I:\MEPC\57\2.doc 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. INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION COMMITTEE 57th session Agenda item 2 MEPC 57/2 19 December 2007 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

Report of the fourth meeting of the GESAMP-Ballast Water Working Group (GESAMP-BWWG)

Note by the Secretariat

SUMMARY

Executive summary: This document contains the report of the fourth meeting of the GESAMP Ballast Water Working Group (GESAMP-BWWG) and includes the evaluation of propos als submitted for approval by the Republic of Korea, Japan and Germany

Action to be taken: Paragraph 4

Related document: GESAMP-BWWG 4/9 (attached)

Introduction

1 The fourth meeting of the GESAMP-BWWG wa s held at IMO’s temporary headquarters from 5 to 9 November 2007 and its report is atta ched to this document as GESAMP-BWWG 4/9.

2 The main purpose of this meeting was to review the proposals for the approval of ballast water management systems (BWMS) that use Active Substances to treat ballast water prior to discharge into the mari ne environment. The reviews of those proposals considered by the Group are shown in annexes 4, 5 and 6 of the attached report.

3 A proposal submitted by South Africa was deferred to the next meeting of the GESAMP-BWWG in January 2008 due to time constraints and will be given priority at that meeting.

Action requested of the Committee

4 The Committee is invited to:

.1 endorse the Group’s proposal (paragraph 7.1) ∗ to introduce a questionnaire to facilitate the description of the BWMS as a set of unit operations and system components describing the indivi dual potential of each system component/operation for human exposure and identifying th e respective Risk Management Measures. Such a questionnair e should be introduced as part of the

∗ Paragraphs referred to in this section are those of GESAMP-BWWG 4/9.MEPC 57/2 - 2 -

I:\MEPC\57\2.doc further development of a Human Exposure Scenario to assist manufacturers in preparing their applicati ons for approval of BWMS;

.2 endorse the view that further guidan ce on selecting the appropriate Assessment Factors (AF) is needed when only two ch ronic NOECs are available for use in the marine risk assessment (paragraph 7.2.1) a nd agree that if chronic tests included the most sensitive organism from the acute set of three tests, then an Assessment Factor (AF) of 100 could be used on a cas e by case basis. If the most sensitive group is not included, then an AF of 1000 should be applied (paragraph 7.2.2);

.3 agree to include the description of the Final Approval process contained in paragraph 7.2.3 in its Methodology for info rmation gathering and conduct of work (the Methodology);

.4 agree to add to the Methodology the provisions related to Human Exposure Scenarios contained in annex 9 of the GESAMP-BWWG third meeting report (document GESAMP-BWWG 3/9) together with the clarifications regarding occupational exposure and the questionnai re referred to in paragraphs 7.1.2 to 7.1.8 described abov e (paragraph 7.2.4);

.5 agree that Final Approval should not be granted to the Electro Clean System as reported by the Republic of Korea in MEPC 57/2/1 (see annex 4 of the current report);

.6 agree that Basic Approval should be granted to the Clear ballast System as reported by Japan in MEPC 57/2/2 (see annex 5 of the current report);

.7 agree that Final Approval should not be granted to the CleanBallast! System as reported by Germany in MEPC 57/2/3 (see annex 6 of the current report); and

.8 approve the report in general.

* * *I:\MEPC\57\2.doc GESAMP-BWWG 4th session Agenda item 9 GESAMP-BWWG 4/9 28 December 2007 Original: ENGLISH

REPORT OF THE FOURTH MEETING OF THE GESAMP-BALLAST WATER WO RKING GROUP (GESAMP-BWWG)

Table of Contents

Section Page Nos.

1 INTRODUCTION..................................................................... 2

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

3 OUTCOME OF MEPC 56...................................................... 3

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

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS ............................................ 5

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

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

8 TENTATIVE DATE FOR THE NEXT MEETING.................... 9

9 CONSIDERATION AND ADOPTION OF THE REPORT ......... 9

ANNEXES

Annex 1 List of members who attended th e fourth session of the GESAMP-BWWG

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

Annex 3 Terms of referen ce for the Technical Group

Annex 4 Review of the ‘Electro Clean’ sy stem, submitted by the Republic of Korea for Final Approval

Annex 5 Review of the ‘ClearBallast’ system (Hitachi), submitted by Japan for Basic Approval

Annex 6 Review of the ‘CleanBallast!’ syst em, submitted by Germany for Final ApprovalGESAMP-BWWG 4/9 - 2 -

I:\MEPC\57\2.doc 1 INTRODUCTION

1.1 The fourth GESAMP Ballast Water Wo rking Group (GESAMP-BWWG) meeting was held at IMO Headquarters, London, from 5 to 9 November 2007, under the chairmanship of Dr. Tim Bowmer. A list of members attending this meeting is shown in annex 1, and the agenda, as adopted by the Group, is set out in annex 2.

1.2 Mr. Miguel Palomares, Director of Mari ne Environment Division, informed the Group that seven proposals for approval had been submitted for consideration by MEPC 57 in accordance with the agreed deadline of 7 September 2007. Mr. Palomares expressed his appreciation for the effort made by the member s of the GESAMP-BWWG to have an additional meeting before MEPC 57 in an attempt to evalua te all the seven submissions. He believed that this would assist in the deve lopment of new ballast water technologies and, consequently, alleviate the concerns of the shipping industry with regard to the availability of such technologies.

1.3 Mr. Palomares informed the Group that, based on their kind agreement to have an additional meeting from 14 to 18 January 2008, a rrangements had been made and the necessary approvals requested from the Chairman of th e MEPC and the Secretary-General of the Organization. He also informed that furthe r development of the Methodology for information gathering and conduct of work (the Methodology) would be postponed to the additional meeting in January 2008 to facilitate the evaluation of proposals during this meeting. He drew the attention of the Group of the im portance of reviewing the various proposals in the chronological order of their submissions to ensure complete transparency and a fair treatment for all the proponent Member States. It sh ould be noted in this cont ext that the outcomes of GESAMP-BWWG (4) and (5) will both be repor ted to MEPC 57. Fi nally, Mr. Palomares expressed his appreciation for the effort made by Dr. Brigitte Behrends in preparing the first four proposals for evaluation by the Group and for liaising with th e respective Member States to provide all the necessary data required for the evaluations.

1.4 Mr. Dandu Pughiuc, Head of the Marine Biosafety Section, Marine Environment Division, welcomed the new members of the Gr oup and wished them every success in their endeavors. He also reported on the contra ctual arrangements and informed the Group on the logistics of the meeting. He reminded the Gr oup that, although MEPC 56 had agreed that the Methodology is a living document in need of further development, the Committee concluded that, as currently drafted, it provides the necessary technical gui dance to conduct the evaluations. Mr. Pughiuc encouraged the members of the Gr oup to focus on the submitted proposals at this session leaving the further development of the Methodology to th e January 2008 meeting.

1.5 Some members of the GESAMP-BWWG were of the view that additional discussion was necessary with regard to the development of a Human Exposure Scenario (HES) as approved by MEPC 56, in order to make the Final Approval pr ocess more efficient. Following a proposal by the Chairman, the Group agreed to increase th e working hours to include this discussion under agenda item 7.

1.6 Consideration of the ba llast water management Sy stem (BWMS) proposal by South Africa contained in MEPC 56/2/3 was de ferred to GESAMP-BWWG (5) in January 2008 and having already been summarized by the IMO consultant will be considered first at that meeting.- 3 - GESAMP-BWWG 4/9

I:\MEPC\57\2.doc 2 ISSUES OF CONFIDENTIALITY

2.1 Three proposals for approval of ballast water management systems submitted by the Republic of Korea (Final Approval), Japan (Bas ic Approval), Germany (Final Approval) have been reviewed at this meeting. The Secretariat informed the Group that the non-confidential parts of the submissions had been circulated as MEPC documents (MEPC 56/2/3 for South Africa; MEPC 57/2/1 for the Republic of Korea; ME PC 57/2/2 for Japan; and MEPC 57/2/3 for Germany) and emphasized that members of the Gr oup were requested to keep the data contained in the application dossiers confidential to protec t the commercial interest s of the manufacturers.

2.2 While noting the agreement of MEPC 55 that all information rela ted to safety and environmental protection, including physical propert ies, environmental fate and toxicity, should be treated as non-confidential, the Group also not ed that the details of the functioning of the BWMS must be regarded as c onfidential to protect the rights of the manufacturer. The Group noted that the Organization, prior to submissi on of the Group’s evaluation report to the MEPC, would consult with the applicant of the proposed BWMS to ensure that the report does not contain any confidential information. In cases wh ere the evaluation report contains confidential information, the Organization would amend it accordingly, having taken the views of the manufacturer into account.

2.3 In the case of requests to IMO from a thir d party for more information regarding an application, the Group was of th e view that it might be appr opriate for the Organization to provide the name and address of the national Administration that had submitted the original application for approval, which could then respond, as it feels appropriate.

2.4 Mr. Pughiuc reported on the conclusion of the Statement of Acceptance of Access to Confidential Information and reminded the Gr oup members of the n eed to hand over any documents, drafts, or any other asso ciated records and reports, for retention in confidence at the end of the meeting or when they are no longer necessary for the work of the Group. He also pointed out to the inventory lists prepared by the IMO Cons ultant for each submission and confirmed that all the folders received from the Member States concerned are made available to the Group.

3 OUTCOME OF MEPC 56

3.1 A comprehensive introduction of the out come of MEPC 56 was provided by the Secretariat (document GESAMP-B WWG 4/3). Particular emphasis was placed on the decisions of MEPC 56 related to the Dr aft Methodology for information gathering and method of work of the GESAMP-BWWG and the Group noted that MEPC 56 had endorsed its view that the GESAMP-BWWG Methodology is a living document in n eed of further development, but that it is currently suitable as technical guidance for use by applicants submitting requests for evaluation of BWMS.

3.2 The Chairman of the GESAMP-BWWG reporte d on his participation at MEPC 56 and encouraged all the members to review the sec tion regarding the ‘Action taken by the Committee’. He emphasized the complexity of the reporting process involving a number of very strict deadlines and the necessity to make each mee ting as efficient and effective as possible.

3.3 The Group noted that MEPC 56 had considered a ll of the issues, from the third session of the GESAMP-BWWG, which had been raised under paragraph 4 of MEPC 56/2/2.GESAMP-BWWG 4/9 - 4 -

I:\MEPC\57\2.doc 3.4 Whilst noting that some concerns had b een raised about specific issues, the Group expressed its appreciation that MEPC had generally agreed with the significant recommendations put to it.

3.5 The Group noted that, as instructed by MEPC 56, the Secretariat had produced an updated version of the Methodology incorp orating changes agreed at MEPC 56, in particular, replacing the mandatory wording by guidance document language. The Group agreed to further develop its Methodology at its next m eeting in January 2008, concentr ating on reviewing as many proposals as they can during this meeting.

3.6 The Group agreed to encourage the MEPC to explore all the options to formalize the Methodology and reiterated the view that onc e a system has received Final Approval under Procedure (G9), the respective applicant should not be requested to submit additional information to meet any changes made to GESAMP-BWWG Methodology after the date of submission.

4 TERMS OF REFERENCE AND TIME FRAME

4.1 The Group agreed to continue to be guide d by the Terms of Reference approved by MEPC 56, as contained in annex 3 of this report.

4.2 The Group agreed to use the table below to determine the timetable for activities related to its regular meetings and, on a case-by-case basis, to decide 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 application dossiers and related documents to be reviewed by 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 confidential data are contained in the report

(3 weeks) Review and approval 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 GESAMP-BWWG in accordance with the 13 we eks deadline for MEPC- 5 - GESAMP-BWWG 4/9

I:\MEPC\57\2.doc 4.3 The Group noted that MEPC 58 will be held from 6 to 10 Oc tober 2008 and, using a time table similar to the one agreed by MEPC 56 a nd reproduced above, the Group agreed that the deadline for submission of application dossier s and related documents for MEPC 58 would be 21 March 2008.

4.4 The Group agreed to furthe r explore the possibility of exte nding the 28 week timeframe to 30 weeks, which would increase the flexibil ity of scheduling the m eeting of the Group. The Group noted, however, that in even years when the MEPC meets twice th e gap between two consecutive sessions may be less than 30 weeks.

4.5 In his summary, the Ch airman of the GESAMP-BWWG concluded that one possible approach to solving this problem could be to furt her increase the membership of the Group to allow submissions to be processed more quickly.

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS

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

.1 Annex 4 Review of the Electro-Clean Ballast Water Treatment System, submitted by Republic of Korea for Final Approval

.2 Annex 5 Review of the Clear Ballast Ballast Water Treatment System

, submitted by Japan

.3 Annex 6 Review of the CleanBallast! Ballast Water Treatment System

, submitted by Germany

5.2 Whilst it is recommended that the summary, results and discussion of each of the reviews are considered in detail, the Group recommended that:

.1 the Electro-Clean Ballast Water Treatment System, submitted by Republic of Korea is NOT granted Final Approval;

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

, submitted by Japan; and

.3 the CleanBallast! Ballast Water Treatment System , submitted by Germany is NOT granted Final Approval.

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

6.1 The Secretariat introduced an inquiry receive d from the Government of China regarding the possibility of submitting toxicity testing of the treated ballast water for Basic Approval as opposed to laboratory tests; the query is outlined in documen t GESAMP-BWWG 4/6.

6.2 The Group noted that in pract ice some manufacturers may c onduct toxicity testing using the treated ballast water discharged from the la nd-based testing facilities , and use the toxicity testing data obtained from th e land-based testing facilities to apply for Basic Approval.GESAMP-BWWG 4/9 - 6 -

I:\MEPC\57\2.doc 6.3 Since the treated ballast water discharged from the land-based testing facilities may well reflect the situation more accurate ly than that simulated in the laboratory, the Group was of the view that the toxicity testi ng data obtained from the land-bas ed testing facilities should be accepted for Basic Approval provided that the testing items, procedures and results as required in Procedure (G9) and the Methodol ogy are fully complied with.

6.4 However, the Group pointed out that land-based, full-scale testing facilities can be quite inflexible (one or two tanks); and as several se ts of environmental conditions are to be covered, e.g. salinity and organic loading, a bench scale/pilot scal e system may often allow questions to be answered more effectively during Basic Approval.

6.5 The submission of ecotoxicity tests usi ng water from a land based facility for Basic Approval would not in any way pr eclude the GESAMP BWWG from requiring further/improved testing for Final Approval.

7 ANY OTHER BUSINESS

7.1 Development of a Human Exposure Scenario (BWWG 3/9)

7.1.1 The Group noted the endorsement by MEPC 56 of its proposal to develop a Human Exposure Scenario document.

“Having considered the report of the Balla st Water Review Group (MEPC 56/WP.4) and the comments made by various delegations, the Committee :

- endorsed the need for a Human Exposure Scenario (HES) as part of the Risk Assessment procedure for ballast water management systems, and instructed the Ballast Water Working Group and BLG 12 to further co nsider the HES through formal technical negotiations based on the outline provided by GESAMP BWWG. In this respect, the Committee invited Members and observers to submit their comments on annex 9 of the GESAMP-BWWG report attached to document MEPC 56/2/2 for further consideration on this matter at BLG 12.”

7.1.2 From the submissions received by the GESAMP-BWWG to date, it is clear that manufacturers need further advice on how to appr oach exposure assessment. In this respect, the Group identified the need to further define how occupational exposure may occur on board ships as a result of BWM systems being operated.

7.1.3 In annex 9 of the report on the third meeting of the Group (GESAMP-BWWG 3/9), a framework was outlined for assessing the risks to human health. This consisted of four steps:

.1 Hazard identification – what are the substances of concern and what are their effects?

.2 Dose (concentration) – response (eff ect) relation – what is the relationship between the dose and either the sever ity or the frequency of the effect?

.3 Exposure assessment – what is the inte nsity, and the durati on or frequency of exposure to an agent?

.4 Risk characterization – how to qua ntify the risk from the above data?- 7 - GESAMP-BWWG 4/9

I:\MEPC\57\2.doc The Group considered that in general, step 1 was adequately considered in most submissions. However, steps 2 and 3 generally lacked sufficien t information, leading to a worse case approach to risk assessment.

7.1.4 The identification of ‘unit operations’ in the whole BWM process of each system is important to the understanding human exposures. To achieve this, mo re information than contained in the submissions to da te is required from applicants . The term ‘uni t operation’ is used in chemical process engineering to describe a basic step in a process. A chemical or other manufacturing/treatment process may have many unit operations. Occupational hygienists depend on knowledge of such unit operations to be able to determine exposure to chemicals involved in each step of a process. A simila r approach is proposed with regard to BWMS evaluations.

7.1.5 Applicants should be requeste d to describe the ballast wate r treatment proc ess associated with their system as a set of unit operations, i. e. in doing so, identifying clearly which individual system components of a BWMS are likely to lead to human exposure to active substances, relevant substances and by-products. Then, fo r each system component, including connecting piping, a description of such exposures needs to be provided, e.g. chemical storage, chemical application, processing of trea ted ballast water, ballast tank operations, including associated piping, as well as discharge operations. Applicants should then state the risk reduction measures envisaged for all of the above-defined unit operations, i.e. stating clear Personal Protective Equipment requirements fo r each step in the process.

7.1.6 Maintenance, equipment failure and accident si tuations should be considered separately from conditions of normal operation.

7.1.7 On this basis it will be possible to gather ad equate information on individual systems that will facilitate a much improved human health risk assessment. It may be possible to categorize similar systems on the basis of such accumulated information. This could then lead towards the development of a human exposure scenario model.

7.1.8 The Group agreed to develop a questionna ire on human exposure and unit operations (see draft Guidelines for ballast water sampling (G2)) to help manufacturers provide the right data and to better assess human exposure scen arios associated with BWMS on board ships.

7.2 Methodology for information gathering and conduct of work (the Methodology)

7.2.1 In the evaluation of BWMS, during GESA MP-BWWG meetings 1 through 4, the Group noted that occasionally only two chronic NOECs are available for use in the marine risk assessment and that in such cases, further gui dance on selecting the appropriate assessment factors is needed.

7.2.2 The Group agreed that if chronic tests incl uded the most sensitive organism from the acute set of three tests, then an Assessment Fact or (AF) of 100 could be used on a case by case basis. If the most sensitive group is not in cluded, then an AF of 1000 should be applied.GESAMP-BWWG 4/9 - 8 -

I:\MEPC\57\2.doc 7.2.3 The Group agreed to add the description of the Final Approval process based on the previous consideration contained in paragraphs 5.4 to 5.6 of its third report (GESAMP-BWWG 3/9) to the Methodology. Th e Final Approval process, as summarized below, will be added under section 10 of the Methodology:

“10.1 In accordance with paragraph 5.2.1 of the Procedure (G9) for Final Approval

, the discharge testing should be performed as part of the la nd-based type approval process using the treated ballast water discharge.

10.2 In order to obtain Final Approval in accordance with paragraph 8.2 of Procedure (G9) the following criteria have to be met:

.1 Basic Approval has to be given first;

.2 the Member of the Organization, submitting an application should conduct the Type Approval tests in accordan ce with Guidelines for Approval of Ballast Water Management Systems (G 8). Although Guidelines (G8) are concerned with efficacy testing, para graph 1.6.4 of part 1 of its annex provides the link between the Guidelines (G8) and the Procedure (G9) and consequently the test results from both Guidelines (G8) and Procedure (G9) would be used by MEPC to grant Final Approval . This would then allow the Administration to issue a Type Approval Certificate as shown in the appendix to Guidelines (G8). In this contex t Type Approval of any equipment used onboard ship should be given when the relevant approval body is satisfied that the Quality Assurance programme employed by the manufacturer will ensure that the equipment can be produced consistently to the required specification and the risk s to the ship and crew have been adequately addressed;

.3 apart from any other conditions required for Type Approval , the full scale land based tests, using the system in the same way that fulfilled the efficacy requirements, would need to show that the residual toxicity of the treated ballast water is no worse than the results obtained for Basic Approval;

.4 toxicity testing should be done on tw o types of seawater at two appropriate time intervals, after treatment, and organism s normally found in the selected types of seawater should be used in the toxicity testing;

.5 all information related to Total Residual Oxidants (TROs), Total Residual Chlorine (TRC) and the chemicals in cluded in such groupings, including their concentrations, should be provided to the GESAMP-BWWG for Final Approval when requested as part of its evaluation for Basic Approval;

.6 in addition to the basic data set ne eded for the treated ballast water and the individual chemicals produced by th e system – as identified in the Methodology for Basic Approval – a generated meaningful PEC/PNEC ratio would be required for Final Approval; and- 9 - GESAMP-BWWG 4/9

I:\MEPC\57\2.doc .7 the application for Final Approval s hould reflect the concerns identified during consideration of Basic Approval. This would mean that in some cases only acute toxicity testing w ould be needed for Final Approval and in some cases chronic toxicity might be needed whilst in others both acute and chronic data might be required.”

7.2.4 The Group also agreed to add a section on developing Human Exposure Scenarios using the guidance contained in annex 9 of its thir d report (GESAMP-BWWG 3/9) supplemented by the above clarification regarding occupationa l exposure and the proposed questionnaire.

8 TENTATIVE DATE FOR THE NEXT MEETING

8.1 The Gr oup agreed that its next meeting will take place from 14 to 18 January 2008 and should review the remaining four proposal s received before the submission deadline of 7 September 2007.

9 CONSIDERATION AND ADOPTION OF THE REPORT

9.1 A draft report of the 4th meeting of the GESAMP-BWWG was produced on 9 November 2007, and, after a paragraph-by-p aragraph review, th e Group agreed on the final text and requested the Secretariat to make the necessary changes to ensure consistency with IMO documents format and style.

9.2 The Chairman expressed his appreciation fo r the long hours and substantial efforts made by the members of the Group throughout the week, valued the work done by the IMO consultant both in preparation and duri ng the meeting week and clos ed the meeting at 18.00 hrs.

***GESAMP-BWWG 4/9

I:\MEPC\57\2.doc ANNEX 1

LIST OF MEMBERS WHO ATTEN DED THE FOURTH SESSION OF THE GESAMP BALLAST WATER WORKING GROUP

Dr. C.T. Bowmer (Chairman) TNO Chemistry Utrechtseweg 48 Post Box 360 3700 AJ Zeist The Netherlands E-mail: Tel: Fax:

Mobile: tim.bowmer@tno.nl +31 30 694 4645 +31 30 694 4099

+31 6 5318-1352

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 Technical 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 Toranomon Minatoku-ku Tokyo 105-0001 Japan E-mail: Tel: Fax: s-hanayama@sof.or.jp +81 3 3502 1886 +81 3 3502 2033

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

Mobile: annette.kronborg@adalia.se +46 8 510 149 36 +46 8 510 126 02

+46 70 483 11 23GESAMP-BWWG 4/9 ANNEX 1 Page 2

I:\MEPC\57\2.doc 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 4401

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 Marena Ltd. St. Annenstr. 27 Jever D-26441 Germany E-mail: Tel:

Mobile: brigitte.behrends@marenaltd.com +49 (0) 4461 984 098

+49 (0) 16 2244 3484

GESAMP

Mr. Fredrik Haag GESAMP Officer Marine Environment Division International Maritime Organization 4 Albert Embankment London SE1 7SR United Kingdom E-mail: Tel: Fax: fhaag@imo.org +44 (0)20 7463 4139 (Direct) +44 (0)20 7587 3210GESAMP-BWWG 4/9 ANNEX 1 Page 3

I:\MEPC\57\2.doc 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. Huang Tianbing Technical Officer, Marine Biosafety Section Marine Environment Division International Maritime Organization 4 Albert Embankment London SE1 7SR United Kingdom E-mail: Tel: Fax: thuang@imo.org +44 (0)20 7463 4198 (Direct) +44 (0)20 7587 3261

***GESAMP-BWWG 4/9

I:\MEPC\57\2.doc ANNEX 2

AGENDA FOR THE FOURTH SESSION OF THE GESAMP BALLAST WATER WORKING GROUP

1 Introduction

2 Issues of confidentiality

3 Outcome of MEPC 56

4 Terms of reference and time frame

5 Review of proposals for approval of Ballast Water Management Systems

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

7 Any other business

8 Date for the next meeting

9 Consideration and adoption of the report

***GESAMP-BWWG 4/9

I:\MEPC\57\2.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 57.

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

In particular, the Group should undertake:

.1 Scientific evaluation of the data -set in the proposal for approval (see paragraphs 4.2, 6.1, 8.1.2.3, 8.1.2.4 of 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 charact erization and analysis contained in the proposal for approval (see paragraph 5.3 of G9);

.6 Scientific recommendations on whether the proposal has demons trated 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 toxicity of the disc harge conforms to the evaluation undertaken for Basic Approval and that the prev ious evaluation of the risks to the ship and personnel including consideration of the storage, handling and appl ication of the active substance remains valid. The evaluation will be reported to MEPC (see paragraph 8.2 of G9).

4 The Group shall keep confid ential all data, the disclosu re of which would undermine protection of the commercial interests of the applicant, including intellectual property.

***

∗ G9 stands equivalent for MEPC 53/2/1, annex, as amended: Procedure for approval of ballast water management systems that make use of Active Substances (G9).GESAMP-BWWG 4/9

I:\MEPC\57\2.doc ANNEX 4

REVIEW OF PROPOSAL FOR THE APPROVAL OF ACTIVE SUBSTANCES

Electro-Clean System using electrolytic disinfection

Submitted for Final Approval by the Republic of Korea as MEPC 57/2/1

0 SUMMARY

0

. 1 Final Approval of the Electro-Clean System (ECS) using electrolytic disinfection is not recommended to be granted based on the subm ission provided by the Republic of Korea

. 0.2 The Group noted that the proposed system is based on electroly tic disinfection of seawater and brackish water. The ballast water is disinfected through oxidation, including the production of active substances such as hydroxyl ra dicals and Free Active Ch lorine. In addition, various by-products defined as Relevant Chemi cals are produced from reactions between Active substances and naturally occurring compounds in the treated water. The group noted that hydrogen and chlorine gases are also generated in the system. The activ e substances are not required to be stored onboard as they are generated on demand. The submission informs that a neutralizing stage will be re quired to ensure that the maxi mum designed TRC-concentration (2 mg/L) is not exceeded.

