide monomers as its impurity

below 0.2%. Procedures shoul d be included in the Qual ity Assurance Program to ensure that only PASA with an acrylamid e monomer content of less than 0.2% is supplied for the operation of this BWMS

0.2 The Group recalled that Basic Approval of the Hitachi BWMS (ClearBallast) was given by MEPC and the report was available as document MEPC 57/2 (BWWG 4, annex 5, Report of Application for Basic Approval).

0.3 The Group wished to stress that the evaluati on of the ClearBallast system in this report did not take account of the potential risk mitigation effect of the a ddition of a heat treatment step as suggested by the applicant during the exchange of information (Questions and Answers) at the meeting of GESAMP-BWWG 9. Therefore, heat tr eatment which has not yet been developed by the applicant was explicitly not considered is this report.

0.4 The Group limited itself to the system as presented, and regarded this as generally complete but identified a number of points which in its opinion need fu rther attention. Some operational procedures appear sti ll to be developed, such as de finitive safety and maintenance procedures and manuals.GESAMP-BWWG 9/6

ANNEX 4 Page 2

I:\MEPC\59\2-19.doc 0.5 The Group noted that the ClearBallast Ballas t Water Management System (BWMS) uses a combination of Coagulation and then Magnetic Sepa ration to treat the ballast water, and as such there is no biocidal activity involved in the treatment process, which produces significant quantities of separated floc material (sentence deemed to be confidential and removed at the request of the submitting Administration). Th erefore the Group concluded that adequate management of the flocculated material is one of the key issues needed to prevent risks to human health or the environment according to the principles of the BWM Convention. The Group

recalled that the flocculated material consists of a condensed mixture of organic matter and organisms including bacteria and po tentially pathogens that is no t disinfected by any chemicals. Therefore, particularly careful management w ill be needed for this flocculated material. The Group was of the opinion that such material may pose a risk if discharged at sea.

0.6 The Group recognized that the system relies on various Active Substan ces (triiron tetraoxide, PAC and PASA) with potential safety and enviro nmental concerns and th e Group has reviewed the

hazards and risks associated with each of the Active Substances, together with one relevant chemical (acrylamide monomers which occur as an impurity in PASA).

0.7 The Group highlighted that the acryla mide impurity in PASA has toxicological properties of high co ncern towards human health as th is chemical has carcinogenic (IARC classification 2A, proba ble carcinogenic to humans (IARC, 1994)) and neurotoxic properties. Therefore it was stressed that the quality of th e polyacrylamide (PAS A) needs to be strictly controlled by adequate se lection of the suppliers in order to keep the concentration of acrylamide monomers as its impurity belo w 0.2%. Procedures should be included in the Quality Assurance Program to ensure that only PASA with an acrylamide content of less than 0.2% is supplied for the operation of this BWMS.

0.8 In addition, the Group noted the provision by the applicant of detailed analytical results for the Active Substances, relevant chemical and other chemicals in treated ballast water. However, the Group noted that no quantitative analysis of th e potential biological content of the flocculated material (e.g., analysis of viable pathogens) was provided as had been requested at Basic Approval.

0.9 The Group noted that the human health a ssessment provided by the applicant addressed the risks related to occupational exposure which included a description of the different working operations in the system according to the r ecommendations made by BWWG 4, annex 5, Report of Application for Basic Approval.

0.10 The Group also noted that according to the applicant, additional safety measures concerning occupational exposure are planned to be implemented in or der to minimize the risk of human exposure to chemicals used in this system . The Group considered that the procedures and measures to be put in place related to handling an d disposal of the collected flocs will necessarily have to take into account strict engineering control measures and detailed instructions. Furthermore, adequate PPE/RPE , should be included in the Operation Ma nual to provide the necessary QA standards. Alternatively a fully auto mated system for the treatment and handling of the flocculated material should be incorporated in the BWMS.

0.11 The Group, not wanting to delay system a pproval unnecessarily a nd taking the unusual, biocide-free design of the system into accoun t, considered that the applicant had provided sufficient information for BWWG to recommend to MEPC that it be granted Final Approval and that any outstanding aspects could be dealt with by the Administ ration prior to Type Approval.GESAMP-BWWG 9/6

ANNEX 4 Page 3

I:\MEPC\59\2-19.doc 0.12 The Group noted that the total weight of an operational syst em appears high compared to other proposed ballast water management syst ems, and recommended that the Administration approving a ship installation ensures that this fact or is fully taken into account when determining a suitable location, the additional effect on ship stability of a gravity fed “buffer tank” may also

be found a relevant consider ation in this respect.

0.13 The Group recognized that the applicant has provided detailed information on ecotoxicity testing of treated ballast water, environmenta l risk assessment for aquatic organisms and proposals for maximum allowable discharge con centrations for the Active Substances and relevant chemical. The Group accepted the view of the applicant that there should be no unacceptable risks to the environment posed by the use of this BWMS, based on individual

calculations for the different substances as well as estimations using the MAMPEC-model.

0.14 The Group, having reviewed the dossier an d additional responses requested of the applicant, was of the opinion that the system should be considered generally safe for the environment, the crew and human health, when th is BWMS is correctly operated. To this end, the Group strongly recommended that the MEPC invites the Admini stration undertaking the Type Approval testing under Guidelines (G8) to ensure that all issues and concerns have been addressed prior to issuing a Type A pproval Certificate for this system.

.1 The procedure for handling the floccula ted material that contains a condensed mixture of organic matter and organism s including bacteria and potentially pathogens is unclear. In the flocs all material is concen trated and the instructions on how to handle this potentially bio-ha zardous material should be clear and unambiguous to all crew concerned. Theref ore, prior to operating the system, the applicant will have to provide an Operat ion/Technical Manual where all safety procedures should be explicitly described including the different risk mitigation measures and PPE/RPE prescribed in all handling, storage and treatment steps of the flocculated material generated by the system.

.2 The Group noted that a gravity “buffer tank” is a requirement of the system.

Additional water level error detection device s will require to be incorporated into the BWT equipment control system to counter the potential for high

level/overflow and low level in the “ buffer tank”. The Group noted that the system evaluated does not utilize a disc harge pump connected directly to the outflow of the filter separator

.

.3 The questions relating to the provisi on of a drain from residue tank and its cleaning requirement were not answered to the Groups satisfaction and need to be dealt with appropriately by describing the safety proced ures extensively in the Technical/Operations Manual.

.4 The Group considered that the mainte nance requirements provided were very general and that these should be suppleme nted in the final Technical Manual with

sufficient detail to enable full assessment of both the work actually required and the potential for operator exposure.GESAMP-BWWG 9/6

ANNEX 4 Page 4

I:\MEPC\59\2-19.doc 1 INTRODUCTION

1.1 The data used to evaluate this system we re extracted from that supplied by Japan in document MEPC 59/2/5, which was supplemente d by additional information provided by the applicant after a request for further in formation by the Group during its meeting.

2 COMPLETENESS OF DOSSIER AND APPLICANT RESPONSES TO DATA REQUESTS FROM GROUP

2.1 The Group recalled that it had already provi ded the following questions and concerns during its evaluation of th e application for Basic A pproval of the system (see MEPC 57/2 – BWWG 4, annex 5, Report of Application for Basic Approval), section 0.4 of Summary (.1 to .13) and sec tion 9.4 of Conclusions (.1 to .15) which it considered should be addressed by the applicant prio r to application for Final Appr oval. The applicant’s responses received, and the Group’s reaction to these responses is shown below, as a summary table:GESAMP-BWWG 9/6ANNEX 4Page 5I:\MEPC\59\2-19.docTable 1: Applicant’s Responses to Data Requests from the Group at evaluation for Basic ApprovalSectionNo.Refs. fromBA Report(Summary,0.4 andConclusions,9.4)Group’s Question Applicant’sResponse and Section No. inthis ReportGroup’s Reaction2.1.1 .1 and .1An adequate quality assurance programme needs tobe developed for the entire systemincluding thequality of PASA at industrial production.Hitachi Plant Technologies, Ltd. will assume controland responsibility for the quality of the entire system(design, construction and maintenance of equipmentmain unit, and supply of consumable chemicals).See Section 5.2.1 for information on acrylamidemonomers in PASAThe Group was generally satisfiedwith this response, however it wasnoted that all the necessaryqualifying detail is not included inthe dossier.2.1.2 .2 and .2For final approval, the human health risks of thesystem will be evaluated by the GESAMP BWWGon the basis of its individual unit operations, i.e. eachcomponent of the system requiring operator attention.The manufacturer is therefore requested to describeseparately the potential human health risks associatedwith each major componentof the system and todescribe the measures necessary to prevent humanexposure for each such component. In particular, themethods employed for the collection, treatment anddisposal of floc and their potential for occupationalexposure need to be described. Additionally, therecommended risk reduction measures need clearexplanation and documentation, e.g., for eachprocedure such as floc collection, dewatering, drying,incineration, sterilization, storage and disposal inwhatever form.In the assessment of crewexposure, the risks of eachcomponent of the system associated with the unitoperations have been identified and clearly indicated.To eliminate the material risks, the equipmentsettings have been reviewed from the viewpoint ofcrew safety, and statements regarding the use ofsuitable protective gear and safety gear have beenadded. On the basis of this review, the risksassociated with operationsfor the collection, storageand disposal of flocs have been identified, andmeasures to reduce these risks are considered anddescribed.See Sections 3.1 and 3.2 for description of thesystem controls and safety considerationsThe Group was generally satisfiedwith this response, however all thenecessary qualifying detail is notincluded in the dossier. The riskmitigation measures identifiedconsist only of generalisationswhere specific process detail isrequired. Such detail should beavailable in the system operationalmanual that is recommended toform part of the dossier. Thismanual was not made available forthe Group to review.GESAMP-BWWG 9/6ANNEX 4Page 6I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summary,0.4 andConclusions,9.4)Group’s Question Applicant’sResponse and Section No. inthis ReportGroup’s Reaction2.1.3 .3 and .5The storage and handling of the three ActiveSubstances on board needs to be carefully controlledand the proposed safety measures adequatelydocumented, particularly bearing in mind thecorrosive properties of poly aluminum chloride.The physical and chemical states of the three ActiveSubstances are specified, the risks they pose to theship’s hull are characterized and assessed, and thenthe guidelines for theirstorage and handling areproposed. In particular, withregard to PAC which isslightly corrosive to metals, measures are in place forthe prevention and avoidance of hull corrosion byusing resin coatings at surfaces in contact with thismaterial.See Section 3.2 for safety considerations andSection 5.1 for risks to ships safety (seephysico-chemical data in Appendix)The Group was generally satisfiedwith this response, however againthe specific detail considerednecessary was not provided in thedossier with generalisations onlyprovided. The detailed provisionsfor protection against corrosion forthe storage of PAC wereconsidered adequate.2.1.4 .4 and .6One major human health issue regarding the ActiveSubstances relates to the residual acrylamidemonomer contained in the polyacrylamide, which hasa range of associated human health hazards andwhich, in parallel to best practices in drinking waterpurification, needs to be maintained at appropriatelylow concentrations. The quality of thepolyacrylamide active substance needs to be strictlycontrolled and included in the QA program to ensureacceptably low concentrations of acrylamidemonomer.The maximum allowable discharge concentration(MADC) is based on the collected data on thehazards to human health and aquatic organisms byresidual acrylamide monomers in polyacrylamide.Polyacrylamide of sufficient quality to satisfy thesedesign concentrations is supplied by Hitachi PlantTechnologies, Ltd.See Section 5.2.1 for information on acrylamidemonomers in PASA. MADCs are described inSection 6.4The Group was satisfied with thisresponse.GESAMP-BWWG 9/6ANNEX 4Page 7I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summary,0.4 andConclusions,9.4)Group’s Question Applicant’s Response and Section No. inthis ReportGroup’s Reaction2.1.5 .5 and .7The BWMS appears from the technical description tobe partly open, allowing for possible occupationalexposure to the crew to system processes and waste.This is a potential weakness of the system thatremains to be adequately addressed.The constituent equipment of this system has a fullyclosed structure in orderto prevent the leakage orescape of liquid or dust particles. With regard to thepossibility of exposure to crewmembers whilecarrying out their work, the assessment and measuresare included in a response to the points raised inSummary 0.4.2 / Conclusions 9.4.2.See Sections 3.1 and 3.2 for description of thesystem controls and safety considerationsThe Group was satisfied with thisresponse.2.1.6 .6 and .8Human health issues related to the potentialconcentration of pathogens in the flocs need to beexamined and assessed in detail. The flocs couldunder heavily polluted intake conditions, have thepotential to form a biohazard.Considering the possibility of pathogenic bacteriacontained in the intake water, safety measures forhuman health have been established against thepotential risks of pathogenic bacteria exposure risksto ship crew. To promote careful handling ofcollected flocs in preparation of bacteria captured infloc, labels are affixed to the collected flocs storagetanks and carrying containers recommending the useof protective gear and promoting care with regard topathogenic bacteria in the floc storage and landingprocesses, and stating that the storage tanks andtransportation containers are to be kept closed.See Section 4.2 for assessment of exposure to ships’crew (see Section 3.2 for safety considerations)The Group was not satisfied withthis response. The handling,storage and treatment of theflocculated material require furtheraddressing by the applicantGESAMP-BWWG 9/6ANNEX 4Page 8I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summary,0.4 andConclusions,9.4)Group’s Question Applicant’s Response and Section No. inthis ReportGroup’s Reaction2.1.7 .7 and .9Adequate separation of the flocs from the treatedwater is crucial to the successful operation for thesystem. When scaling up to larger treatmentcapacities, this aspect must be addressed by theapplicant, to ensure the human and environmentalrisks of the treated ballast water remains acceptable.When the equipment is scaled up, its processingperformance does not changeand there is no risk onscaling up this system. In addition, the human andenvironmental risks via treated ballast water andoperations relating to the system remain acceptablewith appropriate measures.This is not only backedup by theory, but has also been clearly demonstratedfrom the results of comparative verification tests ofprototype test setup and land-based test setup.See Section 4.2 for assessment of exposure toships’ crew and Section 6.2 for ecotoxicity testingof treated ballast waterThe Group was satisfied with thisresponse2.1.8 .8 and .10The positioning and operation of the proposed prefiltration, as well as post filtration and its residuefeedback system must be better described anddocumented. The procedures and processes forroutine system maintenance, emergency procedures,filter and sludge conveyor cleaning, and thetreatment and handling of the sludge must be definedand detailed.The flow paths of water and flocs including theinstallation point of the filter separator unit, the flowof treated water, and the flow of filter residuestrapped in the filter separator unit have beenexplicitly indicated. Daily and periodic maintenance,recovery procedures for error and emergencysituations, cleaning of the filter unit of filterseparator, and cleaning offloc collection mechanismof magnetic separator have been expressed clearly inthe corresponding descriptions. The treatment andhandling of collected flocs have been addressedwithin the concerns raised in Summary 0.4.2/Conclusions 9.4.2.See Sections 3.1 and 3.2 for description of thesystem controls and safety considerationsThe Group was not satisfied withthis response. The flow of filterresidues requires furtherclarification. The detail providedby the line diagram and text withinthe dossier are not considered togive clarify the actual situation.GESAMP-BWWG 9/6ANNEX 4Page 9I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summary,0.4 andConclusions,9.4)Group’s Question Applicant’s Response and Section No. inthis ReportGroup’s Reaction2.1.9 .9 and .11The risk to the marine environment from the residualActive Substances must be assessed. Concentrationsof heavy metals, aluminum, iron, acrylamidemonomer, VOCs, and faecal coliforms must bemeasured in the intake water, collected sludge andthe discharged ballast water from the representativeballast waters associated with testing under G8. Theenvironmental risks of discharging polyacrylamide, anon-biodegradable polymer to shore and anysubsequent disposal restrictions must be assessed.The results of analysing the content of toxic heavymetals, aluminum, iron, acrylamide monomers,VOCs and faecal coliforms in treated ballast waterand flocs have been presented. The potential risks andhazards have been assessed on the basis of thoseresults. The method of measuring polyacrylamide inthe treated water and influent has been developed,and the results of this chemical analysis have beenreported.See Section 3.4 for analysis of Active Substances,relevant chemical and other chemicals, withresultant human health assessment in Section 4The Group was not satisfied withthis response, in that faecalcoliforms in the collected sludgehave not been measured. So thatquantitative assessment forbiohazard risk cannot be evaluated.2.1.10 .10 and .12Disposal of the collected sludge to shore-based wastereception facilities should be according to therelevant IMO regulations. The availability ofsuitable harbour reception facilities needs to beconsidered.Concerns regarding the disposal and handling ofcollected flocs have beenaddressed in the concernsraised in Summary 0.4.2/Conclusions 9.4.2. Theprocess of unloading and disposing flocs should beperformed in accordance withthe domestic law andthe MARPOL Convention.See Sections 3.1 and 3.2 for description of thesystem controls and safety considerations, withrespect to storage, handling and disposal of flocmaterialThe Group was not satisfied withthis response. The dossier informs“procedures overseas are beingstudied at present” and that “thelist of recommended wastedisposers are to be provided tousers”. The Group considersfurther detailed information isnecessary.GESAMP-BWWG 9/6ANNEX 4Page 10I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summary,0.4 andConclusions,9.4)Group’s Question Applicant’s Response and Section No. inthis ReportGroup’s Reaction2.1.11 .11 and .14and section 8.1.2Additional toxicity testing of the treated BallastWater should be performed using an appropriaterange of conditions.To address this question, experiments have beencarried out and the results have been presented. Theupper limit of the concentration of added chemicalsfor toxicity tests have been determined on the basis oftests in which the chemicals were added at twice andthree times the standard quantities in order to studythe flocculating performance.Consequently the upperlimit of chemicals concentration for adequatecoagulation performance has been detected asapproximately twice the standard amounts. From thisresult, the maximum amount of chemicals to beadded under the condition of higher concentration ofchemicals was taken to be twice the standard amount.The results of toxicity tests performed using thiseffluent are shown. In addition, to evaluate the effectof seawater with a higher concentration of theresidual Active Substances on marine organisms,ecotoxicity tests were carried out using seawatercontaining flocs generated by this system. The testresults indicate that flocs in such water at the ratedcondition of chemicals had no effect on aquaticorganisms such as zooplankton and fish. Theseexperiments were conducted by a GLP compliantlaboratory.See Section 6.2 for ecotoxicity testing of treatedballast waterThe Group was satisfied with thisresponseGESAMP-BWWG 9/6ANNEX 4Page 11I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summary,0.4 andConclusions,9.4)Group’s Question Applicant’s Response and Section No. inthis ReportGroup’s Reaction2.1.12 .12 and .13The risk assessment carriedout by the applicant inthe submission cannot be accepted, as it is unclearhow the risk assessment was performed and howboth the PEC and PNEC for Aluminum-ions andother relevant chemicalshave been established.In addition to the hazard data at the time of theapplication for Basic Approval, other reference,research and academic reports have been surveyed,subsequently risk assessment has been performedwith reference to typical risk assessments report.See Section 6.3 for risk assessment of chemicalsfor aquatic organismsThe Group was satisfied with thisresponse2.1.13 .13 and .15The maximum allowable discharge concentrationshould be set against the parameters that can bemeasured at such low levels. According to theapplicant, it is difficult to measure the amount ofPASA directly, if its concentration in water is low.This situation is considered to be unsatisfactory bythe Group and an acceptable analytical methodshould be developed for confirming the maximumallowable discharge concentration for relevantparameters.The PASA analysis method and measurement resultshave been developed according to the points raised inSummary 0.4.9 / Conclusions 9.4.11. On the basis ofthe analytical results and other studies, the maximumallowable discharge concentration (MADC) has beenestablished by considering the risk assessment inaccordance with the points raised in Summary 0.4.12/Conclusions 9.4.13.See Section 6.3 for risk assessment of chemicalsfor aquatic organisms, while MADCs aredescribed in Section 6.4The Group was satisfied with thisresponse2.1.14 Summary 0.5As there may be a risk to the ship of flooding throughthe sludge discharge arrangements should equipmentmalfunction occur, this possibility should receiveadditional consideration and assessment of the actualrisk involved prior to shipboard installation.Concerns regarding the disposal and handling ofcollected flocs have beenaddressed in the concernsraised in Summary 0.4.2/Conclusions 9.4.2. Theprocess of unloading and disposing flocs should beperformed in accordance withthe domestic law andthe MARPOL Convention.See Sections 3.1 and 3.2 for description of thesystem controls and safety considerations, withrespect to storage, handling and disposal of flocmaterialThe Group was satisfied with thisresponse. The precautionarymeasures indicated in the dossierwould appear to adequately coverthe identified risk.GESAMP-BWWG 9/6

ANNEX 4 Page 12

I:\MEPC\59\2-19.doc 2.2 During the GESAMP-BWWG meeting, the Group posed to the applicant several questions (a total of 20) on issues it felt needed further clarification in order to complete the evaluation for Basic Approval. The Group’s questions (in bold text ), the applicant’s responses (in plain text) and the Group’s conclusions on the responses provided (in italic text ) are noted as

follows:

Question 1:

1 The most significant proble m identified is that this BWMS produces large amounts of effluent stream (flocculated material for disposal). The Group needs much more precise clarification how to ensure the ad equate management for this disposal procedure. How is it ensured that all th e flocs are safe enough to handle with the usual procedure?

Response 1:

.1 The prevention of leakage of collected flocs from the equipment of this system is

ensured via a closed structur e of transfer pathways within the system (covering all pathways from the magnetic separator via the collected flocs storage tank to the discharge of the collected flocs from the same) (refer to 3.7.5 in the dossier).

.2 Moreover, where the flocs ar e retained in mid-flow of the pathway, such abnormal

retention is detected as an abnormal in crease in water surface level via the level meter. When any such increase is detected, the system operation is controlled to stop automatically (3.12.3).

.3 In addition, considering the maintenance pr ocedure, safety measures, which include safety signage, the use of protective gears a nd airtight containers, must also be clearly ensured or stated (3.13 (2) in the dossier)).

.4 With the above mentioned terms, the safety of ship crews and the ship body from the

collected flocs is ensured.

The Group did not consider that this response fully answers the questi on. Specific detail of potential for the hazards that ma y be present in the floc materi al is required, together with associated risk assessment. The PPE required to be used in each case where potential contact is identified needs specifying. The Group did not consider the generi c statements regarding the use of PPE to provide sufficient risk mitigation.

Question 2:

2 How is it ensured the flocs are not dumpe d to sea? How is this ensured formally? For example according to MARPOL A nnex V or BWM convention itself?

Response 2:

.1 The collected flocs shall be proce ssed based on the BWM Convention and its Guidelines (G1, G4 and G12), MARPOL An nex V, and the relevant regulations

based on those conventions in the coun try of the reception facility on-land.GESAMP-BWWG 9/6

ANNEX 4 Page 13

I:\MEPC\59\2-19.doc .2 One of the methods used to manage the coll ected flocs in this system is installing a meter such as a level gauge to know the collected floc volume in the storage tank. In addition, the stored volume and that landed from the ship will be recorded in order to monitor the storage volume.

The Group was of the opinion that the framewor k indicated by the applicant how to prevent dumping the flocs was not appropriate, because the Guidelines for sediment reception facilities (G1) and Guidelines on design and construction to faci litate sediment control on ships (G12)

should be addressed as the issu e for management of sediment, not for the flocculated material from this BWMS. Also the reception facility fo r sediment under Guidelines (G1) does not exist everywhere around the world at this moment, so that the applicant cannot ensure an adequate management of flocculated mate rial related to se diment management. Also, MARPOL Annex V prohibits the dumping waste to sea in general, however, the Group believed that this flocculated material could have the potential risks of biohazard, same as “M edical Waste”. Therefore, the management of such pathogenic material would be out of scope of “garbage and waste under usual operation” associated to MARPOL Annex V.

The Group noted that this response gives the first indication of a need for record keeping to provide documented control of sy stem’s flocculated material. It is not clear as to the specific function of the “meter”, as this may be to provide automatic record ing or simple manual reading. The Group considered that such pro cedures should be adequately described in the operation manual, when this becomes available. Specific manufacturer’s instructions will be required to permit correct compil ation of the Ballast Water Management Pl an described in the Guidelines for ballast water management and d evelopment of ballast water management plans (G4) and it is not considered relevant to referenc e Guidelines (G1) and (G 12) that relate only to the handling of sediments removed from ballast wa ter tanks. Specific pr ocedures are required that detail permissible means of disposal of the system’s flocculated material.

The Group noted that this response gives the first indication of a ne ed for record keeping. It is not clear as to the specific func tion of the “meter”, this may be to supply automatic recording or simple manual reading. The Group consider ed that such procedures would be adequately described in an operation manual , if such was available.

Question 3:

3 How is it ensured the flocs are adequately ma naged at reception facili ties on-land? Is it possible to guarantee an adequa te reception facility around the world? If not, how is it

ensured that the flocculated material is unload ed only at a port with adequate reception facilities? The Group notes that the applic ant has made detailed proposals about floc disposal in Japan but has provided no informat ion for other ports. If they cannot ensure adequate management of dispos al under the open cycle includi ng reception facilities, the system should be completed with a closed-cyc le in which all the disposal and treatment processes could be done by components on board ship, for example, incineration on

board.

Response 3:

.1 As stated in section 3.15 of the dossier, we are investigating the availability of the reception facilities on-land in countries other than Japan.GESAMP-BWWG 9/6

ANNEX 4 Page 14

I:\MEPC\59\2-19.doc .2 If there is the potential for the collected fl ocs to be processed at reception facilities on-land under the open cycle, consideration wi ll be made as to whether it is possible

to receive the collected flocs at those facil ities or not. The use of protective gears, as described in section of 3.13(3) in the dossi er, is also required for those facilities.

.3 When selling this system to customers, a list of recommended facilities shall be provided, with consideration of the cust omers shipping route information. Where there is no adequate reception facility available, the system, including the heat-treatment process of collected flocs on board, is proposed to customers upon the inquiry.

.4 It is desirable that the collected flocs be treated at the G1 reception facilities for

sediments.

The Group was not satisfied with the res ponse of the Administration on this matter. As has been stated in the evaluation of the system at Ba sic Approval the need was expressed to receive an operation manual, albeit an example. The Group underst ood that it is not feasible to provide a manual for all possible situations onboard ships. Up to now such a manual was not received by the Group. Therefore, too many open ends are still pres ent in the operation of the system and the related potential risk for crew can not be judged sufficiently.

The Group did not consider the possibility or availability of managing flocs, rather the Group considered the practical manual or facilities wh ich is already set to evaluate the safety for managing flocs to crew and environment. The eviden ce of well-operated faci lities supposed to be submitted to evaluate the safety.

Question 4

4 In the case of the proposals for heating or inci neration of flocs, is it possible to make up a closed re-use cycle using heating of flocs? For example, are there any chemical properties changed after heating, such as decomposition of polymer (PAC) by heat? If there are possibilities for such changes, the cycle shou ld be once-through. Ev en in this case, the disinfection before disposal should be cons idered. So floc disinfection by heater or

incineration should be needed for a ll the BWMS in this particular case.

Response 4:

.1 Among the Active Substances used in this system, PAC and PASA can function only once due to their coagulation mechanis m. Therefore, PAC and PASA, as new material, must be injected and used under rated conditi ons. However, tri-iron tetraoxide is reusable provided its magne tization remains unchanged. The magnetic

characteristics of tri-iron tetra-oxide remain unchanged below 200°C even after they

are heated above 200°C. The collected floc s containing the tri-iron tetra-oxide thus can be re-used for the magnetic separati on operation as replacement material.

The Group noted that only tri-iron tetra-oxide can be reused using heater under flocculated material management. However, the completion of decomposition of PAC and PASA should be confirmed in the actual heating process, in which heating duration and temperature should have been defined and ensured.GESAMP-BWWG 9/6

ANNEX 4 Page 15

I:\MEPC\59\2-19.doc The Group did not consider that this response fully answers the questi on. Specific detail of potential for hazard arising from the polymers in floc material after changes with heat is required, together with asso ciated risk assessment.

Question 5:

5 The applicant’s concept for storage of th e floc material is that 0.1% volume of treated ballast water is kept in the stor age tank without any disinfection during the whole leg to another port with reception faci lities? In that case how can the system prevent the bacterial growth in the tank and production of some waste gases (i.e. H 2 S, CH 4 and CO 2 )? Could you kindly provide any results for the measurement of viable bacteria and other organisms in flocs in the storage tank after 5 days (after long leg)?

Response 5:

.1 As days pass, a declining tendency is appare nt in the number of plankton and bacteria present in seawater and sediments. Simila rly, the number of organisms in collected flocs is reasonably assumed to remain constant or less in spite of large growth in the collected flocs storage tank. However, the co llected flocs may still potentially contain organisms.

.2 Since the system does not employ disinfectio n treatment, all transfer pathways of collected flocs in the system are completely closed to prevent human exposure to the collected flocs (as stated in section 3.12.3 of the dossier). Moreover, workers must wear protective gear when engagi ng in maintenance of the system.

.3 As for the generation of waste gases from the stored collected flocs in the storage tank we have no experimental data. This is however virtually negligible, since the ratio of organic matter contained within the collected flocs is extremely low, namely

less than one % relative to that contained in sl udge produced during sewage

treatment.

The Group noted that the applicant does not prov ide any information of tank holding time of flocs, which was clearly requested by the Group in above question.

Also the Group concurred with this views of the applicant that there are no re-growth or pathogenic bacteria or production of gasses in the flocs tanks. The Group recalled that the applicant does not provide any actual measuremen t of either bacteria or organic contents in flocs tank. Also the Group recall ed that if all the PO C and DOC in Guidelines (G8) test soup are condensed to flocs, the concentration should be both 5 g/l. Also if the E. coli, which was detected

in untreated water described in table 5-5 of non-confidential versi on, is condensed to same flocs , then we can easily expect more than 10^7 cfu/ ml, which would be same level as Human waste (Faeces and urine).

The Group was the position that more precise and quantitative assessment for the fate of bacteria in flocs tank, which is based on actual measur ement of density changes, should be needed for evaluation for the risk of bio-hazard.GESAMP-BWWG 9/6

ANNEX 4 Page 16

I:\MEPC\59\2-19.doc Question 6:

6 In the confidential material there is indicated a possibility to employ a flocs treatment step by using a flocculate heat er. There is no detail of such additional equipment, its positioning or operational requirements. Is such a step to be considered? If yes, these details are required for a new assessment of all risks that may be associated.

