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\58\2-8.doc

INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION COMMITTEE 58th session Agenda item 2 MEPC 58/2/8 28 July 2008 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

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

Note by the Secretariat

SUMMARY

Executive summary: This document contains the repo rt of the seventh meeting of the GESAMP-Ballast Water Working Group (GESAMP-BWWG) and includes the evaluation of proposals submitted for approval by Norway, Germany and the Republic of Korea

Strategic direction: 7.1 High-level action: 7.1.2 Planned output: 7.1.2.4

Action to be taken: Paragraph 4

Related document: GESAMP-BWWG 7/9 (attached)

Introduction

1 The seventh meeting of the GESAMP-Ba llast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters from 30 June to 4 July 2008 and its report regarding approval of ballast water management systems that make use of Active Substances to treat ballast water prior to discharge into the marine environment is at tached to this document as GESAMP-BWWG 7/9.

2 The main purpose of this meeting was to revi ew the remaining three proposals, which had been submitted before the deadline establis hed for MEPC 58 (i.e. 21 March 2008) and which could not be reviewed during the regular meet ing of the Group held from 19 to 23 May 2008. The reviews of the proposals evaluated by the Group are shown in annexes 4 to 6 of the attached report.

3 The Group noted that the quality of the info rmation submitted by the applicants has, in general, improved, however, effective communicat ion with the applicants during the meeting week was time consuming and not always possible. The Group reiterated th e need to provide the full data set, in accordance with the existing Me thodology, at the time of the submission of the application dossier.MEPC 58/2/8 - 2 -

I:\MEPC\58\2-8.doc Action requested of the Committee

4 The Committee is invited to:

.1 agree that Final Approval should be granted to the OceanSaver® Ballast Water Management System (OS BWMS) submitted by Norway in document MEPC 58/2/1 (see annex 4);

.2 agree that Basic Approval should be granted to the Ecochlor® Ballast Water Treatment System submitted by Germ any in document MEPC 58/2/2 (see annex 5);

.3 agree that Final Approval s hould not be granted to the NK-O3 BlueBallast System submitted by the Republic of Korea in document MEPC 58/2/3 (see annex 6); and

.4 approve the report in general.

***I:\MEPC\58\2-8.doc GESAMP-BWWG 7th meeting Agenda item 9 GESAMP-BWWG 7/9 4 July 2008 Original: ENGLISH

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

Table of Contents

Section Page Number

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

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

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

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

5 CONSIDERATION OF QUERIES RE GARDING THE WORK OF THE GESAMP-BWWG ...................................................................................... 5

6 ANY OTHER BUSINESS .......................................................................... 7

7 CONSIDERATION AND ADOPTION OF THE REPORT ...................... 7GESAMP-BWWG 7/9 - 2 -

I:\MEPC\58\2-8.doc ANNEXES

Annex 1 List of members who attended the se venth session of the GESAMP-BWWG

Annex 2 Agenda for the seventh session of the GESAMP-BWWG

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

Annex 4 Review of proposals for approval of Ba llast Water Management Systems that make use of Active Substances – O ceanSaver® Ballast Water Management System, submitted for Final Approval by Norway

Annex 5 Review of proposals for approval of Ba llast Water Management Systems that make use of Active Substances – Ecochlor® Ballast Water Treatment System, submitted for Basic Approval by Germany

Annex 6 Review of proposals for approval of Ba llast Water Management Systems that make use of Active Substances – NK-03 Blue Ballast Water Treatment System, submitted for Final Approval by the Republic of Korea- 3 - GESAMP-BWWG 7/9

I:\MEPC\58\2-8.doc 1 INTRODUCTION

1.1 The seventh GESAMP-Ballast Water Wo rking Group (GESAMP-BWWG) meeting was held at IMO Headquarters, London, from 30 June to 4 July 2008, under the chairmanship of Mr. Finn Pedersen. This extraordinary meeti ng was held in addition to the sixth regular meeting in May 2008. The list of pa rticipants is shown in annex 1 and the agenda, as adopted by the Group, is set out in annex 2.

1.2 The meeting was opened by Mr. Dandu Pughiuc , Head, Marine Bios afety Section, who 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 58 in an attempt to review the remaining proposals wh ich had been submitted before the deadline established for MEPC 58 (i.e. 21 March 2008). Mr. Pughiuc informed the Group that, based on their kind agreement to have this additional meeting, arrange ments had been made and the necessary approval requested from the Secretary- General of the Organization for processing the report as a matter of urgency with the necessary relaxation of the deadline for submission of documents to MEPC 58.

1.3 Mr. Pughiuc noted with appreciation the return of Mr. Finn Pedersen, who acted as Chairman for the first two meetings of th e GESAMP-BWWG, and wished all the members of the Group every success in this new endeavour. Particular a ppreciation was expressed for the effort made by Dr. Brigitte Behrends in prepar ing the remaining three pr oposals for evaluation by the Group and for liaising with the respective Memb er States in an attempt to provide all the necessary data required for the evaluations.

1.4 Mr. Pughiuc then reported on the contra ctual arrangements and informed the Group on the logistics of the meeting. He also informed the Group that, at the request of Mr. Egil Dragsund, arrangements had been made for him to be excused when the proposal for approval of the ‘OceanSaver ® Ballast Water Management System’ (Norway) is reviewed, due to his involvement in the development of this technology. Mr. Dragsund t ook no part in this evaluation and his contract was conseque ntly reduced to nine working days.

2 ISSUES OF CONFIDENTIALITY

2.1 One proposal for Basic Approval of a system that makes use of Active Substances had been submitted by Germany (MEPC 58/2/2) a nd proposals for Final Approval had been submitted by Norway (MEPC 58/2/1) and the Republic of Korea (MEPC 58/2/3). 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 GESAMP and MEPC.

2.3 Pursuant to paragraphs 4.2.2, 8.1.1 and 8.1.2.7 of the “Procedure for approval of ballast water management systems that make use of Activ e Substances (G9)”, all information gathered, materials, notes and reports obtained or ma de out during the work of the GESAMP-BWWG, were, and will be, treated as c onfidential. In this respect all the members of the Group and the Consultant signed the Statements of Acceptance related to confidentiality.GESAMP-BWWG 7/9 - 4 -

I:\MEPC\58\2-8.doc 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 her request , during the working hours. They were available for consultation by the members of the Gr oup for the duration of the meeting in the meeting room and returned to the Organizati on’s designated room afte r the working hours.

2.6 On completion of the work, the Chairman of the GESAMP-BWWG obtained from the other members all the documents, drafts and any other associated records and reports, which were transmitted to the Technica l Secretary of the GESAMP-BWWG for retention in confidence. All electronic records and data held on personal computers/laptops were destroyed when they were no longer necessary for the work of the GESAMP-BWWG.

3 TERMS OF REFERENCE AND TIME FRAME

3.1 The Group agreed to continue to be guided by the Terms of Reference approved by MEPC as contained in a nnex 3 of this report.

3.2 The Group used the table previously agr eed by the MEPC and reproduced 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, including 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

(1 week) Administrations confirm that no c onfidential data are contained in the report (3 weeks) Review and appr oval of the report by GESAMP (1 week) Produce the final report addressing the comments by GESAMP

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

3.3 The Group reconfirmed its agreement to tentatively schedule its 8th meeting from 16 to 20 February 2009 subject to the submission of the application dossiers in accordance with the deadline of 19 December 2 008 agreed during its 6th meeting.

3.4 Recognizing the possibility that more th an three proposals may be submitted for its review and approval by MEPC 59, the Group expre ssed its availability to have an additional meeting to accommodate all the proposals provided that all necessary conditions for organizing such a meeting are met.- 5 - GESAMP-BWWG 7/9

I:\MEPC\58\2-8.doc 4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES

4.1 General review of the submissions

4.1.1 The Group agreed to consider the submissions in chronological order and noted that the quality of the information submitted by applicants has generally improved. However, the Group noted that effective communication with the app licants during the meeti ng week was not always possible and reiterated the need to provide the full data set, in accordance with the existing Methodology, when submitting the application dossiers.

4.2 Detailed review of the submissions

4.2.1 A detailed review of the submissions can be seen in:

.1 Annex 4 Review of proposals for a pproval of Ballast Water Management Systems that make use of Active Substances – OceanSaver® Ballast Water Management System , submitted for Final Approval by Norway (document MEPC 58/2/1);

.2 Annex 5 Review of proposals for a pproval of Ballast Water Management Systems that make use of Active Substances – Ecochlor® Ballast Water Treatment System , submitted for Basic Approval by Germany (document MEPC 58/2/2); and

.3 Annex 6 Review of proposals for a pproval of Ballast Water Management Systems that make use of Active Substances – NK-03 Blue Ballast Water Treatment System, submitted for Final Approval by the Republic of Korea (document MEPC 58/2/3).

4.2.2 Having reviewed all of the information associated with the submissions, the Group recommended that:

.1 Final Approval to be granted to the OceanSaver® Ballast Water Management System (OS BWMS) , submitted by Norway in document MEPC 58/2/1;

.2 Basic Approval to be granted to the Ecochlor ® Ballast Water Treatment System

, submitted by Germany in document MEPC 58/2/2; and

.3 Final Approval not be granted to the NK-O3 BlueBallast System , submitted by the Republic of Korea in document MEPC 58/2/3.

5 CONSIDERATION OF QUERIES REGARDING THE WORK OF THE GESAMP-BWWG

5.1 Inquiry on the Final Approval procedures by Greenship Ltd.

5.1.1 The Group considered an inquiry received fr om the Greenship Ltd. (The Netherlands), which sought clarification on the timing and the characteristics of the tests required for the application for Final Approval with reference to annex 6 of the Report of the sixth meeting of the GESAMP-Ballast Water Working Group(MEPC 58/ 2/7). The questions of clarification and the Group’s response are reproduced hereunder:GESAMP-BWWG 7/9 - 6 -

I:\MEPC\58\2-8.doc 1. Period between treatment and analytical and toxicity test s: It should be done immediately after treatment and af ter 2 and/or 5 days according to document MEPC 57/WP.5, paragraph 40.6. According to the review of our application, FAC and relevant by-produc ts should be measured after 2 days’ storage (MEPC 58/2/7, annex 6, paragra ph 7.2.4 ). We understand the following:

1.1 Whole effluent toxicity tests (alg ae, shrimp, fish) immediately after treatment at discharge (2nd treatment) and after 2 days’ storage of this treated ballast water?

Answer: Y e s, with the unders tanding that it is not abs o lutely necessary to take a sample after 2 days; as for the Group, th e discharge at time 0 (zero) is the worst-case situation.

1.2 Chemical analysis (FAC, by-products) of treated ballast water immediately after treatment at intake, after 2 days of storage in the ballast water tanks (= immediately before the 2nd treatment at discharge), immediately after treatment at discharge and after 2 days of storage of the treated ballast water. This is the minimum. We will include a number of extra analyses of FAC to monitor decay of FAC in the tanks and after the 2nd treatment. Is this correct?

Answ e r : For b a ll a s t water m ana g e m e n t s y ste m s li k e Gr e e n s h i p t r e a ti n g b a ll a s t wat e r both at uptake and at discharge, the discharge situation represents the worst case and samples for chemical analys is should therefore mainly be taken from these.

.2 Combination of G8 test cycles and G9 tests: This is a new issue. Greenship has completed the 5-test cycles under G8 in May/June 2007 and has done G9 tests for Basic Approval separately in August 2007. There seems to be no need to repeat the 5-test cycles under G8. We propose a test programme according to G9 and combine this with efficacy testing according to G8. Is this correct?

Answer: Yes, the Group recommends the applicant to thoroughly read Procedure (G9) and, in particular, pa ragraph 5.2.1.2 before further testing is carried out.

.3 Number of measurements of FAC a nd by-product: Some applicants have performed FAC and by-product measurements in 5-test cycles according to G8; others have not. The GESAMP-BWWG is not consistent in its comments on this procedure. We propose a series of FAC and by-product measurements, according to the scheme mentioned in point 1. Basically, this means one test run with a series of observations over a prolonge d time period (approximat ely 4 days). Is this correct?

Answer: The Group recom m ends FAC measu r e m ents a f ter treat m ent and in 1 day intervals until no detectable levels are found to be carried out in all G8 tests. The content of organic matter will vary between each test and the degradation rates of FAC will therefore vary. Degradation rates for FAC in ballast water at discharge are – together with the PNEC – crucial fo r an environmental risk assessment of the discharged FAC. Simila rly, the quantities of disinf ection by-products will vary depending on variations in the organic c ontent of the treated ballast water. For- 7 - GESAMP-BWWG 7/9

I:\MEPC\58\2-8.doc these analyses, the Group recommends anal yses with satisfactorily detection levels to be carried out with samp les from at least two G8 tests.

.4 Greenship is at present not planning to perform tests in fresh water. The BWMS is designed for salt and brackish water systems (>3 PSU), which means, it can operate in 96% of all situations. Is testing in fresh water obligatory for Final Approval?

Answer: N o, the d i sti n ction b etween the d i fferent water t y pes is an efficacy item (Guidelines G8) and has nothing to do with Procedure G9.

6 ANY OTHER BUSINESS

6.1 The Group was informed by the two members assigned during its sixth meeting to liaise with the United States delegation on issues re lated to the Human Exposure Assessment (HEA) on the work carried out and agreed that most of the technical comments regarding this assessment contained in document BLG 12/5/8 (United States) are valid and could be incorporated in the Methodology. However, further discussion with the experts from the United States was still needed on a number of aspects ra ised in the above document. The Group reiterated its invitation to other interested Administrations to send thei r comments and suggestions on this issue to the IMO Secretariat with an understanding that they will be disseminated among the members of the Group at the earliest opportunity.

7 CONSIDERATION AND ADOPTION OF THE REPORT

7.1 A draft report of the seventh meeti ng of the GESAMP-BWWG was produced on 4 July 2008 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.

7.2 Mr. M. Palomares, Director, Marine Envi ronment Division, expr essed his appreciation for the hard work of the Group and congratul ated its members for the results achieved. The Chairman thanked the members of the Group for the long hours and substantial efforts made throughout the week and closed the meeting at 17:30 hrs.

***GESAMP-BWWG 7/9

I:\MEPC\58\2-8.doc ANNEX 1

LIST OF MEMBERS WHO ATTENDED THE SEVENTH SESSION OF THE GESAMP-BALLAST WA TER WORKING GROUP

Mr. Finn Pedersen (Chairman) Senior Scientific Officer ECHA P. O. Box 400 00121 Helsinki Finland E-mail: Tel: Finn.PEDERSEN@echa.europa.eu +358 9 6861 8447

Ms. Teresa Borges Senior Technical Officer Praça Pasteur No. 9 - 1 ◦ esq. 1000-238 Lisboa Portugal E-mail: Tel:

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

+351 9 1779 8048

Mr. Egil Dragsund Principal Marine Biologist Environmental and Te chnical Solutions Det Norske Veritas AS Veritasveien 1 NO- 1322 Høvik Norway E-mail: Tel: Fax:

Mobile: egil.dragsund@dnv.com +47 6757 8894 +47 6757 9911

+47 9702 6956

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 23

Mr. Jan Linders 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 4401GESAMP-BWWG 7/9 ANNEX 1 Page 2

I:\MEPC\58\2-8.doc 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. Brigitte Behrends Marine Environment Chemist Beluga Shipping GMBH P. O. Box 10 72 69 D-28072 Bremen Germany E-mail: Tel: Fax:

Mobile: Brigitte.Behrends@ beluga-group.com +49 (0) 421 160 60 – 5292 +49 (0) 421 160 60 – 42

0049 16-2244-3484

IMO SECRETARIAT

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. 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. Huang Tianbing Technical Officer, Mari ne 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 7/9

I:\MEPC\58\2-8.doc ANNEX 2

AGENDA FOR THE SEVENTH SESSION OF THE GESAMP-BALLAST WATER WORKING GROUP

1 Introduction

2 Issues of confidentiality

3 Terms of reference and time frame

4 Review of proposals for approval of BWMS that make use of Active Substances

5 Consideration of queries regard ing the work of the GESAMP-BWWG

6 Any other business

7 Consideration and adoption of the report

***GESAMP-BWWG 7/9

I:\MEPC\58\2-8.doc ANNEX 3

TERMS OF REFERENCE FOR THE TECHNICAL GROUP

1 Consideration of development of necessary methodologies and information requirements in accordance with G9 ∗ for consideration by MEPC 58.

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 the Group and report to the Organization. In particular, the Group should undertake:

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

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

.3 scientific evaluation of the risks to the ship and personnel to include consideration of the storag e, handling and application of the Active Substance (see paragraph 6.3 of G9);

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

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

.7 preparation of a Report addressing the above-mentioned aspects for consideration by MEPC (see paragraph 8.1.2.10 of 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 MEPC (see paragraph 8.2 of G9).

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

***

∗ “G9” stands for the “Procedure for approval of ballast water management systems that make use of Active Substances (G9)” adopted by resolution MEPC.126 (53).GESAMP-BWWG 7/9

I:\MEPC\58\2-8.doc ANNEX 4

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

OceanSaver® Ballast Water Management System

Submitted for Final Approval by Norway

0 SUMMARY

0.1 Having considered the submission pr ovided by Norway (MEPC 58/2/1) as well as information provided by the applicant, the Group recommends that MEPC grants Final Approval to the OceanSaver® Ballast Water Management System, subject to the Administration verifying that a number of recommendations be fully addressed prior to issuance of a Type Approval Certificate.

0.2 The Group noted that the proposed system treats the ballast water on uptake and discharge. During uptake the ballast water is filtered and then treated by cavitation, nitrogen super-saturation and electrolytic disinfection. During discharge the ballast water is treated by the filtration and cavitation phases only. Additionally, the hypoxic condi tions in the ballast water tanks are maintained by the use of pressure-vacuum valves in th e ballast tank air vent-heads.

0.3 The Group noted that the applicant calcula ted the concentrations of bromoform and dichloromethane in the air just above water su rface based in Henry’s law and compared with the Occupational Exposure Limit value establis hed by the Norwegian Administrative Norms for human exposure to these halogenated organic compounds. The Group noted that bromoform concentrations as representativ e of disinfection by-products are at levels similar to those observed in other ballast water management systems based on chlorine.

0.4 Notwithstanding the above, the Group recommends that due to the measured bromoform in the treated ballast water at concentrations up to 294 μg/L, well above the WHO Guidelines for Drinking Water Quality (<100 μ g/L), risk mitigation measures should be put in place possibly through aeration, to minimize huma n exposure to this halogenated organic compound which may represent a genotoxic/carc inogenic health risk.

0.5 The Group noted the maximum dosage of TRO m easured in the ballast water line of the system is 2.5 mg/L. The Group further noted that the decay of TRO levels has been investigated in natural sea water environm ent after treatment under simula ted ballast water conditions. Highest oxidant concentration measured af ter 5 days was 0.2 mg /L. The system has a TRO characteristic typically in the range of 0–0.3 mg/L at discha rge and is below 0.2 mg/L for more that 85% of all tests undertaken. The applicant claimed that, taking into account the short voyages (e.g. 24 hours), the maximum allowabl e discharge concentration is 0.5 mg /L.

0.6 The Group further noted that th e applicant in accordance with the confidential dossier has foreseen the need to neutralize the treated ballast water before discharge in case the content of Total Residual Oxidants (TRO) exceeds a proposed limit of 0.5 mg/L. Various possible neutralization chemicals are di scussed and the use of sodium thiosulfate pentahydrate is proposed.GESAMP-BWWG 7/9 ANNEX 4 Page 2

I:\MEPC\58\2-8.doc 0.7 The applicant has proposed a PNEC = 0.68 μ g/L for TRO for the aquatic environment based on results of aquatic toxic ity tests. The approach for deriving the PNEC as well as the value proposed is acceptable to the Group.

0.8 In evaluating the environmen tal risk assessment carried out by the applicant, the Group had reservations regarding the assumption of a considerable further degradation of TRO immediately after discharge as proposed by the applicant. The level of TRO is stabilized in the ballast water after treatment at a low concentration and it is unlikely that further degradation through biological pro cesses will take place during d ilution shortly af ter discharge. The Group noted, however, that some furthe r degradation through chemical processes (oxidative reaction) might be expected.

0.9 Using some of the existing risk assessmen t models, the Group noted that a dilution of 735 times at discharge of tr eated ballast water with a c oncentration of TRO = 0.5 mg/L proposed as limit value by the appli cant, is required to avoid eff ects in the aquatic environment. Furthermore, the Group noted that the propose d limit of 0.5 mg/L refers to the content of TRO accepted by the MEPC as a discharge limit for sewage. Furthermore, according to the Rotterdam scenario of the MAMPEC model, a dilution of only approximately 140 times can be assumed. This would correspond to a concentra tion in treated ballast water at discharge of approximately 0.1 mg/L if no degradation of TRO after discharge is taken into account. Considering that the MAMPEC model is recomm ended by MEPC 56 as an interim measure and that some degradation may take pl ace as a result of the chemical oxidative propertie s of TRO, an interim discharge limit value of 0.1-0.2 mg/L TRO is proposed.

0.10 Based on the above deliberations, the Group is of the opinion th at the concentration of TRO in the treated ballast water needs to be controlled and kept at a level not exceeding 0.1 0.2 mg/L.