0.3 The Group noted that the maximum re quired Total Residual Chlorine (TRC) concentration for effective disinfection was 10 mg/L with measured TRC levels at around 1 to 2 mg/L at discharge after 3 to 5 days storage in ballast tanks. Therefore, the Group considers the concentration of 10 mg/L as the Maximum Dosage and the concentration of 2 mg/L as the Maximum Allowable Discharge Concentration according to the G9-evaluation. It was also noted that the required TRC-concentration has been reduced from the levels of 20 – 30 mg/L indicated at Basic Approval.

0.4 The Group noted that a number of land-based and shipboard te sts had been carried out for the evaluation under G8 and to identify di sinfection by-products in accordance with the G9-procedures. However, it was unclear if the discharge toxi city tests had b een conducted on samples drawn from the G8 land-based efficacy tests as required by G9.

0.5 The Group noted that the two water qualities used in the land-based test set-up were not in accordance with the requirements in G8 regardi ng salinity and the content of organic matter (POC and DOC). All tests carried out were in the 15-22 PSU salinity range for brackish water and 28.7-33.4 PSU range for seawater which is not in accordance with the G8 procedure. Furthermore, the organic matter co ncentration was too low in the majority of the tests. Low levels of organic matter will reduce the levels of chlorination by-products produced and thereby also the toxicity of treated ballast water. This substantially increases the uncertainties of conclusions drawn from the ecotoxicity tests pe rformed and from the results from the chemical analysis of treated ballast water.

0.6 The Group noted that the dossi er identified a limited numbe r of active substances and relevant chemicals and that many others have been identified in other dossiers with similar systems and in open literature. The Group furthe r noted that the reacti on between chlorine gas and bromide ions was not discussed in the dossi er. Consequently, the information provided was inadequate for a number of potentially relevant chemicals.GESAMP-BWWG 4/9 ANNEX 4 Page 2

I:\MEPC\57\2.doc 0.7 The Group considered that brominated DBPs (Disinfection By-Products) are the toxicologically relevant compounds generated by the process. As the applicant did not provide information concerning the potential exposure of humans to volatile substances, e.g. as outlined in the Human Exposure Scenario (MEPC 56/2/2, a nnex 9), the Group noted that the Human Risk Assessment could not be adequately completed. The Group, therefore, was only able to adopt a precautionary approach and recommended that human exposure when handling ballast water treatment operations should be restricted and that Risk Mitigation Me asures be put in place.

0.8 The Applicant carried out hydrogen and chlori ne gas measurements during a land-based full-scale system testing and during shipboard te sting. The lower explosion limit (LEL) for hydrogen gas is 4% under standard conditions. The highest values of gas concentration measured during the tests were 1.3% hydrogen and 0.9 ppm (v/v ) chlorine gas, respec tively. The Applicant states that due to the low concentrations no further ventilation system would be required. However, adequate measurement and control m echanisms for hydrogen and chlorine should be pit in place to ensure that dangerous levels do not occur.

0.9 The Applicant carried out corrosion tests using coated test samples exposed to treated and untreated ballast water. No accelerated corrosion to the test panels was found to be due to the treated ballast water. However, no uncoated test samples were used and the test is therefore mainly a test of the coating systems and with li mited valid information about the corrosivity of the treated ballast water.

0.10 The submission indicates that the provision of mitigation procedure using a neutralizing agent, sodium bisulphite, is required to ensure that the maximum allowable discharge concentration of TRC (2 mg/L) is not exceeded. The Group noted that this component has not yet been tested in an operational system; theref ore, the Group considers that confidence in the maintenance of the maximum allowable discha rge concentration of TRC at any given time cannot be ensured at present. In this context, the environmental risks occurring through the use of this system are not acceptable according to G9.

0.11 The Group noted that an ECS system has b een installed on a second vessel for additional shipboard testing. The Applicant states that thes e matters are “still under the test for biological efficacy, influence to the environment a nd risk assessment on crew and ships.”

0.12 Risks to the safety of the ship from the production of hydrogen by the BWMS was reported on by the applicant. The group were satisfied that under the operating conditions described in the application, the concentrations of hydrogen produced during land based and shipboard testing remained at safe levels, i.e. less than one quarter of the LEL of 4%. Care should be take that in fully operational systems that hydrogen levels are not allowed to exceed such safe levels, otherwise ventilation would be required.

0.13 Chlorine gas was also measured in the land based (barge) and ship board tests and at 0.9ppm was considered by the group to be close to the published acute human exposure limits. The group therefore considered that additional risk mitigation measures will be necessary immediately following treatment.

0.14 The Group recommends that corrosivity conti nues to be monitored as part of the normal operation of the ECS system.GESAMP-BWWG 4/9 ANNEX 4 Page 3

I:\MEPC\57\2.doc 1 INTRODUCTION

1.1 The data for this product were extracted from the submission of the Republic of Korea to MEPC (MEPC 57/2/1) and the application dossier.

2 COMPLETENESS OF DOSSIER

2.1 It was noted that the applicant had submitte d the following material for consideration by the GESAMP BWWG:

.1 A non-confidential Application Dossier, which contains a su mmary of the data and results (MEPC 57/2/1).

.2 An Application Dossier for Final Approva l, which contains information about the disinfection mechanism of ECS, a worki ng Procedure, removal Efficiency of microorganisms, data sets of Active Substances and disinfection by-products, toxicity tests with ECS treated water, a risk assessment and the assessment report.

.3 Furthermore, the Applicant submitted appendices with acute and chronic toxicity test protocols, emission scenario protoc ols, MSDS sheets, information about the ECS installation and operation, chemical s data sheets and the shipboard test report.

2.2 The Group identified that the following info rmation was not provided in the dossier:

.1 The applicant did not provide suffici ent information concerning human exposure to active substances, relevant chemi cals and by-products, e .g. a described in MEPC 56/2/2, annex 9.

.2 Full laboratory reports from the ecotoxi city testing and chemical analysis of treated ballast water were not provided. Th ey are referred to in the dossier, but there is no description of how samples were handled before analysis. Furthermore, there is no information about which land based tests (G8) have been used sampling for the purpose of ecotoxicity testing and chemical analysis of disinfection by-products.

.3 The dossier does not provide any info rmation about how the neutralizing agent bisulfite is stored on board and how it is added to the discharged ballast water.

.4 Several of the Active substances and relevant chemicals known from the literature and from other BWMS applying electrolysis of seawater are not identified by the dossier and therefore it does not include sufficient information. Examples are hypobromous acid and hydroxyl radicals.GESAMP-BWWG 4/9 ANNEX 4 Page 4

I:\MEPC\57\2.doc 2.3 The GESAMP-BWWG requested:

.1 Clarification on the way in which the c oncentration of hydrogen (H2) and chlorine (Cl2) were measured and calculated.

.2 Identification of the sample number (T able 6-14 and 6-15 on page 111 of the Application Dossier), which have been analysed for disinfection by-products (page 110).

.3 Information on the Sodium bisulfite:

- MSDS sheets - Storage, usage and handling - How and when is Sodium bisulfite applied?

.4 Which samples were used for ecotoxicity testing?

.5 In the submission for Basic Approval a pre-filtration unit has been mentioned. Since the GESAMP-BWWG could not find a ny information regarding the use of this unit in the submission for Final Approva l, please confirm if this unit is still used and if so, provide detailed information on it.

.6 Regarding H 2 Concentration after treatment. The data indicate that the maximum concentration of H 2 gas in the ballast tank followi ng treatment with SCR is 0.9%.

a) How full was the ballast tank when these readings were taken?

b) Was the concentration of H 2 being expelled from the vent pipe monitored during ballast tank filling?

.7 The various bench tests show H 2 concentrations in excess of 3% being found regularly and very high le vels also experienced. Th e submission states that conditions require to be controlled to ensure H 2 concentrations do not reach dangerous levels. As H 2 lower explosive limit (LEL) is 4%, excess of 3% is considered of concern. How is the concen tration level “controlled”, and what is the real chance of H 2 level in tank and leaving tank vent reaching 4% vv?

2.4. The Applicant answered:

.1 Question 2 was not answered sufficiently in the first instance. The Groups intention for this question was that “T otal Organic Carbons will affect the production rate of DBPs, such as brom oform and HAA”. For this reason, the Group requested the chemical parameters (TOC, POC, etc) of seawater used in DBPs analysis in page 110. After pe rsonal communication this question was answered sufficiently.

.2 Regarding Question 3, the Group discove red after personal communication that the mitigation procedure for the neutralization agent sodium bisulfite was still under development.GESAMP-BWWG 4/9 ANNEX 4 Page 5

I:\MEPC\57\2.doc .3 Answers to the other questions were de livered by the Applicant to the Group’s satisfaction.

3 DESCRIPTION OF BWMS AND DATA-SET REQUIRED IN THE APPLICATION

3.1 Description of the ballast water management system

3.1.1 The applicant informs that the Electro-Cl ean System (ECS) ballast water management system has been engineered for the disinfectio n of micro-organisms without the storage and addition of any synthetic chemi cals onboard. Disinfection is achi eved by direct oxidation of organisms at the electrodes in the cell and due to the Active substances (measured as Total Residual Chlorine, TRC) produced. With th e application of electri c currents, hypochlorite (active substance) is generated in-situ and disinfects the micro-or ganisms. In addition to this, electric potential and OH radicals generated duri ng the electrolysis pro cedure also disinfect micro-organisms. Hypochlorite is highly reac tive and degrades in s eawater containing both organics and inorganics.

3.1.2 The submission for final approval indicates that the system is intende d to treat the ballast water on uptake only. The Group noted that in the application for basic approval the treatment system proposed also included a filtration ph ase, which was no longer apparent. Further communication with the applicant confirmed that the filtration phase was considered no longer required.

3.1.3 The Group noted that in the non-confidential information provi ded it was stated that no substances are added to the system. However, th e confidential Application Dossier informs that a neutralizing agent (sodium bisulfite) may be adde d at discharge. This information advises that sodium bisulfite is to be added when monitore d TRC levels exceed 2 mg/L in the discharged ballast water and that at lower levels no bisulf ite is required, unless lo cal regulations demand a lower TRC discharge level. However, the pr ecise description of this component was not included in the application. The group cannot evaluate how th e TRC concentration should be monitored by reliable sensors in each ballast ta nk and how the mixing rate can be controlled under high volume discharging (such as >1,000 m 3 /h). After further communication with the applicant, the Group concluded that this componen t of the system has not yet been developed or tested in an operational system. Also, the applicant claimed that this mitigation system is used only for rare extreme conditions. The Group ca nnot accept this design concept. The Group has the opinion that for the short voyage less than 2 days etc., the reliability of this component should be the most important key part among the whole ballast water treatment system to ensure the maximum allowance discharge concentration, which is required in G9.

3.1.4 The Group also noted that the system incorpor ated a salinity sensor to control the power to the electrolytical cell and a monitoring of the TRC concentration to maintain the required level of TRC (spectrophotometric measurement with DPD reag ent) and a salinity sensor to maintain the required level of TRC, which is dependant on salinity, but also to avoid discharge of excess TRC.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 The Group noted that the Active Substance id entified by the dossier used in this BWMS is generated onboard when the chloride ions in seawater is oxidized to chlorine gas which subsequently reacts with seawater to produce hypochlorite (OCl - ) and hypochlorous acid (HOCl). The Active substances are measured as Tota l Residual Chlorine (TRC). The Group also considers that bromates and hypobromite a nd hypobromous acid are relevant substances.GESAMP-BWWG 4/9 ANNEX 4 Page 6

I:\MEPC\57\2.doc 3.2.2 To maintain the disinfection of the ballas t water at varying sali nities and suspended matter a TRC concentration of 10 mg/L has been identified by the applicant to be sufficient, even though 20-30 mg/L TRC was applied during the Basic Approval testing. Therefore the initial TRC level has been reduced from 30 mg/L to 10 mg/L.

3.2.4 The submission states that hydroxyl radi cals have a very short lifetime during ECS operation, and also as the ballast water flows quickly through the ECS, there was no notable effect on disinfecti on in the ballast water.

3.2.5 TRC or hypochlorite has been identified as Active Substanc e. The data on hypochlorite from the dossier are summarized in table 1.

Table 1: The identification of hypo chlorite (MEPC 57/2/1, table 5-1)

Item Information IUPAC name hypochlorite CAS number 14380-61-1 UN number 3212 Molar mass 51.452g/mol Empirical formula OCl Structural formula Purity of technical material and identification of impurities Bleach, hypochlorous acid, sodium salt; soda bleach; sodium oxychloride 5% of sodium hypochlorite and 95% of water Stabilizers or necessary additives For pools using liquid chlorine (sodium hypochlorite) or calcium hypochlorite, add st abilizer (cyanuric acid).

3.2.6 The Group noted that several other active s ubstances such as hydrogen gas have been identified in other dossiers with similar systems and in open literature. The Group further noted that the reaction between chlori ne gas and bromide ions was not discussed in the dossier. Chlorine reacts with the bromide ions to form hypobromous acid which should also be presented as an Active substance in the dossier. Similar to the equilibrium hypochlorite/hypochlorous acid hypobromous acid w ill exist in equilibrium with hypobromite.

3.2.7 Hypochlorite, hypochlorous acid, hypobromite and hypobromous acid are all highly reactive and degrade in seawater containing bot h organics and inorganics and consequently produce a number of disinfection by-products (DBP).

3.2.8 TRC includes free residual chlorine of undissociated and dissociated hypochlorite together with undissociated and dissociated hypobromite when chlo rine is dissolved in water, plus combined residual chlorine halogens of chloramines halogeneamines formed by reacting with ammonia.

3.2.9 The two largest identified fractions of chlorination by-products are trihalomethanes (THM) and haloacetic acids (HAA).

3.2.10 Table 2 and Table 3 show the analytic al results of disinfection by-products from electrolysis of brackish (Sum-Jin River, 18 – 20 PSU) and seawater (Ma-San Port, 28 – 30 PSU) by ECS operation at 10 mg/L of TRC. The Group considered that the number of samplesGESAMP-BWWG 4/9 ANNEX 4 Page 7

I:\MEPC\57\2.doc analysed fell far short of a representative amount, to give sufficient confidence in the reliability of the results.

Table 2: List of disinfecti on by-products (THM, HAA and br omate) in the brackish water (18 – 20 PSU) from Sum-Jin River after ECS treatment (MEPC 57/2/1, table 5-2)

List of all potential by-products produced in ballast water

Chemical name CAS number Control water (mg/L) Treated water (mg/L) Detection limit (mg/L)

THM Trichloromethane 000067-66-3 N.D. N.D. < 0.0001 Bromodichloromethane 000075-27-4 N.D. N.D. < 0.0001 Dibromochloromethane 000124-48-1 N.D. 0.0083 < 0.0001 Tribromomethane 000075-25-2 N.D. 0.1081 < 0.0001 THM 0.1164

HAA Monochloroacetic acid 000079-11-8 N.D. N.D. < 0.0001 Dichloroacetic acid 000079-43-6 N.D. N.D. < 0.0001 Trichloroacetic acid 000076-03-9 N.D. N.D. < 0.0001 Monobromoacetic acid 000079-08-3 N.D. N.D. < 0.0001 Dibromoacetic acid 000631-64-1 N.D. 0.0136 < 0.0005 Tribromoacetic acid 000075-96-7 N.D. 0.0042 < 0.0005 Bromochloroacetic acid 005589-96-8 N.D. N.D. < 0.0001 Bromodichloroacetic acid 71333-14-7 N.D. N.D. < 0.0005 Dibromochloroacetic acid 005278-95-5 N.D. N.D. < 0.0005 THAA 0.0178

Bromate ion 015541-45-4 N.D. N.D. < 0.002GESAMP-BWWG 4/9 ANNEX 4 Page 8

I:\MEPC\57\2.doc Table 3: List of disinfection by-products in the seawater of Ma-San Port (28 – 30 PSU) after ECS treatment (MEPC 57/2/1, table 5-3)

List of ALL potential by-products produced in ballast water

Chemical name CAS number Control water (mg/L) Treated water (mg/L) Detection limit (mg/L)

THM Trichloromethane 000067-66-3 N.D. N.D. < 0.0001 Bromodichloromethane 000075-27-4 N.D. N.D. < 0.0001 Dibromochloromethane 000124-48-1 N.D. 0.0093 < 0.0001 Tribromomethane 000075-25-2 N.D. 0.1231 < 0.0001 HAA Monochloroacetic acid 000079-11-8 N.D. N.D. < 0.0001 Dichloroacetic acid 000079-43-6 N.D. N.D. < 0.0001 Trichloroacetic acid 000076-03-9 N.D. N.D. < 0.0001 Monobromoacetic acid 000079-08-3 N.D. N.D. < 0.0001 Dibromoacetic acid 000631-64-1 N.D. 0.0162 < 0.0005 Tribromoacetic acid 000075-96-7 N.D. 0.0051 < 0.0005 Bromochloroacetic acid 005589-96-8 N.D. N.D. < 0.0001 Bromodichloroacetic acid 71333-14-7 N.D. N.D. < 0.0005 Dibromochloroacetic acid 005278-95-5 N.D. N.D. < 0.0005 Bromate ion 015541-45-4 N.D. N.D. < 0.002

3.2.11 As a result of this analysis, four major by- products have been iden tified by the applicant at the two test sites. The four identified by-products of EC S ballast water treatment were dibromochloromethane, tribromomethane, dibromoacetic acid and tribromoacetic acid. The information of these by-products is shown in tables 4-7.

3.2.12 The Group noted that analysis of the land- based tests was carried out under conditions outside the range for salinities and organic carbon as established in G8. Low levels of organic carbon in the samples analyzed may have resulted in low levels of chlorination by-products and thereby the toxicity assessment of the treated ballast water.

3.2.13 As indicated in the report of its 3 rd meeting, the Grou p needs to evalua te the range of potential by-products at detect ion limits, e.g. similar to thos e used in routine surface water monitoring of 0.01-0.05 μg/L, with supporting evid ence of same day analysis and clear evidence of how sample handling, storage and anal ysis were achieved. In general the analysis should at the minimum include all by-produ cts known from similar app lications of oxidants in seawater such as AOX, EOX, Total THM, trichloromethane, chloroform, trib romomethane, bromoform, dibromochlorom ethane, dichlorobr omomethane, monobromoacetic acid, dibromoacetic acid, tribromoac etic acid, bromochloroacetic acid, dibromochloroacetic acid, bromodichloroacetic acid, monobromoacetonitrile, dibromoacetonitrile, bromochloroacetonitrile, 2,4-dibromophenol , 2,6-dibromophenol, 2,4,6-tribromophenol, dibromoethane, 1,2,3-trichloropropane, 2-chloro toluene, 4-chlorotolu ene, 1,2-dibromo-3- chloropropane and 1,2,3-tribromobenzene.GESAMP-BWWG 4/9 ANNEX 4 Page 9

I:\MEPC\57\2.doc Table 4: The information of dibromoc hloromethane (MEPC 57/2/1, table 5-4)

Item Information IUPAC name dibromochloromethane CAS number 124-48-1 UN number N.A. Molar mass 208.28 Empirical formula ClCHBr 2

Structural formula

Purity of technical material and identification of impurities 99% of dibromochloromethane Stabilizers or necessary additives N.A.

Table 5: The information of tribro momethane (MEPC 57/2/1, table 5-5)

Item Information IUPAC name bromoform CAS number 75-25-2 UN number 2515 Molar mass 252.73g/mol Empirical formula CHB 3

Structural formula

Purity of technical material and iden tification of impurities 100% of bromoform

Stabilizers or necessary additives Bromoform is relatively stable in the air

Table 6: The information of dibromoa cetic acid (MEPC 57/2/1, table 5-6)

Item Information IUPAC name dibromoethanoic acid CAS number 631-64-1 UN number N.A. Molar mass 217.84 Empirical formula C 2 H 2 Br 2 O 2 Structural formula

Purity of technical material and identification of impurities 99% of dibromoacetic acid

Stabilizers or necessary additives Stab le at room temperature in closed containers under normal storage and handling conditions without stabilizer.GESAMP-BWWG 4/9 ANNEX 4 Page 10

I:\MEPC\57\2.doc Table 7: The information of tribrom oacetic acid (MEPC 57/2/1, Table 5-7)

Item Information IUPAC name tribromoacetic acid CAS number 75-96-7 UN number N.A. Molar mass 296.74g/mol Empirical formula C 2 HBr 3 O 2 Structural formula

Purity of technical material and identification of impurities 99% of tribromoacetic acid

Stabilizers or necessary additives Stab le at room temperature in closed containers under normal storage and handling conditions without stabilizer.

4 HUMAN HEALTH ASSESSMENT

For the presented data see Appendi x I, part 3, Mammalian toxicity.

4.1 According to the data presented, hypochlorit e is considered to be harmful by inhalation and dibromochloromethane, tribromomethane by oral exposure. On the other hand, tribromomethane is classified as toxic by inhalation (GHS cla ssification, Annex VI, COM (2007) 355 final). Additionally, dibromoacetic acid, is not considered to be an acutely toxic by oral route and for tribromoacetic acid, no data was submitted to assess acute toxicity.

4.2 Hypochlorite is classified as a skin and eye irritant and a sensitizer. Additionally, tribromo-acetic acid is considered to be corrosive to skin and eye. tribromomethane is classified as a skin and eye irritant, causing serious eye irritation (GHS classification, Annex VI, COM (2007) 355 final).

4.3 According to the data presented, there seemed to be no relevant to xicological concerns towards repeated exposure to hypochlorite, dibr omo- and tribromochloromethane, dibromo and tribromoacetic acid.

4.4 From the submitted data, some reproduction toxicological effects were noted in association with exposure to dibromoacetic acid and tribromomethane to rodents at high doses.

4.5 Relevant adverse effects relate d to target organs (liver an d testis) were observed in the data presented. Chlorinated and Brominated DPB, have a potential human genotoxicity/carcinogenicity and w ill therefore need to be kept below toxicologically critical levels (bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L, WHO Guidelines for Drinking Water Quality, 2003).GESAMP-BWWG 4/9 ANNEX 4 Page 11

I:\MEPC\57\2.doc 5 RISK TO SAFETY OF SHIP AND CREW

5.1 Explosion tests

When ECS is operated, hydrogen gas is produced and emitted as a result of the electrolysis process. Hydrogen gas can cause explosions at high concentr ations (4 to 75% v/v air). Therefore consideration of the risk of expl osion by measuring the concentration of hydrogen gases onboard the barge and the M/V STX YOKOHAMA has taken place.

5.1.1 Hydrogen gas tests

5.1.1.1 Test with land-based installation

Hydrogen gas was measured at four different places on the barge and at five different time intervals after the ECS operation. The four places were chosen to be: inside the ballast tank, around the ECS, on the deck, and in the crew li ving quarters. Table 8 shows that only low concentrations of hydrogen gas were generated. There was no risk of explosion. The safety of the ballast tank has been confirmed without th e need of any additional ventilation system.

Table 8: Hydrogen gas concentration on the barge for land-based test (MEPC 57/2/1, 5.1.1.1)

Surveyed location Unit After ECS Elapse of 1 h Elapse of 2 h Elapse of 12 h Elapse of 24 h

Ballast tank area % 0.9 0.5 0.2 N.D. N.D.

Surrounding the ECS % N.D. N.D. N.D. N.D. N.D.

Alongside vessel % N.D. N.D. N.D. N.D. N.D.

Upper regions of vessel % N.D. N.D. N.D. N.D. N.D.

5.1.1.2 Shipboard test

The values of hydrogen gas were m easured in four different place s on board of the ship, and at five different time intervals afte r the ECS operation. The four plac es were chosen to be inside of the ballast tank, around the ECS, on the deck, a nd in the crew living quarters. Table 9 shows that only low concentrations of hydrogen gas were generated. There was no risk of explosion.GESAMP-BWWG 4/9 ANNEX 4 Page 12

I:\MEPC\57\2.doc Table 9: Hydrogen gas concentration on th e M/V STX YOKOHAMA for on board test (MEPC 57/2/1, 5.1.1.1)

Surveyed location Unit After ECS Elapse of 1 h Elapse of 2 h Elapse of 12 h Elapse of 24 h

Ballast tank area % 0.8 0.5 0.2 N.D. N.D.

Surrounding the ECS % N.D. N.D. N.D. N.D. N.D.

Deck % N.D. N.D. N.D. N.D. N.D.

Crew’s quarters % N.D. N.D. N.D. N.D. N.D.

The Group was concerned that the H 2 levels indicated by the va rious tests performed could reach the LEL level for H 2 . However, subsequent communi cation in which the applicant confirmed that the maximum concentrations of H 2 measured at any point during the testing was 1.3% alleviated this concern.

5.2.1 Chlorine gas tests

5.2.1.1 Land-based installation

Chlorine gas concentrations were m easured in four different places and at five di f f erent ti m e intervals after the ECS operation was finished. The four places were chosen to be inside of the ballast tank, around the ECS, on th e port and starboard sides of barge and on the deck of the barge. The results show up to 0.9 ppm of chlorine gas in the ballast tank.

Table 10: Variations of chlo rine gas land-based installati on after land-based test (Ref. MEPC 57/2/1, 5.2.1.1)

Surveyed location Unit After ECS Elapse of 1 hr Elapse of 2 hrs Elapse of 12 hrs Elapse of 24 hrs

Ballast tank area ppm 0.9 0.6 0.3 0.1 N.D.

Surrounding the ECS ppm N.D. N.D. N.D. N.D. N.D.

Alongside vessel ppm N.D. N.D. N.D. N.D. N.D.

Upper regions of vessel ppm N.D. N.D. N.D. N.D. N.D.

5.2.1.2 Shipboard test

The shipboard tests were carried out on the M/V STX YOKOHAMA . Chlorine gas concentrations were measured in four different places and at five different time intervals after the ECS operation was finished. Maximum chlori ne gas concentration was found inside of the ballast tank with 0.7 ppm direc tly after ECS treatment.GESAMP-BWWG 4/9 ANNEX 4 Page 13

I:\MEPC\57\2.doc Table 11: Chlorine gas concentrat ion on the M/V STX YOKOHAMA after shipboard test (Ref. MEPC 57/2/1, 5.2.1.2)

Surveyed location Unit After ECS Elapse of 1 hrs Elapse of 2 hrs Elapse of 12 hrs Elapse of 24 hrs

Ballast tank area ppm 0.7 0.5 0.3 0.1 N.D.

