I:\MEPC\55\2-16.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
55th session Agenda item 2 MEPC 55/2/16 7 July 2006 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

Report of the second meeting of th e GESAMP-Ballast Water Working Group (GESAMP-BWWG)

Note by the Secretariat

SUMMARY

Executive summary: This document contains the repor t of the second meeting of the
GESAMP Ballast Water Work ing Group (GESAMP-BWWG) and includes the evaluation of propos als for the approval of Active Substances submitted by Japan, the Republic of Korea and Sweden.

Action to be taken: Paragraph 4

Related documents: GESAMP-BWWG 2/9 (attached), MEPC 55/2/1, MEPC 55/2/2,MEPC 55/2/6

Introduction

1 The second meeting of the GESAMP-B WWG was held from 22 to 26 May 2006, the report, of which, is attached to this document with the symbol GESAMP-BWWG 2/9. However, this report has still to be reviewed by GESA MP and, should there be any significant amendments to it, these will be reported to the Committee accordingly.

2 The prime purpose of this meeting was to revi ew the proposals for th e approval of Ballast Water Management Systems that use Active Substan ces to treat ballast water prior to discharge
into the marine environment. The reviews for those proposals considered by the Group are shown in annexes 5, 6 and 7 of the attached report.

3 As instructed by MEPC 54, the Group continued to develop the Draft Methodology for Information Gathering and the Conduc t of Work of the GESAMP- BWWG , taking into account the comments made by the Committee and the su bmissions by the United States, Japan and the European Commission. As a result, several issues were raised which require guidance from the
Committee.

Action requested of the Committee

4 The Committee is invited to:

.1 agree that all information related to sa fety and environmental protection, including physical properties, environmental fate and toxicity, should be treated as non-confidential (paragraphs 2.2 and 5.8.2);MEPC 55/2/16 - 2 -

I:\MEPC\55\2-16.doc .2 agree with the Working Group’s re sponses to the comments made in MEPC 55/2/1, MEPC 55/2/2 and ME PC 55/2/6 (sections 5.5, 5.6 and 5.7);

.3 develop criteria which would specify how chemicals used in the treatment of
ballast water can be handled and stored on board ship (paragraphs 5.8.4 to 5.8.6);

.4 develop a suitable Emission Scenario Docu ment (ESD) to be used by applicants and the Group for the Risk Assessment of chemicals associated with ballast water treatment, particularly with regard to calculating the Predicted Environmental Concentration (PEC) (paragraphs 5.8.8 to 5.8.10);

.5 urge applicants to submit their applicati ons in the standardized format indicated in
the Draft methodology for information gat hering and the conduct of work of

GESAMP-BWWG (paragraphs 6.1.2 to 6.1.4 and Annex 4);

.6 advise the Group whether it should consid er full-scale operational risks and, if so, which scenarios for the discharge of trea ted ballast water woul d be relevant and how should they be assessed (paragraphs 6.1.5 and 6.1.6):

.7 agree that the Group should not be request ed to evaluate conceptual systems that do not include details of how the sy stem would be wo rking in practice (paragraph 6.2.1);

.8 agree that all possible chemicals produced by a proposed system should be considered by the Group in order to evalua te the risks associat ed with long-term, high volume, regular discharges into the marine environment and that the Draft Methodology should be amended to reflec t this (paragraphs 7.3 and 7.4);

.9 agree with the proposed schedule of 19 to 23 February 2007 for the third meeting of the Group (paragraph 8.3);

.10 indicate to Administrations that the d eadline for submissions to the third meeting of the BWWG is 15 December 2006 (paragraph 8.4);

.11 agree that Basic Approva l should be granted to the system described in MEPC 55/2 (Japan) for further prototype testing and development and that the various concerns addressed by the Group should be addressed (Annex 5 and, in particular section 0);

.12 agree that Basic Approval should not be given to the system described in MEPC 55/2/3 (Republic of Korea) for the reasons given in Annex 6; and

.13 agree that Basic Approva l should be granted to the system described in MEPC 55/2/4 (Sweden) for further prototyp e testing and development and that the various concerns addressed by the Group should be addressed (Annex 7 and, in particular, section 0).

***I:\MEPC\55\2-16.doc GESAMP-BALLAST WATER WORKING

GROUP
2nd session Agenda item 9 GESAMP-BWWG 2/9 25 May 2006 Original: ENGLISH

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

Table of Contents

Section Page Nos.

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

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

3 OUTCOME OF MEPC 54...................................................... 4

4 TERMS OF REFERENCE ............................................................... 4

5 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR

INFORMATION GATHERING AND THE CONDUCT OF

WORK OF GESAMP-BWWG......................................................... 4-10

6 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES – SUBMITTED BY JAPAN, THE REPUBLIC

OF KOREA AND SWEDEN ........................................................ 10-12

7 CONSIDERATION OF QUERIES FROM MEMBERS AND

INDUSTRY ...................................................................... 12

8 FUTURE WORK PROGRA MME AND TENTATIVE DATE

FOR THE NEXT MEETING ................................................... 12-13

9 CONSIDERATION AND ADOPTION OF THE REPORT ......... 13

ANNEXES

ANNEX 1 LIST OF MEMBERS ATTEN DING THE SECOND SESSION OF THE

GESAMP-BWWG

ANNEX 2 AGENDA FOR THE SECOND SESSION OF THE GESAMP-BWWG

ANNEX 3 TERMS OF REFERENCE FOR THE GESAMP-BWWG

ANNEX 4 DRAFT METHODOLOGY FOR INFORMATION GATHERING AND THE

CONDUCT OF WORK OF GESAMP-BWWGGESAMP-BWWG 2/9 - 2 -

I:\MEPC\55\2-16.doc ANNEX 5 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES –

SUBMITTED BY JAPAN

ANNEX 6 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES –

SUBMITTED BY REPUBLIC OF KOREA

ANNEX 7 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES –

SUBMITTED BY SWEDEN

ANNEX 8 TIMETABLE FOR ACTI VITIES RELATED TO THE 3RD MEETING OF THE

GESAMP-BWWG- 3 - GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc 1 INTRODUCTION

1.1 The second GESAMP Ballast Water Wo rking Group (GESAMP-BWWG) meeting was held at IMO Headquarters, London, from 22 to 26 May 2006, under the chairmanship of
Mr Finn Pedersen. A list of me mbers attending this meeting is shown in annex 1, and the agenda, as adopted by the Group, is set out in annex 2.

1.2 The meeting was opened by Mr. J-C. Sainlo s, MED Director, who informed the Group on
the volume of work for this sess ion and encouraged the participants to do their utmost to try to evaluate all the submissions if possible. Howeve r, he advised the Group that all concerned were aware of time limitations and the Group should not rush its proceedings to the detriment of scientific rigour. Mr. René Coenen, IMO Technical Secretar y of GESAMP, reported on the contractual arrangements and invited the Group to agree upon criteria for identifying alternate members that could be invited to participat e should any of the existing members become unavailable. Mr Dandu Pughiuc, Head of the IMO’s Office for Ballast Water Management, briefed the Group on the outcome of MEPC 54 regarding Ballast Water Management Systems that make use of Active Substances and the specifi c decisions concerning th e work of the Group.

1.3 The Chairman of GESAMP-BWWG briefly re ported on the procedur e for approving the report by GESAMP and on his participation in ME PC 54 and indicated that apart from reviewing the proposals for approval of Active Substan ces, the Group was tasked to continue the development of the Draft Methodology for inform ation gathering and conduct of work taking into account comments made by the Committee a nd further proposals from the Member States.

2 ISSUES OF CONFIDENTIALITY

2.1 Applications for Basic A pproval regarding the use of Active Substances had been submitted by three members of the Organizati on, namely, Japan, the Republic of Korea and Sweden. The Secretariat informed the Group that the non-confidential part s of the submissions had been circulated as MEPC documents and emphasized that members of the Group were requested to keep the data contained in the application dossiers confidential to protect the
commercial interests of the manufacturers.

2.2 When evaluating an application, the Group felt that it should have the right to base its evaluation on any available information and to use this information for justifying its conclusions and recommendations irrespective of confidentiality issues. Wh ile the Group agreed that the details of the functioning of the Ballast Water Management System (BWMS) must be regarded as confidential to protect the rights of the manufac turer, it was considered that all the information related to physical properties, environmental fate and toxicity should be treated as nonconfidential. However, the Group recommended that the Organization, prior to submission of the Groups evaluation report to the MEPC, consults with the Member of th e Organization having proposed the Ballast Water Management System. In cases where the evaluation report contains confidential information, the Organization should d ecide on the future pr ocedures. The Group distinguished between requirements for confidentiality in G9 and the copyright applied to various studies and reports used in the prep aration of the application dossier.

2.3 In the case of requests to IMO from a thir d party for more information regarding an application, the Organization may provide the na me and address of the national Administration that originally submitted the application for approval, which could then respond, as it feels appropriate.GESAMP-BWWG 2/9 - 4 -

I:\MEPC\55\2-16.doc 3 OUTCOME OF MEPC 54

3.1 A comprehensive introduction of the work carried out by relevant IMO bodies in the period from the first meeting of the Group was provided by the Secretariat (document GESAMP-BWWG 2/3). Particular emphasis was placed on the decisi ons of MEPC 54 related to the development of the Draft Methodology for info rmation gathering and method of work of the GESAMP-BWWG and the Group was requested to:

.1 further consider the document MEPC 54/ 2/6 (European Commission) with a view to identify inconsistencies with G9 and advise MEPC 55 accordingly;

.2 consider the use of data waivers when pr eparing the application dossier and advise MEPC 55 accordingly; and

.3 continue the development of the Draf t Methodology during the 2nd meeting of the Group.

3.2 The Group was invited to consider, under agenda item 5, the comments and proposals contained in documents MEPC 55/2/1 (United St ates), MEPC 55/2/2 (Japan) and MEPC 55/2/6 (European Commission), and ta ke action as appropriate.

3.3 The Group was also invited to consider the questions addressed by IUCN and respond to the questions under agenda item 7.

3.4 Finally, the Group was invited to reconsider the work programme, time line and number of application documents that could be evaluate d in one session in the lig ht of the experience gained and advise the Committee accordingly.

4 TERMS OF REFERENCE

4.1 The Group agreed to continue to be guide d by the Terms of Reference approved by MEPC 54 as contained in annex 3 of this report a nd decided to request further clarification from the Marine Environment Protection Committee on some of the specific tasks and in particular regarding the role played by the GESAMP-BWWG during the Final Approval. Detailed requests for clarification are included in section 5 below as they bear particular relevance to the Methodology of information gath ering and the conduct of work.

5 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR INFORMATION

GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG

5.1 The Group recalled that, during its first meeti ng and under severe time constraints, it had developed the draft Methodology for informati on gathering and the c onduct of its work.

5.2 It was noted that the report of its first meeting, which included such draft methodology,
had been submitted to IMO’s Marine Envi ronment Protection Committee (MEPC) as
MEPC 54/2/12.

5.3 The Group noted the comments on its draft methodology, which had been submitted to the fifty-fifth session of MEPC by the United St ates (MEPC 55/2/1), Japan (MEPC 55/2/2) and the European Commission (MEPC 55/2/6).- 5 - GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc 5.4 Having considered these comments in detail, the Group made the points identified in the following paragraphs of this section.

5.5 Comments submitted by the Un ited States (MEPC 55/2/1)

5.5.1 The Group fully supported the view that tran sparency is important in both the Group’s working procedures and its deliberations in order to allow MEPC to make well informed judgements based on the Group’s recommendations. In this context, the Group recognized that any recommendation made to the Committee n eeded to be supported by appropriate data. (MEPC 55/2/1, paragraph 4).

5.5.2 It was recognized that the Group had been selected by GESAMP which also held the CV
of each of the members. Each member of the Group agreed that the CVs could be made available to any Member State on request to the GESAMP IMO Technical Secretary (MEPC 55/2/1, paragraph 4).

5.5.3 Whilst the Group anticipated that its role might be to confirm and validate the
Administration’s assessment of the proposed Active Substances /Preparations for use in the treatment of ballast water, it wished to emphasize its independent scientific role which allows it to make any recommendations that are scientifically based as appropriate. In this respect, the Group urged Member States submitting applications to present an initial Risk Assessment, which would facilitate the development of recommenda tions to MEPC. (MEPC 55/2/1, paragraph 5).

5.5.4 Whilst recognizing its role is purely advisor y, the Group agreed that, if it is going to provide MEPC with well informed, meaningful r ecommendations it would only be able to do this if appropriate data are provide d. In line with its recommenda tory function, the Group amended the text of its draft methodology, replacing demands such as “must” and “required” with less specific terminology such as “should”. However, in an attempt to assist those Governments and industry submitting proposals, it was considered im portant to make it clear that, without the appropriate and correct information, it may not be possible for the Group to assess the BWMS sufficiently, in order to allow an informed reco mmendation to be made to MEPC. (MEPC 55/2/1, paragraph 6).

5.5.5 As indicated in MEPC 55/2/1, paragraph 7, a nd in order to prevent any misunderstanding with respect to testing methodologies, the Group agreed to amend the first sentence of paragraph 2.5.1 to:

Tests should be carried out by international ly recognized guidelines (preferably OECD or equivalents ).

and to introduce a new paragraph 3.0.5 which reads:

Any reference to specific test methods in the following is indicative with the purpose of providing guidance to an Admini stration on possible methods that may be considered. Any other internationally recognis ed test method may also be used as well.

5.5.6 The Group recalled that, in accordance with G9 the evaluation should consider Active
Substances

, Preparations including any of its components and Relevant Chemicals

. (MEPC 55/2/1, paragraph 8). In addition, the Group agreed to the following interpretations of the definitions and requested MEPC to endorse this understanding:GESAMP-BWWG 2/9 - 6 -

I:\MEPC\55\2-16.doc .1 Preparation, as defined in G9, should be limited to the first sentence only, which would be in line with typical definitions us ed in chemicals legislation and with the
similar definition of Mixture used in the Globally Harmonized System (GHS) as shown below for comparison:

Mixture means a mixture or solution com posed of two or more substances in which they do not react ; and

.2 that the definition of Relevant Chemicals in G9, should be transformation and reaction products produced during a nd after employment of the BWMS

.

5.5.7 The Group recognized the concerns expres sed about lack of data with missing justifications causing the Group to state that “in general it woul d not allow any approval”. The Group agreed that this statement was intended to be helpful to the submitting body as it is important to distinguish between mi ssing essential data and data that are not relevant or practical to generate. However, in orde r to overcome this dilemma, it wa s agreed to amend the text to
reflect the fact that lack of da ta with missing justification would make it difficult for the Group to make a meaningful recommendation to MEPC. (MEPC 55/2/1, paragraph 9).

5.5.8 The Group noted that references to data waiver did not appear for all da ta and agreed to add such references into the appropriate places in the draft methodology (MEPC 55/2/1, paragraph 11).

5.5.9 The Group agreed to remove:

.1 General obligations of the Convention; and

.2 Experimental application period.

and to add:

.1 Active Substance;

.2 Preparation;

.3 Other components of a preparation; and

.4 Relevant Chemicals.

to the Definitions section of the Methodology.

5.5.10 Whilst recognizing that G9 does not make a ny reference to shipboard experiments, the Group understood that, following Basic Approval, furt her tests might be carri ed out using one or a few ships to ascertain both the practical functioning of the BWMS and the safety and environmental affects of the system submitted for approval. However, the Group agreed that, if a recommendation for Basic Approval would be subj ect to certain concerns being addressed, it would be important that such concerns had been properly considered by the Administration prior to further development of the system onboard ships and to Final Approval being considered (MEPC 55/2/1, paragraphs 13 and 14).- 7 - GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc 5.6 Comments submitted by Japan (MEPC 55/2/2)

5.6.1 The Group recognized the point, made by Ja pan in MEPC 55/2/2, paragraph 4, that short-term assessment is also very important in the effect assessment of the Active Substances
and Relevant Chemicals.

5.6.2 However, the Group agreed that more time was necessary to consider this point in detail (MEPC 55/2/2, paragraph 5).

5.7 Comments submitted by the Euro pean Commission (MEPC 55/2/6)

5.7.1 The Group recognized that it had been charged with developing a methodology for its
scientific assessment that would allow this to be undertaken in a transparent way and requested
MEPC to endorse this methodol ogy. (MEPC 55/2/6, paragraph 4).

5.7.2 It was agreed that it was impractical fo r the Group to list all in formation submitted but that it would be useful as part of the submissi on made by the applicant. However, it was agreed that any additional data submitted or obtained an d used by the Group in its assessment should be documented in its report to MEPC (MEPC 55/2/6, paragraph 6). In addition, it was emphasized
the need for the deadline of submissions to ME PC to allow time for comments to be made by third parties that can be ta ken into account by the Group.

5.7.3 The Group recognized the opinions related to the mandatory requ irement for certain information (MEPC 55/2/6, paragraphs 7-10) a nd agreed that where the Group needs certain information to reach a scientific opinion, this should be made compulsory and requested MEPC to consider changing G9 to reflect this.

5.7.4 The Group agreed that, when the PEC/PNEC ra tio is >1, this would not necessarily mean that a product could not be recommended for Ba sic Approval but a detaile d analysis would need to be carried out on a case-by-ca se basis if this result is to be overridden (MEPC 55/2/6, paragraph 16).

5.7.5 The Group agreed that it would be useful to know the bioaccumulation potential of chemicals produced in the treatment of ballast water, especially for halogenated organic compounds and that analytical as well as test met hods are available for this purpose. However, it was noted that G9 (paragraphs 5.3.1 and 5.3.7) did not require this aspect to be taken into account in the methodology (MEPC 55/2/6, paragraphs 17-19).

5.7.6 The Group changed the text of the pream bular paragraph as proposed. (MEPC 55/2/6, paragraph 20).

5.7.7 The Group considered the proposals for the definitions of Basic Approval and Final Approval and expressed concern over the use of the phrase possible unacceptabl e adverse effect s in the definition of Basic Approval . Instead, the original phrase a potential for unreasonable risk was preferred as it allowed for suitable precautions to be put in place in order to permit the product to be used. (MEPC 55/2/6, paragraph 21). Furthermore, it was not clear to the Group whether recommendations for Basic Approval s hould only consider the use of the BWMS for development and prototype testi ng, or whether also the possible full-sc ale deployment onboard ships should be considered. This issue is further discussed in paragraphs 5.8.7 to 5.8.8.GESAMP-BWWG 2/9 - 8 -

I:\MEPC\55\2-16.doc 5.7.8 In addition, it was noted that neither of thes e definitions had been included in G9 and the Group requested that they should be added so that they can simp ly be reflected in the Group’s Draft Methodology.

5.7.9 The Group recognized that the paragraph:

“A comprehensive report ........for basic approval.”

was not appropriately placed under th e list of definitions and delete d it as the content was already
reflected elsewhere in the Draft Methodology (MEPC 55/2/6, paragraph 22).

5.7.10 The Group agreed that all results of effect and exposure assessments with the related uncertainty analysis should be added to the list of non-confidential da ta in paragraph 2.4 (MEPC 54/2/12, paragraph 23). The Group also agr eed that Relevant Chemicals (including byand end-products) formed during or after use of the BWMS, including their physico-chemical, human health and environmental properties s hould not be considered as confidential.

5.7.11 The Group recognized that, using the highest toxicity (e.g., lowest LC 50 value) from a range of reported values, might be regarded as taking the safest approach. However, the point was made that an appraisal of the data and its sources sometimes enables the experts to identify values that might be regarded as ou tliers or inappropriate. Therefore, a Weight of Evidence approach should be used for deciding on the most a ppropriate values for use in the effect and risk assessment and is not to be seen as a proba bilistic approach (MEPC 55/2/6, paragraph 24).

5.7.12 The Group recognized that, in general, there is not much difference in sensitivity to chemicals between fresh water and marine orga nisms within the same taxonomical groups and agreed to delete the footnote related to paragraph 3.2.1 of th e Draft Methodology as shown in MEPC 54/2/12. However, the Group also recogni zed that some important groups of organisms, which are present in the marine environment, are not present in freshwater (e.g., rotifers, echinoderms). It was agreed that these groups need to be considered separately whilst recognizing that this is d one to some extent by the use of an appropriate Assessment Factor in the Risk Assessment (MEPC 55/2/6, paragraph 26).

5.7.13 The Group considered the proposal to use a log K
ow >3 instead of log K
ow >5 as a trigger value for deciding when sediment toxicity testin g would be appropriate and noted that the value used in the EU TGD was >3 and so agreed to amend the methodology accordingly (MEPC 55/2/6, paragraph 27).

5.7.14 The Group agreed with the editorial cha nges proposed in MEPC 55/2/6, paragraphs 28, 29, 30, 33, 34, 35, 36, 37, 39, 42, 43.

5.7.15 The Group considered the proposal to upd ate the text on bioaccumulation, partition
coefficient and octanol/water partition coefficient and ame nded the section appropriately (MEPC 55/2/6, paragraphs 31-32).

5.7.16 With regard to the criteria for the identification of PBT substances, the Group recognised that in the EU, the Toxicity criterion also includes CMR or endocrine disrupting effects

. However, as this is not include d in the Procedure G9, it was cons idered that they could not be added to the Draft Methodology of the Group (MEPC 55/2/6, paragra ph 38). The Group, however, would welcome such an amendment of G9.- 9 - GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc 5.7.17 Nevertheless, the Group agreed that the refe rence to Log Pow and BCF in the G9 criteria were probably incorrectly report ed as it would mean that, even if a BCF value had been experimentally determined, this would be overri dden if the product had a Log Pow of >3. As a result, the Group agreed that the criteria should be understood as Experimentally determined BCF>2000 or, if no experim ental BCF has been determined, Log Pow ≥ 3 and amended the text of the Draft Methodology accordingly.

5.8 Other issues discussed

5.8.1 In addition to the specific points raised in the various submissions to MEPC, the Group raised the following issues which it requested ME PC to consider and decide as appropriate:

5.8.2 In considering the matter of confidentiality, the Group agreed that a ll data related to safety and environmental protecti on should be regarded as non-conf idential. It wa s agreed that this should include specific toxicity data generated under the owners hip of the applicant.

5.8.3 Notwithstanding this view, the Group noted that its evaluation report woul d be sent to the applicant so that they could indicate whether th ere are any confidential as pects which need to be removed prior to submitting the report to MEPC.

5.8.4 The Group recognized that ther e were no safety criteria, ba sed on toxicological and/or physical properties, for making recommendations on the safe handling of chemicals employed in systems for treating ballast water. It was emph asized that, as such, chemicals are not simply cargoes, ships carrying them should be regarded more like a workplace environment and employ necessary measures to protect the crew. In addition, it was recognized that, where BWMSs are employed on passenger ships, special considerations would need to be taken into account in order to ensure the safety of such passengers.

5.8.5 In this context, it was recognized that the volumes of any chemicals employed would vary, not only with the type of Management Syst em, but also with the type of ship. Whilst a passenger ship might only require sufficient ballas t water to compensate for the fuel being used, cargo ships might require much more ballast water to compensate for the state of loading of the ship.

5.8.6 It was recognized that the degree of h azard presented by any chemicals involved and the amount required to treat the ballast water might vary considerably therefore, MEPC was requested to consider developing criteria wh ich would specify how such chemicals would be
handled and stored on board (cf., IMDG Code, IBC Code) and whether some chemicals might
not be allowed at all on certain t ypes of ships e.g., passenger ships.

5.8.7 In addition to addressing the points raised by the United States, Japan and the EU, the Group expressed concerns about the definition of Basic Approval and Final Approval . It was recognized that a Basic Approval, as descri bed in the definition, proposed by the EC (MEPC 55/2/6), that would only c onsider controlled discharges in relation to the further development and prototype testing could be co nsidered by the Group when information on discharge conditions are provided. However, recommendati ons regarding Basic Approval for further development and prototype testing could not be seen as a prejudice for a Final Approval. For this, an assessment of environmental concentr ations resulting from di scharges under realistic conditions would be needed. However, the Group is not in possession of information on typical discharge situations that allows it to conduct such assessments.GESAMP-BWWG 2/9 - 10 -

I:\MEPC\55\2-16.doc 5.8.8 As a result, the Group wanted to reit erate its request to MEPC (MEPC 54/21, paragraph 2.12) to indicate the basis of the expos ure and risk assessment, preferably in the form of a suitable Emission Scenario Document (E SD), which should be adopted by MEPC and should specify, for a suitable num ber of realistic scenarios:

.1 the number of ships discharging balla st water into the aquatic environment including volume, duration and frequency;

.2 the dimensions of the receiving environment;

.3 the type of environment e.g., open or closed;

.4 the exchange of water in the environment;

.5 the water salinity range;

.6 the pH range of the water; and

.7 the concentration range of organic material.

5.8.9 However, the Group considered that, even if such an ESD were available, it has no capacity to develop a suitable model that could be used for estimating environmental exposure
concentrations or environmenta l dilution, and would consequently welcome the development and submission of such models, agreed by MEPC, to be used by applicants and the Group in its assessment of applications.

5.8.10 In this context, the Group was aware of the ex istence of models that might be suitable, or might have possibilities to make them suitable, for the intended use. However, the Group emphasised that potential models would need to be evaluated for their pros and cons prior to
acceptance.

6 REVIEW OF PROPOSALS FOR APPROVAL OF ACTIVE SUBSTANCES – SUBMITTED BY JAPAN, THE REPU BLIC OF KOREA AND SWEDEN

6.1 General overview

6.1.1 The Group noted that submissions had b een received from Japan (MEPC 55/2), the Republic of Korea (MEPC 55/2/3) and Sweden (MEPC 55/2/4 and MEPC 55/2/5). However, due to lack of time, the Gr oup was unable to consider the second submission from Sweden (MEPC 55/2/5).

6.1.2 The Group noted that the format of the non- confidential submissions , their associated
confidential data and literature references varied considerably. It was agreed that a standard approach to submitting data would greatly facilitate the workings of the Group as a considerable
amount of time can be wasted in searching through the detailed re ferences in order to validate data or provide more detailed info rmation. It was recogn ized that such a st andardized approach for all toxicological and environmental data was of particular importance.

6.1.3 As a result, the Group request ed that, in addition to a sp ecific complete reference, a photocopy of the relevant part of such a referen ce be included in the supporting data with the- 11 - GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc relevant information highlighted. This is particularly important where the reference is from a large publication which also contains a lo t of data irrelevant to the submission.

6.1.4 The Group also requested that each extracted re ference is clearly identified and that the file containing them includes a complete index of such references. The Group also requested that, where possible, as much data as possibl e should be provided in electronic format to facilitate appropriate searches.

6.1.5 The Group noted that:

.1 Final Approval, as described in G9 and advocated by the United States in MEPC 55/2/1 should only concern confirmation that the toxicity of treated ballast water at discharge conforms to the eval uation undertaken for the Basic Approval;
and

.2 Basic Approval, as proposed in the definition by the EC in MEPC 55/2/6, is restricted to validating risks during prototype or type approval testing.

6.1.6 As a result, the Group recognized that neither of these two definitions request an assessment of risks occurring dur ing full-scale operational applica tion on thousands of ships. The Group, therefore, requested a dvice from MEPC on whether it s hould consider this situation and if so, which assumptions or scenarios for disc harge of treated ballast water are relevant and should be assessed. Awaiting clarification, the Group decided to develop separate recommendations for prototype and type approva l testing and where appropriate for full-scale deployment.

6.1.7 In the interim, it was agreed that recommendations for Basic Approval might take the
form of:

.1 a recommendation regarding further deve lopment and testing onboard or a strictly limited number of ships under controlled conditio ns or land based systems; or

.2 a recommendation, regarding a full-s cale deployment on ma ny ships especially when the possible effects for humans and the environment have been considered as part of the Risk Assessment.

6.2 General points arising from co nsideration of the submissions

6.2.1 The Group agreed that at least one of th e applications did not include a complete description of the system. In this context, it agreed that th e Group should not be requested to evaluate conceptual systems that do not include details of how the system would be working in practice. Such omissions incl uded the details on the maximum dosage of Active Substance and how such maximum dosage and maximum allowa ble discharge concentration would not be exceeded as required by G9 (paragraph 7.1.1).