0.11 In conclusion, having reviewed all the in formation provided by the applicant, the Group agreed to recommend to the MEPC that Final Approval be given to the OceanSaver® Ballast Water Management System, subject to the Admi nistration verifying that all the following recommendations have been fully addressed prior to issuance of a Type Approval Certificate:

.1 maximum allowable dosage of Active Substances at 2.5 mg/L as TRO should be monitored and recorded during uptake by TRO sensors adequately maintained;

.2 maximum allowable discharge concentrations of Active Substances at 0.1-0.2 mg/L as TRO should be ensu red, monitored and recorded during discharge by TRO sensors adequately maintained;

.3 a neutralization system should be fu rther developed and type approved by the Administration;

.4 the health toxicological properties for the handling and applic ation of the proposed neutralizing agent be assessed in orde r to ensure safety for crew; and

.5 the treated ballast water be aerated before discharge in order to reduce the concentration of bromoform.GESAMP-BWWG 7/9 ANNEX 4 Page 3

I:\MEPC\58\2-8.doc 1 INTRODUCTION

1.1 The proposed OceanSaver® Ballast Water Management System (BWMS) was given a Basic Approval by the MEPC 57 (MEPC57/2/10) based on a favourable opinion issued by the GESAMP Ballast Water Working Group at its 5 th meeting in January 2008 after reviewing the application submitted by Norway.

1.2 Following Basic Approval, Norway subm itted an application for Final Approval to MEPC (MEPC 58/2/1) and the applican t has submitted a full application dossier.

2 COMPLETENESS OF THE DOSSIER

2.1 The Group noted that the following documents have been included in the application dossier for Final Approval:

.1 Reports on land-based tes ting of the OceanSaver BWMS;

.2 Corrosion testing with cavitation a nd nitrogen treated ballast water;

.3 A Quality Assurance Plan;

.4 An environmental risk assessment including MAMPEC and Dispersion model;

.5 Safety data sheets and Human Exposure Assessment (HEA);

.6 Operation and maintenance instruct ions results and user manuals; and

.7 Technical information and draw ings of the system components.

2.2 The Group noted that for the data set requi red for Active Substances, Preparations or Relevant Chemicals, the applicant refers to the s ubmission for Basic Approval.

2.3 The Group further noted that all corrosion test s have been undertaken applying filtration, cavitation (C3T) and nitroge n super-saturation only.

2.4 In reviewing the application dossier subm itted, the Group had a number of clarifying questions which were directed to the applicant. The applicant provided a written response to the questions raised which was taken into acc ount in the finalization of the review.

3 DESCRIPTION OF OCEANSAVER ® BALLAST WATER MANAGEMENT SYSTEM

3.1 Overview of the system

3.1.1 The Group noted that the OceanSaver® Balla st Water Management System (OS BWMS) consists of the following treatment units: automatic back-flushing filter, cavitation, nitrogen super-saturation and electrolytic disinfection. The treatment se quence according to the Group’s understanding is illustrated in Figure 1 below and described in the following text.GESAMP-BWWG 7/9 ANNEX 4 Page 4

I:\MEPC\58\2-8.doc Figu r e 1: The OS BWMS: Main Components

3.1.2 The applicant informed that the following treatment sequence applies:

.1 On ballast uptake the water enters a mechanical filtration unit with automatic back flushing to remove particles and organisms, the back-flush effluent is discharged at the point of uptake.

.2 Following filtration, the ballast water is subjected to hydrodynamic cavitation in the C3T unit.

.3 Following cavitation, the ballast water is supersaturated by the injection of nitrogen to cause oxygen deficien cy in the ballast water.

.4 Additionally, the system also incorporat es an isolated electrodialytic process based on the principl es of an electrochemical activation technology, the C2E process. The C2E unit applies the principle of electrochemical activation to a side stream of the main flow, producing a disi nfectant which is retu rned to the main flow at a point following the cavitation and supersaturation phases. The C2E unit SEA Filtration Cavitation C3T

Electrolysis C2E N2-Supersaturation

BWtanks 

### Ballasting

Deballasting

BWtanksCavitation C3T 

### SEA Neutralization Filtration 

# OceanSaverGESAMP-BWWG 7/9 ANNEX 4 Page 5

I:\MEPC\58\2-8.doc does this by generating controlle d amounts of Active Substances in

- situ without adding any Preparations to the water. The a pplicant states that the efficacy of the disinfectant is enhanced by cavitation since the cavit ation causes fragmentation and separation of bacterial colonies. To meet a various range of flow rates, the C2E unit is modularly composed and c onsists of a number of identical cells powered by a number of identical rectifiers.

.5 The ballast water tanks are equippe d with conventional tank ventilation arrangements that include pressure-vac uum devices to evacuate the released oxygen and surplus nitrogen, and to help ma intain nitrogen levels and to prevent air entering the tanks.

.6 During ballast water discharge, the ballast water is treated with the automatic back-flushing filter and the cavitation unit (C3T) again.

3.1.3 The C2E unit cells are mainta ined by flushing with AWACLE AN, a 7% solution of acetic acid. Flushing takes places after ballasting or after approximately 10-12 hours of use. The applicant states that the C2E flushing system is a relatively simple device. The system consists of a 100 L tank in addition to valves and a small pum p. The flushing system is integrated in the OS BWMS and controlled by the OS auto mation with its own start/stop sequences.

3.1.4 The Group noted that the in troduction of the OS BWMS may have impacts that may introduce requirements to other on board ship systems as follows:

.1 Pressure losses due to the treatment uses may require an additional boosting pump and increased pressures may adversely a ffect piping arrangements that may be specified to a lower design pressure specification.

.2 The OS BWMS has an integral automation, calibration and data monitoring, storage and reporting system. This administ rates and controls overall performance between all components/processes within the system and records all measured data in accordance with the requirements as specified in Guidelines for approval of ballast water management systems (G8).

.3 Comprehensive corrosion and coating impact studies including literature assessments, small scale and laboratory studies as well as full scale studies have been conducted. The main objectives of th ese studies have been to verify that the OS BWMS does not accelerate corrosion nor the ageing of corrosion protection systems (coatings) and also th at the system is compliant with the intentions of Performance standard for pr otective coatings for dedicated seawater ballast tanks in all types of ships and double-side skin spaces of bulk carriers adopted by resolution MSC.215(82). It may be noted that the full scale studies included all treatment stages with the exception of the addition of the disinfectants produced by the C2E unit (filtration, cavitation and s uper-saturation). An additional theoretical study has since been undertaken including this treatment stage.GESAMP-BWWG 7/9 ANNEX 4 Page 6

I:\MEPC\58\2-8.doc 3.1.5 The Group noted that the OS BWMS ha s some operational implications.

.1 The performance of the electrolytic di sinfection is limited to a salinity >0.7% (7 g/L). In cases where the ballast water has a lower salinity, feed water will be automatically supplied from the aft-peak tank(s) that will be filled with seawater to ensure that the saline level in the feed water to the unit remains within prescribed levels.

.2 The electrochemical activation tec hnology applied within the C2E unit will generate a limited quantity of hydrogen (H 2 ). For this reason a safe gas evacuation system has been specified and developed to maintain the hydrogen concentration <1%. The system rests upon the principles of collection at source, dilution by air to safe concentration levels and evacuation to open air.

3.1.6 The Group noted that the non-confidential in formation stated that no neutralization substances are added to the system. However, the confidential application dossier informs that a neutralizing procedure is availabl e as an option; adding a neutrali zation agent (sodium thiosulfate pentahydrate) at discharge when monitored TRO le vels exceed 0.5 mg/L in the discharged ballast water. The precise description of this component was not included in either the confidential application or in subsequent supplementary information provided. The Group cannot evaluate how the TRO concentration in the ballast wate r discharge is to be monitored and how the neutralization chemical mixing rates are to be controlled under high volume discharge (such as >1,000 m 3 /h). After further communication with th e applicant, the Group concluded that this component of the system has not yet been fully developed. Also, the applicant claimed that this mitigation system is used only for rare ex treme conditions. The Group has the opinion that in case of emergency where ballast water may need to be discharged not having sufficient exposure time for TRO degradation, the reliability of this ne utralizing component is key to ensure that a maximum allowed discharge concentration of TRO is not exceeded.

3.1.7 The Group also noted that the system incorpor ated a salinity sensor to control the power to the electrolytical ce ll and a monitoring of the TRO concentration to maintain the required level of TRO (spectrophotometric measurement with DPD reagent) and a salinity sensor to maintain the required level of TRO, which is dependant on salinity, but also to avoid discharge of excess TRO.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 The Group noted that the C2E unit of th e OS BWMS creates Active Substances and relevant by-products. Active Substances are produ ced in the anode chamber (anolyte) and to some extent in the cathode chamber (catholyte) of th e C2E unit. The Active Substances formed are primarily hypochlorous acid (HClO), chlorine gas (Cl 2 ), ozone (O 3 ), hydrogen peroxide (H 2 O 2 ), chlorine dioxide (ClO 2 ) and hypoch lorite (ClO - ). In seawater, these oxidan ts react with bromide (Br - ) and generate hypobromous acid and hypobromite ion. The resulting mixture of oxidants (mainly hypochlorous acid, hypochlorite ions , hypobromous acid and hypobromite ion) are named Free Residual Oxidant (FRO) in the literat ure while Total Residual Oxidant (TRO) also includes the halogenamines and other less effect ive oxidants with N-C li nk. The applicant stated that the maximum dosage of TRO in the OS BW MS measured in the ballast water line is 2.5 mg Cl/L.GESAMP-BWWG 7/9 ANNEX 4 Page 7

I:\MEPC\58\2-8.doc 3.3 Active Substances

3.3.1 The Active Substances identified during Basic Approval are list ed in the following two tables:

Treated water High salinity 34 PSU Brackish water 17 PSU Surface water 20 PSU Total chlorine (Cl 2 ) mg/L 1010 870 970 Free chlorine (Cl 2 ) mg/L 980 800 930 Combined chlorine (Cl 2 ) mg/L 30 70 40 Ozone (O 3 ) mg/L 13.7 5.4 10.9 Hydrogen peroxide (H 2 O 2 ) mg/L 2.7 2.1 3.6

Component Chemical Name CAS Number UN Number Molecular Weight (g/mol) Empirical formula Structural formula

Hypochlorous acid 7790-92-3 n/a 52.460 HOCl

Hydrogen peroxide 7722-84-1 2015 34.015 H 2 O 2

Ozone 10028-15-6 47.998 O 3

Chlorine dioxide 10049-04-4 9191 69.5 ClO 2

3.3.2 In addition, also hypobromous acid (HOBr) and hypobromite ion (OBr - ) are considered Active Substances being part of the TRO as described above in section 3.2.1.GESAMP-BWWG 7/9 ANNEX 4 Page 8

I:\MEPC\58\2-8.doc 3.4 Relevant Chemicals

Component Chemical Name CAS Number UN Number Molecular Weight (g/mol) Empirical formula Structural formula

Bromoform 75-25-2 2515 252.731 CHBr 3

Dibromochloromethane 124-48-1 2810 208.290 CHBr 2 Cl

Dichlorobromomethane 75-27-4 8027 163.83 CHBrCl 2

2,4,6 – tribromophenol 118-79-6 2811 330.82 C 6 H 3 Br 3 O

Dibromoacetonitrile 3252-43-5 2810 198.86 C 2 HBr 2 N

Monobromoacetic acid 79-08-3 1938 138.94802 C 2 H 3 BrO 2

3.5 Other chemicals

Component Chemical Name CAS Number UN Number Molecular Weight (g/mol) Empirical formula Structural formula

Nitrogen gas 7727-37-9 1066 28.013 N 2

Sodium thiosulfate pentahydrate 10102-17- 7 248.18 Na 2 S 2 O 3 5H 2 O

4 HUMAN HEALTH ASSESSMENT

4.1 The Group noted that the human health risk assessment of the OS BWMS is based on the work processes under normal operation as well as under accident situations in which exposure to humans may occur. Further, the assessment cove rs the crew on board the ship, and the general public. The applicant addresses nitrogen e xposure, exposure to Active Substances (hypochlorous acid (HClO), ozone (O 3 ), hydrogen peroxide (H 2 O 2 ), chlorine dioxide (ClO 2 ) and hypochlorite (ClO - ) and Relevant Chemicals (TRO and DBP) used in the electrolytic treatment process (C2E), and exposure to the haloge nated by-products in treated ballast water (VOX, AOX). The applicant asse ssed the frequency and duration of exposure to halogenatedGESAMP-BWWG 7/9 ANNEX 4 Page 9

I:\MEPC\58\2-8.doc by-products and made the characterization of th e risk for human health in comparison to the WHO guideline values for dr inking water quality (WHO, 2003).

4.2 The Group noted that bromoform was detected at concentrations up to 294 μg/L which is well above the WHO Guidelines for Drinking Water Quality (<100 μ g/L). If mitigation measures are not put in place namely through aeration, human exposure to this halogenated organic compound may represent a genotoxic/carcinogenic health risk under long-term scenario.

4.3 The Group recommends that in case sodium thiosulphate is to be used in the neutralization process a nd stored onboard ship as undiluted chemical, its human toxicological hazards, namely, the irritative properties towards th e respiratory tract will have to be taken into consideration in the HES and a comp lete MSDS ought to be developed.

4.4 The Group noted that the OS BWMS can either be operated by deck officers or engineers and that exposure of humans to anolyte (AWAC) , catholyte (AWAL) or nitrogen can occur as a result of pipe leakage. Possible nitrogen leakag e and indirect oxygen deplet ion will be detected by oxygen sensors, which are installed in all rooms affected by piping connecting the N 2 generator to the ballast water pipeline as well as in the area where the N 2 generator is located. If the sensors detect a leakage of N 2 , the system automation will record an alarm and the system will enter shutdown mode. Any individual O 2 sensors will activate system shutdown should the O 2 level fall below 19%.

4.5 The Group was informed that during ballasting, the air in the empty balla st tanks will gradually be vented out of the tanks as the air is replaced by the rising water and residual N 2 . The air can contain halogenated compounds found in the ballast wa ter that could imply a health risk if inhaled. The tank air is released through vent-heads usually located on the deck edge, alo ng the deck hatch frame or, less commonly, on th e side of the ship (for instance on car carriers and RO/RO ships). Crew on deck can be exposed to the vented tank air. The ma ximum duration of the exposure equals the duration of the ballasting, which is 10-12 hours for large sh ips. The assessment is done by comparing the WHO dri nking water guidelines with measured concen trations in treated ballast water. The compounds in question are br omodichloromethane, bromoform, chlorodibromomethane, dichloromethane and vinyl chloride. The table below gives WHO guidelines and concentrations in treated ballast water (maximum and mean concentrations) for each of the compounds in question.

BromodichloroMethane Bromoform Chlorodibromomethane Methylene bromide Dibromomethane Dichloromethane Vinyl Chloride

CAS NR 75-27-4 75-25-2 124-48-1 74-95-3 75-09-2 75-01-4 WHO Guideline Value (mg/L) 0.06 0.1 0.1 0.02 0.0003

Highest measured concentration in Ballast water (mg/L) 0.0009 0.3 0.02 0.0004 0.9 0.0003

Mean value of measured concentration in ballast water (mg/L) 0.00004 0.2 0.01 0.0002 0.1 0.0002GESAMP-BWWG 7/9 ANNEX 4 Page 10

I:\MEPC\58\2-8.doc 4.6 The Group noted that bromoform and dich loromethane were found in concentrations higher than the WHO guideline. The applicant calculated the concentration of bromoform and dichloromethane in the air just above the wate r surface using Henry’s law and compared these calculated values with the Norwegian administrative norm for 8 hours work (Occupational Exposure Limit). The concentra tion of bromoform in the air was calculated to 0.004 mg/m 3 and the administrative norm is 5 mg/m 3 . The concentration of dichloromethane was calculated to 0.056 mg/m 3 and the administrative norm is 50 mg/m 3 . Thus, the calculated concentration values in the vented air for these two com pounds are much lower than the Norwegian administrative norms, in what occupati onal exposure threshold values are concerned.

4.7 The Group noted that swimmers could be e xposed to treated ballast water via skin contact, inhalation (of vapours) and swallowing of seawater. Tw o compounds in treated ballast water have been found in concentrations higher than the WHO guideline; bromoform (5 times) and dichloromethane (45 times). When discharged to sea, the dilution in the plume has been modelled to be 1:20 within 50 metres from the discharge. Only if a person gets very close to the point of discharge (a few metres away) there is a risk of human exposure to dichloromethane and bromoform concentrations above W HO guidelines for drinking water.

4.8 The Group noted that as a part of maintaining the cells in the C2E unit, the cells are to be flushed with AWACLEAN, a 7% solution of ace tic acid, which is stored in a 100 L tank. Flushing takes places after ballas ting or after approximately 10- 12 hours of use. The storage tank is filled manually, however, dilutions of acetic acid <10% are not cla ssified as a hazardous chemical according to the current legislation for classification and labelling in Europe (Dir. 2001/59/EC).

4.9 The Group noted that accordin g to SOLAS regulation strict requirements apply to testing for safe breathable atmospheres before personnel are allowed to enter enclosed spaces on board ships. This involves ventilating tanks. Personne l shall monitor the tank's atmosphere during the entering process, using hand-held oxygen conten t monitors. When a ballast water tank is full and N 2 is accumulated in the headspace, oxygen levels will be low. Opening and inspection of the tank will be strictly controlled when the vessel is operating in this m ode. It is noted that, under normal operations, there will be no releases from the ve nt-heads except during ballasting due to the use of P/V (pressure /vacuum) valves.

4.10 The Group noted that human exposure to th e C2E solutions (anolyte (AWAC), catholyte (AWAL)) or to N 2 can occur in the case of breakage in the piping. According to the applicant, this type of fault would be detected by the au tomation system as it includes internal leakage detection (inside the C2E cabinet) and pressure loss monitoring (piping) that monitors the process. In the case of detected leakage, alarms are recorded and an immediate shutdown procedure of the C2E is activated. If the breaka ge is located outside th e C2E cabinet the amount of AWAC and AWAL flui d spilled is limited to the amount w ithin the pipes. According to the applicant, AWAC and AWAL are classified as non-dangerous (Dir. 19 99/45/EC); however due to the high pH of AWAL (pH~12) this solution is regarded as corrosive and therefore risk mitigation measures have to be implemented by the use of engineering controls and personal protective equipment (PPE).GESAMP-BWWG 7/9 ANNEX 4 Page 11

I:\MEPC\58\2-8.doc 4.11 The Group noted that in case of ventilation breakdown or leakage, there is a risk of vapor or fumes to be released. These fumes may cau se dizziness and nausea and inhalation should be avoided. Respiratory protection should be availa ble. The ventilation performance is actively monitored. Any failure will institute an alarm a nd consequently system shutdown. The risk to human health is therefore considered to be low. If the breakage is inside the C2E cabinet, this is a sealed compartment with a built-in detection syst em and the risk of exposure is considerably limited.

4.12 The Group considers that there are safety proc edures in place to minimize the health risk for crew and other persons on th e ship in connection with N 2 leakage from the N 2 generator or piping. Due to possible leak age, sensors detecting O 2 levels are installed in all rooms affected by piping connecting the N 2 generator to the ballast water pipeline as well as in the area where the N 2 generator is located. If the sensors detect a leakage of N 2 , the system will enter shutdown mode. An alarm will be activated if the oxygen le vel is reduced to 19%, and access to the rooms will be denied. The safety procedures will ensure that also adjacent spaces and areas under potential nitrogen migration are closed, secured and warning signs posted. Each of the adjacent spaces will be ventilated to secure that any N 2 that has migrated from the leakage point is vented out.

5 RISK TO SAFETY OF SHIP

5.1 Hydrogen

5.1.1 The Group appreciated the detailed study about hydrogen generation, distribution/dilution in the ballast tanks and safety installations. Hydr ogen is flammable at con centrations of 4% and explosive at levels above 18%. The safe gas ev acuation system includes continuous dilution to less than 1%. The Group noted that risk mitigati on measures are employed to ensure reliable collection of hydrogen at source, continuous dilu tion and evacuation that are considered will ensure that this risk remains acceptable.

5.2 Nitrogen Generator

5.2.1 The Group noted that the BWMS user manua l provided, identifies risks that may be encountered during operation of the Nitrogen Gene rator and specifies risk mitigation measures that are considered appropriate. It is also noted that spaces that could be subject to the leakage of nitrogen gas are to be fitted with low oxygen c ontent alarms for the prot ection of personnel.

5.3 Corrosion

5.3.1 The Group noted that the appl icant carried out two different corrosion tests: one coated test panel exposure in a ballast tank on board of a ship, and a la b test. Both tests were carried out with de-oxygenated water (nitr ogen saturation) without electrol ytic disinfection and untreated

seawater.

5.3.2 The applicant informed that since Basic Approval was granted, two additional corrosion tests have been carried out: one lab test with corrosion and coating studies and, in addition, two shipboard tests over a period of more than 15 months in the ballast tanks of two vessels. All testing has been undertak en applying filtration, cavitati on (C3T) and nitrogen supersaturation only.GESAMP-BWWG 7/9 ANNEX 4 Page 12

I:\MEPC\58\2-8.doc 5.3.3 It was noted that no corrosion tests have b een carried out with the complete OceanSaver® treated ballast water for the system proposed, which would include elec trochemical activation and cavitation.

5.3.4 The Group noted that there was no increased corrosion rate of steel due to cavitation and nitrogen super-saturation. The ballast tank coatin gs showed no increase of rusting, blistering and no loss of adhesion strength. However, as the te sts were carried out w ithout the electrolytic disinfection (C2E unit), the corro sion tests are not representati ve for the whole OS BWMS.

5.3.5 The Group noted that a theoretical study was pr ovided dealing with the potential effect of electrochemical activation by the C2E unit to ca use corrosion/coating impacts in ballast tanks when integrated with the rema inder treatment stages. The work was based on the understanding that TRO would be present over a period of time approximated to 24 hrs with an initial free residual oxidant (FRO) concentration in th e treated seawater is ca. 2 ppm., after 5 h, the FRO concentration is typically below 0.25 ppm and after a day TRO concentrations are typically between 0.05 and 0.25 ppm.