Surrounding the ECS ppm N.D. N.D. N.D. N.D. N.D.

Alongside vessel ppm N.D. N.D. N.D. N.D. N.D.

Upper regions of vessel ppm N.D. N.D. N.D. N.D. N.D.

It is noted by the Group that chlorine levels immediately following treatment in the ballast tank area have been measured at 0.9 ppm (V/V) during so me tests. This is very close to the short term exposure limit for chlorine gas which is 1 ppm, according to the submission. It is recognized that the concentration of chlorine gas in the ballast tank decays comparatively quickly. However, additional risk mitigat ion measures will be necessary immediately following treatment.

5.3 Corrosion effect tests (Ref. MEPC 57/2/1, 5.1.2)

5.3.1 Test conditions

The corrosion tests were performed using coated test panels. Corrosion tests for the control and treated water by ECS were conducted over 6 months using both natural seawater and using artificial seawater of 25 PSU.

5.3.2 Corrosion test results

It was confirmed that the corrosion rate of the test panels in EC S treated seawater did not show significant higher corrosion rates compared to the c ontrol test panels. In this regard the Group accepted that the original concern related to corrosion raised during basic approval was alleviated. However, as only coated test panels were tested, the Group recommends that corrosivity continues to be monitored as part of normal operation of the system.

5.4 Risks to human health

5.4.1 The Group considered that potential human e xposure to the active substances generated by ECS might result in acute health effects (irritati on to skin and respirator y tract). Therefore it is recommended as mandatory to ensure the ap plication of RMM (risk management measures) for the protection of the exposed populations to the main routes of concern: dermal and inhalation.

5.4.2 As acknowledged, chlorinated and brominated DPB, have a potential for bioaccumulation and human genotoxicity/carcinogenicity, therefore these compounds will have to be kept below toxicological critical levels (bromate<10μg/L; bromoform<100μg/L; chloroform<200 μg/L, WHO Guidelines for Drinking Water Quality, 2003).GESAMP-BWWG 4/9 ANNEX 4 Page 14

I:\MEPC\57\2.doc 5.4.3 The Group considered that Chlorinated and Brominated DBPs (Disinfection By-Products) are the toxicologically relevant compounds generate d by the process. As the applicant could not provide information concerning the Human Expo sure Scenario (MEPC 56/2/2, annex 9), the Group noted that an adequate conc lusion as to the outcome of th e Human Risk Assessment could not be achieved. In this sense, the Group adopted a precautionary approach and recommended that human exposure when handling ballast water treatment operations shoul d be restricted and Risk Mitigation Measures (RMM) put in place.

6 RISKS TO THE AQ UATIC ENVIRONMENT

6.1 ASSESSMENT OF PERSISTENCE (P), BIOACCUMULATION (B) AND TOXICITY (T)

The Group already carried out the PBT assessment at Basic Approval. It was concluded that none of the substances applied should be classified as PBT.

7 ASSESSMENT OF TREATED BALLAST WATER

7.1 Toxicity tests

7.1.1 Test conditions

7.1.1.1 All toxicity tests were carried out with the whole effluent of the land-based ECS installations with brackish water from th e Sum-Jin River (15 – 22.3 PSU) and seawater from Ma-San Port (28.7 – 33.4 PSU). The organi c content (TOC, DOC, POC) was significantly lower than required by G8 in the majority of tests. This substantially increases the uncertainties of conclusions drawn from the ecotoxicity tests performed and from results from the chemical analysis of treated ballast water. The tests were performed 3 and 5 da ys after the treatment with 0, 25, 50, 75 and 100% dilutions with culture media or raw water. Table 12 summarizes all toxicity tests, which were carried out. The Group noted that initial TRC levels were set above 2 mg/L, which is the maximum allowable discharge concentration, even when they use the ECS treated water with 5 days tank holding time. Thus the Gr oup considered that this test has not performed under adequate Qualit y Control for the Whole Effluent Toxicity testin g, so that the resultant PNEC value calculated from thes e data could have large uncertainties.

7.1.1.2 The acute and chronic toxicity tests reporte d by the applicant were carried out as static non-replacement tests. As a result the Group cons iders that the exposures in the chronic test were far lower than initial TRC values shown in table 12.GESAMP-BWWG 4/9 ANNEX 4 Page 15

I:\MEPC\57\2.doc Table 12: Overview of all toxicity test s carried out with the ECS treated water

Tank holding

times

[d] Organisms % of discharged water Initial TRC [mg/L]

Invertebrate 100 7.3 3 Fish 100 3.3 Invertebrate 100 1.0 Brackish Water

5 Fish 100 2.7 Invertebrate 100 7.1 3 Fish 100 2.9 Invertebrate 100 1.2 Acute toxicity Seawater

5 Fish 100 3.3 Algae 100 2.5 Invertebrate 40 0.9 3 Fish 40 1.1 Algae 100 1.1 Invertebrate 40 0.5 Brackish Water

5 Fish 40 1.0 Algae 100 2.4 Invertebrate 40 1.0 3 Fish 40 1.5 Algae 100 0.7 Invertebrate 40 0.6 Chronic toxicity Seawater

5 Fish 40 0.9

Table 13: Summary of acute toxicity test s carried out with the ECS treated water (Ref. MEPC 57/2/1, 6.2.1.1, 6.2.2.1, 6.2.3.1 and 6.2.4.1)

FCA Species Salinity [PSU] days LC50 (mg/L) Comments, etc.

C Artemia nauplii 18 3 1.0 (96hr) 50% artificial brackish water + 50% ECS treated water

F Poecilia latipinna 18 3 1.7 (96hr) 25% artificial brackish water + 75% ECS treated water

C Monocorophium acherusicum 30 3 1.4 (96hr) 25% artificial seawater + 75% ESC treated water

F Paralichthys olivaceus 30 3 0.9 (96hr) 50% artificial seawater + 50% ECS treated water

C Artemia nauplii 18 5 1.0 (96hr) 50% artificial brackish water + 50% ECS treated water

F Poecilia latipinna 18 5 1.1 (96hr) 25% artificial brackish water + 75% ECS treated water

C Monocorophium acherusicum 30 5 1.2 (96hr) 100% ECS treated water

F Paralichthys olivaceus 30 5 1.1 (96hr) 25% artificial seawater + 75% ECS treated waterGESAMP-BWWG 4/9 ANNEX 4 Page 16

I:\MEPC\57\2.doc Table 14: Summary of chronic toxicity test s carried out with the ECS treated water (Ref. MEPC 57/2/1, 6.2.1.2, 6.2.2.2, 6.2.3.2 and 6.2.4.2)

FCA Species S [PSU] days NOEC (mg/L) Comments, etc.

A Skeletonema

costatum 18 3 0.8 (96hr) 50% F/2 medium (15ppt) + 50% ECS treated water

C Artemia nauplii 18 3 0.9 (21d) 60% artificial brackish water + 40% ECS treated water

F Poecilia latipinna 18 3 1.1 (62d) 60% artificial brackish water + 40% ECS treated water

A Skeletonema

costatum 30 3 0.6 (96hr) 75% F/2 medium (30ppt) + 25% ECS treated water

C Monocorophium acherusicum 30 3 1.0 (21d) 60% artificial seawater + 40% ECS treated water

F Paralichthys olivaceus 30 3 1.0 (62d) 70% artificial seawater + 30% ECS treated water

A Skeletonema

costatum 18 5 0.5 (96hr) 50% F/2 medium (15ppt) + 50% ECS treated water

C Artemia nauplii 18 5 0.5 (21d) 60% artificial brackish water + 40% ECS treated water

F Poecilia latipinna 18 5 1.0 (21d) 60% artificial brackish water + 40% ECS treated water

A Skeletonema

costatum 30 5 0.3 (96hr) 75% F/2 medium (30ppt) + 25% ECS treated water

C Monocorophium acherusicum 30 5 0.6 (21d) 60% artificial seawater + 40% ECS treated water

F Paralichthys olivaceus 30 5 0.9 (62d) 60% artificial seawater + 40% ECS treated water

7.1.1.4 For some organisms, artificial sea water is not considered to be a well chosen medium for the tests ( Artemia nauplii and Skeletonema costatum ).

7.1.1.5 A large variation of TRC c oncentrations has been observed.

7.1.1.6 From the acute toxicity tests carried out with treated BW it is concluded by the Group that the lowest 96 h LC 50 value for 100% treated ECS wate r can be set at 1.2 mg TRC/L.

7.1.1.7 The lowest chronic aquatic toxicity te sts revealed an NOEC of 0.6 mg TRC/L for 60% artificial seawater pl us 40% ECS treated water. No test s were carried out with 100% ECS treated ballast water.

7.1.1.8 The Group considers that only testing fo r ecotoxicity with tr eated ballast water after 3 and 5 days of storage is insufficient to cover all of the possible storage and discharge conditions. Should treated ballast wa ter need to be discharged on a shorter time scale, then higher TRC values can be expected.GESAMP-BWWG 4/9 ANNEX 4 Page 17

I:\MEPC\57\2.doc 7.2 Degradation of TRC

TRC degradation rates were meas ured daily over the course of a week in the two land-based installations and in the shipboard ballast tank. The initial TRC c oncentration measured just after treatment in the ballas t tank was ca.10 mg/L.

The half-life of TRC in the ballast tank is about 1 d for dark conditions (Table 15). The Group noted that this data clearly indicated that the TRC concentration at discharge with less than 2 days tank hold time would probably exceed 2 mg/L, which is set as the maximum allowable discharge concentration by the applic ant. Thus, the mitigation procedure using a neutralizing agent shou ld be installed to all the trea tment system using this ECS.

Table 15: Degradation of TRC in ballast tanks

TRC (mg/L) After ECS treated (day) Test barge (Sum-Jin River) Test barge (Ma-San Port) M/V STX YOKOHAMA (Bu-San Port) 0 9.7 9.9 7.9 1 4.5 4.8 3.7 2 2.5 2.9 2.3 3 1.9 1.9 1.4 4 1.5 1.6 1.3 5 1.3 1.5 1.3 6 1.3 1.5 1.1 7 1.2 1.4 0.9

7.3 Prediction of discharge and environmental concentrations

7.3.1 Emission scenario of active substance

An analysis of TRC emissions was developed by the applicant for the ECS operation in Bu-San port and In-Cheon Port with the fo llowing varying input parameters:

- Tide: spring, neap

- Volume of discharged water: 33, 50 and 100%

- TRC half-life: 0.5, 1 and 2 days

- initial TRC concentrations: 2 and 10 mg/L

- 250 days with single point dischargeGESAMP-BWWG 4/9 ANNEX 4 Page 18

I:\MEPC\57\2.doc Table 16: Summary of Emission Scenarios in Port of Bu-San at spring and neap tide (MEPC 57/2/1, 7.3.2 and Applicatio n dossier Table 8-38, page 262)

Diffusion area [km 2 ] Tide Initial TRCConcentration [mg/L] TRC half-life Discharged water [%] ≥ 0.05 [mg/L] ≥ 0.1 [mg/L] ≥ 0.2 [mg/L] ≥ 0.3 [mg/L]

spring 10 1 100 1.930 0.990 0.445 0.253 spring 10 1 50 0.990 0.445 0.170 0.098 spring 10 0.5 100 1.105 0.540 0.235 0.160 spring 10 0.5 50 0.540 0.235 0.113 0.044 spring 2 0.5 100 0.185 0.061 0.026 0.007 spring 2 0.5 50 0.059 0.026 0.005 0.002 neap 10 1 100 1.546 0.781 0.415 0.264 neap 10 1 50 0.781 0.415 0.196 0.134 neap 10 0.5 100 0.789 0.443 0.227 0.135 neap 10 0.5 50 0.443 0.227 0.117 0.079 neap 2 0.5 100 0.193 0.089 0.038 0.026 neap 2 0.5 50 0.089 0.037 0.009 0.005

For the Port of In-Cheon the ar eas of the different concentrati on limits were generally lower. Worst-case scenario for the discharge 10 mg/L T RC with a half-life of 2 days and no dilution, where the area for concentrations ≥ 0.05 mg/L limit was 1.930 km 2

. The Group considered that this was an ade quate reflection of the possible short-term TRC concentrations.

7.3.2 PEC calculation

The submission informs that the PEC calculation was obtained according to the Bu-San Port statistics referred to in the Emission scenari o. From the Korea Ocean Science & Engineering Corporation (KOSEC) data the Bu-S an Port water volume is 207,000,000 m 3 and the annual ballast water discharge is 111,683,505 m 3 . The daily ballast discharge is 305,982 m 3 . The ECS operates at maximum 10 mg/L initial TRC con centration and the maximum discharge level is set to be at 2 mg/L. From the assumption that it takes 24 hours for the TRC concentration to completely mix with the seawater the ballast water is consequently calculated in standard to the one day PEC discharge amount. Therefore,

L mg L mg PEC / 00296

. 0 000

, 000

, 207 / 0

. 2 982

, 305

= ×

=

As part of the basic approval the Group informed the applicant that it would be necessary to provide all necessary data includ ing input parameters for the Group to be able to evaluate the risk assessment presented by the applicant.

In evaluating the risk assessment presented for final approval, the Group encountered the same problems. It is unclear how the risk assessment was set up a nd carried out. Copies of the original input data and subsequent calculations would be required in order to allow the Group to reconstruct and evaluate the risk assessment.GESAMP-BWWG 4/9 ANNEX 4 Page 19

I:\MEPC\57\2.doc Furthermore, the organic content (TOC) in te st water was significantly lower than required by G8. The group considered that such conditions in the tests could reduce the probability of causing long term effects in the risk assessments, i.e. on co ntinuous discharge. If the half life data indicated in Tabl e 16 is used in the usual one box m odel considering exchange rate and degradation rate, the PEC value should be nearly twice that which the applicant indicated.

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 PEC/PNEC calculation

.................................................................................................................. (Paragraph deemed to be confidential and removed at the request of the submitting Administration)

8.2 Risk Characterization

.................................................................................................................. (Paragraph deemed to be confidential and removed at the request of the submitting Administration)

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

Risks to the safety of the ship from the production of hydrogen by the BWMS was reported by the applicant. The Group was satisfied that u nder the operating conditi ons described in this application, the concentrations of hydrogen produced during la nd based and shipboard testing remained at safe levels, i.e. less than one quart er of the LEL of 4%. In fully operational systems consideration should be given to monitoring hydrogen levels to ensure that they are not allowed to exceed such safe levels; ventilation should be considered.

Chlorine gas was also measured in the land ba sed (barge) and ship board tests and at 0.9 ppm was considered by the group to be close to publis hed acute exposure limit. The group therefore considered that additional risk mitigatio n measures will be necessary immediately following treatment.

The Group recommends that corrosivity continue s to be monitored as part of the normal operation of the ECS system.

9.2 Risks to the crew and general public

The Group concluded that Chlorina ted and Brominated DBPs (Dis infection By-Products) are the toxicologically relevant com pounds generated by the process as they have a potential for bioaccumulation and human genotoxicity/carcinogeni city; therefore they will have to be kept below toxicologically critical levels (bromate <10 μg/L, bromoform <100 μg/L, chloroform <200 μg/L, WHO Guidelines for Drinking Water Quality, 2003).

The Group also noted that the a pplicant did not provide informa tion concerning potential Human Exposures or any Exposure Scenario related to this BWMS (MEPC 56/2/2, annex 9) and that therefore an adequate conclusion as to the ou tcome of the Human Risk Assessment could not be made. In this sense, the Group adopted a pre cautionary approach and recommended that humanGESAMP-BWWG 4/9 ANNEX 4 Page 20

I:\MEPC\57\2.doc exposure when handling ballast water treatmen t operations should be restricted and Risk Mitigation Measures (RMM) put in place.

9.3 Risks to the environment

Given the current status of the proposals as presented in this application for Final Approval, risks to the aquatic environment cannot be ex cluded. Therefore, measures to lower the TRC levels discharged are required.

9.4 Recommendations

The Group concluded that the Korean application is not ready for final approval. In the report of the GESAMP-BWWG (1) the conclusions and recommendations are stated as follows:

9.3 Mitigation procedures or operations shoul d be established to reduce the TRC to levels that avoid risk to the environmen t in the case of short trips and during the treatment of fresh waters.

9.4 It seems that the applica tion of the ECS leads to creation of substantial amounts of very reactive species, in particular chlorine solutions that may lead to increased corrosion of the tank and piping. The poten tial damage to the ship has not been elucidated.

• The amounts of total residual chlorine (TRC) formed during the electrolytic process result in concentrations in th e treated ballast water that largely exceed limit values established for dischar ge of waste water from land-based point sources. The degradation rate of TRC is so low that substantial concentrations may be expected also at discharge of treated ballast water. In addition, the potential health risks have not been sufficiently characterized.

• Acute aquatic toxicity tests have been conducted with sea water to different species immediately after treatment w ith ECS. The tests showed that a dilution of up to more than 100 times is required before acute toxicity can be avoided.

• The assessment of environmental ex posure concentrati ons have apparently been based directly on the same model calculations with the MAMPEC model as presented in the app lication dossier submitted by a separate applicant. The Group would require access to the input data and more information on the parameters within the model in order to ascertain the validity of the results.

• The aquatic risk assessment based on the measured concentrations in treated ballast water, the dilution model assu ming a dilution of approximately 2,000 times and derived Predicted No-Effect-Concentrations for hypochlorite showed an estimated risk to the aquatic environment.

• The dossier does not include documentati on of which actives are produced in fresh water application. A full documen tation of their properties should be included.GESAMP-BWWG 4/9 ANNEX 4 Page 21

I:\MEPC\57\2.doc • The application dossier does not incl ude documentation of the quality control/quality assurance programme as requested in G9: 4.2.4.

9.5 After considering all of the above concerns , it is the opinion of the Group that the proposal has not demonstrated whether ther e is a potential for unreasonable risk for environment, human health, property and reso urces. The Group therefore considers it appropriate that further land-based studi es be conducted before on board testing eventually takes place. Consequently, the Group recommends that the Organization should grant a basic approval to the proposed Electro Clean System with conditions that land-based testing address the concerns for s hort- and long-term impac ts to the receiving waters before an eventual on-board testing is approved.

The applicant is advised to revisit and address these recommendations.

During the evaluation process and interactions w ith the Korean authorities it showed that research on the mitigation measures was still u nder testing for biological efficacy, influence to the environment and risk on crew and ship.

The recommendations of the GESAMP-BWWG from its initial appraisal of this system are therefore still under development.

Thus, insufficient progress has been achieved to cl arify the concerns of the Group in the current submission for Final Approval.

The Group recommends that first the final results of the mitiga tion measures are implemented into the proposal for Final Approval fo r subsequent consid eration by the Group.

* * *GESAMP-BWWG 4/9 ANNEX 4 Page 22

I:\MEPC\57\2.doc APPENDIX 1

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF HYPOCHLORITE, DIBROMOCHLOROMETHANE, TRIBROMOMETHANE, DIBROMOCHLOROACETIC ACID AND TRIBROMOACETIC ACID

1 PHYSICOCHEMICAL PROPERTIES

Table 17: Physical and chemical properties of hypochlorite (MEPC 57/2/1, 5.2.4)

Property Value Reference Melting point (°C) -25 IUCLID Boiling point (°C) 96-99 IUCLID Flammability Non flammable IUCLID Density (20°C; kg/m 3 ) 1.21~1.23 IUCLID Vapour pressure (20°C ; Pa) 2500 IUCLID Vapour density (air = 1) N.A. MSDS Water solubility (temp; effect of pH; mg/L) Miscible (>11 and 20 oC) IUCLID

pH in solution 14 MSDS Dissociation constant (pKa) N.A. - Oxidation-reduction potential N.A. - Corrosivity to material or equipment N.A. -

Reactivity to container material N.A. - Auto-ignition temperature (°C) N.A. - Explosive properties N.A. -

Oxidizing properties One of the more commonly used oxidizing agents and a very efficient disinfectant: virucide, bactericide and fungicide. It is used for the remnant disinfection of drinkable water IUCLID

Surface tension N.A. - Viscosity Dynamic viscosity 20°C: 2.6mPa.s IUCLID Thermal stability and identity of breakdown products N.A. -

Other physical or chemical properties N.A. -GESAMP-BWWG 4/9 ANNEX 4 Page 23

I:\MEPC\57\2.doc Table 18: Physical and chemical pr operties of dibromochloromethane (MEPC 57/2/1, 5.3.4)

Property Value Reference Melting point (°C) -20 Lide 2000 Boiling point (°C) 120 Lide 2000 Flammability (flash point for liquids; °C) Non-flammable HSDB2004a, 2004b

Density (kg/dm 3 , 20°C) 2.451 Lide 2000 Vapour pressure (20°C ; Pa) 10,133 US EPA Mabey et al . 1982 Vapour density (air = 1) No data IARC 1991a, 1991b Water solubility (temp; effect of pH; mg/L) 2.7x10 3 (20 ° C) Horvath 1982; Heikes 1987

Table 19: Physical and chemical properties of tribromomethane (MEPC 57/2/1, 5.4.4)

Property Value Reference Melting point (°C) -11.87 EPI Suit V 3.20 Boiling point (°C) 167.23 EPI Suit V 3.20 Flammability Non-flammable HSDB 2004a ,2004b Density (20°C; kg/m 3 ) 2.899 Lide, 2000 Vapour pressure (25°C; Pa) 712 EPI Suit V 3.20 Vapour density (air = 1) 8.7 IARC 1991a, 1991b

Water solubility (mg/L) 3.10x10 3 (25°C) Slightly soluble EPI Suit V 3.20

Surface tension (dynes/cm) 41.53 Lewis 1997 Viscosity (mPa.s) at 20°C : 0.58 MSDS

Table 20: Physical and chemical properties of dibromoacetic acid (MEPC 57/2/1, 5.5.4)

Property Value Reference Melting point (°C) 49 Windholz et al ., 1996; Lide, 1999 Boiling point (°C) 195 Adapted Stein & Brown method Flammability N.A. N.A. Density (20°C; kg/dm 3 ) N.A. N.A. Vapour pressure (25°C ; Pa) 3.1 N.A. Vapour density (air = 1) N.A. N.A. Water solubility (temp; effect of pH; (mg/L) 2.214x10 4 at 20  ̊ C Windholz et al ., 1996; Lide, 1999GESAMP-BWWG 4/9 ANNEX 4 Page 24

I:\MEPC\57\2.doc Table 21: Physical and chemical propertie s of dibromoacetic ac id (MEPC 57/2/1, 5.6.4)

Property Value Reference Melting point (°C) 130-133 MSDS Boiling point (°C) 245 MSDS Flammability N.A. N.A. Density (20°C; kg/m 3 ) - - Vapour pressure (20°C ; Pa) 6,666 US EPA Mabey et al , 1982 Vapour density (air = 1) N.A. N.A. Water solubility (temp; effect of pH; (mg/L) 1.199x10 4 (25 ° C) US EPA Mabey et al , 1985

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Table 22: Acute aquatic toxicity of Ac tive Substances and other chemicals (MEPC 57/2/1, tables 5-8, 5-20 and 5-32)

F C A Species LC50 [mg/L] (duration) Reference

Hypochlorite F Pimephales promelas 5.9 (96hr) Curis, et al ., 1981

C Gammarus fasciatus 4.0 (96hr) Ewell et al ., 1986

A Chlorella sorokiniana 0.6 (20hr) Kott et al ., 1969

Dibromochloromethane F Cyprinus carpio 52 (0.75hr) Trns.Am.Fish.Soc.

A Tetrahymena pyriformis 65 (24hr) Sci.Total Environ.

Tribromomethane F Brevoortia tyrannus 12 (96hr) Quarterly Progress Report, 1978.

C Penaeus aztecus 26 (96hr) Quarterly Progress Report, 1978.

A Selenastrum capricornutum 40 (96hr) (EC50) Contract No.68- 01-4646,U.S. EPA

However, the Group noted that no data was presented for hypobromous acid/hypobromite and hypochlorous acid.GESAMP-BWWG 4/9 ANNEX 4 Page 25

I:\MEPC\57\2.doc 2.2 Chronic aquatic toxicity data

Table 23: Chronic aquatic toxicity of Active Substances and other chemicals (MEPC 57/2/1, tables 5-9, 5-21 and 5-33)

F C A Species LC50 or NOEC[mg/L] (duration) Reference

Hypochlorite F Menidia beryl1ina NOEC: 0.18 (7d) Fisher et al ., 1994

C Dreissena polymorpha 295h-LC50: 1.0 Martin, I.D. et al

., 1993

A Skeletonema

costatum 24h-EC50: 0.095 Gentile J.H. et al.

, 1976Dibromochloromethane F Cyprinus carpio LC50: 34 (NR d) Trns.Am.Fish.Soc.

A Tetrahymena pyriformis 24h-LC50 65 Sci.Total Environ.

Tribromomethane F Cyprinodon variegatus 29h-NOEC 2.9 Bull.Environ.Contam .Toxicol. 27(5):596-604 (OECDG Data File)

C Penaeus aztecus NR 0.030 (NR d) Pacific.NorthwestLa b.,Richland.WA:40p (U.S.NTIS NUREG. CR-1297)

A Selenastrum capicornutum 96h-NOEC 10 Contract No.68-01- 4646, U.S.EPA: 9p Dibromoacetic acid N.D. Tribromoacetic N.D.

2.3 Information on production of endocrine disruption

No information on production of endocrine disrupti on related to effect on aquatic organisms of hypochlorite, dibromoacetic acid and tribromoacetic acid is presented to assess this endpoint. Only some data are submitted about po ssible endocrine effects on mammals.

The Group, however, considers these data as irrele vant as the intention of this topic is to safeguard the environment for such effects. The Group is of the opinion that:

• There are no structural alerts as neither of these substances have structures which are known to trigger endocrine receptors, e.g., a be nzene ring with an alcohol or ketone group in a near terminal position and backed by alkyl ‘bulk’.

• Endocrine disruption in the true sense is restricted to horm ones or pseudo-hormones with strengths 10 -4 to 10 -6 lower than predicted chronic aquatic values e.g. estrogen and synthetic estrogen, TBT, DES, etc.GESAMP-BWWG 4/9 ANNEX 4 Page 26

I:\MEPC\57\2.doc • Some inherent characteristics, e.g. vapour pressure, are cons idered high enough to reduce any potential endocrine disrupti ng effect to acceptable levels.