6.2.2 As a result, the Group reque sted MEPC to urge Administ rations to check and validate potential submissions prior to submitting them to the Group for evaluation as requested in paragraph 8 of G9.

6.3 Detailed review of the submissions

6.3.1 A detailed review of the submissions can be seen in:GESAMP-BWWG 2/9 - 12 -

I:\MEPC\55\2-16.doc .1 Annex 5 Basic Approval of Active Subs tances used by Special Pipe Ballast Water Management System (combined with Ozone treatment) submitted by Japan;

.2 Annex 6 Basic Approval of Active S ubstances used by NK Ballast Water Treatment System submitted by the Republic of Korea; and

.3 Annex 7 Basic Approval of Active Substances used by a Ballast Water Management System (EctoSys) submitted by Sweden.

6.3.2 Rather than reproducing the summaries in this section of the report, Members are requested to note that each review contains a summary at the beginning.

7 CONSIDERATION OF QUERIE S FROM MEMBERS AND INDUSTRY

7.1 The Group was informed about the general questions raised by IUCN during MEPC 54, which it addressed in the following paragraphs of this section.

7.2 The Group recognized the concerns expresse d by IUCN that no account was being taken of the possible formation of harmful by- and end- products in either ballast water or the marine
environment.

7.3 In this context, the Group emphasized the need to consider all possible chemicals and mixtures of chemicals produced by proposed system s in order to evaluate the risks associated with long-term, high volume, regul ar discharges into the marine environment. The Group also agreed that safety and environmental data associ ated with such products should also be regarded
as non-confidential.

7.4 As a result, the draft methodology was amended to take these points into account and MEPC was requested to approve such changes.

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE FOR THE NEXT

MEETING

8.1 The IMO Technical Secretary of GESAMP informed the Group on the difficulties to identify suitable mammalian toxicologists and s uggested to agree upon a pr ocedure that could be
used when additional members were needed. Some member s of the Group advised about potential candidates that could match the requ ired profile, however, the Group agreed that ensuring as much as possible a uniform geographical representation is essential. The possibility of recruiting ad-hoc experts when highly specialized expertise is required, was also considered by the Group particularly for chemical reaction kinetics experts.

8.2 Based on the experience gained during the first two meetings, the Group agreed to develop a set of generic profiles for potential members to assist in the development of a pool of experts, accepted by GESAMP, that coul d be called upon for future meetings.

8.3 Taking into account the timeline required for the production and circulation of IMO documents as provided in the Guidelines on or ganization and method of work of the Committee (MSC/Circ.1099, MEPC/Circ.405), the Group agreed that its next session should te ntatively be- 13 - GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc scheduled from 19 to 23 February 2007 to allow sufficient time for evaluation and approval by GESAMP and timely submission to MEPC 56.

8.4 Based on the experience of the first two m eetings and taking into account the time needed for proper preparation of the next meeting, the Group recommended that MEPC 55 invites administrations to submit their pr oposals for approval of Active Substances together with related application dossiers by 15 December 2006 as indicat ed in timetable contained in annex 8 As agreed by MEPC 54, non-confidential data relate d to the proposals for approval of Active
Substances should be submitted to MEPC 55 or at the earliest opportunity af ter that, but not later
than 15 December 2006.

8.5 Recognizing the possibility that more than three application dossiers may be submitted for its review and approval by MEPC 56, the Gr oup expressed its availability to have an additional meeting before February 2007 if all necessary conditions are met and the
non-confidential data related to th e respective proposals have been ci rculated in advance (i.e., at MEPC 55)

9 CONSIDERATION AND ADOPTION OF THE REPORT

9.1 A draft report of the 2 nd meeting of the GESAMP-BWWG was produced on Friday, 26 May 2006 and after a paragraph-by-paragraph re view the 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 1500hrs.

***GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc ANNEX 1

LIST OF MEMBERS ATTENDING THE 2ND SESSION

OF THE GESAMP BALLAST WATER WORKING GROUP

Mr. Finn Pedersen (Chairman) Special Adviser Danish Environmental Protection Agency
Chemicals Unit Strandgade 29 E-mail: fpe@mst.dk DK-1401 Copenhagen E-mail pedersen_finn@hotmail.com
Denmark Tel: +45 32 660289

Ms Teresa Borges
Senior Technical Officer
General Health Directorate
Rua de Arroios 97 1150-053 Lisboa E-mail: tborges@dgsaude.min-saude.pt Portugal Tel: +351 21 3179767

Mr. Egil Dragsund Principal Marine Biologist
Environmental and Te chnical Solutions Det Norske Veritas AS E-mail: egil.dragsund@dnv.com
Veritasveien1 Tel: +47 67 57 8894
NO- 1322 Høvik Fax: +47 67 57 9911 Norway Mobile: +47 97 02 6956

Mr. Shinichi Hanayama
Senior Research Fellow Maritime Technology Department Ocean Policy Research Foundation

1-15 Toranomon Minatoku-ku E-mail: s-hanayama@sof.or.jp Tokyo105-0001 Tel: +813 3502 1886 Japan Fax: +813 3502 2033

Mr. Jan Linders Expert in Environmental Risk assessment
of Pesticides and Biocides

RIVM-SEC P.O Box 1 E-mail: jan.linders@rivm.nl
NL- 3720 BA Bilthoven Tel: +31 30 274 3164
Netherlands Fax: +31 30 274 4401GESAMP-BWWG 2/9

ANNEX 1 Page 2

I:\MEPC\55\2-16.doc Mr. David Tongue Marine Manager International Chamber of Shipping E-mail: david.tongue@marisec.org
12 Carthusian Street Tel: +44 2074718844
London EC1M 6EZ Fax: +44 2074178877 United Kingdom Mobile: +44 (0)7855391258

IMO – GESAMP CONSULTANTS

Mr. John Crayford 2 Dunmow Hill E-mail: j.crayford@ntlworld.com
Fleet Tel: +44 1252 6722 49 Hampshire

GU51 3AN United Kingdom

IMO SECRETARIAT

Mr. Jean-Claude Sainlos
Director
Marine Environment Division International Maritime Organization 4 Albert Embankment E-mail: jsainlos@imo.org London SE1 7SR Tel: +44 (0)20 7587 3142 United Kingdom Fax: +44 (0)207 463 4040

Mr. Dandu Pughiuc IMO Technical Secretary to GESAMP-BWWG International Maritime Organization
Marine Environment Division 4 Albert Embankment E-mail: dpughiuc@imo.org London SE1 7SR Tel: +44 (0)20 7587 3247 United Kingdom Fax: +44 (0)20 7587 3261

Mr. René Coenen IMO Technical Secretary to GESAMP International Maritime Organization
Marine Environment Division 4 Albert Embankment E-mail: rcoenen@imo.org London SE1 7SR Tel: +44 (0)20 7587 3239 United Kingdom Fax: +44 (0)20 7587 3261

***GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc ANNEX 2

PROVISIONAL AGENDA FOR TH E SECOND SESSION OF THE

BALLAST WATER WORKIN G GROUP OF GESAMP

1 Introduction

2 Issues of confidentiality

3 Outcome of MEPC 54

4 Terms of reference and time frame

5 Development of the draft Methodology for info rmation gathering and the conduct of work

6 Review of proposals for a pproval of Active Substances

7 Consideration of queri es regarding the work of the GESAMP-BWWG.

8 Future work programme and tent ative date for the next meeting.

9 Consideration and adoption of the report.

***GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc ANNEX 3

GESAMP-BALLAST WA TER WORKING GROUP

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 54.

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

In particular, the Group should undertake:

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

.2 Scientific evaluation of the assessme nt report contained in the proposal for approval (see paragraph 4.3.1 of G9);

.3 Scientific evaluation of th e risks to the ship and pers onnel to include consideration of the storage, handling and applic ation of the Activ e Substance (see paragraph 6.3 of G9);

.4 Scientific evaluation of any furthe r 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 th e 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 application of the Active Substance remains valid.
The evaluation will be reported to MEPC (see paragraph 8.2 of G9).

∗ 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 2/9

ANNEX 3 Page 2

I:\MEPC\55\2-16.doc 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.

***GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc ANNEX 4

DEVELOPMENT OF A DRAFT M ETHODOLOGY FOR INFORMATION

GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG

1 INTRODUCTION ................................................................................................................. ..3
1.1 Terms and Definitions..................................................................................................3
1.2 Abbreviations used in the text......................................................................................4

2 GENERAL...................................................................................................................... .........5 2.1 Legal provision ............................................................................................................ 5 2.2 Principles of acceptability of BWMS that make use of Active Substances ................6 2.3 Submission of an application for Basic Approval .......................................................6 2.4 Confidentiality and data protection..............................................................................7
2.5 Test Methods............................................................................................................... .8 2.6 Alternatives to testing and non-submission of data .....................................................8
2.7 Procedures and timelines .............................................................................................8 3.0 DATA-SET REQUIRED IN THE APPLICATION............................................................9
3.1 Identification of the Substan ce or Preparation (G9: 4.1) .............................................9 3.1.1 Preparations............................................................................................................. .9
3.1.2 Active Substance....................................................................................................10 3.1.3 Relevant Chemicals (G9: 2.1.4):............................................................................10
3.1.4 Other Chemicals: ...................................................................................................10 3.2 Data on effects on aquatic plants, inverteb rates and fish, and other biota, including sensitive and representative organisms (G9: 4.2.1.1) ............................................................10 3.2.1 Acute aquatic toxicity ............................................................................................10 3.2.2 Chronic aquatic toxicity.........................................................................................11 3.2.3 Endocrine disruption..............................................................................................11 3.2.4 Sediment toxicity ...................................................................................................12 3.2.5 Bioavailability/biomagnification/bioconcentration ...............................................12 3.2.6 Food web/population effects..................................................................................12 3.3.0 Data on mammalian toxicity (G9: 4.2.1.2) ................................................................13 3.3.1 Acute toxicity.........................................................................................................13 3.3.2 Effects on skin and eye ..........................................................................................13 3.3.3 Repeated-dose toxicity...........................................................................................14 3.3.4 Chronic toxicity .....................................................................................................14 3.3.5 Developmental and reproductive toxicity..............................................................15 3.3.6 Carcinogenicity......................................................................................................15 3.3.7 Mutagenicity/genotoxicity .....................................................................................15
3.3.8 Toxicokinetics........................................................................................................16
3.4.0 Data on environmental fate and effect under aerobic and anaerobic conditions .......16 (G9: 4.2.1.3).................................................................................................................. .........16 3.4.1 Modes of degradati on (biotic; abiotic)...................................................................16 3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient ..........17 3.4.4 Reaction with organic matter.................................................................................18 3.4.5 Potential physical effects on wildlife and benthic habitats....................................18
3.4.6 Potential residues in seafood..................................................................................18 3.4.7 Any known interact ive effects ...............................................................................19 3.5 Physical and chemical properties for th e Active Substances and preparations and treated ballast water, if applicable (G9: 4.2.1.4 .....................................................................19 3.5.1 Melting point..........................................................................................................19GESAMP-BWWG 2/9

ANNEX 4 Page 2

I:\MEPC\55\2-16.doc 3.5.2 Boiling point ..........................................................................................................19 3.5.3 Flammability (flash point.......................................................................................19 3.5.7 Oxidation/reduction potential ................................................................................20 3.5.9 Autoignition temperature.......................................................................................20 3.5.10 Explosive properties...............................................................................................20 3.5.11 Oxidising properties...............................................................................................21
3.5.12 Surface tension.......................................................................................................21 3.5.13 Viscosity ............................................................................................................... .21 3.5.14 Thermal stability and identity of relevant breakdown products ............................21 3.5.15 Reactivity towards container material ...................................................................21 3.5.16 pH...................................................................................................................... .....21 3.5.17 Salinity ................................................................................................................ ...22 3.5.18 TOC, DOC, % particulate matter...........................................................................22 3.5.19 Other known relevant physical or chemical hazards .............................................22 3.6 Analytical methods at environmentally relevant concentra tions (G9: 4.2.1.5) .........22

4 USE OF THE ACTIVE SUBSTA NCE OR THE PREPARATION .....................................22 4.1 The manner of application .........................................................................................22

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7) ............................................................23

6 RISK CHARACTERIZATION.............................................................................................24 6.1 Screening for persistence, bioaccu mulation and toxicity (G9: 5.1)...........................24 6.1.1 Persistence (G9: 5.1.1.1)........................................................................................24 6.1.2 Bioaccumulation (G9: 5.1.1.2) ..............................................................................24 6.1.3 Toxicity tests (G9: 5.1.2.3) ....................................................................................24 6.2 Evaluation of the treated ballast water (G9: 5.2) .......................................................25 6.2.2 Final approval ........................................................................................................25 6.2.3 Determination of holding time...............................................................................25 6.3 Risk characterisation and analysis .............................................................................25 6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 2.4.4)..........................25 6.3.2 Characterisation of degradati on route and rate (G9: 5.3.5) .......................................25 6.3.3 Prediction of discharge and e nvironmental concentrations ...................................26 6.3.4 Assessment of potential for bioaccumulation........................................................26
6.3.5 Effects assessment .................................................................................................26 6.3.6 Effects on aquatic organisms .................................................................................27
6.3.7 Effects on sediment................................................................................................28 6.3.8 Comparison of effect assessment with discharge toxicity .....................................28

7 RISK ASSESSMENT............................................................................................................28 7.1 Risk to safety of ship..................................................................................................28
7.2 Risks to human health................................................................................................29 7.3 Risks to the aquatic environment...............................................................................29 8 ASSESSMENT REPORT (G9: 4.3)......................................................................................30

9 MODIFICATION TO THE APPLICATION........................................................................30

10 FINAL APPROVAL..........................................................................................................30

APPENDIX....................................................................................................................... .............31GESAMP-BWWG 2/9

ANNEX 4 Page 3

I:\MEPC\55\2-16.doc 1 INTRODUCTION

This document clarifies the responsibility of the Administration in providing data to the Organization, and the procedures used by the Orga nization for evaluating a pplications, and is, as such, in accordance with Resolution MEPC.126(53) on a Procedure for the approval of Ballast Water Management Systems that make use of Active Substances (G9).

1.1 Terms and Definitions

For the purpose of this paper, these definitions are intende d to supplement those in the
Ballast Water Convention to facilitate a consistent evalua tion of submissions:

.1 Ballast Water Convention means the International Convention for the Control and Management of Ships’ Ba llast Water and Sediments, 2004.

.2 Ballast Water Management means mechanical, physical, chemical and biological processes – either singularly or in combin ation - to remove, render harmless, or avoid the uptake or discha rge of Harmful Aquatic Organisms and Pathogens within Ballast Water and Sediments.

.3 Preparation means any commercial formulati on containing one or more Active Substances including any additives, solvents, auxiliary substances, etc.

.4 Active Substances means a substance or organism , including a virus or a fungus that has a general or specific action on or against Harmful Aquatic Organisms and Pathogens.

.5 Other components of a preparation means any othe r substances in a preparation than the Active Substance(s).

.6 Relevant Chemicals means transformation or reacti on products that are produced during and after employment of the Balla st Water Management System in the Ballast Water or in the receiving environm ent and that may be of concern to the ship’s safety, aquatic envi ronment or human health.

.7 Basic Approval means the approval of the use of Active Substances, according to their proposed manner of application, for prototype or type a pproval testing. The Basic Approval shall confirm that the av ailable information does not indicate possible unacceptable adverse effects or a pot ential for unreasonable risk of such a testing to environment, human health, pr operty or resources. In recommending a Basic Approval, potential ri sks during full-scale depl oyment on commercial ships shall be considered when possible.

.8 Final Approval means the approval of a Ballast Water Management System using an Active Substance or Preparati on to comply with the Convention and includes a review of the Type Approval tests in accordance with Guidelines for Approval of Ballast Water Management Systems. The Final Approval shall confirm that previous evaluations of ri sks to ship, crew and the environment including storage, handling and application of Active S ubstances or Preparations
remain valid and the concerns have been addressed, as well as that the residualGESAMP-BWWG 2/9

ANNEX 4 Page 4

I:\MEPC\55\2-16.doc toxicity of the discharge conforms to the evaluation undertaken for Basic Approval. The risk evaluation at Final Approval should take qualitatively into account cumulative effects that may occur due to the nature of shipping and port operations. It should consider the uncerta inties involved in the application for approval, and as appropriate, provide a dvice on how these uncertainties can be
dealt with.

.9 GESAMP Ballast Wa ter Working Group means the Technical Group that reports through GESAMP to MEPC. Wh en considering the comprehensive proposal, the Group shall take a ccount of any other relevant data as well as other relevant information submitted to it. Experts working for GESAMP-BWWG act independently in thei r individual capacity.

GESAMP is the IMO/FAO/UNESCO-IOC/WMO/WHO/IAEA/UN/UNEP Joint Group of Experts on the Scien tific Aspects of Marine Environmental Protection, an advisory and multi-disciplinary body consisting of specialised experts nominated by the sponsoring agencies. Experts working for GESAMP act independently in thei r individual capacity.

1.2 Abbreviations used in the text

ABBREVIATIONS
< less than < less than or equal to > greater than > greater than or equal to μg microgram

b.p. boiling point bw body weight BWMS Ballast Water Management System

oC degree Celsius (centigrade)
CAS chemical abstract service
cc cubic centimetre

d day(s)

EC50 effect concentration, 50% (m edian effective concentration)

g gram GHS Globally Harmonized System G9 Procedure for approval of Ballast Water Management Systems that make use of Active Substances (G9) Re solution MEPC.126(53) adopted 22 July

2005

h hour

IARC International Agency for Research on CancerGESAMP-BWWG 2/9

ANNEX 4 Page 5

I:\MEPC\55\2-16.doc ABBREVIATIONS IC50 inhibition concentration, 50%; ISO International Organisation for Standardisation IUPAC International Union of Pure and Applied Chemistry

kg kilogram Koc organic carbon-water partition coefficient

l litre LC50 lethal concentration, 50% LD50 lethal dose, 50%
LOAEL lowest observed adverse effect level
LDLO lowest lethal dose
LOEL lowest observed effect level Log P logarithm of the oc tanol/water partition coefficient

MEPC Marine Environment Protection Committee m.p. melting point mg milligram
ml millilitre

ng nanogram NOAEL no-observed-adverse-effect level
NOEL no-observed-effect level

OECD Organisation for Economic Co-operation and Development

Pow octanol-water partition coefficient

TLV threshold limit value US EPA United States Environmental Protection Agency

WHO World Health Organization

wt weight

2 GENERAL

2.1 Legal provision

Regulation D-3.2 of the Internat ional Convention for the Contro l and Management of Ships’ Ballast Water and Sediments, 2004, stipulates th at Ballast Water Management Systems (BWMS) that make use of Active Substances to comply with the Convention shall be approved by the Organization. During its fi fty-third session, the Marine Environment Protection Committee (MEPC) adopted the Procedure for a pproval of Ballast Water Management Systems
that make use of Active Substances (G9) through resolution MEPC.126(53).GESAMP-BWWG 2/9

ANNEX 4 Page 6

I:\MEPC\55\2-16.doc 2.2 Principles of acceptability of BWMS that make use of Active Substances

A Ballast Water Management System that make s use of Active Substances accomplishes its intended purpose through action on Harmful Aquatic Organisms and Pathogens in ships’ ballast water and sediments. However, if the ballast water is still toxic at the time of discharge into the environment, the organisms in the receiving water may suffer unacceptable harm. Both the Active Substance itself or Prepara tion, as well as the Treated Balla st Water, should be subjected to toxicity testing in order to determine if an Active Substance or Preparation can be used and under which conditions the potential for harming th e receiving environment or human health is acceptably low. Ballast Water Management systems that make use of Active Substances and Preparations must be safe in terms of the sh ip, its equipment and the personnel to comply with
the Convention.

2.3 Submission of an application for Basic Approval

2.3.1 The manufacturer of the Ballast Water Mana gement System should evaluate the Active Substance(s) or Preparation(s) and the potential discharge of treated Ballast Water in accordance with the approval criteria specified below (G9: 8.1.2.1). Upon comple tion, the manufacturer should prepare an Application Do ssier on the Ballast Water Mana gement System that makes use
of Active Substances and submit it to the Ma ritime Administration of a Member of the Organization concerned (G9: 8.1.2.2).

2.3.2 The Administration should evaluate the A pplication Dossier and confirm that it is satisfactory and complete before submitting it to IMO.

2.3.3 Applications for basic approval of Active S ubstances to be evaluated by the GESAMP Ballast Water Working Group should be addre ssed to: The Director, Marine Environment Division, International Mariti me Organization, 4 Albert Embankment, London SE1 7SR, United Kingdom.

2.3.4 Application requirements:

.1 a complete Application Dossier includi ng all documents iden tified in 2.3.4 (one paper version), including full study reports and full copies of literature. The complete Application Dossier should contai n a contents list indicating the location of the information in the application. The order in which the information is presented, including overall structure such as how information is presented for the Active Substance, preparation, ballast water, risk assessment, assessment report, should follow this format, including its numbering, which is based on G9;

.2 a non-confidential summary document (a s provided to MEPC) to provide an overview of the application (electronic version);

.3 a summary of the key da ta should be provided in a tabular format (electronic version);

.4 the assessment report (electronic version); and

.5 dossiers already used for re gistration of chemicals can be used to satisfy the data requirements of the G9 procedure (G9: 4.2.5).GESAMP-BWWG 2/9

ANNEX 4 Page 7

I:\MEPC\55\2-16.doc 2.4 Confidentiality and data protection

The confidential information of the submitted doc uments should clearly be identified. Once an approval procedure is completed and the Active Substance is approved, the following data should not be regarded as confidential:

.1 the name and address of the Administration;

.2 the names and addresses of the Administra tions of the Active Substance and/or the preparation (if different);

.3 the names and content of the Active Substa nce(s) in the preparations and the name of the preparation;

.4 the names of Other Components of Prepar ations, in particul ar those which are regarded as dangerous according to the UN GHS or relevant IMO regulations and
contribute to the hazard docum entation of the preparation;

.5 the Relevant Chemicals that may be fo rmed during or after application of the BWMS and that may be of concern for the receiving environment or human health;

.6 physical and chemical data concerning th e Active Substance, the preparation and its components and Relevant Chemicals;

.7 a summary of the results of the tests required pursuant to Section 4.2 of the
Procedure to establish the effects of the substance(s) or prep aration(s) on humans and the environment;

.8 a summary of the results of the tests required on the tr eated ballast water pursuant to Section 5.2 of the Procedure G9;

.9 recommended methods and precautions ag ainst dangers resulting from handling, storage, transport and fire;

.10 any means of rendering the Active S ubstance or preparation harmless;

.11 Safety Data Sheets;

.12 methods of chemical analysis;

.13 methods of disposal of the product and of its packaging;

.14 procedures to be followed and measures to be taken in the case of spillage or leakage;

.15 First Aid and medical advice to be gi ven in the case of injury to persons;

.16 all results of the PBT assessment and the risk characterisation pursuant to Sections 5.1 and 5.3 of Procedure G9; andGESAMP-BWWG 2/9

ANNEX 4 Page 8

I:\MEPC\55\2-16.doc .17 the uncertainty analysis specified in Chapter 6.4.3 of Procedure G9.

2.5 Test Methods

2.5.1 Tests should be carried out under internationa lly recognized guidelines (preferably OECD or equivalent) (G9: 4.2.3), and according to an internationally recognised quali ty assurance system (G9: 4.2.4) (e.g., GLP). Information ma y be derived from existing data where an acceptable justification is provided. Full copies of sources of data (e.g., literature papers) should be provided.

2.5.2 Care should be taken to provide full supporti ng references and copies of the appropriate test laboratory reports in support of each applic ation. If submissions are lacking relevant information it may not be possible for the Group to conduct a thorough risk assessment.

2.5.3 Many substances have acquired large databa ses for many of the hazards concerned and a weight of evidence approach has become necessary to ensure that the ra ting reflects the body of data rather than simply using the most cons ervative value. This , however, requires the
submission of all available end- point data for Active Substan ces and Relevant Chemicals.

2.5.4 The Administration should supply a list of te st substances (for example trade names) specified in study reports and literature data and an explanation of how the tested substances relates to the current application.

2.6 Alternatives to testing a nd non-submission of data

2.6.1 Alternative methods to te sting on live organisms, e.g., in vitro testing methods, QSAR, extrapolation by analogy to known chemicals, or grouping of similar subs tances, may be used whenever justified. Sufficient documentation or references to documentation, on the validity of the method should be provided, as well as documenta tion that the substance or preparation lies within the app licability domain of the method.

2.6.2 Information which is not necessary, owing to the nature of the substance or of its proposed uses and taking into acc ount all proposed risk management measures, need not be supplied. The same applies where it is not scien tifically necessary or technically possible to supply the information. In such cases, a justif ication should be submitted, which would help the Group’s evaluation of the Application Dossier.

2.7 Procedures and timelines

2.7.1 Procedures for the evaluation of the dossier are given in the Appendix to G9. If, in the course of the review by the Ballast Water Work ing Group, it becomes evident that additional data are found to be necessary in order to finalize th e evaluation, the Group may request that such data
are submitted.

2.7.2 The Administration will be in formed, in writing, of the deci sion of the Organization. The Administration may appeal agains t any decision made by the Or ganization. The Organization will consider the appeal and respond in writ ing to the Member of the Organization.

2.7.3 It may be useful for a technical representa tive of the applicant to be available to the
BWWG for an hour or so to answer questions regarding the system.GESAMP-BWWG 2/9

ANNEX 4 Page 9

I:\MEPC\55\2-16.doc 3.0 DATA-SET REQUIRED IN THE APPLICATION

3.0.1 The dossier should contain the information sp ecified in G9. In cases where information requested in accordance with Procedure G9 has not been submitted and no justification for non-submission is provided, the Group may not be able to judge the reasons for not submitting the information which may influence its eval uation and development of recommendations.

3.0.2 For Active Substances and/or preparati ons including any of its components as appropriate, data on properties should be includ ed. For Relevant Chemicals, data should be provided as well.

3.0.3 Fate and effect testing should be performed in the laboratory with Active Substances and preparations (G9: 5.3.1). However, the Group notes that normally assessment of fate (including degradation, bioaccumulation) is not feasible for preparations, but only for individual substances. Therefore degradation and fate testing of preparations may not be appropriate.

3.0.4 For treated ballast water, the Administ ration should provide bot h acute and chronic toxicity data (G9: 5.2.2). The discharge toxi city tests should include chronic test methods performed as part of the land based type approval process with test species (fish, invertebrate, algae) that address the sensit ive life stage (G9: 5.2.4). The results should include acute LC50 values and NOECs, and chronic NOECs or EC50s (G9: 5.2.5). Therefore 100% ballast water discharge should be tested (G9: 5.2.6), if appropriate.

3.0.5 Any reference to specific te st methods in the following is indicative with the purpose of providing guidance to an Administration on possible methods that may be considered. Any other internationally recognised test me thod may also be used as well.

3.1 Identification of the Substan ce or Preparation (G9: 4.1)

3.1.1 Preparations : For each Preparation, the application should include the following information: (G9: 4.2.2):

.1 the Trade name;

.2 compositional information of the Preparation including:

.1 the chemical (IUPAC) name of each component;

.2 the concentration of each component (liquids in g/l; solids in %w/w; gases in %v/v);

.3 the CAS number of each component ;

.4 the UN number and proper shipping name of each component (where relevant); and

.5 an indication of whether the compone nt is an Active Substance (AS) or a
stabilizer or inhibito r or solvent, etc.GESAMP-BWWG 2/9

ANNEX 4 Page 10

I:\MEPC\55\2-16.doc 3.1.2 Active Substance : For each Active Substance, the applicant should provide the following information:

.1 the Trade name (where relevant);

.2 the chemical (IUPAC) name;

.3 the CAS number;

.4 the UN number and proper sh ipping name (where relevant)

.5 the Molar mass;

.6 the empirical formula;

.7 the structural formula;

.8 the purity of the technical material and identification of impurities (chemical name and CAS-numbers, etc.); and

.9 the identity of any stabilisers or necessary additives.