5.3.6 Based on the identified rapid degradation of TRO and on general avai lable literature and experience, the applicant conclude s that it is unlikely that the introduction of the C2E component will have any effect on the coatings applied for corrosive protection of ballast water tanks. Similarly, it is unlikely that the additional treatme nt component will affect corrosion of steel. The Group can agree that it is un likely that the introduc tion of the electrolytic disinfection phase at the levels of TRO specified for this system will affect either the ballast tank coatings or increase substantially the corrosi ve effect on steel components. However, it is recommended that this evaluation be confirmed valid by monitori ng such effects during operation for a suitable period of time.

6 RISKS TO THE AQ UATIC ENVIRONMENT

6.1 Assessment of persi s tence (P), bi o a ccumulation (B) and toxicity (T)

6.1.1 During Basic Approval, the Group concl uded that none of th e Active Substances or Relevant Chemicals fulfilled the PBT criteria.

7 ASSESSMENT OF TREATED BALLAST WATER

7.1 Measured concentrations in treated ballast water

7.1.1 The Group noted that the applicant delivered a deta iled degradation study for Active Substances and relevant by-products dur ing 5 days after treatment of seawater of medium (<22 PSU) and high salinities (> 32 PSU). Free Residual Oxidants (FRO) and Total Residual Oxidants (TRO) were measur ed with the DPD method. Results are shown in the figures below.GESAMP-BWWG 7/9 ANNEX 4 Page 13

I:\MEPC\58\2-8.doc Medium salinity - high organic concentration

0,00 0,25 0,50 0,75 1,00 1,25 1,50 1,75 2,00 2,25 2,50

0 20 40 60 80 100 120 140 160 180 200 220 240 260 280 300 320 Time (min)Total residual oxidant (mg Cl/L) Test 6 Test 7 Test 8 Test 9 Test 10 Test 11 Test 12

Figure 2: Decay of Total Re s i dual Oxidant in treated water from land- b ased appro v al tests with the OceanSaver BWMS measured by the DPD method. Measurements were done in a sample (50 L) taken out immedi ately after treatment.

Medium salinity water - high organic concentration

0,00 0,25 0,50 0,75 1,00 1,25 1,50 1,75 2,00

0 250 500 7 5 0 100 0 1 2 50 1 5 00 175 0 2 0 00 2 2 50 250 0 2 7 50 3 0 00 325 0 3 5 00 3 7 50 400 0 4250 4 5 00 475 0 5000 5 2 50 550 0 5750 6 0 00 625 0 6 5 00 6 7 50 700 0 7 2 50 7 5 00

Time (min)Total residual oxidant (mg Cl/L) Test 6 Test 7 Test 9 Test 10 Test 11 Test 12

1 day 2 days 3 days 4 days 5 days

Figure 3: Decay of Total Residual Oxidant in treated wat e r with m e dium salinity (around 22 PSU) from land-based approval test s with the OceanSaver BWMS measured by the DPD method. Measurements from 0 to 2 hours are done in a sample (50 L) taken out immediately after treatment.GESAMP-BWWG 7/9 ANNEX 4 Page 14

I:\MEPC\58\2-8.doc 7.1.2 The maximum concentrations of TRO were foun d to be 2.5 mg/L in the ballast water line. The concentration decreased rapidly to a maxi mum concentration of 0.2 mg/L after 5 days. To account for discharge of ba llast water after 1 day, the a pplicant proposed 0.5 mg/L as maximum allowable discharge concentration.

7.1.3 The applicant delivered a detailed study on formation of disinfection by-products (DBPs), which include both organic and inorganic substa nces formed when TRO reacts with naturally occurring compounds in the water. DBPs are normally formed in reactions where organic chemicals play a major part. They are called orga nohalogens and are further divided into volatile organohalogens (POX) and extractable organohal ogens (EOX), shown in the figure below.

Figure 4: An outli n e of che m i c al reactions upon e l ectrochlorination treat m ent of natural seawater (figure from Taylor 2006).

7.1.4 The Group noted that the dominating ha logenated organic compound, and THM, was bromoform. Bromoform was detect ed in concentrations up to 294 μ g/L. Bromate was not found in any of the samples. The applicant expected to find some bromate, but explained that the analysis is a challenge in seawater. High salin ity content may interfere with some of the analytical procedures used. The following table shows the measured concentrations of AOX, EOX and oxidation by- products in control and treated water (day 0 and day 5) from Tests 5 and 7.GESAMP-BWWG 7/9 ANNEX 4 Page 15

I:\MEPC\58\2-8.doc Table: Measured DBP in control and treated Ballast Water.

Test 5, day 0, Treated Test 5, day 0, Control Test 5, day 5, Treate d Test 5, day 5, Control Test 7, day 0, Treated Test 7, day 0, Control Test 7, day 5, Treated Test 7, day 5, Control

AOX mg/L 2.9 1.63 0.84 3.74 0.64 3.48 5.04 0.75

Bromate μ g/L <0.003 <0.003 <0.003 <0.003 <0.003 <0.003 <0.003 <0.003

EOX μ g/L <0.01 <0.01 0.07 <0.01 <0.01 <0.01 <0.01 <0.01

Trichloromethane μ g/L <0.5 <0.5 <0 .5 <0.5 <0.5 <0.5 <0.5 <0.5

Dibromochloromethane μ g/L 4.6 <0.5 5.5 <0.5 17 <0.5 15 <0.5 Tribromomethane (Bromoform) μ g/L 110 <1 120 <1 200 <1 230 2.5

Dibromomethane μ g/L <0.5 <0.5 <0 .5 <0.5 <0.5 <0.5 <0.5 <0.5

Dichlorobromomethane μ g/L 0.51 <0.5 <0.5 <0.5 0.93 <0.5 1 2.6 1,2,3-Trichloropropane μ g/L 2.5 2.1 2.3 4.1 2.2 2.6 1.5 1.5 1,2-Dibromo-3- Chlorpropane μ g/L <1 <1 <1 <1 <1 <1 <1 <1

Phenols 2-Chlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 3-Chlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 4-Chlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,3-Dichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,4-Dichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,5-Dichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,6-Dichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 3,4-Dichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 3,5-Dichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,3,4-Trichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,3,5-Trichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,3,6-Trichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,4,5-Trichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,4,6-Trichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 3,4,5-Trichlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1 2,3,4,5- Tetrachlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1

2,3,4,6- Tetrachlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1

2,3,5,6- Tetrachlorophenol μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1

PCP μ g/L <0.1 <0.1 <0 .1 <0.1 <0.1 <0.1 <0.1 <0.1

2-Chlorotoluol μ g/L <0.5 <0.5 <0 .5 <0.5 <0.5 <0.5 <0.5 <0.5

4-Chlorotoluol μ g/L <0.5 <0.5 <0 .5 <0.5 <0.5 <0.5 <0.5 <0.5 1,2,4-Tribromobenzol μ g/L <0.5 <0.5 <0 .5 <0.5 <0.5 <0.5 <0.5 <0.5 1,3,5-Tribromobenzol μ g/L <0.5 <0.5 <0 .5 <0.5 <0.5 <0.5 <0.5 <0.5GESAMP-BWWG 7/9 ANNEX 4 Page 16

I:\MEPC\58\2-8.doc 7.2 Acute and chronic toxicity of treated ballast water

7.2.1 The Group noted that acute and chronic aquati c toxicity tests with species from three trophic levels have been carried out with treated ballast wate r after a 5-day holding period (see table below). Some samples showed a remaining toxicity.

Table: Overview of results of aquatic toxicity tests with treated ballast water

Species Effect concentration A Skeletonema costatum (11 tests, day 5) EC50 (72h) = 39-100% EC10 (72h) = 62% (26-100%) A Skeletonema costatum (numerous tests, day 0) EC50 (72h) = 16-100% EC10 = 5.3-65% C Acartia tonsa (day 5) LC50 (48h) >100% NOEC (48h) >100% C Nitocra spinipes (chronic reproduction test, day 5) NOEC (14d) <100% 20% reduction in fecundity F Scophthalmus maximus (turbot) LC50 (96h) >100% NOEC (28d) ≥ 100%

7.2.2 The Group noted that algae seem to be the most sensitive among the species tested with an average EC10 (NOEC) = 62% (26-100%) for tr eated ballast water samples after 5 days’ holding period.

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Derivation of a Predicted No Effect Concentration (PNEC)

8.1.1 The Group accepted the PNEC of 0.62% corr esponding to a dilution of 160 times, which was calculated on the basis of 11 tests of treated ballast water with Skeletonema costatum for EC10 and an assessment factor of 100 consider ing that this species was the most sensitive species tested in acute and chronic tests with species from three taxonomic groups.

622

. 0 100 % 2

. 62

100 10

= = = EC

average PNEC

8.1.2 The Group also accepted th e proposed PNEC for TRO = 0.68 μ g/L derived from an average measured concentration of TRO = 0.10 mg /L in the treated ballast water tested as proposed in the revised risk assessment.

8.1.3 Noting that the appl icant proposed a PNEC = 29 μ g/L for bromoform, the Group recalled that lower values of PNEC for bromoform had been used in other as sessments of BWMSs.

8.2 Calculation of the Predicted Enviro nmental Concentration (PEC) for the Active Substance and Relevant Chemicals

8.2.1 The Group appreciated that the applicant had conducted m odelling of various scenarios by use of both the MAMPEC m odel and the DREAM model.GESAMP-BWWG 7/9 ANNEX 4 Page 17

I:\MEPC\58\2-8.doc 8.2.2 The MAMPEC v.2.0 model was used for modelling steady-state c oncentrations for two harbours (Port of Rotterdam, Port of Mongstad) ba sed on concrete port statistics. For the Port of Rotterdam, an average dilution of the ballast wa ter at steady-state of 142 times is estimated. Resulting concentrations of TRO and Relevant Chemicals are shown in the table below.

Table: Maximum Allowable Concentrations and calculated emission of di sinfection by-products modelled for Port of Rotterdam and Port of Mongstad

Compound Concentration in treated BW [mg/L] 100% Load Emission [g/d] 40% Load Emission [g/d]

Port of Rotterdam TRO Maximum allowable concentration at discharge 0.5 198461 79384

TRO Maximum allowable concentration after

treatment 2.0 793844 317538

Bromoform 0.294 116695 46678 Dibromochloromethane 0.017 6747 2699 Bromodichloromethane 0.001 397 159 THMs 0.312 123839 49536 Port of Mongstad TRO Maximum allowable concentration at discharge 0.5 26959 10784

TRO Maximum allowable concentration after

treatment 2.0 107836 43135

Bromoform 0.294 15852 6341 Dibromochloromethane 0.017 917 367 Bromodichloromethane 0.001 54 22 THMs 0.312 16822 6729

8.2.3 In modelling the resulting co ncentrations of TRO, degradat ion after discha rge of ballast water with a concentrati on of 0.5 mg/L was incl uded in the model with a proposed degradation rate of 2.77 d -1 . The Group had concerns about this degradation ra te bearing in mind that degradation has already taken place during at least 5 days prior to discharge (cf. Figure 3 in section 7.1).

8.2.4 Further, the DREAM model was used for predicting the fate of the plume of discharged ballast water in terms of PEC/ PNEC ratios for discharge of ba llast water in two harbours (Port of Mongstad, Port of Fredrikstad).

8.3 Calculation of PEC/PNEC ratios

8.3.1 In all scenarios modelled with the MA MPEC model, PEC/PNEC ratios <1 were estimated. However, the estimations for TR O are based on the assumption that further degradation will take place in the environment after discharge during a relatively long time period. However, considering that any effects of the discharge of ballast water are considered toGESAMP-BWWG 7/9 ANNEX 4 Page 18

I:\MEPC\58\2-8.doc be local, it is normally not relevant to include degradation in the estimati ons of the local exposure concentrations. The Group had concerns regardi ng the assumption that degradation will take place immediately after discharge and the model results for TRO. The Group considers that a concentration of TRO of 0.5 mg/L in the disc harged ballast water w ould require a dilution of 735 times to reach the PNEC at 0.68 μ g/L, while only a dilution of approximately 140 times according to the model used can be assumed.

8.3.2 The results of the DREAM modelling of th e fate of the plume of ballast water in two harbour scenarios showed the areas aff ected with PEC/PNEC ratios > 1, which for the Port of Mongstad scenario co vers a large area. For the two s cenarios, the models estimated that risks to the aquatic environment would appear in 1 to 37 million m 3 depending on scenario and inclusion of oxidant decay in the environment in the modelling.

8.4 Other effects of discharge of ballast water

8.4.1 The ballast water treatment process include s a step where the water is super-saturated with nitrogen in order to prevent growth of surviving oxygen dependent organisms after the cavitation step. The remaini ng oxygen level is measured to approximately 2 mg/L.

8.4.2 Modelling of the oxygen content has been conducted for six scenarios and the oxygen content in the plume 50 m away fr om the point of discharge after approximately 20 times dilution is calculated to 5.8 mg/L. The Group noted that the applicant concluded that the discharge will have a local effect on seawater quality in terms of oxygen content.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

9.1.1 The Group concluded that sufficient risk m itigation measures have been incorporated in this BWMS system to reduce the risk to the ship and crew during operation to an acceptable level.

9.1.2 The Group agreed that it is unlikely that the introduction of the electrolytic disinfection phase at the levels of TRO specified for this syst em will affect either the ballast tank coatings or increase substantially the corrosive effect on steel components. However it is recommended that this evaluation is confirmed valid by monitoring such effects during operation for a suitable period of time.

9.2 Risks to the crew and general public

9.2.1 The Group concluded that the concentra tions of AWAC/AWAL in the treated ballast water in association with the foreseen risk mitigation measures indicate that the health risk related to inhalation of tank air fo r the crew and general public is not to be considered relevant.

9.2.2 The Group recommends that due to m easured bromoform at concentrations up to 294 μg/L, well above the WHO Guidelin es for Drinking Water Quality (<100 μ g/L), risk mitigation measures should be put in place namely through aeration, to minimize human exposure to this halogenated organic compound which may repr esent a genotoxic/carcinogenic health risk under l ong term scenario.GESAMP-BWWG 7/9 ANNEX 4 Page 19

I:\MEPC\58\2-8.doc 9.2.3 The Group recommends that in case sodium th iosulfate is to be used in the neutralization process and stored onboard ship as undiluted chemical, its human toxicological hazards regarding the irritative properties towards the respiratory tr act will have to be taken into consideration in the HES and a co m plete MSDS ought to be developed

.

9.3 Risks to the environment

9.3.1 The Group noted that for TRO a PNEC at 0.68 μ g/L is derived. According to the Rotterdam scenario of the MAMPEC model, a d ilution of approximat ely 140 times can be assumed. This would correspond to a concentrati on in treated ballast water at discharge of approximately 0.1 mg/L if no degradation of TRO after discharge is taken into account. Considering that the MAMPEC model is recomm ended by MEPC 56 as an interim measure and that some degradation may take pl ace as a result of the chemical oxidative propertie s of TRO, an interim discharge limit value of 0.1-0.2 mg/L TRO is proposed.

9.3.2 The Group further noted that the system ha s a TRO characteristic t ypically in the range of 0–0.3 mg/L at discharge and is below 0.2 mg/L for more that 85% of all tests undertaken. The highest TRO measured after 5 days was 0.2 mg /L. Furthermore, the Group noted that the limit of 0.5 mg/L proposed by the applicant refers to the content of TRC accepted by the MEPC as a discharge limit for sewage. However, the Group belie ved that such a limit s hould not be used for the much greater volumes of tr eated ballast water. Instead an interim discharge limit value of 0.1-0.2 mg/L should be used for treated ballast water. However, the proposed interim discharge limit value for TRO should be re-vis ited when an agreed Emission Scenario for discharge of ballast water becomes available.

9.3.3 The Group noted that bromoform concentrat ions as representative of disinfection byproducts are at levels similar to those observed in other ballast water management systems based on chlorine. However, the Group had some concern regarding the concentration of bromoform in treated ballast water at discharge. In th e documentation submitted for Basic Approval, concentrations of up to 400 μ g/L were measured. In the documentation submitted for Final Approval, concentrations in two samp les of treated ballast water immediately after treatment and after 5 days were from 110 to 230 μ g/L. Considering that a PNEC value for bromoform would probably be in the μ g/L range, considerable dilution would be required before no risks can be assumed.

9.3.4 Due to nitrogen super-saturation of the ba llast water, the concen tration of dissolved oxygen is relatively low at disc harge (~2 mg/L). The applicant has modelled 6 various scenarios for discharge of ballast water and concluded that the discharge of the ballast water with an oxygen content of 2 mg/L will have a local effect on seawater quality limited to a 50 m distance from the ship.

9.3.5 Based on whole effluent testing, it is conc luded that a PNEC for th e treated ballast water can be set at 0.62% correspond ing to a dilution of 160 times. Using the DREAM model for different scenarios, the applicant estimated that risks to the aquatic environment would appear in 1 to 37 million m 3 depending on scenario and inclusion of oxidant decay in the environment.GESAMP-BWWG 7/9 ANNEX 4 Page 20

I:\MEPC\58\2-8.doc 9.3.6 The applicant indicates that the content of toxic oxidants in the ballast water before discharge may be mitigated by use of a neutralizing agent, sodium thiosulfate pentahydrate. The Group noted, however, that this component has not yet been tested in a full-scale system, nor have details about the system automation been pr ovided. Furthermore, the system seems to be designed to reduce the concentra tion of TRO by 0.5 mg/L irresp ective of whic h concentration of TRO before neutralization. Th erefore, the Group considers that confidence in the maintenance of a m a x i m u m allowable discharge concentration of TRO at any given time needs to be ensured

.

9.4 Conclusions and Recommendations

9.4.1 In conclusion, having reviewed all the information provided by the applicant, the Group agreed to recommend to the MEPC that Final Approval be given to the OceanSaver® Ballast Water Management System, subject to the Admi nistration verifying that all the following recommendations have been fully addressed prior to issuance of a Type Approval Certificate:

.1 maximum allowable dosage of Active Substances at 2.5 mg/L as TRO should be monitored and recorded during uptake by TRO sensors adequately maintained;

.2 maximum allowable discharge concentrations of Active Substances at 0.1-0.2 mg/L as TRO should be ensured, monitored and recorded during discharge by T R O sensors adequ a tely m aintai n ed;

.3 a neutralization system should be further developed and type approved by the Administration;

.4 the health toxicological properties for the handling and applic ation of the proposed neutralizing agent be assessed in order to ensure safety for crew; and

.5 the treated ballast water be aerated before discharge in order to reduce the concentration of bromoform.

***GESAMP-BWWG 7/9

I:\MEPC\58\2-8.doc ANNEX 5

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

Ecochlor® Ballast Water Treatment System

Submitted for Basic Approval by Germany

0 SUMMARY

0.1 Having considered all the information summarized below, the Group recommends that MEPC grant Basic Approval to the Ec ochlor Ballast Water Treatment System.

0.2 The Group noted that the Ecochlor® Ballast Water Treatment System uses Purate® and sulphuric acid to generate chlorine dioxide as Active Substance at a maximum allowable concentration of 5 mg/L. It was also noted from the supplementary information provided that the applicant has introduced a filtration phase prior to treatment by chemical to this BWMS.

0.3 Having considered the informati on provided, the Group agreed that:

.1 after the injection of chlorine dioxide to the ballast water, chlorite ion is produced as a reaction between seaw ater and chlorine dioxide and is considered by the Group to be an Active Subs tance in addition to the chlorine dioxide in need of full evaluation in the application for Final Approval;

.2 Purate ® containing 40% by weight sodium chlorate (NaClO 3 ) and 8% by weight hydrogen peroxide (H 2 O 2 ) is considered to be a Preparation; and

.3 sulfuric acid is considered to be a Relevant Chemical.

0.4 The maximum allowable discharge level of the Active Substances (chlorine dioxide and chlorite) needs to be defined in the application fo r Final Approval.

0.5 The Group considers the Level of Quantific ation (LOQ) for the THMs and HAAs used in the analyses of treated ballast water too high. It is common to determine these contaminants in surface waters at levels of 0.01 – 0.05 μ g/L. It remains to be conf irmed that the potential amount of by-products produced by the system is sufficie ntly low and meets the international standards on these substances. This uncertainty should be <0.1 μ g/L.

0.6 The Group noted that whole effluent ecotoxi city testing still has to be carried out for Final Approval. Samples should be take n during the land-based efficacy tests to meet G8 standards (Ref. G9, 5.2.1) and should include samples taken at day 0, 2 and 5 after treatment to demonstrate conclusively eventual remaining ecotoxicity at discharge after varying holding time in ballast ta nks. Chemical analyses with a suffi cient low LOQ should be carried out on the samples in order to identify substances responsible for any toxic effects encountered.GESAMP-BWWG 7/9 ANNEX 5 Page 2

I:\MEPC\58\2-8.doc 0.7 A full environmental risk assessment is required for the application for Final Approval. This should apply model calculations of environm ental concentrations using defined emissions scenarios and include the use of the maximum allowable discharge level of both Active Substances and the Relevant Chemical s in the treated ballast water as well as the eventual toxicity of the whole effluent sample.

0.8 For Final Approval the Group recommends a dditional long-term (at least three months duration) corrosion tests with the tr eated ballast water to be carried out and also to confirm that epoxy ballast tank coatings commonly in use will not be adversely affected by the use of this BWTS.