Therefore, the Group concludes that no additional information is required on the topic of endocrine disruption for the substances used in this Ballast Water Treatment System under G9.

2.4 Sediment toxicity

There are no data available on the toxicity fo r sediment organisms, but based on table 24 an estimation can be made on possible toxi cological effects for these substances.

Table 24: Summary of Log Pow and Koc val ues for potential sediment toxicity

Compound Log Pow Koc Reference Dibromochloromethane 2.2 MEPC 57/2/1, 5.3.1.4 Tribromomethane 2.4 35.04 CITI (1992), Sangster (1994) EPI Suit V 3.20 MEPC 57/2/1, paragraph 5.4.1.4 Dibromoacetic acid 0.7 1.895 EPI SuitTM, U.S.EPA v3.20 MEPC 57/2/1, paragraph 5.5.1.4 Tribromoacetic 1.71 0.437 EPI SuitTM, U.S.EPA v3.20 MEPC 57/2/1, paragraph 5.6.1.4

The Group agreed that due to the low Log Pow and Koc values being <3 and <500, respectively, the possibility of sediment toxicity w ould be predicted to be very low.

2.5 Bioavailability/Bioconcentration/Biomagnification

Table 25: Summary of Log Pow and BC F values for potential Bioavailability/ Bioconcentration/Biomagnification

Compound Log Pow BCF Reference Hypochlorite -3.42 EPI SuitTM, U.S.EPA v3.20 MEPC 57/2/1, paragraph 5.2.1.5 Dibromochloromethane 2.2 MEPC 57/2/1, 5.3.1.5 Tribromomethane 2.4 14.06 MEPC 57/2/1, 5.4.1.5 Dibromoacetic acid 0.7 3.162 EPI SuitTM, U.S.EPA v3.20 MEPC 57/2/1, 5.5.1.5 Tribromoacetic 1.71 3.162 EPI SuitTM, U.S.EPA v3.20 MEPC 57/2/1, 5.6.1.5

The Group concludes from these data that none of th ese substances is expected to accumulate or magnify in the food chain.

2.6 Food web/Population effects

Reference is made to the low Log Pow and BC F values in Table 25. Because of the low Log Pow and Koc values being <3 and <500, respectiv ely, the possibility of adverse effect on food web should be insignificant.GESAMP-BWWG 4/9 ANNEX 4 Page 27

I:\MEPC\57\2.doc 3 MAMMALIAN TOXICITY

3.1 Acute mammalian toxicity

Table 26: Summary of available data on mammalian toxicity

Compound Unit Value Species Reference

Hypochlorite Oral LD 50 mg/kg 8200 Rat Kaestner, W., cited in BIBRA Toxicity Profile MEPC 57/2/1, 5.2.2.1

Hypochlorite Dermal LD 50 mg/L >10000 Rabbit Bio-fax data summary MEP C57/2/1, 5.2.2.1

Hypochlorite Inhalation LC 50 mg/L >10.5 Rat Bio-fax data summary MEPC 57/2/1, 5.2.2.1Dibromochloromethane Oral LD 50 mg/kg 848-1186 Rat Chu I et al ., 1980 MEPC 57/2/1, 5.3.2.1Tribromomethane Oral LD 50 mg/kg 1147 Rat Chu et al., 1982a MEPC 57/2/1, 5.4.2.1

Tribromomethane Inhalation LC 50 mg/L Classified as toxicant by inhalation Annex VI, COM (2007) 355 final

Dibromoacetic acid Oral LD 50 mg/L L 4480 Rat Woodard et al ., 1941 MEPC 57/2/1, 5.5.2.1Tribromoacetic acid N.D.

According to the presented data, hypochlorite is considered to be harmful by inhalation and dibromochloromethane, tribromomethane by oral exposure. On the other hand, tribromomethane is classified as toxicant by inhalation (GHS cl assification, Annex VI, COM (2007) 355 final). Additionally, dibromoacetic acid, is not considered to be an acute toxicant by oral route and for tribromo-acetic acid, no data was submitted to assess acute toxicity.GESAMP-BWWG 4/9 ANNEX 4 Page 28

I:\MEPC\57\2.doc 3.2 Corrosion/Irritation

Table 27: Summary of available da ta effects on skin and eye

Species Method Results (including scores where available) Reference

Hypochlorite Skin Rabbit OECD 404 Irritating, 2%: 1.2, 20%: 5.3, 35%: 5.2, 50%: 5.3 Loden, M. et al

., 1985 MEPC 57/2/1, 5.2.2.2

Hypochlorite Eye Rabbit - Irritating, Draize score : 11 (0.01Ml), 40 (0.1Ml) Chan, K. Y., 1985 MEPC 57/2/1, 5.2.2.2

Hypochlorite Skin Human Patch test sensitizer Osmundsen, P.E., 1978 MEPC 57/2/1, 5.2.2.2

Dibromochloromethane Skin Rats and mice Gavage for up to 2 years No histological alterations were found in the skin of rats and mice NTP1985,1989a MEPC 57/2/1, 5.3.2.2

Dibromochloromethane Eye Rats and mice Gavage for up to 2 years No histological alterations were found in the skin of rats and mice NTP 1985,1989a MEPC 57/2/1, 5.3.2.2

Tribromomethane Skin Rats and mice - Classified as an irritant Annex VI, COM (2007) 355 final

Tribromomethane Eye Rats and mice - Classified as an irritant (serious eye irritation) Annex VI, COM (2007) 355 final

Tribromoacetic acid Skin and

eye humans Corrosive effect MSDS of tribromoacetic acid MEPC 57/2/1, 5.6.2.2

According to the presented data, hypochlorite is classified as a skin and eye irritant and a sensitizer. Additionally, tribromo-acetic acid is considered to be corrosive to skin and eye. tribromo-methane is classified as skin and eye irritant, causing se rious eye irritation (GHS classification, Annex VI , COM (2007) 355 final).GESAMP-BWWG 4/9 ANNEX 4 Page 29

I:\MEPC\57\2.doc 3.3 Repeated-dose toxicity

Table 28: Repeated-dose toxicity of hypochlorite (MEPC 57/2/1, 5.2.2.4)

Exposure Route Drinking water Exposure Duration 12 months Exposure dose 1, 10 or 100 mg/L Species Rat Method - Results Decrease of blood glutathione with 10 or 100 mg/L, increase of osmotic fragility after 6 months. In animals exposed for 3 months, the 3H-thymidine incorporation into nuclei of rat kidney and testes in the 100 mg/L group was increased. Reference Abdel-Rahman, M.S. et al. , 1984

Table 29: Repeated-dose toxicity of di bromochloromethane (MEPC 57/2/1, 5.3.2.4)

Exposure Route Feeding Exposure Duration 90 days Exposure dose 0, 50, 100 and 200 mg Species Rat Method - Results No changes were found in mortality, clinical signs, ophthalmoscopic examinations co nsidered to be related to treatment. Mean final body wei ght and body weight gain were significantly decreased in male and female high dose animals relative to the vehicle control. Reference Daniel FB, 1990

Table 30: Repeated-dose toxicity of tribromomethane (MEPC 57/2/1, 5.4.2.4)

Exposure Route Receiving gavage Exposure Duration 2 years Exposure dose 200 mg/kg (5d/week) Species Rats and mice Method - Results No significant histopathologica l alterations were detected NOAEL N.A. NOEL N.A. Reference NTP(1989a)GESAMP-BWWG 4/9 ANNEX 4 Page 30

I:\MEPC\57\2.doc Table 31: Repeated-dose toxicity of dibromoacetic acid (MEPC 57/2/1, 5.5.2.4)

Exposure Route Gavage Exposure Duration 14 days

Exposure dose 0, 5, 50, or 250 mg/kg of body weight per day Species Rats Method - Results No effects on body or testicular wei ghts, however epididymal weight in the 250 mg/kg group was significantly lower than that of the control

group Reference Tsuchiya T et al ., 2000

Table 32: Repeated-dose toxicity of tribromoacetic acid (MEPC 57/2/1, 5.6.2.4)

Exposure Route Drinking water Exposure Duration 2 weeks

Exposure dose 0, 30, 100, 300 and 500 mg/L Species Rats Method - Results During the treatment period, all animals survived to the scheduled necropsy and there were no clinical signs of general toxicity noted at any dose level. There were no treatment-related findings in body weights or feed consumption, but th ere was a slight and inconsistent decrease in water consumption in th e 500 mg/L animals. Reference NTP Study Number: RDGT94009

According to the presented data, there seemed to be no relevant toxicological concerns towards repeated exposure to hypochlorite, dibromo- and tribromochloromethane, dibromo- and tribromoacetic acid.

3.4 Development and reproductive toxicity

Table 33: Development and reproductive toxicity test of hypochlorite (MEPC 57/2/1, 5.2.2.5)

Exposure Route Drinking water Exposure Duration 6 months Exposure dose 10 mg/L residual chlorine Species Mouse Method Fertility test Results No detrimental effects on reproduction. NOAEL N.A. NOEL N.A. Reference Les, E. P., 1968GESAMP-BWWG 4/9 ANNEX 4 Page 31

I:\MEPC\57\2.doc Table 34: Development and reproductive to xicity test of dibr omochloromethane (MEPC 57/2/1, 5.3.2.5)

Exposure Route GO (gavage oil) Exposure Duration days 6 to 15 of gestation Exposure dose 200 mg/kg Species Rat Method - Results No alteration in the number of reso rption sites, fetuses per litter, fetal body weights fetal gross malformati ons, or skeletal or visceral anomalies were found. NOAEL 200 mg/kg d NOEL N.A. Reference Ruddick et al. (1983)

Table 35: Development and reproductive toxicity test of tribromomethane (MEPC 57/2/1, 5.4.2.5)

Exposure Route GO (gavage oil) Exposure Duration days 6 to 15 of gestation Exposure dose 200 mg/kg Species Rat Method - Results Increase in the occurrence of skelet al anomalies in offspring of rats NOAEL 100 mg/kg d Reference Ruddick et al. (1983)

Table 36: Development and reproductive to xicity test of dibromoacetic acid (MEPC 57/2/1, 5.5.2.5)

Exposure Route Drinking water Exposure Duration P generation male rats, approx 92 days P generation female rats, through ge station and a 29-day lactation periodF1 generation exposed in utero and during lactation, postweaning/premating exposure of min 71 days (through mating, gestation and lactation) Exposure dose 0, 50, 250 or 650 mg/L (0, 4.4 to 11.6, 22.4 to 55.6, and 52.4 to 132.0 mg/kg/day)

Species Sprague-Dawley rats (2-generations) Method N.A. Results Reproductive effects were seen in high dose F1 males: a significant increase in the unilateral malfor mation of the reproductive tract (small or absent epididymides and small testis) was observed. NOAEL <22,4 mg/kg bw/day [<250 mg/L] Reference Christian et al. , 2002GESAMP-BWWG 4/9 ANNEX 4 Page 32

I:\MEPC\57\2.doc Table 37: Development and reproductive to xicity test of tribromoacetic acid (MEPC 57/2/1, 5.6.2.5)

Exposure Route Drinking water Exposure Duration 2 weeks

Exposure dose 39 mg/kg/day Species Rats Method N.A. Results Female and male reproductive findi ngs were not considered to be treatment related. Reference NTP Study Number: RDGT94009

From the submitted data, some reproduction toxico logical effects were observed however these were associated to exposure to high doses.

3.5 Carcinogenicity

Table 38: Data on carcinogenicity

Species Method Results Reference

Hypochlorite Mice Dermal No skin tumors, no leucemia. Hayatsu, H. et al

., 1971 MEPC 57/2/1, 5.2.2.6

Dibromochloromethane Mice gavage doses of 100mg/kg, 5 days/ week for 2 years Increases in the incidences of hepatocellular adenomas and carcinomas NTP 1985 MEPC 57/2/1, 5.3.2.6

Tribromomethane Rats and mice tribromomethanee in corn oil by gavage 5 days/week for 2 years Not available NTP, 1988 MEPC 57/2/1, 5.4.2.6

Dibromoacetic acid Rats and mice Exposure to dibromoacetic acid in drinking water for 2 weeks, 3 months, or 2 years. Concentrations were 0, 125, 250, 500, 1000, and 2000 mg/L Toxic effects of dibromoacetic acid in the prechronic studies were detected in the liver and testes. Ronald L et al

., 2007 MEPC 57/2/1, 5.5.2.6

Tribromoacetic acid N.D.

Relevant adverse effects related to target organs (liver and testis) were observed in the presented data. Chlorinated and Brominated DPB, have a potential for bioaccumulation and human genotoxicity/carcinogenicity theref ore will have to be kept belo w toxicological critical levels (bromate<10μg/L; bromoform<100μg/L; chlorofo rm<200 μg/L, WHO Guid elines for Drinking Water Quality, 2003).GESAMP-BWWG 4/9 ANNEX 4 Page 33

I:\MEPC\57\2.doc 3.6 Mutagenicity

Table 39: Data on mutagenicity

Species Method Details Results Reference

Hypochlorite Mice Gavage Negative Meier, J.R. et al., 1985 MEPC 57/2/1, 5.2.2.6 Dibromochlor omethane Rats an d mice - Positive Melnick et al 1998 MEPC 57/2/1, 5.3.2.6Tribromomethane Rat an d mice - Positive Melnick et al 1998 MEPC 57/2/1, 5.4.2.6

Dibromoacetic acid Mice Orally via drinking water for 13 weeks Detailed results of the study are not available at this time. NTP, 2003c MEPC 57/2/1, 5.5.2.6

Tribromoaceti c acid Salmone lla - positive Knasmuller,1999 MEPC 57/2/1, 5.6.2.6

Chlorinated and Brominated DPB, has a potential for bioaccumulation and human genotoxicity/carcinogenicity theref ore will have to be kept belo w toxicological critical levels (bromate<10μg/L; bromoform<100μg/L; chlorofo rm<200 μg/L, WHO Guid elines for Drinking Water Quality, 2003)

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

4.1.1 Hydrolysis (Ref. MEPC 57/2/1, 5.2.3.1.2)

Hypochlorite decomposes slowly on standing with the evolution of oxygen. Factors that increase the rate of decomposition are: high initial concentration, increase in temperature, certain metallic impurities, drop in pH below 11 and exposure to light.GESAMP-BWWG 4/9 ANNEX 4 Page 34

I:\MEPC\57\2.doc Table 40: Decomposition of THM and HAA

Seawater or Fresh

water dura tion Results Breakdown products Reference

Dibromochloromethane Hydrolysis Chlorinated

water 28 d The concentration ofdibromochloromethane decreased from 46 μ g/L to 3 μ g/L - Nicholson et al. 2002 MEPC 57/2/1, 5.3.3.1

Tribromochloromethane Hydrolysis Chlorinated water 7 d Decreased from 58 μ g/L to <1

μ g/L N.A. Nicholson et al

. 2002 MEPC 57/2/1, 5.4.3.1

Tribromochloromethane Biodegradation N.A. N.A. Increase in degradation Dibromo -methane Kenneke et al

. 2003; Pecher et al 2002 MEPC 57/2/1, 5.4.3.1Tribromochloromethane Half-life Fresh

water N.A. 5.836 h N.A. EPI Suit V 3.20 MEPC 57/2/1, 5.4.3.1

Dibromoacetic acid Biodegradation Drinking

water 6 m Biodegradation was observed for each of the HAAs Chloride Bethany, 2004 MEPC 57/2/1, 5.5.3.1

Tribromoacetic acid Biodegradation under aerobic conditions Drinking

water 6 m Biodegradation was observed for each of the HAAs Chloride Bethany, 2004 MEPC 57/2/1, 5.6.3.1GESAMP-BWWG 4/9 ANNEX 4 Page 35

I:\MEPC\57\2.doc 4.1.2 Biodegradability (biotic/abiotic)

4.1.3 Bioaccumulation, partition coefficients , octanol/water partition coefficient

Table 41 : Bioaccumulation, partition coeffici ents, octanol/water partition coefficient

Log Pow Koc Bioaccumulative Reference

Hypochlorite -3.42 14.3 No Log Pow: -3.42 BCF: 3.16 Appl. For FA. 5.6.4 p. 101 MEPC 57/2/1, 5.2.3.2

Dibromochlor omethane 2.16 No BCF: 9.188 Kaczmar et al. 1984 Mackay et al . 1982 MEPC 57/2/1, 5.3.3.2

Tribromomethane 2.4 35.04 No BCF: 14.06 Kaczmar et al. 1984 Mackay et al . 1982 MEPC 57/2/1, 5.4.3.2Dibromoacetic acid 0.7 1.895 No BCF: 3.162 EPI Suit V 3.20 MEPC 57/2/1, 5.5.3.2Tribromoacetic acid 1.71 0.437 No BCF: 3.162 EPI SUIT V3.20 MEPC 57/2/1, 5.6.3.2

4.2 Partition Coefficients

4.3 Persistence and identification of main metabolites

Because of low Log Pow and no bioaccumulating pr operties, there was no report on persistence and identification of main metabolites of hypochlorite.

Table 42: Persistence

Persistent Half-life Reference
Hypochlorite No MEPC 57/2/1, 5.2.3.1.1

Dibromochloromethane No flowing aerated water: 0.7-398 h Kaczmar et al. 1984 Mackay et al . 1982 MEPC 57/2/1, 5.3.5.2

Tribromomethane No flowing aerated water: 1-581 h Kaczmar et al. 1984 Mackay et al . 1982 MEPC 57/2/1, 5.4.5.2

Dibromoacetic acid No EPI Suit V 3.20 MEPC 57/2/1, 5.5.5.2

Tribromoacetic acid No EPI SUIT V3.20 MEPC 57/2/1, 5.5.5.2

4.4 Reaction with organic matter

When natural organic matter is treated with hypochlorite compounds (HOCl, OCl - ), high molecular weight chlorinated compounds form in a first step that is followed by the cleavage of benzene rings into trihalomethanes and haloace tic acids. Sodium hypoc hlorite treated humic acid yielded more chloroform than treated fulvic acid.GESAMP-BWWG 4/9 ANNEX 4 Page 36

I:\MEPC\57\2.doc 4.5 Potential physical effects on wildlife and benthic habitats

4.5.1 Sodium hypochlorite is miscible to water (IUCLID, 2000) so it doe sn’t affect physical wildlife and benthic habitats.

4.5.2 For all other by-products (dibromochlorometh ane, tribromomethane, dibromoacetic acid and tribromoacetic acid) the Applicant concludes that due to the density of the compounds and their slight solubility in wa ter there could be a potential physical e ffect on wildlife and benthic habits

4.6 Potential residues in seafood

No data on potential residues in seafood of all identified by-products is available. The Applicant assumes low potential for residues in seafood.GESAMP-BWWG 4/9 ANNEX 4 Page 37

I:\MEPC\57\2.doc 5 OTHER INFORMATION

5.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

Table 43: Analytical methods

Hypochlorite Method DPD method Applicability Yes

Sensitivity Two Ranges: LR – 0.02 to 2.00mg/L and HR – 0.1 to 8.0mg/L as Cl 2

Reference Standard Methods for the Exam ination of Water and Waste Water, 18 th edition, American Public Health Association (APHA), MEPC 57/2/1, 5.2.5.1 Dibromochloro methane Method GC/HSD (gas chromatogra phy – halide specific detector)

Applicability Contaminated soil

Sensitivity Sample detection limit: 0.9 μ g/kg/Accuracy (percent recovery): 94 MEPC 57/2/1, 5.3.5.1 Reference EPA 1986aTribromomethane Method GC-HSD (gas chromatogra phy – halide specific detector)

Applicability Contaminated soil

Sensitivity Sample detection limit: 2 μ g/kg/Accuracy (percent recovery): 96 Reference EPA 1986a, MEPC 57/2/1, 5.4.5.1Dibromoacetic acid Method GC/ECD (Gas chromatography- Electron capture detector)

Applicability Contaminated water Sensitivity Accuracy: 93-116% (US EPA method standard) Reference US EPA 552.2, MEPC 57/2/1, 5.5.5.1Tribromoacetic acid Method GC/ECD (Gas chromatography- Electron capture detector)

Applicability Contaminated water Sensitivity Accuracy: 93~116% (US EPA method standard) Reference US EPA 552.2, MEPC 57/2/1, 5.6.5.1

5.2 Material Safety Data Sheet provided: Yes

5.3 GHS Classification: unknown

5.4 Risk Characterization

***GESAMP-BWWG 4/9

I:\MEPC\57\2.doc ANNEX 5

REVIEW OF PROPOSAL FOR BASIC APPROVAL OF ACTIVE SUBSTANCE

Hitachi Ballast Water Purification System – Clear Ballast

Submitted for Basic Approval by Japan as MEPC 57/2/2

0 SUMMARY

0.1 Basic approval of the Hitachi ballast Wate r Purification System (Clear Ballast) submitted by Japan is recommended to be granted.

0.2 The system is based on standard drinking water purification technology, specifically the flocculation of suspended organic matter by iron tetraoxide and poly aluminium chloride combined with polyacrylamide. Recovery of th e floc is achieved by the use of magnetic disks which attract the iron component of the floc , presumably allowing quicker separation. An attractive aspect of the system is that it uses no biocides and where the environment is concerned, the chemicals employed are relatively harmless.

0.3 The active substances are well known and have a large literature in terms of human and environmental health; the WHO Guidelines on the treatment of drinking water provide good background information in this regard.

0.4 The working group recommended that the applic ant pay careful attention to the following points in order to address a wide range of safe ty considerations before final approval can be granted in the future:

.1 An adequate quality assurance program needs to be developed for the entire system.

.2 For final approval, the human health risk s of the system will be evaluated by the GESAMP BWWG on the basis of its individual unit operations, i.e. each component of the system requiring opera tor attention. The manufacturer is therefore requested to describe separa tely the potential human health risks associated with each major component of the system and to describe the measures necessary to prevent human e xposure for each such compon ent. In particular, the methods employed for the collection, treatm ent and disposal of floc and their potential for occupational exposure need to be described. Additionally, the recommended risk reduction measures n eed clear explanation and documentation, e.g., for each procedure such as floc co llection, dewatering, drying, incineration, sterilization, storage and di sposal in whatever form.

.3 The storage and handling of the three active substances on board needs to be carefully controlled and the proposed sa fety measures ade quately documented, particularly bearing in mi nd the corrosive properties of poly aluminium chloride.

.4 One major human health issue regarding the active substances relates to the residual acrylamide monomer contained in the polyacrylamide, which has a range of associated human health hazards and wh ich, in parallel to best practices in drinking water purificati on, needs to be maintained at appropriately low concentrations. The quality of the polyacrylamide active substance needs to be strictly controlled and included in th e QA program to ensure acceptably low concentrations of acrylamide monomer.GESAMP-BWWG 4/9 ANNEX 5 Page 2

I:\MEPC\57\2.doc .5 The BWM system appears from the tech nical description to be partly open, allowing for possible occupational exposure to the crew to system processes and waste. This is a potential weakness of the system that remains to be adequately addressed.

.6 Human health issues related to the poten tial concentration of pathogens in the flocs need to be examined and assessed in detail. The floc s could under heavily polluted intake conditions, have the potential to form a biohazard.

.7 Adequate separation of the flocs from the treated water is crucial to the successful operation for the system. When scaling up to larger treatment capacities, this aspect must be addressed by the applicant, to ensure the human and environmental risks of the treated ballast water remains acceptable.

.8 The positioning and operation of the proposed pre-filtrati on, as well as post filtration and its residue feedback system must be better described and documented. The procedures and proce sses for routine system maintenance, emergency procedures, filter and sludge conveyor cleaning, and the treatment and handling of the sludge must be defined and detailed.

.9 The risk to the marine environment from the residual active substances must be assessed. Concentrations of heavy metals, aluminium, iron, acrylamide monomer, VOCs, and faecal coliforms must be meas ured in the intake water, collected sludge and the discharged ballast water from the representa tive ballast waters associated with testing under G8. Th e environmental risks of discharging polyacrylamide, a non-biodegradable polymer to shore and any subsequent disposal restrictions must be assessed.

.10 Disposal of the collected sludge to shor e-based waste recepti on facilities should be according to the relevant IMO regulations . The availability of suitable harbour reception facilities needs to be considered.

.11 Additional toxicity testing of the treated Ballast Water should be performed using an appropriate range of conditions.

.12 The risk assessment carried out by the applicant in the submission cannot be accepted by the GESAMP-BWWG, as it is unc lear how the risk assessment was performed and how the both PEC and PNEC of concentration for Aluminium-ions and other relevant chemicals have been established. The Group therefore recommends to the MEPC to request the applicant to prepare a revised risk assessment for consideration in a ny application for Final Approval.

.13 The maximum allowable discharge con centration should be set against the parameters that can be measured at such lo w levels. According to the applicant, it is difficult to measure the amount of PASA directly, if its concentration in water is low. This situation is considered to be unsatisfactory by the Group and an acceptable analytical method should be developed for confirming the maximum allowable discharge concentra tion for relevant parameters.GESAMP-BWWG 4/9 ANNEX 5 Page 3

I:\MEPC\57\2.doc 0.5 As there may be a risk to the ship of fl ooding through the sludge di scharge arrangements should equipment malfunction occur, this possibil ity should receive additi onal consideration and assessment of the actual risk involv ed prior to shi pboard installation.

1 INTRODUCTION

1.1 The data for this document were extracted from the original data supplied by Japan to support its submission MEPC 57/2/2. Furthermore, the document describe s the Hitachi Ballast Water Purification System and its impact on the e nvironment. This system uses coagulation and magnetic separation as the major purification method in accordance with the Procedure (G9).

2 COMPLETENESS OF THE DOSSIER

2.1 The Group noted that the appli cant had provided a full descri ption of the system in the submission including:

.1 a general description of the Clear Ballast system and its components;

.2 a description of the use of the chemical injectors, coagulators, magnetic and filter separators and the sludge storage tank;

.3 data on performance of the system;

.4 a detailed description of the way the pH of the treated ballast water changes;

.5 information about the active substances used in the ballast water treatment although the handling was not sufficiently described (where and when human exposure occurs); and

.6 chemical and toxicological analysis reports of the treated ballast water, it is noted however that copies of the laborat ory certificates were not provided.