3.1.3 Relevant Chemicals (G9: 2.1.4): Where the process might produce by-products when reacting with ballast water, the applicant shou ld provide the following information for those products deemed to be Relevant Chemicals:

.1 the Chemical (IUPAC) name;

.2 the CAS number;

.3 the Molar mass;

.4 the empirical formula; and

.5 the structural formula.

3.1.4 Other Chemicals : Where the process might produce by-products not deemed to be Relevant Chemicals by the applic ant, a justification for such a conclusion should be provided.

3.2 Data on effects on aquatic plants, invert ebrates and fish, and other biota, including sensitive and representative organisms (G9: 4.2.1.1)

3.2.0 For every Active Substance or preparation in cluding any of its components, data should be presented and discussed either on the basis of toxicological tests or existing toxicological knowledge for each end point listed.

3.2.1 Acute aquatic toxicity

3.2.1.1 Short-term L(E)Cx from fr eshwater or saltwater repres entatives of three taxonomic groups (algae, crustaceans and fi sh) representing three trophic le vels (e.g., OECD guidelines 201 (Algae, Growth Inhibition Test), 202 (Daphnia s p. Acute Immobilization Test), 203 (Fish, AcuteGESAMP-BWWG 2/9

ANNEX 4 Page 11

I:\MEPC\55\2-16.doc Toxicity Test), Mysid shrimp acute toxicity test (USEPA 850.1035)) should be accepted. To reduce further any remaining uncertainty, Admini strations should, preferably, also submit data for two additional marine taxonomic groups (e.g., echinoderms, molluscs).

3.2.1.2 In the case of whole effluent testing, EP A, or equivalent, short term methods for estimating the acute toxicity of substances and discharge provide acceptable alternatives

3.2.1.3 Such acute aquatic toxicity data are required for:

.1 Preparations including any of its components; .2 Active Substances; .3 Relevant Chemicals; and .4 Treated ballast water (G9: 5.2.3)

3.2.2 Chronic aquatic toxicity

3.2.2.1 Long-term NOECs or ECx from three freshw ater or saltwater species (normally algae and/or crustaceans and/or fish) representing three trophic levels (e.g., Fish: OECD 210, 215, or 212; Daphnia: OECD 211). To reduce furthe r any remaining uncerta inty, Administrations should preferably also submit two long-term NOE Cs from additional marine taxonomic groups (e.g., echinoderms, molluscs).

3.2.2.2 In case of whole effluent testing, EPA s hort term methods for estimating the chronic toxicity of substances and discharge provide a cceptable alternatives, sin ce the identification of the sensitive sub-lethal endpoints and vulnerable lif e-stages is the ultimate aim of the long-term testing.

3.2.2.3 Such chronic aquatic toxicity data are required for:

.1 Preparations including any of its components; .2 Active Substances; .3 Relevant Chemicals; and .4 Treated ballast water (fish, i nvertebrate, plant) (G9: 5.2.3).

3.2.3 Endocrine disruption

3.2.3.1 Regarding the risks connected to endocrine disrupti on, non-standardized in vivo as well as

in vitro tests may be conducted as long as no interna tionally standardized tests are available (e.g., full-life-cycle test on fish or amphibian me tamorphosis assay). When substantial evidence on such effects is available, this should be taken into account on a case-by-case basis and in the effect assessment for each compartment of releva nce. If there is no indication for endocrine disruption – e.g., due to the structure of the substa nce or results of other available studies – these tests may be waived.

3.2.3.2 Such information on endocrine disruption is required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals.GESAMP-BWWG 2/9

ANNEX 4 Page 12

I:\MEPC\55\2-16.doc 3.2.4 Sediment toxicity

3.2.4.1 Substances that are potentially capable of depositing on or adsorbing to sediments to a significant extent have to be as sessed for toxicity to sediment-d welling organisms. Testing is considered relevant only if log Kow > 3 or if there is similar adsorption behaviour and should include a maximum of three long-term tests with species representing different living and feeding conditions (e.g., Chironomus spec. (OECD 218), Lumbriculus variegates) including a minimum of two tests with marine species.

3.2.4.2 For substances that are persistent in mari ne waters or may accumulate in sediments, a specific marine sediment assessment is necessary.

3.2.4.3 Such information on sediment toxicity is required for:

.1 Preparations including any of its components; .2 Active Substances; .3 Relevant Chemicals; and
.4 Treated Ballast water.

3.2.5 Bioavailability/biomagnification/bioconcentration

3.2.5.1 If log Pow > 3, testing of the bioaccumulati on potential should be co nsidered taking into account the following points:

.1 One bioconcentration factor (BCF) determ ined in a bioconcentration study (at two dosing levels) with fish (e.g., OECD 305) or bivalves. The BCF should be based on uptake/elimination kinetics (k1/k2). Th e half-life for elimination should be reported. Fat content in marine fish typi cally ranges between 0.5 and 15% of the whole body weight. BCF should be normalized to 6% fat;

.2 The biomagnification and persistence in the food web should be discussed based on the results from aquatic toxicity testing, mammalia n toxicity evaluation and bioaccumulation and biodegradation data; and

.3 There are no data requirements on bio-ava ilability since it is considered that the bio-availability in the toxicity test sy stems is equivalent to the conditions under assessment. If the bioavailability of the Active Substance or Relevant Chemical in the discharge or the receiving environmen t is to be assessed, consequently the bio-availability in the toxicity testing is to be reconsidered.

3.2.5.2 Such information on bioavailability/biomagni fication/bioconcentrati on is required for:

.1 Active Substances; .2 Any components of a preparation; and
.3 Relevant Chemicals.

3.2.6 Food web/population effects

3.2.6.1 The biomagnification and persistence in th e food web should be discussed based on the results from aquatic toxicity testing, mammalia n toxicity evaluation and bioaccumulation and biodegradation data.GESAMP-BWWG 2/9

ANNEX 4 Page 13

I:\MEPC\55\2-16.doc 3.2.6.2 An assessment of secondary poisoning is re dundant if for the substance of concern absence of bioaccumulation potential can be dem onstrated (BCF <500 L/kg wet weight for the whole organism at 6% fat). If not, testing should include:

.1 one long-term NOECs based on reproducti on studies with a bird species; and

.2 two NOECs from long-term studies with two mammalian species (from Section 2.3 below).

3.2.6.3 Such information related to the food web/population effects is required for:

.1 Active substances; and
.2 Relevant Chemicals.

3.3.0 Data on mammalian toxicity (G9: 4.2.1.2)

3.3.0.1 Information which is not necessary need not be supplied. In such cases a justification should be submitted. In general, testing with vert ebrate animals should be avoided if other type
of information is available that allows an asse ssment of hazards and risks to humans. Such alternative information may be obtained by validated in vitro methods, Quantitative Structure Activity Relationships (QSAR), gr ouping or read-across with simila r substances. If available, human experience or epidemiological evid ence should be presented and discussed.

3.3.0.2 In general, information should be provided on the Active Substance and the Preparation including any of its co mponents, as appropriate. Information on Relevant Chemicals formed during or after application of the BWMS should be provided as well.

3.3.1 Acute toxicity

3.3.1.1 The acute toxicity should be known for at least two routes of exposure, one of which
should be the oral route. Active Substances or Pr eparations that are gases should be tested by
inhalation.

3.3.1.2 The submission of dermal and/or inhalation studies instead of or in addition to oral studies may be requested depending on the physic o-chemical properties of the substance, the proposed or potential applicati on of the substance/products.

3.3.1.3 Such information on acute toxicity is required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals

3.3.2 Effects on skin and eye

3.3.2.1 The tests shall provide information on the degr ee and nature of ski n, eye and associated mucous membrane irritation, especially with regard to the reversibility of responses. The tests shall provide sufficient information to assess the potential to cause skin sensitization reactions. Animal testing should, whenever possible, be mi nimized. Tests should be performed with the Active Substance(s) or Preparation(s).GESAMP-BWWG 2/9

ANNEX 4 Page 14

I:\MEPC\55\2-16.doc 3.3.2.2 Testing of Active Substances or Prepara tion should include a st udy on acute dermal irritation/corrosion and a study on acute eye irritation/corrosion. The recommended tests are OECD guidelines 404 (Acute Dermal Irritation/Corrosion) and 405 (Acute Eye Irritation/Corrosion). These tests need not be carried out on a strong acid or ba se (pH below 2 or above 11.5). Where the Active Substance or Prepar ation has shown to have potentially corrosive properties, or is a severe skin irritant, an eye ir ritation test shall not be carried out. Results from

in vitro test methods, which are close to valid ation by recognized or ganizations, may be
submitted.

3.3.2.3 The recommended test for Skin Sensitizat ion is OECD guideline 406. While the guinea-pig Maximization test is considered to be the preferred adjuvant t echnique in certain cases there may be good reasons for choosing the Buehler test or the Local Lymph Node Assay (LLNA). However, scientif ic justification shoul d be given when eith er of the two latter
mentioned is used. The test is not needed if the Active Substance or Preparation is already
classified in an internationa lly recognized system or othe rwise known as a sensitizer.

3.3.2.4 Such information related to the effect s on skin and eyes is required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals

3.3.3 Repeated-dose toxicity

3.3.3.1 A 90-day sub-chronic toxicity study in tw o species, one rodent and another mammalian species, using the oral route unless another one is more appropriate.

3.3.3.2 Such information on repeated dose toxicity is required for:

.1 Preparation including any of its components; .2 Active Substance; and
.3 Relevant Chemicals

3.3.4 Chronic toxicity

3.3.4.1 A chronic toxicity study of a minimum duration of 12 months in two species, one rodent and another mammalian species unless a full justification demonstrates that this test is not

necessary.

3.3.4.2 Any chronic study can be combined with a carcinogenicity study.

3.3.4.3 Such information on chronic toxicity is required for:

.1 Preparation including any of its components; .2 Active Substances; and
.3 Relevant Chemicals.GESAMP-BWWG 2/9

ANNEX 4 Page 15

I:\MEPC\55\2-16.doc 3.3.5 Developmental and reproductive toxicity

3.3.5.1 Testing should include:

.1 a two-generation reproduction and fertility study (OECD guideline 416 – Two-Generation Reproduction Toxicity Study); and

.2 a prenatal developmental toxicity (t eratogenicity) stu dy in two species (OECD guideline 414 – Prenatal Developmental Toxicity Study).

3.3.5.2 However, these key data requirements can be modified (either reduced or accelerated or extended) and influenced by factors such as st ructural relationships with a known reproductive toxicant, the results of other toxicity studies (incl. toxic okinetics), concerns for endocrine disruption and anticipated use and human exposure patterns.

Such information on developmental and re productive toxicity is required for:

.1 Preparation including any of its components; .2 Active Substances; and
.3 Relevant Chemicals.

3.3.6 Carcinogenicity

3.3.6.1 Carcinogenicity studies shoul d be performed with one rode nt and one other mammalian species. The carcinogenicity test ing of an Active Substance or preparation may not be needed where justification demonstrates that these tests are not necessar y. Carcinogenicity studies may be combined with the chronic toxicity studies.

3.3.6.2 Such information on carcinoge nicity is required for:

.1 Preparations including any of its components;
.2 Active Substances and
.3 Relevant Chemicals.

3.3.7 Mutagenicity/genotoxicity

3.3.7.1 Genotoxicity data should be ava ilable for Active Substances or preparations from at least three tests: a bacterial gene mutation test, an in vitro mammalian cell cytogenicity study and an

in vitro mammalian cell gene mutation assay. In case of positive or equivocal results, further

in vivo mutagenicity testing with bone marrow assa y for chromosomal damage or a micronucleus test is necessary. If th is test is negative it should be eval uated whether mutagenicity or evidence of DNA damage can be demonstrated in tissue other th an bone marrow.

3.3.7.2 Such information on mutagenicity and genotoxicity is required for:

.1 Preparations including a ny of its components; and .2 Active Substances; and
.3 Relevant Chemicals.GESAMP-BWWG 2/9

ANNEX 4 Page 16

I:\MEPC\55\2-16.doc 3.3.8 Toxicokinetics

3.3.8.1 Basic data on the toxicokinetics of Ac tive Substances and other components of a preparation as well as Relevant Chemicals should be included. Information on adsorption, distribution, metabolism and elim ination (e.g., OECD 417) should be presented, if available, to allow better understanding of toxic effects and a reduction of animal tes ting. The potential for dermal absorption should be evaluated preferably in vitro or by physico-chemical data to reduce the need for any specific dermal toxicity testing.

3.4.0 Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3)

3.4.0.1 The route of abiotic and biotic degradati on of the Active Substa nces, components of a preparation and Relevant Chemicals under aerobi c and anaerobic conditions should be assessed, resulting in the identification of relevant metabolite s in the relevant media (ballast water, marine and fresh waters) (G9: 5.3.4).

3.4.0.2 The partition coefficients solids-water partit ion coefficient (Kd) and/or organic carbon normalized distribution coefficient (Koc) of the Active Substances, components of a preparation and Relevant Chemicals should be determined (G9: 5.3.6).

3.4.0.3 The data submitted in accordance with this paragraph should clarify, in addition to the degradation of the substance, other relevant rout es of dispersion in and from water, such as volatilization, adsorption, sedimentation and tr ansformation into bound residues. Accordingly the exposure of organisms living in water a nd the sediment should be established.

3.4.1 Modes of degradation (biotic; abiotic)

3.4.1.1 Testing should include:

.1 a study on hydrolysis at pH 5, 7, a nd 9 under aerobic conditions according to OECD guideline 111;

.2 a study on ready biodegradability according to OECD guideline 301 (Ready Biodegradability) or equivalent guidelines if the Active Substance is discharged only into fresh water;

.3 a study on ready biodegradability according to OECD guideline 306 (Biodegradability in Seawater) or equivale nt guidelines if the Active Substance is discharged only into marine water; and

.4 studies on ready biodegradability accor ding to OECD guideline 301 (or equivalent guidelines) and OECD guideline 306 (or e quivalent guidelines) if the Active Substance is discharged into estuarine wa ter (e.g., inland harbour with contact to seawater).

3.4.1.2 If the Active Substance is not readily biodegr adable, then the following higher tier studies
should be conducted:

.1 a study on aerobic and anaerobic transfor mation in aquatic sediment systems according to OECD guideline 308 (Aerobic and Anaerobic Transformation inGESAMP-BWWG 2/9

ANNEX 4 Page 17

I:\MEPC\55\2-16.doc Aquatic Sediment Systems) or equivalent guidelines if Koc >500 L/kg, using fresh or marine water depending on kind of aquatic ecosystem where discharge is intended. At least one system with high organic matter/nutrient content and one with low organic matter/nutrient content should be tested (see above);

.2 a study on aerobic transformation of low concentrations of organic contaminants according to OECD guideline 309 (Aerobi c Mineralization in Surface Water – Simulation Biodegradation Test) or equiva lent guidelines, using fresh or marine water depending on the kind of aquatic ec osystem where discha rge is intended;
and

.3 where relevant, a study on photo-tran sformation in water e.g., US EPA OPPTS 835.2210 (1998) and/or OECD Guidance do cument on phototransformation in water (1997)

3.4.1.3 Such information on the modes of degradation are required for:

.1 Active Substances; .2 any other components of preparations; and
.3 Relevant Chemicals

3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

3.4.2.1 Testing should include:

.1 data on bioconcentration and biomagnifi cation, which have alr eady been detailed earlier in this document;

.2 a study into the log Pow according to OECD guideline 107 (Partition Coefficient (n-octanol/water): Shake Flask Me thod), OECD guideline 117 (Partition coefficient - n-octanol/water HPLC method) or equivalent test guidelines. For very hydrophobic compounds a slow sti rring method (OECD 123 (Partition
coefficient - slow stirri ng method) is required:

.3 the partition coefficient between so lids and liquids should be determined e.g., according to EU Technical Guidance Document on Risk Assessment (2003) for at least three inocula, including fr eshwater sediment, ma rine sediment, and particulate matter (sludge)(OECD 106). If no measured data are available for a specific adsorbing material, it is assumed th at all adsorption can be related to the organic matter of the medium, viz. standard ization to Koc. This is only valid for
non-ionic substances. For ionic substa nces the Kp values and the test characteristics (%clay, CEC, %o.c., pH) should be reported.

3.4.2.2 Such information on bioaccumulation and partition coefficients is required for:

.1 Active Substances .2 any other components of preparations; and
.3 Relevant Chemicals.

Persistence and identification of the main metabolite s in the relevant media (ballast water, marine and fresh waters).GESAMP-BWWG 2/9

ANNEX 4 Page 18

I:\MEPC\55\2-16.doc 3.4.3.1 The route of degradation in the higher tier simulation tests specified under section 3.4.1 of this document should be characterized, based on a mass balance including mineralization and
formation of bound residues. Reaction or tr ansformation products formed that may be
considered as Relevant Chemicals should be identified.

3.4.3.2 Such information on persistence and metabolites is required for:

.1 Active Substances; .2 any components of preparations; and
.3 Relevant Chemicals.

3.4.4 Reaction with organic matter

3.4.4.1 The reaction of radicals produced by the action of Active Substances 1 with organic matter shall be addressed qualitatively as to identify pr oducts of concern to the environment and, where possible, quantitatively as to identify environmental concentrations.

3.4.4.2 Radical producing chemicals are capable of forming halogena ted (chlorinated, brominated) hydrocarbons which may be of concer n to environmental or human health, in the presence of organic matter. For these substan ces, the freely and otherwise reasonably available information should be presented and discussed in relation to the proposed manner of application, since they are subject to the decision making criteria.

3.4.4.3 Such information on the reaction wi th organic matter is required for:

.1 Active Substances; and
.2 Relevant Chemicals.

3.4.5 Potential physical effects on wildlife and benthic habitats

3.4.5.1 Data requirements consist of physical-chemical properties also requir ed later. Further guidance can be found in the MEPC approve d hazard evaluation procedure published as GESAMP Reports and Studies No. 64.

3.4.5.2 Such data on the potential physical effects on wildlife and benthic habitats are required
for:

.1 Preparations includi ng any of its components .2 Active Substance; .3 Relevant Chemicals; and
.3 Treated Ballast water

3.4.6 Potential residues in seafood

3.4.6.1 As appropriate, data shall be submitted to assess the risk that residues of the Active Substance end up in seafood, the possible impact on consumer safety and the level of residues that may be tolerated in seafood. Any available monitoring data on residues of the substance in
seafood shall be submitted.

1 MEPC 55/2/6 para 33GESAMP-BWWG 2/9

ANNEX 4 Page 19

I:\MEPC\55\2-16.doc 3.4.6.2 Such data on potential resi dues in seafood are required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals.

3.4.7 Any known interactive effects

3.4.7.1 Any knowledge (or absence of this knowledge ) on interactive effects of the Relevant Chemicals with the ballast water, with other prepar ations to be used in ballast water, with other physical or chemical management of the ballast water, or with the receiving environment, should be reported.

3.4.7.2 Such information on known intera ctive effects is required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals.

3.5 Physical and chemical properties for th e Active Substances and preparations and treated ballast water, if applicable (G9: 4.2.1.4)

Data should be submitted for the Active Subs tances, preparations including any of its components, the treated ballast water on board and the Relevant Chemicals to allow for the
identification of hazards to the cr ew, the ship and the environment.

3.5.1 Melting point

Data on the melting point are required for:

.1 Preparations including a ny of its components; and
.2 Active substances.

3.5.2 Boiling point

Data on the boiling poin t are required for:

.1 Preparations including a ny of its components; and
.2 Active Substances.

3.5.3 Flammability (flash point)

Data on the flash point are required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals

3.5.4 Density (relative density)GESAMP-BWWG 2/9

ANNEX 4 Page 20

I:\MEPC\55\2-16.doc Data on the density are required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Treated Ballast water.

3.5.5 Vapour pressure, vapour density

Data on the vapour pressure and va pour density are required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals.

3.5.6 Water solubility/dissociation constant

Data on the water solubility and dissociation constants are required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals.

3.5.7 Oxidation/reduction potential

Data on the oxidation/reduction potentials are required for:

.1 Preparations including any of its components; .2 Active Substances; .3 Relevant Chemicals; and
.4 Treated Ballast water.

3.5.8 Corrosivity to the materials or equi pment of normal ship construction

Data on the corrosivity to materials of construction are required for:

.1 Preparations including any of its components; .2 Active Substances; .3 Relevant Chemicals; and
.4 Treated Ballast water.

3.5.9 Autoignition temperature

Data on the autoignition temperature are required for:

.1 Preparations including any of its components; .2 Active Substances; and
.3 Relevant Chemicals.

3.5.10 Explosive properties

Data on the explosive properties are required for:GESAMP-BWWG 2/9

ANNEX 4 Page 21

I:\MEPC\55\2-16.doc .1 Preparations; 2
.2 Active Substance; and
.3 Relevant Chemicals.

3.5.11 Oxidizing properties

Data on the oxidizing prope rties are required for:

.1 Preparations; .2 Active Substances; and
.3 Relevant Chemicals.

3.5.12 Surface tension

Data on the surface tension are required for:

.1 Preparations; and
.2 Active Substance.

3.5.13 Viscosity

Data on the viscosity are required for:

.1 Preparations; and
.2 Active Substances.

3.5.14 Thermal stability and identity of relevant breakdown products

Data on the melting point are required for:

.1 Preparations including a ny of its components; and
.2 Active Substances.

3.5.15 Reactivity towards container material

Data on the reactivity towards cont ainer materials are required for:

.1 Preparations including any of its components; .2 Active substances; .3 Relevant Chemicals; and
.4 Treated ballast water.

3.5.16 pH

Data on the pH are required for:

.1 Preparations; and
.2 Treated Ballast water.

2 MEPC 55/2/6, para 34.GESAMP-BWWG 2/9

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I:\MEPC\55\2-16.doc 3.5.17 Salinity

Data on the salinity are required for:

.1 Treated Ballast water.

3.5.18 TOC, DOC, % particulate matter

Data on the TOC, DOC and % of par ticulate matter are required for:

.1 Treated Ballast water.

3.5.19 Other known relevant physi cal or chemical hazards

Data on the any other known relevant physical or chemical hazards are required for:

.1 Preparations including any of its components; .2 Active Substances; .3 Relevant Chemicals; and
.4 Treated Ballast water

3.6 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5)

Recognizing that some methods may only cover a range of ch emicals e.g., TRO, analytical methods at environmentally relevant concentrations are required for

.1 Preparations including any of its components; .2 Active Substance;
.3 Relevant Chemicals.

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION

4.1 The manner of application

4.1.1 The proposal should include the manner of application of the Active Substance or the preparation for the Ballast Water Management (BWM), including required dosage and retention time (G9: 4.2.6).

4.1.2 In relation to point 7 of the Procedure, the dossier should contain the necessary data addressing the following items:

.1 the technical manual or instructions by the Administration, including the product specification, process description, operati onal instructions, details of the major components and materials used, technica l installation specifications, system limitations, and routine maintenance should be provided (BWWG), including quantity to be added to ballast water and maximum concentration of the Active Substance therein;GESAMP-BWWG 2/9

ANNEX 4 Page 23

I:\MEPC\55\2-16.doc .2 recommended methods and precautions concerning handling, use, storage, and
transport;

.3 procedures to be followed in case of fire, and the nature of reaction products, combustion gases, etc.;

.4 Emergency measures in case of an accident;

.5 an indication of the possi bility of destruction or d econtamination following release in the marine environment;

.6 procedures of waste manage ment of the Active Substance;

.7 the possibility of reuse or recycling;

.8 the possibility of neutralization;

.9 conditions for controlled discharge; and

.10 the amount of substance onboard ship

4.1.3 Appropriate risk management measures (e .g., for neutralization of the Active Substance in case of emergency or if PEC/PNEC at discha rge >1) should be described. These management measures are an integral part of the Ballast Water Management System and should be evaluated
in the assessment.

4.1.4 The risk management measures proposed should be evaluated in respect to the hazards to ship, personnel and the environment.

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7)

5.1 With respect to the classification of hazar ds, a detailed technical guidance document has been prepared for the United Nations Globall y Harmonized System of Classification and Labelling of Chemicals (GHS) to aid in interpreting data for classifying substances as dangerous. Reference is also made to the MEPC appr oved hazard evaluation procedure published as GESAMP Reports and Studies No. 64 under the title The Revised GESAMP Hazard Evaluation Procedure for Chemical Substances Carried by Ships, which reflects the GHS for marine environmental protection aspects. The Administ ration is referred to this document for a more detailed guidance on hazard identification.

5.2 The Classification under GHS and the (Materia l) Safety Data Sheet ((M)SDS) should be given for all components of a Preparation (G9: 6.3.2). Where a component is not classified as hazardous under GHS, this should also be clearly stated.

5.3 The same information should also be given for Relevant Chemical s and other by-products produced by the system unless a cl ear justification is provided e.g., the half-life of the by-product
is so short that the hazards cannot be determine d. Key data for these should be summarized in the Key Data Summary Table.GESAMP-BWWG 2/9

ANNEX 4 Page 24

I:\MEPC\55\2-16.doc 6 RISK CHARACTERIZATION

6.1 Screening for persistence, bioaccumu lation and toxicity (G9: 5.1)

6.1.1 Persistence (G9: 5.1.1.1)

6.1.1.1 Persistence is preferably a ssessed in simulation test systems to determine the half-life under relevant conditions. Biodegradation screen ing tests may be used to show that the substances are readily biodegradable. The determination of the half-life should include
assessment of Relevant Chemicals.

6.1.1.2 For persistence and degradation data requi rements, see 3.4.1 and 3.4.3 of this document.

6.1.2 Bioaccumulation (G9: 5.1.1.2)

6.1.2.1 The assessment of the bioaccumulation poten tial should use measured bioconcentration factors in marine (or freshwater organisms). Where test results are not available, the assessment of the bioaccumulation potential of an orga nic substance may be based on the log Pow.

For bioaccumulation data requirements, see 3.2.5 and 3.4.2 of this document.

6.1.3 Toxicity tests (G9: 5.1.2.3)

6.1.3.1 Acute and/or chronic ecotoxicity data, ideally covering the sensitive li fe stages, should be used for the assessment of the toxicity criterion.

6.1.3.2 For ecotoxicity data requiremen ts, see 3.2 of this document.

6.1.3.3 It is necessary to consider, whether an e ffect assessment based on tests in freshwater species offers sufficient certainty that sensitiv e marine species will be covered by any risk

assessment.

6.1.4 Does the Active Substance and/or prep aration meet all three criteria for PBT?

See G9: Table 1

Criterion PBT criteria

Persistence Half-life: > 60 days in marine water, or > 40 days in freshwater,* or > 180 days in marine sediment, or > 120 days in freshwater sedimenta Bioaccumulation Experimentally determined BCF > 2,000, or if no experimentally BCF has been determined, Log Pow ≥ 3 Toxicity Chronic NOEC < 0.01 mg/l

*) For the purpose of marine environmental risk assessment half-life data in freshwater and
freshwater sediment can be overruled by data obtained under marine conditions.

Active Substances or Preparations identified as PBT substances will not be recommended for approval in accordance with pa ragraph 6.4.1 of the Procedure.GESAMP-BWWG 2/9

ANNEX 4 Page 25

I:\MEPC\55\2-16.doc 6.2 Evaluation of the treated ballast water (G9: 5.2)

The advantage of toxicity testing on the ballast wate r discharge is that it integrates and addresses the potential aquatic toxicity of the Active Substance, preparation including any of its components and Relevant Chemicals formed during and after applic ation of the BWMS.

6.2.1 Basic approval

6.2.1.1 Testing should be performed in laboratory of a sample prepared by simulation of the BWMS (G9: 5.2.1)

6.2.1.2 A system using Active Substances or Prepar ations that have received Basic Approval by the Organization may be used for evaluation of Ballast Water Management systems using Active Substances or Preparations for Final Approval (G9: 8.2.1).

6.2.2 Final approval

6.2.2.1 Laboratory toxicity tests with samples of ballast water treated with the BWMS during on-board testing should be conducted (G9: 5.2.2).

6.2.2.2 In accordance with Regulation D-3.2, a Ballast Water Management system using an Active Substance or Preparation to comply with the Convention (which received basic approval) must be approved by the Organization.