0.9 The Group recommends the provision ofappropriate chemical resistant saveall protection by way of the stor age tanks and any other locati ons considered necessary to provide protection to the ship in the event of leakage or spillage of the chemicals used.GESAMP-BWWG 7/9 ANNEX 5 Page 3

I:\MEPC\58\2-8.doc 1 INTRODUCTION

1.1 The data for this document were extracted from the original data supplied by Germany to support its submission MEPC 58/2/2 and the confid ential dossier submitted to the Organization.

2 COMPLETENESS OF THE DOSSIER

2.1 The application dossier contained detailed informati on about Active Substances, the preparation (Purate) and Rele vant Chemicals including their physicochemical and biological properties. Further, the applicant submitted MSDS sheets, quality control sheets, a drawing of Ecochlor® BWTS and references.

2.2 The Group noted that the submission did not contain any original reports on corrosion studies on ballast tank coatings. A theoretical derivation of why no corrosion is expected was submitted in the confidential dossier, and in the non-confidential dossier (section 6.1.2.2) a brief presentation of results from tw o corrosion studies was included. Appropriate corrosion studies should be provided in the appli cation for Final Approval.

2.3 Additional tests have to be performed for effect of the tr eatment system on epoxy coatings used in ballast tanks.

3 DESCRIPTION OF RESOURCE BA LLAST TECHNOLOGIES SYSTEM

3.1 Overview of the system

3.1.1 The Group noted that Ecochlor® BWTS tr eats ballast water with chlorine dioxide in situ using the Eka Chemicals Purate® technology. The applicant informed the Group that following submission of the application, a filtration stag e has been included in the proposed system.

3.1.2 For the generation of chlorine dioxide, Purate ® and sulfuric acid are mixed under controlled conditions. The produced chlorine dioxide is injected into the ma in ballast water line resulting in a concentration of 5 mg/L.

3.1.3 The applicant informed that the Ecochlor ® BWTS consists of self-contained chemical storage modules for Purate ® and sulfuric acid, two separate precursor chemical pumps, a chlorine dioxide generation module (housing for the react or column), a booster pump, a programmable logic controller (PLC), an operato r interface terminal (OIT), a syst em status/start-up panel, and piping to inject chlorine dioxide solution into the ballast water line. Ancillary equipment includes pipelines for chemical vents and re-s upply, and in-line sampling valves.GESAMP-BWWG 7/9 ANNEX 5 Page 4

I:\MEPC\58\2-8.doc Figure: Ecochlor® process diagram

3.1.4 The applicant informed that indivi dual chemical pumps transfer the Purate ® and sulphuric acid to the reactor column within the chlorine dioxide generation module. The optical sensor is not included in the diagramme, but described briefly in the dossier.

3.1.5 The reactor column is under vacuum and is continuously monitored using a pressure transmitter. Loss of vacuum for any reason (loss of water flow, power, etc.) will automatically shut down the system and stop chlorine dioxide production. An alarm is given and the condition resulting in the alarm is displayed on the OIT.

3.1.6 The Group noted that at no time during the pr oduction or injection of chlorine dioxide are any chemicals open to the atmosphere. All chemi cals are completely cont ained in appropriate storage vessels or pipelines duri ng the entire treatment process.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 The Group considered Pura te as a Preparation. Purate ® contains 40% by weight sodium chlorate (NaClO 3 ) and 8% by weight hydrogen peroxide (H 2 O 2 ); the remainder being water.

3.2.2 The applicant considers chlorine di oxide that is generated on board as the only Active Substance. The Group has identified the chlorite ion as an additional Active Substance in need of full evaluation, as ch lorine dioxide has a very short half-life and the aquatic toxicity of the treated ballast water is determined by the content of the chlorite ion present.

3.3 Relevant Chemicals

3.3.1 The applicant identified sulfate ions and ch lorite ions as Relevant Chemicals. However, the Group regarded chlorite ions as Active Subs tance and sulfate as not relevant due to its ubiquitous presence in seawater. Further, th e Group considered the sulfuric acid (78%) as a Relevant Chemical.GESAMP-BWWG 7/9 ANNEX 5 Page 5

I:\MEPC\58\2-8.doc 3.3.2 The Group noted that the applicant states th at the application of chlorine-free chlorine dioxide results in oxidation with out the direct formation of organic by-products such as trihalomethanes (THMs), and that other unwante d by-products such as haloacetic acids (HAAs) are minimized. However, the Group recommends that the possible produc tion of by-products is further investigated in the a pplication for Fi nal Approval.

3.3.3 The table below provides an overview of the chemicals involved in the Ecochlor ® Ballast Water Treatment System.

Ingredient (IUPAC Name) Identification Numbers Chemical Formula Structural Formula Molecular Weight % (w/w) AppliedConcentration Preparation Chemicals

1. Purate ®

a. Hydrogen peroxide b. Sodium chlorate CAS # 7722-84-1 CAS # 7775-09-9 a. H 2 O 2 b. NaClO 3 a.

b. a. 34.01 b. 106.44 a. <8% b. 40% a. 0.05-2.9 M b. 0.5-3.2 M

Active Substance in Ballast Water

Chlorine dioxide CAS# 10049-04-4 ClO 2 67.45 -- <5 mg/L in ballast

water 2. Sodium chlorite (present as chlorite ion) CAS # 7758-19-2 NaClO 2 90.45 <5 mg/L in ballast

water Relevant Chemicals in Ballast Water

Sulfuric acid CAS# 7664-93-9 H 2 SO 4 98.08 78% 0.75-4 M

4 HUMAN HEALTH ASSESSMENT

4.1 The Group considered Purate ® , sulfuric acid, and chlorine dioxide as chemicals of potential toxicological con cern associated to Ecochlor ® BWTS. In addition, low levels of chlorite ion may persist in treated ballas t water and sources of direct exposure to this reaction product have been identified for two different population gr oups: Ecochlor technici ans and ship’s crew.

4.2 Purate® ( 40% w/w NaClO 3 + ≤ 8% w/w H 2 O 2 + 52% Water w/w) : The Group considered sodium chlorate and hydrogen peroxide to be th e critical toxicants in terms of human health effects and therefore addressed the hazards of th ese substances in the preparation Purate® and the further elaboration on risk. In this contex t the Group noted the classi fication according to the current European system for classification and labelling of this preparation as shown in the MSDS provided by the applicant:

O, Xn, N; R9, R22, R36, R51/53GESAMP-BWWG 7/9 ANNEX 5 Page 6

I:\MEPC\58\2-8.doc 4.3 The Group has identified the following health hazards:

.1 Inhalation of Purate ® vapours and/or mists are irritating to the mucous membranes, and may cause nausea, head ache and/or weakness. Inhalation exposure can have an oxidizing effect, and oxidizes haemogl obin in the blood to methaemoglobinemia, causing a reduced ab ility to transport oxygen. This can lead to a lack of oxygen in body tissues.

.2 Inhalation of sulfuric aci d mists or sprays can cause pul monary irritation, irritation of the mucous membranes, coughing an d sore throat. I nhalation of high concentrations may cause respiratory tissue damage, causing lung disorders (chemical pneumonitis and pulmonary edema) and erosion of tooth enamel.

.3 Chlorine dioxide is a strong, corrosive respiratory irritant, an d the respiratory tract appears to the primary target of toxicity in human and animal studies. Reported symptoms include cough, wheezing, headache, nausea, pulmonary oedema and shortness of breath.

.4 Direct exposure to Purate ® may cause moderate irritation to the skin, and can cause severe eye irritation.

.5 Direct exposure to sulfuric acid of the skin or eyes can cause severe irritation, burns and permanent tissue damage. Absorption through the skin is not anticipated to be a signifi cant route of exposure.

.6 Direct exposure to chlorine dioxide so lution may cause redness and skin burns and may cause severe eye irritation.

4.4 The Group noted that the on board areas, or sources of chemicals, with potential for exposure to Purate ® , sulfuric acid and chlorine dioxide are limited to the areas where the BWTS and chemical storage tanks are located, where pipelines traverse, and where chemical re-supply operations take place.

4.5 The potential exposure relating to the Ecochlor ® BWTS that have been identified are direct exposure of skin and eye and air containing vola tiles of the chemicals of potential concern within enclosed ship spaces. Treated ballast water is not considered as a potential pathway for exposure to Purate ® and sulfuric acid because these substances are consumed in the chlorine dioxide generation reaction. Further, chlorine dioxide degradation beha viour indicates that chlorine dioxide will not persist in the environment. However, because chlorine dioxide in solution readily volatilizes, a pot entially complete exposure pathwa y by inhalation of chlorine dioxide from treated ballast water exists.

4.6 The persons with the great est potential for primary exposur e are Ecochlor technicians and, to a lesser extent, ships crew and/or other personnel. Chem ical exposure will only occur in the event of a pipeline or storage tank failure, or an emergency situation in the same space where ship crew may be working. In this unlikely event, the most probable exposure route would be inhalation rather than direct exposure to skin and eye.GESAMP-BWWG 7/9 ANNEX 5 Page 7

I:\MEPC\58\2-8.doc 4.7 During routine system maintenance and chem ical re-supply operati ons chlorine dioxide would not be generated. Thus, these operations will only involve potential exposure to Purate ®

and/or sulfuric acid for Ecochlor technicians.

4.8 The human exposure assessment (HES) submitted by the applicant identified that there is a potential risk of exposure to Purate ® , sulfuric acid and chlorine dioxide by inhalation and direct exposure to skin and eye. Expos ure risks are present during syst em maintenance and chemical re-supply operations, or during emergency situ ations involving the Ecochlor BWTS. According to the applicant, preventative maintenance will require approximately 6 hours per year and chemical re-supply operations will o ccur two - three times per year.

4.9 The Group noted that the applicant, in order to address the identified risks, will implement risk mitigation measures namely the use of PPE consisting of eye protection (chemical goggles), and/or a face shield, along with chemical resist ant clothing and gloves designed for use with Purate ® and sulfuric acid. In addition, these operations are to be conducted in well-ventilated areas or with the use of appropriate engineeri ng controls to prevent inhalation risks. In the event of an emergency situati on where inhalation exposure may occur, respiratory protection devices would be added to the required PPE.

4.10 In conclusion, and according to th e information submitted for the HES and Human Health Risk Characterization, the Group considered that the unit operations where potential human exposure risks exist, e.g. main tenance and refilling ope rations, are limited in duration and frequency and risk mitigation m easures were satisfactorily addressed by the applicant. As these operations are to be perf ormed by the manufacturer’s own personnel, it may be anticipated that all appropriate risk mitigation measures will be fully considered and addressed in the technician training standard procedures.

5 RISK TO SAFETY OF SHIP

5.1 The Group noted that Ecochlor ® BWTS is designed as a self contained module interconnected to the ship’s ball ast water system by a side stream loop in the case where ballast water is used as motive water for the gas gene ration module or only by th e delivery line/injection point for delivering the chlorine dioxide solutio n into the ballast water main. The connecting lines are fitted with valves that isolate the BWTS from the ship’s systems in case of an emergency. The applicant informs that the combination of failsafe measures in the programmable logic controller, th at shut down the BWTS in th e event of malfunction of the system and the isolation valves assure safe conditions during operation of this BWMS. The submission confirms that the system isol ation valves provided have the appropriate approvals by the ship’s classification society and are constructed of materi als appropriate for the application.

5.2 The Group noted that corrosi on studies with a limite d number of test pane ls and for a period of approximately 30 days were carried out (Secti on 6.1.2.2 in MEPC 58/2/2). The original test reports were not provided and de tails about conditions (e.g. expo sure time, ballast operations) during the test were th erefore not available.

5.3 A theoretical derivation of why no corrosion is expected was submitted in the confidential dossier. This was based on pH, sa lt and dissolved oxygen content of the seawater and biofouling, instead of ClO 2 . This was not considered to be relevant by the Group.GESAMP-BWWG 7/9 ANNEX 5 Page 8

I:\MEPC\58\2-8.doc 5.4 The Group considers that there may be an incr eased risk of corrosion arising in the ballast tanks and ballast water piping fr om the oxidizing properties of ch lorine dioxide injected and chlorite produced. It is recommended that the applicant carries out appr opriate corrosion tests with at least 3 months duration and provides these for Final Approval.

5.5 The Group noted that the supplementary info rmation provided by the applicant contained confirmation from a paint supplier that applica tion of these Active Substances at the levels indicated in the dossier would not have a negative effect on coat ings commonly used for ballast tank protection.

5.6 The Group noted that the applicant had identi fied the following fire and explosion risks:

.1 As a solution, Purate ® is non-flammable and does not have explosive properties. Organic materials (i.e. w ood, leather) that become contaminated with Purate ® can ignite by a heat or friction source if they are allo wed to dry. If evaporation of Purate ® solution is allowed, solid sodium chlorate crystals could form. Solid sodium chlorate does not burn, but if exposed to fire it decomposes to give off oxygen, which can feed a fire. Decomposition of Purate ® (in contact with certain metals or alkalis, or upon thermal decomposition) generates oxygen gas, and has the po tential to increase explosion risk.

.2 Sulfuric acid is non-flammable. A lthough sulfuric acid is not flammable or combustible and is not sensitive to static discharge, it is a strong oxidizing agent and is highly reactive. Concentrated sulfuric acid is capable of igniting combustible materials, and contact with water or strong bases can result in a strong exothermic reaction. Contact with common metals can evolve flammable and potentially explosive hydrogen gas. Su lfur oxides may be produced under fire conditions.

.3 These risks are mitigated through proper training, system engineering, identification of a suitable location for the BWTS, the use of chemical storage tanks specifically designed for the chemicals they hold, and proper tank ventilation. Additionally, the space where the BWTS is located is kept clean and free of incompatible materials that can react with the precursor chemicals. Regular inspection and maintenance of the BWTS further reduce any potential risks. The mitigation measures and engine ering controls in place for the precursor chemicals stored on board make the risks of fire and/or explosion extremely low.

.4 Gaseous chlorine dioxide can present explosion hazards under specific conditions. In solution, chlorine dioxide is stable and does not present fire or explosion hazards. Additionally, chlorine dioxide is generated on demand, injected immediately, and never stored on board. Therefore, the risk of fire and/or explosion presented by the Active Substance is extremely low.

5.7 The Group noted that Purate ® and sulfuric acid require the use of incompatible fire fighting medium and therefore recommends that th e Authority approving any installation of this system on board ships for further testing performs an appropriate risk evaluation to ensure that protection in the event of a fire situation is appropriate. It is recommended that any fire fighting and fire mitigation measures considered necessary for the safe installation of this ballast water management system are clearly specified in any submission for Final Approval.GESAMP-BWWG 7/9 ANNEX 5 Page 9

I:\MEPC\58\2-8.doc 5.8 Chemical storage

5.8.1 The precursor chemicals (preparations) ar e the only BWTS chemicals stored on board at any time. The applicant reasons that althoug h 78% sulfuric acid is IMDG Code classified, the BWTS is ship’s equipment and therefore the chemicals are consumables rather than dangerous cargo and so the provisions of the IMDG Code are not applicable. The Group recognizes this reasoning but, however, recommends that the stowage requi rements stipulated in the IMDG Code for these chemicals are followed as far as is practicable when considering appropriate location of this BWTS.

5.8.2 The Group noted that storage containers designed and engineered specifically for Purate ®

and sulfuric acid are utilized with the Ecochlor ® BWTS and therefore th e risk of unintended release, contact with incompatib le materials, or direct personne l chemical exposure is reduced. The applicant informs that to ensure proper chem ical storage, temperature control device(s) can be installed if the BWTS is to be located in an area or on a sh ip where there is potential for temperature extremes.

5.8.3 The Group recommends that a “worst case scenario” should be taken into account when assessing the need for risk mitigation measures related to the storage and use of the applied chemicals. This may be particularly relevant when assessing the need for temperature control devices. The Group further noted that the provisi on of appropriate chemical resistant save-all protection by way of the storage tanks and any ot her locations considered necessary to provide protection to the ship in the even t of leakage or spillage of th e chemicals used, is recommended in the safety data sheets provided and recomm ends that this requirement is followed.

5.9 The Group noted that the applicant cons iders proper training and implementation of standard operating procedures as mitigation of the potential risks of chemical storage on board, and that chemical spill containment kits are to be kept on board for use in the event of spillage or leakage. The applicant states th at the potential for unintended re lease of chemicals associated with the BWTS relates to storage tank failure , delivery pipe failure, and chemical re-supply operations and that the areas for potential release are limited to th e areas where the storage tanks are located, where pipelines traverse, and where chemical re-supply operations take place. The Group noted that the safety data sheets stipul ate the requirement for pr ovision of shower and eye wash facilities near to the storage area for personnel use in the event of contact. It should be ensured that such facilities are provided in an accessible space adjacent to the storage arrangements. Furthermore, any enclosed sp ace where this equipment is located should be provided with a mechanical extr action ventilation system as r ecommended in the safety data sheets provided.

5.10 The Group further noted that a number of a dditional safety measures were included in the system.GESAMP-BWWG 7/9 ANNEX 5 Page 10

I:\MEPC\58\2-8.doc 6 ASSESSMENT OF PERSISTENCE (P), BIOACCUMULATION (B) AND TOXICITY (T)

6.1 The products identified as Active Substances were assessed regarding their Persistence (P), Bioaccumulation potential (B) and th eir Toxicity (T). The assessm ent of these products is shown below:

Criteria Persistence (P) Half-life: >60 d in marine water, or >40 d in freshwater, or >180 d in marine sediment >120 d in freshwater sediment Bioaccumulation (B) BCF >2,000 or Log K ow ≥ 3 Toxicity (T) Chronic NOEC

<0.01mg/L

Chlorine dioxide 3.9 min, clear freshwater at 5 m Criteria fulfilled - No -3.22

Criteria fulfilled - No Lowest chronic NOEC = 0.09 mg/L Criteria fulfilled - No

Chlorite ion 4 d in seawater Criteria fulfilled – No -7.17 (as sodium chlorite) Criteria fulfilled - No Lowest chronic NOEC = 0.18 mg/L Criteria Fulfilled - No

6.2 The Group noted that based on the data presented under 6. 1, none of these chemicals should be considered as fu lfilling the PBT criteria.

7 ASSESSMENT OF TREATED BALLAST WATER

7.1 The Group considered that th e primary reaction product in ba llast water after disinfection with chlorine-free chlorine dioxide, Ecochlor®, is chlorite ion (ClO 2 - ), or sodium chlorite (NaClO 2 ). Chlorite is considered as an additiona l Active Substance. Chemical analysis and known chemical principles of di sinfection using chlorine dioxide that is generated in the chlorine-free method used with the Ecochlor ® BWTS indicate that no other reaction by-products are present at environmentally re levant concentrations. However, biocide treatment of water can raise questions regarding the formation of THMs and/or HAAs.

7.2 The Group noted that experiments to determ ine the concentrations of Active Substances and Relevant Chemicals (T HM) were carried out o n board the M/V Moku Pahu , San Francisco Bay Area (Richmond, CA) and yielded the following results:

Parameter Control Ballast Water Ballast Water Treated On board + 3 Day 13 Feb 2008 Ballast Water Treated On board + 5 Day 15 Feb 2008 PH 7.6 7.3 7.3 FAC <0.05 mg/L <0.05 mg/L -- ClO 2 -- <0.05 mg/L <0.05 mg/L ClO 2 - <0.05 mg/L 0.91 mg/L 0.24 mg/L ClO 3 - <0.10 mg/L 0.49 mg/L 0.49 mg/L Br - 50 mg/L -- --GESAMP-BWWG 7/9 ANNEX 5 Page 11

I:\MEPC\58\2-8.doc Parameter Control Ballast Water Ballast Water Treated On board + 3 Day 13 Feb 2008 Ballast Water Treated On board + 5 Day 15 Feb 2008 BrO 3 - <0.02 mg/L -- <0.02 mg/L (+11 Day) SO 4 -2 1902 mg/L -- 1826 mg/L (+ Day 8) THMs Bromodichloromethane Bromoform Chloroform Dibromochloromethane <1 μ g/L <1 μ g/L <1 μ g/L <1 μ g/L -- <1 μ g/L <1 μ g/L <1 μ g/L <1 μ g/L

HAAs Dibromoacetic acid Dichloroacetic acid Bromoacetic acid Monochloroacetic acid Trichloroacetic acid <1 μ g/L <1 μ g/L <1 μ g/L <1 μ g/L <1 μ g/L -- 12 μ g/L <1 μ g/L <1 μ g/L <1 μ g/L <1 μ g/L

7.3 Assessment of treated ballast water was carried out with water samples collected immediately (within 1 hour) after chlorine dioxide treatment. Samples were packed in dark coolers with ice, and sent for express next day delivery to the laboratory.

7.4 The Group considers the Level of Quantific ation (LOQ) for the THMs and HAAs used in the analyses of treated ballast water as too high. It is common to determine these contaminants in surface waters at levels of 0.01 – 0.05 μ g/L. The potential le vels may therefore be understated, but may as well remain within acceptable limits. It remains to be confirmed that the potential amount of by-products produced by the system is sufficiently lo w and meets the international standards on these substances. This uncertainty should be clarified and verified in additional analyses during the full scale test ing on land and/or onboard ships.

