I:\MEPC\56\2-2.doc For reasons of economy, this document is pr inted in a limited number. Delegates are kindly asked to bring their copies to mee tings and not to request additional copies. INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION

COMMITTEE

56th session Agenda item 2 MEPC 56/2/2 13 April 2007 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

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

Note by the Secretariat

SUMMARY

Executive summary: This document contains the report of the third meeting of the

GESAMP Ballast Water Work ing Group (GESAMP-BWWG) and includes the evaluation of proposals submitted for approval by Norway, the Republic of Korea, Japan and Sweden

Action to be taken: Paragraph 4

Related document: GESAMP-BWWG 3/9 (attached)

Introduction

1 The third meeting of the GESAMP-BWWG wa s held at IMOís temporary headquarters from 19 to 24 February 2007, the report, of which, is attached to this docu ment with the symbol

GESAMP-BWWG 3/9.

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 of those proposals considered by the Group are shown in annexes 5, 6 and 7 of the attached report.

3 As instructed by the Committee, the Group also continue d to develop the Draft Methodology for Information Gathering and the Conduct of Work of the GESAMP-BWWG (the Methodology).

Action requested of the Committee

4 The Committee is invited to (paragraphs referred to are those of GESAMP-BWWG 3/9):

.1 agree that the definition of Relevant Chemicals in G9 be interpreted as shown in paragraph 1.1.6 of the Met hodology (paragraphs 3.2.1 and 3.2.2);MEPC 56/2/2 - 2 -

I:\MEPC\56\2-2.doc .2 agree that all chemicals which might be produce d by a ballast water management system be identified to the Group with a scientific justification for those

considered not to be Relevant Chemicals (paragraphs 3.3.1 to 3.3.5);

.3 agree that the existing IMO Conventions and Codes might se rve as a basis for ensuring that the handling and stowage of chemicals used to tr eat ballast water can be done safely and instruct the appropr iate IMO body to develop the appropriate criteria (paragraphs 3.4.3 to 3.4.5);

.4 agree that the Methodology is a living document in need of further development but that it is currently suitable as a guidance document for applicants submitting requests for evaluation of ballast wa ter treatment systems to the Group (paragraphs 5.1.4 to 5.1.6);

.5 endorse the Groupís proposal for the n eed to have Human Exposure Scenario (HES) as part of the Risk Assessment procedure for ballast water management systems (paragraphs 5.2.4 and annex 9);

.6 endorse the requirement for a suitabl e Emission Scenario Document (ESD) and take action to evaluate the suitability of existing models and develop a new model specifically designed for this task if deemed necessary; (paragraphs 5.3.2 to 5.3.8);

.7 agree with the Groupís interpretation of G8 and G9 for obtaining a Type Approval Certificate (paragraph 5.4.3);

.8 endorse the view that, for Final Approva l, toxicity testing should be done on two types of seawater at two appropriate time intervals after treatment (paragraph 5.4.9);

.9 agree that information on Total Resi dual Oxidants (TRO) and Total Residual Chlorine (TRC) produced by some system s hould be given to the Group as part of the application for evaluation (paragraph 5.5.2);

.10 agree that the toxicity testing identified by the Group in the evaluation for Basic Approval would need to be given to the Group for consideration as part of the Final Approval process (paragraph 5.5.5);

.11 agree that, in order to make a meani ngful recommendation to the Committee, the Group has to do so for the proposed syst em in conjunction with the chemicals used or produced and it is not possib le to limit the evaluation to the Active Substance(s) alone (paragraph 6.1.4);

.12 agree that both Basic Approval a nd Final Approval be granted to the PureBallast System reported by Sweden and Norway in MEPC 55/2/5 and MEPC 56/2/1 (paragraph 6.4.2.1);

.13 agree that Basic Approval be granted for the NKO Ballast Water Treatment System (NKO BWTS) reported by the Republic of Korea in MEPC 55/2/3 (paragraph 6.4.2.2);- 3 - MEPC 56/2/2

I:\MEPC\56\2-2.doc .14 agree that Basic Approval should NOT be granted to the Hybrid Ballast Water Treatment System reported by Japan in MEPC 56/2 (paragraph 6.4.2.3); and

.15 agree to the report in general.

***I:\MEPC\56\2-2.doc GESAMP-BWWG

3rd session Agenda item 9 GESAMP-BWWG 3/9

1 March 2007 Original: ENGLISH

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

Table of Contents

Section Page Nos.

1 INTRODUCTION ÖÖ..ÖÖÖÖÖ.............................................. 3

2 ISSUES OF CONFIDENTIALITY Ö..ÖÖÖÖÖÖ.................... 3

3 OUTCOME OF MEPC 55ÖÖ..ÖÖÖÖÖÖÖÖÖ................... 4

4 TERMS OF REFERENCE AND TIME FRAME ............................. 6

5 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR

INFORMATION GATHERING AND THE CONDUCT OF WORK (ëTHE METHODOLOGYí) ................................................. 6

6 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST

WATER MANAGEMENT SYSTEMS ............................................ 11

7 CONSIDERATION OF QUERIES REGARDING THE WORK

OF THE GESAMP-BWWG ÖÖÖÖÖÖÖÖÖ......................... 14

8 FUTURE WORK PROGRA MME AND TENTATIVE DATE

FOR THE NEXT MEETING ÖÖÖ..ÖÖÖÖ............................ 14

9 CONSIDERATION AND ADOPTION OF THE REPORT ÖÖ... 15

ANNEXES

Annex 1 List of members attending the third session of the GESAMP-BWWG

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

Annex 3 Terms of refere nce for the GESAMP-BWWG

Annex 4 Draft methodology for information gathering and the conduct of work of

GESAMP-BWWGGESAMP-BWWG 3/9 - 2 -

I:\MEPC\56\2-2.doc Annex 5 Review of the PureBallast Management System , submitted by Sweden for Basic Approval and by Norway for Final Approval

Annex 6 Review of the NKO Ballast Water Treatment System , submitted by the Republic

of Korea

Annex 7 Review of the Hybrid Ballast Water Treatment System , submitted by Japan

Annex 8 Timetable for activities related to the 4 th meeting of the GESAMP-BWWG

Annex 9 GESAMP BWWG ñ Human Exposure Assessment- 3 - GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc 1 INTRODUCTION

1.1 The third GESAMP Ballast Water Work ing Group (GESAMP-BWWG 3) meeting was held at IMO Headquarters, London, from 19 to 24 February 2007, under th e chairmanship of Dr. Tim Bowmer. A list of members attending this meeting is shown in annex 1, and the agenda, as adopted by the Group, is set out in annex 2.

1.2 The meeting was opened by Mr. Miguel Paloma res, Director of Marine Environment Division, who informed the Group th at it had been decided to ho ld this third regular meeting instead of one regular and another additional mee ting, as indicated in circular BWM.2/Circ.6. He explained that this was mainly due to the number of proposals submitted for approval, which had been received by the deadlines esta blished in the above Circular and was aiming to optimize the work of the Group and to ensure the most effec tive use of the resources available for the Groupís meetings. He also informed the Group that th e meeting time may be extended over the weekend in order to accomplish the tasks assigned by MEPC 55. Mr. RenÈ Coenen, IMO Technical Secretary of GESAMP, reported on the contractua l arrangements and invited the Group to agree upon criteria for identifying alternate members that could be invited to part icipate, should any of the existing members become unavailable. Mr. Dandu Pughiuc, Head of the Marine BioSafety Section of Marine Environment Division, briefed the Group on the outcome of MEPC 55 regarding Ballast Water Management Systems th at make use of Active Substances and the specific decisions concerning the work of the Group.

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. An application for Final Approval of the system described in document MEPC 55/2/5 (Sweden) was submitted by Norway. The Secretariat informed the Group that the non-confidential parts of the submissions had b een circulated as MEPC documents (MEPC 56/2 for Japan; MEPC 55/2/3, MEPC 55/2/21 and MEPC 55/2/27 for the Republic of Korea; MEPC 55/2/5 for Sweden; and MEPC 56/2/1 for Norway) and emphasized that members of the Group were requested to keep the data containe d in the application do ssiers confidential to protect the commercial intere sts of the manufacturers.

2.2 While noting the agreement of MEPC 55 that all information rela ted to safety and environmental protection, including physical propert ies, environmental fate and toxicity, should be treated as non-confidential, th e Group noted that the details of the functioning of the Ballast Water Management System (BWMS) must be regard ed as confidential to protect the rights of the manufacturer. The Group noted that the Orga nization, prior to subm ission of the Groupís evaluation report to the MEPC, would consult w ith the applicant of th e proposed the Ballast Water Management System to ensure that the report does not contain any confidential

information. In cases where the evaluation report contains confid ential information, the Organization would amend it accordingly, having taken the views of the manufacturer into

account.

2.3 In the case of requests to IMO from a thir d party for more information regarding an application, the Group was of th e view that it might be appr opriate for the Organization to provide the name and address of the national Administration that had submitted the original application for approval, which could then respond, as it feels appropriate.GESAMP-BWWG 3/9 - 4 -

I:\MEPC\56\2-2.doc 3 OUTCOME OF MEPC 55

3.1 General Introduction

3.1.1 A comprehensive introduction to the outcome of MEPC 55 was provided by the Secretariat (document GESAMP-B WWG 3/3). Particular emphasis was placed on the decisions

of MEPC 55 related to the Dr aft Methodology for information gathering and method of work of

the GESAMP-BWWG and the Group was requested to:

.1 complete the development of its ëMet hodology for information gathering and the conduct of workí taking into account comm ents made by various delegations in plenary, and in particular, paragr aphs 2.26.2, 2.26.4 and 2.26.8 of the Report of MEPC 55 (document MEPC 55/23);

.2 consider document MEPC 55/2/29 (Nor way) and make recommendations on the definition and scope of ìActive Substancesî as appropriate; and

.3 provide an outline to facilitate the deve lopment of criteria, which would specify

how chemicals used in the tr eatment of ballast water could be handled and stored on board ship.

3.1.2 The Group noted that MEPC 55 had considered all of the issues, from the second session of the GESAMP-BWWG, which had been ra ised under paragraph 4 of MEPC 55/2/16.

3.1.3 Whilst noting that some concerns had b een raised about specific issues, the Group expressed its appreciation that MEPC had genera lly agreed with the significant recommendations put to it.

3.2 Consideration of MEPC 55/2/29 (Norway)

3.2.1 As requested by MEPC, the Group consider ed the point, made by Norway in document MEPC 55/2/29, that the proposal to add the terms Active Substances, Preparations, Other components of a preparation and Relevant Chemicals ìdeviates from the Procedure for Approval of Ballast Water Management Systems that ma ke use of Active Substances (G9)î. Having considered this concern, the Group made the following points.

.1 the definition of Active Substance in the draft Methodology is exactly the same as that of G9;

.2 it was recognized that the definition of Preparation in the draft Methodology was

an abbreviated version of that in G9 and agreed that it would be amended in accordance with that of G9;

.3 it was recognized that the definition of Relevant Chemical deviates from that of G9. However, it was considered important to include a reference to shipís safety and to include chemicals of concern that might be produced after the treatment process as chemical changes could still be taking place. It was also considered necessary to change the word and to and/or in reference to human health; and

.4 it was considered extremely important to add a reference for Other Chemicals as the Group considered that it needs to be aware of all chemicals that may be- 5 - GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc produced by the treatment in order to ascertain which ones need to be properly

evaluated.

3.2.2 The Group requested MEPC to agree that thes e were important issues to clarify if the GESAMP-BWWG is to provide meaningful recomme ndations to the Committee in relation to the approval of the systems used to treat ballast water.

3.3 Consideration of short-lived and naturally occurring by-products produced by

ballast water treatment

3.3.1 The Group noted that ìA significant number of delegations supported the view that by-products created during the ballast water treatme nt comparable to those occurring naturally and which, due to their short period of existen ce, do not have harmful effects after discharge should not be regarded as Active Substancesî.

3.3.2 However, it was agreed that all chemicals produced by a given system should be identified. Having considered regulation D-3.2 of the Convention and Procedure (G9), the Group could not see any conflict with th e request to identify all chemicals that are either present in the Preparation or produced during th e treatment of the seawater;

3.3.3 However, the Group recognized that some systems may produce ch emicals that also occur naturally in the environment and it was impor tant to be able to make a comparison of the levels of such chemicals produced with those occurring naturally. Ho wever, the Group was of the view that, where comparable levels are to be referred to, these should be supported with

numerical values measured to the same level of sensitivity that is able to measure background

concentrations as well. It was also noted th at other chemicals produced may have such short half-lives that they do not pose a hazard by the time they are released into the environment.

3.3.4 As a result, the Group recommended that su ch chemicals, generated by a system, should be identified with a technical explanation of why th ey need not be evaluate d in detail, regardless of whether they are short-lived or naturally occurring. Without such information, it is not possible for the Group to provide a full and mean ingful recommendation to MEPC on the risks associated with a particular system.

3.3.5 In this context, the Group c onsidered that any system that alters the chemical composition

of seawater should be evaluate d by the Group prior to MEPC cons idering the granting of Final Approval.

3.3.6 The Group requested MEPC to agree with this approach.

3.4 Storage and handling of chemicals used to treat ballast water

3.4.1 The Group recalled that it had re quested MEPC to cons ider developing criteria that would specify how chemicals used to treat ballast wate r should be handled and stored onboard. It was noted that MEPC 55 had then referred the questi on back to the Group to develop an outline of how this might be done.

3.4.2 However, the Group considered that, as IM O had various existing conventions and codes addressing this issue, it was not in a position to make alternative proposals that it considered were outside its expertise.GESAMP-BWWG 3/9 - 6 -

I:\MEPC\56\2-2.doc 3.4.3 Notwithstanding this point of view, the Group agreed that such IMO code s, such as IBC, IMDG and IGC etc, could be considered as a basis for defining the storage requirements of such chemicals and that additional information provi ded by the required MSDSs and product labelling could be employed in the devel opment of handling requirements.

3.4.4 In this context, the Group suggested that spec ial consideration might also be given to the appropriateness of using of certain chemicals on passenger ships as well as the need for giving specific training to crews in their handling and emer gency situations appropriate to the nature of chemicals being employed and the respons ibility of the i ndividuals involved.

3.4.5 Furthermore, the importance of developi ng human exposure scenarios and associated Risk Assessment Procedures was emphasized as being needed in order to assess the human risks involved in the handling and storage of ch emicals used to treat ballast water.

3.5 Methodology for information gathering and the conduct of work

3.5.1 This issue is discussed under agenda item 5.

4 TERMS OF REFERENCE AND TIME FRAME

4.1 The Group agreed to continue to be guide d by the Terms of Reference approved by MEPC 55, as contained in annex 3 of this report, and decided to request fu rther 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 (ëTHE METHODOLGYí)

5.1 Consideration of general points raised by MEPC related to ëthe Methodologyí

5.1.1 The Group noted the request to complete the development of ëthe Methodologyí taking into account comments made by various de legations in plenary, and in particular, paragraphs 2.26.2, 2.26.4 and 2.26.8 of the Report of MEPC 55 (document MEPC 55/23).

5.1.2 The Group were pleased to note that MEPC had agreed with its responses to the

comments made in MEPC 55/2/2 and MEPC 55/2/6. However, it was agreed that in order for the Group to give meaningful recommendations to MEPC, the requirements made in the Methodology would have to be clearly defined in order to be effective.

5.1.3 The discussion related to paragraph 2.26.8, on the consideration of all chemicals produced by a system, is reflected in section 3 of this report.

5.1.4 Notwithstanding any of the discussion re lated to ëthe Met hodologyí, the Group recognized that this remains a living document that will need to be changed in the light of experience gained during the evaluation process.

5.1.5 In this context the Gr oup agreed that when ëthe Methodologyí is cl oser to completion, it should be reviewed by GESAMP, from a tec hnical point of view, and put to MEPC for endorsement as the method to be used in evaluating all applications.- 7 - GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc 5.1.6 However, the Group considered that th e methodology, as shown in annex 4, should provide sufficient guidance to f acilitate applications for Basic Approval that would allow proper evaluations of the risks associated with system s to be carried out. However, the Group also recognized that further work needed to be ca rried out as more experience is gained.