6.2.3 Determination of holding time

6.2.3.1 The test data should be used to determin e the no adverse-effect concentration upon discharge, i.e., the necessary dilution of the treated ballast water. The half-life, decay and dosage rates, system parameters and toxicity should be used to determine the amount of time needed to hold the treated ballast water before discharge ( 5.2.7). An indication of the uncertainty of the holding time should be given, taking into account variables (e.g., temperature, pH, salinity and sediment loading).

6.3 Risk characterization and analysis

6.3.1 Reaction with organic matter (s ee G9: 4.2.1.3; this report 2.4.4)

6.3.1.1 The reaction with organic matter of Active S ubstances and preparations including any of its components should be addresse d qualitatively and quantitatively , so as to identify Relevant Chemicals that may be of concern to the environment.

6.3.2 Characterization of degradatio n route and rate (G9: 5.3.5)

6.3.2.1 The route and rate of abiotic and biotic degradation of the Active Substances and Preparations, including any of its components, under aerobic and anaerobic conditions (see 2.4.1 above) should be assessed, resulting in the characterization of the Active Substances, Preparations including any of its components and Relevant Chemicals in terms of degradation rates under specified conditions (e.g., pH, redox, temperature).GESAMP-BWWG 2/9

ANNEX 4 Page 26

I:\MEPC\55\2-16.doc 6.3.3 Prediction of discharge and environmental concentrations

6.3.3.1 Based on the information on fate and behavi our of Active Substances, Preparations including any of its components and Relevant Chemicals, the discharge concentrations at
selected time intervals shoul d be predicted (G9: 5.3.8).

6.3.3.2 Environmental concentrations after discharge of treated ballast water under controlled conditions during development and type approval tests should be estimated (e.g., by a suitable model simulating the test conditions) and provided in the application dossier for Basic Approval.
Concentrations of treated ball ast water, Active Substances, Relevant Chemicals and other components of Preparations, as a ppropriate, should be estimated.

6.3.3.3 Environmental concentrations, under suit able emission scenarios to be developed describing typical full-scale use and discharge s ituations, should also be estimated for treated ballast water, Active Substances, Relevant Chemi cals and other components of Preparations, as appropriate.

6.3.4 Assessment of potential for bioaccumulation

6.3.4.1 For Active Substances, Preparations incl uding any of its com ponents and Relevant Chemicals, the potential for bioaccumulation s hould be assessed in ma rine or freshwater organisms (fish or bivalves) if the logarithm octanol/water partition coefficient (log Pow) is >3 (G9: 5.3.7).

6.3.5 Effects assessment

6.3.5.1 The effect assessment of the Active Subs tances, Preparations including any of its components and Relevant Chemicals is initially based on a dataset of acute and/or chronic ecotoxicity data for aquatic organisms, being primary produ cers (algae or sea grasses), consumers (crustaceans), pred ators (fish)., (G9: 5.3.9).

6.3.5.2 An effect assessment could also be prepar ed on secondary poisoning to mammalian and avian top-predators where relevant . Only toxicity studies reporti ng on dietary and oral exposure are relevant, as the pathway for secondary poi soning refers exclusively to the uptake of chemicals through the food chain. It might be n ecessary to extrapolate threshold levels for marine species from terrestrial species assumi ng there are interspecies correlations between laboratory bird species and ma rine predatory bird species and between laboratory mammals (e.g., rats) and the considerably larger marine predatory mammals . An assessment of secondary poisoning is redundant if the substance of con cern demonstrates a lack of bioaccumulation potential (e.g., BCF < 500 L/kg wet weight for the whole organism at 6% fat) (G9: 5.3.10).

6.3.5.3 An assessment of effects to sediment species should be conducted unl ess the potential of the substance of concern to partition into th e sediment is low (e.g., Koc < 500 L/kg) (G9: 5.3.11).

6.3.5.4 The effect assessment of the Active Substances, Preparations and Relevant Chemicals, taking the indicated information into account, should be based on internationally recognized guidance (e.g., OECD) (G9: 5.3.13).GESAMP-BWWG 2/9

ANNEX 4 Page 27

I:\MEPC\55\2-16.doc 6.3.6 Effects on aquatic organisms

6.3.6.1 For assessment of effects to the aquatic environment, appropriate Predicted No-EffectConcentrations (PNEC) should be derived. A PNEC is typically derived at a level that, when not exceeded, protects the aquatic ecosystem against t oxic effects of long-term exposures. However, for situations where only short-term exposures are expected, an additional PNEC for short-term exposure may be useful. PNEC values are norma lly derived from short-term and/or long-term aquatic toxicity results for rele vant aquatic species by dividi ng the lowest available effect concentration with an appropriate assessment f actor. For the aquatic effect assessment, the assessment factors, given in Table 2, should be guiding although these may be altered on a caseby-case basis based on expert judge ment. In cases where a comprehe nsive data set is available, the PNEC may be derived with a mathematical model of the sensitivity distribution among species.

6.3.6.2 PNEC values should be derived for any subs tances that may be found in treated ballast
water in concentrations that ma y be of concern for the aquatic environment. The relevance of deriving PNEC values for Active Substances, any other components of preparations and/or
Relevant Chemicals should thus be considered.

6.3.6.3 When aquatic toxicity data are available onl y for freshwater species but a PNEC for the marine environment (PNECsaltwater) is neede d, this may be derived by applying a higher
assessment factor than for the derivation of a PNEC freshwater to reflect the greater uncertainty in protecting sensitive species in saltwater environm ents. Where data are available for additional taxonomic groups, for example rotifers, echinode rms or molluscs, the uncertainties in the extrapolation are reduced and the magnitude of the assessment factor applied to a dataset can be
lowered.

6.3.6.4 For naturally occurring Active Substances not meeting PBT-Criteria and being rapidly degradable, the PNEC could be set along the background concentration in the environmental compartment under consideration.

Table 2 Effect assessment for deriving PNECs for freshwater and saltwater

Assessment Factor Data set PNEClong PNECshort

Freshwater assessment Lowest short-term L(E)C50 from fresh water species representing three trophic levels 1000 10-100

Lowest chronic NOEC from three freshwater or saltwater species represen ting three trophic levels 10

Saltwater assessment Lowest short-term L(E)C50 from marine species representing three trophic levels 1000 10-100

Lowest chronic NOEC from three freshwater or saltwater species represen ting three trophic levels 100

Lowest chronic NOEC from three saltwater species representing three trophic level 100

Lowest chronic NOEC from three freshwater or saltwater species representing three trophic levels +
at least two chronic NOEC s from additional marine taxonomic groups 10GESAMP-BWWG 2/9

ANNEX 4 Page 28

I:\MEPC\55\2-16.doc 6.3.7 Effects on sediment

6.3.7.1 Because sediment constitutes an important compartment of ecosystems, it may be important to perform an effects assessment for the sediment compartment for those substances that are likely to transfer substantially into the sediment. Most of the existing whole sediment tests measure acute toxicity and only a few measur e long-term, sub-lethal endpoints. Only the latter tests are considered applicable to risk assessment because of the long-term exposure of benthic organisms to sediment-bound substances that occur under field c onditions. Due to the generally long-term exposure of benthic organi sms to sediment-bound substances, long-term tests with sub-lethal endpoints like reproduction, growth, emerge nce, sediment avoidance and burrowing activity are regarded as most relevant. It is recommended to use pooled marine and freshwater sediment toxicity data for effect asse ssment for the sediment compartment. However, when sufficient data for ecologically relevant sa ltwater species are available, lower assessment factors can be applied. Since there are no chronic marine se diment test methods that are internationally accepted the results from any te sts should always be evaluated with caution.

Table 3 Effect assessment for deriving PNECs for sediment

Data set Assessment factor

Freshwater assessment Three chronic sediment tests with species representing different living and feeding conditions 10

Saltwater assessment Three chronic sediment tests with species representing different living and feeding conditions 50

Lowest chronic NOEC from three freshwater or saltwater species representing different living and feeding conditions including at least two chronic NOECs from marine species 10

6.3.8 Comparison of effect assessm ent with discharge toxicity

The results of the effect assessment of the substan ces that are likely to be present in the treated ballast water at discharge are comp ared to the results of the toxic ity testing of the treated ballast water. Any unpredicted results (e.g., lack of toxicity or unexpected toxicity in the treated ballast water at discharge) should give rise to a furt her elaboration on the effect assessment (G9: 5.3.14).

7 RISK ASSESSMENT

7.1 Risk to safety of ship

7.1.1 The potential risk to the safety of the ship and crew raised by the operation of the BWMS should be assessed, taking into account the identified risk mitigation measures to be applied and any relevant legislative requirements such as pr ovided in SOLAS and MARPOL. Potential risk to the ship/crew may include, inter alia :

.1 increased corrosion;

.2 fire and explosion;GESAMP-BWWG 2/9

ANNEX 4 Page 29

I:\MEPC\55\2-16.doc .3 storage and handling of the substances;

.4 contact with, or inhala tion of, process products; and

.5 noise.

7.2 Risks to human health

7.2.1 The human health risk assessment should follow generally accepted guidelines including acute and long-term exposure situations. The ri sk assessment should entail hazard identification and, as appropriate, dose (concentration) – re sponse (effect) assessment, exposure assessment and risk characterization. The population groups d eemed to be at risk a nd so to be examined should include crew, passengers and all personnel, including the public, in por ts. Potential health risks connected to the exposure of consumers vi a seafood or persons at the coast (e.g., beach) after discharge should be evaluated. Special attention shou ld be given to servic e and repair of the system by technicians and accidental situatio ns on board (e.g., specific personal protection equipment). The evaluation of the risks to hu man health should include risk reduction (risk management) by regulations based on the SOLAS Convention as well as specific measures proposed by the Administration of th e Ballast Water Management System.

Health effects in humans

7.2.2 The effect assessment of the Active Substances, Preparations and Relevant Chemicals should include a screening on carcinogenic, mutage nic and endocrine disruptive properties. If the screening results give rise to concerns, this should give rise to a further effect assessment (G9: 5.3.12).

7.3 Risks to the aquatic environment

7.3.1 The potential risks to the aquatic environm ent during experimental development and type approval testing should be assessed.

7.3.2 When no aquatic toxicity of the treated ballast water at di scharge is found either through direct testing of the treated ballast water or if the estimates ratios between predicted
concentrations of the Active Subs tance, components of preparations or Relevant Chemicals, as appropriate, and the respective PN EC values are below 1, no furthe r assessment of direct toxic effects to the aquatic environment is necessary.

7.3.3 In other cases, the dilution necessary to en sure that the PNEC values are not exceeded should be calculated by an appropriate model for re levant controlled use and discharge scenarios.

7.3.4 The potential risks to the aquatic environm ent resulting from full-scale deployment onboard ships and discharge of treated ballast water under representative conditions should be assessed. The specific assessment might await fu rther development of an appropriate Emission Scenario Document for discharge of treated ballast water.GESAMP-BWWG 2/9

ANNEX 4 Page 30

I:\MEPC\55\2-16.doc 8 ASSESSMENT REPORT (G9: 4.3)

The Assessment report referred to in point 4.3 of the Procedure shal l at least provide:

.1 an overview of the data and endpoint s on which the risk characterization according to section 6 of the Procedure is based including a description of the quality of test reports;

.2 an assessment of risks to the safety of ships, crew (human health), the environment and resources (e.g., fisheries) during development and type approval testing as well as during full-scale deployment onboard ships in accordance with section 6 of the Procedure;

.3 if any monitoring has been conducted, a summary of the results of that monitoring, including information on the analytical methodology used, ship movements and a general descri ption of the area monitored;

.4 a summary of the available data on e nvironmental exposure and any estimates of environmental concentrations developed th rough the applicati on of mathematical models, using all available environmental fate parameters, preferably those which were determined experimentally, along with an identification or description of the modelling methodology;

.5 an evaluation of the association between the Ballast Water Management System making use of Active Substances or prepar ations containing one or more Active Substances to comply with the Convention in question, the related adverse effects and the environmental concentrations, eith er observed or expected based on the risk assessment and the effluent testing;

.6 a qualitative statement of the level of uncertainty in the evaluation referred to under the preceding paragraph; and

.7 a detailed description of risk manageme nt possibilities, e.g., for neutralization of the Active Substance in case of emergenc y or if PEC/PNEC at discharge >1. These management measures are an integral part of the Ballast Water Management System.

9 MODIFICATION TO THE APPLICATION

9.1 Administrations should report any modificatio ns in names, including trade and technical name, composition or use of the Active Substances and Preparations in the Ballast Water Management systems approved by the Organization, to the Member of the Organization. The Member of the Organization should inform the Organization accordingly (G9: 8.4.1).

9.2 Administrations intending to significan tly change any part of a Ballast Water Management System that has b een approved by the Organization or the Active Substances and Preparations used in it should s ubmit a new application (G9: 8.4.2).

10 FINAL APPROVAL

Further guidance on methodology and testing and sampling for final approval to be added.GESAMP-BWWG 2/9

ANNEX 4 Page 31

I:\MEPC\55\2-16.doc APPENDIX

Key Data Summary Form for the ‘Procedure for approval of BWM systems that Make Use of Active Substances (G9)’

The proposal for approval should include informati on on the data set either for the preparation, or for each component separately (G9: 4.2.2), or fo r the ballast water itse lf in the case of in situ generated systems.

Section 1: Identification (G9 4.1)

Trade name of preparation: Composition of preparation, including id entification of active ingredient(s):

Ingredient (IUPAC name) Identification Numbers (e.g., CAS number) Percentage (indicating units, e.g., w/w, g/l)
Active Substance 1. Other component 2. Other component 3. Other component, etc.

Identification of any Relevant Chem icals (IUPAC name, CAS number):

Section 2: Effects on a quatic organisms (G9: 4.2.1.1)

Acute aquatic toxicity

Test substance Species (e.g., fish, Daphnia, algae) Effect (L(E)C50, duration ; NOEC) Value (units);

range Reference/

comments

Preparation

Active Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Ballast water

Other

Data waivers for acute aquatic toxicity

Species Test substance Test Reason for not supplying

the dataGESAMP-BWWG 2/9

ANNEX 4 Page 32

I:\MEPC\55\2-16.doc Chronic aquatic toxicity

Test substance Species (e.g., fish, Daphnia, algae) Effect (NOEC; duration) Value (units);

range Reference/

comments

Preparation

Active Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Ballast water

Other

Data waivers for chronic aquatic toxicity

Species Test substance Test Reason for not supplying

the data

Information on endocrine disruption

Substance Information on endocrine disruption Preparation

Active Substance Other components (1, 2, 3)

Relevant Chemicals

Other

Sediment toxicity

Test substance Species Effect L(E)C50; duration;

NOEC Value (units);

range Reference/

comments

Preparation

Active
Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Ballast water

OtherGESAMP-BWWG 2/9

ANNEX 4 Page 33

I:\MEPC\55\2-16.doc Data waivers for sediment toxicity

Test substance Species Test Reason for not supplying

the data

Bioavailability/biomagnification/bioconcentration

Substance Log

Pow BCF Cause

for

concern (yes/no) Reference/Comments

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Other

Food web/population effects

Substance Cause for

concern (yes/no) Comments

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Other

Section 3: Data on mamma lian toxicity (G9 4.2.1.2) Acute Toxicity

Substance Species Method guidelines Route; dose levels;
duration of

exposure Endpoint Oral LD50;

Dermal LD50;

Inhalation

LC50

Value (units) Reference/

Comments

Preparation

Active
Substance

Other
components 1.

2.GESAMP-BWWG 2/9

ANNEX 4 Page 34

I:\MEPC\55\2-16.doc

(1, 2, 3) 3.

Relevant
Chemicals

Other

Skin Irritation

Substance Species Method guidelines Average score (24, 48, 72 h) Reversability (yes/no) Result Reference/

Comments

Preparation

Active
Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Other

Eye Irritation

Substance Species Method guidelines Average score (24, 48, 72 h) Reversability (yes/no) Result Reference/

Comments

Preparation

Active
Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Other

Skin sensitization

Substance Species Method guidelines (Buehler, M&K) Sensitiser (y/n) Reference/Comments

Preparation

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant Chemicals

OtherGESAMP-BWWG 2/9

ANNEX 4 Page 35

I:\MEPC\55\2-16.doc Repeated-dose toxicity

Substance Species Method guidelines Route;
Duration of study;

dose levels

and frequency

of application Results NOAEL;

NOEL (units);

range Reference/

Comments

Preparation

Active Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Other

Data waivers for repeated-dose toxicity

Test substance Test; species; route of exposure Reason for not supplying the data

Developmental and reproductive toxicity

Substance Species Method guidelines Route;
Duration ; doses Effects; NOAEL

maternal toxicity; NOAEL embryotoxicity;

NOAEL parental; NOAEL F1;

NOAEL F2 (units); range Reference/

Comments

Preparation

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

OtherGESAMP-BWWG 2/9

ANNEX 4 Page 36

I:\MEPC\55\2-16.doc Data waivers for developmental and reproductive toxicity

Test substance Test; species; route of exposure Reason for not supplying the data

Carcinogenicity

Substance Species Method guidelines Route; Duration; doses; frequency of application Effects; NOAEL;

NOEL (units) Reference/

Comments

Preparation

Active Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Other

Data waivers for carcinogenicity

Test substance Test; species; route of exposure Reason for not supplying the data

Mutagenicity/genotoxicity

Substance Species ( In vitro or in vivo) Method guidelines With/with

out activation; duration;

concentrat
ions tested Results (positive/ negative) Reference/Co

mments

Preparation

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

OtherGESAMP-BWWG 2/9

ANNEX 4 Page 37

I:\MEPC\55\2-16.doc Data waivers for mutagenicity/genotoxicity

Test substance Test; Species; route of exposure Reason for not supplying the data

Section 4: Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3)

Modes of degradation (biotic; abiotic)

Hydrolysis at pH 5, 7, 9

Test substance Test;
duration pH; temp Value (units); half

life Reference/

comments
Active Substance Other components (1, 2, 3) 1.

2.

3.
Relevant Chemicals

Other

Data waivers for hydrolysis

Test substance Test Reason for not supplying the data

Biodegradability

Test substance Test type; duration;

sea- /freshwater Readily biodegradable (y/n) Value (units); half

life Identification

of breakdown products Reference/

comments

Active Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

OtherGESAMP-BWWG 2/9

ANNEX 4 Page 38

I:\MEPC\55\2-16.doc Data waivers for biodegradation

Test substance Test Reason for not supplying the data

Partition coefficients

Test

substance Coefficient (Pow; Koc; other) Test method; pH; temp Value (log units) Reference/

comments

Active
Substance

Other
components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Other

Data waivers for partition coefficients

Test substance Test Reason for not supplying the data

Persistence and identification of the main metabolites

Test substance Test;
duration pH; temp Value (units); half

life Reference/

comments
Active Substance Other components (1, 2, 3) 1.

2.

3.
Relevant Chemicals

Other

Data waivers for persistence and iden tification of the main metabolites

Test substance Test Reason for not supplying the dataGESAMP-BWWG 2/9

ANNEX 4 Page 39

I:\MEPC\55\2-16.doc Reaction with organic matter

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

comments
Active Substance Other components (1, 2, 3) 1.

2.

3.
Relevant Chemicals

Other

Potential physical effects on wildlife and benthic habitats

Test substance Physical description (state, solubility, viscosity) Discussion of potential effects Reference/

comments

Preparation

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant Chemicals

Ballast water

Other

Potential residues in seafood

Test substance Monitoring

data/residues Impact on consumer safety Reference/

comments Preparation

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant Chemicals

Other

Any known interactive effects

Test substance Interaction with other chemicals, BWS, or receiving

environment Discussion of potential

effects Reference/

comments

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant Chemicals

Ballast water

OtherGESAMP-BWWG 2/9

ANNEX 4 Page 40

I:\MEPC\55\2-16.doc Physical and chemical properties for the Acti ve Substances and preparations and treated ballast water, if applicable (G9: 4.2.1.5)

Property (with units and reference) Preparation Active

Substance Other components (1, 2, 3) Relevant
Chemicals Ballast water

Melting point (°C) 1.

2.

3. Boiling point (°C) 1.

2.

3. Flammability (flash point for liquids; °C) 1.

2.

3. Density (20 °C; kg/m3) Vapour pressure (20 °C; Pa) 1.

2.

3. Vapour density (air = 1) 1.

2.

3. Water solubility (temp; effect of pH; mg/l) 1.

2.

3. 1.

2.

3. pH in solution

Dissociation constant (pKa) 1.

2.

3. 1.

2.

3.

Oxidation-reduction potential Corrosivity to material or equipment 1.

2.

3. 1.

2.

3. Reactivity to container
material Autoignition temperature (°C) Explosive properties Oxidising properties

Surface tension Viscosity 1.

2.

3. Thermal stability and identity of breakdown products Other physical or chemical properties 1.

2.

3. 1.

2.

3. Shaded cells, data not required Salinity, TOC, DOC, and % particulate matter are required for the ballast water used in type approval testing.GESAMP-BWWG 2/9

ANNEX 4 Page 41

I:\MEPC\55\2-16.doc Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5)

Substance Analytical method; conditions; applicability (water/sediment) Sensitivity Reference/

comments

Preparation

Active Substance

Relevant
Chemicals

Other

Use of the preparation Brief description of the handling storage and use:

Material safety data sheets

Substance Provided (yes/no) Classification according to

GHS Reference/

comments Preparation

Active Substance Other components (1, 2, 3) 1.

2.

3.
Other

Risk characterization

Substance Persistent (y/n) Bioacumulative (y/n) Toxic (y/n) Reference/

comments Preparation

Active Substance Other components (1, 2, 3) 1.

2.

3.

Relevant
Chemicals

Other

Evaluation of the treated ballast water

Conclusion of the half-l ife of the toxicity of the treated ballast water, and the recommended holding time.

Risk characterization
Conclusion on the effects of reaction with organic matter

Conclusion of persistence Conclusion on the discharge concentration

***GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc ANNEX 5

REVIEW OF PROPOSAL FOR APPR OVAL OF ACTIVE SUBSTANCE

Ozone - submitted by Japan

0 SUMMARY

0.1 The Group noted that the Active Substance (o zone) is generated on demand and so there will not be any safety hazards a ssociated with the storage of th e chemical onboard. However, as ozone is very toxic by inhalation and may also have long-term health effects, appropriate
measures must be taken to ensure that there is no hazardous human exposure to this chemical.

0.2 The Group noted that two by-products of the system (hypobromous acid ion and hypobromous acid were generated in such small amounts as not to be regarded as Relevant
Chemicals but that bromate ion should be. Howe ver, the Group also considered that bromoform might be generated in sufficient quantities to pr oduce a potential risk a nd that this should be investigated further.

0.3 The Group noted that bromate ion has a high potential for mutagenicity and carcinogenicity and, therefore, human exposure should be avoided completely. This is particularly important if the crew has to enter a ballast water tank after treatment.

0.4 The Group agreed that neither Ozone nor bromate ion exhibi ted PBT potential but bromoform needs to be considered in detail, if considered to be a Relevant Chemical, once the
data are made available.

0.5 The Group agreed that Ozone does not pose any environmental risk due to its very short
half-life. However the Total Residual Oxidan t (TRO) by-products, which include bromate ions, are a cause for concern along with bromoform.

0.6 As the Group had major reservations about the estimation of the Predicted Environmental Concentration (PEC), it was concluded that the TRO should not present an unacceptable risk to the environment during further prototype deve lopment and testing pr ovided that sufficient dilution of discharged ballast wate r is secured. Nevertheless, this aspect should be considered in greater detail once a standard environmental sc enario has been agreed by MEPC which can be run by suitable models.

0.7 However, the Group did not agree with th e applicant that bromoform should not be regarded as a Relevant Chemical and so prop osed that further information on the generated amounts and the physical and biological properti es is provided along with the associated predicted environmental fate so that a prope r Risk Assessment can be carried out on this by-product of the system.GESAMP-BWWG 2/9

ANNEX 5 Page 2

I:\MEPC\55\2-16.doc 0.8 Whilst recognizing that the a pplication contained much of the information required by the Group to carry out an evaluation of the potent ial hazards and a subseq uent Risk Assessment associated with the proposed system , the Group had a number of concerns, inter alia :

.1 more information is required regarding the formation of bromoform and its associated risks;

.2 more information is required regarding the effects of discha rges during onboard testing and development;

.3 more information is required regardi ng the potential environmental effects should Final Approval be granted which would allow the system to become operational on a large scale, i.e., installed on many ships;

0.9 The Group recommended that Basic Approval be granted to the system described in the Japanese submission (MEPC 55/2) for further pr ototype testing and development, based on the Guidelines developed by the Organization. The va rious concerns raised should be addressed to the satisfaction of the Group and MEPC. This recommendation does not prej udice the re sults of an eventual risk assessment of a full-scale oper ational application to be considered for Final Approval. Therefore, the Group st ressed that, at this stage, it wa s not possible to judge whether the system would be suitable for recommending Final Approval.

1 INTRODUCTION

1.1 Data used to evaluate this product we re, primarily, extracted from MEPC 55/2 and supplemented with additional information provide d by the applicant or identified by the Group
from other sources.

1.2 Whilst the applicant had provided a consider able amount of additional reference data, these were incorporated in large extracts of information which was not relevant to the submission. The Group agreed that this made iden tification of the releva nt data for validation difficult and time-consuming.

2 COMPLETENESS OF DOSSIER

2.1 The Group noted that full information about the quality contro l/quality assurance programme implemented in the testing process of the Ballast Water Management System was not provided in the dossier. In addition, it was noted that, whilst the testing of the treated ballast
water had been done to GLP standa rds, other data provided were taken from the literature where the quality of the data could not be determined.

2.2 It was noted that MEPC 55/2 states that the reaction between Ozone and bromate ion in the seawater produces hypobromous acid ion, hypobrom ous acid and bromate ion and the ratio of such reaction products varies with pH. It was al so noted that MEPC 55/2 states further that only the bromate ion is generated in the pH range of 5 to 8 which is the assumed range of ballast

water.GESAMP-BWWG 2/9

ANNEX 5 Page 3

I:\MEPC\55\2-16.doc 2.3 As a result, no data were provided for hypobromous acid ion or hypobromous acid. The Group considered that it might ha ve been useful to see quantita tive data to support this claim.

2.4 It was further noted that the dossier did not include information about other chemicals such as bromoform that may be relevant accordi ng to open available literature (see section 3.3). The Group therefore recommended th at relevant sampling and analys is is included in the further testing onboard ships and in landbased tests and th at these data are submitted in the application for final approval.

3 DESCRIPTION OF BWMS

3.1 BWMS components

3.1.1 The submission informs that the ballast water treatment and disinfecting system comprises of four main sections as follows:

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

.2 the second contains a mechanical trea tment element and a chemical treatment element where ozone generated on board is injected into the ballast water;

.3 the third is a gas/liquid separation un it where undissolved oz one is removed and then destroyed; and

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

3.1.2 It was noted that the system is designed to store the treated ballast water in the ballast
tank for at least 48 hours before it is discharged. It wa s also noted that the applicant had stated that with post treatment, even a storage time of less than 48 hours will reduce the concentration to an acceptable level.

3.1.3 It was noted that the applican t had indicated that the treatment system is fully automated with the controls intended to be integrated in the ships ballasting consol. The in-line main treatment unit is to be located in the ships ba llast main after the main ballast pump and the disinfection treatment will be applied during uptake of ballast water.

3.2 Application

3.2.1 Ozone will be generated on demand and will be injected into the ballast water to a maximum level of 4 mg Ozone/litre ballast water. It is recommended that the treated water
remain in the ballast tank for at least 48h to ensure th e decay of Relevant Chemicals to a level acceptable to the receiving environment. The system includes a ballast water discharge conditioning unit to treat oxidants remaini ng in the ballast water at discharge.

3.2.2 It was noted that there is no need to store ozone on boa rd ship and the submission identifies the intended safety measures to be put in place that will re duce the risk of crew
exposure to ozone.GESAMP-BWWG 2/9

ANNEX 5 Page 4

I:\MEPC\55\2-16.doc 3.3 Active Substance(s)

3.3.1 The manufacturer indicates that:

.1 ozone is the Active Substan ce employed in this system; and

.2 bromate ions, which are generated to a level of 3.3mg TRO/litre ballast water following treatment with ozone at 4mg/l, should be consider ed as Relevant
Chemicals.