Response 6:

.1 Since the system does not employ disinfectio n treatment, all transfer pathways of collected flocs in the system are completely closed to prevent human exposure to the collected flocs (as stated in section 3.12.3 of the dossier). Moreover, workers must wear protective gear when engagi ng in maintenance of the system.

.2 However, as stated in section 3.15 of the dossier, where sufficient steam is available on board, this can be harnessed to elimin ate organisms contained in the collected

flocs via heat-treatment processing of the latter.

.3 An example of a device for the heat-treatme nt processing of floc s is shown and stated in Figure 3.31 in sections of 3.15. This devi ce will be assessed by the relevant agency as an optional piece of equipment for the system.

.4 All the transfer pathways of collected fl ocs in the system, from the collected flocs storage tank to the heat-treatment proces sing device, are enclosed with a closed structure, virtually eliminat ing the possibility of huma n exposure to the collected flocs. However, handling the flocs treated by heat-treatment processing is safer and easier, since the organisms contained in the flocs have been annihilated.

.5 It is desirable that the heat-treatment pr ocessing device be in stalled in the engine room, since the device includes heating parts. Moreover, part of the piping within the device should be covered or shielded by a heat insulator to prevent human burn injuries.

The Group did not consider the possible met hods for handling the flocs but well-designed manual or equipment to evaluate the safety.

The Group noted that a possibility to employ a floc s treatment step by usi ng a flocculate heater is mentioned in the confidential material. The applicant was requested to submit detailed information on such additional equipment, it s positioning and operati onal requirements. The answer received did not fulfil th ese criteria and the Group was not in a position to assess the safety and environmental issues of such an optional step.GESAMP-BWWG 9/6

ANNEX 4 Page 17

I:\MEPC\59\2-19.doc Question 7:

7 The LOD unit in Table 4-12 p 23 of the no n-confidential submission for heavy metal in eluted floc is given as mg/L. Can you recalculate or estimate to mg/kg as in Table 4-2 and 4-3 also p 23?

Response 7:

.1 The data shown in Tables 4-12 of the non- confidential submission for heavy metal in collected flocs was measured by eluti on analysis. Therefore it is difficult to recalculate the density to mg/kg.

.2 The Group noted lack of mass based concentrat ions of heavy metals in floc since an

elution based method was used. The answer from the applicant on this issue does not include concentrations in mg/kg nor does it allow for such cal culation by providing the mass of floc. The Group concludes that an assessment of the ri sk associated with heavy metals in the floc is therefore not possible at the present level of information

and this should be further evaluated.

Question 8:

8 The results of ecotoxicity testing from th e confidential dossier show significant

differences between control and treated groups in mortalit y and weight (Figure 2 to Figure 5) in pp. 33-35 of IDEA (2007c) and the results from the equivalent 2008 test. The same toxicity test in 2008 showed no significant difference between control and treated group. How do you explain this anomaly?

Response 8:

.1 As for mortality, statistical significant differences emerged between the control and certain treatment groups in the Early life st age toxicity test (ID EA 2007c), whereas no significant difference was observed in th e Acute toxicity tests (IDEA 2008f and IDEA 2008g), as pointed out by the GESA MP. However, the mortalities in the treatment groups were smaller than those of the control group, hence the indication of the statistical significant difference in ID EA (2007c). The result of the Early Life Stage toxicity test indicated no mortality in the treatment group exposed to 100% treated-water (i.e. at the 1/1 group). This result was cons istent with the results from the IDEA (2008f) and IDEA (2008g).

.2 Regarding the Early life stage toxicity test (IDEA 2007c); the cumulative mortality in the control group from embryo to 28 da ys post-hatching was 23.5% (i.e. 1.7% and 21.8% during the embryonic and post-hatc h phases respectively). This mortality is within the 9-32% range in the control gr oup of the Early Life Stage toxicity test

for Java medaka , as conducted by the testing facilit y. We believe the test results of the IDEA (2007c) test to be reliable.GESAMP-BWWG 9/6

ANNEX 4 Page 18

I:\MEPC\59\2-19.doc .3 As indicated by the GESAMP, in the Earl y life stage toxicity test (IDEA 2007c), a statistical significant difference emerged between the control and treatment groups regarding the endpoint for em bryonic and larval growth, i.e. the time to hatching (Figure 2 on p. 33), and the length and weig ht at 28 days post- hatching (Figures 4 and 5 in pp. 34-35). However, as discussed in paragraph 6 on p. 25, the results show

that the treated water had no adverse effects on the Early Life Stage of Java medaka

.

.4 To conclude, the results of IDEA ( 2007c), IDEA (2008f), and IDEA (2008g), are consistent in showing that the treated water had no adve rse (lethal an d sub-lethal)

effects on Java medaka . It should be noted, however, that the results cannot be simply compared, because the life stage of the test organism and the duration of exposure varied among the three tests.

The Group was satisfied with this response from the applicant.

Question 9:

9 Acrylamide monomer in PASA – there are 3 references to this impurity:

– p. 38 on confidential dossier less than 0.2%, – Appendix 2 of confidential dossier t echnical report showing less than 0.05%, – Report of BWWG 4 (Basic Approval) 0.05%.

Please confirm the value used for QA.

Response 9:

.1 As stated in section 7.5.1.4 (p. 105) of the confidential dossi er, considering the evaluation data on toxicity for acryl-amide monomers and its dosage concentration of the system, it has been confirmed that no eff ect on ecosystem is caused, even in cases when 100% of the treated water (non-dilu ted water treated wi th seawater) is discharged, even when using PASA in whic h 2% or less of acryl-amide monomer is

contained.

.2 Studies and investigation by our group have determined th e existence of two types of

PASA on the market. It is ensured that the acryl-amide monomer content in PASA

is 0.2% or less in one of those two and 0.05% or less in the othe r. These figures are guaranteed by the manufacturers.

.3 When acryl-amide monomer is contained in PASA as an impurity at a ratio of 0.2% or less, safety is ensured based on the studi es mentioned above. The value of 0.2% is

thus stated in the dossier.

The Group was satisfied with this response from the applicant.GESAMP-BWWG 9/6

ANNEX 4 Page 19

I:\MEPC\59\2-19.doc Question 10:

10 At Basic Approval it was raised that a QA programme needed to be developed for the entire system. Detail of QA received in 3.11 is for th e manufacturing process but not for system operational process which wa s asked for. It is noted that Hitachi states it will assume responsibility for ma intenance, how is this to happen? Please

note section 4.1.2 of the GESAMP BWWG Methodology informs what the dossier should contain; is a definitive technical manual available?

Response 10:

.1 A technical manual for the system operati onal process is employed for operation of

onboard test and land-based test. The manual is being assessed by the relevant agency at the present for G8 application procedures . Operation procedure is stated in section of 3.8 and work operation is stated in s ection of 7.3.3.1 in the dossier. Details of

maintenance and its essential conten ts are stated in section of 3.13.

The Group suggested that as it would appear a Technical Manual exists, then this should have been supplied as a part of the submitted dossier as recommended under the approved GESAMP-BWWG Methodology. If this had been made available possibly many of the questions raised by the Group coul d have been clarified as the pr ocedural information provided in sections 3.8, 7.3.3.1 and 3.13 is noted to mainly provide a general and limited overview and is lacking the specific detail normall y expected that provides the basis for sound evaluation and certainty in the safety assessment being undertaken.

Question 11:

11 It is noted that the required retention time for flocculation is stated as two minutes. This must require a comparatively large volume of ballast water retention in the treatment plant to attain the stated thro ughputs. For information please advise the total operational weight of the five prop osed systems, including full floc storage

tanks.

Response 11:

.1 Please refer the following table showing th e wet weight including full floc storage

tanks.

Type [m 3 /h] 200 400 800 1200 1600 Weight (wet) t 27 54 100 148 198

The Group noted that the operational weight of this ballast water tr eatment system may also be a significant consideration in Ad ministration approval for any i ndividual ship installation as careful choice of a suitable location with regard to scantling strength and effect to stability will be necessary.GESAMP-BWWG 9/6

ANNEX 4 Page 20

I:\MEPC\59\2-19.doc Question 12:

12 In section 3.3 of confidential dossier it is stated that the suspended solid uptake is low – how can this be guaranteed in normal operation, especially now that there is no pre-filter with the system? Please give de tails of the effect on the system process if the uptake water continuous ly contains high SS.

Response 12:

.1 The Coagulation technique can treat and purify influent with high SS concentration such as IMO soup using electrical neutra lization on particle surface charge by PAC and bridge functions by PASA to form fl ocs. Indeed, the method of coagulation of sedimentation is employed in the field of waster water proces sing with high SS

concentration.

.2 The flocs are removed efficiently by the magnetic separator and this method of coagulation magnetic separation is not eas ily affected by SS concentration of influent. Pre-filter is thus unnecessary to remove SS in advance before coagulation technique.

The Group was satisfied with this response.

Question 13:

13 In section 3.4 of the confid ential dossier it is stated discharge from the filter separator is by either gravity or pump. Does use of a pump affect carry over from

this filter unit? What test s have been carried out to confirm continued correct operation with use of a discharge pump?

Response 13:

.1 Part of the equipment is omitted in the schematic diagram shown in Figure 3-3. Therefore, the explanation is given using Figure 4-2. In this system, the effluent from the filter separator, and the treated water, are discharged into ballast tank and buffer tank by gravity as shown in Figure 4-2. Pumps are used to send the treated water to the respective ballast tanks.

The Group noted that this response is the first indication that a gravity “buffer tank” is a requirement of the system. Notwithstanding the operational limitations this will impose, additional water level error detection devices will require to be incorporated to the BWT equipment control system to counter the potenti al for high level/overfl ow and low level in the newly identified “buffer tank”. The Group noted that the system evaluat ed does not utilize a discharge pump connected directly to the outflow of the filter separator.GESAMP-BWWG 9/6

ANNEX 4 Page 21

I:\MEPC\59\2-19.doc Question 14:

14 On page 14 of confidential dossier is a reply to GESAMP BWWG Basic Approval comment on proposed pre-filtration and resi due feed back system . It is noted that the system does not now have a pre-filter component and there is detail provided on the filter separator. There is no detail information on “ residue tank” from filter washing. Is there a drain from this tank? Wh at is the cleaning requirement? Please supply full detail of this residue feedback loop.

Response 14:

.1 As stated in section of 3.7.4, the filter separator consists of a sealed filter separator casing, a rotating filter, filte r-washing sprays, and filter residue collecting trough and

these machines are installed within the s ealed casing (closed structure). The water after magnetic separation flows inside the f ilter separator drum and then the filtered water flows out of the filter separator drum. And the treated water is sent to the ballast tank (refer to previous answer 4).

.2 The trapped flocs on the filter surface are collected with filter washing (the flow rate of the washing water with washed off fl ocs is around 1% of the treatment rated capacity for ballast water purification operation) and sent into filter washing residue tank. The water containing the residue is return ed to the ballast water feed pipe before the first chemical injection points to form ne w floc in the next untreated ballast water cycle (see Figures 3-2, 3-3 and 3-12).

The Group was not satisfied with this response. The questions relating to the provision of a drain from residue tank and its clea ning requirement were not answered.

Question 15:

15 In 3.5.1 the environmental considerati ons detail slant required being less than 22.5 degrees. Is this in both directions ? Is there any limitatio n on operation of equipment when ship is rolling or pitching?

Response 15:

.1 The environmental setting of the system on slant is within 22.5 degrees all-around. The recommended operation condition of sl ant is within 5 degrees all-around. However, the operation itself can be conduc ted in the condition where slant is higher than 5 degrees.

The Group was satisfied with this response. The operational recommendations identified will require to be clearly identif ied in the Technical Manual.GESAMP-BWWG 9/6

ANNEX 4 Page 22

I:\MEPC\59\2-19.doc Question 16:

16 Detailed procedures for handling and st orage of chemicals are not provided in 3.14.2. Detail of PPE required to be used is necessary for each case. General

reference to need for PPE is not considered sufficient for safety.

Response:

.1 PPE must be used when handling chemi cals. Detail of PPE when handling the chemicals is stated in section of 3.13. (3) A.

The Group was not satisfied with this response. Spec ific detail of the PPE recommended to be used in any given situation is not provided as requested, only general examples of PPE and signage is made available.

Question 17:

17 In 3.15 it is stated “proper me thod for treatment of floc” is required. It is considered

that this waste stream must be viewed as bio-hazard material and all appropriate safety measures are required. What is prop er method? There is no detail of correct procedure for loading of sealed containers for discharge of floc. This operation is considered safety critical for operating personnel and full details of how such decanting of floc into the containers is requested. There is also reference to this operation in 7.3.3.1, again detailed procedures with risk mitigation measures is required. What is asked for is detailed minimum requirements for handling that will be applicable and required of all ballast wa ter treatment installations irrespective of ship type.

Response 17:

.1 In the original application dossier, the pr ocedure of landing and disposing collected flocs is based on the understanding it is most hazardous to hull and humans. The concept is based on unloading w ith sealed containers after temporary storage in the onboard tank to carry it to on-land facility for disposal. However, there are some processes remaining that require manual ha ndling depending on user’s discretionary operation. Therefore it is found to be difficult to ensure complete safety throughout the entire process.

.2 Therefore, we are now considering employi ng the concept of installing heat-treatment system for the collected flocs such as stat ed in 3.15 of non-confid ential in order to ensure the complete safety through the fl oc treatment process. Heating system can eliminate the bacteria in the flocs, and then biohazard risks can be eliminated. In this case, onboard incinerato r or steam is assumed as the s ource of heat and the choice depends on the situation of the individua l ship. The device employing steam will be assessed by the Administration as an opti onal piece of equipment for the system.GESAMP-BWWG 9/6

ANNEX 4 Page 23

I:\MEPC\59\2-19.doc The Group was not satisfied with this response. It would appear that the applicant is now to incorporate a heat treatment component for the treatment of the flocculated material as a definitive risk control measure. The Group recognized that heat treatment could be an effective means of mitigating the risks identi fied, but as no detail of what th e treatment will be is provided, and then no assessment of the adequacy of su ch treatment can be made. The Group also considered that effective and adequat e risk mitigation procedures c ould be specified to be put in place for the safe handli ng of untreated flocculated material by personnel, but such measures have not been identified or specified in either the dossier or the replies to the request for additional information.

Question 18:

18 There would be potential risk that the floc s will adhere at the magnetic disk array, especially around the centre of array, wh ere scraper and washing water could not reach easily. Are there any potential risks that after long term use, the efficient surface of the array would be blocked with adhered flocs, and therefore the removal efficacy of flocs will be decreased? To mo nitor such potential decrease of removal efficacy, the Group feels SS sensor will be needed after separator.

Response 18:

.1 It is important to remove all of the fl ocs on the magnetic disk for operation because the removal step is essential for purificat ion efficacy. The scrape r blade mechanism is

flexible and fit the surface of the disk, and therefore the scraper can wipe the sticking flocs on the whole attractive surface efficiently. Moreover, the scraper blade and surface of the disk is to be washed by th e spray shooting water alongside the edge of the scraper blade during the shut down m ode. The shooting water reaches the centre of the disk and removes easily the remaini ng floc that has high fluidity because the spray washes immediately after submersion.

.2 If the removal performance of fl ocs by magnetic separator decreases SS concentration of effluent from magnetic separator increases. The load for filter separator thus increases. Consequently, the water level in the filter separator may rise and level switch in the filter separator will detect the unusual rise in water level and stop intake automatically as stated in section of 3.12.2.

.3 As was pointed out, sensors to measur e SS concentration of magnetic separation

effluent were tested. Howe ver, the abovementioned det ection method, which is the one using water level in filter separator, wa s found to be more effective and practical especially from the view point of sensitivity.

The Group received efficient answer and satisfied with that.GESAMP-BWWG 9/6

ANNEX 4 Page 24

I:\MEPC\59\2-19.doc Question 19:

19 In the confidential dossier at sect ion 6.2.1, you say that capacity of 50 m 3 /hr was used. The group feels this should be 200, not 50. Have you any comment?

Response 19:

.1 The chronic toxicity test de scribed in section 6.2.1 of the confidential dossier utilized the treated water samples generated by the pr ototype setup (treatment rated capacity of 50 m3/hr). Floc removal performance was improved on the land based test setup (present system, treatment rated capacity of 200m3/hr) compared with the prototype test setup (refer to sections 5.1 and 5.3 of the confidential dossier), although both setups have the same system diagrams (sections 3.3 and 3.4 in the confidential dossier). This meant the chronic toxicity test used less purified treated water.

.2 Chronic toxicity tests require treated water sa mples (water samples) on a daily basis for an extended period (longer than 40 days) (I DEA 2007a, 2007b, 2007c). Processing of seawater by the prototype test setup, which is practically capab le of providing treated water samples, was carried out and supplied to the te st facility daily. The treated water samples, which are supplied for the chronic tests from the prototype test setup, were: (1) produced

under conditions where the final chemical dos age concentrations were two times higher than those of the rated processing condi tions for this system (section 6.2.2 of the confidential dossier), and (2) may have a highe r concentration of aluminum remaining in the treated water (Table 4-4 in Appendix 4) than in the present system (such as the land-based test setup with TRC of 200m3/h) (Table 5-7 in the confidential dossier). Taken together with the results of chronic toxicity tests in algae, invertebrate and fish, the present system, which has been improved compared to the prototype test setup, is expected to be much safer and have virtua lly no toxic impact on aquatic organisms (Table 6-8 in the confidential dossier).

The Group was satisfied with this response from the applicant.

Question 20:

20 On page 62 (section 6.2.2), you say “... samp les of treated water were carried into the test facility the next day ...” What does this mean? How long were the samples stored – is overnight 12 hours, or more, or less? Please specify how long?

Response 20:

.1 The laboratory where the toxicity tests we re conducted is about 150 km from the site where the prototype test setup is installed. Th is chronic toxicity te st required treated water samples on a daily basis for an extende d period (longer than 40 days). It took an average of about 16 hours to transport the treated water samples from the test setup to the laboratory for the toxicity te sts. They were transported to the test laboratory in cool (4°C), shaded conditions. Immediately afte r being delivered to the laboratory, the treated water was applied to the chronic test s and kept for 24 hours until the next batch

of treated water was delivered the following day (IDEA, 2007a, b, c).

.2 The relevant physical chemical properties of the Active Substances expected to

remain in the treated water by this system are stable and virtually non-reactive (sections 7.1.2, 3.2 and 3.3 in the confidentia l dossier). The transportation duration of treated water, which is stated above, thus has no effect on the chronic toxicity test

results.GESAMP-BWWG 9/6

ANNEX 4 Page 25

I:\MEPC\59\2-19.doc The Group was satisfied with this response from the applicant.

2.3 In view of the above responses from the ap plicant to questions posed by the Group during evaluation for Basic Approval (see at section 2.1 above), together with responses from the applicant to questions posed by the Group during the GESAMP-BWWG meeting (see at section 2.2 above), and considering all the data and information submitted by the applicant in the dossier, the Group is not sati sfied with the comple teness of the dossier received from the applicant. The Group draws to particular attention the following points to be included in those addressed by the applicant for evaluati on at Final Approval:

• The procedure for personnel handling the flo cculated material is unclear. In the flocs

all material is concentrated and the inst ructions on how to ha ndle this potentially

hazardous material should be clear and w ithout any doubt to all crew concerned.

• The Group notes that a gravity “buffer ta nk” is a requirement of the system.

Additional water level error detection devices will require to be incorporated to the BWT equipment control system to counter the potential for high level/overflow and low level in the “buffer tank”. The Group notes that the system evaluated does not utilize a discharge pump connected directly to the outflow of the filter separator

.

• The questions relating to the provision of a drain from residue tank and its cleaning requirement were not answered to the Groups satisfaction.

• Specific detail of the PPE recommended to be used in any given situation has not been provided.

• The applicant informs of the intention to incorporate a heat tr eatment component for

the treatment of the flocculated material as a definitive risk control measure. Heat treatment could possibly be an effective means of mitigating the risks identified, but

as no detail of what the treatment is to be has been provided, no assessment of the adequacy of such treatment has been made . The Group considered that effective and adequate risk mitigation procedures could be specified and put in place for the safe handling of untreated flocculated material by personnel, but such measures have not been identified or specified in either the dossier or the replies to the request for additional information. The handling, stor age and treatment of the flocculated material require to be satisfactorily addressed.

• The Group considered that the maintenance requirements provided were very general and require to be supplemented in the final Technical Manual with sufficient detail to

enable full assessment of both the work ac tually required and the potential for

operator exposure.

3 DESCRIPTION OF THE SYSTEM

3.1 Overview

3.1.1 The Group recalled that this Ballast Wate r Management System (BWMS) had already

been described and reviewed in the report for Basic Approval. The Group noted that after the Basic Approval was granted, from April to Oc tober 2008 shipboard testing of this system with a treatment rated capacity of 50 m3/h mounted on board an LPG carrier belonging to Yuyo Steamship Co., Ltd. and built by Mits ubishi Heavy Industries Ltd, was performed.GESAMP-BWWG 9/6

ANNEX 4 Page 26

I:\MEPC\59\2-19.doc From April 2008, land-based tests were also pe rformed in Tokyo Bay, using a land-based test set-up (treatment rated capacity of 200 m 3 /h).

3.1.2 The Group recalled that Figure 1 schematically shows the BWMS. First, triiron tetraoxide

and PAC are added to intake wate r containing marine organisms. Next, PASA is added to form

flocs of about 1 mm in diameter . These flocs are then separate d from the ballast water using permanent magnets. Finally, any flocs that we re not removed by the magnetic separation are removed by filtering to produce treated water.

The Group noted that the maximum dose for these Active Substances was set as follows:

5 mg/L of PAC (as Al) 30 mg/L of triir on tetraoxide (Fe 3 O 4 ) 1 mg/L of PASA

The Group also noted that these dose are not chan ged according with any water conditions so that the BWMS dose note include any cont rol scheme to change the dose.

3.1.3 The Group noted that the residue from filter washing is returned to the ballast feed pipes before the first chemical (triiron tetraoxide) in jection point through a fi lter washing residue tank and treated together with untreated wate r to maintain clear water processing.

3.1.4 The Group noted that, with this system, the ballast water can be purified either during storage in the ballast tank, during intake, or during discharge. Pu rification during intake is the most effective way to ensure that a minimal am ount of organisms and SS enter the ballast tanks and thus reduces sediment build-up in the tanks. Therefore, this application for Final Approval focuses on the system components and opera tions for purificati on during intake.

Hitachi ballast water purification system

Magnetic

seprator

Coagulator Filter

separator

Filter residue from filter
washing (to be treated with seawater)

Collected flocs

storage tank Treated water (to ballast tank)

Ballast

pump Ballast water PASA

Landing and waste

treatment, etc. Flash

mixer Flocculator Triiron tetraoxide

PAC

Residue tank

from filter

washing Chemical injectors

Figure 1 – Schematic process diagram of BWMS

This figure was supplied by the app licant. It is to be noted that the system proposed discharges treated ballast water to a gravity fed buffer ta nk prior to pumping to th e ballast tanks (see 3.1.7 and Figure 3).GESAMP-BWWG 9/6

ANNEX 4 Page 27

I:\MEPC\59\2-19.doc 3.1.5 The Group noted that according to the applicant, it is necessary to inst all the system in a closed casing with thermal insu lation, ventilation, etc to achieve the environment settings shown

below:

Environmental settings: Temperature: 0 to 50 degrees Celsius

Humidity: less than 90%

Slope: less than 22.5 degrees

3.1.6 The Group noted that according to the applicant, the BWMS (ClearBallast) is automatically operated by the controller, and no op erator is required onsite. An operator operates the control panel in the centre console room to issue a remote command for starting the equipment and monitors the operational status i ndicated on the control panel’s display during operation. If no problems occur, the operator is only required to issue a remote command for stopping the equipment.

3.1.7 The Group noted that in the response to additiona l questions the applicant informed of the need for a gravity-fed “buffer tank” to receive the ballast water outlet from the filter separator prior to pumping to the ship’s ballast water system . The flow rate through this “buffer tank” will also need to be regulated and controlled in the auto matic function of the BWMS.

3.1.8 The Group noted that according to the applican t, there are three operational modes for the system – Setup mode, Operatio nal mode and Shut down mode:

− In Setup mode, chemicals required for this system are prepared automatically and the system automatically checks that the devices operate normally.

− In Operation mode, the system starts and stops operation correspond ing to ballast water pump operation.

− In Shutdown mode, upon receiving the stop comm and from the centre console room, the machines in this system are stopped auto matically, the inside of the system (constituents machines) is cleaned, and prepar ations for the next operation are performed.

3.1.9 On the question of storage of floc material on-board ship, the Group noted that a tank is used to temporarily store flocs collected by the magnetic separator (the volume of collected flocs with water is about 0.1 % of ballast water proc essing throughput). The tank is equipped with a dedicated pump for drawing the collected fl ocs, which can be performed without manual operation.

3.1.10 The Group noted the following information provided by the applicant. Treatment of collected flocs should be appropriately conduc ted in accordance with the MARPOL Convention. A proper method for treatment of the floc should be designed according to requirements of users

because the available methods diffe r depending on ship types, route, ship space and utility supply capacity (such as electric power and steam). Accord ing to the applicant, after it is temporarily stored in its onboard storage tank, the collected floc s are put into sealed containers and loaded on a barge using the ship’s crane to carry it to land. (Sentences deemed to be confidential and removed at the request of the submitting Administ ration). However the Group noted that the risk assessment for flocs when managed with various methods, also, practical equipments with wellGESAMP-BWWG 9/6

ANNEX 4 Page 28

I:\MEPC\59\2-19.doc organized manual for managing flocs should be established from the references of risk

assessment.

3.1.11 The Group note d that detailed information had been suppli ed by the ap plicant, concerning onshore unloadin g and disposal of collected floc in Japan, which is in accordance with domestic law (Law for the Prevention of Ma rine Pollution and Maritime Disasters, based on the MARPOL Convention). The collected floc s unloaded on land are sent to the waste disposers, and are dehydrated or incinerated as for normal sludge or industrial wastes. However, the Group noted that the applican t should prepare the da ta of risk assessment in handling with flocs to land deposition for this specific chem icals produced by the applicant such as aluminum, poly acrylamide and organic matters in the coagulants.

3.1.12 The Group noted that it is now intended to incorporate a heat treatment unit to the system to mitigate the inherent risk to personnel handling untreated flocculated material. The operational procedures of such a unit will need to be assessed so as to ensure the effectiveness of the treatment to be proposed. If the intention is also to facilitate re duction of the sludge by de-watering, then such procedur es should also receive an offici al approval. The Group evaluated the current system explicitly wi thout the heat treatment unit.

3.2 Safety Considerations

3.2.1 The Group noted that according to the appli cant, operation and monitoring of this system is automated, so no operators or crew are required. Some ma nual operations are required for refilling the chemicals into the storage tank, un loading the collected flocs, and maintenance checks; the frequency of such manual operation s will depend on system usage. The applicant informs all equipment comes in a closed-structure, pressure resistant casing to prevent leakage and scattering of liquid and chemicals.

3.2.2 The Group noted that problems identified by the applicant in this system are classified into three categories related to flow rate, wate r level (water height in tanks and casings) and equipment. Any irregularities are detected by se nsors which are controlle d and monitored by the control system. If irregularities are detected in this system by the sensor, the equipment is automatically controlled corresponding to its er ror level by the control system while a warning buzzer and indication lamp start to operate. After an error is de tected and the equipment shuts down automatically, the operator s hould check the control panel’s di splay to identify the error and perform inspection and recovery work. Since the equipment is not automatically reset after an error is solved, the operator should issue a command to re-start opera tion after checking that the operation/control panel in the centre console room does not indicate any error.

3.2.3 Furthermore, the Group noted that if a blac kout occurs while the equipment is operating, the equipment stops operations, and automatically c ontrolled valves are re set to starting position. The intake valve automatically closes when the power supply stops, preventing ballast water leakage from pipes or other areas. The performan ce of this system is assured by keeping the water flow velocity in piping and constituents machines (coagulator, magnetic separator and filter separator) within a certain range, and so can be scaled up while keeping the rated flow velocity. This method of scaling up is the same as general centrifugal pumps and piping, and so poses no specific risks.

3.2.4 The Group noted that according to the appli cant, the system is produced in a designated factory (ISO9001 certified factory) of Hitachi Pl ant Technologies Ltd, which has a strict qualityGESAMP-BWWG 9/6

ANNEX 4 Page 29

I:\MEPC\59\2-19.doc control programme, and meets the required qualit y, by the Guidelines for approval of Ballast Water Management Systems (G8). The factory cont rols quality according to the quality control programme in the respective stages of production.

3.2.5 The Group recognizes that the applicant has pa id particular attention to the issue of prevention of chemical leakage in order to protect the safety of humans and the ships. The following preventive measures ar e listed by the applicant:

.1 Measures for preventing leakage from the chemical storage tank

Plastics such as PE (polyethylene) are used for the wetted surface of the storage tank and the injection line of PAC, which is slightly corrosive to metals, to avoid the risk of leakage caused by corrosion. Th e closed structure of the respective

chemical tanks reduces the risks of ch emical leakage and scattering. Each chemical storage tank has level sensors to detect chemical leakage and alert crew and is protected by a save-all . The leaked chemicals are sent to the filter washing residue tank, and are treated appropriately.

.2 Measures for preventing liquid leak age in the chemical injection line

The causes of chemical leakage from the chemical injection line are corrosion, an unusual pressure rise in th e piping and degradation of packing gland of flange junction, so special care is taken for the materials and structure of the chemical injection line. The injection line is equippe d with a pressure safety valve to safe guard against unusual pressure increase and the increased pressure, and the

chemical are returned to the chemical in jection storage tank. In creased pressure is relieved in the chemical storage tank. Th erefore, the possibility of chemical leakages from unusual pressure increases is eliminated. The packing gland on flange junction is checked and replaced periodically.

3.2.6 In addition, the Group noted that the appl icant provided the following information on preventing leaks of water and collected flocs:

.1 Measures for preventing water leakage from the equipment

The causes of water leakage are corrosion and equipment defect, so special care is taken for the painting and structure of th e equipment and operation control at the time of any problems.

.2 Measures for preventing wa ter leakage from the piping

The causes of water leakage from the pi ping are corrosion a nd unusual pressure rises in the piping, so special care is taken for surface treatment of the wetted surface and operation control in the event the piping becomes occluded.