5.2 Development of a Human Exposure Scenario (HES)

5.2.1 In considering the need for an HES, the Gr oup agreed that in order to identify the risks associated with human exposure and safety of the ship, it was particularly important to:

.1 provide a full description of the pro cesses and individual operations in which exposure may occur when using the BW MS both onboard and, where appropriate, loading and storing the Active S ubstance or Preparation onboard;

.2 ascertain the duration and frequency of such tasks;

.3 identify situations in which a reducti on of amenities and in terference with other uses of the sea might be caused by the discharge of treated ballast water into the

sea;

.4 identify Personal Protective Equipment ( PPE) and control measures to be used in order to reduce and mitigate exposure; and

.5 ascertain the potential of the system to cause damage to the ship or its equipment.

5.2.2 It was recognized that it is not sufficient to just evaluate the haza rds associated with the treated ballast water and that this approach only allows a qualitative risk assessment to be carried out. Whilst recognizing that Pr ocedure (G9) only demands a qualitative approach, the Group considered that this would nearly always result in a worst case approach and would not necessarily allow meaningful recommendations to be made to MEPC in a consistent manner. For example, although the use of PPE can always be considered, this might end up as an indiscriminate recommendation that would, err oneously, suggest no risk and so remove the necessity to conduct further refine ment of the risk assessment.

5.2.3 In recognizing these requirements, the Gr oup agreed on the above approach that would need to be taken to develop a quantitative risk a ssessment with respect to human health and ship safety.

5.2.4 Having agreed on these points, the Group deve loped and approach to HES as shown in annex 9 and requested MEPC to endorse it.

5.3 Development of an Emission Scenario Document (ESD)

5.3.1 The Group noted that there ar e a number of potentially usef ul models available including USES 4.0, EUSES 2.0, REMA, MAM-PEC, CHEMMAP, EXAMS. However, the Group did not have an overview of the quality and possibilities of these models.

5.3.2 As a result, the Group recommended that, as part of the development of an ESD, a detailed comparison of these, and other models should be made to see if they are suitable or could be adapted for this purpose. It was agreed that the outcome of such a comparison could be

used to recommend a model for use in the further evaluation of BWMS.GESAMP-BWWG 3/9 - 8 -

I:\MEPC\56\2-2.doc 5.3.3 It was also agreed that any recommended m odel should then be made available to the Group for its own application du ring the evaluation process.

5.3.4 In considering the sort of scenario to be run by such a model, the Gr oup agreed that a rather simplified emission scenario would defi ne the receiving water compartment with the discharge events, e.g. the volume of the receiving water, the number of ships discharging ballast water, the amount of discharged volume , the potential tidal exchange factor.

5.3.5 It was also agreed that more advanced mode ls might also be very useful and that such models might need more data su ch as volatilization a nd photolytic degradati on in order to obtain

a more realistic and state-of-t he-art calculation of Predicted Environmental Concentrations (PECs).

5.3.6 In making these observations, the Group recogni zed that all such substance related data are already included in the dossier, including the id entity of the discharg ed chemicals and their physico/chemical data, sorption char acteristics and degradation rates.

5.3.7 In this context, the Group welcomed th e submission, by the UK to BLG (BLG 11/4/11) that made suggestions for a possible outline of a specific ESD tailored to a specific treatment that could be used in the process of Final Approval. It was recognized that this would be a very

useful basis for further discus sion and development of the subj ect. The Group expressed its appreciation of the paper submitted by the UK a nd hoped that the above views, relating to the use/development of a suitable ESD could be taken into account when the subject is discussed at IMO meetings.

5.3.8 Whilst recognizing the various difficulties in developing any such model, the Group agreed that, in order to provide MEPC with meaningful and consistent recommendations a standardized system should be developed for use by all applicants providing PECs after a specified period following the discharge of ballast water into the environment.

5.4 Consideration of the requirements for Basic Approval and Final Approval

5.4.1 Recognizing that an app lication had been made for both Basic Approval and Final Approval of a system, the Group considered that it was important to note the requirements identified in G8 and G9 for both proce sses. As a result, it was noted that:

.1 ìfor the Basic Approval Process, discharge testing should be performed in a laboratory using tec hniques and equipment to simulate ballast water discharge following treatment by the Preparationî, whilst,

.2 ìfor Final Approval, the discharge testing should be performed as part of the land-based type approval process using the treated ballast water discharge.î

Ref: G9, paragraph 5.2.1

5.4.2 Furthermore, the Group noted that Basic Approval involves:

.1 the generation of data by the manufacturer;

.2 endorsement by the Administration;- 9 - GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc .3 evaluation by the Group; and

.4 approval by MEPC.

5.4.3 In order to obtain Final Approval , the Group noted that, in accordance with paragraph 8.2 of Procedure (G9):

.1 Basic Approval has to be given first;

.2 ìthe Member of the Organization, submitting an application should conduct the Type Approval tests in acco rdance with Guidelines for Approval of Ballast Water Management Systems (G8)î.

.2.1 In considering this point, the Group noted that Guidelines (G8) is concerned with efficacy testing but paragraph 1.6.4 of part 1 of the annex, states:

ìPotential hazards for the environment should be identified and documented based on environmental studies performed to the extent necessary to assure that no harmful effects are to be expected. In the case of Ballast Water Management Systems that make use of Active Substan ces or Preparations containing one or more Active Substances the procedure described in the Procedure for the Approval of Ballast Water Management Systems that make use of Active Substances should be followed. The equipment must then ensure that dosage of

the Active Substance and the maximum allowable discharge concentration are kept under the approved cr iteria at all times.î

.2.2 It was understood that this was a refere nce to G9, which describes the evaluations carried out by the Group and that provid es a link between the two guidelines.

.2.3 The Group considered that the procedural details of the process for obtaining Final Approval were not really clear. However, it was understood that the test results from both Guidelines (G8) and (G9) would be used by MEPC to grant Final Approval and that this would then allo w the Administration to issue a Type Approval Certificate as shown in the appendi x to Guidelines (G8).

.2.4 In this context, the Group recognized that Type Approval of any equipment used onboard ship is given when the relevant body is satisfied that the Quality Assurance programme employed by the ma nufacturer will ensure that the equipment can be produced consisten tly to the required specification.

.2.5 It was, also, understood that before Type Approval of any Ballast Water Management System is granted, the risks to the ship and crew have been adequately addressed.

.2.6 the Group noted that, for Final Approval to be granted, apart from any other requirement required for Type Approval , the full scale land based tests, using the system in the same way that fulfilled the efficacy requirements, would need to show that the residual toxicity of the treated ballast water is no worse than the results obtained for Basic Approval.GESAMP-BWWG 3/9 - 10 -

I:\MEPC\56\2-2.doc 5.4.4 Notwithstanding the above understanding of the processes involve d, the Group had the following concerns.

5.4.5 It was noted that under Guidelines (G8), e fficacy testing for Final Approval is required for two of the three identified water types (fres h, brackish and sea). However, the full-scale land based toxicity testing, stipulated under G 9, only requires testing of one water-type.

5.4.6 However, the Group considered that, if e fficacy testing was required for two types of water then toxicity testing should be dealt with in a similar manner. It was thought that this was particularly important because the various amounts of Dissolved Organic Carbon (DOC) and Total Suspended Solids (TSS) could have a mark ed effect on the quantities of by products produced by the treatment process that, in turn, w ould affect the toxicity of the treated ballast

water.

5.4.7 In this context, the Group also consider ed that the time-period between treatment and testing could also affect the toxi city of the treated ballast wate r and so consideration should be given to testing such water at two time intervals, i.e. shortly after treatment, reflecting the minimum permitted discharge time, and follo wing an appropriate longer interval.

5.4.8 Furthermore, it was agreed that organisms normally found in the selected types of

seawater should be used in the toxicity testing.

5.4.9 As a result, MEPC was requested to endorse the view that for Final Approval, toxicity testing should be done on two types of seawater at two appropriate time intervals, after treatment,

and that this should be re flected in the Methodology.

5.5 Further requirements for Final Approval

5.5.1 In addition to these propos als, the Group recognized that the concentrations of Total Residual Oxidants (TRO) and Total Residual Ch lorine (TRC) produced, by those systems that create such by-products, could al so vary with differing types of seawater. Furthermore, the specific chemicals covered by such group descripti ons could also vary in quality and quantity.

5.5.2 As a result, MEPC was requested to agree th at all information rela ted to TROs, TRCs and the chemicals included in such groupings shou ld be provided to the Group for Final Approval when requested as part of its evaluation for Basic Approval.

5.5.3 Furthermore, in considering paragraphs 5.2.2 to 5.2.7 and, in particular 5.2.5 of Procedure (G9), the Group considered that th ere was no sense in establishing a NOEC for short-term toxicity testing and therefore r ecommended that this requirement is removed.

5.5.4 The Group agreed that for Basic Approval the basic data set identified in the Methodology is needed for the tr eated ballast water and the indi vidual chemicals produced by the system. In addition a generated meani ngful PEC/PNEC ratio would be required.

5.5.5 It was emphasized that the application fo r Final Approval should reflect the concerns identified during consideration of Basic Approval. This would mean that in some cases only acute toxicity testing would be needed for Final Approval and in some cases chronic toxicity might be needed whilst in others both acute and chronic data might be required.

5.5.6 This would allow the Group to consider the qu ality of the data presented that would be reflected by the assessment fact or used to generate the a ppropriate risk assessment.- 11 - GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc 5.6 Other specific issues re lated to the methodology

5.6.1 In considering ëthe Methodologyí, the Group agreed that:

.1 further guidance needs to be added in order to explain the requirements for Final Approval;

.1.1 in this context, it was noted that toxi city testing for Final Approval is, currently, allowed to be carried out using full-scale land based tests. However, it was also noted that efficacy testing demanded two seawater types and onboard testing. As a result, the Group considered that this approach woul d also be appropriate for toxicity testing.

.2 further guidance should be given to the methods used for reporting the

concentrations of Total Residual Oxidan ts (TROs) and Total Residual Chlorine (TRCs);

.3 various editorial changes were re quired in paragra phs 3.0.4, 3.2.4, 3.3.0.1, 6.1.4 and 7.2.1 of ëthe Methodologyí.

6 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER

MANAGEMENT SYSTEMS

6.1 Concerns with the approach

6.1.1 Prior to considering the specific applicati ons, the Group noted that the objective of the Procedure for Approval of Ballast Water Management Systems that make use of Active Substances (G9) is to determine the acceptability of the Active Substances and Preparations, containing one or more Active Substances, and th eir application in Ballast Water Management Systems (Ref: G9, paragraph 1.3).

6.1.2 It was also noted that the definition of Preparations include s Relevant Chemicals (G9, paragraph 2.1.3) and so it is the practice of the Group to evaluate the hazards and risks

associated with all such chemicals relevant to a ballast water management system, in order to make a meaningful recommendation to MEPC.

6.1.3 However, concern was expressed that G9 indicates that ìAn Active Substance or Preparation may be used for Prototype or Type Approval testing for the approval of different BWMS without going through Basic Approval againî.

6.1.4 Such concern was based on a recognition of the fact that the quantity of each potential chemical by-product, created during the treatment ballast water, mi ght vary in accordance with the method of application of the Active Subs tance and quantity used. Whilst the same by-products might be produced theoretically, in practice the amount produced will dictate both the hazard and potential risk.

6.1.5 In addition, the safety risk s associated with a particul ar Active Substance might be acceptable in a system granted Basic Approval but could be of serious concern when used in a different system.GESAMP-BWWG 3/9 - 12 -

I:\MEPC\56\2-2.doc 6.1.6 This led to the concern that if the Group we re to recommend Basic Approval of an Active Substance based on a very effectiv e delivery system, this would allow the same chemical to be used in an inefficient system that might prod uce hazardous by-products in such quantities that

could cause adverse effects.

6.1.7 It was, therefore, agreed th at it was not possible to evalua te an Active Substance without taking the whole system into account. Consequen tly MEPC was invited to take this into account and agree that the Group should be charged with the evaluation of the applicantís ballast water treatment system rather than just the Active Substance.

6.1.8 Furthermore, the Group requested MEPC to either agree that paragraph 8.1.2.12 of Procedure G9 should be interpreted as, or amended to read:

ìSpecific ballast water management systems employing Active Substances or Preparations receiving basic approval by the Organization may be used for prototype or type approval testing based on the guid elines developed by the Organization.î

6.1.9 In reviewing those applica tions for systems that produced certain by produc ts such as THMs, the Group considered that, unless it can be demonstrated that the levels of these compounds produced do not present an unacceptabl e human health risk, appropriate mitigation measure must be put in place to prevent human c ontact with the treated ballast water. Such measure might, for example, include the use of Personal Protective Equipment (PPE) when entering ballast water tanks.

6.2 General review of the submissions

6.2.1 The Group noted that submissions had been received from the Republic of Korea (NKO3 Ballast Water Treatment System), Sweden (P ureBallast) and Japan (Hybrid Ballast Water Treatment System) as part of the applications for Basic Approval.

6.2.2 In addition, it was noted that Norway had also made a submission for PureBallast as part of an application for Final Approval.

6.2.3 The Group noted that the application for Basi c Approval of PureBallast had been carried forward from the last meeting whereas the appli cation for Final Approval had been made later to

this session.

6.2.4 When considering the applications from Sweden and Norway for Basic Approval and Final Approval of PureBallast, the Group recogni zed some constraints in considering both Applications. In an attempt to approach this in a logical manner, the Group initially considered the application for Basic Approval. However, in taking this approach, sufficient problems were identified with the Basic Approva l application, taken in isolat ion, to cast doubts on whether a recommendation to approve this sy stem could be made to MEPC.

6.2.5 As a result, the Group then considered the da ta associated with bot h Basic Approval and Final Approval together whilst recognizing that, strictly spea king, Basic Approval should have been granted first. However, to facilitate the pro cess, the Group consider ed all of the data submitted when making recommendations for Basic Approval and Final Approval.

6.2.6 Having considered all of the data together the Group emphasized that it was important that the appropriate ecotoxicity testing should be carried out usi ng the same treated ballast water types used for efficacy testing a nd referred to in Procedure G8.- 13 - GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc 6.2.7 The Group noted that many of the ballast water management systems reviewed by the BWWG are based on the production of free radicals or production/addition of reactive chemicals such as chlorine, ozone or hydrogen peroxide, a ll of which react with seawater to produce a similar set of brominated reaction products , albeit in different concentrations.

6.2.8 Furthermore, it was noted that some of these common reaction products, such as bromoform and bromate ions, have significant h azards to human health and the environment

associated with them. While individual BWMS submissions have attempted to measure the concentrations of these reaction products at either the basic or final approval stage, or both, the levels of detection used (ca. 1 μg/L) generally fell short of those used in routine surface water monitoring (0.01-0.05 μg/L). While the Group did not feel it ne cessary to refuse approval to

individual submissions on this ba sis, concern remains that such reaction products had not been

considered at a satisfact ory quantification level.

6.2.9 Therefore, the Group, in considering the volume s of ballast water that might be treated by such systems in representative ports and harbours, felt that th e cumulative production of such reaction products needs further examination with regards to both the potential risks to the

environment and human health.

6.3 General reflections on the submissions

6.3.1 Although three applications for basic approval were revi ewed, the Group noted that BWM systems as described in the submissions from Sweden/Norway (UV/TiO2) and the Republic of Korea (ozone generati on) had already been installed on board ship(s) for some time previously. Therefore, the important safeguards, provided by the G9 Basi c Approval, safety/risk evaluation, have been lost in th ese cases. In the cas e of the Sweden/Norway application, land based testing had already been carried out by the time the application for Basic Approval had been reviewed and any feedback from the Group re garding safety and risk concerns could not be implemented.