3.3.2 It was noted that, in a similar system employing ozone as the Active Substance, the applicant indicated that bromoform should be considered as a Relevant Chemical. When this point was queried, the applicant informed the Group that bromoform would only be produced in any significant quantities at pH va lues lower than found in seawater . However, it was noted that in the available open literature there were several papers 3 documenting other Relevant Chemical products (halogenated organic compounds) that ma y be formed in low concentrations when applying Ozonation of seawater with a certain organic carbon content.

3.3.4 It was further noted that th e level of bromate and other oxi dants in treated ballast water will depend on the organic content of seawater. An increase in the organic content will increase
the oxidant demand of the seawater and there by reduce the bromate (or the total residual oxidant – TRO) concentration.

3 .1 Driedger, A., et al. 2001. Inactivation of Ba cillus subtilis spores and formation of bromate during Ozonation. Wat. Res. Vol. 35, No. 12, pp. 2950 – 2960. (included in the Korean application)

.2 von Gunten, U. & Hoigné, L., 1994. Bromate formation during ozonation of bromide-containing waters: bromate formation mechanisms. Environ. Sci. Technology, 32(1), pp.1234-1242. (included
and referred in the Ja panese application)

.3 Fabbricino, M. & G.V. Korshin, 2005. Forma tion of disinfection by-products and applicability of differential absorbance spectroscopy to monitor halogenation in chlo rinated coastal and deep ocean seawater. Desalination 176 (2005), pp. 57 – 69.GESAMP-BWWG 2/9

ANNEX 5 Page 5

I:\MEPC\55\2-16.doc 4 PHYSICOCHEMICAL PROPERTIES

4.1 The following table was copied directly from table 5 of the annex to MEPC 55/2.

Physical property Ozone Bromate ion ( Potassium bromate )

CAS number 10028-15-6 7789-38-0
Molecule weight 48.0 2 ) 167.0

Liquid concentration 1358g/L ( at

- 112°C ) 3) ―

Evaporation heat 15.2kJ/moL 3 )

― °Melting point

- 193°C 2 ) (350°C)

Boiling point

- 112°C 2 ) (Decomposes at 370°C)

Flammability Non-combustible but prom otes burning of other
substances. No inflammability to liquid 2 )

. ―

Density (20°C) 2.144g/L(N.T.P) (at 0°C, 101kPa) 3) (3.27 g/m 3 )

Vapour pressure (20°C; Pa) >1 atm 4 )

― Vapour density (air=1) 1.6 2 ) (air=1) ―

Water solubility 0.1g/100mL (at 0°C) 2 ) 7.5g/100ml (25°C) (133 g/l @ 40°C) pH in solution

― ― Dissociation constant(pKa) Definition fo r liquid; no relation with gas. 8.62 Oxidation reduction potential 2.07V 3

、 5 )

― Corrosivity to Material Yes Yes

Reactivity to container material Yes

―

Auto ignition temperature (°C) Noncombustible but promotes burning of other substances. Vari ous reactions may cause a fire or explosion. 2 ) ―

Explosive Properties May cause a fire or explosion when heated or coming in contact with a combustible material (alkene, ether) 2 ) ―

Oxidizing properties Yes missing

Surface tension 3.84×10 -2 N/mm (at

- 183°C) 3) ―

Viscosity 1.57×10 -3 Pa.s (at

- 183°C) 3 ) 66.6 ~ 67.6 ※ Thermal stability and breakdown product Oxygen

― Other physical and Chemical property Nothing of noteworthy Oxidizing property

※ Value assuming the water coefficient of viscosity at 0°C to be 100 ( density, 14.02
~ 34.64wt% )

― : data not required

4.2 It should be noted that the dashes indicate ”d ata not required” which might not be strictly correct. If it is not applicable or relevant th en, perhaps this should be indicated and the reason given.

5.0 HUMAN HEALTH HAZARDS

5.0.1 Based on existing literature data concerning ozonation as a disinfection system and taking into account that the presence of bromide ion in the seawater leads to the formation of additional brominated DBPs (Disinfectant By-Products), the Group decided to consider bromoform also asGESAMP-BWWG 2/9

ANNEX 5 Page 6

I:\MEPC\55\2-16.doc Relevant Chemical and thus, whenever the inform ation is available, to consider it along with bromate as to toxicological effects assessment.

5.1 Acute toxicity

5.1.1 The acute toxicity data evaluated by the Group are presented in the following tables:

Ozone Exposure Route Value ra nge Species Reference

Inhalation LC 50 (mg/L/4h) 0.012 – 0.014 Mouse Cheminfo by CCOHS (Canadian Centre for Occupational Health and Safety)

Oral LD 50 (mg/kg bw) n.a.
Dermal LD 50 (mg/kg bw) n.a. n.a. not applicable

Bromate Exposure Route Va lue Range Species Reference

Oral LD 50 (mg/kg bw)) 280-495 Rats, Mice, and

Hamsters WHO, 2005

Sub-acute toxicity NOAEL oral (mg/kg bw/day) 2 weeks 108 (based on changes in enzyme activities) SPF mice WHO, 2005

Bromoform Exposure Route Va lue Range Species Reference

Oral LD 50 (mg/kg bw)) 1388-1550 Rats and Mice EHC 216, 2000

5.1.2 The Group accepted the non submission of oral and dermal toxicity data for ozone due to
the fact that it is a gas and thus inhalation is the main exposure route of concern. However, it would be advisable that a justif ication covering this aspect was presented by the applicant. The same applies as above for the acceptance of mi ssing inhalation and dermal toxicity data for
bromate.

5.1.3 Ozone : from submitted information and several studies in humans mentioned in literature (EHC 216, 2000), the group concluded that even very low doses of ozone can be harmful to the upper respiratory tract and the lungs. In addition, s ynergistic effects seem to exist, as exposure to very low concentrations initially increases reactiv ity of the airways to other inhaled substances (bronchial hyperresponsiveness) a nd cause inflammatory response in the respiratory tissue. Other symptoms observed following acute exposu re to 0.5-1.5μg/L (0. 25 - 0.75 ppm) include cough, shortness of breath, tightness of the ches t, dyspnea, headache and nausea. More severe symptoms have been observed following con centrations higher than 0.002mg/L (1ppm) that included reduce lung function, extreme fatigue, dizzi ness, inability to sleep and cyanosis. An acute occupational exposure to approximately to 0.022mg/L (11 ppm ) caused severe respiratory
irritation and almost caused unconsciousness. A 30 min exposure to 0.1 mg/L (50 ppm) is considered potentially lethal.

5.1.4 Bromate : lethal doses seem to be very similar across rodent species, also the toxic signs and symptoms; at autopsy, hyperaemia of the stom ach was observed and congestion of the lungs. Also, damage to renal tubules including necrosis in the proximal tubular epithelium. Sub-acute adverse effects from bromate (potassium bromate) were reported in an oral study made with SPF mice during 2 weeks as changes in enzyme activities, at doses of 270mg/kg bw/day and above. A NOAEL was set at 108mg/kg bw/day (WHO, 2005).GESAMP-BWWG 2/9

ANNEX 5 Page 7

I:\MEPC\55\2-16.doc 5.1.5 Bromoform: among the brominated trihalomethane s THMs, bromoform is ranked as the least potent as a lethal acute oral toxicant. Toxi c signs are reported relati ng to disruption of renal
function.

5.2 Effects on skin and eye

5.2.1 Ozone : based on applicant’s submitted inform ation (EHS, 1990), ozone seems not to cause any adverse effect on the skin but is irritating to the ey es when exposed to 0.004mg/L (2ppm) for several minutes; other in formation (CCOHS) refers that ozone gas can probably cause skin irritation due to its oxidizing ability, but only at concentrations capable of causing severe respiratory injury.

5.2.2 A summary of the skin and eye irritancy poten tial of ozone and bromat e ions is shown in the following table:

Ozone Observation Species Reference/Comments

Skin Not irritant EHP (1990) Eyes Irritant (>0.04mg/L for several minutes) Human EHP (1990)

Bromate

Skin Irritant Human RTECS Eyes Irritant Human RTECS

5.3 Irritation to the respiratory tract

The Group noted that inhalation exposure to oz one causes coughing and/or breathing difficulties at 0.03μg/L to 1.2μg/L (0.015-0.6 ppm) (inf ormation retrieved from MSDS).

5.4 Repeated dose toxicity

5.4.1 Ozone : from the available information, it was not possible to address the dose-response effects in relation to repeated inhalation exposur e (sub-chronic, 90 days) to ozone. However, the Group may predict similar effect s on the lungs of humans and other mammals even at low concentrations. In addition, it is referred in literature that the se verity of respiratory responses seem to be reduced following repeated daily exposures due to an apparently “functional adaptation”.

5.4.2 Bromate: it was noted that the exposure of rats to bromate for 15 weeks demonstrated a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg bw/day. One study via oral route, made with F344 rats, for 13 weeks, showed, at a dose of 63 mg/kg bw/day, adverse effects with significant increases in blood serum parameters indi cative of liver and kidney toxicity (including glutamate oxaloacetate transaminase, lactat e dehydrogenase, cholines terase and blood urea nitrogen).

5.4.3 Bromoform: a 13-week study was performed in rats where a NOAEL of 25mg/kg bw/day could be derived on the basis of the absence of liver lesions whereas in the study in mice was 100mg/kg bw/day (NTP, 1989).GESAMP-BWWG 2/9

ANNEX 5 Page 8

I:\MEPC\55\2-16.doc 5.5 Chronic and long-term toxicity

5.5.1 Ozone: in a series of well conducted studies, mice and rats exposed to 0.01-0.02mg/kg bw/day for 105 to 130 weeks had increased inci dence of non-carcinogenic lesions of the nose and lungs (NTP,1994). Several studie s also examined the effects of the long-term effects on monkeys. Exposures ranging fr om 0.003-0.013mg/kg bw/day for 3-18 months consistently showed significant structural alterations to lung s. Many of them seem to be irreversible six months after exposure stopped (COSHH).

5.5.2 Studies in humans examining the potential effects of long-te rm occupational exposures to ozone have reported headaches, irritation to nose and throat, chest constriction and lung congestion in exposed workers. These studies suggest that long-term exposures to ozone may result in impaired lung function which is consistent with animal study results

5.5.3 Bromate: the systemic toxicity of bromate (adm inistered as potassium salt) has been reported from long-term studies designed to eval uate bromate carcinogenicity in F344 rats and B6C3F1 mice (WHO, 2005). The data show that the kidney is the major target organ of bromate-associated toxicity and that rats are more sensitive than mice to bromate treatment.

5.5.4Following fifteen month exposure to 30mg/ kg bw/day of bromate in drinking water, changes to the kidneys of the exposed rats were observed al ong with increased blood urea nitrogen and structural abnormalities of the cor tical tubules. From these observations, NOAEL could not be determined but a LOAEL of 30mg of bromate/kg bw/day had been identified as part of the study.

5.5.5 Bromoform was studied in a 2-year study with ra ts resulting in a small increase in tumours of the large intestine, at dose of 200mg/kg bw/day.

5.6 Mutagenicity/Genotoxicity

5.6.1 Ozone: there are a number of studies in l iterature to examine the potential for mutagenicity of ozone in humans but due to some deficiencies not all of them seem to be
conclusive.

5.6.1.1 However, the Group noted that positive results (cytogenetic aberrations) were observed in the lymphocytes of hamsters exposed to 0.0048-0.086mg/kg bw for 5 hours and in the lung macrophages of female rats exposed to 0.0024-0 .016mg/kg bw for 6 hours. However, several studies have shown however, that ozone is mutagenic in bacter ia and in mammalian and human
cells in vitro following inhalation exposure (NTP, 1994; Mutation Research, 1992).

5.6.2 Bromate: in particular potassium bromat e, is considered mutagenic both in vitro and

in vivo . In fact, positive results were obtained in bacteria test (Ames test), chromosome
aberrations in cultured Chinese hamster fibrobl ast cells, acute cytogenetic effects on rat bone
marrow cells and in the mouse micronucleus test.

5.6.3 Bromoform: bromoform is largely positive in b acterial assays of mutagenicity and appeared to be more potent than the other brominated THMs. In vivo studies have given contradictory results.

5.6.4 From the available information, the Group conc luded that there may be a concern towards the mutagenicity/genotoxicity potential of ozon e following inhalation exposure and towardsGESAMP-BWWG 2/9

ANNEX 5 Page 9

I:\MEPC\55\2-16.doc subsequent brominated by-products, in particul ar potassium bromate, following oral exposure may be of concern.

5.7 Developmental and reproductive toxicity

5.7.1 Ozone: a study reported offspring of rats con tinuously exposed to 0.02 or 0.03mg/kg bw for four days during middle or la te pregnancy had reduced growth rates after birth and delayed behavioural development. Maternal toxicity was not reported.

5.7.1.1 Another study reported a decrease in foetal body weight gain in the offspring of mice exposed to 0.024 but not to 0.008 or 0.016mg/kg bw , on days 7-17 of pregnancy. Signs of maternal toxicity were observed (Tox. Applied Pharmac.,1979).

5.7.2 Embryotoxicity (increased resorptions) was observed in rats exposed to 0.03 and 0.04mg/kg bw, but not 0.013-0.025mg/kg bw. Matern al toxicity was not reported (COSHH).

5.7.2.1 Continuous exposure of mice from six days prio r to mating to postnatal day 22 resulted in reduced body weight and slight effects in ne urobehaviour development of the offspring. Maternal toxicity was not evaluated (Arch.Toxicology, 1995).

5.7.3 No effects on reproductive performance (proport ion of successful pregna ncies, litter size, offspring viability and sex ratio ) were noted in mice exposed fo r 6 days prior to mating to postnatal day 22 (dose was not referred) (Arch.Toxicology, 1995).

5.7.4 Bromate : no effects on reproductive performan ce had been observed in a study made
with rats and mice fed with 15mg potassium bromate per kg body weight over five and eight generations, respectively. Based on the test re sults, the Group concluded that bromate does not indicate to have developmen tal or reproductive toxicity.

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

5.8 Carcinogenicity

5.8.1 Ozone: no data were submitted by the applicant for the carcinogenicity potential assessment of ozone. From a study with rats and mice expos ed to 0.0024, 0.01 and 0.02mg/kg bw of ozone for 105 to 130 weeks, ther e was no evidence for carcinogenicity in male and female rats, inconclusive evidence in male mice, and some evidence in female mice. Ozone did not have tumour promoter properties (NTP, 1994).

5.8.2 No human carcinogenicity information relate d to ozone exposure is available. The
American Conference of Governmental Industri al Hygienists (ACGIH) has designated this
chemical as not classified as a human carcinogen (A4).

5.8.3 Bromate: is an active oxidant in biological sy stems and has been shown to cause an increase in renal tumours, peritoneal mesothelio mas and thyroid follicular cell tumours in rats,GESAMP-BWWG 2/9

ANNEX 5 Page 10

I:\MEPC\55\2-16.doc and to a lesser extent in hamsters and mice. Th e lowest dose at which an increased incidence of
renal tumours was observed in rats was 6mg/kg bw/day.

5.8.4 A clear dose-response relationship has been observed in tumour incidence and the severity/progression of tumours. The weight of evidence clearly indicates that bromate has the potential to be a human carcinogen.

5.8.4.1 IARC classified it in Group 2B (possible human carcinogen).

5.8.5 Bromoform: IARC has evaluated carcinogenicity of bromoform and concluded that there is inadequate evidence for its carcinogeni city in humans and limited evidence for its carcinogenicity in experimental animals. IARC cla ssified Bromoform in Gr oup 3 (not classifiable as to its carcinogenic potential to humans).

5.9 Toxicokinetics

5.9.1 Ozone : is absorbed in both the upper and lower resp iratory tract. It is a potent oxidant that reacts with protein and lipids, particularly within biological membranes. A small amount of
inhaled ozone is absorbed into the blood. The ex treme reactivity of ozone limits its ability to
accumulate.

5.9.2 Bromate: following from oral administration, br omate is rapidly absorbed from the Gastro Intestinal Tract (GIT). It was not detected in rat tissues following intragastric dose, but was significantly increased in plasma, red bl ood cells, pancreas, kidneys, stomach, and small
intestine.

5.9.3 Bromate may be converted into hypobromic acid by hypochloric acid in the stomach. Liver and kidney tissues may degrade bromate to bromide by a process involving glutathione, although only small amounts appear to be reduced in this way. Br omate is excreted mainly by urine as bromate and bromide; some may also be eliminated by faeces. Bromate concentrations in urine peak at about 1h, and bromate is not detectable in plasma after 2h.

5.9.4 Bromoform : toxikocinetic information was no t found by the Group however some
considerations can be draw. Although bromoform appear to have greater propensity for metabolism, it appears to be less potent toxicant and carcinogen based on the NTP (1985,1987) bioassays and numerous in vivo toxicity studies. A possible expl anation is less bioavailability resulting from the greater lipophilicity of th is compound (logPow~240) which, together with greater reactivity of bromoform metabolites, may also prevent it from reaching critical target
sites.

5.10 Conclusions from Human Health Hazard Assessment:

5.10.1 From the human health effects assessment a nd taking into considera tion the substances at
the effective concentrations in the disinfection process describe d in the Japane se Application Dossier, the Group is able to reach the following conclusions:

5.10.2 Ozone: Ozone is very toxic by inhalati on route and it is, therefore, highly recommendable to apply strict mitigation measur es to avoid human inhalation exposure during the process. In addition, by oral exposure and due to its oxidant properties, there may be a concern towards ozone potential for mutagenicity.GESAMP-BWWG 2/9

ANNEX 5 Page 11

I:\MEPC\55\2-16.doc 5.10.3 Bromate (potassium bromate): Several studies i ndicate high potential for mutagenicity/ carcinogenicity in humans. Th e current MCL (Maximum Contam inant Level) in the United States is 0.010mg/L and the maximum contaminan t level goal is zero, because of the possibility that bromate may function as a genotoxic carcinoge n. Therefore the exposure should be totally
avoided.

5.10.4 Bromoform and other brominated DBP: as highly reactive compounds capable of bioaccumulating, exposure to these on the long-term should be minimized.

5.10.5 Other relevant factors whic h have to be taken into acc ount when assessing human exposure towards chemicals include:

.1 the variability in individual sensitivity; and

.2 the fact that complex mixtures of di sinfectants and DBPs, according to the actual knowledge, interact in an additive way, at low concentration. Therefore, the Group raised an additional concern about the potential for cumulative toxicological effects of the mixture of chemicals genera ted by the system proposed by the Japanese Application.

6 RISKS TO SAFETY OF SHIP AND CREW

6.1 The submission recognises and identifies that the use of ozone as an Active Substance presents a potential risk to the crew in that oz one in the atmosphere in relatively small quantities is an irritant and in slightly higher concentratio ns is acutely toxic. Recognised National standard permitted values for maximum average levels for ozone can be as low as 0.05ppm/24hr (State of New York). The applicant indicated that the risk of exposure of the crew to ozone is mitigated by the provision of ozone densitometer monitoring to areas that may be affected by leakage from the system linked to visible a nd audible alarms and an automa tic system shut down function together with ozone level monitoring at the ba llast tank air vents. The inclusion of a gas separation unit together with a waste ozone destruction unit after the treatment unit further reduces the risk of free ozone being re leased in the ball ast tank.

6.2 The group considers the BWMS risk reduction measures proposed adequately mitigate concerns relating to the use of ozone as an Active Substance to an acceptable risk level. It is also recognised that in most cases the presence of ozone is readily identifiable in small concentrations by smell. It is recommended that placards giving additional warnings of the hazards related to the inhalation of ozone be provided onboa rd to promote a general awareness.

6.3 The Group noted that the submission reasons that only a negligible amount of material will be generated by reaction with organic matter when using ozone as a disinfectant. However, other studies have determined that, in sea wate r, the production of carcinogenic brominated trihalomethanes (THMs), including bromoform, may be significant.

6.4 As a result, the Group recommended that the THM levels in the ballast tank are regularly measured during the further prototype development and testing period and that precautionary measures to mitigate any risk to the crew from contact with THMs are put in place until it can be demonstrated that the risk is negligible.GESAMP-BWWG 2/9

ANNEX 5 Page 12

I:\MEPC\55\2-16.doc 6.5 It was considered that the system confi guration could potentially produce significant noise with a possibility of affect to the health of crew working in the vicinity of the system. It is recommended that operational noise levels are mon itored during shipboard tr ials and verified to remain within the IMO accepte d limits for machinery spaces.

6.6 The submission identifies the risk of corrosi on arising from the oxidi zing effects of ozone
and concludes that the only areas requiring materials with additional corrosion resistance properties such as stainless steel are those cont ained within the addition al requirements for the provision of the BWMS. It is recommended that the initial assessment of a limited corrosive effect is verified by regularly monitoring the actu al conditions of the ships ballast system piping, protective coatings and ballast tank st ructure during the onboard trial period.

7 ENVIRONMENTAL FATE AND EXPOSURE

7.1 Environmental fate and behaviour properties

7.1.1 The Group noted that when ozone is injected into ballast water it re acts with both the natural organic and inorganic compounds and it depr edates with a half-life of about six sec. to 30 sec. Some of the degradation rates for dissolv ed ozone are shown in Table T7.3 below. Even in the ballast tank, dissolved ozone exists in a very short time, and during the degradation process it produces some oxidants.

7.1.2 The Group also noted that main fate c onsidered in the ballast tank and marine
environment is that of those oxidants.

Table T7.1 Overview of fate fo r dissolved ozone in water media

. Degradation Rate for ozone

Test
Substance 1⁄2 Life Time Degradation

Process References

Ozone (sea water) 5.8sec Abiotic Theoretical rate (W.Haag et al.,1983)

Ozone (sea water) 5.3 sec Abiotic Theoretical rate (W.Haag et al.,1983)

Ozone (fresh water) 30 min Abiotic Theoretical rate (Siddi qui M.S. et all,1995)

7.2 Fate in ballast water tanks

7.2.1 Some of the main reactions when ozone is injected into seawater are shown below:

.1 O 3 + Br → O 2 + OBr

.2 O 3 + OBr → 2O 2 + Br

.3 2O 3 + OBr → 2O 2 + BrO 3 -

.4 Br - + O 3 ↔ OBr

.5 OBr - + H + ↔ HOBrGESAMP-BWWG 2/9

ANNEX 5 Page 13

I:\MEPC\55\2-16.doc .6 HOBr + Organic matter → CHBr 3

.7 HOBr + NH 3 ↔ NH 2 Br

7.2.2 The application dossier claims that the r eaction #6 and #7 do not occur in the high pH(>8) and water with high contents of bromium compounds. Ho wever, with reference to its comments in Section 3.3 the Group recommended that th is process should be analysed further.

7.2.3 The Group noted that two met hods for identification of the concentration of bromate ion in treated ballast water are applie d (ion chromatogram and iodine titr ation). It was, however, not always clear for the Group which of these met hods that were applied in the toxicity and degradation tests carried out by the a pplicant and included in the dossier.

7.2.4 The results of analyses applying iodine titration include al l oxidants presen t in the treated ballast water and is given as mg TRO per litre (TRO = Total Residual Oxidant) in the dossier. As several Relevant Chemicals may be present in the treated ballast water, the Group recommended that toxicity data and degradation data found in an alyses of the treated ballast water are related to TRO and not only to the concentration of bromate ion.

7.2.5 The dossier states that the initial concentr ation of Active Substance in the ballast tanks is 3.3 mg/l given as TRO depending on salinity, orga nic content, pH and ot her properties of the treated water. TRO is degraded through a numbe r of reactions between the oxidants and other
natural chemicals in the sea water.

7.3 Fate in the environment

7.3.1 It was noted that the dossier presented a various numb er for the degradation rates of Active Substances and Relevant Chemicals, they are summarised as follows.

Table T7.2 Overview of fate of Relevant Chemicals in seawater

. Degradation Rate for Relevant Chemicals

Test
Substance 1⁄2 Life Time Degradation

process References

Bromate ion ~12h Abiotic MEPC55/2, p8,No Ref.

Bromate ion 226 sec Biotic Ref.26

TRO 15h Abiotic Dossier
Comment: Measured value in low TOC natural seawater(1.1mg-TOC/l)

7.3.2 In general, the degradation rate of TRO in the clean natural sea water given in the dossier
is similar to other availa ble studies and dossiers.

7.3.3 The group noted that the dossi er did not include any inform ation about degradation rates
in sediment and freshwater for bromate ions or TRO.

7.3.4 Bioaccumulations

The Group noted that the bromate ion is not bioaccu mulative. Data for bromoform is not given in the dossier, but is included in the table (T7.3) below.GESAMP-BWWG 2/9

ANNEX 5 Page 14

I:\MEPC\55\2-16.doc Table T7.3 Bioaccumulation data for Relevant Chemicals

Bioaccumulation (B) Test Substance Log Pow B criterion fulfilled (Yes/No)

Ozone Missing (<1) No

Bromate ion <1 No

Bromoform 2.40 No

7.4 Environmental exposure

7.4.1 From the results of the different characte ristics of the chemicals in the Japanese application the Group concluded th at TRO would be the most important group of chemicals to take into account for the risk assessment, excluding bromoform. In the dossier, the environmental exposure was estimated using the model MAM-PEC, for the port of Rotterdam. An overview of the assumptions of the 4 scenarios is given in table T7.4.

Table T7.4 Exposure sc enarios considered.

# Resulting maximum
concentration (mg/L) Scenario description

1 0.16 anticipated normal concentra tion in ballast water 48h after ozone treatment with discharge treatment 2 1.6 concentration following the maximum concentration of ozone

treatment 3 3.44 average concentration immediately after ozone treatment 4 4.56 anticipated concentration w ithout discharge (decomposition)

treatment

7.4.2 According to the submission, the model predic ts that average concentrations of TRO in
the water of the harbour afte r a period of 10 years in use are estimated to amount: 0.278, 2.78,
5.81 and 7.93 μ g/L, respectively.

7.4.3 As these results were obtain ed with a model that has not yet been evaluated by the Group or a body of IMO, the Group considered that these results should be interp reted with care and be only used as indicative. The Group also noted th at the Rotterdam harbour scenario was based on an average dilution of treated ba llast water after discharge of mo re than 1,000 times and that in many other environments and even in some basins of Rotterdam harbour, such a high dilution might not be found. Relevant scenarios s hould be developed and agreed upon before representative environmental exposur e concentrations can be estimated.GESAMP-BWWG 2/9

ANNEX 5 Page 15

I:\MEPC\55\2-16.doc 8 ENVIRONMENTAL EFFECTS

8.1 Aquatic toxicity of Active Substance & Relevant Chemical

8.1.1 Acute aquatic toxicity

The data on the acute toxicity of the Active Subs tance and the Relevant Chemical is shown in
table T8.1.

Table T8.1 Overview of acute toxicity data.

Test
Substance F
C

A Species Effect Value (mg/L)

F Oncorhynchus mykiss 96h LC 50 0.0093

C Missing Ozone

A Missing

F Cyprinus carpio 41h LC 50 0.26

C Polycelis nigra 24h LC 50 32

M Crassostrea gigas 24h NOEC 32 Bromate
ion

A Missing

F = Fish, C = Crustacea, A = Algae, M = Molluscs

8.1.2 Chronic aquatic toxicity

8.1.2.1 The data on the chronic toxicity of the Ac tive Substance and the Re levant Chemical is
shown in table T8.2.

Table T8.2 Overview of chronic toxicity data.

Test
Substance F
C

A Species Effect Value (mg/L)

F Oncorhynchus mykiss 90d NOEC 0.005

C Missing Ozone A Missing

F Missing

C Missing Bromate
ion A Skeletonema costatum 7d NOEC 0.125

8.1.3 Derivation of the Predicted No Effect Concentration (PNEC)

8.1.3.1 As the group accepts the minor role of ozone after the treatment of the ballast water the
risk assessment has been focussed on bromate i on. Therefore only for bromate the PNEC has been derived. The acute toxicity data presente d in the Table T8.1 is considered complete for bromate but Table T8.2 does not show a complete data set for the chronic toxicity of bromate.