Abbreviations

2.2 PAC (Poly Aluminium Chloride) : An inorganic coagulant consisting of poly aluminium chloride and referring to basic aluminium chloride.

2.3 PASA (Poly Acrylamide Sodium Acrylate) : A cross linking chemical consisting of high molecular weight polymer particles with a negatively charged surface, which forms a coagulation of fine particles su spended in water such as a susp ension colloid. It is a kind of Anionic High-Polymer Coagulant.

2.4 SS (Suspended Solids) : Particulate substances in water which are insoluble in water such as a suspension or colloid. Suspended solids ar e one of the indices that express the extent of suspension in water.GESAMP-BWWG 4/9 ANNEX 5 Page 4

I:\MEPC\57\2.doc 3 DESCRIPTION OF RESOURCE BA LLAST TECHNOLOGIES SYSTEM

3.1 Description of the ballast water management system

According to the applicant, the ClearBallast System purifies wa ter by removing target organisms and other objects using flocculating agents. It is advised that the system effectively promotes collision between these small target organisms a nd aggregates to form flocs, and separates the floc by magnetic separation technology to purify balla st water. The submission states that the system efficiently removes suspended solids, as well as bacteria and plankton. The group noted that the efficiency of the total removal process of PAC as Aluminium amo unted to a minimum of about 98.4%. The Group recognized that the applicant applies the same number of removal efficacy for risk characterization of other active substances and relevant chemicals, such as PASA and its impurity; acrylamide monomer. However, the group no ted that this estimation for any substances other than Aluminium should be reviewed by the actual measurement results and/or mass flow analysis of substances.

3. 1.1 Principle of purification of the system

This system employs a coagulation and magne tic separation method, in which organisms and other target objects are coag ulated using coagulants and separated by magnetic separation technology. Specifically, coagulants and triiron te traoxide are added to the seawater to form small agglomerates of about 1 mm in diameter called flocs, containing plankton, bacteria and sand. These flocs are then separated from the seawater using permanent magnets. Finally, any flocs not removed by the magnetic separation are removed by a rotating filter drum.

PAC and PASA

Triiron tetraoxide Plankton Bacteria

Figure 1: Schematic structure of a floc

It is noted that the proposal states that the ballas t water can be treated either during storage in the ballast tank, during intake, or during discharge. Purification during in take is stated to be the most effective way to ensure that a minimal amount of organism s and SS enter the ballast tanks and thus reduces sediment build-up in the tanks. The results provi ded relate to operations for purification during intake.

System Process

The active substances are mixed in separate slurry mixers prior to individual injection into the system. The coagulation phase consists of a Flash mixer followed by a Flocculation reactor. The triiron tetraoxide and PAC slurries are injected into the balla st water prior to the Flash mixer. PASA is supplied as either a liqui d or a dry powder which is mixed into a slurry and is injected into the ballast water after the Flash mixer and prior to the Flocculation reactor where the ballast water is retained for a period to achieve floc culation of the impurities. The flocs are then removed on a magnetic disc array wh ere the sludge so generated is led away to a sludge tank by aGESAMP-BWWG 4/9 ANNEX 5 Page 5

I:\MEPC\57\2.doc conveyor. The ballast water is then fine filtered in a rotating filter drum before being directed to the ballast tank. The filtered material from the fina l filter is sent to a holding tank prior to being re-introduced to the system at the start of the process for re-t reatment. The submission informs that it is intended at present for the waste slu dge generated to be tem porarily stored on board prior to packing, or drying and pa cking and then landed ashore. The submission states that the system is fully automated so that the only ma nual handling required is during loading of the chemicals to the storage tanks and during packing and handling of the process sludge to land.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 Active Substances

Triiron tetraoxide, PAC, and PA SA correspond to Active Substan ces (Table 1). The submission states that “in this purification system, since almost all the additiv e agents collected in the flocs are removed, the amount of Active Substances rele ased into the environm ent together with the treated ballast water is negligible”. The Group is of the opinion that this statement requires further analytical verification.

Table 1: Active Substances (R ef. MEPC 57/2/2, 5.1.2 table 5-1)

Active Substance 1 Active Substance 2 Active Substance 3

Name of substance (IUPAC) Triiron tetraoxide Polyaluminum chloride Acrylamide sodium acrylate copolymer Synonym (used in this document) Triiron tetraoxide PAC PASA

CAS number 1317-61-9 1327-41-9 25085-02-3 UN number None None None Shipping name None None None Molar weight 231.53 Not applicable More than several million Empirical formula or structural formula Fe 3 O 4 Al n (OH) m Cl (3n-m) 0<m<3n CH 2 CH CH 2 n CH

m

CONH 2 COONa Purity 100% Percent of content: 10-11% of water solution (aluminium oxide equivalent) 90% or more

Impurity None None Acrylamide monomer: 0.05% or less (CAS No. 79-06-1) Stabilizers or additives None None NoneGESAMP-BWWG 4/9 ANNEX 5 Page 6

I:\MEPC\57\2.doc 3.2.3 Relevant substances (Ref. MEPC 57/2/2, 5.1.4)

The group considered that the acrylamide monom ers contained in PASA as an impurity are relevant to the hazard and risk assessment. The Group noted that although the mass concentration is only 0.05% or less of PASA, a data survey against the Quality for PASA production was nevertheless perf ormed by the applicant.

4 HUMAN HEALTH ASSESSMENT

The Group considers that there is a potential risk of short-te rm exposure to humans concerning the active substances (PAC and PASA) due to ma nual operations that can take place during the process, namely, pouring the chemicals into th e storage tank and preparing for unloading of the sludge.

The major concerns for PAC are the irritating properties (MSDS, 2003) and for PASA the toxicity of the residual acrylamide monomers. Therefore, during thos e exposure situations workers are recommended to wear protective gear (PPE and RPE).

Additionally, the Group wants to stress that according to the scientific literature (EU, 2002; CIR, 2005), there is a critical human health concern related to exposure towards acrylamide monomers.

The Group also noted that acrylamide monomers content were measured in the untreated and treated BW however the relevant measurements to be made in terms of human exposure should be conducted in the sludge and other materials where the concen tration of poten tially toxic compounds can occur (pathogens, metals).

However, the Group noted that a detailed descrip tion of the handling oper ator tasks was missing and therefore an appropriate quantitative human h ealth risk assessment c ould not be performed Figure 2 could serve as a basis for defining ta sks that may pose a risk of human exposure.GESAMP-BWWG 4/9 ANNEX 5 Page 7

I:\MEPC\57\2.doc B

C + D Seawater Ballast pump Magnetic separator PASA Chemical injectors

Filter separator Ballast tank P Filter washing water

Resi due from filter

Filter residue tank P Sludge

Sludge tank F lash mixer Flocculation reactor Triiron tetraoxide & PAC Chemical injector

Coagulator A

E

F

G

Figure 2: Tasks that may pose a human exposure risk

A – adding coagulants (PAC, PASA) & triiron tetraoxide B – potential aerosols emitting from magnetic separators C – maintenance of sludge conve yor and sludge collection process D – aerosols from sludge dryi ng and dry sludge processing E – transferring the wet sl udge into containers F – handling of containers for unloading G – processing of waste ashore

5 RISK TO SAFETY OF SHIP AND CREW

The submission states that there is no risk to ship safety as th e physical properties of the active substances are “not corrosive, do not react with the storage tank, do not ignite spontaneously, do not vaporize, and do not have oxi dizing properties under the assumed on-board circumstances.”. This may be correct when the active substances have been diluted for injection to the system, however, the MSDS for PAC informs that it ha s a pH of 2-3, is corrosive and requires appropriate safety precautions for storage and hand ling. It is noted that the proposal requires this material to be loaded into storage tanks made of plastic, or lined with plastic on the inner surface to prevent corrosion of the tank due to contact w ith the acidic chemical and also acid resistant materials are required to be used for feeding pi pes. A save-all is also to be provided around the PAC storage tank to contain leakage. The Group considers that the risk of corrosion from the storage of PAC to the ships structure has been adequately considered and appropriate precautionary measures are proposed. It should be ensured that the safety measures that have been identified are correctly implemente d and followed for shipboard installation.

The operational parameters of th e magnetic disc array together with its conveyor system for sludge discharge and the rotating filter drum are not fully described in the submission. As it is possible that these components may be required to operate at atmospheric pressure it is considered that it may be necessary to incorporat e appropriate safety meas ures to the shipboard installation to prevent flooding s hould equipment malfunction occur.GESAMP-BWWG 4/9 ANNEX 5 Page 8

I:\MEPC\57\2.doc The submission informs that the process is au tomated and that manual handling of the active substances is limited to the loading of the storage tanks.

The use of PPE is stipulated when the chemi cals are poured into the storage tank and a notice regarding the use of appropr iate protective gear is to be placed on the injector. It is also informed that to prevent scattering of the powder, the storage tank and piping ar e equipped with safety valves and tightly sealed and that a forced ventilation exhaust duct is to be provided close to the storage tank prevents any spille d dust from scattering. The group c onsiders that th e applicant has identified the risks inherent in the loading of the active substances to the storage tanks and that appropriate mitigation measures are proposed. It may also be appropriate to additionally consider the provision of washing facilities as iden tified in the MSDS for PAC in the vicinity of the storage facility and the positioning of the storage spac e air exhaust vent outlets.

The possibility of the risks aris ing to the crew exposure from aerosols potentially emitted from the slurry mixing tanks, the magnetic disc array, the rotating filter drum, and the sludge transport and handling arrangements, includin g any sludge drying operations re quires to be considered and appropriate safety mitigation measures introduced.

The submission informs that the flocs extracted form a sludge consisting of chemicals, SS, plankton, bacteria, etc. Contact wi th this sludge should therefore be considered a potential risk to human health, and appropriate risk mitigation measures are required to be implemented, additionally to those already defined, where hum an exposure may be anticipated. Maintenance procedures, especially to the sludge conveyor and sludge processing equipment may be of particular relevance in this regard.

It is noted that th e present consideration for the disposal of the sludge generated is to temporarily store the sludge on board, then to transfer to individual containe rs or remove the water content with driers prior to unloading to land. As the discharge of sh ips’ waste to shore reception facilities is regulated under th e various MARPOL Annexes, depe ndant upon the classification of the waste, further analysis of the sludge generate d will be required so as to ensure appropriate handling and treatment.

The availability of suitable reception facilities will require further careful consideration to ensure timely disposal from a ship fitted with this ballast water treatment system can be achieved.

6 RISKS TO THE AQ UATIC ENVIRONMENT

6.1 Persistence (MEPC 57/2/3, 8.1.1)

Triiron tetraoxide and PAC are inorganic compounds so that hydrolysis a nd biodegradability are not applicable. Triiron tetraoxide occurs natu rally and PAC dissociates into chloride and aluminium ions.

PASA is persistent and is not easily biodegraded. PASA was hardly degraded after 300 h and is not readily hydrolysed in the aqua tic environment. Other literature states that degradation of PASA may take seve ral years (Khaitan et al ., 2003)1.

1 Khaitan, S., Erickson, L.E., Hutchinson, S.L. & Ka rthikleyan, R. (2003) Biodegradation of Hydrocarbons in a Soil Containing Polyacrylam ide. Proceedings of the 10th Annual Petroleum Environmental Conference, 10 November 2003, Houston, USA.GESAMP-BWWG 4/9 ANNEX 5 Page 9

I:\MEPC\57\2.doc Acrylamide monomers hydrolysis ha lf-life is >1 year, but they ar e biodegradable with a half-life of 33-55 h in water and in 18-95 h in soils. Ther efore, acrylamide monomer is not considered a persistent substance.

6.1.2 Bioaccumulation (MEPC 57/2/3, 8.1.2)

Triiron tetraoxide is not considered to bioaccumulate in living organisms.

For PAC the bioaccumulation of aluminium salts has been investigated. BCF values of aluminium are between 76 and 190 for marine fish and between 36 and 123 for freshwater fish. Therefore, PAC is not considered to bioaccumulate to significant extent.

6.1.3 Toxicity tests

For triiron tetraoxide no ecotoxicological data are available, but the group is of the opinion that these data are not needed because of the inorgani c nature of the substance. The most relevant value for PAC is the 0.02 mg/L as Aluminium. PASA has a lowest NOEC of 75 mg/L. Finally, acrylamide monomer has a NOEC of 2.04 mg/L.

6.1.4 Do the Active Substances and/preparat ion meet all three criteria for PBT?

Table 2: Assessment of PBT (MEPC 57/2/3, 8.1.4)

Persistence (P) Half-life: >60d in seawater >40d in freshwater >180d in sea sediment >120d in fw sediment Bioaccumulation (B) Log Pow >3 Toxicity (T) Chronic NOEC<0.01 mg/L

Triiron tetraoxide Not applicable No No

PAC Not applicable No No PASA Yes No No Acrylamide

monomers No No No

Therefore, the Group concludes that none of the Ac tive Substances are classified as PBT substances.

7 ASSESSMENT OF TREATED BALLAST WATER

7.1 The Group noted that The Applic ant carried out toxi city tests with sa ltwater species of three trophic levels (algae, invertebrates and fish ) with treated ballast water from a land-based installation and techniques that simulate the Cl earBallast treatment system. Tests were carried out with twice as much of the three chemical s (triiron tetraoxide, PAC, and PASA) compared usual operation (for more details: IDEA Consultants, Inc., 2007a; 2007b; 2007c and MEPC 57/2/2 6.2).

7.2 The acute toxicity study in algae was conduc ted according to the International standard ISO 10253 and the US EPA. Growth rate of S keletonema costatum with undiluted and dilutedGESAMP-BWWG 4/9 ANNEX 5 Page 10

I:\MEPC\57\2.doc ballast water was tested for this study. As the undiluted water sample show ed no reduction of the growth rate, the other data (IDEA consu ltants Inc. 2007a) are no t presented here.

7.3 The chronic toxicity study was ca rried out with the marine gammarid Hyale barbicornis with the modified method reported by Anasco et al. and the US-EPA guidelines “Short-term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Marine and Estuarine Organisms, Thir d Edition” (2002).

7.4 The fish toxicity study was carried out with the saltwater fish Java medaka, Oryzias javanicus in accordance with the OECD guidelin es No.210 and US-EPA guidelines for chronic toxicity.

Table 3: Summary of acute/chronic toxicity results with treated ballast water

FCA Species Salinity [PSU] days Concentration of treated water [%] NOEC R eferences/ Comments

A Skeletonema

costatum (acute) 31.2 3 0 100% IDEA consultants Inc. 2007a

C Hyale barbicornis (chronic) 30-30.5 21 100 100% IDEA consultants Inc. 2007b

F Oryzias javanicus (chronic) 26.9- 31.8 28 100, 50, 25, 12.5, 6.25 100% IDEA consultants Inc. 2007c

8 ENVIRONMENTAL RISK ASSESSMENT

From table 4, the Group concludes that Aluminium - -ions are very toxic (acute and chronic) to aquatic organisms. Therefore, it should be clar ified whether or not exposure to Aluminium-ions or to PAC occurs after a pplication of the system.GESAMP-BWWG 4/9 ANNEX 5 Page 11

I:\MEPC\57\2.doc Table 4: Derivation of a Predicted No Effect Concentration (PNEC)

Lowest Toxicity value (mg/L), # of trophic levels Assessment factor PNEC (mg/L) 48-h LC 0 (acute), 1 > 1,000 1000 > 1 PNECshort Triiron tetraoxide Chronic data N.A. 48-h LC 50 (acute), 3 840 1000 0.84 PNECshort PAC

Chronic data N.A. 96-h LC 50 (acute), 2 0.097 1000 0.000097 PNECshort PAC (aluminium ions) 28-day NOEC (chronic), 2 0.02 100 0.0002 PNEClong

48-h LC 50 (acute), 2 180 1000 0.18 PNECshort PASA

30-day NOEC (chronic), 1 75 100 0.75 PNEClong

96-h LC 50 (acute), 3 59 1000 0.059 PNECshort Acrylamide

monomers 28-day NOEC (chronic), 1 2.04 100 0.02 PNEClong

8.1.2 Assessment of treated ballast wat er by ecotoxicity test (G9: 5.3.14)

A chronic ecotoxicity test was conducted based on GLP principles and in accordance with test guidelines established by OECD, ISO, and USEPA to assess the effects of ballast water treated by the Hitachi Ballast Purificati on System on aquatic organisms (for details, see section 6). The expected concentrations of each substance are:

1.38 mg/L triiron tetraoxide,

0.3 mg/L PAC,

0.02 mg/L aluminium ions,

0.032 mg/L PASA, and

0.001 mg/L acrylamide monomers.

It should be taken into account that the quantitie s of chemicals added in the normal operation are half of those added in the test.

From table 21, the Group concludes that treated Balla st discharged water indicate no toxicity to any organisms from the three trophic levels tested. However, the group noted that copies of the laboratory certificates were not provided. Furthermore, the group recommends that the applicant should conduct the additional toxicity testing under higher concentration of PAC and PASA at the laboratory scale, e.g. using samples taken before the post filtering.GESAMP-BWWG 4/9 ANNEX 5 Page 12

I:\MEPC\57\2.doc Table 5: NOEC of treated ballast water

Test substance Classification of organism Organism species End point Toxicity (Maximum no observed effect concentration)

Algae Skeletonema

costatum NOEC for 72 hrs 100% treated ballast water

Invertebrates Hyale barbicornis NOEC for 21 days 100% treated ballast water Treated ballast

water Concentrations of AS see text Fish Oryzias javanicus NOEC for 40 days 100% treated ballast water

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

For the discharge calculations, the MAM-PEC model was applied fo r the prediction of dissolved aluminium concentrations in the Port of Rotterd am, assuming all ships operating in the harbour use a ClearBallast Sy stem (CERI, 2007b).

In the chemical analysis of the treated ballast water 0.08 mg/L aluminium corresponding to 0.15 mg/L PAC were found. This repres ents 1.6% of the orig inally injected amount of PAC. PASA is considered to be discharged in the same ratio as PAC resulting in a discharge concentration of 0.016 mg/L.

Table 6: Summary of predicted discharged concentration PEC (MEPC 57/2/3, 8.3.2, table 8-2)

Predicted concentration at discharge (mg/L) PEC (mg/L) Triiron tetraoxide 0.69 <0.69 PAC 0.15 <0.15 PAC (aluminium ions) 0.01 <0.00358 *

PASA 0.016 <0.016 Acrylamide monomers 0.00005 <0.00005

* Maximum estimated of environmental concentration based on the MAM-PEC Model.

The Applicant applies half the detection limit to Aluminium, although elsewhere in the dossier Aluminium is reported as having been detected in a concentra tion of 0.08 mg/L in the treated ballast water.

Applying 0.08 mg/L, the daily load for the Port of Rotterdam would be 31752 g/d and the PEC would increase to 0.02864 mg/L.

It is unclear for the Group, where the concentrat ion of 0.0035 mg/L (Alumi nium) comes from, as Kobayashi et al. (2006) only refers to Japanese seawater. It is also unclear to the Group, how the applicant calculated the PEC value given in the ta ble above and therefore the Group is concerned about the use of this number as PEC.GESAMP-BWWG 4/9 ANNEX 5 Page 13

I:\MEPC\57\2.doc The Applicant concluded that Aluminium ions in the ballast water discharged from the Hitachi Ballast Water Purification System do not have an influence on the environmental concentration. (CERI, 2007b). However, the Group is concer ned about accumulation of Aluminium in the sediment in the long-term, as shown by the MAM-PEC model.

8.3 Calculation of PEC/PNEC ratios

If exposure to Aluminium - -ions occurs at higher concentrations than established as PNEC in the table under 8.1, effects to aquati c organisms can not be excluded.

Based on the reasoning with regard to the PEC for Aluminium given above, the Group was unable to accept the risk assessment as calculat ed by the applicant. As the PEC’s for PASA, triiron tetraoxide and acrylamide monomer refer to the above valu e, they are also found to be unacceptable. The Group therefore recommends to the MEPC to request the applicant to prepare a revised risk assessment for considerati on in any application for Final Approval.

As the Active Substances used are not consider ed to be especially harmful to the marine environment in the limited quantities that would be required for further testing of the system on land or at sea, the lack of a risk assessment is not considered as a sufficient reason for rejecting the application for Basic Approval in this case.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

The Group notes that risk mitigation measures fo r the safe storage and handling of the Active Substances to be used have been identified. It is to be ensured th at the safety measures that have been identified are correctly implemente d and followed for shipboard installation.

As there may be a risk to the ship of floodi ng through the sludge discharge arrangements, should equipment malfunction occur, this possibility should receive additional consideration and assessment of the actual risk involv ed prior to shi pboard installation.

The sludge handling, storage and discharge arra ngements require an additional assessment of safety considerations prior to shipboard trials.

9.2 Risks to the ship and crew and general public

The Group recommends that for Final Approval the applicant provides additional information about frequency and duration of the tasks related to the rele vant occupational scenarios (please see Figure 2 – Tasks that may pose a human exposure risk). For this purpose the Applicant is recommended to refer to MEPC 56, annex 9.

9.3 Risks to the environment

Based on the reasoning with regard to the PEC for Aluminium given above, the Group was unable to accept the risk assessment as calculat ed by the applicant. As the PECs for PASA, triiron tetraoxide and acrylamide monomer refer to the above valu e, they are also found to be unacceptable. The Group therefore recommends to the MEPC to request the applicant to prepare a revised risk assessment for considerati on in any application for Final Approval.GESAMP-BWWG 4/9 ANNEX 5 Page 14

I:\MEPC\57\2.doc As the Active Substances used are not consider ed to be especially harmful to the marine environment in the limited quantities that would be required for further testing of the system on land or at sea, the lack of a risk assessment is not considered as a sufficient reason for rejecting the application for Basic Approval in this case.

Therefore, it is recommended by the Group, that an updated risk asse ssment is added to a possible future Final Approval submission, in wh ich for Aluminium a correct approach of the background concentration is included.

9.4 Conclusions

Based on the available information the Group concludes that sufficient information was submitted to recommend Basic Approval to Hitachi Ballast Water Purification System – ClearBallast. Nevertheless, a considerable am ount of additional information is considered necessary before any Final Approval could be succe ssful for in the future. A summary of this information is given below:

.1 An adequate quality assurance program needs to be developed for the entire system including the quality of PA SA at industrial production.

.2 The human health risks of the system will be evaluated by the GESAMP-BWWG on the basis of its individual unit operations, i.e. each component of the system requiring operator attention. The manufacturer is therefore reque sted to describe separately the potential huma n health risks associated with each major component of the system and to describe the measur es necessary to prevent human exposure. In particular, the methods employed for th e collection, treatment and disposal of floc and their potential for occupationa l exposure and the recommended risk reduction measures need clear expl anation and documentation, e.g. any procedures such as floc collection, dewa tering, drying, incinera tion, sterilization, storage and disposal in whatever form.

.3 The system is based on standard drinking water purif ication technology, specifically the flocculation of suspende d organic matter by iron tetraoxide and poly aluminium chloride combined with poly acrylamide. Recovery of the floc is achieved by the use of magnetic disks wh ich attract the iron component of the floc, presumably allowing quicker separati on. An attractive asp ect of the system is that it uses no biocides and where the environment is concerned, the chemicals employed are relatively harmless.

.4 The active substances are well known a nd have a large literature in terms of human and environmental health; the WHO Guidelines on the treatment of drinking water provide good background information.

.5 The storage and handling of the three active substances on board needs to be carefully controlled and the proposed sa fety measures ade quately documented, particularly bearing in mi nd the corrosive properties of poly aluminium chloride.

.6 One major human health issue with the active substances relates to the residual acrylamide monomer contained in the pol yacrylamide, which has a range of associated human health hazards and whic h, in parallel to best practices in drinking water purificati on, needs to be maintained at appropriately lowGESAMP-BWWG 4/9 ANNEX 5 Page 15

I:\MEPC\57\2.doc concentrations. The quality of the polyacrylamide active substance needs to be strictly controlled and in cluded in the QA program.

.7 The BWM system appears from the tech nical description to be partly open, allowing for possible occupational exposure to the crew to system processes and waste. This is a potential weakness of the system that remains to be adequately addressed.

.8 Human health issues related to the poten tial concentration of pathogens in the flocs need to be examined and assessed in detail. The floc s could under heavily polluted intake conditions, have the potential to form a biohazard.

.9 Adequate separation of the flocs from the treated water is crucial to the successful operation for the system. When scaling up to larger treatment capacities, this aspect must be addressed by the applicant, to ensure the human and environmental risks of the treated ballast water remains acceptable.

.10 The positioning and operation of the proposed pre-filtration, post filtration and its related post filtration residue feedback system must be better described and documented. The procedures and proce sses for routine system maintenance, emergency procedures, filter and sludge conveyor cleaning, and the treatment and handling of the sludge must be defined and detailed.

.11 The risk to the marine environment from the residual active s ubstances must be assessed. Concentrations of heavy metals, aluminium, iron, acrylamide monomer, VOCs, and faecal coliforms must be meas ured in the intake water, collected sludge and the discharged ballast water from the representa tive ballast waters associated with testing under G8. Th e environmental risks of discharging polyacrylamide, a non-biodegradable polymer to shore and any subsequent disposal restrictions must be assessed.

.12 Disposal of the collected sludge to s hore waste reception facilities is to be according to the relevant IMO regulations. The availability of suitable harbour reception facilities needs to be considered.

.13 The risk assessment carried out by the applicant in the submission can not be accepted by the GESAMP-BWWG as it is unclear how the risk assessment was performed and how the both PEC and PNEC concentration of Aluminium-ions and other active substances and re levant have been established.

.14 Additional toxicity testing of the treated Ballast Water should be performed using more residual substances.

.15 The maximum allowance discharge con centration should be set against the parameters that can be measured at such low level. According to the applicant, it is difficult to measure the amount of PASA directly, if its c oncentration in water is low. This situation is considered to be unsatisfactory by the Group and an acceptable analytical method should be developed for confirming the maximum allowance discharge concentration for adequate parameters.

* * *GESAMP-BWWG 4/9 ANNEX 5 Page 16

I:\MEPC\57\2.doc APPENDIX 1

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF TRIIRON TETRAOXIDE, PAC, PASA A ND ACRYLAMIDE MONOMERS

1 PHYSICOCHEMICAL PROPERTIES

1.1 The following table shows the physicochemical properties of triir on tetraoxide, PAC, PASA, acrylamide monomers, a nd treated ballast water.