6.3.2 The Group raised the following points of concer n associated with the G9 risk assessment procedure:

.1 In the absence of an Emission Scen ario Document (ESD) or Human Exposure Assessment applying to the shipboard environment, human health risk assessment can presently only be carried out at on a qualitative basis. How conservative the Groupís approach, therefore, needs to be in order to cover such uncertainties was difficult to ascertain. In many of the submissions evaluated to date, both the technical complexity of the BWM syst ems combined with sometimes vague descriptions of the intended method of operation did not help in this regard (some systems appear to be still in the conceptual or design phase).

.2 Cumulative risks to the environment due to the use of BW M systems in large ports have yet to be considered. The focus on the risks posed by individual BWM systems is too limited given that most of those evaluated to date for Basic Approval produce a similar se t of reaction by-products.

.3 Real quality control standards on eco toxicity and analytical chemistry of simulated or actual BWMS discharges were lacking in nearly all submissions. Frequently it was difficult to assess when and how ballast water was treated in the pilot/full scale systems described by a given submission, how long it was stored, when samples were taken and how long, after sampling, these were tested orGESAMP-BWWG 3/9 - 14 -

I:\MEPC\56\2-2.doc analysed. This lead, in turn, to uncertainty as to the validity of the results obtained and had a direct impact on the reliabil ity of human or environmental risk

assessment described in the submissions.

6.4 Detailed review of the submissions

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

.1 Annex 5 Review of the PureBallast Management System , submitted by Sweden for Basic Approval and by Norway for Final Approval by

Sweden

.2 Annex 6 Review of the NKO Ballast Water Treatment System , submitted by the Republic of Korea

.3 Annex 7 Review of the Hybrid Ballast Water Treatment System , submitted by Japan

6.4.2 Whilst it is recommended that the summary and results and discussion of each of the

reviews are considered in de tail, the Group recommended that:

.1 both Basic Approval and Fina l Approval be granted to the PureBallast Management System submitted by Sweden and Norway;

.2 Basic Approval be granted to the NKO Ballast Water Treatment System submitted by the Republic of Korea; and

.3 the Hybrid Ballast Water Treatment System submitted by Japan is NOT granted Basic Approval.

7 CONSIDERATION OF QUERIES REGARDING THE WORK OF THE

GESAMP-BWWG

7.1 No submissions were made under this agenda item.

8 FUTURE WORK PROGRAMME AND TENTATIVE DATE FOR THE NEXT

MEETING

8.1 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-MEPC.1/Circ.1), the Group agr eed that its next session shou ld tentatively be scheduled

from 29 October to 2 November 2007 to allow sufficient time for evaluation and approval by GESAMP and timely submission to MEPC 57.

8.2 Based on the experience of the previous meetings and taki ng into account the time needed for proper preparation of the next meeting, the Group recommended that MEPC 56 invites Administrations to submit their pr oposals for approval of Active Subs tances together with related application dossiers by 31 Augus t 2007 as indicated in timetabl e contained in annex 8. As previously agreed by the MEPC, non-confidential data related to the proposals for approval of

Active Substances should be submitt ed to MEPC 56 or at the earlie st opportunity after that, but not later than 31 August 2007.- 15 - GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc 9 CONSIDERATION AND ADOPTION OF THE REPORT

9.1 A draft report of the 3rd meeti ng of the GESAMP-BWWG was produced on 24 March 2007, and, after a paragraph-by-paragr aph review, 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 14.30hrs.

***GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc ANNEX 1

LIST OF MEMBERS ATTENDING THE 2ND SESSION

OF THE GESAMP BALLAST WATER WORKING GROUP

Dr. C.T. Bowmer (Chairman) TNO Chemistry Utrechtseweg 48 PostBox 360 E-mail: tim.bowmer@tno.nl

3700 AJ Zeist Tel: +31 30 6944645

The Netherlands Fax: +31 30 6944099

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 H ̄vik Fax: +47 67 57 9911 Norway Mobile: +47 97 02 6956

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. 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 3/9

ANNEX 1 Page 2

I:\MEPC\56\2-2.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 ñGESAMP CONSULTANTS

Mr. John Crayford 2 Dunmow Hill E-mail: j.crayford@ntlworld.com Fleet Tel: +44 (0)1252 672245 Hampshire

GU51 3AN United Kingdom

IMO SECRETARIAT

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. RenÈ 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

***GESAM-BWWG 3/9

I:\MEPC\56\2-2.doc ANNEX 2

PROVISIONAL AGENDA FOR TH E THIRD SESSION OF THE

BALLAST WATER WORKIN G GROUP OF GESAMP

1 Introduction

2 Issues of confidentiality

3 Outcome of MEPC 55

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 approval of Ballast Water Management Systems

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 3/9

I:\MEPC\56\2-2.doc ANNEX 3

TERMS OF REFERENCE FOR THE TECHNICAL GROUP

1 Consideration of development of necessary methodologies and information requirements

in accordance with G9 ∗ for consideration by MEPC 56.

2 For Basic Approval, the Group should revi ew the comprehensive proposal submitted by the Member of the Organization along with any additional data submitted as well as other

relevant information available to th e Group and report to the Organization.

In particular, the Group should undertake:

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

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

.3 Scientific evaluation of th e risks to the ship and pers onnel to include consideration of the storage, handling and application of the active substance (see paragraph 6.3 of G9);

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

.5 Scientific review of the risk charact erization and analysis contained in the proposal for approval (see paragraph 5.3 of G9);

.6 Scientific recommendations on whether the proposal has demons trated a potential for unreasonable risk to the environment, human health, property or resources (see paragraph 8.1.2.8 of G9); and

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

3 For Final Approval, the Gr oup should review the discharg e testing (field) data and confirm that the residual toxicity of the disc harge conforms to the evaluation undertaken for Basic Approval and that the prev ious evaluation of the risks to the ship and personnel including consideration of the storage, ha ndling and application of the active substance remains valid. The evaluation will be reported to ME PC (see paragraph 8.2 of G9).

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

***

∗ G9 stands equivalent for MEPC 53/2/1, annex, as amended: Procedure for approval of ballast water management systems that make use of Active Substances (G9).GESAMP-BWWG 3/9

I:\MEPC\56\2-2.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 a nd non-submission of data ................................................8

2.7 Procedures and timelines ..........................................................................................9

3.0 DA T A-SE T REQUIR E D IN THE APPLICA T IO N

.......................................................... . 9

3.1 Identification of the Substa nce or Preparation (G9: 4.1) .......................................9 3.1.1 Preparation s

........................................................................................................... 9

3.1.2 Active Substanc e

.................................................................................................. 10

3.1.3 Relevant Chemicals (G9: 2.1.4) :

......................................................................... 10

3.1.4 Other Chemicals :

................................................................................................. 11

3.2 Data on effects on aquatic plants, in vertebrates and fish, and other biota, including sensitive and represen tative organisms (G9: 4.2.1.1) ...........................11 3.2.1 Acute aquatic toxicity .......................................................................................... 11 3.2.2 Chronic aquatic toxicity ...................................................................................... 11 3.2.3 Endocrine disruption........................................................................................... 12 3.2.4 Sediment toxicity.................................................................................................. 12 3.2.5 Bioavailability/biomagnification/bioconcentration........................................... 12 3.2.6 Food web/population effects ............................................................................... 13

3.3.0 Data on mammalian toxicity (G9: 4.2.1.2) ............................................................13 3.3.1 Acute toxicity........................................................................................................ 14 3.3.2 Effects on skin and eye ........................................................................................ 14 3.3.3 Repeated-dose toxicity......................................................................................... 14 3.3.4 Chronic toxicity.................................................................................................... 15 3.3.5 Developmental and reproductive toxicity.......................................................... 15 3.3.6 Carcinogenicity .................................................................................................... 15 3.3.7 Mutagenicity/genotoxicity ................................................................................... 16

3.3.8 Toxicokinetics....................................................................................................... 16

3.4.0 Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3) ..............................................................................................................16 3.4.1 Modes of degradation (biotic; abiotic) ............................................................... 16 3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient... 17

3.4.3 Persistence and identification of the main metabolities in the relevant media (ballast w ater, marine and fresh waters )

........................................................... 18 3.4.4 Reaction with organic matter ............................................................................. 18 3.4.5 Potential physical effects on wildlife and benthic habitats .............................. 19

3.4.6 Potential residues in seafood............................................................................... 19 3.4.7 Any known interactive effects............................................................................. 19

3.5 Physical and chemical properties for the Active Substances and preparations

and treate d ballast w ater, if applicable (G9: 4.2.1.4 )

........................................... 20 3.5.1 Melting poin t

........................................................................................................ 20 3.5.2 Boiling point ......................................................................................................... 20

3.5.3 Flammability (flash point )

................................................................................... 20GESAMP-BWWG 3/9

ANNEX 4 Page 2

I:\MEPC\56\2-2.doc 3.5.4 Density (relative density )

..................................................................................... 20

3.5.5 Vapour pressure, vapour densit y

....................................................................... 20

3.5.6 Water sol u bilit y / diss o ciation con s tan t

............................................................... 20 3.5.7 Oxidation/reduction potential............................................................................. 21

3.5.8 Corrosivity to the materials or equ i pment of n ormal ship constructio n

........ 21 3.5.9 Auto-ignition temperature .................................................................................. 21 3.5.10 Explosive properties............................................................................................. 21 3.5.11 Oxidizing properties ............................................................................................ 21

3.5.12 Surface tension ..................................................................................................... 22 3.5.13 Viscosity ...............................................................................................................

. 22 3.5.14 Thermal stability and identity of relevant breakdown products .................... 22 3.5.15 Reactivity towards container material............................................................... 22 3.5.16 pH ......................................................................................................................

.... 22 3.5.17 Salinity ................................................................................................................

.. 22 3.5.18 TOC, DOC, % particulate matter...................................................................... 22 3.5.19 Other known relevant physica l or chemical hazards ....................................... 23

3.6 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5) .23

4 USE OF THE ACTIVE SUBSTA NCE OR THE PREPARATION ...............................23

4.1 The manner of application ......................................................................................23

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7) ........................................................24

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)............................................................................ 25 6.1.3 Toxicity tests (G9: 5.1.2.3)................................................................................... 25

6.2 Evaluation of the treated ballast water (G9: 5.2) .................................................25 6.2.1 Basic approva l

...................................................................................................... 25 6.2.2 Final approval ...................................................................................................... 26 6.2.3 Determination of holding time............................................................................ 26

6.3 Risk characterization and analysis .........................................................................26 6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 2.4.4).................... 26

6.3.2 Characterization of degradat ion route and rate (G9: 5.3.5) ................................26 6.3.3 Prediction of discharge and environmental concentrations ............................ 26 6.3.4 Assessment of potential for bioaccumulation.................................................... 27

6.3.5 Effects assessment ................................................................................................ 27 6.3.6 Effects on aquatic organisms .............................................................................. 27

6.3.7 Effects on sediment .............................................................................................. 28 6.3.8 Comparison of effect assessm ent with discharge toxicity ................................ 29

7 RISK ASSESSMENT ..........................................................................................................29

7.1 Risk to safety of ship ................................................................................................29

7.2 Risks to human health .............................................................................................29

7.3 Risks to the aquatic environment ...........................................................................30

8 ASSESSMENT REPORT (G9: 4.3) ...................................................................................30

9 MODIFICATION TO THE APPLICATION ...................................................................31

10 FINAL APPROVAL ............................................................................................................31GESAMP-BWWG 3/9

ANNEX 4 Page 3

I:\MEPC\56\2-2.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 evaluation of submissions:

.1 Ballast Water Convention means the International Convention for the Control and Management of Shipsí Ballast Water and Sediments, 2004.

.2 Ballast Water Management means mechanical, physical, chemical and biological processes ñ either singularly or in combination ñ 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. This term also includes any Active Substances generated onboard for purposes of Ballast Water Management and any relevant chemicals formed in the Ballast Water Management system that make use of Active Substances to comply with the Convention.

.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, other than the Active Substance(s) or subs tances, other than Relevant Chemicals, produced during the treatme nt of ballast water.

.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 shipís safety, aquatic environment and/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 te sts in accordance with Guidelines forGESAMP-BWWG 3/9

ANNEX 4 Page 4

I:\MEPC\56\2-2.doc Approval of Ballast Water Management Systems. The Final Approval shall confirm that previous eval uations of risks 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 residual toxicity of the discharge conforms to the evaluation undertaken for Basic Approval. The risk evalua tion at Final Approval shou ld 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

°C degree Celsius (Centigrade)

CAS Chemical Abstract Service

cc cubic centimetre

d day(s)

EC 50 effect concentration, 50% (med ian effective concentration)

g gram GHS Globally Harmonized System G9 Procedure for approval of Ballast Water Management Systems that make use of Active Substances (G9) Resolution MEPC.126(53) adopted 22 July 2005GESAMP-BWWG 3/9

ANNEX 4 Page 5

I:\MEPC\56\2-2.doc ABBREVIATIONS

h hour

IARC International Agency for Research on Cancer

IC 50 inhibition concentration, 50%; ISO International Organiza tion for Standardization IUPAC International Union of Pure and Applied Chemistry

kg kilogram Koc organic carbon-water partition coefficient

l litre

LC 50 lethal concentration, 50%

LD 50 lethal dose, 50%

LOAEL lowest observed adverse effect level

LDLO lowest lethal dose

LOEL lowest observed effect level Log P logarithm of the octanol /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 Organization the Internati onal Maritime Organization

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 International Conven tion for the Control and Management of Shipsí Ballast Water and Sediments, 2004, stipul ates that Ballast Water Management Systems (BWMS) that make use of Active Substances to comply with the Convention shall be approved by the Organization. During its fifty-third session, the Mari ne Environment ProtectionGESAMP-BWWG 3/9

ANNEX 4 Page 6

I:\MEPC\56\2-2.doc 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).

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 shipsí 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 th at 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 treat ed Ballast Water in accordance with the approval criteria specified below (G9: 8.1.2.1). Upon comple tion, the manufacturer should prepare an Application Dossier for the Ba llast Water Management System that makes use

of Active Substances and submit it to the Ma ritime Administration of a Member of the Organization. (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 the Ba llast Water Treatment System, associated with Active Substances, to be evaluated by the GESAMP Ballast Wa ter Working Group should

be addressed to: The Director , Marine Environmen t Division, International Maritime Organization, 4 Albert Embankment , London SE1 7SR, United Kingdom.

2.3.4 Application requirements:

.1 a complete Application Dossier including all documents identified in this paragraph (one paper version), including full study reports and full copies of literature. The complete Application Dossier should contain a contents list indicating the location of the information in the application. The order in which the information is presented, including ove rall structure such as how information is presented for the Active Substance, pr eparation, 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);GESAMP-BWWG 3/9

ANNEX 4 Page 7

I:\MEPC\56\2-2.doc .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).

2.4 Confidentiality and data protection

The confidential information of the submitted documents should clear ly be identified. Once an approval procedure is completed and the System using 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 amount of the Active Substance(s) in the preparations and the name of the preparation;

.4 the names of Other Components of Prepar ations, in particular those that 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 names of Relevant Chemicals that ma y be formed during or after application of the BWMS and that may be of concer n for the receiving environment or human health;

.5.1 the names of Other Chemicals that may be formed during or after the application of the BWMS with a t echnical justification for why they

should not be treated as Relevant Chemicals

.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 against 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;GESAMP-BWWG 3/9

ANNEX 4 Page 8

I:\MEPC\56\2-2.doc .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 give n 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; and

.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 internationally recognized guidelines (preferably OECD or equivalent) (G9: 4.2.3), and according to an internationall y 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 database s for many of the hazards concerned and a weight of evidence approach has become necessary to ensure that the rating 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 test ing 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 that is not necessary, owing to th e nature of the substan ce or of its proposed uses and taking into account all proposed risk management measur es, need not be supplied. The same applies where it is not scientifically necessary or t echnically possible to supply the information. In such cases, a justification should be submitted, which would help the Groupís evaluation of the Application Dossier.GESAMP-BWWG 3/9

ANNEX 4 Page 9

I:\MEPC\56\2-2.doc 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 informed, in writ ing, of the decision of the Organization. The Administration may appeal agai nst any decision made by the Organization. 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 representati ve of the applicant to be available to the

BWWG for an hour or so to answer questions regarding the system.