.3 Measures for preventing leakage of collected flocs

Sufficient care is taken for the paintin g and structure of the equipment and operation control at the time of any error to prevent floc leakage.GESAMP-BWWG 9/6

ANNEX 4 Page 30

I:\MEPC\59\2-19.doc 3.2.7 The Group noted that the applicant advised ad equate electrical prot ection safety devices are provided for the local control panel and equi pment have been incorporated to the BWMS.

3.2.8 The Group noted the following informati on provided by the applicant on system maintenance - the Hitachi BWMS is operated au tomatically, and so no i ndividual operation by ship crew is required and no dedicated operators are needed. This section describes the inspection work to be performed by the operator. The ch eck results are to be recorded and managed:

.1 Daily inspection

Daily inspection requires only visual inspection of the following items before and after operation:

- checking of error display;

- storage quantity of chemicals;

- leakage from the equipment and piping;

- appearance of the equipment and instruments; and

- loose nuts and bolts.

.2 Periodic inspection/maintenance

The outline is described below:

- checking the operation of the devices (operation, vibration, abnormal sound, deformation, damage and oil leakage): monthly;

- checking the storage status of chem icals (check the powder supply opening and liquid storage tank interior): monthly;

- inspection and refilling of lubricant: monthly;

- cleaning of the st rainer: monthly;

- replacement of the lubricant: yearly;

- inspection/replacement of consumables: yearly;

cleaning of the chemical storage tank: yearly;

- inspection and clean ing of the local c ontrol panel (loosene ss, contact status, damage on the insulated section, defo rmation and discoloration): yearly;

- checking of insulation resistance for th e cable and transformer: at docking;

- checking of sequence: at docking;

- checking of the painting a nd lining: at docking; and

- disassembly for maintenance: every 5 yearsGESAMP-BWWG 9/6

ANNEX 4 Page 31

I:\MEPC\59\2-19.doc 3.2.9 The Group considered that th e maintenance requirements prov ided were very general and require to be supplemented in the final Technical Manual with sufficient detail to enable full assessment of both the work actually require d and the potential for operator exposure.

3.2.10 The Group noted the following informa tion provided by the applicant on safety measures for humans and the ship - safety preca utions are required for inspection, recovery and maintenance work because chemicals, collected flocs or lubricant may leak and humans could be exposed to it. Basic safety precautions and actio ns in case of leakage or exposure are described

below:

1 Safety precautions

When supplying/inspecting chemicals and pe rforming recovery work for leakage, operators should wear protective gear and take measures to prevent the leaked chemical from spreading and reduce the associated risks, because the chemicals could cause injury to operators and damage to the ship.

2 Emergency treatment for exposure and measures in case of leakage

If any chemicals or collected flocs lea k, and a person is exposed to it, MSDS

counter measures should be taken. As eye exposure poses the highest risk, a portable eye washer should be equipped near the working area. The chemicals used in this system do not have a risk of ignitability or self-reaction, and the preventive measures for leakage describe d assure the safety of humans and the hull structure. Material Safety Data Sh eets (MSDS) for each chemical must be indicated in the same or adjacent area on board the ship, in which the chemical is

stored.

3.2.11 The Group noted the following inform ation provided by the applicant. While transporting flocs in sealed containers, there ar e potential risks that the contained flocs leak, subsequently the operator may be exposed to it. Th erefore, containers that are sufficiently sturdy,

sealed and anti-corrosive should be used for hand ling and transportation of flocs, to minimize the risk. In addition, during the opera tion of transferring flocs from onboard storage tanks to landing containers, operators are required to wear protective gear. Acco rdingly, risks of flocs to the workers are minimal, even if a small amount of flocs leaks in the equipment due to device

malfunction. The sealed containers also minimize risk of exposure during handling and transfer to land-based facilities. Consequently, the Group accepted that there could be appropriate measures to minimize the risk of human exposur e to flocs through all of the exposure scenarios identified; however, such measures have not been adequately detailed in the information provided to ensure th e necessary certainty.

3.2.12 The Group, noted that human exposure risk mitigation could be adequately addressed through the use of engineering control measures and the use of relevant PPE, however, the recommendations in this regard given in the dossi er are only general indicat ions and nor specific requirements assessed necessary on each individual case by case situation.GESAMP-BWWG 9/6

ANNEX 4 Page 32

I:\MEPC\59\2-19.doc 3.3 Chemicals used in the system (information provided by the applicant)

3.3.1 The Group recalled that the following chemicals are used in the BWMS:

1 Triiron tetraoxide

Name of substance (IUPAC): triiron tetraoxide

Molecular formula or structural formula: Fe 3 O 4

2 PAC

Name of substance (IUPAC): Basic aluminum chloride Synonym: Polyaluminum chloride Molecular formula or structural formula: [Al 2 (OH)

n Cl 6-n ]

m (1 ≤ n ≤ 5, m ≤ 10)

3 PASA

Name of substance (IUPAC): Acryla mide sodium acrylate copolymer Synonym: Polymeric Acrylamide Sodium Acrylate

Molecular formula or structural formula:

CH 2 CH CH 2 n CH

m

CONH 2 COONa

3.3.2 The Group noted the following data provided by the applicant - in th e standard operation of the BWMS using the coagul ation and magnetic separation method, the amounts of chemicals added to ballast water are as given below in Tabl e 2, and the applicant states that these are the concentrations used for all analyses of treated ba llast water described in this section (see below).

Table 2: Standard rated concentration of chemicals

Agent Concentration (mg/L)

Triiron tetraoxide 30 PAC 5 (as Al)

PASA 1

3.3.3 The Group noted that the applicant states th e qualities of water trea ted by the land-based and shipboard test equipments w ith respect to regulation D-2 of the BWM Convention all satisfy regulation D-2, verifying that th is technology is reliable unde r both land-based and shipboard

conditions.GESAMP-BWWG 9/6

ANNEX 4 Page 33

I:\MEPC\59\2-19.doc 3.4 Active Substances (AS), Relevant Chem icals (RC) and Other Chemicals (OC)

3.4.1 The Group noted that the applicant has prov ided analyses of treated ballast water for Active Substances, relevant chemical and other chemicals as part of this application for Final Approval. Samples of untreated ballast water and treated ballast water were taken from the appropriate sampling positions indicated in Figure 2.

Tokyo

Bay Intake

pump Treatment equipment Simulated

Ballast Water Tank Tokyo Bay

Untreated water is sampled. Treated water is sampled at the outlet of the rotary filter separator, which is the final stage of the system. Feed

Tank

Treated water is s sampled after 5 days’ storage.

Figure 2 – Schematic diagram of treat ed ballast water sampling positions

3.4.2 The Group noted that according to the appli cant, in this BWMS, the Active Substances are as follows – triiron tetraoxide, PAC and PA SA, which are responsibl e for inactivating all harmful aquatic micro-organisms and pathogens pres ent in the ballast wate r. The applicant has provided analyses of treated ballast water for Ac tive Substances as part of this application for Final Approval, with the following results (u sing the land-based test setup on reclaimed land in Tokyo Bay with treatment rated capacity of 200 m 3 /hr) – Tables 3-5:

Table 3: Aluminum concentration of tr eated ballast water

Sample Value Limit of Detection

Untreated Water 0.048

Treated Water 0.022 0.001 mg/L

Table 4: Iron concentration of treated ballast water

Sample Value Limit of Detection

Untreated Water 0.05

Treated Water Not detected 0.01 mg/LGESAMP-BWWG 9/6

ANNEX 4 Page 34

I:\MEPC\59\2-19.doc Table 5: PASA concentration of treated balla st water (measured by PGC-MS)

Sample Untreated Water Treated Water Limit of

Detection 1 Not detected Not detected 0.1 mg/L 2 Not detected Not detected 0.1 mg/L

3.4.3 The Group recalled that in this BWMS, the acrylamide monomer (which occurs as an impurity in PASA) should be treated as a releva nt chemical. The applicant has provided analyses

of treated ballast water for this relevant chemical as part of this applic ation for Final Approval, with the following results – Table 6

Table 6: Acrylamide monomer con centration of treated ballast water

Sample Value Limit of Detection

Untreated Water Not detected

Treated Water Not detected 0.0001 mg/L

The Group recognizes that from these results, no acrylamide monomer was detected in either

treated or untreate d ballast water.

3.4.4 The Group noted that the applicant has id entified certain other chemicals as being possible resultant products of the treatment system and had analysed the treated ballast water for them, as part of the application for Final Approva l, with the following results – Tables 7 and 8:

Table 7: Heavy Metals concentration of treated ballast water

Metal Value Limit of

Detection Cadmium (Cd) Not detected. 0.002 mg/L Lead (Pb) Not detected. 0.005 mg/L Mercury (Hg) Not detected. 0.0001 mg/L Chromium [VI] (Cr[VI]) Not detected. 0.02 mg/L Arsenic (As) Not detected. 0.001 mg/L Selenium (Se) Not detected. 0.001 mg/LGESAMP-BWWG 9/6

ANNEX 4 Page 35

I:\MEPC\59\2-19.doc Table 8: VOCs concentrations of treated ballast water (measured by purge-and-trap gas chromatograph-mass spectrometry )

VOC Value

1,1-dichloroethylen e Not detected.

Dichloromethane Not detected.

Trans-1,2- dichloroethylene Not detected.

Cis-1,2- dichloroethylene Not detected.

Chloroform Not detected.

1,1,1-trichloroethane Not detected.

Carbon tetrachloride Not detected.

Benzene Not detected.

1,2-dichloroethane Not detected.

Trichloroethylene Not detected.

1,2-dichloropropane Not detected.

Bromodichloromethane Not detected.

Cis-1,3-dichloropropene Not detected.

Toluene Not detected.

Trans-1,3-dichloropropene Not detected.

1,1,2-trichloroethane Not detected.

Tetrachloroethylene Not detected.

Dibromochloromethane Not detected.

m,p-xylene Not detected.

o-xylene Not detected.

Bromoform Not detected.

p-dichlorobenzene Not detected.

Limit of Detection: 0.0001 mg/L as converted into toluene

3.4.5 The Group noted that the appli cant has provided an alytical results fo r heavy metal, VOC, and acrylamide monomer in the collected floc ma terial during the land-based test associated with Guidelines (G8) efficacy testing. The analysis used the collected flocs produced in processing seawater at the land-based test setup and/or prototype test setup on reclaimed land in Tokyo Bay. Results obtained are presented below in Tables 9-11.GESAMP-BWWG 9/6

ANNEX 4 Page 36

I:\MEPC\59\2-19.doc 3.4.6 However, the applicant did not perform the actual measurement for the concentration of either other chemical properties (i.e. POC, DOC and DO) or density of bacteria. So that the chemical and biochemical changes in flocs coul d not be evaluated. The Group is of the opinion that this system has a potential risk for the bacterial growth in the tank and production of some waste gases (i.e. H 2 S, CH 4 and CO 2 ). The Group strongly request to the applicant that more precise and quantitative assessment for the change in flocs tank with actual measurement of relevant parameters should be needed for eval uation for not only for the risk of bio-hazard but also the ship safety.

Table 9: Heavy metal concentrations in floc (by elution analysis)

Metal Value Limit of

Detection Mercury (Hg) Not detected. 0.0005 mg/L Cadmium (Cd) Not detected. 0.001 mg/L Lead (Pb) Not detected. 0.001 mg/L Chromium [VI] (CrVI]) Not detected. 0.005 mg/L Selenium (Se) Not detected. 0.001 mg/L

Table 10: VOCs in floc ( by purge and trap gas chro matography-mass spectrometry )

Item Value

Benzene Not detected.

Tetrachloroethylene Not detected.

Trichloroethylene Not detected.

1,2-dichloroethane Not detected.

Dichloromethane Not detected.

1,1,1-trichloroethane Not detected.

Carbon tetrachloride Not detected.

1,1-dichloroethylene Not detected.

Cis-1,2-dichloroethylene Not detected.

1,1,2-trichloroethane Not detected.

1,3-dichloropropene Not detected.

Limit of Detection: 0.0001mg/L as conversion into Toluene

Table 11: Acrylamide monomer in floc (chromatography-mass spectrometry)

Substance Value Limit of

Detection

Acrylamide monomer Not detected. 0.02 mg/kgGESAMP-BWWG 9/6

ANNEX 4 Page 37

I:\MEPC\59\2-19.doc 4 HUMAN HEALTH RISK ASSESSMENT

4.1 Hazard assessment

The Group had reviewed during its BWWG 4/9 the potential human health hazards associated with the Active Substances (Triiron tetraoxi de, PAC and PASA) and Relevant Chemical (Acrylamide Monomers) used by this system. Th e main hazardous properties are the following:

Triiron tetraoxide:

Inhalation of iron oxide dus t during occupational exposu re can cause a benign pneumoconiosis.

PAC:

PAC is irritating to skin and eyes (accordi ng to supplier MSDS, ie self-classification). LOAEL was 0.25 mg/m 3 or more with lung injury o ccurring at a PAC concentration of 0.25 mg/m 3 or more.

PASA:

The toxicological concern associated with PA SA is due to the occu rrence of the monomer (acrylamide).

Acrylamide:

Acrylamide is toxic if swallowed according to GHS classification (LD 50 between 50 and 300 mg/kg), irritating to skin and eyes , sensitising. Furthermore acrylamide is a neurotoxicant, a reprotoxican t, and it also has mutageni c and carcinogenic properties.

Risks associated with exposure of the crew

The Group requested that the risk to the crew w ould need to be assessed on the basis of the individual unit operations. In this sense, the applicant submitted for Final Approval the description of the working opera tions that could raise a con cern in terms of occupational exposure and the safety measures planned to be implemented to reduce the risk associated with each component of the system.GESAMP-BWWG 9/6

ANNEX 4 Page 38

I:\MEPC\59\2-19.doc Figure 3 – Work operations in this system entailing the risk of worker exposure

(Diagram elaborated by the Group for the Ba sic Approval report (BWWG 4/9) and further adapted by the Group for the Final Approval report (BWWG 9/9)

Work operations pointed out by GESAMP-BWWG 4/ 9 representing potential risks to the crew included the operations A to G as shown in Figure 3. According to this, the Group examined the following exposure scenarios:

A – Injection of flocculants (P AC and PASA) and triiron tetraoxide

The Group identified a work operation prior to A wh ich is addressed by the applicant as G in the confidential dossier namely the “Delivery of ch emicals”. This operation can involve a) manual handling of the chemicals packages (20 kg) (tri iron tetraoxide, PAC and PASA) and b) opening the packages and filling the containers. Thes e situations can lead to crew exposure to dusts/powders/particles w ith hazardous properties.

According to the applicant the ri sk can be properly controlled by means of installing a forced

exhaust in the worksite in addition to the use of protective personal equipment (PPE). The Group agreed that if the proposed measures are to be put in place, the risk would be acceptable.

B – Potential aerosol discharged (e mitted) from the magnetic separator

The Group agreed with the applicant that as it is a sealing casing, the risk of being exposed to the discharged aerosol when working in vicinity of the magnetic separator under normal operational

conditions is minimal.

C – Maintenance of the screw conveyer used for floc collection and process of floc

collection

Taking into consideration that the magnetic separator including the screw conveyor and the transportation path lines of collected flocs are within the sealed casings of the magnetic separator, the Group concluded that the risk of human exposure during this maintenance work seems to be acceptable.GESAMP-BWWG 9/6

ANNEX 4 Page 39

I:\MEPC\59\2-19.doc D – Transferring process of co llected flocs containing water into dedicated sealed storing

containers

The Group had a strong concern about the manual decanting of the collected flocs (storage tank)

into the dedicated containers because these ma terials represent a bioh azard (viable pathogens) and a potential chemical hazard due to the presence Active Substances and its residues/impurities, namely acrylamide monomers . The Group considered that these risks could only be mitigated by implementation of strict engineering control measures, QA standards, instructions manual and specified PPE/RPE or fully automated system of collecting flocs to

ashore treatment facilities.

E – Debarkation of dedicated sealed containers storing collected flocs

Please see comments above (D)

F – Treatment of collected flocs on land

Please see comments above (D).

4.2 Human Exposure Scenarios related to General Public

4.2.1 The Group concurred with the applicant that the general public target groups would be people subject to indirect exposur e by way of sea bathing or thr ough the environmen t or the food chain. The Group recalled that in the Methodolo gy for information gathering and the conduct of work of the GESAMP-BWWG (IMO circular BWM.2/Circ.13, Appendix 2, “Human Exposure Assessment”) the following procedur es for the assessment of exposur e and risk to human health

have been recommended:

.1 identification of exposure routes and development of exposure scenarios for respective exposure routes; and

.2 estimation of the amounts of exposur e (intake) and risk assessment.

4.2.2 The Group noted that the a pplicant had supplied literature data on NOAEL to be used in

the assessment of risk to human health, (see below in Table 13). In additi on, the results on assays of chemicals in treated ballast water ha ve been collected together in Table 12 below.

Table 12: Summary of results of assays of chemicals in treated ballast water (taken from tables above)

Substance Concentration in

treated ballast water Limit of Detection

Aluminum 0.022 mg/L 0.002 mg/L PASA n.d. 0.1 mg/L Acrylamide monomer n.d. 0.0001 mg/L Iron n.d. 0.01 mg/LGESAMP-BWWG 9/6

ANNEX 4 Page 40

I:\MEPC\59\2-19.doc Table 13: Data on toxicity studies in mammals utilized in risk assessment

Substance Test Route Species Duration Result References

PASA Repeated toxicity Oral (feeding) Dog 2 years NOAEL:

>1250 mg/kg/day 1) Cosmetic Ingredient Review, 2005

Acrylamide

monomers Repeated toxicity Oral (drinking

water) Rat 90days NOAEL:

0.2 mg/kg/day EU, 2002; NTP-CERHR,

2005

Aluminum (Guideline for drinking water treatment facility) 0.2mg/L (small facility) 0.1mg/L (large facility) WHO, 2003

1) convert mixing ratio 5% of dose level into dose amount per kilogram of body weight (food intake data referred to Lehman, A.J. (1954) )

4.2.3 The Group considered that the NOAEL used to calculate the different MOS would need to be allocated with the appropriate assessme nt factor (AF). As a standard procedure and according to the Methodology BWWG 3/9, annex 9, th e use of an AF of 100 (10 for interspecies variability and 10 for intraspe cies variability) is recommende d in order to address the uncertainties deriving from the extrapolation of re sults from animal toxicity testing to human

exposure.

4.3 Exposure of general population through the environment and food chain

4.3.1 The Group recalled that possible scenarios of exposure to the general population through the environment and food chain are limited to the following:

Scenario 1: Oral exposure (through water dr inking) of sea bathers and workers in the surrounding water areas; and

Scenario 2: Oral exposure to the general popu lation through the food chain (by way of marine foods).

4.3.2 Examining the data in Tables 12 and 13 a bove, the Group concurred with the applicant

that the concentration of alum inum in treated balla st water is 0.022 mg/L and this value is substantially lower than the allowed concentration of aluminum in tap water specified by the WHO, that is, 0.1 mg/L or 0.2 mg/L (for la rge and small drinking water treatment plants, respectively). Therefore, the Group considered that the concentration of aluminum (PAC) in treated ballast water discharged from this BW MS would not raise a concern to human health.

In what regards the assessment of risk to the general population of oral exposure through the food chain by way of marine products and taking into consideration that aluminum did not shown bioaccumulative properties in marine fish, the Gr oup concluded that the risk to PAC through the food chain would be also acceptable.GESAMP-BWWG 9/6

ANNEX 4 Page 41

I:\MEPC\59\2-19.doc 4.3.3 In the case of PASA, the Group noted the data in Tables 12 and 13 above and while the

concentration of PASA in treated ballast wa ter can only be a maxi mum of 0.1 mg/L, its concentration is expected to be further dilute d in the discharged water area. The Group agreed with the applicant that MOS can be estimated in accordance with a worst-case scenario, in which no dilution in water is assumed to occur, under the assumption that the water concentration

of PASA derived from treated ballast water is 0.1 mg/L.

MOS = 1,250 mg/kg/day/(0.003 mg/kg/day)

= 4.2 x 10 6

The Group concurred with the applicant that sin ce this MOS value is c onsiderably higher than the MOSref (100), it can be judg ed that exposure through drinki ng water to PASA derived from discharged treated ballast water will represent an acceptable risk to sea bathers or workers in surrounding water areas. Moreover in the assessment of risk to the general population of oral exposure through the food chain by way of marine products, the Group believes that bioconcentration for PASA in marine organisms s howed to be of low poten tial and therefore the human health risk is considered to be acceptable.

4.3.4 In the case of acrylamide monomer, the Group noted the data above in Tables 12 and 13 and while the concentration of acrylamide monomer in treated ballast water was found to be less than 0.0001 mg/L, its concentration is expected to be further diluted in the discharged water area. The Group agreed with the applicant that MOS can be estimated in accordance with a worst-case scenario, in which no dilution in water is assume d to occur and the concentration of acrylamide

monomer derived from treated balla st water is set at 0.0001 mg/L.

MOS = 0.2 mg/kg/day/(3.3 x 10 -6 mg/kg/day)

= 6.7 x 10 4

The Group concurred with the applicant that sin ce this MOS value is c onsiderably higher than the MOSref (100) and considered conservative because it was based on a drinking water worst case scenario (oral intake per day of 2L/person), it can be judged that ex posure through drinking water to acrylamide monomers derived from discharged treated ballast water will represent an acceptable risk to sea bathers or wo rkers in surrounding water areas.

Moreover in the assessment of risk to the genera l population of oral expo sure through the food chain by way of marine products, the Group be lieves that bioconcentration for acrylamide monomers in marine organisms showed to be of low potential and therefore the human health risk is considered to be acceptable.

4.3.5 In the case of trii ron tetraoxide, the Group noted the data above in Tables 12 and 13 and

while the concentration of iron in treated ballast water was found to be less than 0.01 mg/L, and its concentration is expected to be further dilu ted in discharged water area. On the other hand, the Group recalled that the concentr ation of iron in water has been reported to be 0.01 mg/L in seawater and 1 mg/L in river water (OECD, 20 07). The Group agreed with the applicant that these findings indicate that iron concentration in treated ballast water is similar to or less than

that in the water areas into which treated ballas t water is to be discha rged, and that iron in discharged treated ballast water will not alter the iron concentration in the environment. Therefore, the Group judged that the amount of iron, which is deri ved from discharged treated ballast water, ingested by sea bathers or wo rkers in surrounding water areas through waterGESAMP-BWWG 9/6

ANNEX 4 Page 42

I:\MEPC\59\2-19.doc drinking is not relevant. Moreove r in the assessment of risk to the general population of oral exposure through the food chain by way of marine products, the Group recalled the information in the Basic Approval application dossier that the accumulation of iron in the marine organisms does not need to be considered. Taken together, it would appear that there is no risk to the health of humans (the general population) by the oral route through the food chain.

5 RISKS TO SAFETY OF THE SHIP , ITS CREW AND THE GENERAL PUBLIC

5.1 Safety of the ship

5.1.1 The Group noted the specific countermeasures th at can be employed in this system to deal with identified potential emergency and safety problems during the balla st water purification

have been described and discu ssed above. A description of the various safety measures developed by the applicant is given above in section 3.2.

5.1.2 In line with the mention in the Report of the Application for Basic Approval of this system, the Group concurred with the applicant th at the treated water should have no increased corrosivity effect to ballast water tanks or ot her equipment in the ship, compared with normal

seawater.

5.1.3 Moreover, the Group concurred with the st atement in the Report of the Application for Basic Approval of this system, that issues connected with the storage on board ship of the acidic and potentially corrosive un-diluted PA C, have been sufficiently addressed by the applicant by specifying the use of appropriate protective coati ngs to storage arrangements and piping subject to direct c ontact with undiluted PAC.

5.2 Safety of the crew

5.2.1 Based on the evaluation in the above section 4, the Group considered that risk to safety of the ships’ crew by exposure to chemicals can be mitigated to an acceptable level by the safety measures planned to be put in place by the a pplicant. However, the Group considers that procedures and measures to be put in place relate d to handling and disposal of the collected flocs require additional strict engineering control measures and deta iled instructions for procedures, together with specified PPE/RPE, to be included to the required Operation Manual thus providing the necessary QA standards, or alternatively a fully automated system for the treatment and handling of the flocculated material should be incorporated to the BWMS.

5.3 Safety of the general public

5.3.1 Based on the evaluation in the above section 4, the Group agreed that the Active Substances and Relevant Chemical pr oduced by this system do not pose a significant risk to the general public (sea bathers and workers in the su rrounding water areas) and through the food chain (by way of marine foods).GESAMP-BWWG 9/6

ANNEX 4 Page 43

I:\MEPC\59\2-19.doc 6 ENVIRONMENTAL RISK ASSESSMENT

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

6.1.1 The Group recalled that as corrobor ated at the Basic Approval, none of the Active Substances triiron tetraoxide, PAC and PASA, nor the acry lamide monomers are

classified as PBT substances.

6.1.2 Based on these results, the Group concluded that these chemicals should not be classified

as PBT-substances.

6.2 Ecotoxicity testing of treated ballast water

6.2.1 The Group noted that in this section, the resu lts of acute and chronic aquatic ecotoxicity studies performed by the applicant with 100% tr eated ballast water as a test substance are presented in accordance with the Procedure for approval of ballast water management systems that make use of Active Substances (G9).

6.2.2 Acute aquatic ecotoxicity tests

6.2.2.1 The Group noted that the acute ecotoxicity tests for high and low salinity water were performed using the land-based test setup of the Hitachi BWMS, and employing 1-day-hold and 5-day-hold 100% treated ballast water sample s on algae, invertebrates and fish. From the results shown in Tables 14 and 15, the Group concluded that 100% treated ballast water, which is a non-diluted sample of treated ballast water, has no acute toxicity impact on these aquatic species.

Table 14: Acute NOEC of 100% treated ball ast water for high salin ity water (>32 psu)

Test sample Classification Species End point NOEC

Algae Skeletonema

costatum Growth
inhibition
72-h NOEC 100% treated
ballast water *

Invertebrate Hyale
barbicornis Mortality
96-h NOEC 100% treated
ballast water * 1-day-hold treated water discharge sample

Fish Oryzias javanicus Mortality
96-h NOEC 100% treated
ballast water *

Algae Skeletonema

costatum Growth
inhibition
72-h NOEC 100% treated
ballast water *

Invertebrate Hyale
barbicornis Mortality
96-h NOEC 100% treated
ballast water * 5-day-hold treated water discharge sample

Fish Oryzias javanicus Mortality
96-h NOEC 100%treated
ballast water *

* No effects were observed in 100% treated ballast wa ter which is a non-diluted sample of treated water.GESAMP-BWWG 9/6

ANNEX 4 Page 44

I:\MEPC\59\2-19.doc Table 15: Acute NOEC of 100% treated ball ast water for low salin ity water (<22 psu)

Test sample Classification Species End point NOEC

Algae Skeletonema

costatum Growth
inhibition
72-h NOEC 100% treated
ballast water *

Invertebrate Hyale
barbicornis Mortality
96-h NOEC 100% treated
ballast water * 1-day-hold treated water discharge sample

Fish Oryzias javanicus Mortality
96-h NOEC 100% treated
ballast water *

Algae Skeletonema

costatum Growth
inhibition
72-h NOEC 100% treated
ballast water *

Invertebrate Hyale
barbicornis Mortality
96-h NOEC 100% treated
ballast water * 5-day-hold treated water discharge sample

Fish Oryzias javanicus Mortality
96-h NOEC 100% treated
ballast water *

* No effects were observed in 100% treated ballast wa ter which is a non-diluted sample of treated water.

6.2.3 Chronic aquatic ecotoxicity tests

6.2.3.1 The Group noted that the chronic ecotoxicity tests for high salinity water were performed using the land-based test setup of the Hitachi BWMS, an d employing 100% treated ballast water samples on algae, invertebrates a nd fish. The Group noted that according to the applicant, the Active Substances were injected into seawater collected from Tokyo Bay to produce final concentrations two times higher than those of th e standard rated processing conditions for this system and these water sample s were analyzed (see Table 16 for results). Approximately 20 L of the treated water was sampled from the effluent in the outfall of the filter separator when the processing had been carried out for 16 to 32 minutes. The sample of treated water was put in a 20 L polyethylene bottle and tran sported to the test facility in cool, shaded conditions. All the samples of trea ted water were carried into the test facility the next day and were used in the chronic ecotoxicity tests.

6.2.3.2 From the results shown in Table 17, th e Group concluded that 100% treated ballast water, which is a non-diluted sample of treated ba llast water, has no chroni c ecotoxicity effects in any of the species tested.

Table 16: Final concentrations of chemicals after injection for chr onic ecotoxicity test

Active Substance Concentration in untreated

seawater for chronic ecotoxicity tests Triiron tetraoxide 60 mg/L PAC 10 mg/L (as Al) PASA 2 mg/LGESAMP-BWWG 9/6

ANNEX 4 Page 45

I:\MEPC\59\2-19.doc Table 17: NOEC on chronic ecotoxicity of 100% treated ballast water for high salinity water (>32 psu)

Test sample Classification Species End point NOEC

Algae Skeletonema

costatum Growth inhibition
72-h NOEC 100% treated
ballast water *

Invertebrate Hyale
barbicornis Mortality 21-days NOEC 100% treated
ballast water * Treated
ballast

water Fish Oryzias javanicus Post-hatch mortality 40-days NOEC 100% treated
ballast water *

*No effects were observed in 100% treated ballast water which is a non-diluted sample of treated water.

6.2.4 Ecotoxicity tests of water with flocs

6.2.4.1 The Group noted that according to the applicant, water containing fl ocs generated by this system using the standard rated concentr ation of Active Substa nces, was employed for ecotoxicity tests. Th e Group noted that the stated test results indicate that flocs in treated water (100% floc water) had no physical effect on aquatic organisms such as zooplankton and fish.

6.3 Risk assessments of chem icals for aquatic organisms

6.3.1 The Group recalled that in the Report of th e Application for Basic Approval of this system, the PEC/PNEC ratios and risk assessments as calculated by the applicant were not accepted by the Group and the applicant was requested to completely revise its risk assessment for aquatic organisms.

6.3.2 The Group noted that in the dossier for Final Approval, the applicant has treated the risk assessment of aluminum (in PAC) differently to the other chemicals in this system (triiron tetraoxide, PASA and acrylamide monom ers). In addition, th e Group referred to the summary of results of assays of chemicals in treated ballast wa ter (see above in Table 12), where aluminum is the only one of the four chemicals th at is routinely detected in the treated ballast water even though its concentration is reported by th e applicant to be significantly lower than the concentration in natural seawater (see above at sections 3.4.2 and 3.4.3 for a ll analytical results).