Only conductivity data were extracted from th e extended version of th e Application Dossier.

Table 1: Physicochemical properties of Active Substances and Relevant Chemicals

Triiron tetraoxide PAC PASA Acrylamide

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

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

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

Density (20°C; kg/m 3 ) 5,200 (5.2g/cm 3 ) 1) 1,340 (1.34g/cm 3 ) 2) Bulk specific gravity; 0.55- 0.65 4) 1,130(1.13g/cm 3 ) 3) NR

Vapour pressure (20°C; Pa) Not Applicable Non-evaporable 5) Non-evaporable

#2 1 3) NR

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

Water solubility g/L Insoluble 6) Soluble 1) Mixing with water forms highly viscous gel-like material 4) 2,040 (25°C) NR

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

Corrosivity to materiaequipment None Corrosive to metals None None None

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

Explosive properties Not Applicable None None None 7) NR

Oxidizing properties Not Applicable None 5) None 4) None 7) NR

Surface tension None Equal to water because of aqueous solution None None NR

Viscosity (mPa.s) None 28mPa ・ s (25°C) 2) Mixing with water forms highly viscous gel-like material 4) 2.71 mPa ・ s (25°C) (50% aqueous solution) 8) 1.55cP (16°C)

Thermal stability Transformed into iron oxide (Fe 2 O 3 ) by Non flammable Combustible by heating at high temperature Violently polymerizes when heated to over 85°C or when NRGESAMP-BWWG 4/9 ANNEX 5 Page 17

I:\MEPC\57\2.doc Triiron tetraoxide PAC PASA Acrylamide

monomers Treated ballast water heating in air 1) exposed to of light or oxidizing agents. When heated to decomposition, fumes and nitrogen oxide are generated. 3), 8) Reactivity to container material None None None None NR

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

Salinity N.D.

Conductivity 4.5 S/m

TOC 1.3 mg/L

DOC N.D.

Other physicochemical properties None None None Because acrylamide readily polymerizes, common products contain polymerization inhibitors 1) None

Dissociation constant (pKa) Not Applicable No dissociable

group No dissociable

group No dissociable

group NR

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

#1 Non-combustible under conditions of normal use (normal pressure, 0-50°C). #2 Non-evaporable under normal pressure and normal temperature because of high molecular weight polymers (several million or more).

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Da ta (Ref. MEPC 56/2/3, 3.1.1)

2.1.1 There are no triiron te traoxide acute toxicity data for al gae and invertebrates. Considering that naturally-occurring triiron tetr aoxide is abundant in the environment and is not absorbed or accumulated in the body due to consisting of water insoluble particles, the toxicity of triiron tetraoxide for algae and invertebrates is considered to be very low.

2.1.2 No data on the PASA acute toxicity in algae are reported. As PASA consists of particles containing high molecular weight polymers (several millions or more), it is not absorbed and accumulated in the body. The toxicity of PASA in algae is considered to be low, not including any physical harmful effect.GESAMP-BWWG 4/9 ANNEX 5 Page 18

I:\MEPC\57\2.doc 2.1.3 A summary of the acute aquatic toxicity da ta for Triiron tetraoxide, PAC, PASA and Acrylamide monomers is shown in the table below:

FCA Species Effect Conc. [mg/L] Reference

Triiron tetraoxide F Leuciscus idus (Japanese dace) 48 h LC 0 > 1,000 EU, 2000a

PAC A Seaweed 48 h LC 50growth 1,500 (pH not adjusted) >10,000 (pH adjusted) Asada Chemical Ind. 2003

Manila clams 48 h LC 50 6800 (pH not adjusted) >10,000 (pH adjusted) Asada Chemical Ind. 2003

F Oryzias latipes 48 h LC 50 840 (pH not adjusted) >10,000 (pH adjusted) Asada Chemical Ind. 2003

PAC asaluminiumion I Ctenodrilus

serratus (marine sand worm) 96 h LC 50 0.097 IPCS, 1997; Petrich and Reish, 1979

F Pimephales promelas 96 h LC 50 4.25 (pH 6.5- 7.5) IPCS, 1997

PASA C Ceriodaphnia dubia (Freshwater) 48 h LC 50 218 De Rosemond and Liber, 2004

F Girella punctata 48 h LC 50 840 Tabata and Ishibashi, 1984

F Oryzias latipes

, Carassius

auratus , Cyprinus carpio

, Salvelinus namaycush

, 48-h LC 50 48-h LC 50

48-h LC 50 96-h LC 50 180 350 and >600 mg/L 250 >600 Tabata and Ishibashi, 1984

Dia-Nitrix, 2004; Liver et al ., 2005; Tabata and Ishibashi, 1984 Acrylamide

monomers A Pseudokirchneriella subcapitata (Freshwater) 72 h EC 50Growth 33.8 EU, 2002

Acrylamide

monomer C Mysidopsis bahia 96 h LC 50 78 EU, 2002

Acrylamide

monomer F Daphnia magna 48 h EC 50 98 EU, 2002

Acrylamide

monomer F Danio rerio 96 h LC 50 59 Kovriznych and Urbancikova, 2001GESAMP-BWWG 4/9 ANNEX 5 Page 19

I:\MEPC\57\2.doc 2.2 Chronic Aquatic Toxicity Data

2.2.1 There are no chronic toxicity data availa ble for triiron tetraoxide and PAC in aquatic organisms. Naturally occurring triiron tetraoxide is abundant in the envi ronment. Although it is highly possible that wild organisms are exposed to this substance, no adverse effects have been identified. Therefore, it may be concluded that chronic toxicity of triiron tetraoxide is not significant.

2.2.2 To evaluate the toxicity of PAC in aqua tic organisms, data on water soluble aluminium salts such as aluminium chloride can be examined because the salts are dissociated in water and form the same aqua complex as PA C. Data on the chronic toxicity of acrylamide monomers were gathered because traces of unpol ymerized acrylamide monomers rema in in PASA as an impurity.

2.2.3 A summary of the chronic aquatic toxic ity data for aluminium ions, PASA and acrylamide monomers is shown in the table below:

FCA Species Effect Conc. [mg/L] Reference

Aluminiumions Ctenodrilus

serratus (polychaete) 28 d NOEC 0.02 pH: 7.6 - 8.0 Petrich and Reish, 1979 not cited

Aluminiumions F Salvelinus fontinali s (Freshwater) 60 d NOEC 0.088 pH: 6.5 - 6.6 Asada Chemical Ind. 2003

PASA F Salvelinus namaycush (Freshwater) 30 d NOEC 75 (activity) 300 (growth +survival) Liver et al. , 2005

Acrylamide

monomers A Pseudokirchneriella subcapitata (Freshwater) 72 h NOEC 16 (growth) EU, 2002

Acrylamide

monomer C Mysidopsis bahia 28 d NOEC 2.04 Springborn Bionomics, 1985

2.3 Information on Endocrine Disruption

There are no data submitted or other reports ma de available on triiron tetraoxide, PAC, PASA, and acrylamide monomers having an effect on e ndocrine disruption in aquatic organisms. None of these substances are listed as susp ected endocrine disruptor s (MOE, 2005). The Group concludes that no additional data are required on the potential endoc rine disrupting effects of the substances under consideration for th is Ballast Water System under G9.

2.4 Sediment Toxicity

2.4.1 There are no reports of sediment toxicity of triiron tetraoxide, PAC, or PASA.

2.4.2 Triiron tetraoxide and PAC are inorganic co mpounds, which occur as tr iiron tetraoxide or aqua-complex ions of aluminium in the sediment . As these substances are naturally occurring elements, the probability of these substances ha ving an adverse effect on the sediment organisms is considered to be low.GESAMP-BWWG 4/9 ANNEX 5 Page 20

I:\MEPC\57\2.doc 2.4.3 Although PASA is accumulated in the sediment, it is not absorbed or accumulated in the sediment organisms because it consists of particles of high mol ecular weight polymers (several million or more). Therefore, the po ssibility of PASA having an adverse effect on sediment organisms is considered to be low.

2.4.4 Acrylamide monomers (P ASA impurity) are biodegraded and mineralized easily. The possibility of acrylamide mo nomers being accumulated in the sediment and the possibility of adverse effects on sediment organisms is lo w due to the high wate r solubility, and low K OW and K OC

. Water solubility is 2040 g/L (IPCS, 2000) log K OW -1.65 to -0.67 and K OC 0.195 L/kg, (EU, 2002).

Therefore, Acrylamide monomers are not absorb ed or accumulated in the sediment and the possibility of adverse effects on se diment organisms is very low.

2.5 Bioavailability/Biomagnification/Bioconcentration

2.5.1 Instead of PAC, data on water-soluble alum inium salts were examined to evaluate the bioconcentration factors.

2.5.2 No reports on the bioconcentration of triiron tetraoxide were found. However, because it consists of water insoluble particles, triiron te traoxide is not absorbed or accumulated in living organisms and has no bioaccumulation.

2.5.3 A summary of the chronic aquatic toxic ity data for aluminium ions, PASA and acrylamide monomers is shown in the table below:

FCA Species BCF Comments Reference

Aluminium chloride F Salvelinus fontinali s (Freshwater) 36 200 μg Al/L, 56 d pH 7.2; 1% mortality Cleveland et al

., 1991

Unspecified Al salt F Salmo salar 76-190 60 d, pH 5.5 33-264 μg/L Buckler et al

., 1995

PASAAnionic polyacrylamide F Cyprinus carpio 0.23- 0.32 0.33- 0.35 0.26- 0.41 0.1 mg/L 2 weeks breeding 4 weeks breeding 6 weeks breeding OEC, 2003

Acrylamide

monomer F Cyprinus carpio 0.26 0.77 1 mg/L, 20 d 10 mg/L, 20 d EU, 2002

Acrylamide

monomer F Oryzias latipes 0.31 2.53 1 mg/L, 20 d 10 mg/L, 20 d EU, 2002

Acrylamide

monomer F Oncorhynchus mykiss 1.44 1.65 0.71 mg/L, 72 h Whole body Internal organs EU, 2002GESAMP-BWWG 4/9 ANNEX 5 Page 21

I:\MEPC\57\2.doc 3 MAMMALIAN TOXICITY

3.1 Acute mammalian Toxicity

3.1.1 Triiron tetraoxide, PAC and PA SA are considered to have low acute toxicity by the oral route. No data were submitted for dermal and i nhalation routes therefore they cannot be fully evaluated and MSDS were of poor quality. Ac rylamide monomer is toxic if swallowed (GHS classification, Annex VI, CO M (2007) 355 final), and also harm ful if inhaled or in contact with skin.

3.1.2 A summary of the mammalian toxicity data for triiron tetraoxide, PAC, PASA and acrylamide monomers is shown in the table below:

Exposure path Animal species End point Value mg/kg bodyweight Reference

Triiron tetraoxide Oral Rats LD 50 >10,000 EU, 2000a

PAC Oral Mice LD 50 Ca. 7,000 EU, 2000b Rats LD 50 >2,000 EU, 2000b PASA Oral Rats LD 50 >4,000 Cosmetic Ingredient Review, 2005 Acrylamide

monomers Oral Mice, rats, rabbits, and guinea pigs LD 50 150 - 180 ACGIH, 2001a

Acrylamide

monomers Oral Mice and rats LD 50 107 - 203 EU, 2002

Acrylamide

monomers Percutaneous Rabbits LD 50 Ca. 1,150 EU, 2002

3.2 Corrosion/Irritation

3.2.2 Effect on skin

3.2.2.1 PAC is irritating to skin (self classi fication by supplier) and acrylamide monomer is also irritating to skin (GHS classi fication, Annex VI, CO M (2007) 355 final).

3.2.2.2 A summary of the effects on skin irri tation for triiron tetraoxide, PAC, PASA and acrylamide monomers is shown in the table below:

Substance Species Methods Result Reference/ Comments Triiron tetraoxide Rabbits OECDTG404 Not irritating EU, 2000a

PAC Rabbits OECDTG404 Not irritating EU, 2000b

PAC Rabbits, mice, and pigs Not specified Not irritating EU, 2000b

PAC Humans Not specified irritating EU, 2000b

PASA Rabbits Not specified Not irritating Cosmetic Ingredient Review, 2005GESAMP-BWWG 4/9 ANNEX 5 Page 22

I:\MEPC\57\2.doc Acrylamide

monomers Rabbits Not specified No: for uninjured skin Very mild erythema and edema: for injured skin ACGIH, 2001a

Acrylamide

monomers Rabbits Not specified irritating EU, 2002

Acrylamide

monomers Humans Occupational

exposure Dermal irritation, skin separation EU, 2002

3.2.3 Effects on eye

3.2.3.1 PAC is irritating to eyes (self classification by supplie r) and acrylamide monomer is also irritating to eyes, causing serious eye irritation (GHS classification, Annex VI, COM (2007) 355 final).

3.2.3.2 A summary of the Effects on eyes for trii ron tetraoxide, PAC, PASA and acrylamide monomers is shown in the table below:

Substance Species Method Guidelines Result Reference/ Comments Triiron tetraoxide No data No data No data EU, 2000a

PAC Rabbits OECDTG404 Mild EU, 2000b PAC Humans Not specified irritation EU, 2000b

PASA Rabbits Not specified Solid: Mild 5% water solution: No Cosmetic Ingredient Review, 2005

Acrylamide

monomers Rabbits Not specified 10% water solution: Mild 40% water solution: irritating ACGIH, 2001a

Acrylamide

monomers Rabbits Not specified irritating EU, 2002

3.1 Sensitization

3.1.1 Acrylamide is a skin sensitiser (GHS cl assification, Annex VI, COM (2007) 355 final).

3.1.2 A summary of the effects on sensitizati on for triiron tetraoxide, PAC, PASA and acrylamide monomers is shown in the table below:

Substance Species Method Guidelines Sensitizer (yes/no) Reference/ Comments Triiron tetraoxide Guinea pigs Not specified Not sensitising EU, 2000a

PAC Rabbits Not specified Not sensitising EU, 2000b

PASA No data No data Not expected to be a sensitizer Cosmetic Ingredient Review, 2005

Acrylamide

monomers Guinea pigs Not specified Sensitizer EU, 2002GESAMP-BWWG 4/9 ANNEX 5 Page 23

I:\MEPC\57\2.doc 3.4 Repeated-Dose Toxicity

3.4.1 Triiron tetraoxide

3.4.1.1 There is a report on intravenous (iv) ad ministration in rats over three weeks and intravenous (iv) administration in dogs over th ree weeks, which shows that pigment deposition increases in cells of the reticuloendothelial syst em but no injury in tissues occurs (EU, 2000a). Triiron tetraoxide is expected to have no adverse effects wi th repeated dose toxicity (subacute/subchronic toxicity) because it consists of insoluble inorganic microparticles which are not absorbed in the body.

3.4.2 PAC

3.4.2.1 In an inhalation exposure test of 22 days in which PAC solutions of 0.34 μg/L and 2.5 μg/L were given to rats 4 hours a day at a frequency of 5 days a week, no toxicity or accumulation in tissues were observed (EU, 2000b).

3.4.3 PASA

3.4.3.1 No chronic toxicity was observed in a te st in which feedstuffs containing 500 to 50,000 ppm of polyacrylamide were given to rats and dogs (Cosmetic Ingredient Review, 2005). PASA is expected to have no a dverse effects with rep eated dose toxicity (subacute/subchronic toxicity) because it consists of high molecular wei ght polymer particles (several million or more) which are not absorbed in the body.

3.4.4 Acrylamide monomers

According to several tests by pe r oral administration to laborat ory animals, the major toxic effects are on the nervous system and male gene rative organs. Acrylamide is classified according to its properties to cause damage to organs through prolonged or repeated contact (GHS classification, Annex VI, CO M (2007) 355 final). A summary of the effects on repeated dose toxicity for acrylamide monomers is shown in the table below:

Species days Dose Effects Reference/ Comments

Rats 90 d 3-400 mg/kg feed Neurotoxicity above 300 mg/kg, seminiferous epithelium degeneration at 400 mg/kg, NOAEL 110 mg/kg (5.5 mg/kg bodyweight day) ACGIH, 2001a

Rats 90 d 0.05-20 mg/kg bodyweight day Neurotoxicity above 1mg/kg/bw Severe degeneration of peripheral nerves at 20mg/kg/bw NOAEL 0.2mg/kg/bw ACGIH, 2001a

Humans N.D. N.D. adverse effects on the central nerve system, loss of muscle strength, disturbance of muscle co-ordination, gait abnormality, tremor, and hallucination ACGIH, 2001aGESAMP-BWWG 4/9 ANNEX 5 Page 24

I:\MEPC\57\2.doc 3.5 Chronic toxicity

3.5.1 Triiron tetraoxide (Ref. MEPC 57/2/2, 5.3.5)

No data on chronic toxicity for laboratory animals are available. However, inhalation of iron oxide dust or fume during occupational e xposure can cause a benign pneumoconiosis (ACGIH, 2001b).

3.5.2 PAC (Ref. MEPC 57/2/2, 5.3.5)

3.5.2.1 In several reports on inhalation exposure us ing laboratory animals, the accumulation of aluminium in the lungs, lymph nodes around the l ung alveoli, and adre nal glands, and lung disorders are reported. In tests in which rats and guinea pigs were exposed to three levels of PAC content, 0.25, 2.5, and 25 mg/m 3 for 6 hours a day at a frequenc y of five days a week for six months, the value of the:

3.5.2.2 NOAEL could not be obtained, LOAEL was 0.25 mg/m 3 (EU, 2000b), with lung injury occurring at a PAC concentration of 0.25 mg/m 3 or more, increase in weight was suppressed at a concentration of 25 mg/m 3

. 3.5.2.3 PAC is widely used in the municipal purif ication of water, and no adverse effects to human health have been identified (AWWA, 2004).

3.5.3 PASA (Ref. MEPC 57/2/2, 5.3.5)

Several tests have been conducted in which feedstuffs containing 500 to 100,000 mg/kg of polyacrylamide were given to rats for two years. No toxic effects or path ological changes related to the administration were observed in any of the tests (Cosmetic In gredient Review, 2005). Regarding chronic toxicity in humans, no a dverse effects have been observed on workers exposed to dust containing polyacrylamide (1 mg/m 3 ) over five years or more in polyacrylamide manufacturing plants (Cosmetic Ingredient Review, 2005).

3.5 Development and Reproductive Toxicity

3.5.1 Triiron tetraoxide (Ref. MEPC 57/2/2, 5.3.6)

3.5.1.1 There are no data available on the reproduc tive and developmental toxicity of triiron tetraoxide.

3.5.2 PAC (Ref. MEPC 57/2/2, 5.3.6)

3.5.2.1 The reference used by the applicant (E U, 2000b; U.S., NIOSH, RTECS, 2007) is considered not valid by the Group to asse ss the reproductive/developmental toxicity.

3.5.3 PASA (Ref. MEPC 57/2/2, 5.3.6)

3.5.3.1 No effects on reproduction were observed in a three-generation test in which feedstuffs containing two levels of polyacr ylamide, 500 and 2,000 , were given to rats (Cosmetic Ingredient Review, 2005).GESAMP-BWWG 4/9 ANNEX 5 Page 25

I:\MEPC\57\2.doc 3.5.4 Acrylamide monomers (Ref. MEPC 57/2/2, 5.3.6)

3.5.4.1 There are several reports of reproductive toxicity in per oral administration to laboratory animals, and it has been shown that male genital toxicity and male sterility are caused. The value of the NOAEL with the effect on fertili ty potential was 5 mg/kg/day as for rats, and was 9 mg/kg/day as for mice (EU, 2002). Acryla mide is suspected to damage fertility (GHS classification, Annex VI, COM (2007) 355 final).

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

3.6.1 Carcinogenicity

3.6.1.1 Acrylamide is classified according to its carcinogenic properties (may cause cancer) (GHS classification, Annex VI , COM (2007) 355 final).

3.6.1.2 A summary of the Carcinogenicity data for triiron tetraoxi de, PAC, PASA and acrylamide monomers is shown in the table below:

AS Species Effects Reference/ Comments

Triiron tetraoxide IARC (Intern. Agency Res. Cancer) Group 3 (not classifiable as to carcinogenicity to humans), CAS 1309-37-1 (ferric oxide) (IARC, 1987)

PAC as aluminium potassium sulfate Insufficient information available to assess this endpoint MEPC 57/2/2, 5.3.8

PASA aspolyacrylamide Rats 500 to 100,000 mg/kg in food, 2 years: no lesions observed Cosmetic Ingredient Review, 2005

PASA aspolyacrylamide Dogs 500 to 50,000 ppm in food, 2 years: no lesions observed Cosmetic Ingredient Review, 2005

Acrylamide

monomers Rats Dosage via drinking water Increase in the incidence ratio of tumors; relationship with endocrine disruption and genotoxicity is suggested EU, 2002

Acrylamide

monomers Humans IARC Group 2A (probably carcinogenic to humans) IARC, 1994

3.6.2 Mutagenicity/genotoxicity

3.6.2.1 Acrylamide is classified according to its mutagenic properties (may cause genetic defects) (GHS classi fication, Annex VI, CO M (2007) 355 final).GESAMP-BWWG 4/9 ANNEX 5 Page 26

I:\MEPC\57\2.doc 3.6.2.2 A summary of the mutagenicity/genotoxi city data for triiron tetraoxide, PAC, PASA and acrylamide monomers is shown in the table below:

AS Species Effects Reference/ Comments

Triiron tetraoxide Salmonella typhimurium in vitro (Ames test) Negative EU, 2000a

PAC as aluminium Sulphate Salmonella typhimurium in vitro (Ames test) Negative IPCS, 1997 (Not submitted)

PAC as aluminium sulfate Mouse Negative on gene mutation (L5178Y cells of lymphoma) IPCS, 1997 (Not submitted)

PAC as aluminium Sulphate Human leucocytes Positive in chromosomal aberration

test IPCS, 1997 (Not submitted)

PAC as aluminium chloride Mice In vivo (intraperitone al) Positive (induction of chromosomal aberrations in marrow cells) IPCS, 1997 (Not submitted)

PAC as aluminium sulphate Rats In vivo (intraperitone al) Positive (induction of chromosomal aberrations in marrow cells) IPCS, 1997 (Not submitted)

PASA No data available in the submission MEPC 57/2/2, 5.3.7 Acrylamide

monomers Bacteria in vitro Negative MEPC 57/2/2, 5.3.7

Acrylamide

monomers Animal cells In vitro Positive micronucleus test, unscheduled DNA synthesis (UDS) test, and sister chromatid exchange (SCE) test MEPC 57/2/2, 5.3.7

Acrylamide

monomers Somatic cells In vivo Mutagenic in vivo (see text below) EU, 2002

Acrylamide

monomers Germ cells In vivo Mutagenic in vivo (see text below) EU, 2002

3.6.2.2 Acrylamide monomers are clearly mutage nic in vivo in somatic cells, producing positive results particular ly in the bone marrow micronucleus assay. The pattern of results indicated clastogenicity or interference with mitosis rather than gene mutation activity (EU, 2002).

3.6.2.3 Clearly positive in vivo in a number of different germ cell assays (chromosome aberrations, micronucleus assay, UDS, dominant lethal assays, heritable tran slocation, and specific locus assays) indicating that it is a germ cell mutagen (EU, 2002).

3.6.2.4 It has been suggested that the possible mechanism for ge notoxic effects of acrylamide in mammalian systems is by acrylamide neurotoxici ty occuring in both cen tral and peripherical nervous system likely through mi crotubule disruption (CIR, 2005).GESAMP-BWWG 4/9 ANNEX 5 Page 27

I:\MEPC\57\2.doc 3.7 Toxicokinetics

3.7.1 A summary of the toxicokineti cs data for triiron tetraoxi de, PAC, PASA and acrylamide monomers is shown in the table below:

AS Method Effects Reference/ Comments

Triiron tetraoxide Rats 2h inhalation Clearance half-life was 47 d (EU, 2000a,)

Triiron tetraoxide Human Evidence from several surveys with occupational exposure suggest that there is accumulation of dust iron oxide in the lungs ACGIH, 2001b

PAC Rats 24 months inhalation accumulation of aluminium in the lungs, secondary to adrenal glands EU, 2000b

PAC Guinea pigs 21 months inhalation. accumulation of aluminium in the lungs, secondary to lymph nodes EU, 2000b

PASA Rats Per oral administration: acrylamide was found in faeces and bowel contents, but not in body tissues. Cosmetic Ingredient Review, 2005

Acrylamide

monomers Rats and mice Oral and percutaneous absorption, Excretion with urine or exhalation as CO 2 in breath, only small proportion is excreted with faeces. EU, 2002

Acrylamide

monomers Rats selective accumulation in nerve cells was not observed ACGIH, 2001a

3.7.2 Acrylamide monomers showed to be rapidly absorbed orally and percutaneously by different species so that unchanged substances and metabolites are widely distributed in living organisms. In particular, they are distribute d to the male reproductive organs and to unborn babies through the placenta. There are only limited data on the in vivo fate of acrylamide monomers in humans, and it has been indicat ed that acrylamide is absorbed orally or percutaneously because acrylamide monomer adduc ts are detected in hemoglobin (EU, 2002).

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

4.1.1 Hydrolysis (Ref. MEPC 57/2/2, 5.4.1.1)

4.1.1.1 Hydrolysis properties do not apply to triiron tetraoxide and PAC because they are inorganic compounds. Since the half-life period of acrylamide monomers for hydrolysis is more than one year under the conditions of pH 5 to 9 and 55°C, acrylamide monomers are considered not to be easily hydrolyzed in environmental wa ter (EU, 2002). Therefore, it is assumed that PASA is resistant to hydrolysis, as in the cas e of acrylamide in environmental water.GESAMP-BWWG 4/9 ANNEX 5 Page 28

I:\MEPC\57\2.doc 4.1.2 Biodegradability (biotic/abio tic) (Ref. MEPC 57/2/2, 5.4.1.2)

4.1.2.1 Biodegradability does not apply to triiron tetraoxide or PAC because they are inorganic compounds. Regardin g the biodegradability of PASA , there is a report on the degradation rate of activated sludge taken from an urban sewa ge treatment plant using the coulometer method, in which PASA was assessed to be non-biodegradable because it was hardly degraded after 300 hours (OEC, 2003). The group c onsiders PASA as fairly undegradable as its degradation does not take place in se veral years (Khaitan et al., 2003) 2.