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 that may influence its ev aluation and developmen t of recommendations.

3.0.2 For Active Substances and/or Preparatio ns 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 toxicity 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 sensitive life stage (G 9: 5.2.4). The results should include acute LC50 values and chronic NOECs (G9: 5.2.5). Therefore 100% concentrat ions of samples of 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:GESAMP-BWWG 3/9

ANNEX 4 Page 10

I:\MEPC\56\2-2.doc .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 inhibitor or solvent, etc.

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 classification in accordance with the UN GHS system;

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

.10 the identity of any stabilis ers or necessary additives.

3.1.3 Relevant Chemicals (G9: 2.1.4) : Where the process migh t produce by-products when reacting with ballast water, the applicant should 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;GESAMP-BWWG 3/9

ANNEX 4 Page 11

I:\MEPC\56\2-2.doc .5 the structural formula; and

.6 the classification in accordance with the GHS system.

3.1.4 Other Chemicals : Where the process might produce by-products not deemed to be Relevant Chemicals by the appli cant, 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 levels (e.g., OECD guidelines 201 (Algae, Growth Inhibition Test), 202 (Daphnia s p. Acute Immobilization Test), 203 (Fish, Acute 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 gr oups (e.g., echinoderms, molluscs).

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

3.2.1.3 Such acute aquatic toxici ty data are required for:

.1 Preparations includi ng 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 life-stages is th e ultimate aim of the long-term testing.

3.2.2.3 Such chronic aquatic toxicity data are required for:

.1 Preparations includi ng any of its components; .2 Active Substances;GESAMP-BWWG 3/9

ANNEX 4 Page 12

I:\MEPC\56\2-2.doc .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 meta morphosis 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 ñ e.g., due to the structure of the substa nce or results of other available studies ñ these tests may be waived.

3.2.3.2 Such information on endocrine disruption is required for:

.1 Preparations includi ng any of its components; .2 Active Substances; and

.3 Relevant Chemicals.

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 diffe rent 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 marine 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 includi ng 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 bioaccumul ation potential should be considered taking into account the following points:

.1 One bioconcentration factor (BCF) determ ined in a bioconcentr ation 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 elim ination 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;GESAMP-BWWG 3/9

ANNEX 4 Page 13

I:\MEPC\56\2-2.doc .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 toxi city test systems 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, mamma lian toxicity evaluation and bioaccumulation and biodegradation data.

3.2.6.2 An assessment of secondary poisoning is redundant if fo r the substance of concern absence of bioaccumulation potential can be de monstrated (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 that is deemed to be unnecessary need not be supplied. However, in such cases a scientific ju stification should be submitted in order to explain why the data have not been provided. In general, testing with vertebrate 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 ev idence 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 components, as appropriate. Information on Relevant Chemicals formed during or after application of the BWMS should be provided as well.GESAMP-BWWG 3/9

ANNEX 4 Page 14

I:\MEPC\56\2-2.doc 3.3.1 Acute toxicity

3.3.1.1 The acute toxicity should be known for at least two routes of e xposure, 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 includi ng 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 skin, 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).

3.3.2.2 Testing of Active Substances or Prepar ation should include a study on acute dermal irritation/corrosion and a study on acute eye ir ritation/corrosion. The recommended tests are OECD guidelines 404 (Acute Dermal Irri tation/Corrosion) and 405 (Acute Eye Irritation/Corrosion). These tests need not be ca rried out on a strong acid or base (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 valida tion by recognized or ganizations, may be

submitted.

3.3.2.3 The recommended test for Skin Sensitiz ation is OECD guidel ine 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 includi ng 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 two species, one rodent and another mammalian species, using the oral route unless another one is more appropriate.GESAMP-BWWG 3/9

ANNEX 4 Page 15

I:\MEPC\56\2-2.doc 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 dur ation of 12 months in two species, one rodent and another mammalian species unless a full ju stification 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.

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 ñ Two-Generation Reproducti on Toxicity Study); and

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

3.3.5.2 However, these key data requirements can be modified (either re duced or accelerated or extended) and influenced by factors such as structural 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 should be perf ormed with one rodent and one other mammalian species. The carcinogenicity testing of an Active Substance or preparation may not be needed where justification de monstrates that these tests are not necessary. Carcinogenicity studies may be combined with the chronic toxicity studies.

3.3.6.2 Such information on carcinogenicity is required for:GESAMP-BWWG 3/9

ANNEX 4 Page 16

I:\MEPC\56\2-2.doc .1 Preparations includi ng any of its components; .2 Active Substances; and

.3 Relevant Chemicals.

3.3.7 Mutagenicity/genotoxicity

3.3.7.1 Genotoxicity data should be available for Ac tive 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 assay for chromosoma l damage or a micronucleus test is necessary. If th is test is negative it should be eval uated whether mutageni city or evidence of DNA damage can be demonstrated in tissue other than bone marrow.

3.3.7.2 Such information on mutagenicity and genotoxicity is required for:

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

.3 Relevant Chemicals.

3.3.8 Toxicokinetics

3.3.8.1 Basic data on the toxicokinetics of Ac tive Substances and ot her components of a preparation as well as Relevant Chemicals should be included. Info rmation on absorption, 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 Substances, components of a preparation and Relevant Chemi cals under aerobic and anaerobic c onditions should be assessed, resulting in the identification of relevant metabolit es 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) a nd/or organic carbon

normalized distribution coefficien t (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 accordan ce 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, sedime ntation and transformation 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:GESAMP-BWWG 3/9

ANNEX 4 Page 17

I:\MEPC\56\2-2.doc .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 equivalent 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 equivalent guidelines) if the Active Substance is discharged into estuarine water (e.g., inla nd harbour with contact to seawater).

3.4.1.2 If the Active Substance is not readily bi odegradable, then th e following higher tier

studies should be conducted:

.1 a study on aerobic and anaerobic transformation in aquatic sediment systems according to OECD guideline 308 (Aerobic and Anaerobic Transformation in 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 cont ent 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 ñ Simulation Biodegradation Test) or equivale nt 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 is 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 already been detailed earlier in this document;GESAMP-BWWG 3/9

ANNEX 4 Page 18

I:\MEPC\56\2-2.doc .2 a study into the log Pow according to OECD guideline 107 (Partition Coefficient (n-octanol/water): Shak e Flask Method), OECD guideline 117 (Partition coefficient ñ n-octanol/water HPLC method) or equivalent test guidelines. For very hydrophobic compounds a slow sti rring method (OECD 123 (Partition

coefficient ñ 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 that 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 pa rtition coefficients is required for:

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

.3 Relevant Chemicals.

3.4.3 Persistence and identification of the main metabolites in the rel evant media (ballast

w ater, marine and fre s h w aters)

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, base d on a mass balance incl uding 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 identif y products of concern to the environment and, where possible, quantitatively as to id entify environmental concentrations.

3.4.4.2 Radical producing chemicals are capable of forming haloge nated (chlorinated, brominated) hydrocarbons that 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.

1 MEPC 55/2/6, paragraph 33.GESAMP-BWWG 3/9

ANNEX 4 Page 19

I:\MEPC\56\2-2.doc 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 required 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 effect s on wildlife and benthic habitats are required

for:

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

.4 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 residue s of the substance in

seafood shall be submitted.

3.4.6.2 Such data on potential resi dues in seafood are required for:

.1 Preparations includi ng 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 interactiv e 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 wa ter, or with the receiving environment, should be reported.

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

.1 Preparations includi ng any of its components; .2 Active Substances; and

.3 Relevant Chemicals.GESAMP-BWWG 3/9

ANNEX 4 Page 20

I:\MEPC\56\2-2.doc 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 any of its components; and

.2 Active substances.

3.5.2 Boiling point

Data on the boiling poin t are required for:

.1 Preparations including any of its components; and

.2 Active Substances.

3.5.3 Flammability (flash point)

Data on the flash point are required for:

.1 Preparations includi ng any of its components; .2 Active Substances; and

.3 Relevant Chemicals.

3.5.4 Density (relative density)

Data on the density are required for:

.1 Preparations includi ng 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 includi ng any of its components; .2 Active Substances; and

.3 Relevant Chemicals.

3.5.6 Water solubility/dissociation constant

Data on the water solubility and diss ociation constants are required for:GESAMP-BWWG 3/9

ANNEX 4 Page 21

I:\MEPC\56\2-2.doc .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 po tentials are required for:

.1 Preparations includi ng 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 material s of construction are required for:

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

.4 Treated Ballast water.

3.5.9 Auto-ignition temperature

Data on the auto-ignition te mperature are required for:

.1 Preparations includi ng any of its components; .2 Active Substances; and

.3 Relevant Chemicals.

3.5.10 Explosive properties

Data on the explosive prope rties are required for:

.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.

2 MEPC 55/2/6, paragraph 34.GESAMP-BWWG 3/9

ANNEX 4 Page 22

I:\MEPC\56\2-2.doc 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 viscosit y 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 any 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 includi ng 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.

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 pa rticulate matter are required for:

.1 Treated Ballast water.GESAMP-BWWG 3/9

ANNEX 4 Page 23

I:\MEPC\56\2-2.doc 3.5.19 Other known relevant physical or chemical hazards

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

.1 Preparations includi ng 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 chemicals e.g., TRO, analytical methods at environmentally relevant concentrations are required for:

.1 Preparations includi ng any of its components; .2 Active Substance; and

.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, th e 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;

.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 possibility of dest ruction or decontamination following release in the marine environment;

.6 procedures of waste manage ment of the Active Substance;GESAMP-BWWG 3/9

ANNEX 4 Page 24

I:\MEPC\56\2-2.doc .7 the possibility of reuse or recycling;

.8 the possibility of neutralization;

.9 conditions for contro lled 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 Globally Harmonized System of Classification and Labelling of Chemicals (GHS) to aid in interpreti ng data for classifying su bstances as dangerous. Reference is also made to the MEPC appr oved hazard evaluation procedure published as GESAMP Reports and Studies No. 64 under the tit le 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 Chemicals and other by-products produced by the system unless a cl ear justificatio n is provided e.g., the ha lf-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.

6 RISK CHARACTERIZATION

6.1 Screening for persistence, bioaccu mulation and toxicity (G9: 5.1)

6.1.1 Persistence (G9: 5.1.1.1)

6.1.1.1 Persistence is prefer ably assessed in simula tion test systems to de termine the half-life under relevant conditions. Biodegradation scr eening 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 requirements, see 3.4.1 and 3.4.3 of this

document.GESAMP-BWWG 3/9

ANNEX 4 Page 25

I:\MEPC\56\2-2.doc 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 life 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 effect 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 prepar ation 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 sediments, or > 120 days in freshwater sediments 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 para graph 6.4.1 of the Procedure.

6.2 Evaluation of the treated ballast water (G9: 5.2)

The advantage of toxicity testing on the ballast water 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).GESAMP-BWWG 3/9

ANNEX 4 Page 26

I:\MEPC\56\2-2.doc 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 Full-scale land-based toxicity tests with samples of ballast water treated with the

BWMS under test conditions an d a scale as defined in Guide lines (G8) during onboard testing should be conducted (G9: 5.2.2).

6.2.2.2 In accordance with Regulation D-3.2, a Balla st Water Management system using an Active Substance or Preparation to comply with the Convention (that 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 determ ine the no adverse-eff ect 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 befo re discharge (5.2.7). An indicat ion of the uncer tainty of the holding time should be give n, taking into account variables (e.g., temperat ure, pH, salinity and sediment loading).

6.3 Risk characterization and analysis

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

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

6.3.2 Characterization of degradat ion 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).

6.3.3 Prediction of discharge and environmental concentrations

6.3.3.1 Based on the information on fate and beha viour of Active Substa nces, 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 discharg e of treated ballast water under controlled conditions during development and t ype 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.GESAMP-BWWG 3/9

ANNEX 4 Page 27

I:\MEPC\56\2-2.doc 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 Chem icals 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), predators (fish), (G9: 5.3.9).

6.3.5.2 An effect assessment could also be prep ared on secondary poisoning to mammalian and avian top-predators where relevant. Only toxicity studies reporting on dietary and oral exposure are relevant, as the pathway for secondar y poisoning refers exclus ively 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 orga nism at 6% fat) (G9: 5.3.10).

6.3.5.3 An assessment of effects to sediment species should be conducted unless the potential

of the substance of concern to partition into the sediment is low (e.g., Koc < 500 L/kg) (G9: 5.3.11).

6.3.5.4 The effect assessment of the Active Substan ces, Preparations and Relevant Chemicals, taking the indicated information into account, should be based on internationally recognized guidance (e.g., OECD) (G9: 5.3.13).

6.3.6 Effects on aquatic organisms

6.3.6.1 For assessment of effects to the aqua tic environment, appropriate Predicted No-Effect-Concentrations (PNEC) should be derived. A PNEC is typically deri ved at a level that, when not exceeded, protects the aquatic ecosystem against toxic effects of long-term exposures. However, for situations where only s hort-term exposures are expected, an additional PNEC for short-term exposure may be useful. PNEC values are normally derived from shortterm and/or long-term aquatic toxicity results fo r relevant aquatic species by dividing the lowest available effect concentration with an appropria te assessment factor. For the aquatic effect assessment, the assessment factor s, given in Table 2, should be guiding although these may be altered on a case-by-case basis ba sed on expert judgement. In cases where a comprehensive dataGESAMP-BWWG 3/9

ANNEX 4 Page 28

I:\MEPC\56\2-2.doc set is available, the PNEC ma y be derived with a mathemati cal 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 may be of concern for the aquatic environment. The relevance of deriving PNEC values for Active Substances, a ny other components of preparations and/or

Relevant Chemicals shoul d thus be considered.

6.3.6.3 When aquatic toxicity data are available only for freshwater species but a PNEC for the marine environment (PNECsaltw ater) is needed, this may be derived by applying a higher

assessment factor than for the deri vation of a PNECfreshwater to re flect 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-Criteri a and being rapidly degradable, the PNEC could be set along the background concentration in the environmental compartment under consideration.

Table 2 Effect assessment for de riving PNECs for freshwater and saltwater

Assessment Factor Data set PNEClong PNECshort

Freshwater assessment Lowest short-term L(E)C 50 from fresh water species representing thr ee 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)C 50 from marine species representing thr ee 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 thr ee trophic level 100

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

at least two chronic NOECs from additional marine taxonomic groups 10

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 appl icable to risk assessment becaus e 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 organisms to sedime nt-bound substances, long-term tests with sub-lethal endpoints like reproduction, growth, emerge nce, sediment avoidance andGESAMP-BWWG 3/9

ANNEX 4 Page 29

I:\MEPC\56\2-2.doc burrowing activity are regarded as most relevant. It is recomm ended 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. Sinc e there are no chronic marine se diment test methods that are internationally accepted the results from any test s should always be evaluated with caution.

Table 3 Effect assess ment 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 toxici ty 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 e ffect 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;

.3 storage and handling of the substances;

.4 contact with, or inhalati on of, process products; and

.5 noise.

7.2 Risks to human health

7.2.1 The human health risk assessment should fo llow generally accepted guidelines including acute and long-term exposure situations. The ri sk assessment should entail hazard identificationGESAMP-BWWG 3/9

ANNEX 4 Page 30

I:\MEPC\56\2-2.doc and, as appropriate, dose (concentration) ñ re sponse (effect) assessment, exposure assessment

and risk characterization. The population groups deemed to be at risk and so to be examined should include crew, passengers and all personnel, including the public, in por ts. Poten tial health risks connected to the exposure of consumers via seafood or pe rsons at the coast (e.g., beach) after discharge should be evaluated. Special attention s hould be given to serv ice 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 includ e risk reduction (risk management) by regulations based on the SOLAS Convention as well as specific measures proposed by the manufacturer and of the Ballast Water Management System that should then be assessed by the Administration concerned.