8.1.3.2 To establish the PNEC the lowest value of the acute a nd of the chronic data are considered: 41h LC50 = 0.26 mg/L for Cyprinus carpio and 7d NOEC = 0.125 mg/L forGESAMP-BWWG 2/9

ANNEX 5 Page 16

I:\MEPC\55\2-16.doc Skeletonema costatum . Applying an assessment factor of 1000 to the first and of 100 to the
second reveals a PNEC of 0.26 μ g/L as the lowest value. Furthe rmore, no chronic toxicity data
are available for the most sens itive group of species (fish). Therefore, the value of 0.26 μ g/L is
considered the PNEC.

8.2 Aquatic toxicity of treated ballast water

8.2.1 The Group noted that the Comp any had indicated that ther e were no existing chronic toxicity data for either ozone or bromate ions. However, chronic toxicity tests had been carried out on the treated ballast water containing bromat e ions following treatment with ozone at the maximum recommended rate of 4mg/L. The results of these experiments are show in Table T8.3.

Table T8.3 Results of chr onic toxicity experiment.

Test
Substance F
C

A Species Effect Value

F Oryzias javanicus 21d NOEC 100% treated ballast

water
C Hyale barbicorins 21d NOEC 100% treated ballast

water Treated ballast water containing

bromate ions (0.16 mg/L as TRO) A Skeletonema costatum 72h NOEC 100% treated ballast

water

8.2.2 The Group concluded from this experiment th at no chronic toxicity of treated ballast water was measured and, furthermore, that exposure of the environment will not exceed a concentration of 0.16 mg/L as TRO.

9 ENVIRONMENTAL RI SK CHARACTERIZATION

9.1 PBT assessment

9.1.1 Based on the assessment of PBT shown in the table below, the Group agreed that neither
ozone nor bromate ion should be classified as PBT chemicals

Compound Persistence (P)
1⁄2 Life:
>60d in seawater
>40d in freshwater
>180d in sea sediment
>120d in fw sediment Bioaccumulation (B)
BCF > 2000 Log Pow >3 Toxicity (T) Chronic NOEC<0.01 mg/l

Ozone No No Yes

Bromate ion No No No

9.2 Assessment of treated ballast water

9.2.1 According to the experiment carried out (see section 8.2) it was established that a concentration of 0.16 mg/L of TR O did not affect several orga nisms after treatment of 100%
ballast water with ozone.GESAMP-BWWG 2/9

ANNEX 5 Page 17

I:\MEPC\55\2-16.doc 9.2.2 However, the group considered that there wa s a discrepancy between the toxicity data available on bromate (see Tables T8.1 and T8.2) resulting in a derived PNEC for bromate of

0.26 μ g/L and the concentration of bromate in treate d ballast water at 0.16 mg/L causing no effect in the chronic toxicity tests with tr eated ballast water (cf., Table T8.3).

9.2.3 As a result it was agreed that before a fi nal assessment can be made, further information
or clarification is n eeded on this point.

9.3 Environmental risk assessment

9.3.1 The Group noted that the half-life for ozone in seawater was 5.3 s to 30 min. depending on the ambient conditions and so would be degrad ed prior to being released into the marine
environment.

9.3.2 It was noted that the lowest measured acu te toxicity for bromate ions was 0.26mg/l and
that the lowest chronic No Effect Concen tration (NOEC) for br omate ions was 0.125mg/l resulting in an estimated PNEC of 0.26 μ g/L whilst the concentration of bromate ions in the ballast water prior to discharge was commonly 0.16 mg/l (measured as TRO).

9.3.3 However, the Predicted Environmental Con centration (PEC) in th e Rotterdam harbour had been calculated using the MAM-PEC model (version 1.6) for th e following concentrations of
the bromate ions measured as Total Residual Ox idant (TRO) which might be present in ballast water prior to discharge:

.1 0.16 mg/l anticipated normal concentra tion 48h after ozone treatment with discharge treatment; .2 1.6 mg/l anticipated concentrati on without discharge (decomposition)
treatment; .3 3.44 mg/l average concentration imme diately after ozone treatment; and .4 4.56 mg/l concentration following th e maximum concentration of ozone

treatment.

9.3.4 It was noted that cases .3 and .4 were both acci dental discharges which are not realistic to model for a 10 year period. The PEC values for scenarios 3 and 4, given in the Table 9.1 below, are therefore highly conservative.

Table T9.1 Risk assessment for bromate (as TRO)

Bromate discharge PEC in harbour after 10y (μg/l) PNEC (μg/l) PEC/PNEC

0.16 mg/l 0.722 0.26 2.78

1.6mg/l 7.22 0.26 27.8 3.34mg/l 15.1 0.26 58.1 4.56mg/l 20.6 0.26 79.2

9.3.5 It was noted that on page 16 section 9.2 in th e dossier the applicant concluded that long term effects will be sufficiently secured wit hout decomposition treatment. However, the Group considered that this was an analysis performed without the use of an as sessment factor. As a result, it was agreed that treatment at discharg e (decomposition treatment) would be necessary to
achieve PEC/PNEC values below 1.GESAMP-BWWG 2/9

ANNEX 5 Page 18

I:\MEPC\55\2-16.doc 9.3.6 These results of the model MAM-PEC shoul d be evaluated with care and should be considered as indicative values only. As suita ble emission scenarios are not available to the Group, it would be useful to evaluate potential m odels, in future, for their usefulness in the
evaluation of Active Substances under G9.

9.3.7 Based on this estimation, the risk for aquati c organisms after exposure to bromate ions produced during ozone treatment of ballast water cannot be ruled out.

9.3.8 Bromoform: The applicant considered the substance bromoform not as a Relevant Chemical. However, the GESAMP BWWG does not agree with this. Although bromoform may be formed in quite small quantities the mere possi bility of formation of bromoform together with the known characteristics, phys/chem., fate, ec otoxicity and mammalian toxicity, the Group
considers that an assess ment of the formation of bromofor m should be done before application for Final Approval.

10 CONCLUSIONS AND RECOMMENDATIONS

10.1 Risks to safety of ships

10.1.1 It was noted that the applicant had indi cated that the need for corrosion resistant materials, due to the corrosive effect of oz one, would be limited to the additional piping and equipment required for the fitting of the treatment system.

10.2 Risks to crew

10.2.1 It was recognized that, as ozone is generate d as required, there will not be a need to store the Active Substance. As a result, the only pote ntial exposure of the crew will be from leaks around the generator and its associated piping when the ballast water is being treated.

10.2.2 However, the Group noted that there was a poten tial risk to the health of the crew arising from the exposure to ozone from accidental syst em leakage. It was acknowledged that the submission recognised this risk and identified onboa rd risk control measures to be put in place that will reduce the possi bility of crew exposure to ozone if a plant leak age should occur. The group also identified the possibility that bromin ated trihalomethanes (THM’s), which are known to be potentially carcinogenic, could be presen t in the ballast tanks as a consequence of the disinfection process, and that this potential risk to crew health should, eventually, be further explored by monitoring this class of chemicals. It was also felt that there was a possibility that the process itself could give rise to excessive noise levels in the vicinity of the treatment unit.

10.2.3 This potential exposure scenario affects th e way the hazardous properties of the Active
Substance and Relevant Chemicals need to be co nsidered when evaluating the risks to the crew.

10.3 Risks to the environment

10.3.1 Under normal operating conditions it is expected that the di scharge concentration of TRO will be about 0.16 mg/L as TRO. Compared w ith the derived PNEC for bromate of 0.26μg/l, a dilution of more than 500 times would be requir ed before long-term toxi city can be avoided. The Group was not aware of information that a llows an evaluation of whether this can be
obtained under realistic and representative conditions.GESAMP-BWWG 2/9

ANNEX 5 Page 19

I:\MEPC\55\2-16.doc 10.3.2 However, provided that a sufficient dilution of discharge ballast water can be assured, the Group was of the opinion that prototype develo pment and testing could be conducted without unreasonable risks to the aquatic environment. This conclusion does not prejudice any future conclusions regarding environmental risks associ ated with full-scale operational implementation of the proposed BWMS.

10.3.3 Moreover, the formation of the chemical bromoform has not been considered as a potential hazard. According to the Group, this substance should have been identified as a Relevant Chemical and, therefore, an appropriate Risk Assessment should have been carried out.

10.4 Recommendations

10.4.1 Having considered the available inform ation the Group recommended that Basic Approval is given to this propos al. The Group also recommended that Basic Approval should be limited to further prototype developm ent and type approval testing only.

10.4.2 Furthermore, the Group recommended that th e following conditions should apply during the further development and testing of the proposed system:

.1 due consideration should be given to the fact that the risk assessment currently performed has been based upon an incomple te data set and therefore the risk
assessment should be considered as indi cative only. A complete data set may
result in a different conclusion.

.2 due consideration should be given to the fact that the information on the substance bromoform as a possible Relevant Chemical is considered insufficient for a risk assessment on this chemical on all topics, therefore, additional information should be provided on this substance.

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

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

.5 it should be confirmed that noise levels when the system is in operation remain within permitted levels for machinery spaces; and

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

.7 the apparent discrepancy between the m easured chronic toxicity of the treated
ballast water and the assessment of brom ate should be investigated further. Awaiting the results of such investigations , the discharge of ba llast water treated with ozone during further development a nd testing should only take place under
controlled conditions and into an environment where a sufficient dilution can be assured for avoiding unreasonable ri sks to the aquatic environment.GESAMP-BWWG 2/9

ANNEX 5 Page 20

I:\MEPC\55\2-16.doc 10.4.2 The Group suggested that MEPC invites the Admi nistration of Japan to ensure that all the above conditions are taken into account and appropr iate measures are put in place during further development and testing of the Special Pipe Ba llast Water Management System (combined with Ozone treatment).

10.4.4 Furthermore, the group emphasized that it could not judge whether a full-scale deployment would cause unacceptable environmenta l damage as no repres entative and realistic emission scenarios are available. Consequently, suitable realistic scenarios describing emissions of treated ballast water into representative wa ter courses should be de veloped, documented and applied for assessing the environmental risks under full-scale deployment of the proposed system. Such scenarios should desc ribe various release s ituations with regard to dimensions of the receiving environment, water flow and exch ange, number of ships, frequency, duration and volume of discharges of treated ballast water, etc. The Group encouraged MEPC to consider the development and agreement of such emission scenarios, which should then be applied by the applicant in an eventual application for Final Approval.

***GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc ANNEX 6

REVIEW OF PROPOSAL FOR APPR OVAL OF ACTIVE SUBSTANCE

Ozone - submitted by the Republic of Korea

0 SUMMARY

0.1 The Group noted that the application took the fo rm of a general concept for a system to be developed. As such, there were no firm proposals for the actual BWMS to be installed and so this aspect could not be evaluated.

0.2 The Group noted that the applicant had id entified bromate ions and bromoform as Relevant Chemicals formed as by-products from treating ballast water with ozone.

0.3 The Group noted that bromate ion has a high potential for mutagenicity and carcinogenicity and therefore human exposure should be avoided comple tely. This is particularly important if the crew has to enter a ballast water tank after treatment.

0.4 However, as the application only provided ge neric details on the safety requirements for the proposed system, it was not possible to evalua te it adequately. In addition, no information was supplied regarding the potentia l corrosivity of the Active Substance or Relevant Chemicals to the materials of construction of the ship a nd the associated equipment to be used in the proposed system.

0.5 As no information had been provided on the do se of ozone to be us ed in the application, the Group could not give an estimation of the concentration levels of ozone and Relevant Chemicals expected to be found in the environment.

0.6 However, the Group anticipate d that ozone would not presen t an environmental risk due
to its short half-life but the levels of bromat e ions (TRO) and bromoform would need to be thoroughly investigated before a recommendation related to Basic Approval could be anticipated.

0.7 Due to the lack of required data, the Group we re unable to carry out any meaningful Risk
Assessment and so do not recommend that this system be given Basic Approval

1 INTRODUCTION

1.1 The data for this product were extracted from data supplied by the Republic of Korea to support its submission MEPC 55/2/3 and supplemen ted by additional information identified by the Group. Where more than one value were iden tified for any of the properties, only those considered by the Group to be the most rele vant were included in this summary dossier.

2 COMPLETENESS OF DOSSIER

2.1 The Group noted that information about th e following subjects was not included in the
dossier:GESAMP-BWWG 2/9

ANNEX 6 Page 2

I:\MEPC\55\2-16.doc .1 quality control/quality assurance programm e implemented in the testing process of the Ballast Water Management System;

.2 an overview of the ballast water manage ment system (BWMS) with description of the components of the system;

.3 an overview of how the BWMS may be integrated to the ships ballast water system and how control of the system is to be effected;

.4 the planned dosage of ozone to be inject ed into the ballast water and applied in several of the experiments presented in the dossier. This information was later provided by request from the Group in a m eeting with technical experts from the applicant and in an email dated 25 May 2006;

.5 how ozone will be injected into the ballast water pipe;

.6 safety considerations regarding the pres ence of free ozone in the ballast tanks; and

.7 a full consideration of the corrosive imp lications arising from the use of ozone.

3.0 DESCRIPTION OF BWMS

3.0.1 It was noted that the submi ssion indicates the inte ntion to select a sh ip, design a single point Ozone injection system for this ship, insta ll the system and test effectiveness. Only the general concept for such a system was provided with no firm proposals for the actual BWMS to be installed. The generic safety requirem ents for an ozone system were provided.

3.1 Application

3.1.1 It was noted that the only component of the BWMS identified in the dossier was the application of ozone generated onb oard as ballast water treatmen t to be applied through a single point injection system.

3.1.2 The submission indicated that whilst ozone has been used to disinfect drinking water safely , the presence of bromide ions in seawater leads to the formation of bromate ions and bromoform which is not the case with drinking water.

3.2 Active Substance(s)

3.2.1 The Active Substance in this BWMS is ozone.

3.2.2 When ozone is injected into seawater, it wa s noted that the appli cant had indicated that the following Relevant Chemicals will be formed:

.1 bromate ion (BrO 3 - ) is produced from the reaction of ozone with bromides in seawater. It will be found as an equ ilibrium between bromate ion, hypbromous acid and sodium bromate; and

.2 bromoform (CHBr 3 ) is produced from the reaction of ozone with naturally occurring organic matter in water used for ballast.GESAMP-BWWG 2/9

ANNEX 6 Page 3

I:\MEPC\55\2-16.doc 3.2.3 It was noted that another proposal submitted for the use of ozone as the Active Substance to treat ballast water, did not indicate that bromoform would be pr oduced in potentially significant amounts.

3.2.4 Identity of Active Substa nce and Relevant Chemicals

3.2.4.1 Table T3.1 gives the information on the identity of the Active Substance whilst Table T3.2 gives the identity informa tion for the Relevant Chemicals.

Table T3.1 Identification on the Active Substance.

Chemical

name CAS number (UN number) Molar mass Empirical
formula Structural
formula Purity

Ozone 10028-15-6 (1956) 48.00 O 3 10 – 15%
w/w

Table T3.2 Identification on the Relevant Chemicals.

Chemical

name CAS
number (UN number) Molar mass Empirical
formula Structural formula Purity

Hydrogen hypobromite 13517-11-8 96.91 HOBr HO-Br By-product

Bromoform 75-25-2 (2515) 252.73 CHBr 3 By-product

Bromate ion 15541-45-4 127.90 BrO 3 - By-productGESAMP-BWWG 2/9

ANNEX 6 Page 4

I:\MEPC\55\2-16.doc 4 PHYSICOCHEMICAL PROPERTIES

4.1 The following table (T4.1) shows the proper ties of the Active Substance (Ozone) and
Relevant Chemicals.

Table T4.1: Physicochemical properties of Active Substances and Relevant Chemicals

Physical property Ozone Sodium bromate Potassium bromate Bromoform
CAS number 10028-15-6 7789-38-0 7758-01-2 75-25-2 Molecule weight 48 150.90 167.01 252.77 Melting point Missing 38°C ???? 350°C 8.0-8.5 °C
Boiling point -111.9°C Missing At 370°C decomposes 149.5 °C

Flash point Missing Missing Missing Missing Density (20°C) 2.14 kg/m 3 3.339g/m 3 3.27 g/m 3 Missing Vapour pressure @ 20°C (Pa) 5460000 Missing Missing 0.667

Vapour density (air=1) 2.144 g/l @ 0°C Missing Missing 8.72 (air = 1) (calculated)

Water solubility Missing 275 g/l @ 0°C 909 g/l @ 100°C 133 g/l @ 40°C 497.5 g/l @ 100°C 3100mg/l (25°C)

pH in solution Missing Missing Missing Not available
Octanol / water partition coefficient (log Pow) 0.38

Dissociation constant(pKa) Missing Missing Missing 2.06

Oxidation reduction potential 2.07 E

o (V) Missing Missing Missing

Corrosivity to
Material Yes Missing Missing Not corrosive

Reactivity to
container material Missing Missing Missing Missing

Auto ignition temperature (°C) Missing Missing Missing Missing

Explosive Properties Yes Missing Missing Missing

Oxidizing properties Powerful oxidiser Missing Missing Missing

Surface tension Missing Missing Missing 46.18 mN/m at 15 °C Viscosity Missing Missing Missing 2.15 mPa.s (dynamic) Thermal stability
and breakdown product Missing Missing Missing Gradually decomposes at elevation of temperature

Other physical and Chemical property Missing Missing Missing Missing

4.2 It should be noted that the mi ssing data in the table T3 above might be important for a full assessment. If it is not applicable or relevant then this should be indi cated and the reason given.

5 HUMAN HEALTH HAZARDS

5.0.1 Based on existing literature data concerning ozonation as a disinfection system and taking into account that the presence of bromide ion in the seawater leads to the formation of additional brominated DBPs (Disinfectant By-Products), the Group decided to treat bromoform also as Relevant Chemical and thus, whenever the inform ation is available, to consider it along with bromate as to human toxicological effects assessment.GESAMP-BWWG 2/9

ANNEX 6 Page 5

I:\MEPC\55\2-16.doc 5.1 Acute toxicity

5.1.1 The acute toxicity data evaluated by the Group are presented in the following tables:

Ozone Exposure Route Value ra nge Species Reference

Inhalation LC 50 (mg/L/4h) 0.012 – 0.014 Mouse Cheminfo by CCOHS (Canadian Centre for Occupational Health and Safety)

Oral LD 50 (mg/kg bw) n.a.
Dermal LD 50 (mg/kg bw) n.a. n.a. not applicable

Bromate Exposure Route Va lue Range Species Reference

Oral LD 50 (mg/kg bw)) 280-495 Rats, Mice, and Hamsters WHO, 2005 Sub-acute toxicity NOAEL oral (mg/kg bw/day) 2 weeks 108 (based on changes in enzyme activities) SPF mice WHO, 2005

Bromoform Exposure Route Va lue Range Species Reference

Oral LD 50 (mg/kg bw)) 1388-1550 Rats and Mice EHC 216, 2000

5.1.2 The Group accepted the non submission of oral and dermal toxicity data for ozone due to
the fact that it is a gas and thus inhalation is the main exposure route of concern. However, it would be advisable that a justif ication covering this aspect was presented by the applicant. The same applies as above for the acceptance of mi ssing inhalation and dermal toxicity data for
bromate.

5.1.3 Ozone : from submitted information and several studies in humans mentioned in literature (EHC 216, 2000), the group concluded that even very low doses of ozone can be harmful to the upper respiratory tract and the lungs. In addition, th ere seems to exist synergetically effects, as exposure to very low concentratio ns initially increases reactivity of the airways to other inhaled substances (bronchial hyperres ponsiveness) and cause inflammato ry response in the respiratory tissue. Other symptoms observed following acute exposure to 0.5-1.5μg/L (0.25 - 0.75 ppm) include cough, shortness of breat h, tightness of the chest, dyspnea, headache and nausea. More severe symptoms have been observed following concentrations higher than 0.02mg/L (1ppm) that included reduce lung function, extreme fatigue, dizziness, inability to sleep and cyanosis. An acute occupational exposure to approximate ly to 0.022mg/L (11 ppm) caused severe respiratory irritation and almost caused unc onsciousness. A 30 mn exposure to 0.1 mg/L (50 ppm) is considered potentially lethal.

5.1.4 Bromate : lethal doses seem to be very similar across rodent species, also the toxic signs and symptoms; at autopsy, hyperaemia of the stom ach was observed and congestion of the lungs. Also, damage to renal tubules including necrosis in the proximal tubular epithelium. Sub-acute adverse effects from bromate (potassium bromat e) were reported in a oral study made with SPF mice during two weeks as changes in enzyme activities, at doses of 270mg/kg bw/day and above. A NOAEL was set at 108mg/kg bw/day (WHO, 2005).

5.5.5 Bromoform: among the brominated THMs, bromoform is ranked as the least potent as a
lethal acute oral toxicant. Toxic signs are reported relating to disruption of renal function.GESAMP-BWWG 2/9

ANNEX 6 Page 6

I:\MEPC\55\2-16.doc 5.2 Effects on skin and eye

5.2.1 Ozone : based on applicant’s submitted inform ation (EHS, 1990), ozone seems not to cause any adverse effect on the skin but is irr itating to the eyes when exposed to 4mg/L (2ppm) for several minutes; other information (CCOHS) re fers that ozone gas can probably cause skin irritation due to its oxidizing ability, but only at concentrations capable of causing severe respiratory injury.

5.2.2 A summary of the skin and eye irritancy poten tial of ozone and bromat e ions is shown in the following table:

Ozone Observation Species Reference/Comments

Skin Not irritant EHP (1990) Eyes Irritant (>0.04mg/L for several minutes) Human EHP (1990)

Bromate

Skin Irritant Human RTECS Eyes Irritant Human RTECS

5.3 Irritation to the respiratory tract

The Group noted that inhalation exposure to oz one causes coughing and/or breathing difficulties at 0.03μg/L to 1.2μg/L (0.015-0.6 ppm) (inf ormation retrieved from MSDS).

5.4 Repeated dose toxicity

5.4.1 Ozone : from the available information, it was not possible to address the dose-response effects in relation to repeated inhalation exposur e (sub-chronic, 90 days) to ozone. However, the Group may predict similar effect s on the lungs of humans and other mammals even at low concentrations. In addition, it is referred in literature that the se verity of respiratory responses seem to be reduced following repeated daily exposures due to an apparently “functional adaptation”.

5.4.2 Bromate: it was noted that the exposure of rats to bromate for 15 weeks demonstrated a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg bw/day. One study via oral route, made with F344 rats, for 13 weeks, showed, at a dose of 63 mg/kg bw/day, adverse effects with significant increases in blood serum parameters indi cative of liver and kidney toxicity (including glutamate oxaloacetate transaminase, lactat e dehydrogenase, cholines terase and blood urea nitrogen).

5.4.3 Bromoform: a 13-week study was performed in rats where a NOAEL of 25mg/kg bw/day could be derive d on the basis of the absence of liver lesions whereas in the study in mice was 100mg/kg bw/day (NTP, 1989).

5.5 Chronic and long-term toxicity

5.5.1 Ozone: in a series of well conducted st udies, mice and rats exposed to 0.01-0.02mg/kg bw/day for 105 to 130 weeks had increased incidence of non-carcinogenic lesions of the nose and lungs (N TP,1994). Several studies also ex amined the effects of the longterm effects on monkeys. Exposures ranging from 0.003-0.013mg/kg bw/day for 3-18 monthsGESAMP-BWWG 2/9

ANNEX 6 Page 7

I:\MEPC\55\2-16.doc consistently showed significant st ructural alterations to lungs. Many of them seem to be
irreversible six months afte r exposure stopped (COSHH).

5.5.2 Studies in humans examining the potential effects of long-te rm occupational exposures to ozone have reported headaches, irritation to nose and throat, chest constriction and lung congestion in exposed workers. These studies suggest that long-term exposures to ozone may result in impaired lung function which is consistent to animal studies results.

5.5.3 Bromate: the systemic toxicity of bromate (adm inistered as potassium salt) has been reported from long-term studies designed to eval uate bromate carcinogenicity in F344 rats and B6C3F1 mice (WHO, 2005). The data show that the kidney is the major target organ of bromate-associated toxicity and that rats are more sensitive than mice to bromate treatment.

5.5.4 Following 15 months’ exposure to 30mg/kg bw/day of bromate in drinking water, changes to the kidneys of the exposed rats were observed al ong with increased blood urea nitrogen and structural abnormalities of the cor tical tubules. From these observations, NOAEL could not be determined but a LOAEL of 30mg of bromate/kg bw/day had been identified as part of the study.

5.5.5 Bromoform was studied in a 2-year study with ra ts resulting in a small increase in tumours of the large intestine, at dose of 200mg/kg bw/day.

5.6 Mutagenicity/Genotoxicity

5.6.1 Ozone: there are a number of studies in l iterature to examine the potential for mutagenicity of ozone in humans but due to some deficiencies not all of them seem to be
conclusive.

5.6.2 However, the Group noted that positive results (cytogenetic aberrations) were observed in the lymphocytes of hamsters exposed to 0.0048-0.086mg/kg bw for 5 hours and in the lung macrophages of female rats exposed to 0.0024-0 .016mg/kg bw for 6 hours. However, several studies have shown that ozone is mutagenic in bacteria and in mammalian and human cells

in vitro following inhalation exposure (NTP, 1994; Mutation Research, 1992).

5.6.3 Bromate: in particular potassium bromat e, is considered mutagenic both in vitro and

in vivo . In fact, positive results were obtained in bacteria test (Ames test), chromosome
aberrations in cultured Chinese hamster fibrobl ast cells, acute cytogenetic effects on rat bone
marrow cells and in the mouse micronucleus test.

5.6.4 Bromoform: bromoform is largely positive in b acterial assays of mutagenicity and appeared to be more potent than the other brominated THMs. In vivo studies have given contradictory results.

5.6.5 From the available information, the Group conc luded that there may be a concern towards the mutagenicity/genotoxicity potential of ozon e following inhalation exposure and towards subsequent brominated by-products , in particular potassium brom ate, following oral exposure.GESAMP-BWWG 2/9

ANNEX 6 Page 8

I:\MEPC\55\2-16.doc 5.7 Developmental and reproductive toxicity

5.7.1 Ozone: a study reported offspring of rats con tinuously exposed to 0.02 or 0.03mg/kg bw for four days during middle or la te pregnancy had reduced growth rates after birth and delayed behavioural development. Matern al toxicity was not reported.

5.7.2 Another study reported a decrease in foetal body weight gain in the offspring of mice exposed to 0.024 but not to 0.008 or 0.016mg/kg bw , on days 7-17 of pregnancy. Signs of maternal toxicity were observed (Tox. Applied Pharmac.,1979).

5.7.3 Embryotoxicity (increased resorptions) was observed in rats exposed to 0.03 and 0.04mg/kg bw, but not 0.013-0.025mg/kg bw. Matern al toxicity was not reported (COSHH).

5.7.4 Continuous exposure of mice from six days prio r to mating to postnatal day 22 resulted in reduced body weight and slight effects in ne urobehaviour development of the offspring. Maternal toxicity was not evaluated (Arch.Toxicology, 1995).

5.7.5 No effects on reproductive performance (proport ion of successful pregna ncies, litter size, offspring viability and sex ratio) were noted in mice exposed for six days prior to mating to postnatal day 22 (dose was not referred) (Arch.Toxicology, 1995).

5.7.6 Bromate : no effects on reproductive performan ce had been observed in a study made
with rats and mice fed with 15mg potassium bromate per kg body weight over five and eight generations, respectively. Based on the test re sults, the Group concluded that bromate does not indicate to have developmen tal or reproductive toxicity.

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

5.8 Carcinogenicity

5.8.1 Ozone: no data were submitted by the applicant for the carcinogenicity potential assessment of ozone. From a study with rats and mice expos ed to 0.0024, 0.01 and 0.02mg/kg bw of ozone for 105 to 130 weeks, ther e was no evidence for carcinogenicity in male and female rats, inconclusive evidence in male mice, and some evidence in female mice. Ozone did not have tumour promoter properties (NTP, 1994).