6.3.3 Based on this situation with aluminum concen tration in treated ballast water being lower than in natural seawater, the Group agreed with the applicant that aquatic organisms are quite unlikely to be exposed to harmful levels of al uminum as a result of PAC being used in this system that produces detectable aluminum levels in the treated ballast water, particularly bearing

in mind that the treated ballast water will be mixed with the receivin g natural seawater upon discharge. In order to be su re, the Group performed a worst-cas e risk assessment for aluminum in the form of a PEC/PNEC ratio calculation, as follows, based on data provided by the applicant in the dossier for Final Approval:

Concentration of Al in treated ballas t water (from Table 12 above) = 0.022 mg/L; Using a default dilution rate of 10, PEC = 0.0022 mg/L; Worst case chronic toxicity NOEC for Al (fro m data provided in Appendix) = 0.4 mg/L; Using Assessment Factor of 100, then PNEC = 0.004 mg/L;

Then PEC/PNEC ratio = 0.55

The Group considered that the risk as sessment for aluminum is acceptable.GESAMP-BWWG 9/6

ANNEX 4 Page 46

I:\MEPC\59\2-19.doc Bearing in mind the points above and also ta king into account the information provided by the applicant concerning the backgr ound concentration of aluminum in open seas (variation is from 0.03 μg/L in intermediate deep ocean wa ters (0.15 μg/L in surface waters at sea) to 800 μg/L in rivers) (Table 7- 6, p. 91, confidential do ssier), the Group considered that the risk assessment for aluminum is acceptable. The concentr ation in discharges balla st water is likely to decrease the Al-concentration in the receiving waters.

6.3.4 In addition, the Group noted that the applicant has provided results of tests using influent

seawater to which kaolin was added to increase the SS concentration and the concentrations of

aluminum ions in the influent water to a much higher level than in natural seawater. The test results are shown in Table 18 below. The Group recalled that kaolin is a natural mineral containing aluminum so the concentrations of total aluminum in the influent were several times higher than in natural seawater. The results show that the total aluminum concentrations in the

treated ballast water were still lo wer than in influent seawater.

Table 18: Results of analysis of aluminum

(Case where kaolin was added to influent seawater)

Influent Treated water Detection limit 0.34 mg/L 0.044 mg/L 0.001 mg/L

The Group concluded that even in this case of elevated aluminum levels, the treated ballast water

has no effect on aluminum concentra tion in the water area discharged.

6.3.5 Turning their attention now to triiron tetraoxide, PASA and acrylamide monomers, the Group noted that the applicant has performed a risk assessment of these chemi cals on aquatic organisms based on the calculation of PEC/PNEC ratios, using litera ture aquatic ecotoxicity data (see Appendix) to provide PNEC values (see Tabl e 19 below), with PEC values taken from the analytical data of treated ba llast water in Table 12 above.

Table 19: PNECs for triiron tetraoxide, PASA and acrylamide monomers

Substance Toxicity (mg/L) Assessment

factor PNEC (mg/L)

Triiron

tetraoxide 48-h LC 0 (acute) > 1,000 1000 > 1 PNECshort

48-h LC 50 (acute) 180 1000 0.18 PNECshort

PASA 30-day NOEC (chronic) 75 100 0.75 PNEClong

96-h LC 50 (acute) 59 1000 0.059 PNECshort Acrylamide

monomers 28-day NOEC (chronic) 2.04 100 0.02 PNEClongGESAMP-BWWG 9/6

ANNEX 4 Page 47

I:\MEPC\59\2-19.doc 6.3.6 The Group concurred with the applicant th at the PEC/PNEC ratios shown in Table 20

below are all lower than 1 for all these three Active Substances. Therefore, the Group agreed there is no risk to aquatic organisms from these th ree Active Substances used in this system.

Table 20: PEC/PNEC ratio for triiron te traoxide, PASA and acrylamide monomers

Substance PEC (mg/L) PNEC (mg/L) PEC/PNEC

ratio

Triiron tetraoxide < 0.01 > 1 < 0.01

PASA < 0.1 0.18 < 0.56 Acrylamide monomers < 0.0001 0.02 < 0.005

6.4 To establish the maximum allo wable discharge concentrations

6.4.1 The Group noted that the applicant has provided proposals for maximum allowable discharge concentrations (MADC) of all chemicals in the ballast water, ba sed on consideration of the PNEC values calculated above, assessment reports evaluated by in ternational bodies and governmental bodies (see in Appendix), and syst em dosage concentration of each substance.

6.4.2 In the case of aluminum, the Group noted that th e applicant proposes to base the MADC on Canada’s 0.074 mg/L (see data in Appendix), wh ich is the strictest cr iterion stated. At a background concentration of 0.074 mg/L, the M ADC of aluminum is 0.22 mg/L according to the MAMPEC (Ver. 1.6) model simulation (CER I, 2008). The default commercial harbour of

the MAMPEC model is half the size of Rotterdam Port, and other conditi ons were used without change. In addition, the Group notedthe applicant states that considering this simulation, at a background concentration less than 0.074 mg/L, it may be clear that the calculated result of MAMPEC is to be less than 0.074 mg/L in the case of an emission load of 0.22 mg/L. On the other hand, at a background concentration larger than 0.074 mg/L, aquatic organisms living in the area are expected to have so me tolerance to such concentrations of aluminum. In this case,

the result calculated with MAMPEC is le ss than the backgr ound concentration (larger than 0.074 mg/L) when the emission load is 0.22 mg/L, so it is concluded that the discharged ballast water has li ttle impact on the aquatic envir onment. Considering all of the above, the Group notes the MADC of alumin um proposed by the applicant is 0.22 mg/L. The Group agrees with this value.

6.4.3 In the case of iron, the Group noted that the applicant proposes to base the MADC on the following discussion. Iron is one of the most abunda nt metals in the Earth’s crust and is found in natural fresh waters at levels ranging from 0.5 to 50 mg/L. Iron is known as an essential element in human and other organisms’ nutrition and th ere is no data on bi otoxic forms of iron. Therefore, it is difficult to es tablish the MADC from an ecotoxic ity point of view as specified

in Metals Environmental Risk Assessmen t Guidance (UK, International Council of Mining & Metals). In the Hitachi BWMS, the applicant stated that triiron tetraoxide is added as slurry and NOT a solution, so that dissolution of iron ions into either ballast water or the ecosystem may not occur. Therefore, the Grou p noted the MADC of iron is proposed by the applicant as 30 mg/L. The Group agrees with this value.GESAMP-BWWG 9/6

ANNEX 4 Page 48

I:\MEPC\59\2-19.doc 6.4.4 In the case of PASA, the Group noted that the applicant proposes to base the MADC on the PNEC of PASA at 0.18 mg/L in Table 20 ab ove. Furthermore, ac cording to water quality guidelines of Canada’s CCME, the US EPA and similar bodies in ot her countries, d ilution may be considered because, for the most part, the immedi ate concentration of substances at the discharge point will not be an ade quate representation of the concentration of the substa nce in the water body as a whole. For instance, for the most part, aquatic li fe will not be exposed to the concentration of the substance in the pipe but rather to the receiving wa ters mixed with effluent. The Group notes that the applicant states there is no simulation model to examine dilution similar to MAMPEC, and which is specialized for a macromolecular or ganic compound such as PASA, so an alternativ e approach is

considered such as the use of dilution factors. Ca nada’s CCME has established a framework of Effluents Discharge Objectives considering dilu tion factors. For lakes and enclosed bays, the

default dilution factor is a maximum of 1 in 10. Following this framework as an example, the Group notes that the applicant pr oposes the MADC of PASA is 1.8 mg/L. The Group agreed with this value.

6.4.5 In the case of acrylamide monomers, the Group notes that the applicant proposes to base the MADC on the PNEC of acrylamide monomers at 0.02 mg/L in Tabl e 20 above. The Group noted that according to the applicant, some para meters required to simulate the discharge load by MAMPEC are unclear, so that a dilution f actor of 10 may be a pplied as for PASA. Thus calculated, the Group noted that the M ADC of acrylamide monomers proposed by the applicant is 0.2 mg/L. The Group agreed with this value.

6.4.6 Based on the above discussion, the Group c oncurred with the ap plicant that each substance can comply with the established MADC values taking into ac count the properties of each substance and the specifications and mechan isms of the Hitachi BWMS. It was concluded by the Group that this system presents no risk to the aquatic environment.

6.4.7 The applicant performed its calculation with the MAMPEC-model version 1.6. As the Group did not have this versi on available, it estimated the concentrations with version 2.0. The main difference is the more dynamic characte r of the new version. Ne vertheless the initial concentrations concurred exactly with the ones provided by the a pplicant. Therefore, the Group considered the calculations of the applicant acceptable.

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to safety of the ship

7.1.1 The Group noted that specific countermeasures can be employed in th is system to deal with envisaged emergency and safety problem s during the ballast water treatment plant operation, and that subject to all the necessary identified risk mitigation measures being detail developed and implemented this BWMS should pres ent no undue risks to the safety of the ship.

7.2 Risks to the crew and general public

7.2.1 The Group considered that risk to safety of the ships’ crew by exposure to chemicals can be mitigated by the safety measures planned to be put in place by the applicant. However, the Group considers that procedures and measures to be put in place related to handling and disposal of the collected flocs require additional strict engineering contro l measures and detailed instructions for procedures, together with specified PPE/R PE, to be included to the required Operation Manual thus providing the n ecessary QA standards, or alternatively a fully automated system for the treatment and hand ling of the flocculated material should be incorporated to the BWMS.GESAMP-BWWG 9/6

ANNEX 4 Page 49

I:\MEPC\59\2-19.doc 7.2.2 The Group also concluded that the Active Su bstances and Relevant Chemical produced by this system do not pose a significa nt risk to the general public (sea bathers and workers in the surrounding water areas) and through the f ood chain (by way of marine foods).

7.3 Risks to the environment

7.3.1 Having reviewed all of the information subm itted with this applic ation, the Group agreed that this system will not cause any harm to the environment. The initial estimations of

the PEC/PNEC values for the different substanc es were all < 1, except the value for aluminum. As the background concentration of Al is gene rally higher than what was produced by this system, it was considered that the PEC for Al was not to cause any harm to the receiving water. In addition, the MAMPEC calculati ons of the applicant concurred with the results achieved by the Group, although another version of the model was used.

7.3.2 However the chemicals for coagulation, such as aluminum is well known as its toxicity, and the complexity of mechanical operation for disinfection, the applican t should prepare the managing program when the BWMS is not functioned normally.

7.4 Recommendation

7.4.1 Having reviewed all the data and informa tion submitted by Japan with the application for Final Approval and the information receive d from the applicant during the GESAMP-BWWG meeting, the Group recommended to MEPC that Fi nal Approval be given to the Hitachi BWMS (ClearBallast) provided that the concerns and issu es raised in this revi ew are addressed by the applicant to the satisfaction of the Administration. To a void unreasonable risk to the environment, to humans and to resources the system should be operated with the following

restrictions:

.1 Maximum allowable dosages of Active Substances

The maximum dose for these Active Substances should be set as follows:

5 mg/L of PAC (as Al) 30 mg/L of triir on tetraoxide (Fe 3 O 4 ) 1 mg/L of PASA; and

.2 Maximum allowable discharge concen trations of Active Substances

The system should ensure a maximum disc harge concentration of all the Active Substances and relevant chemicals, if the separation and filtering process are functionally operated. To ensure these processes, the water level in these components should be recorded during ballast water intake.

.3 PASA

PASA needs to be strictly controlled by adequate selection of the suppliers in order to keep the concentration of acrylamide monomers as its impurity

below 0.2%. Procedures should be include d in the Quality Assurance Program to ensure that only PASA with an acrylamid e monomer content of less than 0.2% is supplied for the operation of this BWMS.GESAMP-BWWG 9/6

ANNEX 4 Page 50

I:\MEPC\59\2-19.doc 7.4.2 The Group, not wanting to delay system a pproval unnecessarily a nd taking the unusual, biocide-free design of the syst em into account, considered that the applicant had provided

sufficient information for BWWG to recommend to MEPC that it be gr anted Final Approval and that any outstanding aspects could be dealt with by the Administ ration prior to Type Approval.

7.4.3 The Group, having reviewed the dossier an d additional responses requested of the applicant, was of the opinion th at the system should be considered generally safe for the environment, the crew and human health, when th is BWMS is correctly operated. To this end, the Group strongly recommended that the MEPC invites th e Administration undertaking the G8 Type Approval testing to ensure that all i ssues and concerns have been addressed prior to issuing a Type Approval Cer tificate for this system.

.1 The procedure for handling the floccula ted material that contains a condensed mixture of organic matter and organi sms including bacteria and potentially pathogens is unclear. In the flocs all material is concen trated and the instructions on how to handle this potentially bio-ha zardous material should be clear and unambiguous to all crew concerned. Theref ore, prior to operating the system, the applicant will have to provide an Operat ion/Technical Manual where all safety procedures should be explicitly described including the different risk mitigation measures and PPE/RPE prescribed in all handling, storage and treatment steps of the flocculated material generated by the system.

.2 The Group noted that a gravity “buffer tank” is a requirement of the system.

Additional water level error detection devices will require to be incorporated into the BWT equipment control system to c ounter the potential for high level/overflow

and low level in the “buffer tank”. The Group notes that the system evaluated does not utilize a discharge pump connected direc tly to the outflow of the filter separator.

.3 The questions relating to the provision of a drain from residue tank and its cleaning requirement were not answered to the Groups satisfaction and need to be dealt with appropriately by describing the safety procedures extensively in the Technical/Operations Manual.

.4 The Group considered that the mainte nance requirements provided were very general and that these shoul d be supplemented in the final Technical Manual with

sufficient detail to enable full assessment of both the work act ually required and the potential for operator exposure.

* * *GESAMP-BWWG 9/6

ANNEX 4 Page 51

I:\MEPC\59\2-19.doc Appendix

PHYSICOCHEMICAL AND BIOLOGICAL PROP ERTIES OF ACTIVE SUBSTANCES (TRIIRON TETRAOXIDE, PAC AND PA SA) AND RELEVANT CHEMICAL (ACRYLAMIDE MONOMERS)

1 EFFECTS ON AQUATIC ORGANISMS

1.1 Aluminum

1.1.1 The Group notes that the applicant states alum inum is the most abundant metallic element

on earth and constitutes 8.13% of the earth's crust. Natural sources of al uminum released to aquatic systems include weathering of rocks, glacial deposits and so ils and their derivative minerals and atmospheric deposition of dust pa rticles (WHO, 1997; EC and HC, 2000). It is not recognized as a toxic substance in natural marine environment due to the high concentration of it found in clay particles in marine waters and its relatively constant pH of approximately 8.2. Clay particles tend to bind ra pidly with aluminum and form large colloids, thus removing aluminum from the water column. Therefore, th e concentrations of di ssolved aluminum in seawater remain low in accordance with the equ ilibrium of aluminum specifications, in spite of

the existence of a wide variet y of natural aluminum sources (WHO, 1997; CCME, 2003; EC and HC, 2000).

1.1.2 Previous risk assessment of aluminum in reports of inte rnational bodies and governmental bodies – provided by applicant

The following is a summary of representative ev aluations of aluminum effects as previously reported by international bodies and governmental bodies:

WHO, Environmental Health Criteria, 194 Aluminum, 1997

Hazards posed to human health by aluminum have been systematically identified in a number of previous studies. However, no evidence has ye t been produced that supports the primary

causative role of aluminum in Alzheimer’s dis ease that has been suggested. Nor is there any

indication that aluminum is carci nogenic. Taking these facts together, it has been concluded that there is insufficient health-related evidence to ju stify revising the exis ting WHO Drinking-Water Guidelines with respect to aluminum.

WHO, Guideline for dri nking water quality, 2006

Owing to the limited amount of data relevant to the effects of aluminum on animals and the uncertainty surrounding available data on its effect on humans, no accurate health-based guideline values on it can be deri ved. However, practicable leve ls based on optimization of the coagulation process in drinking-water plants using aluminum-based coagulants have been derived as 0.1 mg/L or less in large water treat ment facilities, and 0.2 mg/L or less in small

facilities.GESAMP-BWWG 9/6

ANNEX 4 Page 52

I:\MEPC\59\2-19.doc EC and HC (2000), Canadian Environmental Pr otection Act 1999, Priority Substances List Assessment Report for Aluminum Chloride, Aluminum Nitrate, Aluminum Sulfate

This report characterized the environmental ri sk of aluminum posed to pelagic organisms. Environmental exposure to aluminum in water is a ssumed to be greatest in areas in proximity to places where process wastewater (backwash water) is directly released to aquatic environments from drinking water treatment plants. Table 5 of EC and HC (2000) presents estimated total aluminum concentrations in backwash waters for 13 drinking water treatment plants, including those with the highest estimated levels of con centration. The total aluminum levels present in effluent from drinking water treatment plant wastewater were measured (Table 5 of EC and HC, 2000; 0.76~115mg/L). In order to estimate the amount of bioavailable aluminum present in rivers, the report performed speciation w ith MINEQL + and WHAM models. These models

calculated the concentration levels of dissolv ed inorganic monomeric forms of aluminum following the releases of wastewater from selected drinking water treatment plants, using the estimated aluminum level in effluents and assuming a 1:10 dilution.

The possibility that modeled c oncentrations overestim ate actual values is further supported by measured data. The report concluded that organism s are unlikely to be exposed to harmful levels of aluminum as a result of using aluminum to treat water.

In a study done with collected floc s, it was concluded that all th e collected flocs tested were non-toxic using a microbial test and acutely and subacutely non-toxic to rainbow trout.

1.1.3 Risk assessment of aluminum on aquatic organisms – provided by applicant

The following is a summary of representative ev aluations of aluminum effects as previously reported by international bodies and governmental bodies. As a prerequisite for assessing the influence of aluminum contained in treated ballast water, the literature of aluminum concentration in natural water areas was surveyed especially where intake/discharge of ballast

water is conducted.

Consideration of natura l background concentration in risk as sessment has been recommended in guidance for the risk assessment of various meta ls, and this recommendation has been carried out (ICMM, 2007a, b; EA 2008, etc.).

Risk assessment from a quantitat ive evaluation of aluminum risk according to EC and HC (2000)

Key studies of the acute toxicity and chronic toxicity of aluminum selected from the hazard data on aluminum for aquatic organisms. Considering that the total aluminum concentration in the

treated ballast water usi ng this system was 1/10 to 1/10000 sm aller than that in the effluent described in the report (0.76 to 115mg/L, EC and HC, 2000), it can be reasonably concluded that organisms are unlikely to be exposed to harmful levels of aluminum resulting from the use of

aluminum for ballast water treatment.GESAMP-BWWG 9/6

ANNEX 4 Page 53

I:\MEPC\59\2-19.doc Key studies of the acute toxicity of aluminum

Substance Biological
classification Organism species End point Toxicity (mg/L)

Skeletonema costatum

, SW Growth
inhibition
72-h EC 50 4.65 Algae

Pseudokirchneriella subcapitata, FW Growth
inhibition
96-h EC 50 0.57

Invertebrates Nitocra spinipes , SW Mortality
96-h LC 50 10

Shellfish Physa sp. , FW Mortality
96-h LC 50 30.6 Aluminum
ions

Amphibia Bufo americanus , FW Mortality
96-h LC 50 0.86

Abbreviations: SW: marine species, FW: fresh water species

Key studies of chronic toxicity of aluminum

Substance Biological
classification Organism species End point Toxicity (mg/L)
Skeletonema costatum

, SW Growth
inhibition
72-h NOEC 1.04 Algae

Pseudokirchneriella subcapitata, FW Growth
inhibition
96-h NOEC < 0.4 Aluminum
ions

Invertebrates Ceriodaphnia sp. , FW Mortality 8-day NOEC 4.9

Abbreviations; SW: marine species, FW: fresh water species.

Effects of aluminum accumulated in sediments in discharge water areas

The report on aluminum assessment by EC and HC (2000) of Canada revealed that they conducted toxicity studies of flocs collected in the proc ess of drinking water treatment and found no significant toxicity e ither in studies using micro-orga nisms or in acute or subacute toxicity studies using rainbow trout (fish). In a simulation using the MAMPEC model, the

contents of aluminum in sediments after 10 years of accumulation have been calculated at 0.000777-0.0349 mg/g. Since this range of simulated contents is substantially smaller than the aluminum content in natural soil, aluminum adso rbed to sediments may not exert adverse effects on living organisms.

1.1.4 Establishing the maximum allowable discharge concentration for aluminum

It is practical to manage the total concen tration of dissolved monomeric aluminum and particulate aluminum for risk management with respect to human species and aquatic organisms. In the United States and Canada, relevant water quality criteria have been established, but there are no criteria in Japan and the United Kingdom.GESAMP-BWWG 9/6

ANNEX 4 Page 54

I:\MEPC\59\2-19.doc Criteria for aluminum in water

Country Environmental Criteria Notes

Canada 0.074 mg/L Minimum criterion for fresh water. Aluminum is not expected to be toxic

in the natural marine environment.

USA CMC: 0.75 mg/L (Criteria Maximum Concentration) CCC: 0.084 mg/L (Criteria Continuous Concentration) Both criteria are freshwater criteria.

No criteria for seawater.

UK n.a. - Japan n.a. -

n.a.: no established criteria

1.2 Triiron tetraoxide, PASA, and acrylamide monomers

1.2.1 The Group noted that the applicant had provide d key studies of acute toxicity and chronic toxicity respectively extracted from the hazard data that are used for calculation of PNEC values of substances employed for Hitachi BWMS.

Key studies of acute toxicity of triiron tetraoxide, PASA, and acrylamide monomers

Test
substance Biological
classificatio

n Organism species End point Toxicity (mg/L)

Algae 1 n.a. n.a. No data
Invertebrates n.a. n.a. No data Triiron
tetraoxide
Fish Leuciscus idus , FW Mortality
48-h LC 0 * > 1,000

Algae n.a. n.a. No data
Invertebrates Ceriodaphnia dubia

, FW Mortality
48-h LC 50 218

Girella punctata , SW Mortality
48-h LC 50 840 PASA

Fish

Oryzias latipes , FW Mortality
48-h LC 50 180

Algae Pseudokirchneriella subcapitata , FW Growth inhibition
72-h EC 50 33.8

Mysidopsis bahia , SW Mortality
96-h LC 50 78 Invertebrates

Daphnia magna , FW Swimming
inhibition
48-h EC 50 98 Acrylamide

monomers

Algae Danio rerio , FW Mortality
96-h LC 50 59

Abbreviations: SW: marine speci es, FW: fresh water speci es, n.a.: not available * This evaluation is using LC 0 in which no lethality occurs, because this evaluation stands safer value than using LC 50

.GESAMP-BWWG 9/6

ANNEX 4 Page 55

I:\MEPC\59\2-19.doc Key studies of chronic toxicity of triir on tetraoxide, PASA, and acrylamide monomers

Substance Biological
classification Organism species End point Toxicity (mg/L) Algae n.a. n.a. No data
Invertebrates n.a. n.a. No data Triiron
tetraoxide

Fish n.a. n.a. No data Algae n.a. n.a. No data
Invertebrates n.a. n.a. No data PASA

Fish Salvelinus namaycush

, FW Mortality 30-day NOEC 75

Algae Pseudokirchneriella subcapitata , FW Growth
inhibition
72-h NOEC 16

Invertebrates Mysidopsis bahia , SW Mortality 28-day NOEC 2.04 Acrylamide

monomers

Fish n.a. n.a. No data
Abbreviations; SW: marine species, FW: fresh water species, n.a.: not available

1.3 Information on Endocrine Disruption

1.3.1 The Group noted that no reports indicating th at these chemicals might have any endocrine effects on aquatic organisms had been found. Th e Group agreed that, as with other similar applications there was no reason to suspect that the Active Substances and relevant chemical would have any endocrine disrupting effects.

1.4 Sediment toxicity/bioavaila bility/biomagnification/bioconce ntration/foodweb-population

effects

1.4.1 The Group agreed that the Active Substances and relevant chemical are neither expected

to adsorb to sediment nor to accumulate in the food web.

2 MAMMALIAN TOXICITY

2.1 Risk to human health

2.1.1 Data on NOAELs to be used in the assessment of risk to human health

Key studies utilized in the asse ssment of risk to human health

Substance Test Species Route Duration Result References

Iron oxide (Reference) Occupation Human Inhalation - TLV-TWA: 5 mg/m 3 1) ACGIH,
2005

Triiron
tetraoxide Repeated toxicity - Oral (drinking

water) - - -

PAC Repeated toxicity Rat Inhalation 6 months LOAEL: 0.25 mg/m 3 Steinhagen
et al ., 1978

PAC Repeated toxicity - Oral (drinking

water) - - -GESAMP-BWWG 9/6

ANNEX 4 Page 56

I:\MEPC\59\2-19.doc Substance Test Species Route Duration Result References

Aluminum (Reference) Repeated toxicity Human Oral (drinking

water) 0.1 mg/L or
less 2) 0.2 mg/L or
less WHO, 2003b

PASA Repeated toxicity - Inhalation - - -

PASA Repeated toxicity - Oral (drinking

water) - - -

PASA Repeated toxicity Rat, dog Oral (feeding) 2 years NOAEL:
>5% Cosmetic Ingredient

Review,

2005 Acrylamide

monomers Occupation Human Inhalation - TLV-TWA: 0.03 mg/m 3 3) ACGIH,
2005

Acrylamide

monomers Repeated toxicity Rat Oral (drinking

water) 90 days NOAEL:
0.2 mg/kg/day EU, 2002;
NTPCERHR,

2005

1) Measured as respirable fraction of the aerosol. 2) Owing to the uncertainty surrounding the human data and the limitations of the animal data as a model for humans, a health-based guideline value for aluminum cannot be derived at this time (WHO, 2003b). Therefore, the practicable level is derived based on optimization of the coagulation process in drinking-water plants using aluminum-based coagulants, to minimize aluminum levels in finished water. Concentrations of aluminum of 0.1 mg/L or less are achievable in large water treatment facilities. For small facilities (e.g., those serving fewer than 10,000 people), 0.2 mg/L or less is a practicable level for aluminum in finished water (WHO, 2003b). 3) Measured as inhalable fraction and vapour.GESAMP-BWWG 9/6

ANNEX 4 Page 57

I:\MEPC\59\2-19.doc 3 PHYSICAL AND CHEMICAL PROPERTIES

3.1 Physical chemical properties of Active Substances, relevant chemical and treated ballast water (G9:4.2.1.4)

3.1.1 The Group noted that the relevant physical chemical properties be low provided by the applicant show that all the subs tances listed are well known and that the chemicals employed are relatively harmless except for undiluted PAC soluti on, which is acidic and slightly corrosive, as stated in the application for Basic Approval. In water, the chemical characteristics of the listed materials other than PAC are relatively simple. However, dissolved aluminum compounds, including PAC, show complicated chemical characteristics.

Physical chemical properties

Property Triiron

tetraoxide PAC PASA Acrylamide

monomers Treated

ballast

water

CAS No. 1317-61-9 1327-41-9 25085-02-3 79-06-1 None Melting point (°C) 1,538 1) About -12 2) Not Applicable 84.5 1) NR 9)

Boiling point (°C) Not Applicable About 103 2) Not Applicable 125 at 3kPa 1) NR

Flammability (Flash point for liquids; °C) Not Applicable Noncombustible 5) None #1, 4) 138 (closed method) 3) NR

Density (20°C; kg/m 3 ) 5,200 (5.2g/cm 3 ) 1) 1,340 (1.34g/cm 3 ) 2) Bulk specific gravity;

0.55-0.65 4) 1,130(1.13g/cm 3 )
3) NR

Vapour pressure (20°C; Pa) Not Applicable Non-evaporable
5) Nonevaporable #2 1 3) NR

Vapor density (air = 1) Not Applicable Not Applicable Not Applicable 2.46 (calculated value) NR

Water solubility g/L Insoluble 6) Soluble 1) Mixing with

water forms highly viscous gel-like material
4) 2,040 (25°C) NR

Oxidationreduction potential Not Applicable None 5) None 4) None 7) None

Corrosivity to

material equipment None Corrosive to

metals None None None

Autoignition temperature (°C) Not Applicable Noncombustible 5) None 4) 424 3) NR

Explosive properties Not Applicable None None None 7) NR

Oxidizing properties Not Applicable None 5) None 4) None 7) NRGESAMP-BWWG 9/6

ANNEX 4 Page 58

I:\MEPC\59\2-19.doc Property Triiron

tetraoxide PAC PASA Acrylamide

monomers Treated

ballast

water Surface tension None Equal to water

because of aqueous solution None None NR

Viscosity (mPa.s) None 28mPa·s (25°C)
2) Mixing with

water forms highly viscous gel-like

material 4) 2.71 mPa·s (25°C) (50% aqueous solution) 8) 1.55cP (16°C)

Thermal stability Transformed

into iron

oxide (Fe 2 O 3 ) by heating in

air 1) Non flammable Combustible by heating at high

temperature Violently polymerizes when

heated to over

85°C or when exposed to of light or oxidizing

agents.
When heated to decomposition,

fumes and nitrogen oxide are generated. 3), 8) NR

Reactivity to storage tank

material None None None None NR

pH in solution NR NR 4.3 (15%) 1) NR NR 7 - 7.3

Salinity N.D.

Conductivity 4.5 S/m

TOC 1.3 mg/L

DOC N.D.

Other physicochemical properties None None None Because acrylamidereadily polymerizes, common products contain polymerization

inhibitors 1) None

Dissociation constant (pKa) Not Applicable No dissociable

group No dissociable

group No dissociable

group NR

1) Merck, 2006, 2) EU, 2000b, 3) IPCS, 2000, 4) Dia-Nitrix, 2004, 5) Asada Chemical Industry, 2003, 6) Dean,1999, 7) EU, 2002, 8) HSDB, 2007, 9) NR: not required for G9

1.1 #1 Non-combustible under conditions of no rmal use (normal pressure, 0-50°C). #2 Non-evaporable under normal pressure and normal temperature because of high molecular weight polymers (several million or more).GESAMP-BWWG 9/6

ANNEX 4 Page 59

I:\MEPC\59\2-19.doc 4 OTHER INFORMATION

4.1 pH and SS

4.1.1 The Group noted that the applicant has prov ided analytical resu lts for pH and SS

concentration in treated ballast water. The tabl e below shows the average pH values of treated ballast water and untreated water. These analys es were carried out with both the prototype in 2007 and the land-based setup in 2008. The pH of treated water is lower than that of untreated water, but differs only slightly. The pH reducti on is limited in the ambient water environment due to the mechanism of equilibrium, as describe d in the Basic Approval Application. Therefore no pH-reducing effect is expected in the aqueous environment, considering that the treated water is discharged immediately after treatment.