Health effects in humans

7.2.2 The effect assessment of the Active Substances, Preparations and Relevant Chemicals should include a screening on carc inogenic, mutagenic 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 balla st water at discharge is found either through direct testing of the treated ballast water or if the estimates ratios between predicted concentrations of the Active Substance, components of preparations or Relevant Chemicals, as appropriate, and the respective PNEC values are below 1, no further assessment of direct toxic effects to the aquatic environment is necessary.

7.3.3 In other cases, the dilution ne cessary to ensure 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.

8 ASSESSMENT REPORT (G9: 4.3)

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

.1 an overview of the da ta and endpoints 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;GESAMP-BWWG 3/9

ANNEX 4 Page 31

I:\MEPC\56\2-2.doc .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 that were determined experimentally, along with an identification or description of the modelling methodology;

.5 an evaluation of the association betw een the Ballast Water Management System making use of Active Substances or prepar ations containing one or more Active Substances to comply with the Conventi on in question, the related adverse effects and the environmental concentrations, eith er observed or e xpected based on the

risk assessment and th e 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 modificati ons in names, including trade and technical name, composition or use of the Active Substan ces 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 significantly change a ny part of a Ballast Water Management System that has been 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 appr oval to be added.GESAMP-BWWG 3/9

ANNEX 4 Page 32

I:\MEPC\56\2-2.doc Key Data Summary Form for the Procedure for approval of BWM Systems that Make Use of Active Substances

(For each piece of data selected for the Summar y Form, the range of data that this has been chosen from should be included as an appendix e .g. If the Summary Form includes an Acute Oral

LD 50 for a Rat, the appendix should include the comple te list of values identif ied in the literature

from which this value was chos en as a proposal to the BWWG)

1 Chemical Identification

Trade Name of Preparation Composition of Preparation Component Chemical Name CAS Number Concentration (%) AS, RC or Other*

* Indicate whether the chemical is believed to be one of the following, giving justification for each proposal:

AS = Active Substance

RC = Relevant Chemical

Other = Any other Chemical e.g. solvent

List of ALL potential by-products produced in ballast water

Chemical Name CAS Number Concentration (%) (bio)degradation

rate or half-life

Notes: 1 A separate index for the Active Substanc e(s) and all by-products should be created unless a scientific explanation is pr ovided to justify not including them.

2 A chemical analysis should also be pr ovided to show the concentration of possible by-products produced in the treated ballast wa ter. Such analyses should be carried

out to a level of detection commensurate with the level of naturally occurring

chemical in seawater and/or the level that could be justified as not being hazardous to human health or the environment, where appropriate.

3 A clear description of, or reference to, the chemical analysis should be provided along with the length of time, after treatment , that the analysis was carried out. It

is recommended that there should be:

.1 one analysis carried out following the shortest possible time that the treated ballast water would be pe rmitted to be discharged; and

.2 one analysis carried out [5] five days later.GESAMP-BWWG 3/9

ANNEX 4 Page 33

I:\MEPC\56\2-2.doc Data required for each component of th e Preparation and by-product produced

in ballast water

Chemical Name

ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ.

Where the applicant considers that it is not necessary to complete the data form for a given chemical, a full justification must be gi ven (e.g. the 1⁄2-life of the chemical is only a few seconds and so will have disappeared by the time the ballast water is discharged into the sea)

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Species LC 50 (mg/l/duration) Reference/Comments/Justification for missing data

Fish

Crustacea Algae

2.2 Chronic Aquatic Toxicity Data

Species LC 50 (mg/l/duration)

or NOEC(mg/l/duration Reference/Comments/Justification for missing data

Fish

Crustacea Algae

2.3 Information on Endocrine Disruption

Species Information Reference/Comments/Justification for missing data

Fish

Crustacea Algae

2.4 Sediment Toxicity

Species Information Reference/Comments/Justification for missing data

Fish

Crustacea AlgaeGESAMP-BWWG 3/9

ANNEX 4 Page 34

I:\MEPC\56\2-2.doc 2.5 Bioavailability/Biomagnification/Bioconcentration

Log Pow Reference/Comments/Just ification for missing data

BCF

2.6 Food Web/Population Effects

A description of potential food web and population effects is required supported by a full justification

3 MAMMALIAN TOXICITY

3.1 Acute mammalian Toxicity

Value Species Reference /Comments/Justification for missing data

Oral LD 50 (mg/l)

Dermal LD 50 (mg/l)

Inhalation LC 50 (mg/l/4h)

3.2 Corrosion/Irritation

Species Method Results (including scores where available) Reference/Comments/Justification for missing data

Skin Eye

3.3 Sensitization

Species Method (e.g. Buehler,

M&K) Results (Sensitizer Y/N) Reference/Comments/Justification for missing data

Skin

Inhalation

3.4 Repeated-Dose Toxicity

Exposure Route Exposure Duration Exposure dose Species

Method

Results

NOAEL

NOEL

Reference/Comments/ Justification for missing dataGESAMP-BWWG 3/9

ANNEX 4 Page 35

I:\MEPC\56\2-2.doc 3.5 Development and Reproductive Toxicity

Exposure Route Exposure Duration Exposure dose Species

Method

Results

NOAEL

NOEL

Reference/Comments/ Justification for missing data

3.6 Carcinogenicity/Mutagenicity/Reprotoxicity

Species Method Details Results Reference/Comments/

Justification for

missing data Carcinogenicity Mutagenicity Reprotoxicity

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND

ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

Sea

water or

Fresh

Water Test

Duration Results Break-down products Reference/Comments/

Justification for

missing data

Hydrolysis at pH 5 Hydrolysis at pH 7 Hydrolysis at pH 9 Biodegradation

1/2 - Life NR

4.2 Partition Coefficients

Method Results Reference/Comments/ Justification for missing data Log Pow

KocGESAMP-BWWG 3/9

ANNEX 4 Page 36

I:\MEPC\56\2-2.doc 4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference/Comments/ Justification for missing data

Persistence

4.4 Reaction with Organic Matter

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.6 Potential Residues in Seafood

4.7 Any Known Interactive Effects

5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES,

PREPARATIONS AND TREATED BALLA ST WATER IF APPLICABLE

Property Value Reference/Comments/ Justification for missing data Melting point (°C) Boiling point (°C) Flammability (flash point for liquids; °C) Density (20 °C; kg/m 3 ) Vapour pressure (20 °C; Pa) Vapour density (air = 1) Water solubility (temp; effect of pH; mg/l) pH in solution Dissociation constant (pKa)

Oxidation-reduct ion potential Corrosivity to mat erial or equipment Reactivity to container material Auto-ignition temperature (°C) Explosive properties Oxidising properties

Surface tension Viscosity Thermal stability and identity of breakdown products Other physical or chemical properties

6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at environmentally Relevant

Concentrations

Method Applicability Sensitivity

Reference/Comments/ Justification for missing dataGESAMP-BWWG 3/9

ANNEX 4 Page 37

I:\MEPC\56\2-2.doc 6.2 Material Safety Data Sheet provided (Yes/No)ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ

6.3 GHS Classification ÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖÖ.

6.4 Risk Characterization

Persistent (y/n) Bioacumulative (y/n) Toxic (y/n) Reference/Comments/ Justification for missing data

***GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc ANNEX 5

REVIEW OF PROPOSALS FOR APPR OVAL OF ACTIVE SUBSTANCES

PureBallast Management System

Submitted for Basic Approval by Sweden as MEPC 55/2/5 and by Norway for Final Approval as MEPC 56/2/1

0 SUMMARY

0.1 The Group noted that the PureBallast Syst em uses a combination of filtration and Advanced Oxidation Technology that produces free radi cals in order to treat ballast water. These free radicals were expected to ha ve half-lives in the order of mi cro seconds to milliseconds and, for this reason, it was neither ne cessary nor practical to provide their physical characteristic or toxicological profiles.

0.2 The Group were also satisfied that, as th e system does not involve the storage or generation of chemicals to treat ballast water, there were no associated safety problems.

0.3 However, it was recognized that the process would generate free radicals that might react with naturally occurring organic molecules to form by-products with safety and environmental

concerns.

0.4 Based on results from chemical analyses of treated ballast water, the Group concurred with the views of the applican t that it was not necessary to provide toxicological and ecotoxicological data on these pr oducts and that an evaluation of the effects of treated ballast water should suffice to provide a recommenda tion regarding both Basic Approval and Final Approval.

0.5 The Group noted that the G9 procedures require that ìPro posed procedures for the use and technical equipment introduced needs to be taken into accountî. However, it was also noted that neither procedures for use of the treatmen t system, nor confirmation that the equipment is suitable for use on board a ship had been provide d for evaluation by the Group. As a result, the Group proposed that the following procedures should be properly documented so that they can be taken into account by the Administration prior to issuing a Type Approval Certificate should MEPC grant Final Approval:

.1 the UV lamps require a ìwarm-upî time before the system is ready for use. Full operating and maintenance procedures requi re to be evaluated to provide all necessary considerations for operators and crew safety;

.2 the electric power requirement of the sy stem will not be an insignificant additional ship service demand. It requires to be confirmed that the equipment meets all regulatory standards for equipment to be installed on board a ship, both with regard to construction and prevention of electric shock to personnel; and

.3 the submission indicated that the corrosivity to the materials or equipment of normal ship construction due to possible formation of certain compounds by use of the system was to be further inves tigated. The results of this further investigation should be assessed to conf irm that any corrosion effect remains acceptable.GESAMP-BWWG 3/9

ANNEX 5 Page 2

I:\MEPC\56\2-2.doc 0.6 As a result, the Group recommended that Final Approval be granted to this system on the conditions that the Administration verify that the concerns raised with regard to the ship and crew safety have been fully addressed prior to issuance of a Type Approval Certificate.

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by Sweden in document MEPC 55/2/5 that was supported by a dditional confidential information provided to the GESAMP-BWWG Secretariat and that suppli ed by Norway in document MEPC 56/2/1, that also was supported by additiona l confidential information pr ovided to the GESAMP-BWWG

secretariat.

2 COMPLETENESS OF THE DOSSIER

2.1 The Group noted that the applicant had provi ded some ecotoxicity data for the treated

ballast water that demonstrated a lack of toxicity. Whilst the Group identified some shortcomings associated with these toxicity stud ies, it was envisaged th at any new tests were unlikely to reveal different results because of the very short-lived radicals generated by the
system.

2.2 The Group also considered that the Level of Quantification (LOQ) associated with the chemical analysis of the potential by-products measured was too high and that much lower

detection limits are achievable.

2.3 Some concern was expressed that some of the chemicals analysed for might still be produced at levels lower than the de tection limits used by the applicant.

2.4 Whilst no other physico-chemi cal properties, fate and beha viour in the environment and mammalian toxicity data had been provided, the Gr oup agreed that this was not necessary, from the aquatic toxicity pe rspective, due to the low level of by-products being produced by the system. However, it was considered that, even at such low levels, there might be some potential for causing a risk to human health.

2.5 However, the Group agreed th at information should have b een provided describing the actual use onboard of the equipmen t together with a statement that it was suitable for use onboard. Nevertheless, the Group considered that , providing the Administ ration addresses these points when considering Type Approval, this aspect should not prevent the Group from recommending that both Basic Approval and Final Approval be granted to this system.

3 DESCRIPTION OF THE BWMS

3.1 Overview of the system

3.1.1 The submission indicates that the system is intended to treat the ballast water both on uptake and at discharge. The use of a secondary discharge treatment is to address any potential for re-growth of organisms in the ballast tank. The treatment system consists of the following two phases:GESAMP-BWWG 3/9

ANNEX 5 Page 3

I:\MEPC\56\2-2.doc .1 Filtration (50μ m) (uptake only) for removal of larger pa rticles and organisms as

well as to reduce the level of sediments in the ballast tanks, it is informed that the filter used is of the automatic back flushing type;

.2 Treatment with the AOT (Ad vanced Oxidation Technology) that involves:

.1 the in situ formation of free radicals; and

.2 direct photo-effects.

The submission states that a special UV light wavelength spectrum is used in

combination with a TiO 2 based catalyst. It is conf irmed that no substances are added in the process.

3.1.2 The Group also noted that the description of the system indicated that it incorporated full automation, including CIP (cleaning in place) and alarm facilities.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 It was noted that the proposed system invol ves filtration followed by a patented system for producing free radicals in situ with the aid of a titanium catal yst. As a result, chemicals are neither required to be stored onboard nor generated on demand.

3.2.2 However, it was recognized that the proces s would generate free radicals that were expected to have half-lives in the order of mi cro seconds to milliseconds, but that might react with naturally occurring organic molecules to form by-products with safety and environmental concerns. Whilst agreeing that such free radicals s hould be regarded as either Active Substances or Relevant Chemicals, it was agreed that, due to their short half-life it was neither necessary nor practical to provide their physical char acteristic or toxicological profiles.

3.2.3 It was noted that the appli cant had identified the followi ng chemicals as being possible resultant products of the treatment system and had analysed the ballast water for them, as part of the application for Basic Approva l, with the following results:

Test Compound Before treatment After treatment

Bromate <0.01 mg/L <0.01 mg/L Absorbed organic halogens 76 μ g Cl/L 77 μ g Cl/L Extractable organic halogens <2 μ g/L <2 μ g/L Chlorophenols (18 substances) < 0.01 μ g/L < 0.01 μ g/L Chloroform (CHCl 3 ) 2 μ g/L 1 μ g/L Bromoform (CHBr 3 ) <1 μ g/L <1 μ g/L Dichlorobromomethane (CHCl 2 Br) <1 μ g/L <1 μ g/L Dibromochloromethane (CHClBr 2 ) <1 μ g/L <1 μ g/L

3.2.4 The Group considered that, a lthough the submission indicated that these analyses have been carried out using the best available te chniques it was not convin ced as the Level of Quantification (LOQ) is considered too high in some cases as can be seen from the above table.GESAMP-BWWG 3/9

ANNEX 5 Page 4

I:\MEPC\56\2-2.doc 3.2.5 However, the Group also noted the followi ng analyses of chemicals that had been submitted as part of the application for Final Approval.

Test Compound Before treatment After treatment Absorbed organic halogens 450 μ g Cl/L 570 μ g Cl/L Extractable organic halogens <50 μ g/L <50 μ g/L Chlorophenols (18 substances) <0.1 μ g/L <0.1 μ g/L Chloroform (CHCl 3 ) <0.3 μ g/L <0.3 μ g/L Bromoform (CHBr 3 ) <0.2 μ g/L <0.2 μ g/L Dichlorobromomethane (CHCl 2 Br) <0.1 μ g/L <0.1 μ g/L Dibromochloromethane (CHClBr 2 ) <0.1 μ g/L <0.1 μ g/L Total Residual Chlorine (TRC) <20 μ g Cl/L <20 μg Cl/L

3.2.6 Based on these results, the Group concurred with the views of the app licant that it was not necessary to provide toxicological and eco-toxic ological data on these products and that an

evaluation of the effects of tr eated ballast water should suffi ce to provide a recommendation regarding Basic Approval.

3.2.7 However, concern was expressed that the te st water used in the application for Basic Approval was artificial seawater and so the chemical analysis may not reflect a true representation of the eff ects on natural seawater.

3.2.8 However, the applicant provided additional in formation that showed that the artificial seawater had been made using tap water that contained 3.5-4 mg/L of dissolved organic compounds that made the Total Organic Com pounds present at a level of 3.8-4.3 mg/L. Furthermore, the tests carried out for Final Approval used treated natural seawater.