7.5 A full assessment of the degradation and half-life for chlorite and chlorate ions is required for FA.

7.6 The Group noted that a number of ecotoxicity tests of treated ballast wa ter were provided in the dossier. For toxicity testing on treated ball ast water from shipboard studies (data presented in Tables T2.9 and T2.10 of MEPC 58/2/2), the ballast water remained in the ballast tanks until samples were collected 5 days after treatment. Water samples were then stored in the dark, in coolers at 4oC while onboard the ship. For deliver y to the laboratory, the samples were packed on ice in coolers and shipped express for next day delivery. However, the documentation contained no information about wate r qualities such as content of or ganic matter in the test water. A full evaluation of the remaining ecotoxicity in treated ballast water at varying holding time in ballast water tanks should be provided in the application for Final Approval.GESAMP-BWWG 7/9 ANNEX 5 Page 12

I:\MEPC\58\2-8.doc 8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Derivation of Predicted No E ffect Concentrations (PNEC)

8.1.1 For chlorine dioxide, a PNEC for the aqua tic environment can be derived from aquatic toxicity data provided in the summary of the proposal as well as in the documentation. The lowest reported acute aquatic toxicity for freshwater organisms wa s reported for juvenile fathead minnows ( Pimephales promelas ) with a LC50 = 0.02 mg/L. For marine species, the lowest reported acute aquatic t oxicity was for brine shrimp ( Artemia ) with a LC70 = 0.047 mg/L and a NOEC = 0.024 mg/L. The Group noted that th e effect concentrations reported in the summary of the proposal for tests conducted by Nautilus Environmental (2005, 2006) showing higher acute and chronic effect concentrations were based on measured concentrations of chlorine dioxide at the start of the exposure peri ods. Considering the rapid breakdown of chlorine dioxide, these values might underestimate the aquatic toxicity of chlorine dioxide. Consequently, the lowest reliable toxicity data to be used for derivation of a PNEC are the above mentioned acute toxicity data. Applying an applicati on factor of 1000 leads to PNEC = 0.02-0.05 μ g/L.

8.1.2 For chlorite, the lowest reported acute toxi city data for freshwater species are 0.022 mg/L for Ceriodaphnia dubia and 0.0146-1.4 mg/L for Daphnia magna . The lowest reported toxicity data for ma rine species are for Mysidopsis bahia with LC50 = 0.576 mg/L and a NOEC = 0.18 mg/L for 7-day growth. The latter te st is not considered a chronic test. Applying an application factor of 1000 leads to PNEC = 0.6 μ g/L.

8.1.3 In a toxicity testing of two samples of treated ballast water, the lowest acute LC50 was 37.7% (v/v) for Mysidopsis bahia and the lowest chroni c EC50 was >81% (v/v) for Mytilus sp . Chlorite was measured in the two samples to 0.41 and 2.35 mg/L. By calculation, these values compare well with the chlorite ion toxicity observed for M. bahia . Considering the PNEC derived for chlorite ions at 0.6 μ g/L, a dilution of the ba llast water at discharge of 680-3,900 times will be needed to avoid long-term risks to aquatic organisms.

8.2 Calculation of the Predicted Enviro nmental Concentration (PEC) for the Active Substance and Relevant Chemicals

8.2.1 The Group noted that the ballast water treated with 5. 0 mg/L of chlorine dioxide contained chlorite ion concentra tions ranging from <0.1 to 2.37 mg/L. Therefore, the PEC for chlorite ion in treated ballast water is <0.1 - 2.37 mg/L. This range is a result of the varied chlorite ion demand of different waters and factor s such as organic load, pH and temperature that affect the decay rate.

8.2.2 The applicant did not apply any model to predict environmental c oncentrations. However, a dilution factor of 100 could be applied corresponding to the recommended value for estimating dilution of discharges to the marine environm ent in the EU Technical Guidance document for risk assessment.

8.2.3 Further the Group noted that the PEC for chlo rine dioxide is 0 mg/L, as the ballast water treated with Ecochlor ® BWTS had concentrations of chlo rine dioxide <0.05 at the time of discharge.

8.2.4 The Group noted that the PEC for the chlor ite ion in the worst case could be estimated to be 24 μ g/L.GESAMP-BWWG 7/9 ANNEX 5 Page 13

I:\MEPC\58\2-8.doc 8.3 Calculation of PEC/PNEC ratios

8.3.1 The Group noted that for chlorine di oxide, it was not relevant to consider a PEC/PNEC ratio.

8.3.2 For chlorite, the estimated PEC/PNEC ratio based on the available assumptions is estimated to be approximately 40. Thus, a ri sk to the local aquatic environment may be anticipated.

8.3.3 The applicant states that a situation wher e the PEC/PNEC ratio is >1 at discharge is not anticipated. However, this cannot be subs tantiated from the information provided in the application documentation.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

Provided the risks identified in section 5 are m itigated by the implementation of appropriate risk mitigation measures the Group considers that the risk s that can be foreseen as inherent to this system should be acceptable so as to allow furt her testing and developmen t. All risk mitigation measures required for the safe use of this sy stem should be detailed in any application for Final Approval.

9.2 Risks to the crew and general public

According to the information submitted in the HES and Human Health Risk Characterization, the Group is able to conclude that the operations where potential human exposure risks exist, e.g. maintenance and refilling operations, are limited in duration and frequency and the concerned risk mitigation measures were satisf actorily addressed by the applicant. As these operations are to be performed by the manufacturer ’s own personnel, it ma y be anticipated that all appropriate risk mitigation measures will be fu lly considered and addressed in the technician training standard procedures.

9.3 Risks to the environment

Based on the available information, the Group c onsiders that the Active Substance chlorine dioxide degrades very quickly after application a nd will not be present in treated ballast water at discharge. The reaction product, the chlorite ion, will however normally be present in the treated ballast water at discharge. The chlorite ion is probably the main toxi c component in treated ballast water.

The applicant did not derive a PNEC for chlorite ion and neither did he estimate the PEC for relevant scenarios. Based on the information av ailable, the Group conduc ted a preliminary risk assessment, which showed a possible risk to the aquatic environment after discharge of ballast water applying Ecochlor BWTS.

The Group recommends that in a possible applic ation for Final Approval, the database for deriving the PNEC for chlorite should be improved and that PECs should be estimated for relevant scenarios in order to better assess th e possible risks to the aquatic environment.GESAMP-BWWG 7/9 ANNEX 5 Page 14

I:\MEPC\58\2-8.doc 9.4 Conclusion and recommendation

Based on the information submitted by the a pplicant, the Group recommends that MEPC grant Basic Approval to the Ecochlor Ballast Water Treatment System.

* * *GESAMP-BWWG 7/9 ANNEX 5 Page 15

I:\MEPC\58\2-8.doc APPENDIX 1

PHYSICOCHEMICAL AND BIOLOGICAL PROPER TIES OF PURATE, SULFURIC ACID, CHLORINE DIOXIDE, SULF ATE AND SODIUM CHLORITE

1 CHEMICAL IDENTIFICATION

1.1 The Group recognized that Purate and sulfur ic acid were preparations which generate chlorine dioxide as Active Substance. Sulfate and chlorite ions are Relevant Chemicals.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute aquatic toxicity

Information on acute toxicity to aquatic organi sms is summarized below. The Group noted that only some of this information was included in the summary of the proposal for basic approval, and that further information was provid ed in the confidential documentation.

Test Substance F C A Species Test Type EC50 mg/L NOEC mg/L Reference/

comments

Preparations

1. Purate ® -- -- -- -- See Section 2.0.1.1 for justification of not providing data

2. Sulfuric acid -- -- -- -- See Section 2.0.3.1 for justification of not providing data

Active Substance

F Menidia beryllina 96 hr survival a >0.4 0.4 Nautilus Env. 2005

F Clupea payáis 96 hr survival 0.35 0.22 Nautilus Env. 2005

F Pimephales promelas (juvenile) 96 hr survival 0.02 Wilde et al. 1983

C Mysidopsis bahia 48 hr survival a 0.4 0.14 Nautilus Env. 2005

C Artemia salina (nauplii) (EC70) 0.047 0.024 Puente et al. 1992

A Skeletonema

costatum 96 hr growth 3.09 - Nautilus Env. 2006 1. Chlorine dioxide

A Macrocystis pyrifera 48 hr germination 0.20 0.14 Nautilus Env. 2006GESAMP-BWWG 7/9 ANNEX 5 Page 16

I:\MEPC\58\2-8.doc Test Substance F C A Species Test Type EC50 mg/L NOEC mg/L Reference/

comments

Relevant Chemicals

F Cyprinidon variegatus 96 hr survival 75.0 13.9 Env. Sci. Eng. 1994b

C Mysidopsis bahia 96 hr survival 0.58 NR Env. Sci. Eng. 1994a

C Ceriodaphnia dubia NR 0.022 NR Cited in Nautilus Env. 2007

C Daphnia magna NR 0.0146 -1.4 NR Cited in Nautilus Env. 2007

A Selenastrum capricornutum 96 hr growth 0.8 Wijk et al. 1998 2. Chlorite Ion (Sodium chlorite)

A Macrocystis pyrifera 48 hr germ. >15.4 15.4 Nautilus Env. 2007

Treated Ballast Water

C Mysidopsis bahia 48 hr survival 38.7% 25% Nautilus Env. 2006 5.0 mg/L dose of ClO 2 C Mysidopsis bahia 48 hr survival 37.7% 25% Nautilus Env. 2006

F = Fish, C = Crustacean, A = Algae, NR = Not Reported.

a Calculated on the basis of data from th e chronic toxicity test with this species.

b Reported NOEC is highly conservative because the next concentration tested was 10-times higher (see discussion in section 2.1.2.1).GESAMP-BWWG 7/9 ANNEX 5 Page 17

I:\MEPC\58\2-8.doc 2.2 Chronic aquatic toxicity

Test Substance F C A M Species Test Type EC50 mg/L NOEC mg/L Reference/ Comments

Preparations

1. Purate ® -- -- -- -- See section 2.0.1.1 for justification of not providing data

2. Sulfuric acid -- -- -- -- See section 2.0.3.1 for justification of not providing data

Active Substance

F Menidia beryllina 7 d surv/growth >0.4 0.4 Nautilus Env. 2005

F Clupea pallasi 18 d embryo development >0.33 0.33 Nautilus Env. 2005

C Mysidopsis bahia 7 d surv/growth ~ 0.4 0.04 a Nautilus Env. 2005

A Macrocystis pyrifera 48 hr germination 0.20 0.14 Nautilus Env. 2006

A Skeletonema costatum 96 hr growth - 2.09 Nautilus Env. 2006 Chlorine dioxide

M Mytilus edulis 48 hr development 0.22 0.09 Nautilus Env. 2005

Relevant Chemicals 1. Sulfate ion/sulfuric acid -- -- -- -- See section 2.0.3.1 for justification of not providing data

F Atherinops affinis 7 d surv/growth >13.8 6.9 Nautilus Env. 2007

C Mysidopsis bahia 7 d surv/growth 0.25 0.18 Nautilus Env. 2007

A Macrocystis pyrifera 48 hr germ. >15.4 15.4 Nautilus Env. 2007

E Strongylocentrotus purpuratus Development 10.4 5.0 Nautilus Env. 2007 2. Chlorite ion (sodium chlorite)

M Crassostrea virginica Development 21.4 14.3 Env. Sci. Eng. 1994c

Treated Ballast Water

M Mytilus sp. Development >81% 81% Nautilus Env. 2006

M Mytilus sp. Development >84% 84% Nautilus Env. 2006 C Mysidopsis bahia 48 hr survival -- 12% b Nautilus Env. 2006 5.0 mg/L dose of ClO 2

C Mysidopsis bahia 48 hr survival -- 11.7% b Nautilus Env. 2006

F = Fish, C = Crustacean, A = Algae , M = Mollusk, E = Echinoderm

a Reported NOEC is highly conservative be cause the next concentration (NOEC) tested was 10-times higher.

b Chronic NOEC calculated using acute-to-chronic ratio of 3.22.GESAMP-BWWG 7/9 ANNEX 5 Page 18

I:\MEPC\58\2-8.doc 2.3 Information on Endocrine Disruption

Substance Information on Endocrine Disruption Preparation Chemicals

1. Purate ® a. Hydrogen peroxide b. Sodium chlorate a. Physical and chemical properties present no evidence to suggest endocrine disruption. b. Physical and chemical properties present no evidence to suggest endocrine disruption.

2. Sulfuric acid Physical and chemical properties present no evidence to suggest endocrine disruption. Active Substance in Ballast Water

Chlorine dioxide Physical and chemical properties present no evidence to suggest endocrine disruption. Relevant Chemicals in Ballast Water 1. Sulfate ion (as sodium sulfate or sulfuric acid) Physical and chemical properties present no evidence to suggest endocrine disruption. 2. Sodium chlorite (as chlorite ion) Physical and chemical properties present no evidence to suggest endocrine disruption.

2.4 Sediment toxicity/bioavail a bility/biomagnification/bioco n ce n tratio n / foo d w eb-population effects

2.4.1 Se d i me n t toxicity

Substance Information on Sediment Toxicity Preparation Chemicals

1. Purate ® a. Hydrogen peroxide b. Sodium chlorate a. Physical and chemical properties present no evidence to suggest accumulation in sediment. See sections 2.1.4 and 2.4. b. Physical and chemical properties present no evidence to suggest accumulation in sediment.

2. Sulfuric acid Physical and chemical properties present no evidence to suggest accumulation in sediment. Active Substance in Ballast Water

Chlorine dioxide Physical and chemical properties present no evidence to suggest accumulation in sediment. Relevant Chemicals in Ballast Water 1. Sulfate ion (as sodium sulfate or sulfuric acid) Physical and chemical properties present no evidence to suggest accumulation in sediment.

2. Sodium chlorite (as chlorite ion) Physical and chemical properties present no evidence to suggest accumulation in sediment.GESAMP-BWWG 7/9 ANNEX 5 Page 19

I:\MEPC\58\2-8.doc 2.4.2 Bioavailability, Biomagnification, Bioconcentration/Food Web Effects

Substance Log K ow Bioaccumulation BCF >2,000 Cause for concern? (yes/no) Comments

Chlorine dioxide -3.22 No available data No

Chlorite ion -7.17 (as sodium

chlorite) No available data No Neither chemical would be expected to bioaccumulate or persist in the food web.

Justification for not supplying data

Purate ® Not Relevant – chlorine dioxide an d chlorite are the only constituents potentially present in treated ballast wa ter that will be discharged to the environment.

Sulfuric acid Not Relevant – chlorine dioxide an d chlorite are the only constituents potentially present in treated ballast wa ter that will be discharged to the environment.

3 MAMMALIAN TOXICITY

3.1 Acute mammalian toxicity

Test Substance Exposure Route Species Value range Reference/

comments

Preparations

Purate ®

Sodium chlorate a. Acute Oral LD50 b. Inhalation LC50 a. Rat b. Rat a. >5000 mg/kg b. 5.6 mg/L/4hr Purate ® MSDS, Eka Chemicals

Hydrogen peroxide (10%) a. Acute Oral LD50 b. Inhalation LC50 a. Rat b. Rat a.1500 - >5000 mg/kg b. 122 mg/L/4hr Purate ® MSDS, Eka Chemicals

Sulfuric acid a. Acute Oral LD50 b. Inhalation LC50 a. Rat b. Rat a. 2140 mg/kg b. 0.375 mg/L/4hr OECD SIDS SIAR, SIAM 11 (January 2001), UNEP Publications

Active Substance

Chlorine dioxide a. Acute Oral LD50 (EPA OPPTS Method 870.1100) b. Inhalation (nose) LC50 a. Rat

b. Rat a. 292 mg/kg (males) 340 mg/kg (females) b. 32 mg/L (90 mg/m 3 ) a. USEPA RED for chlorine dioxide and sodium chlorite b. Schorsch (1995) cited in IPCS chlorine dioxide (Gas) 2002) CICADS 37.GESAMP-BWWG 7/9 ANNEX 5 Page 20

I:\MEPC\58\2-8.doc 3.1.1 Sodium chlorate and hydrogen peroxide are classified under GHS as acute tox 4 via the oral route, in addition, chlorine dioxid e is toxic if swallowed (acute tox 3), whereas hydrogen peroxide is harmful if inhale d (acute tox 4) (GHS cla ssification, Annex VI, COM (2007) 355 final). According to the OECD SIDS for sulfuric acid, the LC50 valu es observed in acute inhalation studies are all low and most likely due to the corrosiv e/irritant effect of the substance.

3.2 Corrosion/irritation

Test Substance Skin Eye Sensitization Reference/ Comments

Preparations

Purate ®

Sodium chlorate Not irritating to rabbits Mildly irritating to rabbits Not sensitizing to guinea pigs. Purate ® MSDS, Eka Chemicals

Hydrogen peroxide At concentrations <35%, not a skin irritant Highly corrosive/ irritating at concentrations >8 % Not sensitizing to guinea pigs at 6% concentration Purate ® MSDS, Eka Chemicals

Sulfuric acid Severely irritating to contaminated tissue Severe irritant Not known to be a sensitizer Sulfuric acid MSDS, Basic Chemical Solutions

Active Substance

Chlorine dioxide Irritant Strong irritant Not located Chlorine dioxide MSDS, Eka Chemicals

3.2.1 Hydrogen peroxide, sulfur ic acid and chlorine dioxide ar e all classified under GHS as corrosive (categories 1A fo r hydrogen peroxide and su lfuric acid, category 1B for chlorine dioxide) (GHS classification, Annex VI, COM (2007) 355 final).GESAMP-BWWG 7/9 ANNEX 5 Page 21

I:\MEPC\58\2-8.doc 3.3 Sensitization

n.d.

3.4 Repeated Dose Toxicity

Test Substance Exposure Route Species Value range Reference/

comments

Preparations

Purate ®

Sodium chlorate a. Oral, 90- d subchronic b. Oral, 90- d subchronic a. Rodent

b. Dog a. NOAEL 100 mg/kg/ d

b. NOAEL 360 mg/kg/ d EKA Study 86- 3112 EPA Guideline 82-1 (1987) EKA Study 863114 EPA Guideline 82-1 (1987)

Hydrogen peroxide (10%) a. Oral, 90- d subchronic b. Oral, 90- d subchronic a. Rodent b. Other mammal a. NOEL 30-56.2 mg/kg b. Not located Ito et al. 1976 and Kawasaki et al. , 1969, cited by SCCP

Sulfuric acid 28 d, inhalation (nose only) Rat NOEL/NOAEL not identified OECD SIDS SIAR, SIAM 11 (January 2001), UNEP Publications

Active Substance

Chlorine dioxide a. Inhalation, 60 d b. Oral, 90- d subchronic a. Rat b. Rat a. LOAEL – 1 mg/L (2.8 mg/m 3 ) b. 2-15 mg/kg in drinking water.No treatment related deaths, clinical signs or effects on hematology, clinical chemistry or organ weights. Dose-related decrease in water consumption and food consumption in high dose only. Nasal cavity was identified as the target tissue with hyperplasia, squamous metaplasia and inflammatory

responses USEPA Tox. Review of Chlorine dioxide and chlorite, 2000 Daniel, 1990, cited in IPCS Chlorine dioxide (Gas) 2002) CICADS 37.

3.4.1 According to the presented and existi ng data there seems to be a concentrationdependent development of thyroid lesions in rode nts exposed to sodium chlorate in drinking water. The relevance of these findings to human exposure needs to be elucidated (Toxicologic Pathology, 2001). Most of the potentia l adverse effects are associated with blood oxidation (i.e. EPA study, 1987).GESAMP-BWWG 7/9 ANNEX 5 Page 22

I:\MEPC\58\2-8.doc 3.4.2 According to the presented data, there se emed to be relevant toxicological concerns towards repeated exposure to hydrogen peroxide. This is also confirmed in the RAR on hydrogen peroxide.

3.4.3 In numerous repeated inhalation studies with sulfuric acid aerosol, toxicity was confined to changes in the structure and function of the respiratory tract, sugges ting that it has a local effect and no systemic effects (OECD SIDS).

3.4.4 According to the presented data subchroni c studies with chlorine dioxide suggest the same kind of findings as with sulfuric acid (local inflammatory response rather than systemic effects).

3.5 Chronic and long-term toxicity

3.5.1 The Group noted that there are no data pr esented with regards to chronic and long-term toxicity.

3.6 Developmental and Reproductive Toxicity

Test Substance Exposure Route Species Value range Reference/ Comments

Preparations Purate ®

Sodium chlorate Oral, 1,000 mg/kg d, 6-15 d gestation Rat Not teratogenic Purate ® MSDS, Eka Chemicals

Hydrogen peroxide -- -- Sufficient data not available Purate ® MSDS, Eka Chemicals

Sulfuric acid -- -- Not reported or expected to

cause teratogenic or reproductive toxicity. OECD SIDS SIAR, SIAM 11 (January 2001), UNEP Publications

Active Substance

Chlorine dioxide a. Gavage, (0, 2.5, 5.0 or 10 mg/kg doses in water, prior to and during mating) Rat NOAEL: 10 mg/kg- d USEPA Tox. Review of chlorine dioxide and chlorite, 2000GESAMP-BWWG 7/9 ANNEX 5 Page 23

I:\MEPC\58\2-8.doc 3.6.1 According to the presented data (MSDS) , sodium chlorate is not teratogenic.

3.6.2 According to existing data ((RAR, hydroge n peroxide), there are no appropriate animal studies available for a complete evaluation of reproductive and developmental toxicity. Two limited studies with mice and rats e xposed to hydrogen peroxide in drinking water suggested no grave disturbances on th e male or female reproductive functions (Wales et al. , 1959, Hankin, 1958). With re gards to developmental toxicity a decision was reached on the presumption that conventional st udy protocols (e.g., administration in drinking water) were unlikely to show specific embryonal or foetal e ffects, firstly, because it is doubtful whether hydrogen peroxide (as opposed to its degrada tion products oxygen and water) would reach the foetus and, secondly, because local effects in the mother possibly causing nutritional disturbances and general toxicity, are expected.