Average pH value of treated ballast water

Treatment system Sample pH

Untreated water 8.5 Land-based setup Treated water 7.1

Untreated water 8.3 Prototype Treated water 7.0 (n=10)

The table below shows the average SS concentrati on in treated water and untreated water. The

results show that the SS concentration in the treated water of the loaded test was lower than 1 mg/L, as it also was in the control test.

SS concentration of treated ballast water

(Unit: mg/L)

SS concentration Treatment

system Test Before

treatment After

Treatment LOD

Control 1) 5 or < 5 < 1 Land-Based Test Equipment Loaded test 2) 50 ~ 60 < 1 1

Control 1) 5 or < 5 < 1 Prototype Equipment Loaded test 2) 50 ~ 60 < 1 1

1) Actual seawater taken from Tokyo Bay, LOD: Limit of Detection; (n=10) 2) Kaolin was added to the actual seawater before the treatment

4.1.2 The Group noted the applicant st ates the above test results show that this system is appropriate for use in large-scale treatment in terms of its pH and SS removing performance.

***GESAMP-BWWG 9/6

I:\MEPC\59\2-19.doc ANNEX 5

REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

Greenship Sedinox Ballast Water Management System

Submitted for Final Approval by the Netherlands

0 SUMMARY

0.1 Having reviewed all the data and inform ation submitted by the Netherlands with the application for Final Approval and the info rmation received from the Applicant during the GESAMP-BWWG meeting, the Group recommended to MEPC that Final Approval be given to the Greenship Sedinox BWMS.

0.2 The Group recalled that Basic Approval of the Greenship Sedinox BWMS was given by MEPC 58 (under the name of Greenship’s BWMS) and the report is available at document MEPC 58/2/7 (GESAMP-B WWG (6), annex 6, Report of Application for Basic Approval).

0.3 The Group noted that in response to th e comment of the GESAMP-BWWG that the system needed refinement (MEPC 58/2/7, a nnex 6, paragraph 2.1.9), the Applicant has significantly refined the sy stem without changing the principles of the treatment. The refinement consists of three main adjustments: (1 ) lowering the maximum dose concentration of Active Substance at uptake, (2) removal of the disinfection at ballast water discharge and (3) installing online continuous monitoring of Active Substance during uptake with

continuous feedback to the elec trolytic cells to maintain an optimum dose concentration of Active Substance. The Group reviewed these modi fications in detail and noted that significant improvements to the BWMS have resulted.

0.4 In view of the responses from the Applican t to questions posed by the Group and listed in the Basic Approval Report, together with the information received from the Applicant during the GESAMP-BWWG meeting, the Group was satisfi ed with the completeness of the dossier received from the Applicant.

0.5 The Group noted that the Greenship Sedi nox Ballast Water Management System (BWMS)

uses a combination of sedimentation and in situ electrolysis using seawater to produce

the Active Substance to treat the ballast water.

0.6 As the BWMS does not require the stor age of chemicals on board ship, the Group recognized that there will not be any a ssociated storage safety problems.

0.7 The Group recognized that the system utilises an Active Substance with potential safety and environmental concerns and the Group reviewed the hazards and risks associated with

the Active Substance.

0.8 The Group recognized that the Applicant ha d provided detailed information on system controls and safety considerations for installa tion of the BWMS on board ship, together with provisions for maintenance and emergency opera tions of the system. As such the Group considered that the Greenship Sedinox BWMS s hould present no unacceptabl e risks to the safety of the ship.GESAMP-BWWG 9/6

ANNEX 5 Page 2

I:\MEPC\59\2-19.doc 0.9 In addition, the Group noted the provision by th e Applicant of detailed analytical results and

assessments for the Active Substance and other chem icals in treated ballast water. The Group accepted the view of the Applicant that there are no unaccep table risks in the chemical composition of ballast water, presented to marine ecosystems or human health (even in the worst case), by the use of

this BWMS.

0.10 However, the Group was of the opinion that the system could have some uncertainties regarding how to ensure the maximum dose of Active Substance, particularly for the reliability of controlling this dose under varied chemical parame ters in natural seawater and for the long-term durability of all sensors. The Group recalled to the Committee that these issues are significantly important for this system, because the concept of the treatment proposed by the applicant is that ballast water treated with a low level of Active Substance does not need any mitigation or post treatment, such as neutralisation or aeration. The Group considered that if the maximum dose of Active Substance of FAC is 1 mg/kg, which is clearly less than that of other systems, was ensured under all conditions, the need for the mitigation to ensure the maximum allowable discharge concentration is less. In conclusion, the Group requested to the Committee to invite the Administration conducting Type Approval to verify that all recommendations concerning the reliability and durability for the system (includi ng those at 0.14) have been fully addressed prior to issuance of the Type Appr oval Certificate. Furthermore, the Group strongly recommended to the applicant that the FAC shoul d be automatically monitored and recorded not only at the treatment stage, but also at the discharge stag e to ensure that the discharge concentration stipulated below is always met.

0.11 The Group noted the detailed human health assessment provided by the Applicant that includes occupational exposure to ships’ crew, BWMS operators a nd the exposure of the general public via the environment and the food chain. The Group accepted the view of the Applicant that there should be no unacceptable risks to hum an health posed by the use of this BWMS.

0.12 Moreover, the Group recognized that the Appli cant had provided detailed information on ecotoxicity testing of treated ballast water, envi ronmental risk assessment for aquatic organisms and a proposal for maximum discharge concen tration for the Active Substance. The Group accepted the view of the Applicant that there sh ould be no unacceptable risks to the environment posed by the use of this BWMS, based on the maximum allowable discharge concentration presented under 0.14.

0.13 The Group noted that a quality assurance proj ect plan (QAPP) was in place from the start of the tests performed for this ap plication for Final Approval.

0.14 In conclusion, having reviewed all the in formation provided by the Applicant, the Group agreed to recommend to the MEPC that Fina l Approval be given to the Greenship Sedinox BWMS, subject to the Administration verifying that these four recommendations have been fully addressed prior to issuance of a Type Approval Certificate:

.1 evaluate that the maximum allowable Active Substance (FAC) dose of 1 mg/kg

could be ensured with FAC sensors ad equately calibrated during test-bed treatment operation against seawater (>32 PSU) and low salinity brackish water. For this evaluation, FAC dose should be adequately measured both by DPD method and FAC sensor;GESAMP-BWWG 9/6

ANNEX 5 Page 3

I:\MEPC\59\2-19.doc .2 evaluate that the maximum allowable Active Substance (FAC) dose of 1 mg/kg

could be ensured with FAC sensors ad equately calibrated during on board operation against seawater (>32 PSU) and low salinity brackish water;

.3 evaluate that the maximum allowabl e discharge concentration of Active Substance (FAC) at discharge should be kept to a level not exceeding the range of 0.01-0.20 mg/kg even after a short leg. During the Type Approval procedure by the Administration, the Applicant s hould decide on the maximum allowable discharge concentration of TR O in the range of 0.01-0.20 mg/kg and this value should be approved by the Administration. This parameter should be monitored and automatically recorded by FAC sensor adequately calibrated and maintained;

and

.4 evaluate the operation and installati on manuals, which include the adequate timings for the various maintenance pr ocedures. Particul arly, the maximum

duration for the calibration of FAC sensor should be provided by the Applicant to ensure the long term dur ability of the BWMS.

1 INTRODUCTION

1.1 The data used to evaluate this syst em were extracted from that supplied by the Netherlands in document MEPC 59/2/6, whic h was supplemented by additional information provided by the Applicant after a request for furt her information by the Group during its meeting.

2 COMPLETENESS OF DOSSIER AND APPLICANT RESPONSES TO DATA REQUESTS FROM THE GROUP

2.1 The Group recalled that it ha d already posed certain questions during its evaluation of the application for Basic Approval of the system (see MEPC 58/2/7, GESAMP-BWWG (6), annex 6, Report of Application for Basic Approval), sec tions 0.5/0.6.2, 0.6.3 and 0.6.4 of Summary and sections 2.1.1.1 to 2.1.1.6, 2.1.2 to 2.1.7 and 2.1.9 of ch apter 2 which it considered should be addressed by the Applicant for Final Approval. In addition, during the GESAMP-BWWG meeting, the Group pos ed a total of 15 further questio ns to the Applicant. The Applicant has responded to all these questions and the Group’s questions, the Applicant’s responses and the reactions of the Group to the A pplicant’s responses are shown in Table 1 below:GESAMP-BWWG 9/6ANNEX 5Page 4I:\MEPC\59\2-19.docTable 1 Applicant Responses toData Requests set by the GroupSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.1 0.5/0.6.21.2The Applicant did not provide information concerningthe Human Exposure Scenario (MEPC 56/2/2, annex 9) andtherefore the risk characterization for human health could notbe adequately performed.Also request from Group for MSDS.This application contains a quantified riskcharacterization for humanhealth using EUSES 2.1(see section 4.4 and appendix IX).MSDS are provided for FAC and all relevantby-products (see appendix V).The Group was satisfied with thisresponse2.1.2 0.6.3 The organic content of the test water with treated naturalseawater shouldbe provided.The organic content of the water of tests for FinalApproval is reported in section 3.3.5 and appendix III.The Group noted the informationwas provided, however severalparameters did not meet Guidelines(G8) criteria.2.1.3 0.6.4 The Level of Quantification (LOQ) for the haloacetic acidswas too high. This may lead to understatement of thepotential levels in the treated ballast water. This uncertaintyshould be clarified in additional analyses during the full scaletesting on land and/or onboard ships by the Applicant.The level of quantification (LOQ) for haloacetic acidsduring the tests for Final Approval was 1 μg/L innatural surface water. In the Netherlands no laboratorycould be found with better performance (see sections3.3.8 and 3.3.9 and appendix III).The Group noted the LOQavailable in the Netherlands.2.1.4 2.1.1.1 A more detailed description of system layout should beprovided.The Applicant has providedthe complete system layout in appendix I.The Group was satisfied with thisresponse.2.1.5 2.1.1.2 Details of the protection devices and failsafe controlsincorporated should be provided.Protection devices and failsafe controls: see section 3.2and appendix I.The Group was satisfied with thisresponse.2.1.6 2.1.1.31.3Specific details of the treatment should be provided(e.g., is treatment upon intake and/or treatment upondischarge).Details of the treatment: see sections 3.1 and 3.3 andappendix I.The Group was satisfied with thisresponse.2.1.7 2.1.1.4 Maximum dose concentration – the Group noted that this wasstated as 2 mg/L but not consistently reported throughout thedocumentation.Maximum dose concentration: the proposed maximumdose concentration is 1 mg/kg (see for detailssections 3.1 to 3.3 and appendices I and III).The Group was satisfied with thisresponse.GESAMP-BWWG 9/6ANNEX 5Page 5I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.8 2.1.1.5 Maximum allowable discharge concentration (MADC) – theGroup wanted to know the MADC that the system wouldproduce NOT what is allowable.The proposed MADC is < 0.01 mg/kg (see for detailssection 6.4 and appendix III).The Group was satisfied with theApplicant’s proposal.2.1.9 2.1.1.6 Information on means ofdetermining and controlling dosagerates (including differing salinity of uptake water) should beprovided.Means of determining and controlling doserates: see sections 3.1 to 3.3 and appendix I.The Group was satisfied with thisresponse. However, the Group hasconcerns with the reliability ofmeasurements of the FAC sensor.2.1.10 2.1.22It was noted that the tests referred to in the submissionhad been carried out with a single dose of 10 mg/L sodiumhypochlorite and this resulted in table 2.4 where differentdisinfection by-products had been determined. It was notclear what would happen if the system had been applied atboth ballasting and deballasting – the Group wanted to knowthe concentration of by-products at the point of discharge.The concentrations of Active Substance and byproducts at the point of discharge are reported insection 3.3.The Group was satisfied with thisresponse.2.1.11 2.1.3 The quantification of THM and HAA for salted fresh watermay be completely different from those obtained from naturalseawater or brackish water – the Applicant indicated that testshad been carried out in natural seawater.See for the quantification of THM and HAA in naturalsurface water section 3.3.The Group was satisfied with thisresponse.2.1.12 2.1.4 The Group needed clarification of whetherthe doses are forboth ballast intake and discharge and how it is ensured thatthe maximum concentration of FAC is environmentallyacceptable at the time of discharge – the Group agreed that acomplete description of monitoring and control systemswould be needed.See for a complete description of monitoring andcontrol systems section 3.2 and appendix I.The Group was satisfied with thisresponse.GESAMP-BWWG 9/6ANNEX 5Page 6I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.13 2.1.5 The Group noted the application indicated that the generationof free hydrogen gas does not pose risk to the ship or crewbut requested further verification of this statement – theGroup recognized that the theoretical calculations indicatedlittle risk, however, as hydrogen will be entrained in solutionand the treated ballast water in the tank will have little freevolume then this risk will require further evaluation duringfull scale testing to verify the calculated no risk indicated.See for hydrogen measurements section 5.1.3 andappendix III.The Group was satisfied with thisresponse.2.1.14 2.1.6 Results of the corrosion monitoring need to be presented. See for a complete description of the corrosive effectssection 5.1.2 and appendix VII.The Group was satisfied with thisresponse.2.1.15 2.1.7 The risks associated with the additional known by-productsmay need to be quantified e.g. dibromochloromethane andbromochloroacetic acid.Risks associated with by-products are reported insection 6.3 and appendices IV, V, VIII and IX.The Group was satisfied with thisresponse.2.1.16 2.1.9 The Group requested the input parameters used to run theMAMPEC model for all Substances – the calculated PEC hadbeen made using a degradation rate for FAC but if this wasnot applied the resultant PEC produces a PEC/PNEC ratioof 70 and 110. Whilst recognizing that the PEC is a longterm steady state value, some concern was still expressed thatthe short term exposure had not been taken properly intoaccount. It was also agreedthat this treatment systemrequired further development and refinement as systemdischarging this level of FAC would probably not berecommended, by the Group, for Final Approval.The BWMS has been significantly refined. Themaximum dose concentration of FAC has been reducedand the treatment at discharge abolished. A system foronline dose control and failsafe controls has beeninstalled (See section 3.2 and appendix I). Outcomeson PEC/PNEC ratio calculations are reported insection 6.3 and appendix VIII; measurements of FACin the plume of the discharge of treated ballast water,immediately after uptake andtreatment, are reported insection 6.4 and appendix III to illustrate the absence ofthe risk of short-term exposure. Under normaloperating conditions, ballast water will not bedischarged immediately after uptake and treatment.The Group noted that the Applicantprovided the information associatedwith this matter.GESAMP-BWWG 9/6ANNEX 5Page 7I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.17Question 1 The FAC concentration is stated by the Applicant to beregulated by the level of actual concentration whenever thewater quality is changed on a case by case basis. Thereforethe monitoring of FAC level is very important in order to notproduce excessive disinfectant by-products. A detailed designof regulating FAC in both hardware and software (to includethe probe) should be explained.Is it possible to present thedata for the actual experimentthat proves the system worksprecisely?a) The FAC measuring device has an electric motordriven pressure proof flow armature for recirculation ofsample water. The sample water is kept in motion thuskeeping the FAC potentiostatic sensor free of debris(Keeping it clean).b) For experiment see Appendix II(Attached Calibration report from Omegam of10 September 2008).All measuring instruments are calibrated before use. Alltests/analyses are done byaccredited bodies/laboratories.c) The instrument is fixed on a maximum allowableFAC level of 1 mg/kg.The Group noted that the motordriven flow armature and automaticclean up procedure have beeninstalled in the FAC sensor. However,the Group recalled that all BWMSshould ensure both maximumdischarge dose of Active Substanceand the maximum dischargeconcentration. The informationprovided by the applicant still hassome uncertainties how to ensurethese parameters. The Groupemphasized that measuring the FAClevel in this system is one of the mostimportant processes to prevent excessActive Substance dose and relevantchemicals production under the variedconditions of natural sea and freshwater. The Group noted that theapplicant only provided one result oflinearity and of FAC monitored bysensor just after calibration inseawater, and onlyprovided the datathat the dose of FAC is controlledto 1 mg/kg only at one condition ofbrackish water. So that the systemcould have some uncertainties how toensure the maximum dose of FAC,particularly for the reliability ofcontrolling this dose under variedchemical parameters in naturalseawater and for the long-termdurability of all sensors, because theGESAMP-BWWG 9/6ANNEX 5Page 8I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s responsecontinuous interferences of ions inballast water could cause decrease ofthe sensitivities of the sensors. TheGroup recalled that these issues aresignificantly important for this systembecause, with a low level of ActiveSubstance, it does not need anymitigation or post treatment, such asneutralization or aeration. The Groupconsiders that if the maximum dose ofFAC at 1 mg/kg in seawater/brackishwater and 0.38 mg/kg in fresh water,which is clearly at a lower level thanthat of other BWMS, was ensuredunder all condition, the need for themitigation process to ensure themaximum allowable dischargeconcentration is less. Additionally, theGroup suggested that to increase thereliability of the BWMS, in all theFAC monitoring, FAC sensors shouldbe located in parallel so that theMonitor & Control units can maintainsuitable monitoring and easily detectthe lack of signal or sensor’smalfunctions or decrease ofsensitivity.The Group is satisfied with theresponse from the Applicant toQuestion 1.GESAMP-BWWG 9/6ANNEX 5Page 9I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.18Question 2 Is there any proposed method in cases where the maximumconcentration of FAC proposedis exceeded, for example,when the ballast water should be discharged at the portbecause of the short voyage etc?Normal controlling that is done by the control unitkeeps the FAC amount lower than 1 mg/kg byarranging an appropriate amount of power to the powerunit of the Termanox. When the FAC is in excess of 1mg/kg due to any mishap ofthe unit there is a pre alarmfollowed by an alarm 30 seconds later and immediateshut down of the operation.The failure is registered andshown on the display. After which, fault-finding willhave to follow. See further the answer to question 3.The Group was satisfied with theresponse from the Applicant toQuestion 2.2.1.19Question 3 Is there any reason that the application does not include theecotoxicity and chemical analysis data for seawater, and thedata of storage intervals in de-ballasting from the ballastwater tank?The question is not fully clear. The application includesecotoxicity and chemical analyses of treated seawater,incl. controls (= untreated seawater). Tests forecotoxicity were done in treated ballast waterimmediately after treatment (T=0) and after 48 hours(T=48) storage according the G9 guideline. Chemicalanalyses were done additionally after different storagetime intervals: see tables 3 to 8 in the applicationdocument.Test for discharged ballast water atvarious times of storage issatisfactory and the Group notedthat the ecotoxicity data for naturalseawater has been submittedaccording to Procedure (G9).The Group was satisfied with theresponse from the Applicant toQuestion 3.2.1.20Question 4 The dilution factor of treated ballast water in WETecotoxicity test should be 1/2. Is there any reason why you donot follow that, or the reference can be submitted to defendthe dilution you made?We are not aware of any guidance that prescribes adilution factor of 2. Theprocedure (see MEPC 57/21,annex 1, art. 5.2.6, page 8) prescribes, that a dilutionseries should be tested. This was done and is reportedin the Imares report (Appendix VI Tox. tests Imares,table 2, page 9). This series included a dilutionof 56.2%.The Group was satisfied with theresponse from the Applicant toQuestion 4.2.1.21Question 5 Is it accepted to define the fresh water as 0.5% of salinity? Isthere a reference to define that?The generally accepted definition for fresh water iswater with a salt content of less than 1 % (see Lenntechwater FAQ pages http://www.lenntech.com/WaterFAQ.htm ).The Group was satisfied with theresponse from the Applicant toQuestion 5.GESAMP-BWWG 9/6ANNEX 5Page 10I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.22Question 6 The lack of a fish WET test is not mentioned inMEPC 59/2/5. In the report from IMARES C82/08 appearingin the confidential material appendix VI, it is stated that fishtests are waived since previoustests indicated that fish larvaewere not affected. A reference is made to Kaag &Sneekes 2007 (IMARES report C091/07), included as text inMEPC 58/2/7, annex 6. In annex 6 there appears to be only ashort two line paragraph on the results noting a “good (87.5%to 100%)” survival throughout tests. For the Group to agreeto waive acute and chronic fish ecotoxicity tests (which isspecifically required in the Methodology) on this basis, theoriginal data must be submitted.The Imares report C091/07 isattached; see for originaldata the data tables in the appendix.The Group was satisfied with theresponse from the Applicant toQuestion 6.2.1.23Question 7 The ecotoxicity test data suggest residual toxicity in bothfreshwater and marine algae species (up to x20 dilutionrequired for the freshwaterspecies to reach NOEC) andtherefore even more to reachPNEC. Do these results, and thefact that a 48h holding timewas able to reduce toxicityconsiderably, lead to any suggestions from the Applicant forlimitations in the applicability of the BWMS in relation todischarge in freshwater or holding time needed.For the calculation of environmental risks, theApplicant has assumed a worst case scenario, i.e., deballasting immediately after treatment with a maximumconcentration of 1 mg/kg FAC. The results show thatthe environmental risks at all times stay well within thesafety ratio (PEC/PNEC < 1) for FAC and relevant byproducts (see table 12 of the application). Therefore,the Applicant does not see any limitation in theapplicability of the BWMS, either in fresh or salt water.The Group was satisfied with theresponse from the Applicant toQuestion 7.GESAMP-BWWG 9/6ANNEX 5Page 11I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.24Question 8 The Applicant set the maximum dose for FAC as 1 mg/kg.However, could the Applicant kindly provide someclarification for this criterion?For all treatment of seawater,is the FAC fixed to 1 mg/kg? Because certain paragraphs,such as 2.3, have indicated a possibility that 0.1 mg/kg FAChas enough efficacy for Guidelines (G8). Does the Applicanthave any intention to reduce the dose for FAC at sea? Also,para 3.3.1 of dossier stated that maximum FAC monitored forbrackish water was only 0.38 mg/kg. Was the systemoperated with serial Termanox? In that case, is this thetheoretical limitation for brackish water? And finally, arethere any actual FAC measurements for fresh water using 3serial Termanox in operation?The Applicant has refined the BWMS after the BWWGhad expressed concern on high FAC concentrations atde-ballasting in the review for Basic Approval of theGreenship BWMS (see MEPC 58/2/7, annex 6,point 2.1.9). It was decided to lower the FACconcentrations to a level which would not cause anyenvironmental concern and at the same time guaranteescompliance to efficacy criteria under G8. The choicefor 1 mg/kg as a maximum for treatment and 0.1 mg/kgas a minimum was based on tests which show thatenvironmental risks are negligible with 1 mg/kg atdischarge and efficacy criteria are still met withtreatment with 0.1 mg/kg FAC. Thus the system is nowdesigned that a maximum of 1 mg/kg and a minimumof 0.1 mg/kg is allowed. The system gives an alarm andstops intake in case FAC concentrations get out of theselimits (see also answers to your questions 9 to 12).During the tests reportedthe system was operatedwith 3 serial Termanox devices. So, the value of 0.38mg/kg in fresh water (not in brackish) was achievedwith 3 Termanox in serial operation.The Group was satisfied with theresponse from the Applicant toQuestion 8.GESAMP-BWWG 9/6ANNEX 5Page 12I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.25Question 9 The appendix 3 (Technical Manual) provides that thePotentiostatic sensor will be used for monitoring andcontrolling the FAC. Could you provide the relationshipbetween FAC, which was measured manually by DPDmethod, and the sensor’s output of FAC, which was estimatedonly from Potentiostatic value, pH and temperature? Also theGroup has some concern that this one single relationship orformula cannot be applied to wide ranges of salinity andalkalinity. The Group has the position that additional salinitymonitoring should be needed for compensation, which is notdescribed in the appendix. TheGroup feels that more directand sophisticated monitoring sensors (such as monitoring thedifference of each parameter before and after Termanox) forFAC should be needed particularly in use for low salinitywater.Various FAC measuring instruments are being testedover the past 8 years of R&D. These instrumentsneeded to be calibrated explicitly. Our measuringequipment has been calibrated with the DPD method ofOmegam Water (Accreditation number L410). See alsoanswer to Question 1, b.Additional salinity monitoring is done as you can seeon the scheme (attached). Itis measured just behind thepump. The amount of NaCl converted to PSU (seeadditional graphs and info attached) is sent to thecontrol unit, which in turn activates the power to theTermanox unitsDuring all the tests done in the past years never everwere there mishaps or deviations. All tests have beendone after a DPD calibration check. The same is doneon the NaCl sensor. In most cases we worked withredundant measuring equipment.We do have failure indications of all sensors in ourcontrol unit (f.e. P; FAC; NaCl; Power; PLC; Flow),resulting in a common alarm in the engine room.The Aldos/Grundfos company is bringing this kind ofequipment on the marketsince 1975. Our measuringequipment is on the market since 2000 and is provenvery solid. We have used this equipment for our testingand it never failed.The Group was satisfied with theresponse from the Applicant toQuestion 9.The conclusions of the Group wereexplained at Question 1.GESAMP-BWWG 9/6ANNEX 5Page 13I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.26Question 10 The diagramin the Operational Manual indicated that theFAC and relevant parameters would be monitored andrecorded. However, there are no descriptions how to controlthe Termanox by FAC values or other parameters such aselectrical current through electrodes. Could you provide moreinformation how to ensure the maximum FAC doseas 1 mg/kg from the Termanox, using these parameters?By measuring NaCl value before the water goesthrough the system, the control unit has pre-informationand is able to control the power unit on the Termanoxin such a way that the FAC value will end up betweenthe 0.01 and 1 mg/kg. The voltage has a fixed value andthe control is done by varying the amps. Allcomponents are Marine Equipment Directive (MED)approved at Lloyds Register. Failure is indicated by apre alarm, an alarm and then shut down.The Group was satisfied with theresponse from the Applicant toQuestion 10.The conclusions of the Group wereexplained at Question 1.2.1.27Question 11 The Applicant claimed in their Operational Manual that “Ifthe amount of NaCl is <3PSU, the water is stipulated as fresh(IMO regulations). Then a third Termanox will have to beinstalled.” So the Group has the position that the system withonly two Termanox components, which is the usual case,cannot be operated in fresh water. That means a limitation ofapplication. Please clarify?Since only 4 % of the world ship movements is inwater with less than 3 PSU we decided to have aflexible possibility on the Termanox units. All ourtesting was done with the possibility of using theeTermanox units.We only needed two whenoperating in brackish andsalt water but three when operating in water with lessthan 3 PSU in order to get sufficient FAC.In so doing we managed to have a low energyconsumption in all cases, which helps in the NOX/SOX equation in the end as well.The Group was satisfied with theresponse from the Applicant toQuestion 11.2.1.28Question 12 Also even with two Termanox components, how could theoperation mode be switched to serial Termanox operationalmode automatically? The Applicant only stated that“Depending on FAC level, seawater temperature and amountof NaCl the start-up of the installation will include the firstand/or the second Termanox.” There is no description howthe system monitor will calculate the conductivity level(NaCl) in the Operational Manual. What is the actualcriterion for switching?Because NaCl is measured by start up (excelcalculation table is in the appendix) and processed bythe control unit. The control unit switches on 1, 2and/or 3 Termanox units. By measuring the FAC andputting that back to the control unit, the power to theTermanox units is continuouslyreadjusted in such away that we have sufficient FAC with the lowestpossible power consumption.The Group was satisfied with theresponse from the Applicant toQuestion 12.GESAMP-BWWG 9/6ANNEX 5Page 14I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.29Question 13 The Applicant set maximum allowable dischargeconcentration for FAC as “<0.01 mg/kg”. However, thiscriterion was based only on 2 typical degradation ratesdescribed in appendix III. How is it ensured that themaximum discharge concentration at very short voyage (lessthan 1 day) will be achieved, and with another (lower)degradation rate for FAC? Or does the Applicant intend to setthe minimum holding time for treated ballast water, such as“the treated ballast water should be discharged after morethan 2 days tank holding time”? Please clarify.The maximum discharge concentration of 1 mg/kgFAC occurs only when, e.g., for security reasons thetreated intake water will be discharged immediately,actually during intake. We consider this a theoreticalsituation. Nevertheless the Applicant has calculatedenvironmental risks with a worst caseFAC concentration of 1 mg/kg (see also answer toquestion 7). FAC breaks down very rapidly: see table 3on page 13 of the application, 60%within 30 minutes and 90% within 2 hours. Similar datacan be found in literature (see reference 62: RARhypochlorite). Based on these data, the Applicant doesnot see a need to set minimum holding times of treatedballast water. The proposed maximum allowabledischarge concentration of 0.01 mg/kg is reachedwithin 4 hours, which is a very short time betweenintake and actual arrival in another harbour. TheApplicant has no objection if the GESAMP-BWWGallows a maximum allowable discharge concentrationof 0.1-0.2 mg/kg (see also GESAMP-BWWG 7/9,annex 4, review of application by Norway).The Group confirmed that settingof the maximum dischargeconcentration of FAC as 0.01mg/kg was only provided from 2degradation curves described inappendix III and literature-basedevidence. The Group recalled thatin other BWMS using anelectrolysis module, they indicateda slower degradation rateparticularly in clean seawater andin low salinity water. So that, theGroup concurred with theApplicant’s statement that themaximum discharge concentration(<0.01 mg/kg) can be theoreticallyensured under these conditions.The Group’s position on theseissues is stated at paragraphs 0.10and 0.14 in this report.Secondly, according to the resultsof ecotoxicity testing for algaeliving in fresh water, there wasclearly some residual toxicity evenafter 48 hours tank holding time,when the FAC had been alreadydegraded to <0.01 mg/kg. So that,even with 0.01 mg/kg residualFAC, some dilution by receivingwater and degradation undersunlight would be needed at thedischarge point. In summary,GESAMP-BWWG 9/6ANNEX 5Page 15I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s responsealthough the whole effluent tests(WET) showed some residualtoxicity for algae, the Group didnot consider this a risk for theenvironment as on a daily basisthere would be a dilution in thereceiving harbour of a factor ofabout 350. With this the Group feltsatisfied that there would be nounacceptable risks for theenvironment.Additionally, the Group suggestedthat, for the reliability of thesystems, all the FAC sensorsshould be located in parallel so thatthe M&C units can easily detect thelack of signal or sensor’smalfunctions, including decrease ofsensitivity.The Group is satisfied with theresponse from the Applicant toQuestion 13.GESAMP-BWWG 9/6ANNEX 5Page 16I:\MEPC\59\2-19.docSectionNo.Refs. fromBA Report(Summaryandchapter 2) orQuestion No.from meetingGroup’s Question Applicant’s Responseand Section No. in this Report(Appendix Nos. refer to the Applicant’s confidentialdossier)Group’s Reaction to theApplicant’s response2.1.30Question 14 Does your system always have three Termanox unitsinstalled, or not?Termanox units in operation:Salinity range > 32 – one Termanox must be inoperation;Salinity range >3 - <32 – two Termanox must be inoperation;Salinity range < 3 – three Termanox must be inoperation.If a ship has a worldwide certificate(so, also for asalinity range of < 3 PSU); then the ship must have 3Termanox units. In that case the answer is: there mustbe installed three Termanox units.The Group was satisfied with theresponse from the Applicant toQuestion 14.2.1.31Question 15 Please can you confirm that the measurement units of TRCand FAC are expressed in mg Cl2per litre.Yes, TRC and FAC are calculated “back” inequivalents of Cl2and expressed as mg Cl2/L. Thedisinfection is caused by hypochlorite in water. Totalavailable free chlorine includes in principle 3 species ofchlorine: gaseous chlorine, hypochlorous acid andhypochlorite (the dissociated form of hypochlorousacid). The distribution among these 3 species is highlypH dependent in aqueous solutions. At pH above 4,gaseous chlorine is practically absent in water. AtpH above 8, practically only the hypochlorite anion ispresent. In regular seawater (pH about 7.8),hypochlorite and hypochlorous acid are about 50/50.See for further details: the EU RAR for hypochlorite:par. 2.4, 2.5 and 2.6 (reference 62).The Group was satisfied with theresponse from the Applicant toQuestion 15.GESAMP-BWWG 9/6

ANNEX 5 Page 17

I:\MEPC\59\2-19.doc 2.2 In view of the above responses from the A pplicant to questions pos ed by the Group, and considering all the data and information submitted by the Applicant in this dossier, the Group was satisfied with the completeness of the dossier received from the Applicant.