3.2.9 In addition, the applicant provided the follo wing information to explain the reason for the very low levels of chemicals produ ced as by-products by the system:

Clarification on Wallenius-AOT Chemical Description

The process description presented is based upon the current scient ific knowledge about photo-catalyses, free radical and marine chemistry cited in the references. Albeit that the Wallenius AOT-process generates dichloridyl an d dibromidyl radicals in sea water, it does not involve any formation of elemental chlorine (Cl 2) or Bromine (Br 2 ). Elemental chlorine and bromine give rise to environmental stress. This chemistry is not operative in the Wallenius AOT-process, and consequently, neither is the associated environmental concern. It should be pointed out that the radicals produced in the AOT-treatment unit are not different from those naturally formed by sun light in the surface layer of seawater. Any potential reaction product that may be formed have been proposed and measured to support the chemical process reduction, e.g. th e content of chloroform was reduced. Most significantly, all biologica l tests performed have shown that the water treated by the Wallenius AOT- process does not display any adverse effect.

3.2.10 As a result, the Group agreed no significant amount of chem icals were identified in the seawater, after treatment with the system, wh ich would require additional toxicological or ecotoxicological information to be evaluated.GESAMP-BWWG 3/9

ANNEX 5 Page 5

I:\MEPC\56\2-2.doc 3.2.11 Based on this information, the Group agreed that it was not necessary to evaluate the properties of any Active Substance or Relevant Chemical associated with this system. Instead, a

brief evaluation was carried out on the data generated by testing the treated ballast water, the results of which, are shown in the appendix to this annex.

4 HUMAN HEALTH ASSESSMENT

4.1 The disinfection principle of AOT/TiO2/UV is based on cellular oxid ative stress with lysis caused by the generated in situ free radicals and direct phot o-effects. These synergistic

effects are considered sufficien tly efficacious to inactivate mi croorganisms under a certain level of concentration/m3. The major modes of reac tion will be one-electron transfer (Br2-, CO3-, Cl2-, radicals) or addi tion hydroxyl radicals.

4.2 Per se , TiO 2 is considered non-toxic as shown by its use in reconstructive surgery and Ti implants in human clinical care.

4.3 In the photo-catalytic processes, it is a ssumed that the formation of bromate, BrO 3 - , a known human carcinogenic, is unlikely to occur due to the fact that it would require multiple one-electron oxidation steps. Also , the process prevents the produc tion of ozone and its related

adverse effects.

4.4 The active free radicals produced in the submitted AOT-treatment unit were dichloridyl (Cl 2 - ), chlorbromidyl (ClBr - ), dibromidyl (Br 2 - ) and carbonate (CO 3 - ) that have a very short half-life (micro- to milliseconds) an d therefore transient effects.

4.5 The by-products of disinfection that we re identified and measured were mainly chloro- and bromo-organic compounds. From th ese, especially bromate, chloroform and bromoform have a potential for bioaccumulation and human carcinogenicity therefore will have to be kept below toxicological critical levels (bromate<10μg/L; bromoform<100μg/L; chloroform<200 μg/L, WHO Guidelines for Dri nking Water Quality, 2003) or to be removed during the ballast water treat ment and at discharge.

4.6 Although the concentrations of these mentione d chemicals were considered to be below LOQ, the Group considered that the LOQ was considerably high fo r the quantification of these particular compounds and that the sensitivity of the analytical method could be improved as to give satisfactory and conclusive measurements to be able to evaluate human toxicological effects produced by the system.

4.7 Taking into consideration that the current MCL (M aximum Contaminant Level) in US for

bromate (potassium bromate) is 10μg/L (very close to the LOQ of the analytical method) and the maximum contaminant level goal is zero, human exposure should be totally avoided during ballast water treatment and at discharge.

4.8 Additionally, brominated THM compounds are normally volatile liquids at room temperature therefore, as chemicals vaporiz e during water usage, inhalation becomes an important exposure route and should be minimized.

4.9 From the above information it is concluded that the critical health effects resulting from human exposure to the active substances and re levant compounds will be related mostly toGESAMP-BWWG 3/9

ANNEX 5 Page 6

I:\MEPC\56\2-2.doc respiratory toxicity and carcinoge nicity, depending on the severity of exposure and presumably under medium and long term scenarios (e.g. occupational exposure).

4.10 Other factors may be relevant when asse ssing human exposure towards this group of chemicals that include, inter alia :

.1 the variability in human individual sensitivity; and

.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 RISKS TO THE SAFETY OF SHIP AND CREW

5.1 The Group noted that the submission identified th e only potential risk to the ship and its crew present in the PureBallast system was re lated to UV irradiation and overheating in the treatment unit from the UV lamps. The submission confirmed that these identified risks had been addressed by system safety measures that ensure that there is no risk of personnel exposure to

UV-irradiation and that automatic shut down, in a no flow s ituation, in order to prevent overheating.

5.2 The submission recognises that, concerning sh ip and personnel safet y, the G9 procedures require that ìProposed procedures for the use and technical equipment introduced needs to be taken into accountî. However neither proce dures for use of the treatment system, nor confirmation that the equipment is suitable fo r use on board a ship had been provided for evaluation by the Group. It was noted that the submission states that ìThe system has been evaluated by Lloyds Classification Society and had been approved w ith regards to ship and crew safetyî, however the Group noted that the referenced approva l certificate only relates to examination and pressure testing of the system and the connecting piping to the existing ballast
water system.

5.2.1 The Group noted that the UV lamp s require a ìwarm-upî time before the system is ready for use. Full operating and main tenance procedures require to be evaluated to provide all necessary considerations for operators and crew safety.

5.2.2 The Group noted that the electric power requi rement of the system will not be an insignificant additional ship service demand. It requires to be confirmed that the equipment meets all regulatory standards for equipment to be installed on board a ship, both with regard to construction and prevention of electric shock to personnel.

5.2.3 The Group noted that the submission indicated that the corrosivity to the materials or equipment of normal ship construction due to po ssible formation of certain compounds by use of the system was to be further investigated. The results of this further investigation should be assessed to confirm that any corro sion effect remains acceptable.

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

6.1 The Group recognized that is was not possible to ev aluate the persistency, bioaccumulation and toxicity of any chemicals produced by the system as they were eitherGESAMP-BWWG 3/9

ANNEX 5 Page 7

I:\MEPC\56\2-2.doc short-lived or not dete ctable. Assessment of the PBT-crit eria is therefore considered not required.

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 Derivation of the Predicted No Effect Concentration (PNEC)

7.1.1 In the dossier for Basic Approval several ecoto xicity tests were ava ilable (see section 3.1 in the appendix to this document). The Group c onfirmed that the data provided do not indicate a potential risk to the environment and agreed that the derivation of a PNEC is not possible as the nature of the system does not involve the use of chemicals that make the derivation of a PNEC neither possible nor necessary. The Group noted that no effect s had been observed during chronic toxicity tests, using a100% c oncentration of treated ballast water.

7.2 Calculation of the Predicted Environmental Concentration (PEC)

7.2.1 The Group agreed that there would be no point in calcula ting the PEC of the treated ballast water as it was recognized that a 100% concentration of treated ballast water discharge would be acceptable under any situation.

7.3 Calculation of the PEC/PNEC ratios

7.3.1 The Group noted that neither the PEC nor the PNEC had been derived. The Group agreed that it was not necessary to do so as th e PEC/PNEC ratio could be regarded as less than one for all practical purposes.

8 CONCLUSIONS AND RECOMMENDATIONS

8.1 Risks to the safety of the ship

8.1.1 Subject to the concerns expr essed in section 5 and paragra ph 0.5 of this annex, the Group agreed that this system was not likely to cause any con cern with regards to the safety of the ship.

8.2 Risk to the crew and the general public

8.2.1 It was recognized that the levels of potentially hazardous chemicals produced by this system were generally lower than the detection lim its of the methods used to analyze for them. However, the Group considered that there might still be some human health concerns and so agreed that human exposure onboa rd should be avoided until it ca n be demonstrated that the levels of such chemicals, if produced, are be low the threshold limits for any toxicological

concerns.

8.3 Risks to the environment

8.3.1 Based on the toxicity tests carried out on the treated ballast water, the Group agreed that this system was not likely to cause any c oncern with regards to the environment.GESAMP-BWWG 3/9

ANNEX 5 Page 8

I:\MEPC\56\2-2.doc 8.4 Conclusions

8.4.1 Having considered all of the data submitte d both for Basic Approval and Final Approval the Group agreed to recommend to MEPC that Basic Approval be gr anted to this system and that Final Approval also be granted subject to the Administration veri fying that the concerns raised with regard to ship and crew safety have been fully addressed prior to issuance of a Type Approval certificate.GESAMP-BWWG 3/9

ANNEX 5 Page 9

I:\MEPC\56\2-2.doc Appendix

BIOLOGICAL PROPERTIES OF TREATED BALLAST WATER

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group recognized that it was both unneces sary and irrelevant to report the physical properties of treated ballast water.

2 MAMMALIAN TOXICITY

2.1 The Group noted that the applicant had indi cated that, as there were no measurable chemical by-products, it was unnecessary to test for:

.1 acute toxicity;

.2 effects on skin and eyes;

.3 chronic and long-term toxicity;

.4 development and reproductive toxicity;

.5 carcinogenicity; and

.6 mutagenicity.

3 ENVIRONMENTAL EFFECTS

3.0 Not withstanding the observation noted in paragraph 2.1 of this appendix, the Group noted that some aquatic toxicity tests had been carried out using:

.1 treated ballast water using ar tificial seawater (asw); and

.2 treated ballast water ta ken from an Oslo fjord (ofw) at 1m and 60m depth.

3.1 Acute Aquatic Toxicity Data

3.1.1 The table below summarizes the Groupís eval uation of the acute a quatic toxicity of

treated ballast water.

Species LC/EC 50 (mg/l/duration) Reference/Comments/Justification for missing data

Fish Scophthalmus

maximus >100% (ofw) NIVA 5296-2006, section 3.7, p23

Crustacea Artemia franciscana >100%/24h (asw) MEPC 55/2/5 Annex, Appendix 4, p39

Algae ?? ?? Not needed as chronic toxicity <100%

Rotifer Brachionus plicatilis >100%/48h (asw) MEPC 55/2/5 Annex, Appendix 4, p38GESAMP-BWWG 3/9

ANNEX 5 Page 10

I:\MEPC\56\2-2.doc 3.2 Chronic Aquatic Toxicity Data

3.2.1 The table below summarized the Groupís eval uation of the chronic aquatic toxicity of

treated ballast water.

B

or
F Species LC 50 (mg/l/duration)

or NOEC(mg/l/duration Reference/Comments/Justification for missing data

B Scophthalmus

maximus >100%/28d (ofw) NOEC (growth test) NIVA 5296-2006, section 3.7, p23

Fish F Scophthalmus

maximus >100% (acute and growth test)

Note: 27% deaths cf

control of 9% deaths. MEPC 56/2/1 Annex, Appendix 4, pp. 7 and 20-23

B Nitocra spinipes >100%/16d (ofw) Reproduction test NIVA 5296-2006, section 3.7, p23

Crustacea F Nitocra spinipes >100% (reproduction test) MEPC 56/2/1 Annex, Appendix 4, pp. 7 and 20-23

B Phaeodactylum

tricornutum >100%/72h (NOEC) MEPC 55/2/5 Annex, Appendix 4, p35

B Dunaliella

tertiolecta >100%/72h (NOEC) MEPC 55/2/5 Annex, Appendix 4, p36 Algae

F Skeletonema

costatum >100% (growth inhibition) MEPC 56/2/1 Annex, Appendix 4, pp. 7 and 20-23, test carried after 10 days of storage, not accepted

Where: B=data submitted for Basic Approval; and F=data submitted for Final Approval.

3.3 Information on Endocrine Disruption

3.3.1 It was noted that the endocri ne disruption potentia l of treated ballast water had not been tested for specifically but the applicant reported that juvenile developm ent and reproduction had

not been affected in the i nvertebrate test organisms ( Brachionus plicatilis ) used in the short-term toxicity tests (Ref: MEPC 55/2/5, annex, Appendix 4, p.38).

3.3.2 In addition, the app licant had reported that no potential endocrin e disrupting chemicals

had been identified in the treated water.

3.3.3 Based on this information, the Group agreed th at the treated ballast water was unlikely to have any endocrine disrupting effects.

3.4 Sediment Toxicity

3.4.1 The Group noted that the applicant had indica ted that, based on the chemical analysis and toxicity tests of the treated ballast water, ther e would not be any sedime nt toxicity associated

with the treated ballast water.GESAMP-BWWG 3/9

ANNEX 5 Page 11

I:\MEPC\56\2-2.doc 3.5 Bioavailability/Biomagnification/Bioconcentration

3.5.1 The Group noted that the applicant had indica ted that, based on the chemical analysis of the treated ballast water, there was no indicati on of any chemical by-products that might be

bioaccumulated.

3.6 Food Web/Population Effects

3.6.1 The Group noted that the applicant had indicate d that, as the full stre ngth treated ballast water did not have any measurable effect on any of the test species, it would unlikely for the diluted ballast water to have any negative effects on ecological communities at environmentally

relevant concentrations.

3.7 Environmental Fate and Behaviour

3.7.1 The Group recognized that the Active Substa nces produced by the system had very short half-lives (micro to milliseconds) and so there wa s no need to consider their environmental fate any further.

3.7.2 The Group also noted that the applicant had re ported that there no de tectable by-products had been identified following treatment of the arti ficial seawater with the PureBallast system.

***GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc ANNEX 6

REVIEW OF PROPOSAL FOR APPR OVAL OF ACTIVE SUBSTANCE

NKO3 Ballast Water Treatm ent System (NKO3 BWTS) (Previously reviewed as Ozone)

Submitted by the Republic of Korea

0 SUMMARY

0.1 The Group noted that the NKO3 System uses ozone as an Active Substance to treat

ballast water and that the Total Residual Oxid ants ((TRO) a mixture of hypobromous acid and hypobromite ions), bromate ions and bromoform ar e resultant by-products of the system when used on seawater that are regarded as Relevant Ch emicals that needed to be reviewed. Resultant by-products and relevant chemicals when used in fr esh water ballast situations are not identified and information must be provided in the Final Approval application.

0.2 Having considered the Active S ubstances and each of the Re levant Chemicals, the Group agreed that:

.1 due to its very short half-life, ozone (ca 5secs) does not present any environmental threat and whilst it is very toxic by inha lation, it should be safe to use providing that strict control measures are app lied to ensure that human exposure is prevented;

.2 whilst bromate ions are deemed to be genotox ic/carcinogenic, the environmental concentrations produced are well below the Maximum Contaminant Level (MCL) (10μg/L) and so are not considered to be a human health ris k. In addition, the

Environmental Risk Assessment indicates that there should be no risk to the environment due to the release of this component;

.3 bromoform is relatively persistent once released into the environment and is both toxic and irritant to mammals. However, due to the low concentrations generated by the ozone treatment, it is not considered to be a human health risk. In addition,

the Environmental Risk Assessment indicate s that there should b no risk to the environment due to the release of this component;

.4 Whilst the level of TRO produced by the system is relatively high, the short half life and the lack of any da ta to suggest that this mixture might be toxic to mammals, suggests that this chemical shou ld not be considered to be a human

health risk.

0.3 As a result, the Group agreed to recomme nd that Basic Approval be given to the NKO3 Ballast Water Treatment System (NKO3 BWTS) submitted by the Republic of Korea.

0.4 Notwithstanding this recommendation, the Grou p requested MEPC to note that, in order to recommend Final Approval for this system, the applicant would need to provide data on the following items:GESAMP-BWWG 3/9

ANNEX 6 Page 2

I:\MEPC\56\2-2.doc .1 For Bromate ions:

.1.1 acute dermal toxicity data;

.1.2 acute inhalation toxicity data;

.1.3 acute algal toxicity data; and

.1.4 chronic fish, algae and crustacea toxicity data.

.2 For Bromoform:

.2.1 acute dermal toxicity data;

.2.2 acute inhalation toxicity data;

.2.3 sensitization data;

.2.4 chronic crustacea data; and

.2.5 chronic algae data.

.3 For TRO:

.3.1 re-assessment of all acute and ch ronic mammalian toxicity data if available; and

.3.2 re-assessment of all ch ronic aquatic t oxicity data.