3.6.3 Since sulfuric acid is a direct-acting toxicant, and since it is not likely that it will reach the reproductive organs, reproductive effects in mammal s are not likely to occur following exposure to sulfuric acid by any route. In a developm ental toxicity/teratoge nicity study conducted by inhalation with sulfuric acid aerosol, the NOAEL for maternal toxicity appears to be 20 mg/m 3 in mice and rabbits. No evidence of foetotoxicity or teratogenicity was seen in either species (OECD, SIDS).

3.6.4 In the USEPA Tox review of chlorine di oxide there is a refere nce to a developmental study on rats. In this study, a NOAEL of 20 mg/L was established based on decreased exploratory and locomotor activities in the offspring. Chlorine dioxide has been shown to impair neurobehavioural and neurologi cal development in rats expos ed perinatally. Significant depression of thyroid hormones ha s also been observed in rats and monkeys exposed to it in drinking-water studies. A guideline value has not been established for chlorine dioxide because of its rapid hydrolysis to chlo rite and because the chlorite provisional guideline value is adequately protective for potential to xicity from chlorine dioxide.GESAMP-BWWG 7/9 ANNEX 5 Page 24

I:\MEPC\58\2-8.doc 3.7 Carcinogenicity, Muta genicity/Genotoxicity

Test Substance Exposure Route Species Value range Reference/ Comments

Preparations Purate ®

Sodium chlorate -- -- Not considered to be carcinogenic or mutagenic. Purate ® MSDS, Eka Chemicals

Hydrogen peroxide -- -- Mutagenicity, in vitro: mutagenic without metabolic activation, not mutagenic with metabolic activation. In vivo : no mutagenic effect after oral administration. Carcinogenicity: animal experiments do not show clear evident in different species. Purate ® MSDS, Eka Chemicals

Sulfuric acid - - Not considered carcinogenic or mutagenic. Sulfuric acid MSDS, Basic Chemical Solutions

Active Substance

Chlorine dioxide -- -- Carcinogenicity: Sufficient data not available. Genotoxicity: both positive and negative results. See Section 2.2.6 of dossier. USEPA RED for chlorine dioxide and sodium chlorite; USEPA Tox. Review of chlorine dioxide and chlorite, 2000

3.7.1 According to the presen ted data (MSDS) sodium chlo rate is not mutagenic or carcinogenic.

3.7.2 According to existing da ta ((RAR, hydrogen peroxide) it can be concluded that the special nature of demonstrated carcinogenicity of hydrogen peroxide, and the overall evidence available, cast some doubt on wh ether hydrogen peroxide should be regarded as a carcinogen of practical significance. The weak effect found in complete carcinogenesis studies in mice as well as in some promotion studies suggest promo tion type of activity and possible underlying genotoxic mechanisms. Given the fact that mammalian cells have of necessity built defenses against reactive oxyg en species arising in endogenous me tabolism, the injuries caused by hydrogen peroxide may well be non-stochastic, i.e. have a dose/dose rate threshold. This evidence, however, is not suffi cient to trigger classification.

According to a conclusion in existing literature (RAR on hydrogen peroxide) hydrogen peroxide is a mutagen and genotoxicant in a variety of in vitro test systems.GESAMP-BWWG 7/9 ANNEX 5 Page 25

I:\MEPC\58\2-8.doc 3.7.3 According to the presented data (OECD, SIDS), sulfuric acid has been shown to be without effect in gene tic toxicity studies in vitro (bacterial test). It ha s been shown to cause chromosomal aberrations in a non-bacterial test in vitro . The chromosomal effects are well known to be a consequence of reduced pH, be ing seen using any strong acid. There are no in vivo mutagenicity studies available.

No carcinogenic effect was obs erved in carcinogenicity stud ies conducted by inhalation with sulfuric acid aerosol usi ng 3 different animal species. Small increases in tumor incidence were reported in rats and mice after chro nic gastric intubation or intratra cheal instillation of sulfuric acid solution, but no clear conclusion can be drawn from these studies.

IARC has concluded that “occupational exposu re” to strong inorgani c mists containing sulfuric acid is carcinogenic for humans (Group 1). Concerns have been raised that confounding factors could not be fully excluded.

3.7.4 From USEPA RED for chlori ne dioxide: Chlorine dioxide has not been assessed for its carcinogenic potential. The available dermal carcinogenicity studies do not definitely characterize the carcino genicity of chlorine dioxide. On e subchronic rat study examined the effects of administration of chlorine dioxide at dose levels of 0, 25, 50, 100 or 200 mg/L for 90 days in drinking water. In this subchroni c rat study a significant in crease in the incidence of nasal lesions was found at a ll dose levels tested . The significance of these findings is uncertain, as they have not been observed in other long-term studies of chlorine dioxide.

3.7.5 Data on the mutagenicity of chlorine dioxi de indicate that negative effects were reported in one study from a 400-fold drinking water con centrate of chlorine dioxide, whereas a 4000-fold concentrate was mutagenic only in the absence of metabolic activation. In another study, chlorine dioxide was positive for forward mutations under non- activated conditions. Chlorine dioxide was positive for structural chromosomal aberrations under non-activated and activated conditions and was negative for increased transformed foci up to cytotoxic levels. In one mouse study on chlorine dioxide, in vivo micronucleus and bone marrow chromo somal assays were negative as was a sperm-head abnormality assay.

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Environmental fate

Test Substance Test Reason for not supplying the data Active Substance

Chlorine dioxide Hydrolysis at pH 5, 7, 9; Chlorine dioxide does not hydrolyze to an appreciable extent; remains in solution as a dissolved gas. See Section 2.3.1. Degradation is through oxidative reactions. Chlorite ionGESAMP-BWWG 7/9 ANNEX 5 Page 26

I:\MEPC\58\2-8.doc 4.2 Partition Coefficients

Test Substance Log Kow Reference/Comments Active Substance

Chlorine dioxide -3.22 USEPA Reregistration Eligibility Decision (RED) for Chlorine dioxide and sodium chlorite (Case 4023), August 2006

Chlorite ion -7.17 (as sodium

chlorite) USEPA Reregistration Eligibility Decision (RED) for Chlorine dioxide and sodium chlorite (Case 4023), August 2006

4.3 Persistence and Identifica tion of Main Metabolites

Test Substance Test Reason for not supplying the data Active Substance

Chlorine dioxide -- Physical and chemical properties (highly soluble, inorganic, decay behaviour) do not indicate persistence.

Chloride is the primary urinary metabolite (see section 2.2.8).

Chlorite ion -- Physical and chemical properties (highly soluble, inorganic, decay behaviour) do not indicate persistence.

Chloride is the primary urinary metabolite (see section 2.2.8).

4.4 Reaction with Organic Matter

Test Substance Discussion of the reaction, including formation of hazardous byproducts Reference/ Comments

Active Substance

Chlorine dioxide Chlorine dioxide is an oxidizing agent. Chlorine dioxide does not chlorinate organic matter, thus its use does not promote the formation of trihalomethanes (THMs). The primary product of chlorine dioxide reduction is chlorite ion. USEPA Office of Water, http://www.epa.gov/ safewater/ mdbp/pdf/alter/ chapt_4.pdf

Chlorite ion The reaction of chlorite ion with organic matter does not produce harmful organic chemical species and typically results in a chemical reduction of chlorite ion to chloride ion, which is ubiquitous in the marine environment. Therefore, theproduction of harmful organic byproducts is not anticipated. Review of the Environmental Fate and Effects of Chlorine dioxide and chlorite, Nautilus Environmental, 2007GESAMP-BWWG 7/9 ANNEX 5 Page 27

I:\MEPC\58\2-8.doc 4.5 Potential Physical Effects on Wildlife and Benthic Habitats

Test Substance Physical Description Discussion of Potential Effects Reference/ Comments

Preparations

Purate ® Purate ® is an aqueous solution with water-like viscosity. Purate ® is non-organic and the sodium chlorate and hydrogen peroxide components of Purate ®

are both soluble in water. Based on the chemical properties in Table T2-10, Purate ® is not expected to accumulate in sediments, form surface slicks or deposit on the seabed. Compared physical and chemical properties to criteria used in GESAMP Reports and Studies No.64.

Sulfuric acid Sulfuric acid is a clear, dense, odorless liquid. Sulfuric acid is miscible and completely ionizes in water. Based on the chemical properties in Table T2-10, sulfuric acid is not expected to accumulate in sediments, form surface slicks or deposit on the seabed. Compared physical and chemical properties to criteria used in GESAMP Reports and Studies No.64.

Active Substance

Chlorine dioxide When dissolved in water, chlorine dioxide generated with the Ecochlor ® BWTS forms a pale green solution. The solution has a viscosity and solubility similar to water and an odor similar to chlorine. Based on the chemical properties in Table T2-10, chlorine dioxide is not expected to accumulate in sediments, form surface slicks or deposit on the seabed. Compared physical and chemical properties to criteria used in GESAMP Reports and Studies No.64.

Chlorite ion The chlorite ion present in treated ballast water is completely soluble, and has a viscosity similar to the treated water. At the low concentration present in treated water chlorite will not have an identifiable color or odor. Based on the chemical properties in Table T2-10, chlorite is not expected to accumulate in sediments, form surface slicks or deposit on the seabed. Compared physical and chemical properties to criteria used in GESAMP Reports and Studies No.64.GESAMP-BWWG 7/9 ANNEX 5 Page 28

I:\MEPC\58\2-8.doc Treated Ballast Water

Treated Ballast Water The properties of the treated water are generally unaffected by chorine dioxide treatment. pH ranges from 6.7 to 7.6. Based on the chemical properties in Table T2-10, treated ballast water is not expected to have an effect on marine sediments, form surface slicks or deposits on the seabed. Compared physical and chemical properties to criteria used in GESAMP Reports and Studies No. 64.

4.6 Potential Residues in Seafood

Substances Discussion

Purate ® , Sulfuric acid , Chlorine dioxide, chlorite Ion, Treated Ballast Water Physical and chemical pr operties (highly soluble, inorganic, and/or decay behavi or) of all substances used with the Ecochlor ® BWTS or created by the treatment process to not indicate the potential for residues in seafood.

4.7 Any Known Interactive Effects

Substances Discussion

Purate ® , sulfuric acid , Chlorine dioxide, chlorite Ion, Treated Ballast Water There are no other known or anticipated interactive effects expected with any substance involved with the Ecochlor ® BWTS process.GESAMP-BWWG 7/9 ANNEX 5 Page 29

I:\MEPC\58\2-8.doc 5 PHYSICAL AND CHEMICAL PROP ERTIES: PREPARATIONS, ACTIVE SUBSTANCE, RELEVANT CHEMICAL S AND TREATED BALLAST WATER

Physical/Chemical Property (with units & reference) Preparations

1. Purate ®

2. Sulfuric acid (78% by weight) Active Substance

Chlorine dioxide (solution) Relevant Chemical

Sodium chlorite Treated Ballast Water

Melting point (oC) 1. -29 2. -11.3 Same as water (0oC) Boiling point (oC) 1. 111 2. 193 Same as water (100oC) Flammability (flash point for liquids; oC) 1. Non flammable a 2. Non flammable Not applicable

Density (20oC; kg/m 3 ) 1. 1370 ca. 2. 1708 1000 - 1035 ca (for dilute sol’n in seawater) Vapor pressure 1. 6700 Pa (40oC, 40% sodium chlorate sol’n) 2. <133.32 Pa (37.8oC) 399.9 Pa (30oC)

Vapor density (air=1) 1. Similar to water b 2. 3.4 @ boiling Point 2.3

Water solubility (temp; effect of pH; mg/L) 3.0 g/L @ 25oC and 34 mmHg 39 g/100 ml at 17°C (from solid form) pH in solution 1. 2 ca 2. <1 (1% aq.sol’n) ca 6.7 - 7.6

Dissociation constant (pKa) 1.72 i 1.72 i

Oxidation-reduction potential 1. Strong Oxidizer 2. Strong Oxidizer 0.95 V @ pH 4-7 ca 100 – 700 mV k

Corrosivity to material or equipment 1. See note c 2. Corrosive Produced in situ and delivered to ballast tanks with materials designed for ClO2. Similar to untreated ballast water (see Section 6.1.2) Similar to untreated ballast water (see section 6.1.2)

Reactivity to container material 1. Yes d

2. Yes e Produced in situ

, not stored Autoignition temperature (oC) 1. Not applicable 2. No Data Available Not applicable

Explosive properties Stable as an aqueous sol’n jGESAMP-BWWG 7/9 ANNEX 5 Page 30

I:\MEPC\58\2-8.doc Physical/Chemical Property (with units & reference) Preparations

1. Purate ®

2. Sulfuric acid (78% by weight) Active Substance

Chlorine dioxide (solution) Relevant Chemical

Sodium chlorite Treated Ballast Water

Oxidizing properties 1. Strong oxidizer f 2. Strong oxidizer g Intended for use as disinfectant/ oxidizer Surface tension 1. See note h

2. Not Available Similar to intake

water

Viscosity (20oC) 1. 1.8 mPa.s 2. 26.7 mPa.s Same as treated

seawater The low concentration will not affect typical seawater viscosity 1060 cP (20oC) (same as seawater)

Thermal stability and identity of breakdown products Avoid elevated temps to avoid/reduce evolution of ClO2 gas. Other physical or chemical properties 1. Liquid slight blue colour w/ slightly pungent odour. 2. Dense, viscous, colourless, odourless liquid Pale green/yellow solution with an odour similar to chlorine. -- --

Salinity 23.8 – 24.7 PSU

TOC/DOC, % Particulate Matter 3271 μ g/L (TOC) 3073 μ g/L (DOC) 6.05% l

a Contact with organic materials e.g. textiles, wood or leather may cause fire, if allowed to dry. Contamination from various metals or organic ma terials may cause rapid decomposition, resulting in oxygen gas release and pressure build-up if not properly vented.

b Purate ® is a solution of sodium chlorate and hydrogen per oxide containing 52% water. The only relevant vapour present is water vapor.

c Purate ® is corrosive to carbon steel, copper, and brass. Stai nless steel 316 and 316L are suita ble. Non-metal materials such as CPVC, PVDF, PTFE, ECTFE, and vinyl ester re sins offer excellent perform ance. Polyethylene and polypropylene offer good performance, typically for storage tanks.

d Materials to Avoid: Incompatible mate rials and chemicals such as organic mate rials, alkaline substances, strong acids, phosphorus, sulfur, sulfides, sulfites, an d metal/ammonium salts. Cont aminated organic materials ignite readily if allowed to dry. Decomposes in contact wi th certain metals and alkalis, which gene rates oxygen gas. Risk of explosion.GESAMP-BWWG 7/9 ANNEX 5 Page 31

I:\MEPC\58\2-8.doc e Do not store near bases, halides, sulfid es, picrates, nitrates, chlorates, carbides, fulminates, cyanides, and reducing agents. Do not allow water to enter containers. Sulfuric acid may be safely stored in properly designed bulk storage tanks.

f Contamination from various metals or organic materials may cause rapid decomposition, resulting in oxygen gas release. Assists combustion. Contaminated clothing will b ecome highly combustible if allowed to dry, and may be ignited by friction or heat.

g Sulfuric acid is not flammable or com bustible. However, it is hi ghly reactive. Concentrated sulfuric acid is a strong oxidizer capable of igniting combustible materials on contact.

h No test data is available. Expect it to be similar to a water solution of ionic salts, like sodium chloride.

i The pKa for chlorous acid (HClO 2 ) is 1.72. HClO 2 ↔ ClO 2 - + H +

j BWTS chlorine dioxide solution (5 mg/L) is >99.5+% water a nd is generally water-like. Highly concentrated solutions (>8000 mg/L) can be explosive.

k At higher end of range immediately afte r chlorine dioxide treatment, then decr eases to values similar to untreated ballast water.

l % Particulate matter calculated as follows: 100 * (TOC-DOC)/TOC.GESAMP-BWWG 7/9 ANNEX 5 Page 32

I:\MEPC\58\2-8.doc 6. OTHER INFORMATION

6.1 Material Safety Data Sheets and GHS Classification

Substance MSDS Provided (Yes/No) Classification Reference/ Comments

Preparations

Purate ® Yes O, Xn, N R-phrases: R9, R22, R36, R51/53 S-phrases: S3/4, S36/37/39, S46, S61 European Union directive on classification of hazardous preparations (1999/45/EC)

Sulfuric acid Yes Health: Acute Tox: Category 3 (oral, dermal) Eye Effects: Category 1 Skin Corrosion: Category 1 Skin Sensitization: No category proposed Mutagenicity: No category proposed Carcinogenicity: Not a suspected cancer-causing agent Reproductive/Developments: No category proposed Target Organ Toxicity (repeated): Category 3 Environmental: Acute Aquatic Tox: Acute 2 Chronic Aquatic Tox: Chronic 2 Physical: Corrosive to Metals: Category 1 GHS Classification System (United Nations, 1 st Revised Edition, 2005)

Active Substance

Chlorine dioxide Yes R-phrases: R20, R36/37/38 S-phrases: S24/25, S26, S36/37/39 European Union directive on classification of hazardous substances (2001/59/EC) Annex IGESAMP-BWWG 7/9 ANNEX 5 Page 33

I:\MEPC\58\2-8.doc 6.2 Risk Characterization

Substance Persistent (Yes/No)

Half-life: >60 d in marine water, or >40 d in freshwater, or >180 d in marine sediment >120 d in freshwater sediment Bioaccumulative (Yes/No)

BCF >2,000 or Log Kow ≥ 3 Toxic (Yes/No)

Chronic NOEC <0.01mg/L

Chlorine dioxide No No No

Chlorite ion No No No

6.3 Analytical Methods at Environm entally Relevant Concentrations

Test Substance Analytical Methods Sensitivity

Active Substance

Chlorine dioxide Chlorine dioxide residuals are measured using the lissamine green B (LGB) chemistry (USEPA Method 327) 0.1 to 20 mg/L

Chlorite ion Chlorite ion residuals are measured by ion chromatography (IC) (USEPA method 300.1) 5.0 μ g/L to concentrations in excess of 5.0 mg/L

Treated Ballast Water Treated Ballast Water See above methods for analysing chlorine dioxide and chlorite i on in treated ballast

water. --

***GESAMP-BWWG 7/9

I:\MEPC\58\2-8.doc ANNEX 6

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

NK-O3 Blue Ballast Water Treatment System

Submitted for Final Approval by the Republic of Korea

0 SUMMARY

0.1 Final Approval of the NK- O3 Blue Ballast Water Treatm ent System using ozone, based on the submission provided by the Republic of Korea is not recommended.

0.2 The Group noted that the proposed system applies onboard ozone ge neration without any chemicals carried on board the ship. A maximum dosag e of 2.5 mg/L ozone is then injected into the incoming ballast water for treatment. No dedi cated filtration unit is included in the system. Ozone and TRO are classified as Ac tive Substances for this system.

0.3 The applicant states that dosage of ozone is monitored and controlled automatically with a TRO sensor in the ballast water line after inj ection of ozone controlling the flow of injected gas. The Group, however, considered that an im proved control system would be necessary to ensure correct dosing.

0.4 During review at the GESAMP-BWWG-7 meeti ng, the Group noted th at no report on the results of chemical analyses was available in the dossier. After re questing supplementary information, the applicant had submitted one page with results of the chemical analyses. However, no information on which samples had been analysed, how the analyses had been carried out, which laboratory that had been ca rried out the analyses, and which quality control system that was in place was submitted, and ne ither was the report dated and signed. The Group noted that this report submitted did not meet stan dard requirements and that it was not possible to assess the validity of the results presented.

0.5 The Group noted that degradation within a period of 48 h of TRO was presented based on results from four of the land-based G8 tests show ing that most of the TRO has been degraded in this period. Based on these results the applicant proposed a holding time for ballast water treated with NK-O3 to be 2 days at minimum. Howeve r, this is not accepta ble for the Group as no ecotoxicity testing has been carried out on samp les from such holding time and no exact values for remaining TRO from the land-based tests were presented. The Group additionally noted that the dossier included information, which indicated that TRO levels were well above detectable levels after 2 days.

0.6 A figure presenting the degradation rates of TRO in the 48 h period is comparable to other applications and data from open literatur e using ozone to treat water with high organic content. The Group noted, however, that ha lf-life of 15 hours has been reported for another BWMS using ozonation resu lting in concentrations at 160 μ g/L at de-ballasting after 5 days. Further, the Group noted that a half -life of 1–2 days was presented by the applicant in the Basic Approval dossier. This leads to a calculated 0.13 mg/L of TRO at discharge after 5 days tank holding. The Group recommends th at further analysis and tests on degradation rates of TRO in the ballast tanks should be conducte d to verify the actual conditions attained.GESAMP-BWWG 7/9 ANNEX 6 Page 2

I:\MEPC\58\2-8.doc 0.7 The Group noted that Whole Effluent Toxi city (WET) tests base d on samples from two land-based G8 tests were included in the dossier. Samples were ta ken at discharge after 5 days holding time. However, the dossier was inconsistent in the presented dates of tests and samples received at laboratory and the Group is th erefore uncertain about the QA procedures implemented in the sample handling.

0.8 The Group considered that ha logenated DBPs (Disinfection By-Products) are the relevant substances generated by the process including halogenated acetic acids (HAA) and trihalomethanes (THM).

0.9 The Group noted that the applicant conducted new in vivo studies to evaluate the Whole Effluent Toxicity (WET) for the endpoints of acute toxicity and genotoxicity/mutagenicity. In this context, the Group wants to inform that it disapproves of animal te sting for the purpose of generating new data, being not required to be submitted fo r Whole Effluent Toxicity. Unnecessary testing of animals s hould be discouraged by all means.