3 DESCRIPTION OF THE SYSTEM

3.1 Overview

3.1.1 The Group recalled that this Ballast Wate r Management System (BWMS) had already been described and reviewed in the report fo r Basic Approval. The Group noted that after the Basic Approval was granted, Greenship had abolished the second disinfection step at discharge, since treatment at uptake results in full compliance to the efficacy criteria and discharge standard of regulation D-2 of the Convention. Bearing in mind the changes to the system since the granting of Basic Approval, th e Group noted that Figure 1 schematically shows the BWMS being reviewed for Final Approval.

3.1.2 The Group recalled that the Applicant proposes a BWMS that combines destruction and

removal of biota and removal of sediment at uptake of ballast water using a patented multi hydrocyclone technology followed by a mild disinfecti on step, using chloride ions in seawater in an electrolytic process to produce Active Substance in situ for the killing of remaining micro-organisms.

3.1.3 The Group noted that the electrolytic pr ocess produces Free Active Chlorine (FAC) as Active Substance from chloride ions present in natural seawater on board. Furthermore, the Group noted that according to the Applicant, a major advantage of this type of electrolytic cell is the long lasting coating. The elect rolytic cells can disi nfect with a minimum of maintenance (once a year cleaning is al l that is required) for the duration of approximately 5 years. Furthermore, the Group noted that the FAC calculations by the Applicant were equivalent to the TRO unit values (mg Cl 2 /L) more normally provided by other Applicants.

Ballasting

Î Î Î

De-ballasting Í

Figure 1 – Schematic process diagram of BWMS

3.1.4 As the BWMS does not require the stor age of chemicals on board ship, the Group recognized that there will not be any a ssociated storage safety problems.

3.1.5 Therefore, the Group recognized that this ap plication for Final Approval focuses on the system components and operations for ba llast water treatment during intake. Sedimentation Electrolysis

Ballast

Water

TanksGESAMP-BWWG 9/6

ANNEX 5 Page 18

I:\MEPC\59\2-19.doc 3.2 Safety and Control

3.2.1 The Group noted the information provided by th e Applicant, stating that the BWMS is equipped with a number of measuring points to m easure a variety of parameters like pressure, flow, NaCl, FAC, temperature, etc, and the data coming from these measuring points are entered into the monitoring and control unit of the syst em that manages and controls the power unit and the valves in order to have a safe and correct op eration of the system. And if needed, in case of malfunction, to close the system or parts thereof down.

3.2.2 The Group also noted that the system incorporates control equipment, which automatically and continuously monitors and ad justs necessary amperage s of the electrolytic units during operation. One visual alarm is for the operation of the el ectrolytic cells. The

maximum allowable dose concentration of the BWMS is regulated through continuous monitoring of the FAC concentration in the syst em itself during uptake of ballast water. The FAC monitoring unit is registering FAC con centration, pH and water temperature. The

sensor is able to measure FA C concentration in the range of 0.01-2.0 mg/kg. In practice a minimum of 0.1 mg/kg and a maximum value of 1.0 mg/kg for FAC concentration will be preset in the control unit for alarm purposes. According to the Applicant, the control equipment stores data for at least 24 months and can display or print records for official inspection and the equipment is Marine Equipment Directive (MED) approved.

3.2.3 In addition, the Group noted the detailed info rmation presented by the Applicant on safety and control of the BWMS, in appendix I of the Applicant’s confidential dossier. This appendix presents details of the system layout an d its operation, as required in the review for Basic Approval by the GESAMP-BWWG. The protection devices and failsafe controls are described in appendix I, technical manual at pa ges 49 to 54. The two components of the BWMS have no moving parts. Safety controls are inco rporated for a number of parameters: pressure,

flow and maximum-minimum allowable dose con centration of FAC (see technical manual in appendix I).

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

3.3.1 The Group recalled the chemical reactions involved in the electr olysis of natural seawater, as reviewed and described in detail fo r the evaluation of Basic Approval of the BWMS. In summary, electrolysis of aqueous NaCl solu tion gives a mixture of h ydrogen gas and chlorine gas and an aqueous sodium hydroxide solution. Th e chlorine gas then reacts with the aqueous mixture to form sodium hypochlorite and Free Activ e Chlorine (FAC) is produced which acts as

the disinfectant Active Substa nce. In addition, the Group not ed that various halogenated by-products and bromide analogues can also be produ ced by electrolysis of natural seawater due to the reaction with organic compounds and other components in seawater such as ammonia. These are variously referred to as relevant chem icals or other chemicals, but for the purpose of this review, the Group referred to all these by-products and an alogues as “Other Chemicals”.

3.3.2 The Group recalled information provided by the Applicant explaining that FAC production inside an electrolysis cell depends on chloride co ncentrations in the natural water and the settings of the cell. In practice in this BWMS, brackish an d salt water is pumped via two cells at uptake; in

fresh water a third cell needs to be added in order to produce the ne eded dose for disinfection (see for details in appendix 1 of Applicant’s confiden tial dossier). The range of values that can be

measured with the online sensor in treated natural water, situated at a distance of 10 x D (pipe diameter) after the cells, is 0.01-2.0 mg/kg. Th e Group noted that this online sensor adjusts FAC production at a continuous consta nt level of maximum 1.0 mg/kg.GESAMP-BWWG 9/6

ANNEX 5 Page 19

I:\MEPC\59\2-19.doc 3.3.3 The Group noted that the Applicant has prov ided analyses of treated ballast water for Active Substances and other chemicals as pa rt of this application for Final Approval. Samples of untreated ballast wate r and treated ballast water were taken during tests of a full-scale

BWMS with natural surface wate rs, according to the require ments of sections 4 and 5 of Procedure (G9). The Group noted that according to the Applicant, a BWMS with a capacity

of 100 m 3 /h was installed on board of a moored ship. This equipment had been tested already for two years on board of M.V. Elizabeth (see also Appendices II and VII of confidential dossier). It was the same equipment as used in 2007 for G8 land-based efficacy tests and the tests for the Basic Approval a pplication (see MEPC 57/2/7).

3.3.4 The Group noted the following information provided by the Applicant. The BWMS treated two types of surface wate r and the treated ballast water was stored in a storage tank during 2 days. In August 2008 brackish water from the harbour of Harlingen, the Netherlands, at

the border of the Wadd ensea (test location 1), was treate d and stored. In September 2008

fresh water from the “van Harinxma Channel”, just afte r the sea-locks of Harlingen harbour (test location 2), was treated and stored. Samples for chemical analysis and ecotoxicity evaluation for this Final Approval application, were taken at different time intervals after treatment and distributed to different speciali zed laboratories with full accreditation. Control samples consisted

of untreated natural surface water.

3.3.5 The Group noted the following results in Tabl es 2 and 3 presenting th e characteristics of

the brackish and fresh waters used in this testing by the Applicant.

Table 2: Characteristics of brackish water

Oxygen

% Temperature

oC Salinity

‰ pH TSS, mg/L DOC, mg/L POC, mg/L TOC, mg/L

91.7 19.3 18.8 7.93 15 8.5 - 7.5

Note from Applicant – TOC is lower than DOC. Theoretically this is not possible, because DOC is part of TOC. Explanation of the mi nor difference is a measurement inaccuracy.

Table 3: Characteristics of fresh water

Oxygen

% Temperature,

oC Salinity

‰ pH TSS, mg/L DOC, mg/L POC, mg/L TOC, mg/L

94.3 16.2 2.8 7.84 9.9 14 1.0 15

Details of the analytical methodology and results are contained in appendix III of confidential

dossier.GESAMP-BWWG 9/6

ANNEX 5 Page 20

I:\MEPC\59\2-19.doc 3.3.6 The Group noted that Active Substance (FAC) was analyzed by Omegam-Water, Wognum, the Netherlands. The analyses were performed with the same sensor as used for the online measurements during treatment of ballast water. The sensor was calibrated by Omegam-Water using the method according to NEN/EN/ISO 7393-2. Results are reported for control samples (source water) and samples taken from the stored treat ed ballast water at different time intervals: immediately after treatment (T=0), after 30 min (T =0.5), 1 h (T=1), 2 h (T =2), 4 h (T=4), 12 h (T=12) and 48 h (T=48). Tables 4 and 5 present the results for the two types of water. The dose rates of FAC, measured on line immediately afte r the cells, were 1.0 mg/kg for brackish water and 0.38 mg/kg for fresh water.

Table 4: Concentrations of FAC in mg/L in treated brackish water

Control T=0 T=0.5 T=2 T=4 T=12 T=48

<0.01 1.0 0.4 0.1 <0.01 < 0.01 < 0.01

Table 5: Concentrations of FAC in mg/L in treated fresh water

Control T=0 T=0.5 T=2 T=4 T=12 T=48

<0.01 0.38 0.2 < 0.01 <0.01 < 0.01 < 0.01

See for details of the analytical methodology and re sults: appendix III and for the FAC data set: appendix IV.

3.3.7 The Group noted that halogenated other chemicals were analysed by Omegam-Laboratoria, Amsterdam, the Netherla nds. The analyses were performed according to NEN/EN/ISO 15680. Results are reported for control samples (source water) and samples

taken from the stored treated ballast water at diffe rent time intervals: immediately after treatment (T=0), after 30 min (T=0.5), 2 h (T =2), 4 h (T=4), 12 h (T=12) a nd 48 h (T=48). Tables 6 and 7 present the results for the two types of water.GESAMP-BWWG 9/6

ANNEX 5 Page 21

I:\MEPC\59\2-19.doc

Table 6: Concentrations in μg/L of halogena ted other chemicals in t reated brackish water

Control T=0 T=0.5 T=2 T=4 T=12 T=48

dichloromethane <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0

1,1-dichloroethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

1,2-dichloroethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

trans-1,2-dichloroethene <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

cis-1,2-dichloroethene <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5
1,2-dichloropropane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

trichloromethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

tetrachloromethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

1,1,1-trichloroethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

1,1,2-trichloroethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

trichloroethene <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

tetrachloroethene <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

tribromomethane <0.5 47 70 80 73 82 84

sum C/T dichloroethene 0.7 0.7 0.7 0.7 0.7 0.7 0.7
sum chloroaliphatics 2.9 2.9 2.9 2.9 2.9 2.9 2.9

Volatile chlorinated aliphatics – remainder:

dibromomethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

bromodichloromethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

dibromochloromethane <0.5 3.8 5.2 5.9 5.4 6 6.3GESAMP-BWWG 9/6

ANNEX 5 Page 22

I:\MEPC\59\2-19.doc Table 7: Concentrations in μg/L of haloge nated other chemicals in treated fresh water

Control T=0 T=0.5 T=2 T=4 T=12 T=48

dichloromethane <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0

1,1-dichloroethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

1,2-dichloroethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

trans-1,2-dichloroethene <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

cis-1,2-dichloroethene <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5
1,2-dichloropropane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

trichloromethane <0.1 0.3 0.4 0.5 0.6 0.8 0.9

tetrachloromethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

1,1,1-trichloroethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

1,1,2-trichloroethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

trichloroethene <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

tetrachloroethene <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

tribromomethane <0.5 11 14 15 15 16 16

sum C/T dichloroethene 0.7 0.7 0.7 0.7 0.7 0.7 0.7
sum chloroaliphatics 2.9 3.1 3.2 3.3 3.4 3.6 3.7

Volatile chlorinated aliphatics – remainder:

dibromomethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

bromodichloromethane <0.5 2.6 3.6 4.0 4.3 4.7 4.9

dibromochloromethane <0.5 9.9 13 13 14 15 16

See for details of the analytic al methodology and results in appe ndix III of the confidential

dossier. For the data sets of tribromometh ane (bromoform), dibromochloromethane and dichlorobromomethane in appendix IV of the confidential dossier.

3.3.8 The Group no ted that the other chemicals (haloacetic acids and chloramines) were analyzed by RPS Analyse BV, Breda, the Neth erlands. The analyses of haloac etic acids were performed by GC-MS. Results are reported for control samples (source water) and samples taken from the stored

treated ballast water at different time intervals: immediately after treatm ent (T=0), after 30 min (T=0.5), 2 h (T=2), 4 h (T=4), 12 h (T=12) and 48 h (T=48). Tables 8 and 9 present the results for the two types of water. The analyses for chlo ramines were performed by titration. Chloramines were not detected in both types of treated surface water (detection limit: 0.1 mg/L).GESAMP-BWWG 9/6

ANNEX 5 Page 23

I:\MEPC\59\2-19.doc

Table 8: Concentrations in mg/L of chlorami nes and in μg/L of halogenated acetic acids

in treated brackish water

Control T=0 T=0.5 T=2 T=4 T=12 T=48

monochloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

dichloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

trichloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

chloroacetic acid <1 <1 <1 <1 <1 <1 <1

dichloroacetic acid <1 <1 <1 <1 <1 <1 <1

bromoacetic acid <1 24 72 77 59 86 5.8

trichloroacetic acid <1 <1 <1 <1 <1 <1 <1

dibromoacetic acid <1 40 76 64 47 69 3.6

bromochloroacetic acid <1 4.1 6.7 5.8 4.5 6.2 <1

bromodichloroacetic acid <1 2.2 3,2 2.3 2.4 3.1 2.8

dibromochloroacetic acid <1 <1 <1 <1 <1 <1 <1

tribromoacetic acid <1 9.9 14 12 12 13 12

Table 9: Concentrations in mg/L of chlorami nes and in μg/L of halogenated acetic acids

in treated fresh water

Control T=0 T=0.5 T=2 T=4 T=12 T=48

monochloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

dichloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

trichloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1

chloroacetic acid <1 7 5.3 7.1 4.5 4.1 1.3

dichloroacetic acid <1 5.1 5.5 5.4 3.8 3.6 6.4

trichloroacetic acid <1 <1 <1 <1 <1 <1 <1

bromoacetic acid <1 17 16 15 12 9.9 12

dibromoacetic acid <1 39 40 40 31 32 30

tribromoacetic acid <1 <1 <1 <1 <1 <1 <1

bromochloroacetic acid <1 24 23 22 18 17 17

dibromochloroacetic acid <1 <1 <1 <1 <1 <1 <1

bromodichloroacetic acid <1 <1 <1 <1 <1 <1 <1

See for details of the analytical methodology and re sults: appendix III. For the data sets of chloroacetic acid, bromoacetic ac id, dichloroacetic acid, dibromoacetic acid, bromochloroacetic acid, bromodichloroacetic acid and tribromoacetic acid: appendix IV.

3.3.9 The Group recognized the comprehensive natu re of the data sets provided by the Applicant on the analysis of Active Substance and other chemicals in treated ballast water. However, the Group notes that in the review of th e Basic Approval application of this Applicant, the GESAMP-BWWG expressed concern about the le vel of detection of the haloacetic acids: (MEPC 58/2/7, annex 6, paragraph 0.6.4). In a statement from the Applicant, the Group was informed that the Applicant “coul d not find a laboratory with a better performance than 1 μg/L.GESAMP-BWWG 9/6

ANNEX 5 Page 24

I:\MEPC\59\2-19.doc Given the MRR, the Applicant considers that the application of Best Available Technique (BAT)

in the Netherlands is sa tisfactory”. Although the Group was not satisfied with this response since the choice of BAT should not be limited to only on e country and other Appli cants have been able to find laboratories capable of analysing haloace tic acids down to 0.1 μg/L , it is accepted because the haloacetic acids with PEC/PNEC ratio closest to one (Table 13; bromoacetic acid and dibromoacetic acid) are both found in concen trations above the limit of detection.

4 HUMAN HEALTH ASSESSMENT

4.1 Identification of routes of human ex posure and risk assessment parameters

4.1.1 The Group concurred with the Applicant th at the target groups are ships’ crew and BWMS operators, who may be at risk of oc cupational exposure as we ll as the general public who may be subjected to indirect exposure by way of sea bathi ng or through the environment or the food chain. The Group recalle d that in the Methodology for information gathering and the conduct of work of the GESAMP-BWWG (IM O circular BWM.2/Circ.13, Appendix 2, “Human Exposure Assessment”) th e following procedures for th e assessment of exposure and

risk to human health have been recommended:

.1 identification of exposure routes and development of exposure scenarios for respective exposure routes; and

.2 estimation of the amounts of exposur e (intake) and risk assessment.

4.1.2 Moreover the Group recalled that risk assess ment is to be conducted by comparing the margin of safety (MOS), which can be calcu lated by dividing the NOAEL (no observed adverse effect level) allocated with the appropriate AF * by the estimated amount of exposure, with MOSref (100) in compliance with the “H uman Exposure Assessment” mentioned above, as

follows – MOS = NOAEL/estimated exposure amount

* As a standard procedure an d according to the Methodology BWWG 3/9, an nex 9, the use of an AF of 100 (10 for interspecies variability and 10 for intraspecies variability) is recommended in order to address the uncertainties deriving from the extrapolation of results from animal toxicity te sting to human exposure.

4.2 Assessment of exposure to ships’ crew

4.2.1 The Group recalled the recommendations of the GESAMP-BWWG “Human Exposure Assessment”, in that work operations to be performed in the BWMS that may entail risk of occupational exposure should be identified. Mo reover the Group concurred with the statement from the Applicant that measures adopted in this BWMS make it possible to minimize the risk of human exposure to Active Substance or other ch emicals in this system, through the exposure routes of concern assessed (derma l and inhalation). A summary of all the various safety measures developed by the Applicant is given above in section 3.2.

4.2.2 Therefore the Group considered th at exposure and risk to human health of the ships’ crew and BWMS operators by exposure to Active Substance and other chemicals is judged to be acceptable due to the measures developed by the Applicant for installation on board ship for Final Approval.GESAMP-BWWG 9/6

ANNEX 5 Page 25

I:\MEPC\59\2-19.doc 4.2.3 In addition, the Group recommended that preca utionary measures, e.g., by using personal protective equipment (PPE) should be followed when any operator enters the ballast tanks for inspection or for sampling operational procedures.

4.3 Exposure of general public thro ugh the environment and food chain

4.3.1 The Group recalled that possible scenarios of exposure to the general public through the environment and food chain are limited to the following:

Scenario 1: Oral exposure (through water dr inking) of sea bather s and workers in the surrounding water areas; and

Scenario 2: Oral exposure to the general public through the food chai n (by way of marine foods).

4.4 Risk assessment calculations with EUSES model (provided by Applicant)

4.4.1 The Group noted that the Applicant has provi ded detailed data on human health risk assessment using the EUSES model (version 2.1), and appendix IX of the confidential dossier presents the summary report on calculations.

4.4.2 The EUSES model calculated MOS valu es for the system and MOS/MOS ref (MRR) values for the occupational scenarios (dermal a nd inhalation routes). Th ese were based on the assumptions of the number of events of 2/year , exposure duration of 8- 10 h, dealing only with acute risks and taking into consideration the un it operation which represents the worst case exposure scenario at the working site, the Term anox part of the BWMS. These MRR values are presented below in Table 10.

4.4.3 The Gr oup noted that for the gene ral public the main routes evaluated by EUSES were inhalation, oral inta ke by drinking water and eatin g fish. Only the chronic risk was calculated. If the

MRR value was ≥ 1 a safety margin of at least 100 wa s obtained and the ri sk was considered acceptable.

Table 10: MRR (MOS/MOS ref ) values from EUSES model

MRR (MOS/MOS ref ) lowest value Substance Ships’ crew a General public b

FAC 502 6.31E+4

Tribromomethane 36.1 4.71E+3

Dibromochloromethane 6.49E+3 3.07E+5

Bromodichloromethane 1.39E+4 2.94E+4

Bromoacetic acid 3.22E+3 1.54E+5

Chloroacetic acid 2.76E+5 4.70E+6

Dibromoacetic acid 2.45E+6 6.49E+6

Dichloroacetic acid 1.30E+5 2.92E+6

Bromochloroacetic acid 2.57E+4 2.86E+6

Bromodichloroacetic acid 3.58E+4 4.74E+5

Tribromoacetic acid 1.06E+2 7.66E+4

a Based on acute toxicity data

b Based on repetitive dose and/or development toxicity dataGESAMP-BWWG 9/6

ANNEX 5 Page 26

I:\MEPC\59\2-19.doc 4.4.4 The Group concurred with the Applicant that, from the EUSES calculations in Table 10 it is clear that MRR values for ships’ crew (BWM S operators included) and the general public for all substances produced by the BWMS are much larger than 1. The highest risk (under unrealistic worst-case assumptions) is observed for tribromomethane, which still has a margin of safety of 3610 for ships’ crew an d a margin of safety of 4.71 x 10 5 for the general public. Therefore, the Group was satisfied that these results show that the BWMS does not pose an unacceptable risk to ships’ crew (BWMS opera tors included) and to the general public.

5 RISKS TO SAFETY OF THE SHIP , ITS CREW AND THE GENERAL PUBLIC

5.1 Safety of the ship

5.1.1 The Group noted that specific countermeasures that can be employed in this system to deal with envisaged emergency and safety problem s during the ballast water treatment have been summarised above. In particul ar a summary of the various safety measures developed by the Applicant is given above in section 3.2.

5.1.2 The Group concurred with the Applicant that the treated ballast water should have no increased corrosivity effect to ballast water tank s or other equipment in the ship, compared with

normal seawater as the treatment levels of FAC are stipulated as a maximum 1 mg/kg which is recognized as the lower limit for an y corrosive effect from chlorine . The Applican t states that

the sedimentation unit is made of a synthetic material, resulting in a lightweight construction and preventing corrosion within the system. The electroly tic cell itself, including connecting pipes, is fully protected by special coatings against corros ion. The ballast water tanks in principle are subject to corrosion, especially i mmediately after treatment, so th erefore these tanks are normally coated against corrosion. This regular practice is expected to be sufficient for treated ballast water. The FAC produced by the BWMS will be present in low concentrations and disappears quickly (see above at section 3.3.6). The Group not ed the Applicant states that the BWMS has been used for two years on MV “Elizabeth” and corrosion of ballast wa ter tanks was monitored and inspected by Germanischer Lloyd. Accordi ng to the shipowner no sign of any corrosion could be observed after two years (see for de tails appendix VII of confidential dossier).

5.1.3 The Group recalled that as mentioned above at section 3.3.1, during electrolysis hydrogen gas (H 2 ) is produced. According to the Applicant, theoretica lly the cell produces 0.0186

mol H 2 gas per ampere (A) per hou r, which equals 7.5 g H 2 per hour under standard operation

with 200 A. With a fl ow in the cell of 100 m 3 /hour, this results in a H 2 gas concentration of less than 0.1 mg/kg. The Gr oup agreed with the Applicant that this is far below any dangerous

concentration. This was conf irmed by the Applicant using H 2 measurements in the head space of the ballast water storage tank immediately after tr eatment. All results (b rackish and fresh water treatment) were below detection (< 0.05 %v/v). For details: see appendix III of Applicant’s

confidential dossier.

5.2 Safety of the crew

5.2.1 The Group considered that risk to safety of the ships’ crew (BWMS operators included) by exposure to chemicals and treated ballast wa ter is judged to be acceptable based on the measures developed by the Applicant for inst allation on board ship, this being confirmed by EUSES calculations. A summary of the various safety measures developed by the Applicant is given above in section 3.2. The Group considered that in this system, the risk to ships’ crew is judged to be appropriately managed based on the facts that the Active Substance (FAC) isGESAMP-BWWG 9/6

ANNEX 5 Page 27

I:\MEPC\59\2-19.doc produced in situ as well as that system components are a dopted that are expected to minimize the exposure risk of ships’ crew to chemicals a nd ballast water before and after treatment.

5.3 Safety of the general public

5.3.1 It is reasonably considered by the Group that the system ha s an acceptable risk to the health of the general public in light of the outco me of results of human risk assessment developed by EUSES.

6 ENVIRONMENTAL RISK ASSESSMENT

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

6.1.1 The Group recalled that as corrobora ted at the Basic Approval, neither

the Active Substance nor the other chemicals are classified as PBT subs tances. The Group noted

that in order to re-confirm the situation the A pplicant has made a further comprehensive listing of P, B and T criteria for the Active Substance and other chemicals found in the treated ballast water, with results being presented in Table 11.

Table 11: PBT evaluation of Acti ve Substance and other chemicals (as provided by the Applicant)

Chemical Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Hypochlorous acid No 1⁄2-Life: 0.058 days in water (Taylor, 1993) No Log Pow=-3.42 No 7d NOEC for unknown species, 0.0027 mg/l (MEPC 58/2/7, annex 6)

Bromodichloromethane No 1⁄2-Life: 0.08 days in water (EU-RAR Hypochlorite, par. 3.1.2) No LogPow= 1.88 No Oryzias latipes NOEC= 0.78 mg/l/21days (MEPC 58/2/7, annex 7)

Dibromochloromethane No 1⁄2-Life: 0.11 days in water (EU-RAR Hypochlorite, par. 3.1.2) No Log Pow = 2.08 No Daphnia magna NOEC = 0.063 mg/l/21days (GLP) (MEPC 58/2/7, annex 7)

Tribromomethane No 1⁄2-Life: 0.30 days in water (EU-RAR Hypochlorite, par. 3.1.2) No Log Pow = 0.38 No Cyprinodon variegates NOEC= 4.8 mg/l/28 days (MEPC 58/2/7, annex 6)

Dichloroacetic acid No 1⁄2-Life: 5.4 days in water (Hashimoto et al ., 1998) No Log Pow = 0.92 No Nitocra spinipes LC50= 23 mg/l/96 h (MEPC 58/2/7, annex 7, original reference unknown)

Bromochloroacetic acid No 1⁄2-Life: 2.7 days in water (Hashimoto et al ., 1998) No Log Pow = 0.61 No Pimephales promelas LC 50 = 6.9 mg/l/96 h (Dibromoacetic acid)

Dibromoacetic acid No 1⁄2-Life: 3.1 days in water (Hashimoto et al ., 1998) No Log Pow = 1.22 No Pimephales promelas LC 50 = 6.9 mg/l/96 h (Mayes et al, 1985)

Tribromoacetic acid No 1⁄2-Life: 0.04 days in water (Yuefeng Xie, 2004) Spontaneous decomposition in water (EU-RAR Hypochlorite, par. 3.1.2) No Log Pow = 1.71 No Pimephales promelas LC 50 = 6.9 (mg/l/96 h) (Dibromoacetic acid)GESAMP-BWWG 9/6

ANNEX 5 Page 28

I:\MEPC\59\2-19.doc Chemical Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n)

Chloroacetic acid No 1⁄2-Life: 3.9 days in water (Hanson et al ., 2002) No Log Pow = 0.22 No Daphnia magna, 48 h EC 50 = 77 mg/l (US-EPA Ecotoxicology database, 2008)

Bromoacetic acid No 1⁄2-Life:3.2 days in water (Hashimoto et al ., 1998) No Log Pow = 0.295 No Daphnia magna NOEC= 1.6 mg/l/21days (Kuhn, R. et al. , 1989)

Bromodichloroacetic

acid No 1⁄2-Life: 3.6 days in water (Hashimoto et al ., 1998) No Log Pow =1.71 (tribromoacetic acid) No Pimephales promelas LC 50 = 6.9 (mg/l/96 h) (Dibromoacetic acid)

6.1.2 Based on these results, the Group concluded that these chemicals should not be classified

as PBT-substances.

6.2 Ecotoxicity testing of treated ballast water

6.2.1 The Group noted that in this section, the resu lts of aquatic ecotoxic ity studies performed by the Applicant with 100% treated ballast water as a test substa nce are presented in accordance with the Procedure for approval of ballast water management systems that make use of Active Substances (G9). According to the Applicant, samples for the ecotoxicity tests were taken during full scale land-base d tests in the summer of 2008 with the same equipment as used on board a ship for 2 years (see appe ndix VII of Applicant’s dossier) and as used for Guideline (G8) test cycles performed in the summer of 2007 (see appendix II). The A pplicant considers this procedure in compliance with the Methodology and in compliance with Procedure (G9), and the Group agreed w ith this view.

6.2.2 The Group noted that the Applicant has comm issioned the Institute for Marine Resources and Ecosystem Studies of Wageningen IMARES, Den Helder, the Netherlands, to perform the prescribed toxicity tests on the treated ballast water. Samples of two types of treated ballast water (brackish with salinity <20‰ and fresh w ith salinity <5‰) were taken under the same technical conditions as samples taken for chemi cal analysis (see chapter 3, section 3.3.4 of this document). Ballast water treatment was perfor med as normal using both sedimentation and electrolysis steps. The full report is presented in appendix VI of the Applicant’s dossier.