5.8.2 No human carcinogenicity information relate d to ozone exposure wa s available. The
American Conference of Governmental Industri al Hygienists (ACGIH) has designated this
chemical as not classifiable as a human carcinogen (A4).

5.8.3 Bromate: is an active oxidant in biological sy stems and has been shown to cause an increase in renal tumours, peritoneal mesothelio mas and thyroid follicular cell tumours in rats,
and to a lesser extent in hamsters and mice. Th e lowest dose at which an increased incidence of
renal tumours was observed in rats was 6mg/kg bw/day.GESAMP-BWWG 2/9

ANNEX 6 Page 9

I:\MEPC\55\2-16.doc 5.8.4 A clear dose-response relationship has been observed in tumour incidence and the severity/progression of tumours. The weight of evidence clearly indicates that bromate has the potential to be human carcinogen.

5.8.5 IARC classified it in Group 2B (possible human carcinogen).

5.8.6 Bromoform: IARC has evaluated carcinogenicity of bromoform and concluded that there is inadequate evidence for its carcinogeni city in humans and limited evidence for its carcinogenicity in experimental animals. IARC classified Bromoform in Group 3 (not
classifiable as to its carci nogenic potential to humans).

5.9 Toxicokinetics

5.9.1 Ozone : is absorbed in both the upper and lower resp iratory tract. It is a potent oxidant that reacts with protein and lipids, particularly within biological membranes. A small amount of inhaled ozone is absorbed into the blood. The extreme reactivity of ozone limits its ability to
accumulate.

5.9.2 Bromate: following from oral administration, bromat e is rapidly absorbed from the GIT. It was not detected in rat tissues following intragastric dose, but was significantly increased in plasma, red blood cells, pancreas, kidne ys, stomach, and sm all intestine.

5.9.3 Bromate may be converted into hypobromic acid by hypochloric acid in the stomach. Liver and kidney tissues may degrade bromate to bromide by a process involving glutathione, although only small amounts appear to be reduced in this way. Br omate is excreted mainly by urine as bromate and bromide; some may also be eliminated by faeces. Bromate concentrations in urine peak at about 1h, and bromate is not detectable in plasma after 2h.

5.9.4 Bromoform : toxikocinetic information was not found by the Group however some
considerations can be draw. Although bromoform appear to have greater propensity for metabolism, it appears to be less potent toxicant and carcinogen based on the NTP (1985,1987) bioassays and numerous in vivo toxicity studies. A possible expl anation is less bioavailability resulting from the greater lipophilicity of th is compound (logPow~240) which, together with greater reactivity of bromoform metabolites, may also prevent it from reaching critical target
sites.

5.9.5 Bromoform : Limited data indicate that bromoform is rapidly and efficiently taken up by the Gastro Intestinal Tract (GIT) but further st udies to confirm and refine estimates would be
valuable. No toxicokinetic data exist for inhalation exposure and dermal absorption. Of particular interest would be studies that seek to clarify the role of metabolism in toxicity, the mechanism by which metabolites and adducts le ad to toxic effects, and the protective
mechanisms such as cellular antioxi dants. Available toxicity data indicate that target tissues are similar in humans, rats and mice. Limited data suggest that effect leve ls are generally similar across species (US Department of Health and Human Services, 2005).

5.9.6 Although bromoform has greater propensity for metabolism, it appears to be less potent toxicant and carcinogen than other brominat ed THM based on the NTP (1985,1987) bioassays
and numerous in vivo toxicity studies. A possible explanatio n is the less bioavailability resulting from the greater lipophilicity of this compound (logPow~240) wh ich associated to greater reactivity of bromoform metabolites, may prev ent it from reaching critical target sites.GESAMP-BWWG 2/9

ANNEX 6 Page 10

I:\MEPC\55\2-16.doc 5.10 Conclusions from Human Health Hazard Assessment:

5.10.1 From the human health effects assessment a nd taking into considera tion the substances at
the effective concentrations in the disinfection process descri bed in the republic of Korea’s Application Dossier, the Group was able to reach the following conclusions:

5.10.2 Ozone: very toxic by inhalation route and theref ore highly recommenda ble to apply strict mitigation measures to avoid human inhalation expos ure during the process. In addition, by oral exposure and due to its oxidant properties, there may be a conc ern towards ozone potential for mutagenicity.

5.10.3 Bromate (potassium bromate): several st udies indicate high potential for mutagenicity/carcinogenicity in humans. The current MCL (Maximum Contaminant Level) in the United States is 0.010mg/L and the maximum c ontaminant level goal is zero, because of the possibility that bromate may func tion as a genotoxic carcinogen. Therefore the exposure should be totally avoided.

5.10.4 Bromoform and other brominated DBP: as highly reactive compounds capable of bioaccumulating, exposure to these on the long-term should be minimized.

5.10.5 Other relevant factors whic h have to be taken into acc ount when assessing human exposure towards chemicals:

.1 the variability in individual sensitivity; and

.2 the fact that complex mixtures of disi nfectants and DBPs, according to the actual knowledge, interact in an additive way, at low concentration. Therefore, the Group raised an additional concern about the potential for cumulative toxicological effects of the mixture of chemicals genera ted by the system proposed by the Korean Application

6 RISKS TO SAFETY OF SHIP AND CREW

6.1 The Group noted that the dossier provided ge neric safety requirements required for an ozone system. However, no indication was give n on how these requirements are to be applied when such a system is used onboard a ship. Ther efore a quantitative assessm ent of the risks with such an application and use of ozone was unobtainable.

6.2 The proposal indicates that the pr oduction of the carcinogenic Brominated Trihalomethanes (THM’s) may be significant but no risk mitigation measures have been proposed.

6.3 An indication of the corrosive properties that may be associated with high oxidising agents and a potential assessment of the corrosive effect that may be experienced in the ballast tank was provided. However, there appeared to be no consideration of corrosion problems that may be anticipated in ballast water piping as a result of installation of such a system.GESAMP-BWWG 2/9

ANNEX 6 Page 11

I:\MEPC\55\2-16.doc 7 ENVIRONMENTAL FATE AND EXPOSURE

7.1 Environmental fate and behaviour properties

7.1.1 Table T7.1 gives an overview of the data ava ilable for different processes occurring in the
environment.

Table T7.1 Overview of fate processe s for ozone, bromate ion and bromoform.

Property Ozone Bromate ion Bromoform Hydrolysis pH5 (seawater) ≤ 5 sec pH7 (seawater) ≤ 5 sec pH9 (seawater) ≤ 5 sec Photolysis Degradation in seawater Ready biodegradation 1 h Biodegradation W: 38 d
S: 75 d
Sed: 340 d

A: 380 d Sorption (K
oc ) 2.06

Bioconcentration 14 Anaerobic degradation

7.1.2 It was noted that:

.1 bromoform is stable in water;

.2 no information was available the oxidati on or photolysis of bromoform in water;
and

.3 only limited biodegradation had been observed for bromoform.

7.2 Fate in ballast water tanks

7.2.1 As stated in the applicati on dossier the formation of the Active Substance is described with the following reaction equations:

O 3 + Br - O 2 + OBr - k = 160 ± 20 M -1 s -1

O 2 + OBr - 2O 2 + Br - k = 330 ± 60 M -1 s -1

OBr - + H 3 O + HOBr + H 2 O k = 2.09 10 9 M -1 s -1

HOBr + H 2 O OBr - + H 3 O + pKa = 8.8 ~ 9.0

2O 3 +OBr - 2O 2 + BrO 3 - k = 100 ± 20 M -1 s -1

HOBr + NH 3 NH 2 Br + H 2 O k = 7.5 10 7 M -1 s -1

where O 3 and OBr - are considered the real actives a nd k is the reacti on rate constant. In the Figure F1 these main reactions of the chemistry of ozone are depicted.GESAMP-BWWG 2/9

ANNEX 6 Page 12

I:\MEPC\55\2-16.doc Figure F1 Main reaction scheme for ozone.

7.2.2 The Group noted that, as no information ha d been provided on the dose of ozone during the application to ballast water it was not possibl e to give an estimation of the concentration
levels of ozone and the Relevant Chemicals in the environment. Further inquiry revealed that a normal operation procedure would result in a concentration of about 1 mg O 3 /L. The maximum
concentration of O 3 would be 1.7 mg O 3 /L ballast water. It should however be noted that this concentration is applied to the ballast water befo re performing its disinf ecting activity. However, the applicant indicated that the concentration of Ozone released from the tank would be close to

zero.

7.2.3 The group concluded that the main components to take into account for the risk assessment would be bromate (as TRO) and bromof orm. Further consider ations are therefore
focussed on these two chemicals.

7.3 Fate in the environment

Bioaccumulation (B) Test Substance Log Pow BCF B (Yes/No)

Ozone Missing (<1) Missing Missing (No)

TRO Missing Missing Missing

Bromate ion Missing Missing Missing

Bromoform 2.40 (EPI Suite) 14 No

7.4 Environmental exposure

7.4.1 The Group noted that the applicant ha d not provided any information on the environmental exposure risks of the Activ e Substance or Relevant Chemicals.GESAMP-BWWG 2/9

ANNEX 6 Page 13

I:\MEPC\55\2-16.doc 8 ENVIRONMENTAL EFFECTS

8.1 Aquatic toxicity of Active Substa nce/Preparation/Relevant Chemicals

Acute aquatic toxicity data in fish, crustaceans, algae and othe r organisms. The data on the acute toxicity of the Active Substance and the Re levant Chemical is shown in Table T8.1.

Table T8.1 Overview of acute toxicity data.

Test
Substance F
C

A Species Effect Value

F Morone americana 96-h LC 50 0.20 mg/L as TRO

C Daphnia magna 48-h LC 50 0.011 mg/L Ozone

A Nannochloris sp. 72-h E bg C

x <0.45 mg/L as TRO

F Morone saxatilis 96-h LC 50 0.08 mg/L as TRO

C Crab 48-h LC 50 0.08 mg/L as TRO Total
Residual

Oxidant

(TRO) A Skeletonema costatum 24-h E bg C

x <0.1 mg/L as TRO

F Oncorhynchus keta 96-h LC 50 512 mg/L

C Crassostrea gigas 48-h EC 50 30 mg/L Bromate
ion A Missing

F Cyprinodon variegates 96-h LC 50 7.1 mg/L

C Americamysis bahia 96-h LC 50 24.4 mg/L Bromoform

A Skeletonema costatum 168-h IC 50 32 mg/L F = Fish, C = Crustacea, A = Algae

8.1.2 Based on these data the 96-h LC 50 = 0.08 mg/L as TRO is selected as the value to take
into account in the further considerations on the risk assessment. For bromate the 48-h EC 50 = 30 mg/L will be used and for bromoform the 96-h LC 50 = 7.1 mg/L.

8.1.3 No data waivers were considered necessary as all the required data had been provided.

8.2 Chronic Aquatic toxicity of Active Substance/Preparation/Relevant Chemicals

8.2.1 The only data provided on the chronic toxici ty of one of the Relevant Chemicals are
shown in table T8.2.

Table T8.2 Overview of chronic toxicity data.

Test
Substance F
C

A Species Effect Value

F Cyprinodon variegates 28-d NOEC 4.8 mg/L

C Bromoform

AGESAMP-BWWG 2/9

ANNEX 6 Page 14

I:\MEPC\55\2-16.doc 8.2.2 The only value available for deriving a ch ronic PNEC for bromoform is therefore 28-d NOEC = 4.8 mg/L for the species Cyprinodon variegates . This value was used in the
further considerations on the risk assessment.

8.3 Derivation of a Predicted No Effect Concentration (PNEC)

8.3.1 TRO : As for TRO only acute toxicity data are available the PNEC will be derived by an
assessment factor of 1000 on the lowest value: PNEC = 0.08 μ g/L as TRO.

8.3.2 Bromate : As there appeared to be a discrepancy between the data submitted by this applicant and that submitted by another appli cant, the Group decided to use those values calculated for the Japanese submission.

8.3.3 Bromoform: As for bromoform there is one chroni c value available. An assessment factor of 100 is applied to this value resulting in a PNEC chronic = 48 μ g/L and 3 acute data, the lowest of which is 7.1 mg/L. Using an assessment factor of 1000 the PNEC acute is established at

7.1 μ g/L. Of these two data the lowest value is taken as the resu lting PNEC: PNEC = 7.1 μ g/L as
bromoform.

9 ENVIRONMENTAL RI SK CHARACTERIZATION

9.1 PBT Assessment

9.1.1 Three products were identified as being re levant to assess for their Persistence (P), Bioaccumulation potential (B) and th eir Toxicity (T). The assessm ent of these products is shown
below:

Compound Persistence (P)
1⁄2 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

Ozone No No

Bromate ion No

Bromoform Yes No No

9.1.2 The Group agreed that, although no information was available on the B-characteristics of
ozone and bromate ion it was not expected that any of these subs tances would meet the criteria
and should be classified as a PBT substance.

9.2 Assessment of treated ballast water

9.2.1 The Group noted that experiments to determin e the concentrations of Active Substances (Ozone) and Relevant Chemicals (Bromate ions and Bromoform) yielded the following results:GESAMP-BWWG 2/9

ANNEX 6 Page 15

I:\MEPC\55\2-16.doc Concentration (mg/L)

Ozone 1.36 at time zero Total Residual Oxidant (TRO) 5.0

Bromate ion <0.002 (Detection Limit)

Bromoform 0.136 (max. observed)

9.2.2 From these data the group concludes that the maximum concentra tion relevant for the
environment would be TRO and bromoform. Th e concentration for TRO of 5 mg/L and for bromoform 0.136 mg/L would be relevant to take in to account for further exposure of the aquatic
environment.

9.3 Environmental risk assessment

9.3.1 The Group noted that the half-life for ozone in seawater was reported as only 5.8s and so would be degraded prior to being rel eased into the marine environment.

9.3.2 The Group agreed that as the applicant had not provided any information on the Predicted Environmental Concentrations (PECs), it was not possible to carry out a proper

Risk Assessment.

10 CONCLUSIONS AND RECOMMENDATIONS

10.1 Due to missing basic information about th e components of the BWMS which were not
included in the dossier such as:

.1 an overview of the ballast water manage ment system (BWMS) with description of the components of the system;

.2 an overview of how the BWMS may be integrated to the ships ballast water system and how control of the system is to be effected;

.3 how ozone will be injected into the ballast water pipe;

.4 safety considerations regarding the pres ence of free ozone in the ballast tanks; and

.5 a full consideration of the corrosive imp lications arising from the use of ozone.

the Group was not able to carry out a proper eval uation of the hazards or a meaningful Risk Assessment of the system.

10.2 The Group agreed that the risk to the envi ronment related to the presence of TRO and
bromoform should be further assessed.

10.3 The Group recognized that the exposure to th e Active Substance ozone is very limited as the substance will react with organic matter and th erefore degrades rapidly. On the other hand
the formation of bromate and bromoform as a Relevant Chemical are of serious human and environmental concern. Possibly remaining total residual oxidant (TRO) will still be present in concentrations that may cause concern.GESAMP-BWWG 2/9

ANNEX 6 Page 16

I:\MEPC\55\2-16.doc 10.4 With respect to the environment, the applic ation of ozone as an Active Substance results
in a concern for the release of total residual oxi dant (TRO) and bromoform. Further elaboration on the risks established by additiona l data may reduce these risks.

10.5 Taking all conclusions together the Group di d not recommend giving Basic Approval for the NK Ballast Water Treatment System submitted by Republic of Korea as there are too many questionable topics th at remain unanswered.

***GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc ANNEX 7

REVIEW OF PROPOSAL FOR THE APPROVAL OF ACTIVE SUBSTANCES

EctoSys TM which generates hydroxyl radicals, free active chlorine and hydrogen

Submitted by Sweden

0 SUMMARY

0.1 The Group noted that the proposed system is an electrochemical device which oxidises microorganisms and other contaminants on the elect rode surface. As such, chemicals are neither required to be stored onboard nor generated on demand. However, it was noted that Hydroxyl radicals, Free Active Chlorine and Hydrogen are produced as by-products and should be regarded
as Active Substances and Relevant Chemicals.

0.2 Whilst the applicant indicated that no other harmful substances, such as trihalomethanes, are formed, the Group noted that this was only on small scale tests and so requested further
information once the scale of such tests are increased.

0.3 The Group agreed that the health effects of the Active Substances/Relevant Chemicals are primarily due to acute exposure though 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). As a result, the Group proposed that this aspect should be investigated further.

0.4 Whilst noting that the applic ant had indicated that the levels of hydrogen and oxygen which are formed during the treatment process do not reach hazardous concentrations, concern was expressed that this might not necessarily be the case under all circumstances as the associated safety factor was only x2 and it wa s thought that this might not be enough. As a result, it was proposed that this aspect be investigated further unde r all possible conditions.

0.5 Whilst recognizing that the short-term corrosi vity experiments indicated that the treated
ballast water was not corrosive to the materials of construction, the Group welcomed the fact that the applicant is to carry out furthe r long-term studies in this area.

0.6 Whilst recognizing the difficulties involved, the Group noted that the chemical composition of the ballast water tr eated with the EctoSys system. Furthermore, the Group agreed that most of those identified were degradab le. However, it was proposed that further investigations should be undertaken with halogenated orga nics to show whethe r or not they could
be excluded from the Risk Assessment.

0.7 As the treated ballast water showed si gns of relatively high toxicity, the Group
recommended that ballast water treated with th e EctoSys system would required a relatively high dilution immediately after discharge into the envi ronment in order to avoi d acute toxic effects.

0.8 Taking all factors into acc ount, the Group recommended that Basic Approval is given to the Ectosys system in order to allow further investigation and development to take place. However, the Group stressed that, at this stage, it was not possible to judge whether the system
would be suitable for re commending Final Approval.GESAMP-BWWG 2/9

ANNEX 7 Page 2

I:\MEPC\55\2-16.doc 1 INTRODUCTION

1.1 The data for this product were extracted from the submission of Sweden to MEPC (MEPC 55/2/4) 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 Application Dossier .2 Summary (MEPC 55/2/4)

2.2 The Group noted that an Assessment Report had not been submitted as part of the Application Dossier, but that the Summary, as su bmitted to MEPC 55, was so detailed that no separate Assessment Report was considered necessary.

2.3 The Group further noted that the BWMS was designed for in situ generation of very short-lived active species in the ballast water including hydroxyl radicals and chlorine gas. Due to the short half-life of these species, no data fo r these species were included in the Application Dossier. Further reaction products include free active chlorine and information on various chlorine compounds had been included in th e dossier. Thus, the Group considered the Application Dossier to be complete.

3 DESCRIPTION OF BWMS

3.1 The Group noted that the applicant indicated that the EctoSysTM system is an electrochemical system utilizing electrodes with high oxygen overpoten tial producing powerful disinfectants such as the hydroxyl radical directly into the balla st water, causing oxidation of microorganisms and other contaminants on the electr ode surface. It was further stated that small amounts of harmless disinfecting by -products (i.e., free active chlori ne) are produced that prevent regrowth of species in the tank. Individual modules can be dimensioned for treatment flow rates up to 500m 3 /h. It was also noted that the applicant i ndicated an intention for the ballast water to be typically treated during bot h its uptake and discharge.

3.2 It was also noted that the submission indicated that the Ec toSysTM system generates the
Active Substances in situ and so there are no products to be transported or generated onboard prior to injection into the ballast water.

3.1 Application

3.1.1 The Group noted that the applic ation had indicated that the Ec toSysTM is used for ballast water treatment as the disinfecting step following a mechanical separation of contaminants down to 40-45μm scale. The submission stated that the EctoSysTM comprises an electrochemical cell fitted directly in the ballast water line utilis ing catalytically inactiv e electrodes that produce highly oxidative species without th e problems associated with conve ntional chlorine electrolysis.GESAMP-BWWG 2/9

ANNEX 7 Page 3

I:\MEPC\55\2-16.doc 3.1.2 Furthermore, it was noted that the only proc ess control referred to in the application was “a number of automatic safety clamping devices th at will shut the system off if an external emergency (such as for instance pump failure caus ing decreased flow rates) occurs”. There was no indication of the use of system sensors to monitor the rate of production of the reaction products or control the applied curr ent and so take into account variances in salinity. It was also noted that the application stated that the system is designed for purification and disinfection in high flow applications with c onductive media such as natural s ea water or brackish water, the effect of system in fresh water was not clarified.

3.1.3 The Group further noted that the application da ta provided was mainly based on small-scale pilot equipments and that there wa s indication of possible scaling-up problems that are to be thoroughly investigated and reported during the future test phases. It was agreed that a full assessment and verification of the acceptability of actual system data will be necessary prior to granting a Final Approval to the system.

3.2 Active Substance(s) and Relevant Chemical(s)

3.2.1 It was noted that the submissi on stated that it is not possibl e to make a complete account of all chemical species formed in the reactor, but that the following easily identified Active
Substances and Relevant Chemical s can be produced in detectable concentrations by the small scale system tested prior to the application for basic approval:

.1 Hydroxyl radicals OH·;

.2 Free Active Chlorine which includes the following:

.2.1 Chlorine gas: Cl 2 , .2.2 HOCl and ClO - which react to form sodium hypochlorite at levels of 0.05 - 2 ppm amongst others
.2.3 As the Free Active Chlorine reacts with a range of naturally occurring chemicals it is also referred to as Total Residual Oxidants (TRO); and

.3 Hydrogen gas H 2 (g).

3.2.2 The dossier states that no harmful substa nces such as trihalomethanes (THM) or Absorbable Organic Halogens (AOX) are fo rmed because of cell design and electrode configuration. Table 7 at page 36 in MEPC 55/2/ 4 presents results of analysis performed as documentation for this statement. The Group note d, however, that these tests are only with small scale systems and that other available documenta tion about electrolysis of seawater includes other chemicals that may be formed such as bromate and bromoform. The Group, therefore, recommended that identification of possible Re levant Chemicals should be included in the further assessment of the method together with analysis of these in treated ballast water.

3.2.3 The Group notes further that there is no inform ation in the applicant dossier about Active Substances formed when applying the ballast water treatment system in fresh water.

4 PHYSICOCHEMICAL PROPERTIES

4.1 Physicochemical properties of Relevant Ch emicals formed during application of the proposed system in ballast water ar e presented in the table below.GESAMP-BWWG 2/9

ANNEX 7 Page 4

I:\MEPC\55\2-16.doc Physical property Hydroxyl radical Sodium hypochlorite Hydrogen Bromoform

CAS number 3352-57-6 7681-52-9 01333-74-0 75-25-2
Molecular weight 17.01 74.4 2 252.7

Melting point (°C) -20 to -30 -259°C 8.3°C

Boiling point (°C) 96-120 -253 150° C
Flash point (°C)
Density (20°C)
Vapour pressure @ 20°C (Pa)
Vapour density (air=1)
Water solubility 29.3%
pH in solution
Dissociation constant(pKa) 3100mg/l (25°C)
Oxidation reduction potential Strong oxidiser
Corrosivity to Material 2.06
Reactivity to container material
Auto ignition temperature (°C)

Explosive Properties Anhydrous form is very explosive
Oxidizing properties

Surface tension
Viscosity
Thermal stability and breakdown product Other physical and Chemical property Due to the short half-life (nanoseconds) it is not practical to measure the usual physical properties

All the above data were extracted fr om the manufacturers supporting information (Annex, p11-12)

5 HUMAN HEALTH HAZARDS

5.1 General observations

5.1.1 It was noted that the disinfection system proposed by the Swedish application dossier involves an electrochemical system, EctoSys TM , which generates in practic e an equilibrium solution of chemicals: free chlorine (sodium hypochlorite) and hydroxyl (OH) radicals. The
Active Substances Cl 2 , HOCl, OCl-, and OH radicals ar e produced electrolytically in situ and have presumably a very short-life. Brominated DBPs (Disinfectio n By-Products) will result from the process and will have to be taken into account due to its potential toxicity.

5.1.2 The Group performed a qualitative evaluatio n of the human health effects based on published data whenever there was lack of t oxicological data submitted by the applicant.

5.1.3 Most of the experimental ch lorine toxicity data are found under the WHO drinking-water
disinfectants and disinfectant by-products research program where evidence is normallyGESAMP-BWWG 2/9

ANNEX 7 Page 5

I:\MEPC\55\2-16.doc associated to chlorine administer ed in drinking-water. Although being aware th at this exposure is not particularly relevant to e xposures to chlorine or hypochlorit e in the Ballast Water Treatment processes, the Group consider the data to substantiate the qua litative assessment.

5.2 Acute toxicity

5.2.1 Hydroxyl radicals : systemic toxicity of hydroxyl ions confounds with elevated blood pH. Normal pH of blood is 7.35. The alkalosi s causes hyperactivity to the central nervous system with above pH 7.8, tetanus, extreme ex citability. A short-term mechanism is the respiration compensation. A long-term mechanism is the renal compensation.

5.2.2 Free active chlorine (NaClO -) : irritation, pain, inflammation of mucoses. In severe cases causes ulceration and perforation of gastro in testinal tract. Mild irritation to corrosive injury by dermal route depending on the concen tration. Vapours are not easily formed however with more concentrated solutions and high pH or if mixed with acids higher % of chlorine may be released causing mild to severe irritation of nose and throat. Lethal effects can also occur, derived from aspiration of sodium hypochlorite solution into the l ungs. Health effects depend on concentration and pH of the solution.

5.2.3 Chlorine : Irritant effects on mucoses and skin ar e reported. Acute inflammatory effects of chlorine gas towards the respiratory tract are also well reported because of its use as a chemical warfare agent during World War I (Das & Blanc, 1993). The acute effects seem to be
reversible in 1-4 weeks after exposure. However, two reports suggest that chronic sequelae to acute exposure to chlorine gas may be mo re prevalent than pr eviously appreciated (Moore & Sherman, 1991). The severi ty of the health effects wi ll depend on concentration of chlorine and pH of the solution.

5.3 Effects on skin and eye

5.3.1 Hydroxyl radicals : no available data.

5.3.2 Free active chlorine (NaClO - ) : can cause mild skin irri tation to corrosive injury depending on the duration of cont act, concentration and pH of the solution. In a skin sensitization test, negative results have been obtained for 8% sodium hypochlorite solution.

5.3.2.1 Mild eye irritation to corrosive injury depending on the concentration and pH of the solution and on the duration of contact, as well. If warmed at higher temperature can release significant amounts of gas which is a severe eye irritant. Free Active Chlorine (Sodium hypochlorite) No data provided (values assumed from EC Classification of >10%) Exposure Route Value Species Reference/comments

Inhalation LC 50 (mg/l/4h) >20 Unspecified Not classified by acute toxicity (EC classification)

Oral LD 50 (mg/kg) >2000 Unspecified Not classified by acute toxicity (EC classification)

Dermal LD 50 (mg/kg) >2000 Unspecified Not classified by acute toxicity (EC classification)GESAMP-BWWG 2/9

ANNEX 7 Page 6

I:\MEPC\55\2-16.doc 5.3.3 Chlorine : acute inflammatory effects to expo sed skin. Acute inflammatory effects towards cornea and conjunctiva.

5.4 Irritation to the respiratory tract

5.4.1 Hydroxyl radicals : no available data

5.4.2 Free active chlorine (NaClO - ) : sodium hypochlorite does not easily form vapours
however in more concentrated solu tions and at high pH, form mists that can cause mild to severe
irritation of the nose and throat.

Free active chlorine (NaClO - )

5.4.3 Chlorine : irritant effects by inhalation and ac ute inflammatory effects towards the respiratory tract. This is the major route of con cern, as chlorine gas vapo urs are heavy and settle
down in low areas.

5.5 Repeated dose toxicity

5.5.1 Hydroxyl radicals : no available data

5.5.2 Free active chlorine (NaClO - ) : the concentration required to produce irritation and decreased basal cell viability in the skin of guin ea pigs after an application period of two weeks was 0.5% sodium hypochlorite (equivalent to 139mg/kg bw/day); 0.1% (equivalent to 28mg/kg bw/day) resulted in no effect on basal cell viability relative to control animals (Cotter et al ., 1985).