1 INTRODUCTION

1.1 The data for this product were extracted fr om original data supp lied by the Republic of Korea to support its submission MEPC 55/2/3 and supplemented by additional information identified by the Group. In addition, further information was supplied to the Secretariat of the BWWG Working Group follo wing the decision of MEPC 56 not to grant Basic Approval for the system due to lack of data. The Group noted that the single point side stream ozone injection system that was described in the resubmission documents was different to the diffuser system installed on the Tonsina and described in the origin al description and theref ore is another system than evaluated as part of the Worki ng Group Report under cover of MEPC 55/2/16.

1.2 Where more than one value was identified for any of the properties, only those considered by the Group to be the most relevant were included in this summary dossier.

1.3 For the sake of clarity and completeness, th is review includes extracts taken from the previous review submitted to MEPC 55 as part of the Working Group Report under cover of

MEPC 55/2/16.GESAMP-BWWG 3/9

ANNEX 6 Page 3

I:\MEPC\56\2-2.doc 2 COMPLETENESS OF THE DOSSIER

2.1 The Group recalled that information about the following subjects had not been included in the initial dossier but had, subsequently, been provided and so allowed an evaluation of the system to be carried out:

.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 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, as well as being included in the supplementary data provided to the GE SAMP-BWWG Secretariat post MEPC 55;

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

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

.6 a consideration of the corrosive impli cations arising from the use of ozone. However, supporting data were not provided in the dossier.

2.2 It was noted that the dossier states that the reaction between ozone and bromide in the seawater produces bromate ion, tribromomethane (bromoform) and TRO (hypobromite ion / hypobromous acid) and the ratio of such reaction pr oducts varies with pH and organic loading.

The dossier did include some da ta about bromoform concentrati ons after ozone treatment, but the Group noted that this information was from th e initial installation using multipoint injection that was the former version of the system a nd are therefore in need for confirmation of relevancy.

2.3 It was noted that the dossier did not include information ab out other relevant halogenated chemicals that may be produced according to open av ailable literature and the dossier itself. The Group therefore recommends that additional analys is is included in the further testing onboard ships and in land based tests and that these data are submitted in the application for final approval. The Level of Quantific ation (LOQ) of the analytical methods used for the potential byproducts measured should be at a level that co nfirms that the potential amount of by-products produced by the system is sufficiently low and meets the international standards on these substances. The Group considers the LOQs used to be too high. It is common to determine these contaminants in surface waters at levels of 0.01 ñ 0.05 μg/L.

3 DESCRIPTION OF NKO3 BWTS (B allast Water Treatment System)

3.1 Overview of the system

3.1.1 The Group noted that the NKO3 BWTS treats ballast water by inject ing ozone into the ballast water utilising a novel single point injection system and consists of:GESAMP-BWWG 3/9

ANNEX 6 Page 4

I:\MEPC\56\2-2.doc .1 a system for generating ozone onboard;

.2 a ballast water injecti on and control system; and

.3 an ozone gas destruct unit for use when testing and purging the ozone generator.

3.1.2 In addition, it was noted that full-scale test s following extensive labo ratory and pilot-scale testing had been carried out. The submission indicat es that initial full scale tests had been carried out with ozone utilising a multi point ozone inj ection system on one tanker, and that a single point injection systems has now been installe d on another tanker for further development and testing of the NKO3 BWTS. The test procedures include parallel tests with untreated ballast

water for control to be undertak en. The Group noted that the data presented for evaluation mainly originated from the multipoint injection system.

3.1.3 The Group noted that the applicant had provi ded in the submission a full description of the system including:

.1 a general description of the NKO3 BWTS;

.2 a description of the single point side stream ozone injection system;

.3 a general operating and maintenan ce manual for the ozone generation unit;

.4 a description of the control philo sophy for the ozone generation system;

.5 a safety manual for an ozone system;

.6 installation guidance and plans;

.7 piping, instrumentation a nd assembly drawings; and

.8 data sheets for system components.

3.1.4 The Group noted that the single point side stream ozone injection system that was described in the resubmission documents was different to the diffuser system tested in the original description.

3.1.5 The Group noted that the appl icant had indicated that this new system mixed the ozone more efficiently than the original diffuser system, which meant that less ozone was required and,

therefore a smaller amount of the Rele vant Chemicals would be generated.

3.1.6 Having considered the additional information provided, the Group agreed that it satisfied the concerns expressed about the lack of systems data that had been expressed at its previous meeting and the information provided now enabled the appropriate evaluation required for basic approval to be performed.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 The Group noted that the only Active Substa nce used in this BWMS is ozone that is generated onboard. The submission indicates that it is the intention to dose ozone at the rateGESAMP-BWWG 3/9

ANNEX 6 Page 5

I:\MEPC\56\2-2.doc of 1-2 mg/L ballast water although there is othe r information giving the maximum concentration injected as being 2.5 mg/L.

3.2.2 Whilst recognizing that ozone is routinely us ed to disinfect drinking water; when it is injected into seawater, the following Relevant Ch emicals will be formed due to the presence of

bromide ions that are not present in drinking water:

.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, hypobromous acid and sodium bromate;

.2 bromoform (CHBr 3 ) is produced from the reaction of ozone with naturally occurring organic matter in water used for ballast; and

.3 hypobromous acid (HOBr)/hypobromite ion (OBr - ) that, together are referred to as Total Residual Oxidant (TRO).

3.2.3 .Several other by-products have been reporte d in the dossier and in open literature from the reactions between organic matter and TRO.

3.2.4 The following table provides information on the identity of the Active Substance and

Relevant Chemicals.

Table Identification on the Active Substance

Chemical name CAS

number

(UN number) Molar

mass Empirical

formula Structural

formula Max. initial

concentration anticipated in

ballast water

Ozone 10028-15-6 (1956) 48.00 O 3 1-2.5 mg/L

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

Hypobromate

ion TRO

OBr - O-Br 7.5 mg/L

Bromoform 75-25-2 (2515) 252.7 CHBr 3 0.1-0.25 mg/L

Bromate ion 15541-45-4 127.9 BrO 3 - < 2 μg/L

3.2.5 The Group noted the following chemical reactions associated with the treatment of ballast water with ozone by the proposed system:GESAMP-BWWG 3/9

ANNEX 6 Page 6

I:\MEPC\56\2-2.doc O 3 + Br - O 2 + OBr - k = 160 ± 20 M -1 s -1

O 2 + 2OBr - 2O 2 + 2Br - 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 Figure F1 these main reactions of the chemistry of ozone are depicted.

Figure F1 Main reaction scheme for ozone. NOM: Natural Organic Matter

3.2.6 The Group noted that a normal operation procedure would result in an initial

concentration of betw een 1 and 2.5 mg O 3 /L. It was also noted that this was the anticipated concentration prior to ozone performing its di sinfecting activity and that the applicant had

indicated that the concentrati on of ozone released from the tank would be close to zero. However, as ozone will constitute around 12% by wei ght of the total gas injected into the ballast water line, total gas quantities injected can be calc ulated as 15 mg/L. It can be anticipated that

some of the ozone will not be dissolved and that so me of the injected gas w ill be released into the

ballast tanks from which it will be ventilated.

3.2.7 In addition, it was noted that ozone inte racts with naturally occurring bromide ions (hypobromous acid/hypobromite ion) to produce ve ry low quantities of bromoform and bromate ion together with other haloge nated compounds. These bromide ions break down slowly in the dark (half life of 1-2d) but react quicker with sea water under the infl uence of UV radiation.

3.2.7 The Group concluded that the main compone nts to take into ac count for the risk assessment would be bromate, Total Residua l Oxidants (TRO), bromoform and other halogenated compounds.GESAMP-BWWG 3/9

ANNEX 6 Page 7

I:\MEPC\56\2-2.doc 3.2.8 Details of the evaluation of each chemical employed or generated by this system are shown in the appendices as indicated below:

.1 Ozone Appendix 1 .2 Bromate ions Appendix 2 .3 Bromoform Appendix 3 .4 TRO Appendix 4

3.2.9 However, having received additional informa tion related to the application of ozone via the Side Stream Injection System , rather than the original diffuser system used, the Group agreed that, whilst the chemicals identified in paragr aph 3.2.8 could be formed in sufficient amounts to

warrant detailed evaluation:

.1 the amount of bromate ion produced wa s less than the detection limit (<2μg/L);

.2 the amount of bromoform formed reached the maximum of 255 μg/L; and

.3 whilst the amount of TRO (measured as Br - ) produced is a bout 7.5 mg/L, at discharge, this level is expect ed to drop to about 1.2 mg/L after approximately 12 hours holding time in ballast tanks.

3.2.10 The Group took these new facts into account when evaluating this system.

3.2.11 In addition, the Group agreed that the different methods of applying the Active Substance (Ozone), which resulted in differing amounts of by-products emphasized the need for the Group to evaluate the risks associated with th e whole system rather than limiting the analysis

to the chemicals involved.

4 HUMAN HEALTH ASSESSMENT

4.1 Taking into consideration the concentrations of Active Subs tance and Relevant Chemicals associated with the disinfection process describe d in the republic of Kor eaís Application Dossier, the Group was able to reach the following conclusions:

.1 Ozone is very toxic by inhalation as well as being irritant to eyes. Whilst not being classified as a carcinogen, there are concerns about its mutagenic potential. As a result strict mitigation measures should be applied to avoid human inhalation exposure during the process.

.2 Bromate (potassium bromate): e xhibits a high potential for mutagenicity/carcinogenicity in hu mans. The current MCL (Maximum Contaminant Level) in the United States is 10μg/L and the maximum contaminant level goal is zero, because of the possi bility that bromate may be a genotoxic carcinogen. Although <2 μg/L (limit of detect ion) of bromate ions were detected in the treated ballast water, the Group considered that the risks to humans health

could be of concern and ther efore risk mitigation measures should be put in place in order to minimise occupational exposure.GESAMP-BWWG 3/9

ANNEX 6 Page 8

I:\MEPC\56\2-2.doc .2.1 It was noted that the applicant clai med that there would be no threat to

human health from bromate ions unle ss they are ingested. It was also noted that the applicant had indica ted that any ballast tank would be emptied and fully ventilated before th e crew were allowed to enter under normal circumstances. As a result, the applicant claimed that there was no risk of inhalation or ingesti on of treated ballast water.

.2.2 However, the Group recognized that, ap art from the crew, members of the public need to be taken into consider ation as exposure could occur both by ingestion and inhalation when swimming in the sea. In this context, it was noted that the U.S.EPA regulate the level of bromate in drinking water to 10 μg/L (WHO Guidelines for Drinking water Quality, 2003) and a lower level in swimming pools.

.3 Bromoform is toxic both by oral ingestion and inhalation as well as being irritant to skin, eyes and the respiratory tract. EPA classified brom oform as a probable human carcinogen, group B2 (EPA, 2005). Th e primary routes of exposure are ingestion and inhalation (from volatized compounds) and dermal exposure during bathing. Bromoform is readily absorbed from GIT and may be absorbed through the respiratory tract and skin. They are rapidly distribut ed throughout the body. Principal health effects asso ciated with inhalation or oral exposure to bromoform are central nervous system depressi on and liver and kidney damage.

.3.1 There is strong evidence that the hepa totoxicity of bromoform is due to its metabolism into reactive intermediates and highly reactive trihalomethyl

free radicals.

.3.2 Oral MRL (Minimal Risk Levels) have been derived for: - acute-duration oral exposure (14 days or less).of 0.7 mg/kg/day; - intermediate-duration exposure (15-364 days) of 0.2 mg/kg/day; - chronic-duration exposure (365 da ys or more) of 0.02 mg/kg/day.

As a result, human exposure to this compound must be kept under critical toxicological levels.

.3.3 Taking into consideratio n the relevant toxic effe cts and the concentration

measured in the treated ballas t water (max. 0.255mg/L), the Group considered that bromoform represents a potential risk fo r human health in case of oral and inhalation exposure a nd therefore, the system should be optimized.

4.2 Other relevant factors that have to be taken into account when assessing human exposure

towards chemicals include:

.1 the variability in individual sens itivity (e.g. genetic polymorphism); and

.2 the fact that complex mixt ures of disinfectants and DBPs interact in an additive way, at low concentrations (EHC 216, WH O, 2000). As a result, there is an additional concern regarding the potential for cumulative toxicological effects of the mixture of chemicals generated by th e system proposed by this application.GESAMP-BWWG 3/9

ANNEX 6 Page 9

I:\MEPC\56\2-2.doc 5 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL

PUBLIC

5.1 The Group recalled that, during the first review of this application, it had been noted that only generic safety requirements required for an ozone system had been described and that no indication had been given on how these requirement s were to be applied when such a system would be used onboard a ship. The present subm ission is recognised to address the previous concerns raised with regards to system information.

5.2 It was also noted that the present submission indicates th at the prototype system did develop ozone leaks at several locations and instances over the test period. It was reported that at

times the odour of ozone was noticeable at certain locations on deck and in a control room.

5.3 The Group recognised the potential for risk to the health of the cr ew arising from the possibility of exposure to ozone from system leakage. However, th e Group noted that the submission acknowledges this risk and identifies onboard risk control measures that will reduce the possibility of personnel exposure to ozone if plant leakages should occur. The submission indicates that the system will be protected by ozone gas detectors that will shut down ozone generators should the ozone in the working envi ronment exceed set limits. The ambient ozone alarm set points are advised as 0.1 ppmv fo r alarm and 0.3 ppmv for equipment shut down respectively. It was noted th at the ozone safety manual pres ented recommends shut down at a level of 0.2 ppmv, and the Group therefore c onsiders that the recommendation should be

followed.

5.4 The Group noted that the submission states that the improved ozone injection technology provides a high level of the ozone entering into solution, and that ozone has a half life of 5.8 seconds when in solution. The Group still has so me concern that gaseous ozone will enter the ballast tank with a consequential ri sk of personnel exposure, particul arly in the area of the tank air vent during filling of a ballas t tank, and recommends safety proce dures to be put in place to

counter such risk until it can be verified no such risk is raised.

5.5 With regard to missing information, identified in the previous eval uation, related to any corrosion potential to the shipsí materials of cons truction that might exist, the Group noted that the applicant had, now, reported test results that showed that ozone treate d ballast water does not increase the rate of corrosion. Indeed, ozone decreases the rate of corrosion by killing those micro-organisms that secrete corrosive acids. The Group recommends that the positive test results referred are verified in practice.

5.6 The Group noted that the submi ssion states that crew will ne ver enter a tank prior to the tank being fully ventilated and dried. This is unfo rtunately not the case in practice as it is nearly impossible to ensure a tank being dry, and the vent ilation must also be basic due to tank design and the fact that there are very few ballast tanks with dedicated mechanical ventilation, if any, consequently there will always be some water content no matter how e fficient the drainage arrangements with high humidity conditions within the tank. The su bmission identifies a potential for brominated trihalomethanes to be present in the treated ballast water as a consequence to the process, and indicates that further risk assessment will be performed during the ongoing approval procedure. The Group agrees th is potential risk to crew health to be in

need of further consideration and testing to provide confirmation that the potential risk level will remain acceptable in all cases.GESAMP-BWWG 3/9

ANNEX 6 Page 10

I:\MEPC\56\2-2.doc 5.7 As a result, the Group considered that, from th e ship and crew safety perspective provided

the above recommendations are taken into accoun t the system may be recommended for Basic Approval.

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

6.1 Three products were identifie d as being relevant to asse ss for their Pers istence (P), Bioaccumulation potential (B) and th eir Toxicity (T). The assessm ent of these products is shown

below:

Compound Persistence (P)

Half life:

>60d in seawater

>40d in freshwater

>180d in sea sediment

>120d in fw sediment Bioaccumulation (B) Log Pow >3 Toxicity (T) Chronic NOEC<0.01 mg/L

Ozone No (Half life=5.8 sec) No (Log Pow=-0.87) No

Bromate ion No? No (Log Pow=0.63) No

Bromoform Yes (Half life 340d in sediment) No (Log Pow=2.4&BCF=14) No (4.8 mg/L)

6.2 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 therefore none of these substances s hould be classified as a PBT substance.