6.2.3 The Group noted that the ecotoxicity tests we re performed using three aquatic organisms: two algae ( Phaeodactylum tricornutum and Pseudokirchneriella subcapitata ) and a crustacean (the brine shimp Artemia franciscana ). The test species were adapted to the desired salinity regime prior to testing. Accord ing to the Applicant, tests were performed directly after treatment and 48 hours after treatment and storage in a container. For each test, dilutions of 10% 18%, 33%, 56% and 100% treat ed ballast water were made, using untreated ballast water (only hydrocyclone treated) as dilution medium a nd blank. The Group noted that tests with fish were not conducted, since according to appendix VI of the Applicant’s dossier, previous tests (in Basic Approval application) indicated that fish larvae were not affected. In this test

on Solea solea egg yolk larvae, survival is monitored and 87.5-100% fish larvae were shown to

survive in treated ballast water.

6.2.4 The Group noted the following re sults. Treated ballast water s howed no negative effects in the tests with the brine shrimp, but it caused a significant effect on both algal species. The freshwater species P. subcapitata appeared to be the most sens itive. Table 12 below gives anGESAMP-BWWG 9/6

ANNEX 5 Page 29

I:\MEPC\59\2-19.doc overview of results for the algae tests (see for explanation of sample codes and sample characteristics: page 29, appendi x A of appendix VI of Applicant’ s dossier). In July, tests in duplicate were done with treated ballast wate r immediately after uptake (sample codes 200807). In August and September, tests were done imme diately after uptake and after 48 hours storage (sample codes 200808 and 200809).

Table 12: Summary results of the algae eco toxicity tests with treated ballast water

Phaeodactylum tricornutum Sample code NOEC (m/m%) LOEC (m/m%) EC 50 (m/m%)

2008070853b

2008070853b

2008082553

2008082700 Intake intake (duplo)

intake discharge 17.0

17.0

17.2

30.2 30.2

30.2

30.2

53.7 48.7 (47.6 – 49.7) 44.0 (42.5 – 45.6) 32.8 (30.3 – 35.4)

>95.6

Pseudokirchneriella subcapitata Sample code NOEC (m/m%) LOEC (m/m%) EC 50 (m/m%)

2008070853f

2008070853f

2008091553

2008091700 Intake Intake (duplo)

Intake discharge <9.3

<9.3

9.4

29.6 9.3

9.3

16.6

52.7 16.9 (16.3 – 17.1) 15.3 (13.3 – 17.5) 20.3 (19.1 – 21.7) 58.7 (51.0 – 67.6)

6.2.5 The Group concluded from these re sults that on average a 6–fold ( P. tricornutum ) to 20-fold dilution ( P. subcapitata ) is needed to reach NOEC in the testing of treated ballast water. According to the Applic ant, in some ballast water test s, a clear eff ect of volatile

substances was observed in the bl ank wells that were added as co ntrol for volatile substances. This effect was observed in all tests with the freshwater algae P. subcapitata and in the August 26 test with the marine algae P. tricornutum . The effect was limited and did not affect the performance of the test.

6.3 Risk assessments of chem icals for aquatic organisms

6.3.1 The Group recalled that in th e Report of the Application for Basic Approval of this system, the PEC/PNEC ratios as calculated by the Applicant, were not accepted by the Group and the Applicant was requested to revise its risk assessment for aquatic organisms.

6.3.2 In responding to this request, the Group not ed that in the dossier for Final Approval, the Applicant has used the model MAMPEC (ver sion 2.0) to obtain values for Predicted Environmental Concentration (PEC). In this appl ication, a standard commercial harbour has been used with an exchange volume of 259,000,000 m 3 per tidal period of 12.4 hours. The daily volume of discharged treated ballast water and the c oncentration of the Active Substance and other chemicals are critical input data. According to an investigation by Haskoning, commissioned in 2008 by the authorities of the Port of Rotterd am, a realistic average value of ballast water discharge is 50,000 m 3 per day, and this is the value used in this application. According to the Applicant, for all MAMPEC calculations the highest chemical concentration from the time series of measurements, with either brackish or fresh water, was used. (See Tables 4 to 9 in chapter 3 of this document). The Group accepted that this im plies the worst case scenario, e.g., for Active Substance (FAC) the maximum allowable dose con centration of 1 mg/kg wa s used, instead of the discharge concentration (< 0.01 mg/kg). All input data and results of the MAMPEC calculations and the Haskoning report are presented in appendix VIII of the Applicant’s dossier.GESAMP-BWWG 9/6

ANNEX 5 Page 30

I:\MEPC\59\2-19.doc 6.3.3 In the case of the Active Substance (FAC), the Group noted the following data provided by the Applicant:

Predicted Environmental Concentrat ion (PEC) from MAMPEC model –

Main input data for FAC is: Load: 50 kg/day (based on 50,000 m 3 /day and maximum of 1.0 mg/L); Half life: 0.058 days in water. The MAM-PEC model calculates for FAC a steady state situation (= PE C) in the harbour

of 0.013 μ g/L and of 0.002 μ g/L in the surroundings.

Effects on aquatic organism s: Predicted No Effect Concentrations (PNEC) – In various documents, predicted no effect concen trations of FAC (PNEC) have been calculated

with different outcomes. Annex 7 to docum ent MEPC 56/2/2 (review by the GESAMP-BWWG of the application by Japan, MEPC 56/2), reports a value of 0.07 μ g/L. Document MEPC 57/2/1 (application by Korea) reports 8 μ g/L. The GESAMP-BWWG used 0.27 μ g/L in document MEPC 58/2/7, annex 6.

6.3.4 The Group noted that similar data from the Applicant on PEC and PNEC for all the other chemicals, is presented in the Appe ndix (section 1.1) to this document.

6.3.5 The Group was satisfied that in order to a ssess the risk to the aquatic environment, the Applicant has calculated the PEC/PNEC ratio for the Active Substance (FAC or hypochlorite) and the other chemicals, and the results are presented below in Table 13.

Table 13: PEC/PNEC ra tios for Active Substance and other chemicals

Chemical PEC (Max) (mg/L) Toxicity (mg/L) Factor Applied PNEC (mg/L) PEC/PNEC (Max)

Hypochlorite 1.33E-05 2.7E-03 10 2.7E-04 4.9E-02

Bromodichloromethane 8.47E-07 0.78 500 1.56E-03 5.4E-04

Dibromochloromethane 3.62E-07 0.063 500 1.26E-04 2.9E-03

Tribromomethane 4.04E-06 4.8 100 4.8E-02 0.8E-04

Chloroacetic acid 2.03E-06 77 10,000 77E-04 2.6E-04

Bromoacetic acid 2.30E-05 1.6 500 3.2E-03 0.7E-02

Dichloroacetic acid 2.33E-06 23 1,000 23E-03 0.1E-03

Bromochloroacetic acid 5.71E-06 6.9 1000 6.9E-03 0.8E-03

Dibromoacetic acid 2.00E-05 6.9 1,000 6.9E-03 0.3E-02

Tribromoacetic acid 1.32E-07 6.9 1,000 6.9E-03 0.2E-04

Bromodichloroacetic acid 6.53E-07 6.9 1,000 6.9E-03 0.9E-04

6.3.6 The Group concurred with the calculations of the Applicant concerning the results of the MAMPEC model. The Group was able to recalculate the results w ith the same assumptions as the Applicant. Therefore, the Group was satisfied with the establishment of the PEC values in the receiving waters.

6.3.7 The Group concluded from these results th at the PEC/PNEC ratio s for Active Substance and all other chemicals are far below 1, even though a worst case scenario has been used: maximum dose (FAC) and maximu m concentration of other chemicals found in treated ballast water. The Group was satisfied that this indica tes there is no unacceptable risk to the aquatic environment from any of thes e chemicals. The highest PE C/PNEC ratio was found forGESAMP-BWWG 9/6

ANNEX 5 Page 31

I:\MEPC\59\2-19.doc FAC: 4.9E-02. The Group considered that even this value will not occur during normal operation

of the BWMS since no FAC could be detected in the treated, stored ballast water 4 hours after treatment (see Tables 4 and 5, chapter 3). Moreov er, the Group recalled that FAC concentrations are regulated on line and the maximum dose concen tration will be kept at a constant level, regardless of TSS or TOC/DOC/POC content. In addition, the marg in of safety of the PEC/PNEC

ratio for FAC and other chemicals is such that no adverse effects will occur if higher concentrations will be produced as a result of hi gher concentrations of organic carbon content in the intake water.

6.3.8 The Group obtained further information on th e consequences of the 6-20 fold dilution required for algae mentioned earlier (see section 6.2.5 in this report ) in relation to the discharge

into the environment of treated ballast wate r. The calculation of PEC values with the model MAMPEC and comparison to toxicity tes ting NOEC data for brackish and fresh water were carried out by the Group. It shows that the dilution effect of the MAMPEC model is about a factor 350. With this figure in mind it wa s not expected by the Gr oup that there will be unacceptable risks for algae in the receiving waters.

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to safety of the ship

7.1.1 The Group noted that specific countermeasures that can be employed in this system to deal with envisaged emergency and safety problem s during the ballast water treatment have been

well described and discussed above , and as such the Group consider ed that the Greenship Sedinox BWMS should present no risks to the safety of the ship.

7.2 Risks to the crew and general public

7.2.1 The Group considered that the Greenship Sedinox BWMS has no unacceptable risk to the health of the crew and the genera l public regarding the exposure to chemicals and treated ballast water, based on the facts that the Active Substance (FAC) is produced in situ and on the measures developed by the App licant for installation on board ship. This was confirmed by the outcome of the human health risk assessment performed by the EUSES model (v. 2.1).

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. Although the whole effluent tests (WET) showed some residual toxicity for algae th e Group did not consider this a risk for the environment as on a daily basis there would be a d ilution in the receiving harbour of a factor of about 350. With this figure in mind, the Group felt satisfied that there w ill be no unacceptable

risks for the environment.GESAMP-BWWG 9/6

ANNEX 5 Page 32

I:\MEPC\59\2-19.doc 7.4 Recommendation

7.4.1 In conclusion, having reviewed all the in formation provided by the Applicant, the Group agreed to recommend to the MEPC that Fina l Approval be given to the Greenship Sedinox BWMS, subject to the Administration verifying that these four recommendations have been fully addressed prior to issuance of a Type Approval Certificate:

.1 evaluate that the maximum allowable Active Substance (FAC) dose of 1 mg/kg

could be ensured with FAC sensors ad equately calibrated during test-bed treatment operation against seawater (>32 PSU) and low salinity brackish water. For this evaluation, FAC dose should be adequately measured both by DPD method and FAC sensor;

.2 evaluate that the maximum allowable Active Substance (FAC) dose of 1 mg/kg

could be ensured with FAC sensors adequately calibrated during onboard operation against seawater (>32 PSU) and low salinity brackish water;

.3 evaluate that the maximum allowabl e discharge concentration of Active Substance (FAC) at discharge should be kept to a level not exceeding the range of 0.01-0.20 mg/kg even after a short leg. During the Type Approval procedure by the Administration, the Applicant s hould decide on the maximum allowable discharge concentration of TR O in the range of 0.01-0.20 mg/kg and this value should be approved by the Administration. This parameter should be monitored and automatically recorded by FAC sensor adequately calibrated and maintained;

and

.4 evaluate the operation and installati on manuals, which include the adequate timings for the various maintenance pr ocedures. Particul arly, the maximum

duration for the calibration of FAC sensor should be provided by the Applicant to ensure the long term dur ability of the BWMS.

* * *GESAMP-BWWG 9/6

ANNEX 5 Page 33

I:\MEPC\59\2-19.doc Appendix

PROPERTIES OF ACTIVE SUBS TANCE AND OTHER CHEMICALS

1 EFFECTS ON AQUATIC ORGANISMS

1.1 Input data for calculation of PE C/PNEC ratio for other chemicals

1.1.1 Tribromomethane (bromoform)

Predicted environmental concentration (PEC)

Main input data for tribromomethane is:

Load: 4.2 kg/day (based on 50,000 m 3 /day and maximum of 84 μ g/l); Half life: 0.30 days in water.

The MAM-PEC model calculates for tribromomethan e a steady state situation (= PEC) in the

harbour of 0.004 μ g/l and of 0.0009 μ g/l in the surroundings.

Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

In various documents, predicted no effect concen trations of tribromomethane (PNEC) have been

calculated with different outcomes. Anne x 7 to document MEPC 56/2/2 (review by the GESAMP-BWWG of the application by Ja pan, MEPC 56/2), repo rts a value of 7.1 μ g/l. RIVM (2005) reports a value of 1.5 μ g/l. The GESAMP-BWWG used 48 μ g/l in document MEPC 58/2/7, annex 6.

1.1.2 Dibromochloromethane

Predicted environmental concentration (PEC)

Main input data for dibromochloromethane is:

Load: 0.8 kg/day (based on 50, 000 m 3 /day and maximum of 16 μ g/l); Half life: 0.11 days in water.

The MAM-PEC model calculates for dibromochloromethane a steady state situation (= PEC) in

the harbour of 0.00036 μ g/l and of 0.00008 μ g/l in the surroundings.

Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

In various documents, predicted no effect concen trations of dibromochloromethane (PNEC) have

been calculated with different outcomes. An nex 7 to document MEPC 56/2/2 (review by the GESAMP-BWWG of the application by Ja pan, MEPC 56/2) reports a value of 27 μ g/l. Document MEPC 57/2/6 presents 5.2 μ g/l and document MEPC 58/2 presents 3 μ g/l.GESAMP-BWWG 9/6

ANNEX 5 Page 34

I:\MEPC\59\2-19.doc 1.1.3 Tribromoacetic acid

Predicted environmental concentration (PEC)

Main input data for tribromoacetic acid is:

Load: 0.7 kg/day (based on 50, 000 m 3 /day and maximum of 14 μ g/l); Half life: 0.04 days in water.

The MAM-PEC model calculates for tribromoacetic acid a steady state situation (= PEC) in the

harbour of 0.0001 μ g/l and of 0.00002 μ g/l in the surroundings.

Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

Document MEPC 58/2 reports a value of 10 μ g/l. Document MEPC 58/2/7, annex 7 reports 6.9 μ g/l.

1.1.4 Dibromoacetic acid

Predicted environmental concentration (PEC)

Main input data for 2, 2 dibromoacetic acid is:

Load: 3.8 kg/day (based on 50,000 m 3 /day and maximum of 76 μ g/l); Half life: 3.1 days in water (calculated).

The MAM-PEC model calculates for 2,2 dibromoacetic acid a steady state situation (= PEC) in

the harbour of 0.020 μ g/l and of 0.0016 μ g/l in the surroundings.

Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

In various documents, the predicted no effect c oncentrations of 2,2 dibromoacetic acid (PNEC)

have been derived with different outcomes. Annex 7 to document MEPC 56/2/2 (review by the GESAMP-BWWG of the application by Japan, MEPC56/2), reports a value of 6.9 μ g/l. Document MEPC 58/2/7, annex 7, reports 6.9 μ g/l and document MEC 58/2 6.5 μ g/l.

1.1.5 Bromodichloromethane

Predicted environmental concentration (PEC)

Main input data for bromodichloromethane is:

Load: 0.245 kg/day (based on 50,000 m 3 /day and maximum of 4.9 μ g/l); Half life: 0.08 days in water.

The MAM-PEC model calculates fo r bromodichloromethane a steady state situation (= PEC) in

the harbour of 0.0008 μ g/l and of 0.00017 μ g/l in the surroundings.GESAMP-BWWG 9/6

ANNEX 5 Page 35

I:\MEPC\59\2-19.doc Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

The predicted no effect concentration of bromodichloromethane (PNEC) is 1.58 μ g/l (MEPC 58/2/7, annex 7).

1.1.6 Bromoacetic acid

Predicted environmental concentration (PEC)

Main input data for bromoacetic acid is:

Load: 4.3 kg/day (based on 50,000 m 3 /day and maximum of 86 μ g/l); Half life: 3.2 days in water (calculated).

The MAM-PEC model calculates for bromoacetic acid a steady state situation (= PEC) in the

harbour of 0.023 μ g/l and of 0.0018 μ g/l in the surroundings.

Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

In various documents, predicted no effect concen trations of bromoacetic acid (PNEC) have been

derived with different outcomes. Docu ment MEPC 58/2 reports a value of 3.4 μ g/l and document MEPC 57/2/6 reports even 2 different values: 1.6 μ g/l and 0.12 μ g/l. Document MEPC 58/2/7, annex 7, reports 2.8 μ g/l.

1.1.7 Chloroacetic acid

Predicted environmental concentration (PEC)

Main input data for chloroacetic acid is:

Load: 0.355 kg/day (based on 50,000 m 3 /day and maximum of 7.1 μ g/l). Half life: 3.9 days in water.

The MAM-PEC model calculates for chloroacetic acid a steady state situation (= PEC) in the

harbour of 0.002 μ g/l and of 0.00015 in the surroundings.

Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

Document MEPC 58/2 reports a PNEC of 7.7 μ g/l and 0.066 in MEPC 58/2/7, annex 7.

1.18 Dichloroacetic acid

Predicted environmental concentration (PEC)

Main input data for dichloroacetic acid is:

Load: 0.320 kg/day (based on 50,000 m 3 /day and maximum of 6.4 μ g/l) Half life: 5.4 days in water (calculated)

The MAM-PEC model calculates for chloroacetic acid a steady state situation (= PEC) in the

harbour of 0.0023 μ g/l and of 0.0001 μ g/l in the surroundings.GESAMP-BWWG 9/6

ANNEX 5 Page 36

I:\MEPC\59\2-19.doc Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

Document MEPC 58/2 reports a PNEC of 8.2 μ g/l and the review of this application reports 23 μ g/l (MEPC 58/2/7, annex 7).

1.1.9 Bromodichloroacetic acid

Predicted environmental concentration (PEC)

Main input data for brom odichloroacetic acid is:

Load: 0.160 kg/day (based on 50,000 m 3 /day and maximum of 3.2 μ g/l); Half life: 3.6 days in water (calculated).

The MAM-PEC model calculates for bromodichloroac etic acid a steady state situation (= PEC)

in the harbour of 0.0006 μ g/l and of 0.00006 μ g/l in the surroundings.

Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

No PNEC values were found for bromodichl oroacetic acid or coul d be derived from toxicological data. Therefore, the PNEC values for tribromoacetic acid will be used. Document MEPC 58/2 reports a value of 10 μ g/l. Document MEPC 58/2/7, annex 7 reports 6.9 μ g/l.

1.1.10 Bromochloroacetic acid

Predicted environmental concentration (PEC)

Main input data for br omochloroacetic acid is:

Load: 1.2 kg/day (based on 50,000 m 3 /day and maximum of 24 μ g/l); Half life: 2.7 days in water (calculated).

The MAM-PEC model calculates for bromochloroacetic acid a steady state situation (= PEC) in

the harbour of 0.005 μ g/l and of 0.0005 μ g/l in the surroundings.

Effects on aquatic organi sms: predicted no effect concentrations (PNEC)

Document MEPC 58/2 reports a PNEC of 7.7 μ g/l. Document MEPC 58/2/7, annex 7, reports a

value of 0.07 μ g/l.

1.2 Information on Endocrine Disruption

1.2.1 The Group noted that no reports indicating th at these chemicals might have any endocrine effects on aquatic organisms had been found. Th e Group agreed that, as with other similar applications there was no reason to suspect that the Active Substance an d other chemicals would have any endocrine disrupting effects.GESAMP-BWWG 9/6

ANNEX 5 Page 37

I:\MEPC\59\2-19.doc 1.3 Sediment toxicity / bioavailability / biomagnification / bioconcentration / foodweb

– population effects

1.3.1 The Group agreed that the Active Substance an d other chemicals are neither expected to

adsorb to sediment nor to accumulate in the food web.

***GESAMP-BWWG 9/6

I:\MEPC\59\2-19.doc ANNEX 6

REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

AquaTriComb TM Ballast Water Treatment System

Submitted for Basic Approval by Germany

0 SUMMARY

0.1 Having reviewed all the information received from the Applicant and the information received during the GESAMP-BWWG (9) m eeting, the Group agreed to recommend that Basic Approval be given to the ballast water management system proposed by Germany.

0.2 The Group noted that the Aquaworx ATC GmbH AquaTriComb Ballast Water Management System uses a combination of filt ration, low-pressure UV disinfection, together with low-frequency ultrasound cleaning and di sinfection to treat the ballast water.

0.3 The Group was satisfied that, as the system does not involve the storage or generation

of Active Substances or chemicals to treat ballas t water, there were no a ssociated storage safety problems on board ship.

0.4 The Group noted that the Low-Pressure UV technology in the ballast water management system (BWMS) makes use of electromagnetic radiation (photons) a nd the Low-Frequency Ultrasound technology makes use of ultrasonic osci llation to treat the ballast water and for cleaning purposes. As such, the Group considered th at it was neither nece ssary nor practical to provide the physical characteristics or toxicological profiles of the photons.

0.5 However, it was recognized by the Group th at the 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 in water are expected to be in th e order of micro- to

milli-seconds.

0.6 Based on results from the chemical analyses of treated ballast wate r, the Group concurred with the views of the Applicant that it wa s not necessary to prov ide toxicological and ecotoxicological data on these individual by-pr oducts and that the evaluation of the possible effects of treated ballast water provided in the submitted dossier was sufficient to recommend Basic Approval.

0.7 The Group noted that the UV ra diation level for the ballast water tests during the chemical analysis is set to 400 mJ/cm 2 . Therefore the Group concluded that the maximum dose for this system is stated by the Applicant as 400 mJ/cm 2 during this evaluation under Procedure (G9).

0.8 Currently the Applicant a pplies low-frequency ultrasound cleaning mechanism of both

the UV tubes and filters. If the A pplicant considers it necessary to change this mechanism, then the Group recommends submission of quantified data.

0.9 The Group noted that the submitted dossier di d not contain any results of ecotoxicity testing of treated ballast water. In accord ance with the requirements of Procedure (G9), the Group recommended that acute and chronic a quatic ecotoxicity testi ng of treated ballast water should be performed by the Applicant, if the BWMS is to be reviewed for Final ApprovalGESAMP-BWWG 9/6

ANNEX 6 Page 2

I:\MEPC\59\2-19.doc in the future. The Group recalled that this requirement of ecotoxici ty testing is part of Basic Approval, so that the Applicant can make use of ballast water from the laboratory-scale BWMS. The Group considered that the possibility for an Applicant to provide chemical analysis and/or acute toxicity testing, in lieu of whole effluent ecotoxi city testing for Final Approval should not be permitted in this particular case as ecotoxicity testing was not supplied for the Basic Approval evaluation, and this is a necessa ry step to provide certainty of environmental acceptability.

0.10 The Group noted that the potential hazards for human health, related to overheating of UV lamps and exposure to UV ir radiation and ultrasonic oscill ation resulting from operating this system, were sufficiently addressed by the A pplicant by engineering control measures put in place and training of operators. Therefore, the Gr oup concluded that the risks to the crew from exposure were sufficiently mitigated by the measures identified and put in place.

0.11 The Group recommended that an application for Final Approval of this system includes confirmation by testing, th at the effluent from the filter back flush during application of treatment at ballast water discharge, is effectively treated by UV radiation, as indicated by the Applicant in their replies to additional questions posed by the Group during this evaluation.

0.12 In addition, the Group noted that all the disinfection by -products measured in the discharged ballast water were under LOD (limit of detection). The Group considered that these

chemicals are short-lived and w ould not pose a toxicological con cern towards the general public swimming and eating fish from the area.

0.13 Having reviewed all the data and information submitted by Germany for Basic Approval and the information supplied by the Applicant in response to questions posed by the Group during this GESAMP-BWWG meeti ng, the Group had the following requests for information, if this system is to be reviewed for Final Appr oval in the future – see requests at points 0.8, 0.9 and 0.11 in this summary.

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted fr om that supplied by Germany in document MEPC 59/2/8, supplemented by additio nal confidential information provided by the Applicant.

2 COMPLETENESS OF DOSSIER

2.1 During the GESAMP-BWWG meeting, the Group posed to the Applicant a total of 6 questions on issues it felt needed further clarification in order to complete the evaluation for Basic Approval. The Group’s questions, the Applicant’s resp onses and the Group’s conclusions on the responses provide d are listed below, as follows:GESAMP-BWWG 9/6ANNEX 6Page 3I:\MEPC\59\2-19.docSectionNo.Question No.from meetingGroup’s Question Applicant’s Response Group’s Reaction to theApplicant’s response2.1.1 Question 1 The description of the operation of the system appearsunclear as to whether the treatment is applied only at ballastwater uptake or at both uptake and discharge. In the nonconfidential submission, section 1.3 “Technology overview”it would appear that the treatment is applied only at ballastwater intake, however in the dossier, section 1.4 “Conclusion:technology overview”, it is stated in bullet point 3 “duringde-ballast operations”. Pleaseconfirm the intended process.The AquaTriComb BW System is designed to treat theballast water during the uptake as well as before thedischarge. The water will be treated passing the wholeprocess of filtration and UV treatment both during uptakeand before discharge.The Group was satisfied with theApplicant’s response toQuestion 1.2.1.2 Question 2What happens to the filter backwash effluent? Is itdischarged directly overboard? The system description isunclear on this point. It would also be helpful to be providedwith an indication of the percentage flow rate that will beused to provide the filter back-flush function.During ballast operations the filter backflush can beunobjectionable discharged overboard, because it is theplace of origin of the water.The rate of backflush duringballast operation will be 0.7 % of the whole ballast watereffluent.During de-ballast operations the ballast water from thetanks is pipelined through the complete pre- and aftertreatment plant before discharge. We designed oursystem in this way especially with respect to the goal ofballast water treatment - to avoid dispersal of anyorganism via ballast water.Organisms, e.g., bacteria and monocellularphytoplankton, which in spite of effective treatment maygrow again during long ship voyages and detritusparticles, if present in ballast tanks (before the treatmentprocess), will be with this method effectively killed. Forde-ballast water treatment the "Reactor In Reactor" (RIR)has been developed. During de-ballast operations thefiltrated ballast water firstly will be stored intermediatein the transfer container. After this the backflush ispipelined permanent throughthe UV reactor via separatetubes very close along the UV tubes (20 mm distance)which results in an very effective treatment through thehigh energetic impact of the UV radiation. The rate ofbackflush during de-ballast operation will be 0.35% ofthe whole ballast water effluent.The Group was satisfied with theApplicant’s response toQuestion 2.GESAMP-BWWG 9/6ANNEX 6Page 4I:\MEPC\59\2-19.docSectionNo.Question No.from meetingGroup’s Question Applicant’s Response Group’s Reaction to theApplicant’s response2.1.3 Question 3If the system is used also at discharge as would appear tohave been indicated; has any evaluation of constituents of thefilter backwash water, when used during ballast waterdischarge, been performed? If so, please provide the resultsand any assessment of the risk of discharge of active regrowth of organisms or pathogens through this source.a) Constituents -In the RIR (reactor in reactor) the backflush is pipelinedthrough separate tubes very close along the UV tubes (20mm distance), what results invery effective disinfection.Because the “normal” filtered water passing through thereactor is also passing the UVemitters in the same veryclose distance as the water inthe RIR, we assume there isno difference between the normal filtered water and thebackflush water regarding the constituents (substances)of both waters. For this reason we did not evaluate thebackflush water separately from the normal filteredwater.b) Risk of re-growth -The risk of re growth of organisms or pathogens fromfilter backflush is much lower (because treated in the UVreactor RIR) then the tanks ballast water would bedischarged overboard without any treatment or only withone step of treatment (filtration or disinfection). With ourdesigned system the discharge of any water, filterbackflush water and treated water through the whole BWsystem, the risk of re-growth is much more lower thandischarge of water overboard without or only one step oftreatment.The Group was satisfied with theApplicant’s response toQuestion 3.GESAMP-BWWG 9/6ANNEX 6Page 5I:\MEPC\59\2-19.docSectionNo.Question No.from meetingGroup’s Question Applicant’s Response Group’s Reaction to theApplicant’s response2.1.4 Question 4 Applying ultrasound into water can generate very hightemperatures in short periods of time by cavitation accordingto the references submitted. The chemical composition ofseawater may be altered under such conditions, depending onwater quality. The Group needs some assurance (with specificevidence) that there is no adverse chemical reaction in thatcase, recognizing there are lots of references about thedegradation of chemicals, or production of H2O2etc byultrasound.The following expertise (* see text below) was done byTechnical University ofHamburg Harburg (TUHH).We were interested in this expertise because we wantedto optimise our BWTS especially in this way to avoidmuch as possible the generation of any by-products. As aresult of this expertise by the TUHH we decided to apply20 kHz ultrasound for the whole system (filter and UVreactor) and during very short times. The residence timeof ultrasound for the normal filtration process is less than1 second (high flow rate), during the cleaning process ofthe filter less than 10 seconds and during the UVtreatment process again less than 1 second (based onhigh flow rate).For this reason the generation of by-products such asH2O2by ultrasound we can exclude to a very high extendwith our system.Based on consideration of theApplicant’s response, the Grouphad the following request forFinal Approval -Currently the Applicant applieslow-frequency ultrasoundcleaning mechanism of both theUV tubes and filters. If theApplicant considers it necessaryto change this mechanism, thenthe Group recommendedsubmission of quantified data.The Group noted the explanationsfrom TUHH.GESAMP-BWWG 9/6ANNEX 6Page 6I:\MEPC\59\2-19.docSectionNo.Question No.from meetingGroup’s Question Applicant’s Response Group’s Reaction to theApplicant’s response2.1.5 Question 5 There is a description for use of ultrasound for self-cleaningas follows; “The application of low pressure radiation andvery low frequency ultrasound (20 Hz) with extremely shortterm ultrasound impact (< 1 s) generated, based on analysis oftreated water, no Other Chemicals during the treatmentprocess.”Is this level of ultrasound to be applied both to the filter andthe UV tube? The main purpose for cleaning the surface ofUV tube, we are informed is the removal of biofilm.However, the Group believes that low frequency ultrasoundcould have less cleaning effect on such biofilm, pleasecomment. The positioning of the ultrasound probe is unclear,is one probe intended for both Filter and UV tube, or areseparate sources to be provided for each function?Yes, the level of ultrasound is applied in the same wayfor both filter modules and UV emitters: 20 Hz and withoperating times less than 1 second.The results of our test during the last months show, thatthe removal of biofilm from filter modules and UVemitters works very effective. More then this: thegeneration of inorganic accumulations (e.g., CaCO3),which appears in seawater very effective and what isvery hard to remove by normal cleaning systems likewipers, can also be avoided by ultrasound application,also in the range of 20 Hz. This is documented by resultsof Phytoplankton (done by NIOZ), Zooplankton (done byus) and bacteria analysis of samples. The results werevery promising. Another evidence of the higheffectiveness of the cleaning impact from ultrasoundgave us the inspection of filter modules and UV emittersafter months of running time. We could not found anybiofilm or inorganic accumulations.Positioning of ultrasound emitters:For every filter module as well as for the UV reactorsingle Ultrasound emitters are allocated.The Group was satisfied with theApplicant’s response toQuestion 5.GESAMP-BWWG 9/6ANNEX 6Page 7I:\MEPC\59\2-19.docSectionNo.Question No.from meetingGroup’s Question Applicant’s Response Group’s Reaction to theApplicant’s response2.1.6 Question 6 In the non-confidential material acute ecotoxicity of nitrite isgiven in Table 1 (referred to as Table 2 in Table 5) with LC50and EC50values as low as 11.2 and 27.1 mg/L. It is stated thatreliable chronic toxicity data are not available. Nevertheless,based on three chronic NOECs a PNEC of 0.01 mg/L hasbeen suggested from EU member states’ competentauthorities.A reference is made in 5.3.5.1 to acute and chronic toxicitydata in 2.3.2, however, this section does not exist in the nonconfidential material. Where is this chronic ecotoxicity data?How do you explain the nitrite concentrations you havemeasured in discharges?We apologize very much for this wrong phrasing!The same sentence both in the confidential Dossier andin the non confidential submission in chapter 5.3.5.1:Acute and chronic toxicity data have been displayed inchapter 2.3.2.The appropriate phrasing of the sentence is:Acute toxicity data have been displayed inchapter 2.3.1.6.Unfortunately our external expert (TUHH) did not findafter a deep literature search, any data for chronictoxicity.The nitrite concentrations in the freshwater, brackishwater and saltwater pre and post samples shown inAnnex A of the Basic Approval Application (confidentialmaterial) are highly variable, but the freshwater data arenot assessed and not shown in the non-confidentialmaterial, because the statistical method chosen does notallow for their test. Nevertheless, in Table A1 all thePRE data are close to the detection limit and the POSTdata are from detection limit to 0.148 mg/L, which iswell above the PNEC.Fresh water data are not assessed because most of the pretreatment data are below the limit of detection and thusstatistical testing is not possible.For freshwater data on post treatment, the variability isindeed very high. But there are two groups visible, onewith low values and one with higher values. On this basisit is not possible, to calculate even a mean or variancebecause the data are not normally distributed.Nevertheless there are more low values leading to amedian of 0.009. Again this value is slightly above thelimit of detection.We assume that the increased values are due to acarryover from salt water tests which has been donedirectly before the fresh water tests.The Group was satisfied with theApplicant’s responses toQuestion 6.GESAMP-BWWG 9/6ANNEX 6Page 8I:\MEPC\59\2-19.doc* TUHH Expertise statement from Applicant (seeQuestion 4above) -The ultrasound frequency spectrum ranges from 20 kHz and 500 mHz (in liquids and solids). Usually the application options of this large frequency range is divided into two sectors. Highfrequency ultrasound covers 2 to 10 mHz, and low frequency ultrasound covers 20 to 100 kHz (Mason & Lorimer 2002). The latter,also named high power ultrasound, is utilized in watersterilization and waste water treatment since years. In German water treatment plants large ultrasound modules are applied at afrequency of 40 kHz and a sounding period of 20 sec. to killplankton (e.g., copepods and rotifers) (Mason & Peters 2002).The basic process is the induction of cavitation (lat.: cavus = hollow) by the ultrasound treatment. Cavitation, also named hollow suction, is defined as cyclical formation, the growth and thesubsequent collapse of micro bubbles (hollow areas, gaseous bubbles), which cause tissue damage.The bubbles are emerge and collapse within extremely short intervals und release largeamounts of energy into the direct environment. Cavitation concentrates the diffuse energy of ultrasound onto the bubbles.The generation of radicals heavily depends on the frequency and the sounding period. High frequencies enlarge the number of free radicals due to accelerating cavitation (Thompson &Doraiswamy 1999, Abu-Hassanet al. 2006).In a study into sono degradation (degradation by ultrasound) of persistent tensides (LAS) Abu-Hassanet al. (2006) could demonstrate an increase in radical generation in watery dilution withinthe first 60 minutes with ultrasound of 20kHz. The concentration was determined by H2O2 which is generated by the re-combination of hydroxyl radicals (OH ̇+ OH ̇= H2O2).After 60 minutes the H2O2concentration equalled 1400μg/L. only a very small amount was generated within the first 5 minutes (< 100μg/L). The results indicate that a short sounding periodand low frequency (20 kHz) will generate none radicals or if then in extremely low amounts.GESAMP-BWWG 9/6