5.5.2.1 Hasegawa et al. (1986) examined the e ffects of higher concentrations of sodium hypochlorite (0.025, 0.05, 0.1, 0.2 or 0.4%, equivalent to 7, 14, 28, 55 and 111mg/kg bw per day) administered in drinking-water to male and fema le F344 rats for 13 weeks. No evidence of treatment-related pathology was observed in this study.

5.5.2.2 Several rodent studies with administered sodium hypochlorite in drinking-water have suggested immunological changes. Exon et al . (1987) examined immunot oxicological effects of sodium hypochlorite at 5, 15 or 30mg/litre (0.7, 2.1 or 4.2.mg/kg bw per day) in the drinking water of male Sprague-Dawley rats for nine we eks. The effects on macrophage activity suggest that some impairment does occur at relatively low levels of sodium hypochlorite although the significance of which is still unknown. Modificati on of macrophage function seems to be one of the most sensitive responses identified in studies of chlorine or hypochlorite in experimental animals (EHC 216, WHO, 2000). Free Active Chlorine (Sodium hypochlorite) No data provided (values assumed from EC Classification of >10%) Observation Species Reference/Comments

Skin Corrosive after <4h

exposure Unspecified Corrosive (EC Classification)

Eyes Corrosive Unspecified Corrosive (EC Classification)

Observation Species Reference/comments Respiratory

irritation Corrosive Unspecified Corrosive (EC classification)GESAMP-BWWG 2/9

ANNEX 7 Page 7

I:\MEPC\55\2-16.doc 5.5.3 Chlorine : a study from Daniel et al . (1990a) evaluated the toxici ty of chlorine prepared by bubbling chlorine gas into distilled wate r and adjusting pH to 9.4. The nominal concentrations of chlorine were approxim. 0, 3, 10, 16 or 21 mg/kg bw pe r day, administered as drinking-water to both male a nd female Sprague-Dawley rats (10 per sex per dose) for 90 days.

5.5.3.1 No deaths occurred in any treatment gr oup. A NOEL (No Observed Effect Level) of 10 mg/kg bw per day was identifie d by the authors based on redu ced body weight gain however this cannot be considered a true toxicological end-point as can be associated to a reduced palatability of the drinking-water.

5.6 Chronic and long-term toxicity

5.6.1 Hydroxyl radicals : no available data

5.6.2 Free active chlorine (NaClO - ) : from the applicants report it was not possible to conclude if the substance is an occupational sk in sensitizer; however, some sporadic cases are reported in literature.

5.6.3 Chlorine : in a 2-year study, the National Toxi cology Program (NTP , 1992) examined chlorine at 0, 70, 140 or 275 mg/litr e in drinking-water of F344 rats and B6C3F1 mice. The only treatment-related non-tumour pat hology was found to be a dilatatio n of renal tubules in male mice at the highest dose level (275 mg/litre). No non-neoplastic lesions were observed in either
male or female rats.

5.6.3.1 A NOAEL can be derived of approximately 15 mg/kg bw per day in the two-year studies
in rats and mice.

5.6.3.2 Chronic exposure to chlorine gas may cause dyspnea, palpitations, chest pain reactive, upper airways dysfunction syndrome. It is one of the most frequent causes of occupational
asthma.

5.6.3.3 Relevant evidence based on epidemiological studies with survivors from World War I, clearly indicated bronchitis and limited chest and diaphragmatic movement, even emphysema. Most studies suggested high incide nces of acute re spiratory disease and a lesser prevalence of chronic sequelae.

5.7 Mutagenicity/Genotoxicity

5.7.1 Hydroxyl radicals : no available data

5.7.2 Free active chlorine (NaClO - ) : several studies have shown that sodium hypochlorite produces mutagenic responses in b acterial systems and mammalian cells in vitro . However, there is no evidence of activity in mammalian test systems in vivo . It is not clear to what extent this is influenced by the formation of mutageni c by-products as a resu lt of reactions with components of the incubation media (Rosenkranz et al ., 1976).

5.7.3 Chlorine : no available data howeve r, as a strong oxidizi ng agent, chlorine has presumably a potential for chromosomal aberrations, at cytotoxic doses.GESAMP-BWWG 2/9

ANNEX 7 Page 8

I:\MEPC\55\2-16.doc 5.8 Developmental and reproductive toxicity

5.8.1 Hydroxyl radicals : no available data

5.8.2 Free active chlorine (NaClO - ) : some indicative effects of altered sperm shape have
been detected in several studies with chlorina ted drinking-water. Meier et al. (1985b) reported
that oral administration of s odium hypochlorite (pH 8.5) prep ared from chlorine gas and administered at 4 or 8 mg/kg bw per day fo r 5 weeks increased the incidence of sperm
abnormalities in B6C3F1 mice.

5.8.3 Chlorine : in general, animal studies have dem onstrated no reproductive or teratogenic effects of chlorine (Druckrey, 1968) . A number of subse quent studies have studied the effects of chlorine or hypochlorite however th ere is insufficient information to draw conclusions about the potential for developmental t oxicity (EHC 216, WHO, 2000).

5.9 Carcinogenicity

5.9.1 Hydroxyl radicals : no available data.

5.9.2 Free active chlorine (NaClO - ) in most animal studies ther e is a lack of statistical evaluation of the results and lack of dose-resp onse relationship. Sodium hypochlorite is not classified by IARC as to their carci nogenicity to humans (Group 3).

5.9.3 Chlorine : lymphoma has been observed in rela tion to water treatment with chlorine.
Associations with increased renal, bladder and gastric can cers have been registered.

5.10 Toxicokinetics

5.10.1 Hydroxyl radicals : no available data.

5.10.2 Free active chlorine (NaClO - ) : it was shown that hypochlorite does not accumulate in the body, it reacts with ti ssues and apparently is readily absorbed in seru m and eliminated from plasma with a half-life of 44 h.

5.10.3 Chlorine : there are no specific toxicities of chlo rine for which a mechanism needs to be proposed. It is a strong oxidizing ag ent, and it must be presumed that the toxicological mode of action induced at high doses by ei ther gaseous chlorine or solutio ns of hypochlorite is at least partially related to this property.

5.11 Conclusions from Human Health Hazard Assessment:

5.11.1 From the above information it is concluded th at the critical health effects resulting from human exposure to the active s ubstances and relevant 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/reproductive function and carcinogeni city, depending on the severity of exposure and presumably under long term exposures (e.g., occupational scenarios).

5.11.2 Other relevant factors have also to be ta ken into account when assessing human exposure towards chemicals include, inter alia :

.1 the variability in individual sensitivity;GESAMP-BWWG 2/9

ANNEX 7 Page 9

I:\MEPC\55\2-16.doc .2 the fact that complex mixt ures of disinfectants and DB Ps, according to the actual knowledge, interact in an additive way, at low concentration.

5.11.3 Therefore, the Group raised an additional concern toward s the potential for cumulative toxicological effects of the mixtur e of chemicals generated by EctoSys TM

.

5.11.4 Disinfectant By-Products (D BPs) – Trihalomethanes (THMs)

5.11.4.1 THMs are expected to be the most prev alent by-products of disinfection by using
chlorine.

5.11.4.2 These compounds are volatile liquids at room temperature, therefore, as chemicals vaporize during water usage, inha lation becomes an important e xposure route in addition to ingestion.

5.11.4.3 According to experimental data (EHC 216, 2000), a variety of non-neoplastic
toxic effects have been associated with shor t-term and long-term exposure of experimental animals to high doses of THMs, and each of the most common THMs – chloroform, BDCM (bromodichloromethane), DBCM (dibromochlorome thane) and bromoform – has been shown to be carcinogenic to rodents in high-dose chronic studies.

5.11.4.4 Chloroform is generally the predominant THM in chlorinated water and is also the most extensively studied chemical of this class as it has been used for clinical purposes for
decades. Animal studies have indicated that ch loroform can induce cancer only after chronic exposure to cytotoxic doses, th erefore it seems clear that lo w exposures do not trigger these
adverse effects.

5.11.4.5 When bromine is present in the water (e.g., seawater), lipid solubility of the halomethanes is enhanced (and consequently, up take into the tissues) and generally increases their chemical reactivity and the likelihood of bi otransformation to a reactive intermediate.

5.11.4.6 According to existing information (EPA 216, 2000), cancer following chronic exposure is the primary hazard of concern for brominated THMs.

6 RISKS TO SAFETY OF SHIP AND CREW

6.1. The Group concurred with the submission wh ich stated that there are no risks with handling chemicals which can be associated with the EctoSys TM ballast water treatment system as
the Active Substances and Rele vant Chemicals are produced in situ and therefore not handled.

6.2 The Group noted that the dossier presented indicated that trihalomethanes (THMs) is produced as a secondary disinfectio n by-product, but that because of the low levels of chlorines that are formed (<2ppm) combined with the hi gh pH of sea water THM levels are well below United States EPA drinking water st andards. Other studies suggest ed that THM is formed from the breakdown of chlorine and organic matter and that THM generation increases with pH, time, temperature and the amount of organic matter pr esent, and that levels above 1ppm residual chlorine can produce unacceptable levels.GESAMP-BWWG 2/9

ANNEX 7 Page 10

I:\MEPC\55\2-16.doc 6.3 Furthermore it was noted that both H ydrogen and Oxygen are formed during the electrolysis process. The applicant indicate d that no harmful concentrations of hydrogen gas (4%) will build up in the ballast tanks or su rrounding systems and that a reliable degassing system will also be included to the complete ballast water treatment system.

6.4 In addition, it was noted that, as hydrogen gas is explosive, and as THMs have a potential for carcinogenicity, it should be confirmed that re sidual levels of these substances within the ballast tanks following the treatment process in large scale tests re main within acceptable limits for crew and ship safety. This was considered to be particularly releva nt as there remains doubt about the reliability of scaling-up data in this ap plication. It was agreed that it will be necessary to consider the positioning of any system dega ssing discharge vents very carefully. The Group suggested that the possibility of the presence of free chlorine gas in the ballast tank should also
be restricted due to the acut e irritant effects by inhalation.

6.5 It was noted that the applicant had made in itial short term studies into the corrosive properties of the treated ballast water that partly confirm the claim that there is no change following treatment and that long-term corrosion studies had commenced to verify this. The Group noted that other studies had determined th at the presence of resi dual chlorine, even in small quantities, have the ability to degrade tank coatings and dramatically increase normal corrosion rates, the results of the long term corr osion studies, particularly the effect on system piping directly following the treatment plant and ships ballast tanks will be relevant.

7 ENVIRONMENTAL FATE AND EXPOSURE

7.1 Environmental fate and behaviour properties

7.1.1 The Group noted that when seawater is el ectrolysed applying anodi c oxidation utilizing electrodes with high oxygen over potential, organisms are removed both by direct oxidation at the anode (not producing any Active Substances) a nd by forming oxidants in the seawater which indirectly oxidate organisms and other organic carbon in the ballast water.

7.2 Fate in ballast water tanks

7.2.1 The Group noted that the following reactions are formed when seawater (marine and brackish) is electrolysed by use of the method described:

1. H 2 O → 1 / 2 O 2 + 2H + + 2e -
2. H 2 O → •OH + H + + e -
3. •OH → 1 / 2 O 2 + H + + e -
4. 3H 2 O → O 3 + 6H + + 6e -

5. 2Cl - → Cl 2 + 2e -

7.2.2 However, it was also noted that the applicant’s dossier al so included information about other reactions as a result of secondary oxidation compounds (e.g., hydroxyl radicals or hypochlorite reacting with natural ch emicals in seawater). Most of the results from analysis of e.g., THM and AOX documenting concentrations belo w detection limits except concentrations of bromoform at up to 0.07 mg/L. Thus, the Group recommended that more detailed information about these Relevant Chemicals is provide d in the application for final approval.GESAMP-BWWG 2/9

ANNEX 7 Page 11

I:\MEPC\55\2-16.doc 7.2.3 Referring to comments above and informati on given in the applicant dossier the Group recommended that at least the following analysis ar e performed of the treated ballast water in the further land based and onboard testing and docum ented in the application for final approval:

.1 Chloro- and bromo-organic compounds (including THM – Trihalomethane and AOX – Absorbable Organic Halogens);

.2 A general toxicity anal ysis (aggregate acute and chronic toxicity);

.3 Bromate formation.

7.2.4 A number of analyses of free active chlorine, after the first treatment , in various samples treated with the EctoSysTM system had been ca rried out by use of the N,N-diethyl-p-phenylenediamine (DPD) method. In gene ral, the concentrations of free active chlorine were below 2 mg/L. The applicant considers that the free active chlorine should be in terpreted as Total Residual Oxidants (TRO).

7.2.5 In connection with test ing of the aquatic toxici ty of treated ballast water, the application of the EctoSysTM system with treatment at ballasting and deballasting was simulated and the
concentrations of free and residual chlo rine were measured by a DPD method. The concentrations varied considerably, but the major ity of the measured concentrations were in the range of 1-4 mg/L. It was considered notewo rthy that the concentra tions, after the second treatment, in general were much higher than after the first treatment, which might be a result of a
considerable reduction in th e concentration of organics from the first to the second treatment as a result of the first treatment. The Group assumed that the free chlorine m easured here should be interpreted as TRO.

7.2.6 Thus, the Group considered that concentrations of TRO in treated ballast water might also reflect discharges of treated ballast water in real -life situations. However, a further evaluation of these measurements is not possible, but the Grou p would recommend that more specific chemical measurements are undertaken during the further development process.

7.3 Fate in the environment

7.3.1 The EctoSysTM treatment system is intend ed to be applied both at ballasting and deballasting which means that the Relevant Chemicals formed although to some extent
transformed in the ballast water tank during voyage, they will be fo rmed again at discharge of the ballast water. The same transformation processe s as taking place in the ballast water prior to discharge will thus also ta ke place after discharge.GESAMP-BWWG 2/9

ANNEX 7 Page 12

I:\MEPC\55\2-16.doc 7.3.2 An overview of degradation half-lives of Ac tive Substances and Re levant Chemicals is presented in the table below:

Substance Half-life Comment Reference Hydroxyl radical, OH· Nano-seconds Chloride gas, Cl 2 Hypochlorite, ClO and hypochlorous acid, HClO Weeks? Estimated EPI Suite

Free active chlorine (TRO) < 1 hour Reduction to background level

Bromoform Weeks-months? Estimated EPI Suite

7.3.3 Information on octanol/water partition coeffi cients, when available, is provided in the
table below.

Substance Octanol/water partition coefficient (log Pow) Comment Reference

Hydroxyl radical, OH· Not relevant Chloride gas, Cl 2 Hypochlorite, ClO and hypochlorous acid, HClO -3.42 Estimated EPI Suite

Free active chlorine (TRO)

Bromoform 2.4 Measured EPI Suite

7.3.4 Although the Group considered that an octanol /water partition coefficient might not be the most appropriate indicator of a bioaccumulati on potential of small in organic compounds, it is the judgement of the Group that none of the reaction products formed possess properties that allow a significant bioaccumulation.

7.4 Environmental exposure

7.4.1 The Group noted that the applicant had de veloped a model for estimating dilution of ballast water discharged into a port. The model had been run for both a generic port scenario and for the port of Bremerhaven.

7.4.2 Figures showing the results of running th e model for two generic port scenarios of
different sizes in terms of dilutions of the treated ballast water at various points in the ports are
included in the Dossier. Results are also in cluded showing the time from discharge to the (average?) concentration of the treated ballast water is so low that no acute toxic effects are expected. This is discussed further in section 9.3 below.

7.4.3 The Group is not aware of info rmation that can ju stify the choice of input values for setting up one or more realistic models.GESAMP-BWWG 2/9

ANNEX 7 Page 13

I:\MEPC\55\2-16.doc 8 ENVIRONMENTAL EFFECTS

8.1 Aquatic toxicity of Active Substa nce/Preparation/Relevant Chemicals

8.1.1 A large number of test results of acute aqua tic toxicity of Relevant Chemicals to various species were included in the application Dossier and a few of these are summarised in the table
below.

Test
Substance F
C

A Species Effect Value Reference/Comments

F Leiostomus
xanthurus LC 50 0.09mg/L MEPC 55/2/4, Anx, p22 & p26

C Pandalus goniurus LC 50 0.09mg/L MEPC 55/2/4, Anx, p23 & p27

A 11 Phytoplankton species LC 50 0.075 - 0.33mg/L MEPC 55/2/4, Anx, p 25 & p29 Free Active

Chlorine (Sodium hypochlorite)

M Molluscs 48h EC 50 0.26mg/L MEPC 55/2/4, Anx, p31

F Lepomis
macrochirus 96h LC 50 29mg/L MEPC 55/2/4, Anx, p38

C Daphnia magna 48h LC 50 29mg/L MEPC 55/2/4, Anx p38 Bromoform

A LC 50

8.1.2 The Group noted that acute aqua tic toxicity of free active chlo rine is typically seen at concentrations of approx. 0.1 mg/L.

8.1.3 Information on aquatic toxicity afte r long-term exposure is shown below.

Test
Substance F
C

A Species Effect Value Reference/Comments

F Menidia penensulae

eggs 28d NOEC 0.04mg/l Co. rep Anx p23 & p26

C Crassostrea virginica & Rangia cuneata 15d NOEC 0.007mg/l Co. rep Anx p24 & p27 Free Active

Chlorine

A Phytoplankton 21d effect 0.001mg/l Co. rep Anx p25 & p29

8.2 Aquatic toxicity of treated ballast water

8.2.1 Information on acute aquatic toxicity of treat ed ballast water is summarised in the table below. The test samples were prepared by trea ting seawater and a 50:50 mi xture of seawater and fresh water by the EctoSysTM system, storing the tr eated sample for three da ys, and re-treating the sample before initiation of the tests. This approach was intended to simulate the intended application in practice.GESAMP-BWWG 2/9

ANNEX 7 Page 14

I:\MEPC\55\2-16.doc Test
Substance F
C

A Species Effect Value Reference/Comments

F Turbot &
Rainbow trout 24h LC 50 5.5% MEPC 55/2/4 Anx, p41

C Tisbe battagliai 48h LC 50 5.5-14% MEPC 55/2/4 Anx, p42

A
Skeletonema

costatum 72 h EC 50 3.6-9.2% (biomass)

6.4-11% (growth rate) MEPC 55/2/4 Anx, p42 Ballast

Water (Whole

effluent toxicity test) A
Skeletonema

costatum 72h NOEC 3.0% (both biomass and growth rate) MEPC 55/2/4 Anx, p42

The value for treated ballast water shows dilution ratio by natural seawater or 50:50 natural
seawater/freshwater.

8.2.2 The applicant had indicated that there was no need to carry out chro nic toxicity tests for the treated ballast water as the acute tests expo sed the organisms to a higher concentration of
treated ballast water fo r a longer time than would occur in practice. The Group noted that the NOEC obtained in the 72 hours growth test with alg ae should be considered as a chronic toxicity.

8.2.3 The Group welcomed the testing of the aquatic toxicity of treated ba llast water, but also noted that the fish toxicity te sts had been carried out using a duration of exposure of 24 hours while the normal exposure duration for acute toxicity tests with fish is normally 96 hours. Thus, the toxicity may have been underestimated.

8.2.4 The Group recognized that the toxicity had been tested with samples that had been retrieved immediately after a second treatment in accordance with the inte nded use of the system, and that after discharge and dilutio n in the environment the toxicity may be reduced as a result of transformation of the reactive species produced. Ho wever, no information is available on the rate with which the toxicity de grades after discharge.

8.2.5 No internationally agreed approach for de riving a PNEC for complex samples has been developed, but the Danish EPA proposes that an assessment fact or of 10 is used for deriving a short-term PNEC (PNECacute) when acute toxicity data are available fo r three aquatic species (Danish EPA 1995). For ballast water treated w ith the EctoSysTM system, a PNECacute = 0.4% equalling a dilution of approx. 250 times.

9 ENVIRONMENTAL RI SK CHARACTERIZATION

9.1 PBT Assessment

9.1.1 An indication of the complianc e of the Relevant Chemicals w ith the PBT criteria is given
in the table below.GESAMP-BWWG 2/9

ANNEX 7 Page 15

I:\MEPC\55\2-16.doc

Compound Persistence (P) Bioaccumulation (B) Toxicity (T)

Hydroxyl radical, OH· No No ? Chloride gas, Cl 2 No No ? Hypochlorite, ClO - and hypochlorous acid, HClO No No ?

Free Active Chlorine No No Yes

Bromoform Yes? No No?

9.1.2 Based on the overview, the Group concludes th at none of the Relevant Chemicals fulfil
all of the three PBT criteria and consequently, none of the ch emicals can be considered as
PBT substances.

9.2 Assessment of treated ballast water

9.2.1 Concentrations of free and residual chlori ne and TRO has been measured in treated ballast water at typical concentr ations of 1-4 mg/L. Consideri ng that the acute toxicity of hypochlorite representing free active chlorine (or TRO) has been measured at typical concentrations at around 0.1 mg/L , which would then correspond to a dilution of 10-40 times of
the treated ballast water.

9.2.2 Considering that the direct toxicity tests wi th the treated ballast wa ter indeed showed an acute toxicity at 3.6-14% corresponding to diluti ons at 7-28 times, the Group concluded that this corresponded well to the expected dilution required, if free active chlorine is the main cause of the aquatic toxicity.

9.3 Environmental risk assessment

9.3.1 The Group noted that the applicant had run models to determine the Predicted Environmental Concentration (PEC ) of treated ballast water in closed and open harbours using reasonable discharge volumes and unreasonably high ones. The resu lts were expressed in terms
of the time taken to reach the No Observed Eff ect (NOEC) level at 3% of the treated ballast water as determined in acute toxicity tests. Ho wever, this NOEC level was applicable to only the four species representing thr ee groups of organisms and, cons equently, the Group would propose to apply an Assessment Factor of 10 to the lowe st effect concentration derived in an acute toxicity test for deriving a s hort-term PNEC (PNECacute)

9.3.2 The Group noted that a di scharge rate at 5,000 m 3 /h during 10 hours is a reasonable scenario for VLCC, and in this case, the appli cant estimated that only after more than 500 hours
were the treated ballast water diluted so much that no acute toxicity was expected.

9.3.3 Furthermore, the Group noted that under th e worst case scenario, the concentration of
Free Active Chlorine in ballast water during treatment would be < 2 ppm (<2 mg/l) compared to the USA/EPA drinking water standard of 4 mg/l.

9.3.4 Consequently, the Group was of the opinion th at discharge of large volumes of ballast water treated with the EctoSysTM system might result in concentrations of treated ballast water in the receiving environment that might cause acute toxic effects to aquatic organisms.GESAMP-BWWG 2/9

ANNEX 7 Page 16

I:\MEPC\55\2-16.doc 10 CONCLUSIONS AND RECOMMENDATIONS

10.1 Risks to safety of ships

10.1.1 The Group noted that experiment s carried out so far indicate that ballast water treated by the proposed system does not show any increase in corrosive properties to materials used in the hulls of ships. However, the Group noted that other studies ha d shown that th e presence of residual chlorine could greatly in crease corrosion rates. For th is reason, the Group welcomed the intention to perform longer term studies and recommended that further consideration should be given to the results of these tests.

10.2 Risks to crew

10.2.1 The Group noted that any chemicals pr oduced by the system would be produced in situ and so there was no potential exposure from leaki ng delivery pipe work to the ballast water.

10.2.2 It was also noted th at hydrogen gas had been identified by the applicant as a Relevant Chemical and concern was expressed the gas mi ght be produced in sufficient amounts to cause an explosion. However, it was noted that, in experiments carried out in a closed tank environment, the system produced a maximu m of 2000 ppm of hydrogen compared to the 4000 ppm needed for an ignitable mixture with oxyge n. In addition, it was noted that the system was to include a degassing system which would further reduce th is potential risk.

10.2.3 Whilst recognizing that the generation of hydrogen by the system should not cause a safety problem, the results of the tests currently being performed should be taken into account, particularly as the safety ma rgin (x2) was not that great.

10.2.4 Notwithstanding this observat ion, the Group agreed that the only potenti al exposure of the crew to the Active Substances might be via leaki ng pipe work in the pump room but the levels of Free Active Chlorine should not pres ent a safety hazard to the crew.

10.3 Risks to the environment

10.3.1 The Group noted that the characterisation of the chemical composition of ballast water treated with the EctoSysTM system is far from complete. However, most of the individual components identified were considered to be de gradable in the aquatic environment, although formation of halogenated organics as , e.g., bromoform cannot be excluded.

10.3.2 The Group is also aware of that the EctoSysTM system is designed to treat ballast water both at ballasting and deballasting in order to be sufficiently effectiv e. In particular the treatment of ballast water at discharge that has already been treated seems to result in formation of relative high concentrations of TRO, which might be the main reason for a relatively high initial toxicity
of the treated ballast wa ter requiring an initial dilution of up to 250 times in order to avoid acute toxic effects to the aquatic ecosystem.

10.3.3 The Group notes that the measured acute toxic ity of treated ballast water is found at a dilution that corresponds to the dilu tion required if the content of free activ e chlorine is the main component responsible for the toxicity.GESAMP-BWWG 2/9

ANNEX 7 Page 17

I:\MEPC\55\2-16.doc 10.4 Recommendations

10.4.1 Having considered the available informa tion the Group recommends that Basic Approval is given to this proposal. The Gr oup also recommends that Basic Approval should be limited to further prototype development a nd type approval testing only.

10.4.2 Furthermore, the Group recommends that the following conditions should apply during the further development and testing of the proposed system:

.1 discharge of ballast water treated w ith the EctoSysTM system should only take place under controlled conditions and into an environment where a sufficient
dilution can be assured for a voiding acute aquatic toxicity;

.2 degradation of the toxicity of the tr eated ballast water should be studied, in particular during the initia l period after discharge;

.3 further analyses of the content of react ive and potentially toxic species should be provided, in particular the possible formation of halogenated organics;

.4 it might be worthwhile to explore possi bilities to fine-tune the EctoSysTM system so treatment at de-ballasting can be avoide d or at least reduced, as this seems to create a relatively high initial toxicity of the treated ballast water at discharge.

10.4.3 The Group suggested that MEPC invites the Ad ministration of Sweden to ensure that all
the above conditions are taken into account and a ppropriate measures are put in place during further development and te sting of the EctoSysTM.

10.4.4 Furthermore, the group wants to emphasize that it cannot judge whether a full-scale deployment would cause unacceptable environmenta l damage as no repres entative and realistic emission scenarios are available. Consequently, suitable realistic scenarios describing emissions of treated ballast water into representative wa ter courses should be de veloped, documented and applied for assessing the environmental risks under full-scale deployment of the proposed system. Such scenarios should desc ribe various release situations with regard to dimensions of the receiving environment, water flow and exch ange, number of ships, frequency, duration and volume of discharges of treated ba llast water, etc. The Group encourages MEPC to consider the development and agreement of such emission scenarios, which should then be applied by the applicant in an eventual application for Final Approval.

11 REFERENCES

11.1 In evaluating the application, the Gro up made use of the following references:

.1 Application Dossier .2 Summary (MEPC 55/2/4) .3 Disinfectants and Disinfectant By-Pr oducts (Environmental Health Criteria 216, (WHO, 2000) .4 Bromate in Drinking Water (WHO/SDE/WSH/05.08/78, 2005) .5 US-EPA: EPI Suite estimation program and database .6 Danish EPA (1995): Guidance documen t for risk assessm ent of industrial wastewater. Danish EPA, E nvironmental Project No. 298.

***GESAMP-BWWG 2/9

I:\MEPC\55\2-16.doc ANNEX 8

TIMETABLE FOR ACTIVITIES RELATED TO THE 3RD MEETING OF THE

GESAMP-BWWG

Date Activity

15 December 2006 Deadline for submission of application dossiers and related
documents.

15 December 2006-16 February

2007 Preparation of the meeting.

19- 23 February 2007 3rd Meeting of the GESAMP-BWWG.

26 February - 2 March 2007 Editing and completion of the draft report.

5-9 March 2007 Administrations confirm that no confidential data is contained in the report.

12 March – 6 April 2007 Review and approval by GESAMP.

9- 13 April 2007 Produce the final report ba sed on comments by GESAMP.

13 April 2007 13 weeks deadline for MEPC 56 documents.

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