0.10 The Group noted that the applicant carried out corrosion tests usi ng a limited number of test coupons exposed to treated and untreated ballast water in the G8 land-based tests. An exposure time of approximately 100 h was used in the tests and ba sed on these samples average corrosion rates were calculated. The Group recommends additional longer duration tests are carried out with both uncoated and coated samples to verify th e corrosive effect to steel and that the effect of using this BWTS on epoxy coated ballast tanks remains acceptable.

0.11 The Group concludes that the dossier subm itted by the applicant is inconsistent and incomplete as regards:

.1 tracking of samples of treated ballast water sent for chemical analyses and ecotoxicological testing;

.2 reporting of results of chemical analyses;

.3 explaining the remarkable differences be tween previous results and current results;

.4 estimation and/or assessment of Pred icted Environmental Concentrations for Active Substances and Relevant Chemicals; and

.5 environmental risk assessme nt (calculation of PEC/PNEC).

0.12 Due to the above-mentioned inconsistencie s and missing information, the Group is not able to conduct a thorough assessm ent of risks to the aquatic envi ronment of discharge of treated ballast water. Consequently, the Group cannot recommend that a Final Approval be given to NK-O3 Blue Ballast Water Treatment System.GESAMP-BWWG 7/9 ANNEX 6 Page 3

I:\MEPC\58\2-8.doc 1 INTRODUCTION

1.1 The proposed NK-O3 Blue Ballast Wa ter Treatment System using ozone was given a Basic Approval by MEPC 56 based on a favourable opinion issued by the GESAMP-Ballast Water Wo rking Group at its third m eeting in February 2007 after reviewing the application submitted by the Republic of Korea.

1.2 The data for this document were extracted from the original data supplied by the Republic of Korea to support its submission ME PC 58/2/3 and the confidential dossier issued to the Organization.

2 COMPLETENESS OF THE DOSSIER

2.1 A full confidential dossier, including the a pplication for Final A pproval with detailed information about Active Substances and Rele vant Chemicals, results from G8 tests and ecotoxicity tests, and the supporting technical ma nuals and references have been submitted to the GESAMP-BWWG. In detail, these were:

- Summary of Key Data;

- Human exposure assessment;

- MSDS;

- One corrosion test;

- Generic Quality Management Plans and testing reports for G8 and G9 testing;

- Standard operation procedure;

- Manuals for the NK-O3 system; and

- References.

2.2 Within the application dossier presented, the Group identified that some information was missing and also identified topi cs where a further clarification was needed. The Group established a list of que stions for which the answers were needed for a sound evaluation of the system presented by the Korean Administrati on. The questions and answers as well as the Group’s comments to these answers are pr esented in appendix 2 to this document.

3 DESCRIPTION OF NK-O 3 BLUEBALLAST SYSTEM

3.1 Overview of the system

3.1.1. The Group noted that the NK-O3 BlueBallast System uses a shipboard oxygen generator, which takes ambient air and strips away the ni trogen, concentrating the oxygen content – which is then passed through a high frequency electrical field to produce ozone (O 3 ). The ozone is then injected into the incoming ballast water as treatment.

3.1.2 The NK-O3 System is composed of f our integrated modules: oxygen generator, ozone generator, ozone injector, and monitoring and control system.GESAMP-BWWG 7/9 ANNEX 6 Page 4

I:\MEPC\58\2-8.doc 3.1.3 The ozone generator passes the incomi ng oxygen through a high frequency electrical field to produce ozone.

3.1.4 The ozone injector is based on a purpose-built patented ‘sid e-stream injector’. This diverts incoming ballast water from the main ballast pipes into a ‘side-stre am’, where it is injected with ozone before re-entering the main ballast water stream. The applicant stat ed that the BWMS was optimized through use of the side-stream injector design and venture. The Group noted that this change would alter the ratio of production of TRO from ozone gas and this would also change the generation of other Relevant Chemic als. Also, the Group noted that the applicant claims that this change in design would increase the TRO degrada tion rate and lower the production of bromoform in ballast tanks. The Group considers that further measurement and analysis is necessary to confirm the effects of changing the injection design on the Relevant Chemicals.

3.1.5 It was noted that the submission states that the monitoring and control system uses standard technology, and includes a variety of sensors, alarms , meters, valves and switches connected to central control software, and integrat ed with the ship’s overall ballast management system. This allows all aspects of the system to be monitored and controlled and all data on system operation to be kept electronically and printed as required by inspectors. The system includes safety alarms and automatic cut-off switch.

3.1.6 Ancillary equipment consist of a power s upply unit, a compressor to feed air to the oxygen generator, refrigerated dryer to de-hum idify air being fed to the oxygen generator, a chiller, which keeps the ozone ge nerator cool, and an ozone dest ruct system to convert any unused ozone back to oxygen before being released to the atmosphere.

Schematic of overall Layout of the NK-O3 BlueBallast System OXYGEN GENERATOR OZONE INJECTOR OZONE GENERATORGESAMP-BWWG 7/9 ANNEX 6 Page 5

I:\MEPC\58\2-8.doc 3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 The applicant describes the system as follows: when ozone (O 3 ) is injected into the ballast water, it reacts with bromide that occurs na turally in seawater to produce bromide ions. In this process the ozone is destroyed extremely rapidly, and the TRO becomes the main Active Substance.

TRO (Total Residual Oxidants) Chemical name ozone (Triatomic Oxygen) Hypobromous acid Hypobromite ion CAS number 10028-15-6 13517-11-8 - UN number & name 1956 - - Molar mass 48.00 96.91 95.90 Empirical formula O 3 HOBr OBr Structural formula Purity 10~15 wt% By-product By-product

3.2.2 Relevant Chemicals: In seawater th e formed bromide ions rapidly form hypobromous acid and hypobromite ions, which al so react with any organic matte r that may be present in the ballast water to form bromoform. Other po ssible bromide related by-products include bromate ions, dibromoacetic acid an d bromochloroacetic acid.

Chemical name Bromate ion Bromoform (Tribromomethane) CAS number 15541-45-4 75-25-2

Molar mass 127.90 252.73 Empirical formula BrO 3 - CHBr 3 Structural formula

Chemical name Bromochloroethanoic acid (Bromochloroacetic acid) Dibromoethanoic acid (Dibromoacetic acid) CAS number 5589-96-8 631-64-1

Molar mass 173.39 217.84 Empirical formula C 2 H 2 O 2 BrCl C 2 H 2 O 2 Br 2 Structural formula

3.2.3 The Group noted that in cases where sh ips take on fresh-water ballast, brominated compounds are not formed, and the ozone alone is the Active Substance. For seawater ballast, ozone and TRO are the two Acti ve Substances of relevance to the NK-O3 System. The by-products bromoform, dibromoacetic acid and bromochloroacetic acid are collectively referred to as disinfection by-products (DBPs), and ma y be considered as Relevant Chemicals.GESAMP-BWWG 7/9 ANNEX 6 Page 6

I:\MEPC\58\2-8.doc 3.2.4 The discharge characteristics of ballast water treated by the NK-O3 System are indicated by the test results from the chemical analysis co nducted during the land-based (barge) testing, as follows:

Table: Results of chemical analyses of treated ballast water

Active Substance and Relevant Chemicals Unit Control Treated MDL 1)

Ballasting Ozone (Calculated) mg/L - 2.06~ 2.35 (avg 2.20) - TRO mg/L ND 2) 3.62~ 4.84 (avg 4.24) 0.02

Deballasting (n=10) Ozone mg/L ND ND 0.01 TRO mg/L ND ND 0.02 Bromate ion μ g/L ND ND 1.00 Trichloromethane μ g/L ND ND 5.00 Bromodichloromethane μ g/L ND ND 0.70 Dibromochloromethane μ g/L ND ND 0.70 Tribromomethane μ g/L ND ND-28.4 (avg 6.38) 1.00 Monochloroacetic acid μ g/L ND ND 2.13 Dichloroacetic acid μ g/L ND -8.09 (avg 1.38) ND -0.85 (avg 0.20) 0.08 Trichloroacetic acid μ g/L ND -0.36 (avg 0.02) ND -0.70 (avg 0.02) 0.03 Bromochloroacetic acid μ g/L 0.30-9.32 (avg 4.17) 0.78-11.9 (avg 5.97) 0.03 Dibromoacetic acid μ g/L ND -2.64 (avg 0.65) 0.43-8.05 (avg 3.97) 0.04

1) MDL: Method Detection Limit (unit not indicated: mg/L or μ g/L) 2) ND: Not detected (< MDL) 3) For the calculation average va lues, the ND values are used.

3.2.5 The applicant stated that all samples for ch emicals analysis of treated ballast water were taken after 5 days holding time in the ballast wa ter tank. However, in the one-page report on the results of the chemical analyses submitted by the applicant, there was no statement of the timing of sampling. Also, the Group noted that no info rmation for the concentr ation between initial and 5 days were provided, so that the Group ca nnot evaluate the degrad ation rate of TRO only from these results. Lastly, the Group noted th at the assumption of average values for the substances including ND values is not adequate.

3.2.6 During Basic Approval the applicant clea rly stated that TRO has a half-life of between 1 and 2 days in the ballast water tank (i n dark conditions). The Group noted that when calculating a half-life of TRO of one day, this would lead to a residual content of at least 0.13 mg/L TRO in the ballast water tank, and consequently in the discharge after a 5-day tank holding with an initial TRO level of 4.24 mg /L. The Group noted that this calculated value is greater than the detection limit of TRO (0 .02 mg/L) provided by applicant. Therefore, the Group was of the opinion that the degradation of TRO in ballast tank using the same natural seawater in the Port of Busan port has change d significantly between Basic and Final Approval. The Group recognizes that, theoretically, there is th e possibility that design changes in the ballast water management systems between Basic a nd Final Approval could have resulted in two different compositions of oxidant with similar initial TRO values, but completely different degradation rates. However, the Group recommends that additional analysis and validation would be required to enable it to have confidence in the evaluation of chemical identification and degradation rate.GESAMP-BWWG 7/9 ANNEX 6 Page 7

I:\MEPC\58\2-8.doc 4 HUMAN HEALTH ASSESSMENT

4.1 The Group considered the relevant toxicological data that were submitted by the applicant for ozone, TRO and DBP in the c onfidential version (3 .4). Additionally, the Whole Effluent Toxicity (WET) was tested in new in vivo studies for the endpoints of acute toxicity and genotoxi city/mutagenicity.

4.2 In this context, the Group wants to inform that it disapproves of animal testing for the purpose of generating new data that are not required to be submitted for Whole Effluent Toxicity. Unnecessary testing of animals s hould be discouraged by all means.

4.3 The Group noted that MSDS for ozone, bromoform, bromoc hloroacetic acid, dibromoacetic acid have been provided and th at the Human Exposure Assessment (HEA) was elaborated by the applicant.

4.4 The Group noted that safety systems have been foreseen by the applicant to prevent contact of ship personnel to ozone in the vicini ty of the NK-O3 System. These are described in the section “5 Risk to Safety of Ship” below.

4.5 During Basic Approval, the Group raised conc erns about the possibility of free ozone gas being present in the ship’s ballast tanks when they are emptied and that personnel may be exposed when entering the tanks for inspection and maintenance purposes, and also about the possibility of gaseous ozone being emitted from the ballast tank air vents during ballasting.

4.6 The applicant explains that it is highly improbable that ballast tanks w ould ever be opened and entered within a shor t time after the NK-O3 System having been operated, which occurs during ballasting. Ballast tanks need to be emptied prio r to entry, giving more than sufficient time for the breakdown of ozone. To address the perceived concern of the Group, safety procedures have been supplemented to recommend an exclusion zone of 1 metre, to be painted on the ship’s deck around each ballast tank air vent with clear notice for personnel to keep out of these zones during ba llasting. This will be included in crew induction and safety training in ships fitted with the NK-O3 System, as reflected in the updated Operation and Main tenance Manual and Safety Manual for oz one system.

4.7 The applicant suggests risk mitigation m easures concerning bromoform, which could include periodic sampling of system effluent as part of port Stat e control compliance procedures.

5 RISK TO SAFETY OF SHIP

5.1 Free Ozone in vicinity of the NK-O3 System

5.1.1 The Group noted that the following safety pr ecautions have been put in place to prevent exposure of ships crew with ozone:

.1 The use of materials and construction that is designed to prevent any possible leakage of ozone from the system;

.2 A gas separation unit together with a wa ste ozone destruction unit placed after the treatment unit, to destroy ozone produced during start up and te sting of the ozone and convert it back to oxygen prio r to release to the atmosphere;GESAMP-BWWG 7/9 ANNEX 6 Page 8

I:\MEPC\58\2-8.doc .3 An ozone densitometer to detect any po ssible accidental leakag e from the system;

.4 Recommended inspection and maintenance procedures and clear ly outlined safety procedures as contained in supportin g operating manuals for personnel;

.5 An automatic alarm and shut-down system linked to the ozone densitometer. This is designed to trigger if ozone levels in the vicinity of the system exceed 0.2 mg/L (the recommended safe level is 0.1 mg/L); and

.6 Other events that will shut down the system immediately, close all valves and stop all pumps are high ambient oxygen co ncentration (25%), no Volumetric Oxygen Deficit (VOD) avai lable, emergency stop push button pressed and fire alarm.

5.2 Corrosion

5.2.1 The Group noted that the corrosion tests performed with treated ballast water did not show any increased corrosion rates. The side-str eam injector ensures a restricted high dosage area. This is stated to eliminate potential for co rrosion, by concentrating th e ozone in the injector area only, which is made from high- grade, non-corroding stainless steel.

5.3 Fire and Explosion

5.3.1 The Group was informed that a potential fire hazard associated with the NK-O3 System is the temporary storage of oxygen produced during ope ration of the system, wh ich is used as the raw material to produce ozone.

5.3.2 Where oxygen is stored in high pressure cy linders, the submission c onfirms these will be manufactured to international safety standards an d placed within a fire-proof cabinet. Oxygen is purged from the storage system a nd released to atmosphere when the system is not in operation. In case of supplementary oxygen cy linders storage, the cylinders would be manufactured to international safety standards and placed within a fire-proof cabinet and/or located outside of the ship’s engine room.

5.3.3 The Group noted that the whole system is equipped with fire alarm and shut-down systems linked to the ship’s fire alarm system.

6 RISKS TO THE AQ UATIC ENVIRONMENT

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

6.1.1 The Group concluded already at Basic Approval that none of the chemicals involved in the NK O3 BlueBallast System fulfil the PBT criteria.GESAMP-BWWG 7/9 ANNEX 6 Page 9

I:\MEPC\58\2-8.doc 7 ASSESSMENT OF TREATED BALLAST WATER

7.1 Measured concentrations in treated ballast water

7.1.1 The Group noted that chemical analyses had been carried out on samples of treated ballast water taken at de-ballasting after 5 days’ holding time w ith the aim of identifying Active Substances and Relevant Chemicals. A dditional information given by the applicant upon request stated that the samples we re collected from the land based G8 tests performed. A table in the additional information indicated that samples for chemical analysis were collected from all land-based tests.

7.1.2 During review at the GESAMP-BWWG-7 mee ting, the Group noted th at no report on the results of chemical analyses was available in the dossier. After re questing supplementary information, the applicant had submitted one page with results of the chemical analyses. However, no information on which samples had been analyzed, how the analyses had been carried out, which laboratory that had been ca rried out the analyses, and which quality control system that was in place was submitted, and ne ither was the report dated and signed. The Group noted that this report submitted did not meet stan dard requirements and that it was not possible to assess the validity of the results presented.

7.1.3 The maximum expected con centration of TRO resulting fr om ozonation of ballast water has been reported to be maximum 5 mg/L. The Gr oup noted that degradation of TRO in four of the 10 land-based tests were presen ted in the dossier (figure 6.1, page 212). Data for 48 h only was included in a figure showing that most of the TRO was degraded in this period. No data table followed the figure, but based on the figure, the Group understood that detectable levels of TRO were found in at least tw o of the tests at 48 h.

7.1.4 The degradation rates in this period seem to be comparab le to other appli cations and data from open literature using ozone and other oxidant systems to treat water with high organic content. The Group noted, however , that these other systems had reported a slower degradation rate after 48 h resulting in measur able TRO levels after 5 days.

7.1.5 The Group noted that a cons iderably longer half-life was re ported in the Basic Approval and that a half-life of 15 hours has been reported fo r another BWMS using ozonation resulting in concentrations at 160 μ g/L at de-ballasting after 5 days. A high TRO demand may be the result of a high concentration of par ticulate or dissolved organic ca rbon or ammonium. However, the organic content of the test water used in NK-O3 land-based tests was in a comparable range to the levels used in the other system referred above.

7.1.6 The Group noted that except for 5 days’ samp les, no exact TRO values were presented in the dossier and no degradation rates were calcul ated based on the data. Based on the presented data, a 2 days’ holding time only in ballast tanks, as suggested by the applicant, is not acceptable for the Group without further documentation of TRO levels and ecotoxicity testing of the effluent after this period.

7.1.7 Concentrations of bromat e ion were below the MDL at 1 μ g/L. This value corresponds to results presented in the documentation submitted for Basic Approval, where the concentrations were also below the detection limit at 2 μ g/L.GESAMP-BWWG 7/9 ANNEX 6 Page 10

I:\MEPC\58\2-8.doc 7.1.8 Concentrations of bromoform (tribrom omethane) were measured from below MDL (1 μ g/L) to 28 μ g/L with an average concentration calculated by the applicant of 5.6 μ g/L. In the submission for Basic Approval, much highe r concentration with a maximum of 255 μ g/L was reported. The applicant should present a scientif ic explanation for this discrepancy as only reporting that no effects could be determined is not considered su fficient proof. In addition, it is not justified that an average is de termined in the way as presented.

7.1.9 The Group noted that in the additional in formation the applicant suggested that, as bromoform is a volatile compound, this could explain the lower leve l over time. However, evaporation of bromoform is only possible if the ballas t water and/or the sa mple is exposed to air. If the land-based tests are performed w ith simulated ballast tanks, the venting and air exchange is too small for such loss to the atmosphere.

7.2 Acute and chronic toxicity of treated ballast water

7.2.1 The Group noted that a number of Whole Effluent Toxicity (WET) tests had been performed on samples from two of the land-base d (barge) tests with marine water and brackish water (Test cycle 1-2 marine water, and Test cycle 2-1 brackish water). In each test run, one part of the ballast water was treated with ozone while another part was untreated. The dossier stated that the samples were taken at discharge after 5 days’ holding time. In the additional information provided by the appli cant, it was stated that the samples were delivered to the laboratory one day after collection and that ecotoxicity tests star ted the same day. Test 1-2 was carried out from 14th to 19th September 2007 while the ecotoxi city laboratory reports have 18th September as reception date for the samples. The Group, ther efore, is uncertain about the sampling date and the handling of the samples of the ballast water used in the test.

7.2.2 The results of the WET te sts showed that none of the sa mples showed any difference in toxicity between treated and untre ated ballast water. However, th e Group noted that for some of the tests conducted, the ballast water (treated an d untreated) showed a toxi c effect compared to the negative control test with unpolluted sea water.

7.2.3 The Group noted that no ecotoxicity test s were carried out on samples with shorter holding time than 5 days. The Group can theref ore not recommend discharge of ballast water with shorter holding time than 5 days.GESAMP-BWWG 7/9 ANNEX 6 Page 11

I:\MEPC\58\2-8.doc 8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Derivation of a Predicted No Effect Concentration (PNEC)

8.1.1 Data on aquatic toxicity are included in the dossier submitted. Based on these data, the following PNEC values can be derived:

Substance Bromate ion [mg/L] Bromoform [mg/L] Data on toxicity Acute fish 404 7.1 Acute crustaceans 176 24.4 Acute algae >13.6 38.6 Acute oyster 30 40 Chronic fish 4.8 Chronic algae 10 Assessment Factor 1000 10 PNEC 0.03 0.5

8.1.2 The Group noted that in data sets subm itted with other appli cation dossiers, more extensive data sets had been pr ovided for bromoform allowing a more detailed assessment of the aquatic hazards resulting in a PNEC for bromoform at the μ g/L level. Thus, the data set provided is considered insufficient.

8.1.3 The Group further noted that although no in formation had been provided in the dossier submitted by the applicant, a PNEC for TRO had been derived and justified to be 0.68 μ g/L in another application submitted to MEPC.

8.2 Calculation of the Predicted Environmen tal Concentration (PEC) for the Active Substance and Relevant Chemicals

8.2.1 The Group noted that the appli cant did not provide an assessment of Predicted Environmental Concentrati ons of the various Active Substances and Relevant Chemicals including results of use of an appropriate model.

8.3 Calculation of PEC/PNEC ratios

8.3.1 Due to the lack of an appropriate a ssessment of environmental concentrations of Active Substances and Relevant Chemicals af ter discharge of treated ballast water, only a tentative environmental risk assessment can be carried out.

8.3.2 For bromate ions, the environmental risks cannot be estimated, as measured concentrations in the treated ballast water at discharge were below the DML at 1 μ g/L. However, as the DML is below the PNEC, no risks to the aquatic environment are determined.

8.3.3 For bromoform, the measured concentrations in treated ballast water at discharge were below the PNEC that could be derived from the data set provided in the dossier. However, as mentioned above, the Group is uncertain about th e difference in concentr ations of bromoform between the data submitted for Basic Approval and data submitted for Final Approval and,GESAMP-BWWG 7/9 ANNEX 6 Page 12

I:\MEPC\58\2-8.doc furthermore, the Group is aware of additional data that would result in a PNEC-value lower than the measured concentrations in the treated ballast water.