4.1.2.2 The biodegradability of acrylamide monomers has been tested based on OECD TG301D. Since the biochemical oxygen demand (BOD) values for 28 days under the two levels of the concentration of testing subs tance, 2 mg/L and 5 mg/L, were 100 and 53.3%, respectively, it has been determined that acryl amide monomers are easily degraded at lower concentrations (<2 mg/L) (EU, 2002).

4.1.2.3 A summary of the modes of degradation data for acrylamide monomers is shown in the table below:

Substance Method Degradability (Yes/No) Half-Life life period Degradation rate References/ Comments

Acrylamide

monomers OECD 301D Closed bottle BOD 2 mg/L 5 mg/L Yes <2 mg/L No 5 mg/L BOD 2 mg/L: 100% 2 mg/L: 53.3% EU, 2002

Acrylamide

monomers Aerobic degradability test with freshwater microorganisms acclimated for 33-55 h Yes 55-70 h IPCS, 1985

Acrylamide

monomers Aerobic degradability in different soils Yes 18-45 h (25 mg/kg) 95 h (500 mg/kg) EU, 2002

4.2 Partition Coefficients

4.2.1 A partition coefficient is not applicable to triiron tetraoxide or PAC because they are inorganic compounds. Further, a partiti on coefficient is not applicable to PASA because it is a high molecular weight polymer compound.

4.2.2 The octanol/water partition coefficient (log P OW ) for acrylamide monomer is -0.67 to -1.65, and soil adsorption coefficient, K OC, is 0.195 L/kg (EU, 2002).GESAMP-BWWG 4/9 ANNEX 5 Page 29

I:\MEPC\57\2.doc 4.3 Persistence and Identifica tion of Main Metabolites

No generation of degradation prod ucts occurs from a ny of triiron tetraoxi de, PAC, and PASA. Since acrylamide monomers are resistant to hydr olysis and easily biodeg raded and mineralized under aerobic conditions, degradatio n products are not generated.

4.4 Reaction with Organic Matter

Triiron tetraoxide, PAC, PASA, and acrylamide m onomers all do not generate free radicals, and do not react with organic compounds.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

Triiron tetraoxice, PAC, PASA, acrylamide mono mers, and flocs would have no physical effect on the habitat of fish species, avian species , marine mammals or benthic organisms.

4.6 Potential Residues in Seafood

The substances used in this system do not e xhibit bioconcentration and so exhibit no potential persistence in seafood.

4.7 Any Known Interactive Effects

5 OTHER INFORMATION

5.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant Concentrations

5.1.1 Triiron tetraoxide (Ref. MEPC 57/2/2, 5.6)

The sample water is analysed by ICP emission spectroscopic analysis (ICP-AES) and detected as iron ions.

5.1.2 PAC

The sample water is analysed by ICP emission spectroscopic analysis (ICP-AES) and detected as aluminium ions.

5.1.3 PASA

According to the applicant, it is difficult to measure the amount of PASA directly, if its concentration in water is low. This situation is cons idered to be unsatisfactory by the Group and an acceptable analytical method should be developed.

5.1.4 Acrylamide monomers

Acrylamide monomers in the sample water are brominated using potassium bromide solution and potassium bromate solution under acidic conditi ons to obtain dibromo-derivatives. Excess bromine is reduced and eliminated with sodium th iosulfate, and the dibrom o-derivatives are then extracted with ethyl acetate. Trie thylamine is added to the solu tion to remove hydrogen bromide, and the obtained monobromo-derivatives are analysed by gas chromatography (GC).GESAMP-BWWG 4/9 ANNEX 5 Page 30

I:\MEPC\57\2.doc 5.2 Material Safety Data Sheet provided: Yes

5.3 GHS Classification ....................................

5.4 Risk Characterization

Persistence (P) Half life: >60d in seawater >40d in freshwater >180d in sea sediment >120d in fw sediment Bioaccumulation (B) Log Pow >3 Toxicity (T) Chronic NOEC<0.01 mg/L

Triiron tetraoxide Not applicable No No

PAC Not applicable No No PASA Yes No No Acrylamide

monomers No No No

Therefore, the Group concludes that none of the Active Substances is classified as PBT substances.

***GESAMP-BWWG 4/9

I:\MEPC\57\2.doc ANNEX 6

REVIEW OF PROPOSAL FOR THE APPROVAL OF ACTIVE SUBSTANCES

CleanBallast! using the basic approved EctoSys ® technology

Submitted for Final Approval by Germany as MEPC 57/2/3

0 SUMMARY

0.1 Final Approval of the CleanBallast! System the Ectosys ® technology is not recommended to be granted based on the submission provided by Germany.

0.2 The Group noted that the proposed system tr eats the ballast water both on uptake and at discharge. The use of a sec ondary treatment at discharge is to address any potential for re-growth of organisms in the ballast tank. At upta ke the ballast water is filtered and then treated by electrolysis directly in the ballast water pipe. At discharge the ballast water is treated by electrolysis only. Chemicals are not required to be stored onboar d. However, it was noted that e.g. Hydroxyl radicals, Chlorine gas and Hydroge n gas are produced and s hould be regarded as Active Substances and Relevant Chemicals. In addition a number of Disinfection By-Products (DPB) were identified by the Applicant and should be regarded as Relevant Chemicals.

0.3 The required concentrations of Active Subs tances in seawater, measured as Total Residual Oxidants (TRO), are stated in th e submission to reach a maximum of 2 mg/L. The Group noted that no such levels were given for fresh water. Theref ore, the Group considers the concentration of 2 mg/L as both the Maximum Dosage and the Maximum Allowable Discharge Concentration according to G9.

0.4 The Group noted the Applicants explanatio n that the high levels of disinfection by-products such as THM were due to the fact that the EctoSys ® system was run differently in the land based tests than it will be run during normal operation onboard ships. No information from analyses were provided from sa mples taken in land based tests with the electrodes run as the applicant states is the normal way on board sh ips. This was found to be a significant shortcoming in the application.

0.5 The Group noted that no deta iled information about the control system which could ensure that the maximum designed TRO-concen tration is maintained was included in the CleanBallast! system application dossier. Howeve r, the dossier did indicate that an algae monitoring sensor is to be incl uded in the industrialized versi on of the system installed onboard ships. This sensor was still under developm ent and the Group therefore concludes that the control system was not fully deve loped at the time of application.

0.6 The Applicant carried out hydr ogen measurements in a full- scale system. The lowest explosion limit for hydrogen gas is 4% under sta ndard conditions. The highest measured value was 0.25%, which is 16 times below the explosion li mit. It is also not ed that a de-aeration component has been added immediately followi ng the electrolysis ph ase and that a hydrogen content monitor has been included to monitor the discharge from the de-aeration pipe that will shut down the system should hydrogen concentrati ons at this point reach dangerous levels. The Group considers that the information provi ded together with the mitigation measures incorporated are acceptable in addressing this id entified risk. The group recognized that the formation of oxygen in a full-scale te st has not been investigated.GESAMP-BWWG 4/9 ANNEX 6 Page 2

I:\MEPC\57\2.doc 0.7 The Group noted that chronic aquatic toxicity studies were not carried out in a land-based installation as required by the G9 guideline, but in a lab- based installation. The Applicant emphasizes that it is the TRO concentration which is relevant in relation to the toxicity of the treated water and not the scale of the installation. However, the Group considers that it is both the level of TRO and the organic matter concentration which determine the quantity of halogenated by-products (DBP) and therefore also to some extent the toxicity of the treated water. Toxicity tests with water samples from the land based efficacy tests as required by the G8 and G9 guidelines are intended to ensure that ade quate levels of TRO and organic matter are used in all tests and that the chemical characterisat ion of treated water is adequately assessed.

0.8 The Group considered that Brominated DBPs (Disinfection By-Products) are the toxicologically releva nt compounds generated by th e process. As the applic ant was unable to provide adequate information regarding human exposure , e.g. as indicated in GESAMP-BWWG 3.9 and MEPC 57/2/3), the Group noted that an adequate conclusion as to the outcome of the Human Risk Assessment could not be achieved. Therefore, the Group re commended that human exposure when handling ballast water treatment operations should be restricted and RMM put in place.

0.9 The Group noted that tests to determine the corrosive properties of the treated ballast water had yet to commence, and therefore the leve l of the potential risk of accelerated corrosion to the ballast water piping and st ructure that may be raised by us e of this system remains to be assessed.

0.10 Based on information provided in the appli cation for Basic approva l a PEC/PNEC ratio of discharged ballast water in Rotterdam harbou r can be calculated to be 0.85, i.e. below 1 and indicating no cause for concern. Based on th is ratio, the Group concludes that under the conditions of the test there would be a low risk for the environment. However, it is not clear to the Group whether the system will r eally operate as stated, given th at the control system is not fully developed and the EctoSys ® was run differently in the land based tests than it will be in normal operation onboard ships.

0.11 For a final risk assessment to the environm ent the Group needs a better explanation of the presence and performance of the algae or other monitor in addition to information on the validity and applicability of the model use d. Calculations with the MAMPEC-model are recommended as a reference, i.e. using as many of the same parameter values as possible. Under the assumptions used by the applicant in running the model, there seems to be no risk to the environment but the Group needs more informa tion to have confidence in the applied tools and methods.

1 INTRODUCTION

1.1 The data for this product were extrac ted from the submission of Germany to MEPC (MEPC 57/2/3) and the application dossier and additional information received following request of the Group to the applicant.GESAMP-BWWG 4/9 ANNEX 6 Page 3

I:\MEPC\57\2.doc 2 COMPLETENESS OF DOSSIER

2.1 It was noted that the applicant had submitte d the following material for consideration by the GESAMP BWWG:

.1 A non-confidential Application Dossier, which contains a su mmary of the data and results (MEPC 57/2/3).

.2 A confidential Application Dossier for Final Approval, which contains information about the disinfection mechan ism of the CleanBallast! system, results from land-based efficacy tests, ecotoxicity tests, data sets of Active Substances and disinfection by-products.

.3 Further, the Applicant submitted appendices with acute and chronic toxicity test protocols and results fr om chemical analysis.

2.2 The Group noted that the following inform ation was not provided in the dossier:

.1 Long-term corrosion testing that was advised by GESAMP BWWG to be performed following the Basic Approva l submission has not yet commenced.

.2 Information concerning human exposure to active substances , relevant chemicals and by-products or an appropriate Hu man Exposure Scenario (MEPC 56/2/2, annex 9).

3. A full description of the contro l system of the disinfection unit.

2.3 After request of the Group the Applican t submitted the following information:

.1 A summary of acute toxicity of treated ballast water to freshwater organisms with Chemical parameters in fresh water during the CleanBallast ! LBTA process.

.2 Technical information of the CleanBalla st! system, including a block diagram and a manual of the system and a description of the EctoSys ® electrolytic cell.

3 DESCRIPTION OF BWMS AND DATA-SET REQUIRED IN THE APPLICATION

3.1 Description of the ballast water management system

3.1.1 The proposed ballast water treatment system is a combined system intended to treat the ballast water at both uptake and discharge. The system consists of a 50 μm disc filtration phase followed by an electrochemical disinfection phase (EctoSys ® electrolytic cell).

3.1.2 At uptake the ballast water is filtered and then treated by electrolysis directly in the ballast water pipe. At discharge the filter is by-passed and the ballast water is treated by the EctoSys ® component a second time. The use of secondary treatment at discharge is to address any potential for re-growth of organisms in the ballast tank.GESAMP-BWWG 4/9 ANNEX 6 Page 4

I:\MEPC\57\2.doc 3.1.3 The chemicals used for disinfection are dir ectly produced by electro lysis of the ballast water and therefore there is no need for the storage of additional chemicals on board. Organisms are inactivated by indirect oxi dation from Active substances and direct oxidation at the anode surface.

3.1.4 The Active Substances are pr oduced by applying a direct cu rrent between the anodes and cathodes affecting the full flow of ballast wate r. The required concentrations of Active Substances in seawater, measured as Total Re sidual Oxidants, are given by the submission as maximum 2 mg/L. The Group noted that no su ch levels were given for fresh water.

3.1.5 The submission indicates that when run with an over potential betw een the electrodes the system can be operated in fresh water and low sa linity waters. Active su bstances produced under these conditions are hydroxyl radicals. However, a different behaviour of the system could be expected under these circumstances and this was not investigated by the applicant.

3.1.6 The Group noted that no information about the control system which could ensure that he maximum designed TRO-concentration is mainta ined during ballasting and deballasting was included in the CleanBallast! system. However, the dossier indicated that there are plans to incorporate an “algae monitor” as part of its control system to automatically adjust the levels of chemicals generated according to plankton conten t of the treated water. The algae monitor sensor is to be included in the final version of the system to be installed onboard ships. The CleanBallast! version used in the land based test s was therefore considered not to be the final version, but still under development.

3.1.7 A de-aerator is fitted immediately after the electrolysis equipment to reduce the quantity of hydrogen gas in the treated wa ter, the air vent from the de -aerator is monitored for H 2 content for additional safety. The disc filters are automatically back-flushed to sea during the uptake of ballast water and are bypassed and no t used for discharge treatment.

3.1.8 The Group also noted that the description of the sy stem indicated that it incorporated an automatic shut-down in case of leakage.

3.2 Identification of Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 It was noted that the proposed system invol ves filtration followed by a patented system for producing free radicals and lo w levels of chlorine gas in situ with the aid of an electrochemical treatment (EctoSys ® ). As a result, chemicals are neither required to be stored onboard nor generated on demand.

3.2.2 It was recognized that the process would ge nerate free radicals which were expected to have half-lives in the order of micro sec onds to milliseconds, but wh ich might react with naturally occurring organic molecules to form by-products with safety and environmental concerns. Whilst agreeing that such free radicals s hould be regarded as either Active Substances or Relevant Chemicals, it was agreed that, due to their short half-life it was neither necessary nor practical to provide their physical char acteristic or toxicological profiles.GESAMP-BWWG 4/9 ANNEX 6 Page 5

I:\MEPC\57\2.doc 3.2.3 The following Active Substances and Releva nt Chemicals are identified by the dossier:

.1 In seawater, chlorine gas (Cl 2 ) is formed at the anode surface and exists in equilibrium with HOCl and OCl - depending on the pH. These oxidants will react with bromide ions and produce HOBr and BrO -

. .2 Hydrogen gas is formed at the cathode surface by the electrolysis of water.

.3 It was noted that the Applicant had identified a number of disinfection by-products (DPB). The Applicant focuse d on the formation of DBP in high salinity waters, as a resu lt of the request from the Group to investigate the formation of chlorinated organics.

3.2.4 Table 1 lists the concentr ations of disinfection by-produc ts supplied by the Applicant in the non-confidential dossier for land-based type approval tests (LBTA) for cycle 3 plus the values extracted from further 4 LBTA test cycles (extracted from the la b reports). Haloacetic acids (HAA) were analysed in 4 test cycles, only.

Table 1: Analysis of disinfection by-pro ducts in ballast water treated with EctoSys ®

in a land-based full-scale installation (Ref. MEPC 57/2/3, table 1, page 11 and Appl. Dossier file 3, chapter 4).

Deballasting Deballasting

Parameter Unit after treatment tank Effluent treatment Effluent control 1 2 3 TOC mg/L 9.9 (2.3-29.3) 11.2 (3.25-31.1) 12.6 (4.2-34.2) Bromate μg/L 27 55 (26 – 87) <1

Trihalomethanes (THM) Trichloromethane μg/L <0.3 <0.3 <0.3 Dichlorobromomethane μg/L 0.2 (0.2-6) 0.54 (0.5-9) <0.1 Dibromochloromethane μg/L 6.8 (<1-8.5) 13 (<0.1-16) <0.1 Tribromomethane μg/L 180 (170-260) 330 (260-410) <0.1 (<0.1-0.1) Sum THM μg/L 190 (180-270) 340 (270-430) 0 (<0.1-0.1)

Haloacetic acids (HAA) Monochloroacetic acid μg/L 0.14 (<0.1-1.3) 0.57 (0.57-0.76) <0.1 (<0.1-0.12) Dichloroacetic acid μg/L 0.12 (0.12-0.26) 0.26 (0.26-0.44) <0.1 Trichloroacetic acid μg/L <0.05 (<0.05-0.16) 0.06 (<0.05-0.15) 0.08 (<0.05-0.08) Monobromoacetic acid μg/L 0.33 (0.33-1.2) 3 (2.3-4.2) <0.1 Dibromoacetic acid μg/L 21 (20-47) 43 (43-93) <0.1 (<0.1-0.41) Tribromoacetic acid μg/L 0.66 (0.66-1.3) 1.6 (1.6-2.1) <0.1 Sum HAA μg/L 22.25 (22.3-50.1) 48.5 (48.5-100) 0.08 (0.08-0.41)

AOX mg/L Cl 0.08 (0.06-0.57) 0.16 (0.08-0.23) 0.07 (<0.02-0.09)GESAMP-BWWG 4/9 ANNEX 6 Page 6

I:\MEPC\57\2.doc 3.2.5 Sampling points have been determined at several places. One sampling point (1) represents a filtered and electrochemically (EctoSys ® ) treated water sample, which was stored in a treatment tank. Sa mpling point (2) represents the wa ter sample from the treatment tanks, which were treated with EctoSys ® a second time before discharge, whilst sampling point (3) represents an untreated sample (see Table 1).

3.2.6 Bromate concentration was measured during the full-scale tests, but due to matrix effects the LOQ was found to be 0.2 mg/L. All measur ed bromate concentra tions were <0.2 mg/L. Therefore, the applicant additiona lly analysed bromate during the chronic toxicity studies with ICP-MS, where a small-scale laboratory-based CleanBallast! unit was applied. The applicant states that the scale of the installation is of no significance for the formation of bromate, but the level of Total Residual Oxidants is significant.

3.2.7 Based on the results for trihalomethanes th e US-EPA limit for drinking water (80 μg/L) has been exceeded by a factor of 2.75 on average. However, the applicant states that the electrodes worked under reversed polarity, wh ich creates higher TH M concentrations. In a lab-based study during chronic toxicity tests, the THM concentration was found to be 34.45 μg/L at a TRO concentration of 2 mg/L. No information on analytical chemistry were provided from samples taken in land based tests with the electrodes run as the applicant states is the normal way on board ships (see paragraph 3.2.9).

3.2.8 The US-EPA limit of 60 μg/L for total halo acetic acids was exceeded in two cases (71 and 100 μg/L) during deba llasting with EctoSys ® treatment.

3.2.9 The Group noted that the applicant had pr ovided the following additional information to explain the reason for the high levels of chemicals produced as by-products by the system:

Clarification of high THM con centrations by Member State

“

In order to prevent mineral hydroxide deposit s from seawater on the cathode surface, the polarity of the electrodes is reversed in certain time intervals. During normal operation the last electrode is working at cathodic potential reducing effectively THM formed previously in the cell. At reversed polarity, the la st electrode before the water leaves the cell is working at anodic potential at which th e applied current partly forms TRO. When the cell ends with an anode, the TH M formed as disinfection by-product from anodically produced TRO can not be further redu ced at any cathodic surface. This result in higher THM concentration compared to ru nning the electrochemical cell with normal polarity. Due to relatively fr equent polarity reversal, the tr eated water originates from both normal and reversed operation mode of the EctoSys ® resulting in a mean THM concentration during common operation of the Cl eanBallast! system. In contrast, in the test cycle, which results are shown in Tabl e 1, the reversed mode alone was used during both the ballasting and deballasting procedur e and therefore presents the highest THM concentrations possibly produ ced and an unrealistic worst-c ase due to normally applied reversal (Ref. MEPC 57/2/3, 3.5.2.1.1).”GESAMP-BWWG 4/9 ANNEX 6 Page 7

I:\MEPC\57\2.doc 3.3 Data on effects on aquatic plants, invert ebrates and fish, and other biota, including sensitive and representative organisms

3.3.1 Acute aquatic toxicity

3.3.1.1 Haloacetic acids (Ref. extr acted from MEPC 57/2/3, 3.5.2.1.4)

Toxicity of HAA on two aquatic plants ( Myriophyllum, L. gibba ) was investigated in the laboratory by Hanson et al. (2004, I and II). HAA have low toxic effect in the mg/L range for EC 10 and in the g/L range for EC 50 . MCAA was generally the most toxic.

3.3.2 Chronic aquatic toxicity

3.3.2.1 Bromate

Concentrations of up to 13.6 mg/L bromate s timulates cell division of phytoplankton cells. Chronic toxicity of bromate was calculated by Hutchinson et al. 1997 by applying a factor of 10 to the acute toxicity value (31 mg/L), i.e. 3 mg/L.

Table 2: Data on chronic aquatic toxicity of bromate

Organism Bromate mg/L Reference Freshwater Daphnia magna 48 h LC 50 179 Marine Mysid shrimp 96 h LC 50 176 Marine Juvenile fish 96 h LC 50 427-512 Marine Early life stages of fish 96 h LC 50 31 Review by Hutchinson et al . 1997 MEPC 57/2/3, 3.5.2.1.4

The Applicant states that DBP can only form in water with higher salinities and that concentrations of DBP are in the ra nge of drinking water standards.

3.4 Data on mammalian toxicity (G9: 4.2.1.2)

3.4.1 Free Active Chlorine ( Cl 2 , HOCl, OCl-, and OH radicals)

The Group noted that the toxicological dataset for the active substances has been already provided for Basic Approval (MEPC 55/2/4).

3.4.2 Disinfection By-Products (DBP)

3.4.2 Trihalomethanes (Ref. MEPC 57/2/3, 3.5.2.1.4)

3.4.2.1 Acute toxicity

The acute toxicity (LD 50 ) of trihalomethanes (chloroform, bromodichloromethane, chlorodibromomethane and bromoform) to rats has been found to be in the range of 848-1388 mg/kg (Chu et al .., 1980). Clinical effects following singl e oral doses were sedation, ataxia, piloerection, and prostration. In this study, bromoform was the least toxic compound.GESAMP-BWWG 4/9 ANNEX 6 Page 8

I:\MEPC\57\2.doc Chloroform (GHS classification, Annex VI, CO M (2007) 355 final), bromodichloromethane and chlorodibromomethane (self classification by comme rcial suppliers) are all classified as harmful if swallowed. On the other hand, bromoform is classified as toxic by inhalation (GHS classification, Annex VI, COM (2007) 355 final). Bromat e (as potassium bromate) is classified as toxic if swa llowed (GHS classification, A nnex VI, COM (2007) 355 final).

3.4.3 Genotoxicity/Carcinogenicity

Chloroform and other THM have been shown to increase tumours of the liver, kidney or large intestine in rats and mice. The weight of ev idence suggests that chloroform is non-genotoxic and there are data, to indicate that tumours only occu r at high doses where there is also tissue damage (Fawell, 2000).

The evidence suggests that the use of a thre shold approach, based on the tolerable daily intake (TDI) would be the most appropriate way of determining safe leve ls in drinking water (WHO, 1998). The application of this sta ndard to ballast wate r is however unclear.

Chloroform is classified according to its carc inogenic properties (suspected of causing cancer) (GHS classification, Annex VI , COM (2007) 355 final), this conclusion also applies to bromodichloromethane (self classification by co mmercial suppliers). Bromate (as potassium bromate) is classified according to its ca rcinogenic properties (may cause cancer) (GHS classification, Annex VI, COM (2007) 355 final).

3.4.5.2.3 Toxicokinetics/Metabolism

Chloroform, bromodichloromethane, chlorodibr omomethane and bromoform are stored and metabolised rapidly in human body fluids with relatively rapid clearance rates (Batterman et al ., 2002), depending on the lipophilic propert ies (partition coefficients) of the concerned THM.

3.4.6 Modes of degradation (biotic; abiotic)

3.4.6.1 Haloacetic acids (Ref. MEPC 57/2/3, 3.5.2.1.4)

Dichloroacetic acid (DCAA), the third highest ba llast water effluent concentration, is rapidly biodegradable (Rodriguez et al ., in press). MCAA is expected to degrade even faster, due to less halogen in the molecule.

4 HUMAN HEALTH ASSESSMENT

4.1 The assessment of the human health risks of the EctoSys Ballast Water Treatment system has already been evaluated by the Group at Ba sic Approval. The general conclusion was:

4.2 From the supplied information it was conclude d that the critical health effects resulting from human exposure to the activ e substances and re levant compounds existing in the solution are mostly acute in nature; however, some concerns are also addressed in literature related to toxicity to respiratory and developmental/rep roductive function and car cinogenicity, depending on the severity of exposure and presumably under long term exposures (e.g., occupational scenarios).GESAMP-BWWG 4/9 ANNEX 6 Page 9

I:\MEPC\57\2.doc 4.3 Other relevant factors have also to be taken into account when assessing human exposure towards chemicals include, inter alia :

.1 the variability in individual sensitivity;

.2 the fact that complex mixtures of di sinfectants and DBPs, according to current knowledge, interact in an additi ve way, at low concentration.

4.4 The Group expressed concern regarding the pot ential for cumulative to xicological effects of the mixture of chemicals generated by EctoSys TM

.

5 RISK TO SAFETY OF SHIP AND CREW

5.1 Risk to safety of ship

5.1.1 Hydrogen formation

Hydrogen gas can be formed during the electro lytic disinfection proc ess. The reaction mechanism was described in the Application for Basic Approval, ME PC 55/2/4). In the recommendations the Group made at Basic Appr oval, further investigations on potential hydrogen gas formation in full-scale ballast water treatment systems were considered necessary and that the application of a safety f actor of at least 2 should be applied.

The Applicant declares that it is impossibl e to build up explos ive concentrations ( ≥ 4%) of hydrogen gas in the ballast water tanks when usi ng the CleanBallast! system, as the ballast water tanks are open to venting duri ng ballasting and deballasting.

The Group noted that the applican t has performed further tests a nd calculations to determine the levels of hydrogen concentrations that may be experienced during opera tion of the system. It is also noted that a de-aeration component has been added immediately following the electrolysis phase and that a hydrogen content monitor has been included to monitor the discharge from the de-aeration pipe that will shut down the system should hydrogen concentrations at this point reach dangerous le vels. The Group considers that the information provided together with the mitigation measures incorporated are acceptable in addressing this identified risk.