ANNEX 6 Page 9

I:\MEPC\59\2-19.doc 2.2 Having reviewed all the data and information submitted by Germany for Basic Approval and the information supplied by the Applicant in response to questions posed by the Group during this GESAMP-BWWG meeti ng, the Group had the following requests for information, if this system is to be reviewed for Final Approval in the future:

.1 Currently the Applicant a pplies low-frequency ultrasound cleaning mechanism of both the UV tubes and filters. If the Applicant considers it necessary to change this mechanism, then the Group recommended submission of quantified data.

.2 The Group recommended that an applica tion for Final Approval of this system includes confirmation by testing, that the effluent from the filter backflush during application of treatment at ballast wate r discharge, is effectively treated by UV radiation, as indicated by the Applicant in their replies to additional questions posed by the Group during this evaluation.

.3 The Group noted that the submitted dossi er did not contain any results of ecotoxicity testing of treated ballast water. In accordance with the requirements of Procedure (G9), the Group recomme nded that acute and chronic aquatic ecotoxicity testing of treated ballast wa ter should be performe d by the Applicant,

if the BWMS is to be reviewed for Final Approval in the future. The Group recalled that this requirement of ecotoxicity testing is part of Basic Approval, so that the Applicant can make use of ballast water from the laboratory-scale BWMS. The Group considered that the possi bility for an Applicant to provide chemical analysis and/or acute toxici ty testing, in lieu of whole effluent ecotoxicity testing for Final Approval shoul d not be permitted in this particular case as ecotoxicity testing was not supp lied for the Basic Approval evaluation, and this is a necessary step to provide certainty of environmental acceptability.

3 DESCRIPTION OF THE SYSTEM

3.1 Working principles of the AquaTriC omb Ballast Water Management System

3.1.1 The Group noted that the Applicant had s upplied the following information on the basic operation of the system. The ballast water is treate d at intake (ballasting) and again at discharge (de-ballasting). The treatment dur ing intake ensures that a mini mal amount of viable organisms

enters into the ballast water tanks and reduces se diment build-up in the ta nks, 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 or ganisms in the ballast water tanks is prevented. The working principle is disinfection or de struction of organisms through UV radiation and ultrasonic oscillation, without additi on of chemical compounds.

3.1.2 The Group noted that the Aquaworx ATC GmbH AquaTriComb BWMS uses a combination of Filtration, Low-Pressure UV disinfection, together with Low-Frequency Ultrasound cleaning and disinfection to treat the ballast water.GESAMP-BWWG 9/6

ANNEX 6 Page 10

I:\MEPC\59\2-19.doc 3.1.3 The Group noted that the Low-Pressure UV technology in the BWMS makes use of electromagnetic radiation (phot ons) and the Low-Frequency U ltrasound technology makes use of

ultrasonic oscillation and cavitation to trea t the ballast water and for cleaning purposes. The UV-light employed is monochromatic, obtained from mercury vapour la mps, at a wavelength

of 254 nm.

3.1.4 The Group noted that the UV radiation level for the ballast water tests during the chemical analysis is set to 400 mJ/cm 2 . Therefore the Group conclude s that the maximum dose for this BWMS is stated by th e Applicant as 400 mJ/cm 2 during this evaluation under Procedure (G9).

3.1.5 The Group noted the following information prov ided by the Applicant. The BWMS will

be installed in line after the ba llast water pumps with a bypass path way. Both the ballast water intake flow, as well as de-ballasting flow, will be directed via the whole treatment system. The

first treatment module consists of mechanical filtrati on in combination with ultrasonic oscillation for filter self-cleaning, followed by the second m odule of UV radiation also in combination with ultrasound for self-cleaning of UV lamps. The intake water then pa sses to the ballast water tanks and the whole treatment process is repeated at discharge.

3.2 Overview

3.2.1 The AquaTriComb BWMS

3.2.1.1 The Group noted that this BWMS consis ts of: filtration, disinfection of marine organisms through UV radiation and ultrasonic osci llation, cleaning through u ltrasonic oscillation together with controls and auxi liary functions, all arranged into two separate modules as follows:

.1 a filtration with ultrason ic oscillation module; and

.2 a UV reactor with ultrasonic oscillation module.

Then, at ballast water discharge, the whole process is repeated, so the overall treatment scheme is indicated in Figure 1 below.

Ballasting

Î Î Î

Í Í Í

De-Ballasting

Figure 1: Schematic Process Diagram of AquaTriComb BWMS Filtration with

Ultrasound UV Reactor

with

Ultrasound

Ballast

Water

Tank Filtration with

Ultrasound UV Reactor

with

UltrasoundGESAMP-BWWG 9/6

ANNEX 6 Page 11

I:\MEPC\59\2-19.doc 3.2.1.2 The Group accepted that this system repres ents a chemical-free disinfection procedure as no chemical compounds are a dded to the process.

3.2.1.3 The Group decided this application for Basic Approval should focu s on the disinfection of marine organisms through UV radiation and ultr asonic oscillation, as th is is the only area involving 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 confir m and justify this system, the Applicant had developed a pilot scale system and experime nts were performed in accordance with the IMO requirements. The treated ballast water was used for the chemical water analysis (see below for results).

3.2.2.2 The Group noted that according to the App licant, the BWMS test plant volume flow rate is designed at 250 m 3 /h and the capacity can be up-scaled as needed. The ballast water intake is filtered through three identical MicroSintFilte r (MSF) modules to remove particles and organisms. The MSF Aquaworx filter pore size is 35 μm and filter material consists of a sintered high grade steel alloy. The automati c self-cleaning proces s of the filter modul es is realized via permanent ultrasonic oscillation in side the filter tube. By means of reversed flow, the effluent from the filter backflush is disposed of via se parate piping, during appli cation of treatment at ballast water discharge.

3.2.2.3 According to the Applicant, the most im portant impact of the ultrasound is the highly effective and permanent cleaning of the UV-em itter through the ultrasonic transmission along the full length of the UV-reactor, avoiding accumulati ons of bio films or inorganic salts on the quartz-crystal tubes. Inside the UV-reactor the aquatic organisms are lethally affected by UVlight and ultrasound. The Group noted that the A pplicant provides this information for use of ultrasound for self-cleaning - the same level of ultrasound is app lied in the same way for both filter modules and UV emitters; very low freque ncy sound (20 Hz) with extremely short-term ultrasound impact (< 1 s).

3.2.2.4 Abiotic parameters such as pH, conductiv ity, temperature, turb idity, oxygen content, flow rate volume and pressure are recorded during tests online via automatic sensors.

3.2.2.5 The Group noted that, according to the Applicant the performance test was done according to Guidelines (G8). Test results sh owed that the AquaTriComb system meets the Ballast Water Performance Standard contained in regulation D-2 of the Ballast Water Management Convention.

3.3 Safety considerations

3.3.1 The Group noted that the treatment plant is designed to need minimum input from the crew. The crew member performs ballasting and de-ballasting procedures as normal and the AquaTriComb starts operations after activati on of a switch-on device. Further, Aquaworx is offering a training unit to the key shipboard personnel to get familiar with the system.

3.3.2 According to the Applicant, the AquaTriC omb treatment plant is fully automated and completely self-contained with electronic cont rol, switchboard, and control panel includingGESAMP-BWWG 9/6

ANNEX 6 Page 12

I:\MEPC\59\2-19.doc emergency shut-off device. The plant can be read ily pre-mounted for connection to the shipboard power supply system. During the treatment pr ocess no liquid or solid waste appears.

3.3.3 The Group noted that the ultrasonic tube oscilla tors need to be exchanged at the earliest after approximately 16,000 to 20,000 operating hours, the low-pressure UV mercury lamps after about 12,000 operating hours. All other system co mponents do not need any extra maintenance and will be integrated into the routinely a pplied shipboard plant maintenance schedule.

3.3.4 In view of the above cons iderations, the Group was sati sfied that the Applicant had reviewed relevant safety measur es concerning location and handli ng of the plant and training of crew. In connection with a risk assessment, these measures are considered to be adequate to avoid uncontrolled or emergency situations and to operate the ballast water treatment plant in a safe manner, while performing th e necessary tasks to generate the data needed to apply for Final Approval in the future.

3.4 Chemical processes involved (provided by the Applicant)

3.4.1 The Group recognized that the AquaTriC omb BWMS produces photons emitted by the low-pressure UV (LPUV) system, and cavitation generated by the low-fr equency ultra-sound (LFUS) system. The photons and ca vitation effects are entirely res ponsible for the inactivation of harmful aquatic micro-organisms and pathogens pr esent in ballast water. Half lives of the photons in water are expected to be in the or der of micro- to milli-seconds. The photons and

cavitation are not resident in the water and c onsequently cause no harm upon release of treated ballast water. For the pur pose of this review, the Group regarded the photons

as Active Substance.

3.4.2 For the system, the Group noted that ballast water discharge is the treated ballast water that has passed the LPUV system and LFUS system twice each, during ballasting and deballasting, respectively.

3.4.3 The Group recognized that the BWMS does not intentionally add any preparation or

chemicals.

3.4.4 The Group noted that according to the Applicant, the BWMS can produce a

Relevant Chemical. The LPUV and LFUS can be ab sorbed by certain molecules, such as nitrate and dissolved organic matter (DOM) in the seawater and cause photo-chemical and/or sono-chemical reactions to produce reactive oxygen species such as hydroxyl radical (OH•). Therefore hydroxyl radical (OH•) is defined by the Applicant as a Relevant Chemical. However, the Group accepted that the amount of OH• potentially produced in the system is extremely small. The OH• radical reacts with any or ganic compound and exists for about 10 -9 seconds.

3.4.5 It was recognized by the Group that the photons might react with naturally occurring organic molecules in seawater to form disinfec tion by-products (with safety and environmental concerns). The Group referred to thes e by-products as Other Chemicals.

3.4.6 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.GESAMP-BWWG 9/6

ANNEX 6 Page 13

I:\MEPC\59\2-19.doc 3.5 Active Substance (AS), Relevant Chem icals (RC) and Other Chemicals (OC)

3.5.1 Active Substance

3.5.1.1 In this LPUV- and LFUS-based system, the Group accepted that photons are the only Active Substance available to kill and in activate micro-organisms. Accordingly, as the photons and cavitation effects are only available upon turn ing on the system controls, there must be no residual photons or cavitation in both the ballast water and ballast water discharge. Half-lives of the photons are expected to be in the order of micro- to milliseconds.

3.5.1.2 Therefore the Group accepted that the photons and cavitation effects have no chance of being exposed to aquatic plants, invertebrates, fish, and other biota, including sensitive and representative micro-organisms. Th erefore, all tests for effects on su ch biota, are “not applicable”

due to the non-residual characteristic s of the photon and cavitation effects.

3.5.1.3 Likewise, since the photons and cavitation effects are generated in the BWMS, they are never exposing mammals therefore there is no need to provide any data with regards to mammalian toxicity.

3.5.2 Relevant Chemical

3.5.2.1 The Group noted that the hydroxyl radi cal (OH•) is defined by the Applicant as a Relevant Chemical in this BWMS. The Group concurred with the App licant that the extreme reactivity and high oxidizing potential of the hydr oxyl radical (OH•) is indicated by its short half-life, typically na noseconds. Under these circumstan ces where the hydroxyl radical (OH•) can react non-selectively with organic compounds to give possible reaction products, the Group proposed that it was neither necessary nor practic al to provide the phys ical characteristics or toxicological profiles of the hydroxyl radical.

3.5.3 Other Chemicals

3.5.3.1 It was recognized by the Group that the LP UV- and LFUS-based system may react with naturally occurring organic molecules in ballas t water to form by-products with safety and environmental concerns. It was agreed by the Group that it was neither necessary nor practical to individually provide their physical characteristics or toxicological profiles. The Group referred to these by-products as Other Chemicals.

3.5.3.2 It was noted by the Group that the Appli cant had identified certain possible resultant byproducts of the treatment system and had analyzed the ballast water for these other chemicals, as part of the application for Basic Approval. To ev aluate the impact of ballast water treatment on the production of other chemicals, water samples we re analysed chemically before and after the treatment process. All THM, halohydrocarbons , HAA, bromophenols, ac etonitriles, AOX, EOX and TRO (in all 32 substances or substance groups ) were measured before and after treatment, the complete list being shown in Table 1 below.GESAMP-BWWG 9/6

ANNEX 6 Page 14

I:\MEPC\59\2-19.doc Table 1: Possible Other Chemicals, including Levels of Quantification and standardized methods, analysed by three certified labo ratories (as provided by Applicant)

Parameter Level of Quantification (LOQ) Methods Used

Nitrite (NO 2 - ) 0.007 mg/L DIN EN 26 777 1993-04

AOX 0.02 mg/L DIN EN 1485: 1996-11

EOX 0.002 mg/L DIN 38141-S17 1989-11

THM:

Chloroform

Bromoform

Dibromochloromethane

Dichlorobromomethane 0.02 μg/L EN ISO 10301 1997-04

Halohydrocarbon:

1,2- dibromoethane

1,2,3-trichloropropane

2-chlorotoluene

4-chlorotoluene

1,2-dibromo-3-chloropropane

1,2,3-tribromobenzene

1,1,1-Trichlorethane

Carbon tetrachloride

Tetrachlorethene 0.02 μg/L EN ISO 10301 1997-04

HAA:

Monochloracetic acid

Dichloroacetic acid

Trichloroacetic acid

Monobromoacetic acid

Dibromoacetic acid

Tribromoacetic acid

Bromochloroacetic acid

Dibromochloroacetic acid

Bromodichloroacetic acid 1.0 μg/L DIN 38407 F25

Bromophenols:

2,4-Dibromophenol

2,6-Dibromophenol 0.01 μg/L GC-MS after derivatization and

extractionGESAMP-BWWG 9/6

ANNEX 6 Page 15

I:\MEPC\59\2-19.doc Parameter Level of Quantification (LOQ) Methods Used

2,4,6-Tribromophenol 0.04 μg/L GC-MS after derivatization and

extraction

Acetonitriles:

Monobromoacetonitrile

Dibromoacetonitrile

Bromchloroacetonitrile 1.0 μg/L US EPA Method 551.1

TRO: Cl 2 , H 2 O 2, O 3, BrO All substances: 0.05 mg/L EN ISO 7393-1 2000-04 (G4-2)

3.5.3.3 The Group recognized that analysis of tr eated ballast water was carried out by the Applicant using three different salinities (see Ta ble 2 below) and with two to three duplicate samples in several runs (two to four), both befo re and after treatment of the ballast water.

Table 2: Range of salinities during analytic al investigation of Other Chemicals (with temperature ranges from 16.1 to 17.8°C)

Test medium Salinity (PSU)

Freshwater 0

Brackish Water 18.9 – 19.5

Saltwater 31.6 – 33.1

3.5.3.4 The Group noted the following informati on on Levels of Quantification provided by the Applicant. According to the report of GESAMP-BWWG 7 in annex 5 (MEPC 58/2/8) Levels of Quantification (LOQ) for THM and HAA for surface waters are recommended as 0.01-0.05 μg/L. The laboratories involved in the analysis were able to reach LOQ for THM, halohydrocarbons and bromophenols of 0.02 μg/L, which meets th e recommended range. In the case of the HAA, experts of the laboratories sp ent considerable effort to find methods or laboratories, which are able to meet the recomm ended LOQ. The effort to find a solution also included the attempt, to establish and optimize a standardized analytical method regarding this special demand. As the best result, a laboratory was able to reach a LOQ for HAA of 1 μg/L. The Group recognized the work performed by the Applicant and accepted the analytical data provided for Basic Approval.

3.5.3.5 The Group noted the results of analysis repo rted by the Applicant, as follows – all TRO, HAA, THM, halohydrocarbons, acetonitriles and brom ophenols measured in samples before and

after treatment were below their re spective Levels of Quantification.

3.5.3.6 In the case of nitrite ions , the Group noted that analytical values are above the LOQ both

for measurements before and after the ballast wa ter treatment process. Nitrite concentrations especially for brackish and salt wa ter are above the LOQ and show a high variability in samples,

both before and after the ballast water treatment. The Applicant performed a detailed statistical investigation (Mann-Whitney U Test) of nitrite c oncentrations before and after treatment, whichGESAMP-BWWG 9/6

ANNEX 6 Page 16

I:\MEPC\59\2-19.doc were statistically proven to be not significantly different, so the Group accepted that this means

the nitrite ion is not generated by the treatment process. In addition, the Group noted that all nitrite values before and after treatment are within the German, EU, EPA and WHO drinking water regulations.

3.5.3.7 In the case of chloroform , the Group noted that some results for samples before and after treatment were at or slightly above the LOQ (0.02 μg/L), but these values simply indicate that chloroform background concentrations within th e test water in the Bremerhaven harbour are around 0.02 μg/L. From these results the Group c oncluded that the treatment process did not cause higher levels of chloroform.

3.5.3.8 In the case of AOX, the Group noted that this parameter could be measured in some samples at very low concentrations around the LOQ (0.02 mg/L) in samp les before and after treatment, and here again the Group accepted that the same conclusion can be applied as above

for chloroform.

3.6 Conclusions

3.6.1 Based on these results, the Group concurred wi th the views of the Applicant that it was not necessary to provide toxicological and ecoto xicological data on these individual by-products (other chemicals) and that the information pr ovided should suffice to provide a recommendation regarding Basic Appr oval of the BWMS.

3.6.2 The Group agreed that it was not necessary to evaluate the properties of any Active Substance or Relevant Chemical associated with this system.

3.6.3 The Group agreed with the Applicant that potential increases in concentration of all

measured other chemicals in different salinities during ballast water treatment by the AquaTriComb BWMS are shown by water analysis to be below their Levels of Quantification.

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 ir radiation and ultrasonic oscill ation resulting from operating this LPUV- and LFUS-based system, were sufficiently addressed by the Applicant by engineering control measures put in place and tr aining of operators. The Group considered that normal operation and maintenance procedures of the BWMS do not pose any risks to human health. The Group accepted that in the case of an emergency on board ship, it is assumed that the power supply to the BWMS is cut-off anyway, re sulting in cessation of UV-radiation and/or US-oscillation, and associated processes. Theref ore the Group concluded 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 (other chemicals) measured by the Applicant in the discharged ballast water were under their respective LOQ values. The Group considered that thes e chemicals are short-lived and would not pose a toxicological concern towards the general public swimming and eating fish from the area.GESAMP-BWWG 9/6

ANNEX 6 Page 17

I:\MEPC\59\2-19.doc 5 RISKS TO SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC

5.1 Risk to safety of ship

5.1.1 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 on board ship.

5.1.2 The Group noted the Applicant stated that all the intern al components of the AquaTriComb BWMS are designed and cons tructed to match the effects of acoustic cavitation, where appropriate.

5.1.3 The Group noted the Applicant stated that the AquaTriComb BWMS is characterized by the absence of any preparations or aggressive additives or generated substances. Therefore, the Group recognized that the risk of additional corrosion effect was so low that no corrosion supporting, or corrosion stimulating effect s are necessary to this technology.

5.2 Risk to safety of crew

5.2.1 The Group noted that the submission identifie d the only potential risk to the crew present in the BWMS was related to UV irradiation, ultrasonic oscillation and overheating in the treatment unit from the UV lamps. The submission confirmed that these identified risks had been addressed by system safety measures that ensu re that there is no risk of personnel exposure

to UV irradiation and ultrasonic oscillation, and that automatic shut down occurs, in a no-flow situation, in order to prevent overheating.

5.2.2 The Group accepted the following information provided by the Applicant on low frequency ultrasonic oscillation, as providing sufficient reassurance of safety on this issue. By the application of US-oscilla tion at a low frequency for a very limited time period of less than one (1) second only, the size of the cavitation bubbles is as small as possibl e, and the effect of hydroxyl radical generating physical sonolumin escence is reduced to the most practicable minimum. In addition, the effects of acoustic cavitation, which are generated by the ultrasonic oscillation, are restricted to the interior of the filtration and UV reactor modules, respectively.

5.3 Risk to safety of general public

5.3.1 The Group noted that all the disinfection by-products (other chemicals) measured by the Applicant in the discharged ballast wate r were under their respective LOQ values. The Group considered that these chemicals are short-lived and would notpose a toxicological concern towards the general public swimmi ng and eating fish from the area.

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 w ithin 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 theref ore considered not applicable.GESAMP-BWWG 9/6

ANNEX 6 Page 18

I:\MEPC\59\2-19.doc 6.2 Derivation of the Predicted No Effect Concentration (PNEC)

6.2.1 The Group noted that the submitted dossier di d not contain any results of ecotoxicity testing of treated ballast water. In accord ance with the requirements of Procedure (G9), the Group recommended that acute and chronic a quatic ecotoxicity testi ng of treated ballast water should be performed by the Applicant, if the BWMS is to be reviewed for Final Approval

in the future.

6.2.2 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.

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, 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 derived. The Group agreed that it was not necessary to do so in the present assessment.

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 the information provided is sufficient to make a recommendati on regarding Basic Appr oval of the BWMS.

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 ir radiation and ultrasonic oscill ation resulting from operating this system were sufficiently addressed by the A pplicant by engineering c ontrol measures put in place and training of ope rators. Therefore the Group concluded 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 th e disinfection by-products measured in the discharged ballast water were under their respective LOQ values . The Group considered that these chemicals are short-lived and would not pos e a toxicological concer n towards the general public swimming and eating fish from the area.

7.3 Risks to the environment

7.3.1 The Group agreed that the system would not pose a risk to the environment if operated under the description in the dossier received.

7.3.2 Based on the points expressed above, the Gr oup agreed that the information provided

should suffice to make a recommendation regarding Basic Approval of the BWMS.GESAMP-BWWG 9/6

ANNEX 6 Page 19

I:\MEPC\59\2-19.doc 7.3.3 In accordance with the requirements of Pr ocedure (G9), the Group recommended that acute and chronic aquatic ecotoxicity testing of treated ballast water should be performed by the Applicant, if the BWMS is to be re viewed for Final Approval in the future.

7.4 Recommendations

7.4.1 Having considered all of the data submitte d for Basic Approval, and the information supplied by the Applicant in response to questions posed by the Group during this GESAMP-BWWG meeting, the Group agreed to recommend that Basic Approval be given to this system.

7.4.2 The Group considered that the following point s should be addressed by the Applicant if the system is to be evaluated for Final Approval in the future:

.1 Currently the Applicant a pplies low-frequency ultrasound cleaning mechanism of both the UV tubes and filters. If the Applicant considers it necessary to change this mechanism, then the Group recommended submission of quantified data.

.2 The Group recommended that an applica tion for Final Approval of this system includes confirmation by testing, that the effluent from the filter backflush during application of treatment at ballast wate r discharge, is effectively treated by UV radiation, as indicated by the Applicant in their replies to additional questions posed by the Group during this evaluation.

.3 The Group noted that the submitted dossi er did not contain any results of ecotoxicity testing of treated ballast water. In accordance with the requirements of Procedure (G9), the Group recomme nded that acute and chronic aquatic ecotoxicity testing of treated ballast wa ter should be performe d by the Applicant,

if the BWMS is to be reviewed for Final Approval in the future. The Group recalled that this requirement of ecotoxicity testing is part of Basic Approval, so that the Applicant can make use of ballast water from the laboratory-scale BWMS. The Group considered that the possi bility for an Applicant to provide chemical analysis and/or acute toxici ty testing, in lieu of whole effluent ecotoxicity testing for Final Approval shoul d not be permitted in this particular case as ecotoxicity testing was not supp lied for the Basic Approval evaluation, and this is a necessary step to provide certainty of environmental acceptability.

* * *GESAMP-BWWG 9/6

ANNEX 6 Page 20

I:\MEPC\59\2-19.doc Appendix

PROPERTIES OF TREATED BALLAST WATER

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group recognized that it was both unneces sary and irrelevant to report the physical properties of treated ballast water.

2 MAMMALIAN TOXICITY

2.1 The Group noted that the Applicant had indi cated that, as there were no measurable chemical by-products, there was no need to provide any data with regards to mammalian toxicity. The Group agrees with this view.

3 ENVIRONMENTAL EFFECTS

3.1 Ecotoxicological testing of treated ballast water

3.1.1 In accordance with the requirements of Pro cedure (G9), the Group recommends that acute and chronic aquatic ecotoxicity testing of treated ballast water should be performed by the Applicant, if the BWMS is to be re viewed for Final Approval in the future.

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 but the Applican t 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

3.3.1 The Group noted that the Applic ant had indicated that, based on the chemical analysis of the treated ballast water, there would not be any sedime nt toxicity associated with the treated ballast water. The Group agrees with this view.

3.4 Bioavailability/Biomagnification/Bioconcentration

3.4.1 The Group noted that the Applic ant had indicated that, based on the chemical analysis of the treated ballast water, there was no indicati on of any chemical by-products that might be bioaccumulative. The Group agrees with this view.GESAMP-BWWG 9/6

ANNEX 6 Page 21

I:\MEPC\59\2-19.doc 3.5 Food Web/Population Effects

3.5.1 The Group noted that the Applicant had indica ted that, taking into account the results of chemical analysis of 100% treated ballast water, it would be unlikely for the diluted ballast water to have any significant negative effects on ecol ogical communities at environmentally relevant concentrations. The Group agrees with this view.

3.6 Environmental Fate and Behaviour

3.6.1 The Group recognized that there is no chemi cal Active Substance or any assessable relevant chemical produced by the system a nd so there was no need to consider their environmental fate any further.

_______________