8.3.4 The Group noted that no risk assessment of TRO had been provided and that it was not possible for the Group to assess environmenta l risks, as no assessment of environmental concentrations had been provided.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

9.1.1 The Group considers that risks to the safety of the ship arising from the use of this BWTS have been appropriately identified by the applic ant and that adequate ri sk mitigation measures have been incorporated to reduce the a ssociated risk to an acceptable level.

9.1.2 The Group recommends that additional longer term tests are carried out to confirm that the results of the short-term corrosion tests ca rried out and the assump tions made regarding no corrosive effect to steel and no effect to ballast tank coatings arising from the use of this system remain valid.

9.2 Risks to the crew and general public

9.2.1 Based on the submitted information relate d to toxicological data and human exposure assessment, the Group is able to conclude that the NK-O3 Blue Ballast does not pose an undue risk to human health.

9.2.2 The Group recommends that human expos ure when handling ball ast water treatment operations (e.g. inspection and maintenance of ba llast tanks) should be pr evented by engineering control measures and use of adequate PPE/RPE.

9.3 Risks to the environment

9.3.1 With the data presented by the applicant, the Group cannot reach a firm conclusion as to the environmental acceptability of this BWTS. A dditional data is therefore required to enable the Group to perform an effective evaluation. This data should include information on the degradation of TRO, the proposed tank holding time before disc harge, a clear and unambiguous tracking of samples of treated ballast water between sampling and chemical analysis and ecotoxicological testing, a report of the chemical analyses from a certified analytical laboratory, appropriate modelling of enviro nmental concentrations in an appropriate scenario, and a scientific explanation for the low levels of THMs in the system.

9.4 Conclusions and recommendations

9.4.1 The Group concludes that the dossier subm itted by the applicant is inconsistent and incomplete as regards:

.1 tracking of samples of treated ballast water sent for chemical analysis and ecotoxicological testing;

.2 reporting of results of chemical analyses;GESAMP-BWWG 7/9 ANNEX 6 Page 13

I:\MEPC\58\2-8.doc .3 explaining the remarkable differences be tween previous results and current results;

.4 estimation and/or assessment of Pr edicted Environmental Concentrations for Active Substances and Relevant Chemicals; and

.5 environmental risk assessme nt (calculation of PEC/PNEC).

9.4.2 Due to the above-mentioned inconsistenc ies and missing information, the Group is not able to conduct a thorough assessm ent of risks to the aquatic envi ronment of discharge of treated ballast water. Consequently, the Group cannot recommend that a Final Approval be given to NK-O3 Blue Ballast Water Treatment System.

* * *GESAMP-BWWG 7/9 ANNEX 6 Page 14

I:\MEPC\58\2-8.doc APPENDIX 1

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES

WHOLE EFFLUENT

1 CHEMICAL IDENTIFICATION

1.1 The Active Substances in the NK-O3 Ballast water treatment system are ozone and TRO.

1.2 Relevant Substances identified are bromat e, bromoform, bromochloracetic acid and dibromoacetic acid.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute aquatic toxicity

2.1.1 The tests were conducted on the w hole-effluent from the NK-O3 System (WET testing by DAUH-CRC). The full range of tests required by Procedure (G9) was conducted and no acute aquatic toxicity was observed.

Species LC 50 (%/duration) Reference/Comments/ Justification for missing data Fish Cyprinidon variegates Sheepshead minnow > 100% / 96 hours US EPA. (2002)

Zooplankton Brachionus plicatilis Rotifer > 100% / 24 hours ASTM E1440-91

Algae Skeletonema costatum Diatom > 100% / 96 hours ASTM E1218-97a

2.2 Chronic aquatic toxicity

2.2.1 The full range of tests required by Proce dure (G9) was conducted and no chronic aquatic toxicity was observed.

Species LC 50 (%/duration)

or NOEC (%/duration) Reference/Comments/ Justification for missing data

Fish Cyprinidon variegates Sheepshead minnow > 100% / 21 days US EPA. (2002)

Zooplankton Brachionus plicatilis Rotifer > 100% / 4 days Janssen C.R. et al. (1994)

2.3 Endocrine disruption

2.3.1 Endocrine effect screening wa s conducted with fish according to OECD Non-spawning Fish Screening A ssay (Env/JM/MOINO (2004)18). No endocrine disruption was detected. Refer to appendix 3, section 3.3.GESAMP-BWWG 7/9 ANNEX 6 Page 15

I:\MEPC\58\2-8.doc 2.3.2 Endocrine effect screening was al so conducted with Cell lining according to Standard Operating Procedure outlined by Aquatic Toxicology Laboratory Michigan State University 2003 – both treated and non-treated (control) ballast water showed TCDD-EQ significantly higher than the negative control so lution but there was no significant difference between the both treated and non- treated (control) ballast wate r; so it is concluded that elevated TCDD-EQ relative to the negative cont rol solution did not orig inate from the NK-O3

treatment.

Species Information (GSI/duration) Reference/Comments/ Justification for missing data Fish Cyprinidon variegates Sheepshead minnow No Toxicity / 21 days ENV/JM/MONO (2004) 18

2.4 Sediment toxicity

2.4.1 Sediment toxicity was assessed using amphipods in accordance with USEPA.1994, 600/R-94/025 and no toxicity was observed.

Species Information (LC 50 / duration) Reference/Comments/ Justification for

missing data Crustacea Monocorophium acherusicum Amphipod > 100% / 10days US EPA. (1994)

2.5 Bioavailability / biomagnifi cation / bioconcentration

As chemical analysis of ballast water tr eated by the NK-O3 System did not detect any Active Substances, TROs or DBPs, and given th e very short half-lives of these substances plus given that the WET tes ting did not detect any signifi cant toxicity, bioavailability, biomagnification and bioconcentrati on are not considered to be of relevance to this system.

3 DATA ON MAMMALIAN TOXICITY

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation

4.2 Partition Coefficients

4.3 Persistence and Identifica tion of Main Metabolites

4.4 Reaction with Organic Matter

HOBr/OBr - will react with natural organic matter to form bromoform (CHBr 3 ) by the haloform reaction. Besides bromoform, a number of di sinfection products and ot her halogen containing compounds (THMs and HAAs) are produced when oz one and bromide are present in natural waters. All these Relevant Chemicals are natu rally formed in (sea) water so any reaction products can be expected to be of a character similar to those of “natural” decomposition in

water.GESAMP-BWWG 7/9 ANNEX 6 Page 16

I:\MEPC\58\2-8.doc 4.5 Potential Physical Effects on Wildlife and Benthic Habitats As chemical analysis of ballast water tr eated by the NK-O3 System did not detect any Active Substances, TROs or DB Ps, and given the very short ha lf-lives of these substances, plus given that the WET testing di d not detect any signifi cant toxicity, potential physical effects on wildlife and benthic habitats are not consid ered to be of relevance to this system.

4.6 Potential Residues in Seafood

4.7 Any Known Interactive Effects

5 PHYSICAL AND CHEMICAL PROPER TIES: PREPARATIONS, ACTIVE SUBSTANCE, RELEVANT CHEMICALS AND TREATED BALLAST WATER

5.1 This application considers the Whole Effl uent from the NK-O3 System. The physical and chemical properties of Active Substances and Re levant By-products, which might occur in the treated ballast water are listed in the table below.

Active Substance DBPs Property ozone Hypobromous acid Bromoform Dibromoacetic acid Bromochloroacetic acid Melting point( °C ) -192.5 Not available 8.0~8.5 49 27.5~31.5 Boiling point( °C ) -111.9 Not available 149~150 195 210~215Flammability Nonflammable Not available Nonflammable Not available Not available

Density(kg/m 3 ) 2.14 Not available 2,887 No data 1,980 Vapour pressure(Pa) /vapour density 5.46x10 6

/ 1.66 Not available 747 / 8.72 3 /Not available 11 /Not available Water solubility(mg/L) /dissociation constant: 3 /Not applicable Not available / 9 3,100 /Not available 2.20 x 10 4

/ 1.48 4.40 x 10 4

/Not available

Oxidation-reduction potential: 2.07 E 0 (V) Not available Not availabl e Not available Not available

Corrosivity to materials/equipment Corrosive Not available Will attack some forms of plastic, rubber, and

coatings Not available Not available

Autoignition temperature( °C ) Not applicable Not available No da ta Not available Not available

Other known physical or chemical hazards: Colorless to blue gas, characteristic odour(freshly

mown hay) Not available Colorless to yellow liquid, sweet, suffocating,chloroformlike odor Hygroscopic crystal Hygroscopic crystalGESAMP-BWWG 7/9 ANNEX 6 Page 17

I:\MEPC\58\2-8.doc 6 OTHER INFORMATION

6.1 Material Safety Data Sheets and GHS Classification (YES)

6.2 Risk Characterization

6.2.1 Screening for persistency, bioaccumulation and toxicity

No risk of persistency, bioaccumulati on or toxicity has been identified.

6.2.2 Toxicity testing of th e treated ballast water

No toxicity detected.

6.2.3 Risk characterization and analysis

6.3 Analytical methods at environm entally relevant concentrations

The analytical methods at environmentally rele vant concentrations us ed for the NK-O3 WET testing are as follows:

Method Applicability Sensitivity Reference/Comments /Justification Ozone Indigo Colorimetric Method Water 0.01 mg/L Standard Method 4500-O 3 TRO DPD Colorimetric Method Water 0.02 mg/L Standard Method 4500-Cl G Bromate ion Ion chromatographic Method Water 1.0 μ g/L EPA Method 317.0

Bromoform Liquid-Liquid Extraction Gas Chromatographic Method Water 1.0 μ g/L Standard Method 6232B

Bromochloroacetic acid 0.03 μ g/L

Dibromoacetic acid Gas Chromatographic Method Water

0.04 μ g/L EPA Method 552.3

Full details of each method are provided in the full application for Final Approval submitted to the GESAMP-BWWG in accordance with Procedure (G9).

6.4 Tests carried out in accordance with internationally recognized guidelines

All tests were carried out according to the St andard Operating Procedures (SOPs) of the Dong-A University Hospit al Clinical Research Cent re, which is certified to OECD Good Laboratory Pr actice (GLP) standards by:

– Korea Food and Drug Administra tion. Certification No.16, 2005 (http://www.kfda.go.kr);GESAMP-BWWG 7/9 ANNEX 6 Page 18

I:\MEPC\58\2-8.doc – National Institute of Environmenta l Research. Certification No. 2007-12 (http://eng.nier.go.kr); and

– Rural Development Administrator. Certification No. 2007-2 (http://www.rda.go.kr).

Full details of all test methods are contained in the full application for Final Approval submitted to the GESAMP-BWWG in accord ance with Procedure (G9).

6.5 Quality control/quality assurance

Combined Quality Management Plans (QMPs) and Quality Assurance Project Plans (QAPPs) were developed and applied for al l aspects of both the G8 and G9 testing of the NK-O3 System. Extracts (heading structures ) of both QMP/QAPPs are cont ained in Appendix 2 and the full QMP/QAPPs are contained in the full application for Final Approval submitted to the GESAMP-BWWG in accordance with Procedure (G9).

6.6 Assessment Report

The Korean Register of Shipping (KR) has performed an Assessment of quality of G9 test reports, risk characterization of any uncertainty associated with the test results as addressed by Assessment report annexed hereto.

The test results found no significan t levels of potentially toxic s ubstances and no significant acute or chronic effects of the full strength effluent on aquatic organisms. Therefore, no apparent environmental risks could be identified. See appendix.

* * *GESAMP-BWWG 7/9 ANNEX 6 Page 19

I:\MEPC\58\2-8.doc APPENDIX 2

QUESTIONS TO THE APPLICANT WI TH ANSWERS AND COMMENTS TO THE ANSWERS FROM THE GROUP

1 Please confirm from which land based test cycle have the samples fo r ecotoxicity testing been taken? How and how long have the samp les been stored before testing (File 5/14, G8 testing, page 6)?

.1 Samples for eco-toxicity testing were taken from two land-based test cycles (one seawater test cycle 1-2, and one brackish water test cycle 2-1).

Samples were handled, transported and st ored as described in the QAPP for G8 testing (Supporting Documents Vol. I – 2/14 A - Section 2) and in the G8 Testing Report (Supporting Docume nts Vol. I – 5/14 A – Section 4). Samples were delivered to Dong A Universi ty for eco-toxicity testing within 1 day of being collected.

Once delivered to Dong A University, sample s were kept in dark and cold storage and eco-toxicity testing was performe d at the same time immediately on delivering to test facility, in accordance with the QAPP for G9 testing (Supporting Documents Vol. I – 2/14 A) and Standard Operating Procedures for G9 testing (Supporting Documents Vol. I – 3/14).

.2 The Group considered the answer provide d as acceptable, however, an additional question arose on the dates of the sampling regarding test cycle 1-2, because reception dates of the samples in all laboratory reports were dated 18th of September whilst the 5-day test cycle ended on the 19th of September.

2 You state that the re-assessmen t of bromoform is not required as it was not detected, but the chemical analysis indicates that bromoform has been detect ed on average of 5.58 μg/L. Based on our experience this value is very low.

.1 The main reason stated for not conductin g a re-assessment of the toxicity of bromoform specifically is because it is the toxicity of the Whole Effluent, not specific elements – that should be cons idered, consistent with the approach applied to other oxidant-based BWMS th at has been granted G9 Final Approval by MEPC. The lack (or extremely low level) of bromoform detect ed in the treated water is a secondary reason, and the extremely low level detected supports the primary argument.

.2 The Group noted that the applicant did only perform pre liminary WET tests at Basic Approval with Mysid shrimp and topsmelt. And the results clearly indicate effects on Mysid shrimp. Therefor e, it is not possible to compare the similar concept by other applications th at have been granted Final Approval. The levels of bromoform establis hed during the Basic Approval (Confidential Dossier Application for Basic Approval of NK Ballast Water Treatment System that make use of Active Substances, p. 128, Table 6.3.8) wouldGESAMP-BWWG 7/9 ANNEX 6 Page 20

I:\MEPC\58\2-8.doc certainly lead to effects on aquatic or ganisms. Therefore, the results of the currently presented results at Final Appr oval are not consistent with the earlier results. The applicant should present a sc ientifically based explanation for this discrepancy as only reporting that no effects could be determined is not considered sufficient proof.

3 Can you explain the discrepancy between br omoform in the non-confidential submission (av. 5.58 μg/L) and confidential submi ssion (225 μg/L) on page 215 Part C?

.1 The figure of 225 μg/L is a typographical error and should actu ally be 255 μg/L. This figure was derived from observ ations by other parties as reported in GESAMP–BWWG 3/9 (MEPC 56/2/2), and we report it in our submission as a worst case as indicated by the literature. The figure of av. 5.58 μg/L was observed by our own direct testing – it is real data from our testing.

We understand that the leve l of 255 μg/L reported in GESAMP-BWWG 3/9 was measured 12 hrs after treatment, wh ereas our figure of 5.58 μg/L was measured 5 days after treatment (in acco rdance with G8). As bromoform is a volatile compound this could expl ain the lower level over time.

.2 The data here refer to Annex A. The Group is not surprised due to the volatile point of criticism. If the treated ballast water is contained in simulated ballast tanks with restricted ventilation evaporat ion of the THMs, it is not sufficient to reduce the concentration below detectable levels. In addition, it is not justified that an average is determined in the way as presented.

4 Has the degradation rate and the maximum discharge concentration of TRO been confirmed during the land-based G8 testing pr ogramme? Also, please provide water quality parameters for the degradation rates presented.

.1 Please refer Figure 6.1, page 212, f ile 1/14 A for TRO de gradation rates as measured from land-based tests. No de tectable TRO were measured in the discharge during the land-based G8 testing programme as reported in Table 3.1.3.2, page 39 of file 1/14 A and in Annex A attached to this report – the maximum discharge concentra tion of TRO from the G8 testing is therefore nil. Tables 13 and 14 of file 5/14 A present water quality data for the test cycles for which TRO degradation were measured, as presented in Figure 6.1, page 212, file 1/14 A.

.2 The data mentioned in the answer is familiar to the Group. The problem is that, normally, degradation of TRO is occurring after deballasting but generally not at a rate as indicated in the submission lead ing to a concentration below the LOD so quickly. Therefore, the Group has some hes itation to accept these results obtained. So, the Group considers it a pity that no chemical analyses are accompanying the toxicity data. In addition, if these results would be accepted, then a tank holding time of at least 5 days should be taken into account. According to figure 6.1 at page 212, there are still measurable concen trations of TRO in the ballast water.GESAMP-BWWG 7/9 ANNEX 6 Page 21

I:\MEPC\58\2-8.doc 5 What is the maximum concentration of TRO in the ballast water after mixing the main and side streams?

.1 A TRO sensor installed after the oz one injector in bot h the land-based and shipboard system routinely measured th is – results for land-based tests are presented in Appendix 1 of the G8 test report (File 5/14 A) and the maximum concentration measured was 4.84 mg/L. Resu lts for ship-based tests are presented in Appendix 2 of the G8 test report (File 5/14 A) and the maximum concentration measured was 5.22 mg/L.

.2 The Group considered this answer as sufficient.

6 How does the system ensure the appropriate dose of ozone withou t automatic control scheme using appropriate sensors?

.1 If TRO sensors are damaged or inoperab le, the monitoring and control system will automatically switch to alternative mode with the main control parameter becoming the flow-rate, with the dosage of ozone being regulated as follows:

.1 Dose of ozone (mg/L) = Production of ozone (g/hr)/Flow-rate of ballast water (m 3 /hr); and

.2 Production of ozone (g/hr) = Concentration of ozone (g/Nm 3 ) x Flow-rate of ozone (Nm 3 /hr).

Apart from the TRO sensors, if the mon itoring and control system itself becomes inoperable, the overall ballast water mana gement system simply will not operate. The monitoring and control system is integral and essential to the overall system – the system cannot and should not operate without it.

.2 The Group agreed with the first option to control the TRO amount in the systems using the TRO-sensors. However, there is a problem with the second option. The Group is of the opinion that at a failure of the TRO-sensors, the application of the Active Substance to the ballast water tanks should be completely stopped. The Group recommends that the control sc hemes using TRO-sensors should be evaluated in operational on-board ba llast water management systems.

7 The Group notes that corrosi on tests performed appeared to be of relatively short duration to what is normally expected and with a limited number of test plates (File 1/14 – Appendix 4, test report for corrosion ). Is it intended to continue corrosion testing and monitoring before type approval ? Please confirm if evaluation of the treated ballast water effect on Epoxy coatings has been performed and advise results.

.1 The Korea Marine Equipment Resear ch Institute (KOMERI), which undertook our 2007 corrosion tests, is a quality-c ertified and accredited government laboratory with extremely significant e xperience in the te sting of marine equipment, including corrosion testing, fo r the major Korean shipyards and other clients. We are not quite sure of the reference for “ what is normally expected ” above, and understand that KOMERI’s testing procedures are based on international standards (inc. ISO 16276- 1).GESAMP-BWWG 7/9 ANNEX 6 Page 22

I:\MEPC\58\2-8.doc It should be noted that the half life of Ozone in the ballast system is a matter of seconds – orders of magnitude less th an the duration of the 2007corrosion tests conducted by KOMERI (>100 hrs), so the tests are a very conservative representation of actual exposure that would be experienced in a real-life operating system.

In addition to the 2007corrosion tests c onducted by KOMERI, original corrosion tests were conducted in 1999 by the La Qu e Institute of Co rrosion Research in Wrightville Beach, North Carolina, USA – a highly specialized, world leader in corrosion research – using a model ballast tank rather than plates. These tests found no increased corrosion from sparging wi th Ozone, and in fact in some cases found decreased rates of corrosion, most likely due to the pr oduction of bromate ions from Ozone in seawater, which La Qu e Institute states may inhibit corrosion.

Given the positive results to date, the extr emely short half-life of ozone in ballast water (orders of magnitude within th e corrosion test periods), and the anti-corrosion measures incorporated into the design and construction of the system – including the ozone destructor, th e highly-restricted nature of the dosage area achieved with the side-stream injector and the use of corrosion resistant materials in the system as outlined in sect ion 7.1.2 of file 1/14 A – we do not see the rationale for conducting furt her extended corrosion tests.

However, should additional corrosion tes ting be deemed necessary, this can certainly be done under the G8 Type Approval testing procedure – which is intended to address such operational issues.

With regard to evaluation of the treated ballast water effect on Epoxy coatings, all of the panels tested by KOMERI in 2007, as reported in Appendix 4 of File 1/14 A, had epoxy coatings tested according to ISO 16276-1 and no adverse effects were found.

.2 The way the corrosion tests are perfor med for this ballast water management system is not considered acceptable to the Group. Firstly, normal corrosion experiments applying the method of we ight loss of test coupons will take 3 to 6 months, according to the e xperience of the Group, whilst the KOMERI experiments take only about 100 hrs. S econdly, the Group does not consider ozone as the major corrosive agent in th e ballast tank but the remaining TRO as a mixture of oxidants that will increase th e corrosion rates compared to non–treated sea water. Thirdly, the Group does not consider the epoxy coating tests as corrosion tests according to the docum ent referred to in Appendix 4.GESAMP-BWWG 7/9 ANNEX 6 Page 23

I:\MEPC\58\2-8.doc 8 There is no report on the chemical analysis of the disinfection by-pr oducts that is referred to in the non-confidential s ubmission in the documentation presented. We note other technologies using ozone have different values . Can you please explain the difference?

.1 The data in the non-co nfidential submission is derived from Active Substance analysis of the samples taken dur ing land-based tests – as attached in Annex A to this response.

We are not in a position to comment on why our test results may differ from others as we are not specifically aware of what other data is being referred to and we are not familiar with the basis from which such other was derived.

.2 Here, the Group is referring to the reaction to question 3.

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