5.2 Corrosion effect tests (Ref. MEPC 57/2/1, 5.1.2)

The Group noted that the long-term corrosion testi ng that had been advised was to be performed following the Basic Approval pres entation has not yet commenced.

5.3 Risks to human health

The Group considered in the Basic Approval, that the critical health effects associated with human exposure to the active substances generated by the CleanBallast are mostly acute in nature. This concern was reiterated during Final Approval submission and therefore RMM remain to be clearly id entified and implemented.GESAMP-BWWG 4/9 ANNEX 6 Page 10

I:\MEPC\57\2.doc Additionally, the Group rais ed concern in the Basi c Approval regarding expos ure to the relevant DBP compounds such as chlorina ted and brominated under occupa tional scenarios. The Group considered that human health concerns remain in the Final Approval application as there is uncertainty regarding the THM concentrations th at can be generated by the system, namely by electrodes working under reversed polarity. It is acknowledged that the DBP, especially bromate, chloroform and bromoform have a potential for bioaccumulation and human genotoxicity/carcinogenicity and will therefore have to be kept below toxicologically critical levels (bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L, WHO Guidelines for Drinking Water Quality, 2003).

Bromate concentrations were measured at the sampling points during the deballasting (DB) part of the treatment process with values of 27 μg/L and 55 μg/L (see Table 1). Additionally, the concentrations measured for haloacetic acids during deballasting with EctoSys ® treatment, exceeded the US-EPA limit of 60 μg/L. Although the applicant states that the scale of the installation is of no significance for the formation of bromate, the level of Total Residual Oxidants is considered to be significant and therefore the Group c onsidered that th ere is a risk that unacceptable levels of br omate and brominated DBP can be produced by the system.

As the current MCL (Maximum Contamin ant Level) in the USA for bromate (potassium bromate) is 10 μg/L, and the maxi mum contaminant level goal is zero, the Group considers that the human health concern towards exposure to levels of bromate generated by the system still remain to be fully clarified namely by applicant submission of data relating to a human exposure scenario where bromate and other chlorinated and brominated DBP may be present.

The Group noted that the applicant did not prov ide any information concerning human exposure or attempt to describe a Human Exposure Scen ario (MEPC 56/2/2, annex 9); therefore an adequate conclusion as to th e outcome of the Human Risk A ssessment could not be achieved. The Group recommended that human exposure when handling ballast water treatment operations should be restricted and RMM put in place.

6 RISKS TO THE AQ UATIC ENVIRONMENT

6.1 ASSESSMENT OF PERSISTENCE (P ), BIOACCUMULATION (B) AND TOXICITY (T)

6.1.1 Persistence (G9: 5.1.1.1)

This aspect was evaluated during Basic Approval. It was concluded that none of the chemicals used in the EctoSys Ballast Water Treatment system was to be considered as a PBT substance.

6.1.2 Does the Active Substance, Preparation and/or Relevant Chemicals meet all three PBT criteria?

Conclusions on PBT are already evaluated under Basic Approval. The Group concluded that none of the substances used in this BW syst em should be classified as PBT substances.GESAMP-BWWG 4/9 ANNEX 6 Page 11

I:\MEPC\57\2.doc 7 ASSESSMENT OF TREATED BALLAST WATER

7.1 Toxicity tests

7.1.1 Acute toxicity of whol e effluents in LBTA tests

7.1.1.1 Brackish water

The Group noted that acute toxicity tests were carried out with th e treated ballast water from a land based installation (G9: 5.2.3). Tests we re performed with brackish water and with organisms of only one trophic level. In parallel, the degradati on of Total Residual Oxidants (TRO) was determined.

A so-called ‘Kinetic’ ecotoxic ity study was carried out with Tetraselmis suecica during the LBTA tests, during the deballasting procedure, sa mples being taken at a distance of 1 m away from the point of discharge and 30 cm below the water surface.

Table 3: Results of the Ec otox studies (Viability of Tetraselmis s. ) and TRO concentrations for the LBTA cycle 3

Sampling location & ti me Viability TRO [mg/L] Control Treated Corners Control Treated Corners Untreated harbour water 0.649 0.155 *DP 10 min deballasting 0.584 0.581 0.150 *DP 20 min deballasting 0.622 0.699 0.194 *DP 5 min after end of deballasting 0,640 0.668 0.154 *DP 10 min after end of deballasting 0.598 0.637 0.130 Right corner, before discharge 0.625 0.133 Left corner, before discharge 0.621 0.142 Right corner, 30 min after discharge 0.622 0.137 Left corner, 30 min after discharge 0.642 0.148

* DP= discharge point

The EC 50 of the whole effluent was determined by m easuring the reduction of fluorescence of the marine bacterium Vibrio fischeri at predetermined time intervals after ballast water treatment and after sampling. All other measur ements revealed that the EC 50 was not reached.

A high toxicity of the untreated control samples were related to high H 2 S concentrations in the storage tank caused by sul phate reducing bacteria.GESAMP-BWWG 4/9 ANNEX 6 Page 12

I:\MEPC\57\2.doc Table 4: Acute toxicity on whole effluent

FCA Species Salinity [PSU] Time after treatment EC50 (mL/L) References/Comments

B Vibrio fischeri bacteria Brackish

water 10 min >500 ISO 11348-2-L34 MEPC 57/2/3, 3.7.1.1.3

B Vibrio fischeri bacteria Brackish

water 10 min 600 MEPC 57/2/3, 3.7.1.1.3

A Phaeodactylum tricornutum Brackish

water 380 MEPC 57/2/3, 3.7.1.1.4

A Phaeodactylum tricornutum Brackish

water 500 MEPC 57/2/3, 3.7.1.1.4

Toxicity tests with several marine organism were carried out. In the Table below an overview of the results is given. The data c oncern the treated ballast water.

Table 5: Marine organism toxicity test with treated ballast water

T Species L(E)C50 Value Unit Remark B Light bacteria sp. 3h-EC 50 100 % EC 50 not reached B Light bacteria sp. 50m-LC 50 100 % EC 50 not reached A P. tricornutum 72h-EC 50 9 % Inhibition B Light bacteria sp. 30m-LC 50 32 % A P. tricornutum 72h-EC 50 38 % Inhibition B Light bacteria sp. 30m-LC 50 31 % A P. tricornutum 72h-EC 50 23 % Inhibition T refers to type of organi sm: B = bacteria, = A = algae.

The Applicant states that acute toxicity studies with marine algae on the whole effluent were submitted with the Basic Appr oval already (MEPC 55/2/16, annex 7, paragraph 8.2).

7.1.1.2 Freshwater studies

The Applicant also carried out toxicity tests under freshwater conditions, which were delivered following a request from the Group. However, the worst case TRO concentration of 2 mg/L could not be achieved in freshwater. The te st organisms used were the invertebrate Daphnia magma , the algae Scenedesmus sp. and the vertebrate Danio rero

.
7.1.2 Chronic toxicity of whole effluents in LBTA tests

The Group noted that due to the rapid decay of TR O and DBP, the chronic toxicity studies were carried out using a separate ballast water treatment installation (10 m 3 /h) at the laboratory performing the studies. Further, the applicant states that th e TRO level and not the scale of the installation is relevant. The test water was se awater (32-35 PSU) filtered at <10 μm with a constant TRO level of 2 mg/L. This water was led continuously to the test basins to maintain a constant supply of high TRO level water to the test organisms. The results are summarized in Table 5.GESAMP-BWWG 4/9 ANNEX 6 Page 13

I:\MEPC\57\2.doc Table 5: Chronic toxicity tests with treated ballast water and 2 mg/L TRO (b = biomass, r = reproduction, s = survival, h = hatch, l = length, w + dry weight, n.d. = not determinable)

FCA Species Effect Value Reference

A [%] Skeletonema

costatum 96 h E b C 50 NOEC b 96 h E r C 50 NOEC r 3.9 n.d. 6.3 3.2 ISO 10253:1995(E) MEPC 57/2/3, 3.7.2.2 p. 26

C [%] Tisbe battagliai 21 d NOEC s 21 d NOEC r

21 d LOEC s 21 d LOEC r 1.0 3.2

3.2 10 OECD 211 (marine equivalent) MEPC 57/2/3, 3.7.2.3 p. 27

F [mg/L] Cuprinodon Variegates (Sheepshead Minnow) 32 d NOEC h 32 d NOEC s 32 d NOEC l 32 d NOEC w Total NOEC 32 d LOEC h 32 d LOEC s 32 d LOEC l 32 d LOEC w Total LOEC 3.2 1.0 10 10 1.0 10 3.2 >10 >10 3.2 OECD 210 MEPC 57/2/3, 3.7.2.3 p. 27

The reported water quality parameters for the chronic toxicity studies were:

pH: 7.98 – 8.17 Salinity: 34.5 – 35.2 PSU Ammonium N: <10 μg/LGESAMP-BWWG 4/9 ANNEX 6 Page 14

I:\MEPC\57\2.doc 7.2 Degradation of TRO

The Group noted that TRO decay was determined in the dark to prevent photocatalytic degradation. These data confirm the prev ious results and statements (MEPC 55/2/4, paragraph 5.2.7.2) that the TRO de grades rapidly during the firs t 20 minutes. Figure 1 shows measured TRO decay over the initial time period after treatment in undisturbed stored samples (sample port C) during five LBTA deballa sting procedures in brackish water.

TRO degradation in CleanBallast! deballasting effluent

0.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8

0 20 40 60 80 100 120 140 160 Time [min]TRO [mg/l] LBTA cycle 1 LBTA cycle 2 LBTA cycle 3 LBTA cycle 4 LBTA cycle 5

Figure 1: TRO decay in stored efflue nt from the LBTA type approval set-up (without discharge to the receiving water)

From these data it can be concluded that the half life of TR O is about 30 minutes.

7.3 Prediction of discharge and environmental concentrations

7.3.1 Emission scenario of active substance

In their application for Basic Approval, the A pplicant reported carrying out modelling studies of ballast water discharges in generi c, open and closed harbours as well as case studies of ballast water discharge in Bremerhaven, based on the wo rst-case acute NOEC values of the disinfection unit effluent (MEPC55/2/4). This was complement ed with new simulations at the actual site of the land-based type approval installation (Bremerh aven). To confirm mode l predictions, on-site measurements at the land-based installation with direct TRO measurements were carried out.

The measured TRO concentrations were below the predicted concentrations and according to the applicant showed that the model calculates wo rst-case concentrations. TRO concentrations would account for <7% of the harbour concentrati ons shortly after effluent discharge and would be diluted and degraded to <1 ng/L after 7.5 h.

Furthermore, the Applicant carried out a case- study based on the Port of Rotterdam using the MAM-PEC model. The worst-case scenario for the Port of Rotte rdam with all ships using the CleanBallast! system and synchronous discharge rev ealed a total concentrat ion of 0.12 μg/L TRO.GESAMP-BWWG 4/9 ANNEX 6 Page 15

I:\MEPC\57\2.doc Case studies of ballast water di scharge based on Bremerhaven were also carried out. The model predictions were also controll ed by manually taking samples at different distance from the discharge point, and measured for TRO. Ot her model parameters can be found in the Application Dossier.

The simulations included two cases:

.1 Dilution down to 0.3% v/v, the acute NOE C including a safety factor of 10 (Basic approval, MEPC 55/2/4, 9.3).

.2 Dilution down to 0.1%, the chronic NOE C for the whole e ffluent including a safety factor of 10 (Final approval, MEPC 57/2/3).

With the discharge scenarios defi ned by the number of ships, thei r positions and certain loads, the model was used to predict the time taken fo r concentrations to fall below 0.3% and 0.1%, respectively, of the raw effluent co ncentration. With the first-order degradation rate set to fit real data measured in Bremerhaven during the LBTA te st cycles, the results could be summarized in Tables 7 and 8.

Table 7: Harbour modelling results for a closed harbour

Discharge

rate (m 3 /h) Discharge duration (h) Time for concentration to reach 0.3% (h) Time for concentration to reach 0.1% (h) 1000 5 4 5 1000 10 4 5 5000 5 6 7 5000 10 6 7

Table 8: Generic harbour modelling results for a tidal harbour

Discharge

rate (m 3 /h) Discharge duration (h) Time for concentration to

reach 0.3%) (h) Time for concentration to reach 0.1% (h) 1000 5 2 2 1000 10 2 3 5000 5 3 4 5000 10 3 5GESAMP-BWWG 4/9 ANNEX 6 Page 16

I:\MEPC\57\2.doc 7.4 Comparison of effect assessm ent with discharge toxicity

The applicant provided the following in formation regarding risk modelling:

“ Physical processes (i.e. mixing), will be d ifferent for every port and variable within a port, depending primarily on factors such as fresh water input dynamics, tides, and winds. Mixing will have two components, vertica l and lateral, to disperse the oxidant away from the ship’s point of discharge. To assess the potential effect of mixing, the overall decay half-life of the ox idant has to be considered.

Modelling of the ballast water discharge dilution in generic harbours down to the acute NOEC (using a safety factor of 10) resulting from the Final Approval toxicity tests, and also down to the chronic NOEC (incl. safety factor) was performed as a more direct supplement to the toxicity st udies. A specific generic harb our scenario was developed using available data from the harbour of Rotter dam. This specific latter study was used to determine a realistic PEC/PNEC ratio, provided all ships in a representative commercial harbour were equipped with the proposed CleanBallast ! system and under worst-case treatment and discharge conditions. This might also be of use in later joint-efforts of developing an ESD for BWT (paragraph 3.8.4 of the application dossier). ”

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 PNEC and NOEC

In order to estimate the PNEC TRO-saltwater value, the corresponding value for TRC in sea water of 0.3 μg/L was taken, including a sa fety factor of 10. This value is derived from the dilution of the effluent, plus the degrad ation of TRO in natural water to result in a PEC.

It was noted that the LOEC of three marine organisms under long-term exposure conditions to the whole effluent was 1% efflue nt v/v. Therefore, the PNEC for the whole effluent would be 0.14 μg/L according to the Basic Approval dossier.

8.2 PEC

The Group noted that a steady state PEC of th e TRO in Rotterdam under a worst case condition was predicted by the MAM-PE C model to be 0.12 μg/L

8.3 Calculation of PEC/PNEC ratios

The PNEC TRO-saltwater value evaluated by the Group during Basic Approval was 0.14 mg/L including a safety factor of 10. Therefor e the PEC/PNEC ratio is 0.12/0.14 = 0.85. Based on this ratio the Group concludes that under the conditi ons of the test there would be no risk for the environment. However, it is not clear to the Gr oup whether the system really operates like this as the presence and working of the algae monitor is not sufficiently described.GESAMP-BWWG 4/9 ANNEX 6 Page 17

I:\MEPC\57\2.doc 8.4 Assessment of the risk characterization

8.4.1 The Group cannot yet agree to accept the risk characterization and risk assessment as carried out by the applicant, as the functioning of the algae monitor was not clearly described nor was it finally developed. If the re-growth of al gae is relatively small but high enough to trigger the treatment at discharge the le vel of TRO discharged may be relatively high as only a minor part will be used as oxidative agent to rem ove the organisms from the ballast water.

8.4.2 The applicant has used a different model to MAMPEC, for which the Group is not aware of the specific characteristics nor was the group informed about possible reasons to use this model instead of MAMPEC. The Group needs at least some benchmark results to judge the comparability between both models.

8.4.3 The Group concludes that the quality of test reports on whole efflue nt toxicity testing with treated ballast water is considered sufficient.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

The Group noted that the risk of explosion du e to the generation of Hydrogen gas in the electrolysis process identified during the assessme nt for Basic Approval of this system had been fully considered by the applicant. A de-aerator has been incorporated in the system as an additional risk mitigation measure, including a hydrogen monitor in its vent arrangement that will shut down the system should dangerous level of hydrogen be detected. The Group therefore considers that this risk has been adequately addressed and controlled by the applicant.

The Group noted that tests to determine the corrosive propertie s of the treated ballast water had yet to commence, and therefore the level of the potential risk of acceler ated corrosion to the ballast water piping and structures due to the use of this system remain to be assessed.

9.2 Risks to the crew and general public

Chlorinated and Brominated DBPs (Disinfection By-Products) are the toxicologically relevant compounds due to their human ge notoxicity/carcinogenicity potenti al generated by the process. As the applicant did not prov ide information concerning pot ential for human exposure or describe a Human Exposure Scenario (MEPC 56/2/ 2, annex 9), the Group noted that a conclusion as to the outcome of the Human Risk Assessmen t could not be reached. The Group, therefore, can only adopt a precautionary approach and recommend that human exposure when handling ballast water treatment operations should be rest ricted and Risk Mitiga tion Measures be put in place.

9.3 Risks to the environment

9.3.1 The Group noted that both “the maximum dosage concentration” using two treatments and “the maximum allowable discharge concentra tion” for TRC are the same for this system. In general, the maximum dosage concentration is chosen to ensure efficacy to all marine organisms. Thus this dose conc entration (2 mg/L) exerts sufficient acute aquatic toxicity to kill all the organisms even in high densities as de fined in G8. If the second treatment during deballasting was carried out at the same dosage of 2 mg/L, this will clearly have significant ecotoxicity to organisms in the receiving wate r and be entrained into the discharge plume.GESAMP-BWWG 4/9 ANNEX 6 Page 18

I:\MEPC\57\2.doc The Group was of the opinion that the discharge of large volumes of balla st water treated with the CleanBallast! system using EctoSysTM system might result in TRO concentrations in the receiving environment that might cause acu te toxic effects to aquatic organisms (refer MEPC 55/2/16, annex 7, paragraph 9.3.4).

9.3.2 The Group noted that the application shows th at clear short-term effects can occur, so that the ballast water discharge still has non-acceptable risks to ma rine ecosystems, even if the long-term risks, such as PEC/PNEC ratio, described in 6.3.5 are ac ceptable. The Group emphasized that more mitigation procedure at second treatment shoul d be considered.

9.3.3 The group has already recommended to the ap plicant for the mitigation of discharging second treatment water with high acute toxicity at the basic approval (MEPC 55/2/16, annex 7, paragraph 0.7 and 10.4.2.4), as follows.

As the treated ballast water s howed signs of relatively high toxicity, the Group recommended that ballast water treated with the EctoSys sy stem would require a relatively high dilution immediately after discharge into the environm ent in order to avoid acute toxic effects.

Furthermore, the Group recommends that the following conditions s hould apply during the further development and testing of the proposed sy stem: ...... it might be worthwhile to explore possibilities to fine-tune the EctoSy sTM system so treatment at de-b allasting can be avoided or at least reduced, as this seems to cr eate a relatively high initial toxici ty of the treated ballast water at discharge.

9.3.4 The Group was of the opinion that the techni cal evidence to ensu re that the maximum dosage remains below 2 mg/L is not clear in this final application. However, at the final approval, the dossier identifies that “ Studies have shown that the Cl eanBallast! system always fulfils performance and other requirements at initia l (directly after the advanced electrochemical treatment step) concentrations of 2 mg/L To tal Residual Oxidants (TRO) or below in the discharge water.” Thus, the Group noted that using Ec toSysTM in CleanBallast! system, some control scheme for over-potential TRC production to reduce the maximum dose from 4 to 2 mg/L is needed at both treatments. The application do ssier does not contain the description of how the typical TRC capacity is limited and controlled during operation.

9.3.5 The applicant provided an additional feature using “the algae monitor” to control the CleanBallast! system. It is not the task of GESA MP BWWG to evaluate the performance of this monitor; how this monitor can count the vi able number of phytoplankton. However, the information of algae monitor is not completely di sclosed to the Group from applicant, so that the Group cannot to evaluate its performance and reliability at all.

9.3.6 Regarding the total system including this new algae monitor, the Group was concerned that the applicant was unable to provide suffi cient information on this essential component. The Group noted that the algal monitor had not yet been tested in an operational system. Therefore, the Group considers that as this Self-Pro tection procedure is not yet proven in practice and the confidence in the maintenance of the maximum allowable discharge concentration of TRO at any time, cannot be ensured at this phase . The group was of the opinion that the algae monitor seems to be used for the measurement of biological density or efficacy levels and not for the measurement of the chemical properties such as TRO levels. Considering the whole system design, even if the algae monitor sensor has e nough performance and reliability, the total system should first be proven in practice.GESAMP-BWWG 4/9 ANNEX 6 Page 19

I:\MEPC\57\2.doc 9.3.7 The Group also has noted at basic approval that there are possibilities that during the second treatment greater quantities of relevant chemicals may be produced than at the first treatment (refer MEPC 55/2/16, annex 7, 7.2.5). The Group strongly recommended that for the second treatment, the maximum dose of 2 mg/L should be reduced to a minimum needed to achieve the demand for G8 efficacy. Further, if the algae monitor works in practice, the second treatment should be stopped, when there are no viable organisms in the discharged ballast water.

9.3.8 For a final environmental risk assessment the Group needs a better explanation of the presence and performance of the algae monitor and information on the va lidity and applicability of the model used. For reference reasons also calculations with the MAMPEC-model are recommended using as many as possible the same parameter values. Under the assumptions of the applicant there seems no risk for the enviro nment but the Group needs more confidence in the applied tools and methods.

9.4 Recommendations

.1 Final Approval of the CleanBallast ! System the Ectosys technology is not recommended to be granted based on the submission provided by Germany.

.2 The Group noted that the proposed syst em treat the ballast water both on uptake and at discharge. The use of a secondary treatment at discharge is to address any potential for re-growth of organisms in the ballast tank. At uptake the ballast water is filtered and then treated by electrolysis directly in the ballast water pipe. At discharge the ballast water is treated by electrolysis only. Chemicals are not required to be stored onboard. However, it was noted that e.g. Hydroxyl radicals, Chlorine gas and Hydrogen gas are produced and should be regarded as Active Substances and Relevant Chemicals. In addition a number of Disinfection By-Products (DPB) were identified by th e Applicant and should be regarded as Relevant chemicals.

.3 The required concentrations of Active Substances in seawater, measured as Total Residual Oxidants, are given by the submission as maximum 2 mg/L. The Group noted that no such levels were given for fresh water. Therefore, the Group considers the concentration of 2 mg/L as both the Maximum Dosage and the Maximum Allowable Discharge Concentration according to the G9-evaluation, respectively.

.4 The Group noted that the Applicant had expl ained that high levels of disinfection by-products such as THM were due to the fact that the EctoSys ® system was run differently in the land based tests than it will be in normal operation onboard ships. The Group further considered that a full chemical char acterization of water treated by the CleanBallast! system run in normal mode should be provided together with toxicity tests with the same water.

.5 The Group noted that no detailed info rmation about the control system which could ensure that the maximum designed TRO-concentration is maintained was included in the CleanBallast! system. Howe ver, the dossier indicated that an algae monitor sensor is to be included in th e industrialized version of the system installed onboard ships. This sensor was still under development and the Group therefore concludes that th e control system was not fully developed and therefore not an integrated part of the system under evaluation by the Group.GESAMP-BWWG 4/9 ANNEX 6 Page 20

I:\MEPC\57\2.doc .6 The Applicant carried out hydrogen measurements in a full-scale system. The lowest explosion limit for hydrogen gas is 4% under standard conditions. The highest measured value was 0.25%, wh ich is 16 times below the explosion limit. It is also noted that a de-aeration component has been added immediately following the electrolysis phase and th at a hydrogen content monitor has been included to monitor the discharge from th e de-aeration pipe that will shut down the system should hydrogen concentrations at this point reach dangerous levels. The Group considers that the information provided together with the mitigation measures incorporated are acceptable in addressing this identified risk. The group recognised that the formation of oxygen in a full-scale test has not been investigated.

.7 The Group noted that the long-term corrosi on testing that had been advised in the Basic approval evaluation has not yet commenced.

.8 The Group noted that chronic aquatic t oxicity studies were not carried out in a land-based installation as required by th e G9 guideline, but in a lab-based installation. The Applicant emphasizes th at it is the TRO concentration which is relevant in relation to the toxicity of the treated water and not the scale of the installation. The Group considers both the level of TRO and organic matter essential for the quantity of halogenated by-products (DBP) and therefore also for the toxicity of the treated water. Toxici ty tests with water samples from the land based efficacy tests as required by the G8 and G9 guidelines will ensure that adequate levels of TRO and organic matter is used in all tests and the chemical characterisation of treated water.

.9 The Group considered that Brominated DBPs (Disinfection By-Products) are the toxicological relevant com pounds generated by the process. As the applicant couldn’t provide information concer ning the Human Exposure Scenario (3.9. MEPC 57/2/3), the Group noted that an adequate conclusion as to the outcome of the Human Risk Assessment c ould not be achieved. Therefore, the Group recommended that human exposure wh en handling ballast water treatment operations should be restricted and RMM put in place.

.10 The Group noted that the ri sk of explosion due to th e generation of Hydrogen gas in the electrolysis process identified during the assessment for Basic Approval of this system had been fully considered by the applicant. A de-aerator has been incorporated to the system that in cludes a hydrogen mon itor in its vent arrangement that will shut down the sy stem should dangerous level of hydrogen be detected as an additional risk m itigation measure. The Group therefore considers that this risk has been ad equately addressed and controlled by the applicant.

.11 The Group noted that tests to determine the corrosive properties of the treated ballast water had yet to commence, and ther efore the level of the potential risk of accelerated corrosion to the ballast water pi ping and structure that may be raised by use of this system remains to be assessed.GESAMP-BWWG 4/9 ANNEX 6 Page 21

I:\MEPC\57\2.doc .12 Based on information provided in the a pplication for Basic approval a PEC/PNEC ratio of discharged ballast water in Ro tterdam harbor can be calculated to 0.85. Based on this ratio the Group concludes that under the conditions of the test there would be low risk for the environment. For a final risk assessment to the environment the Group needs, however, a be tter explanation of the presence and performance of the algae monitor and info rmation on the validity and applicability of the model used. For reference r easons also calculations with the MAMPEC-model are recommended usin g as many as possible the same parameter values.

Under the assumptions of the applicant th ere seems no risk for the environment but the Group needs more confidence in the applied tools and methods.

.13 During the evaluation process and inter actions with the German authorities it showed that research on the second treatme nt procedure was s till under testing for biological efficacy, influence to the e nvironment and risk on crew and ship.

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