Along with other brominated DBPs, bromofor m is highly stable co mpound and capable of bioaccumulating. As a result, exposure to these on the long-term should be minimized.

7 ASSESSMENT OF TREATED BALLAST WATER

7.1 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:

Concentration (mg/L)

Ozone 2.5 at time zero Total Residual Oxidant (TRO) 7.5

Bromate ion <0.002 (Detection Limit)

Bromoform 0.255 (max. observed)

7.2 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 7.5 mg/L and for bromoform 0.255 mg/L would be relevant to take in to account for further exposure of the aquatic

environment.GESAMP-BWWG 3/9

ANNEX 6 Page 11

I:\MEPC\56\2-2.doc 7.3 In this context, it was noted that the applicant was proposing to install a ferrous ion/charcoal system to eliminate any concern asso ciated with the short-term toxicity due to TRO and bromoform in the discharged ballast water.

8 ENVIRONMENTAL RISK ASSESSMENT

The Group noted that the half-life for ozone in seawater was reported as only 5.8s in

seawater and 30 min in freshwater and so would be degraded prio r to being released into the

marine environment.

8.1 Derivation of a Predicted No Effect Concentration (PNEC)

8.1.1 TRO : As only acute toxicity data were av ailable the PNEC will be derived by an

assessment factor of 1000 on the lowest value: PNEC = 0.08 μ g/L as TRO.

8.1.2 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 other submission.

8.1.3 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.

8.2 Calculation of the Predicted Environmen tal Concentration (PEC) for the Active

Substance and Relevant Chemicals

8.2.1 The Group noted that the applicant had used the MAM-PEC model to generate PECs in

the harbours of Busan and Rotterdam for the various chemicals associated with the NKO3

BWTS.

8.2.2 It was also noted that the model had been a pplied to three different areas in the port of Busan that the applicant had considered to represent:

.1 a marina;

.2 a commercial harbour; and

.3 the open sea.

8.2.3 It was agreed that, due to the short half-lif e of ozone, it was not necessary to model this product. Whilst various result were produced for the different scenar ios, the Group noted that the applicant had used a worst case scenario using th e port of Busan and initi al concentrations are

shown in the table below. Th e Group recognized that emission concentra tions of bromoform should be changed to 255 μg/L according to 3.2.4 fo r a worst case scenario. and that this initial condition, the PEC should be almost doubled.GESAMP-BWWG 3/9

ANNEX 6 Page 12

I:\MEPC\56\2-2.doc Chemical Emission Concentration Predicted Environmental Concentration (PEC) TRO at least 5000 μg/L at least 0.071 μg/L Bromate 2 μg/L 0.003 μg/L Bromoform 136 μg/L 0.276 μg/L

8.3 Calculation of PEC/PNEC ratios

8.3.1 Using the results from the environmental modelling and the estimated PNEC values obtained from aquatic toxicity testing, the Grou p agreed on the following PEC/PNEC ratios for those chemicals associated with this system.

Chemical PEC (μg/L) Toxicity (μg/L) Factor Applied PNEC (μg/L) PEC/PNEC

TRO 0.071 80 (Acute) 1000 at le ast 0.08 at least 0.89 Bromate 0.003 30000 (Acute) 1000 30 0.0001 Bromoform 0.276 710 (Acute) 1000 0.71 0.39

8.3.2 The Group noted that even minor changes in the PEC or PNEC concentration could cause

the PEC/PNEC ratio to rise above 1 in both TRO and bromoform, and that this gives cause for concern as risk might be identified.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

9.1.1 The Group agreed that the risk to the envi ronment, including the atmosphere, related to the presence of TRO, bromoform and other ha logenated organic compound should be further assessed as part of the devel opment of the system and that the amounts reported in this application should be confirme d in any further submission.

9.2 Risks to the crew and general public

9.2.1 The Group agreed that the formation of bromate, bromoform and other halogenated organic compounds as Relevant Chemical may give rise to human health c oncerns if present at critical toxicological levels. The Group noted that the applicant had indicated that the level of such chemicals generated by the system were lo wer than would be of concern. However, the Group remained concerned that the levels of such compounds generated may exceed normally accepted safe levels in practice. It was agreed that these levels should be monitored and safety measures applied until in can be shown that exposure to such levels is safe.

9.2.2 In this context, the Group wished to emphasi ze the points made in section 5 of this report.

9.3 Risks to the environment

9.3.1 The Group recognized that the environmental exposure to the Active Substance ozone is very limited as the substance wi ll react with organic matter and therefore degrades rapidly. Possibly remaining total residual oxidant (TRO) may still be present in concentrations that couldGESAMP-BWWG 3/9

ANNEX 6 Page 13

I:\MEPC\56\2-2.doc cause environmental concern. In recalling its concerns expresse d in paragraph 8.3.2 of this report, the Group agreed that a more thorough Risk Assessment would be required in order to if

such concerns were to be reduced.

9.3.2 The Group suggested that MEPC invites the submitting Administration to ensure that all

the above conditions are taken into account and a ppropriate measures are put in place during further development and testing of the NKO3 system.

9.4 Conclusions

9.4.1 Whilst recommending that Basic Approval be granted to this system, the Group agreed that it would be necessary for the applicant to complete the data forms shown in the appendices to this report, for each of the chemicals produced by this system unless appropriate scientific reasons can be provide d for not doing so.

* * *GESAMP-BWWG 3/9

ANNEX 6 Page 14

I:\MEPC\56\2-2.doc Appendix 1

PHYSICOCHEMICAL AND BIOLOGI CAL PROPERTIES OF OZONE

1 PHYSICOCHEMICAL PROPERTIES

1.1 The following table (A1T1) shows the prope rties of the Active Substance (Ozone).

Table A1T1: Physicochemical properties of Active Substances and Relevant Chemicals

Physical property Ozone
CAS number 10028-15-6 Molecule weight 48 Melting point (°C) -192.7
Boiling point (°C) -111.9
Flash point Non-flammable Density (kg/m 3 ) @ -183 °C 1.5 Vapour pressure (Pa) @ 20°C 167000 Vapour density (air=1) 1.65 Water solubility (g/L) 0.003 pH in solution Not Required Octanol / water partition coefficient (log P
ow ) -0.87 Dissociation constant(pKa) Not Available Oxidation reduction potential (V) 2.07 E
o Corrosivity to Material Yes

Reactivity to container material Reacts with any material liable to
oxidize Auto ignition temperature (°C) Non-flammable

Explosive Properties Explosive when heated or in contact
with combustible material Oxidizing properties Powerful oxidiser Surface tension (dyne/cm) 48.4 Viscosity (cp) @ -183°C 1.55

Thermal stability and breakdown product Thermal oxidative decomposition will produce oxygen Other physical and Chemical property Bluish gas with characteristic odour

2 MAMMALIAN TOXICITY

2.1 Acute mammalian Toxicity

2.1.1 The following table summarizes the acute mammalian toxicity data identified by the Group.

Exposure route Value Species Re ference/Comments/Justification for missing data

Oral LD 50 (mg/kg) n/a n/a

Dermal LD 50 (mg/kg) n/a n/a It was recognized that it is not possible to

determine oral and derm al toxicities for gases

Inhalation LC 50 (mg/l/4h) 0.012 Mouse Cheminfo by CCOHS (Canadian Centre for Occupational Health and Safety)GESAMP-BWWG 3/9

ANNEX 6 Page 15

I:\MEPC\56\2-2.doc 2.1.2 The selected inhalation value was taken from a range of values from which the lowest value for a 4h exposure was taken.

2.2 Corrosion/Irritation

2.2.1 The following table summarizes the mammalian corrosion and irritation data identified by the Group.

Species Method Observation (including

scores where

available) Reference/Comments/Justification for missing data

Skin Not irritant EHP (1990) Eyes Human Irritant (>0.4mg/L for several minutes) EHP (1990)

Respiratory

tract Human Coughing and/or breathing

difficulties at 0.3-1.2μg/L MSDS provide by applicant

2.2.2 The Group noted that from the submitted in formation and several studies in humans mentioned in the 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, there seems to exist synergetical effects, as exposure to very low concentrati ons initially increases reactivity of the airways to other inhaled substances (bronchi al hyperresponsiveness) and cause inflammatory response in the respiratory tissue. Other symp toms observed following acute exposure to 0.5- 1.5μg/L include cough, shortness of breath, tightness of the chest, dyspnea, headache and nausea. More severe symptoms have been observed foll owing concentrations higher than 0.02mg/L that included reduce lung function, extreme fatigue, dizzi ness, inability to sleep and cyanosis. An acute occupational exposure to approximately to 0.022mg/L caused severe respiratory irritation

and almost caused unconsciousness . A 30 min exposure to 0.1 mg/L is considered potentially

lethal.

2.2.3 The Group agreed that, based on applican tís submitted information (EHS, 1990), ozone seems not to cause any adverse effect on the skin but is irritating to the eyes when exposed to 4mg/L for several minutes. Other information (CCOHS) indicates that ozone gas can probably

cause skin irritation due to its oxidizing ability, but only at con centrations capable of causing severe respiratory injury.

2.3 Sensitization

2.3.1 The Group recognized that sta ndard skin sensitiza tion tests are not po ssible for gases and so there were no laboratory data available for this property. It was also noted that there are no data to suggest that ozone might be a sensitizer and it is not classified as such by the EEC.

2.4 Repeated-Dose Toxicity

2.4.1 From the available information, it was not pos sible to address the dose-response effects in relation to repeated inhalation exposure (sub-ch ronic, 90 days) to ozone. However, the GroupGESAMP-BWWG 3/9

ANNEX 6 Page 16

I:\MEPC\56\2-2.doc considered that similar effects 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 ìfunctional adaptationî.

2.4.2 The Group noted that long-term occupationa l exposures to ozone have resulted in headaches, irritation of the nose and throat, ch est constriction and lung congestion in exposed workers. Human population studies indicate that people living in communities with high background ozone levels have expe rience a greater decrease in l ung function over five years than people living in communiti es with lower background levels. These studies suggest that longterm exposures to ozone may result in impaired lung function and are c onsistent with animal studies that have shown that such exposures can impair lung function and cause structural changes to the lungs.

2.5 Chronic and long-term toxicity

2.5.1 The Group noted that, in a series of we ll conducted studies, 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 (NTP, 1994). Seve ral studies also examined the effects of the long-term effects on monkeys. Expos ures ranging from 0.003-0.013mg/kg bw/day for 3-18 months consistently showed significant st ructural alterations to lungs. Many of them seem to be irreversible six months after exposure stopped (COSHH).

2.5.2 In addition, the Group noted that studies in humans exam ining the potential effects of long-term occupational exposures to ozone had reported headaches, irritation to nose and throat, chest constriction and lung congestio n in exposed workers. These studies suggest that long-term exposures to ozone may result in impaired lung f unction that is consistent with the results of

animal studies.

2.6 Development and Reproductive Toxicity

Inhalation Exposure Duration (1) 4 days in middle or late pregnancy (2) 7-17 pregnancy (3) ? (4) 6 days prior to mating to postnatal day 22 Exposure dose (1) 0.02; 0.03mg/kg (2) 0.024 (3) and (4) dose not referred Species (1) rat (2) Mouse (3) rat (4) Mouse

MethodGESAMP-BWWG 3/9

ANNEX 6 Page 17

I:\MEPC\56\2-2.doc Results (1) observed adverse effects: redu ced growth rates after birth and delayed behavioural developm ent; no maternal toxicity (2) observed adverse effects: decrease of fetal body weight gain; maternal toxicity (3) observe adverse effects: embrio toxicity (increas ed resorptions; no maternal toxicity (4) observe adverse effects: redu ced body weight and slight effects in neurobehaviour development of the offspring; maternal tox.

not evaluated

NOAEL (1) not referred (2) 0.016mg/kg /day (3) 0.013mg/kg /day (4) not referred

NOEL

Reference/Comments/ Justification for missing

data

2.6.1 A study reported offspring of rats continuous ly exposed to 0.02 or 0.03mg/kg bw for four days during middle or late pregnancy had re duced growth rates after birth and delayed behavioural development. Matern al toxicity was not reported.

2.6.2 A study reported offspring of rats continuous ly exposed to 0.02 or 0.03mg/kg bw for four days during middle or late pregnancy had re duced growth rates after birth and delayed behavioural development. Matern al toxicity was not reported.

2.6.3 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).

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

2.6.5 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).

2.6.6 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).

2.6.7 Pups from pregnant rats, exposed to 1.0 and 1.5 μ/L during mid gestatio n or late gestation showed transiently reduced neona tal growth rates. The pups deliv ered from dams exposed during late gestation showed retardation in early refl ex development and in open field behaviour. Similarly exposed males remained permanently stunted in growth. (Tox Letters, 5 (1990) 3-9.GESAMP-BWWG 3/9

ANNEX 6 Page 18

I:\MEPC\56\2-2.doc 2.7 Carcinogenicity/Mutagenicity

Species Method Details Results (Yes/No) Reference/Commen

ts/ Justification for missing data Carcinogenicity Rat and

Mouse Lifetime

inhalation exposure to0.12- 1.0μ/L No evidence for carcinogenicity

Mutagenicity Salmonella typhimurium ; lymphocytes of hamsters;

rats macrophages With and without

S9 metabolic

activation Yes, there is

evidence for mutagenicity in

bacteria an

animal cells National Toxicology Program Technical report series No. 440

2.7.1 From a study with rats and mice exposed to 0.0024, 0.01 and 0.02mg/kg bw of ozone for 105 to 130 weeks, there was no evidence for carcinogenicity in male and female rats, inconclusive evidence in male mice, and some ev idence in female mice. Ozone did not have tumour promoter properties (NTP, 1994).

2.7.2 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).

2.7.3 The American Conference of Government al Industrial Hygienists (ACGIH) has designated this chemical as not clas sifiable as a human carcinogen (A4).

2.8 Toxicokinetics

2.8.1 Ozone is absorbed in both the upper and lower respiratory 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 li mits its ability to

accumulate.

2.9 Human health hazards

2.9.1 The Group noted that Ozone is very toxic by inhalation route and therefore apply strict mitigation measures should be applied to avoid human inhalation exposure during the process.

2.9.2 In addition, by exposure and due to its oxidant properties, there may be a concern towards ozone potential for mutagenicity.

2.9.2 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 tr act and the lungs.GESAMP-BWWG 3/9

ANNEX 6 Page 19

I:\MEPC\56\2-2.doc 3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute Aquatic Toxicity

3.1.1 The Group recognized that ozone has a very sh ort life in water (<5 se cs) and so its acute

and chronic toxicities cannot be measured. Howe ver, as indicated by the applicant and shown in

the section on fate and behaviour , the ozone reacts with compone nts of water to produce other oxidants, described as Total Residual Oxidants (T RO) that have an overall effect on the aquatic organisms.

3.1.2 The following table shows the acute toxicity of ozone treated water that is effectively the acute toxicity of TRO in water.

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

C Americamysis bahia 96-h LC 50 24.4 mg/L

A Nannochloris sp. 72-h E bg C

x <0.45 mg/L as TRO

A Skeletonema costatum 168-h IC 50 32 mg/L F=Fish, C=Crustacea, A=Algae

3.2 Chronic Aquatic Toxicity

3.2.1 The Group agreed that, because of its short ha lf-life, it was not possible to provide any data on the chronic aquatic toxicity of ozone.

3.3 Information on Endocrine Disruption

3.3.1 The Group agreed that, because of its short ha lf-life, it was not possible to provide any

data on the endocrine disr uption potential of ozone.

3.4 Sediment Toxicity

4.4.1 The Group recognized that, due to the very s hort half-life of ozone, it was not possible to generate any sediment toxici ty data for this chemical.

3.5 Bioavailability/Biomagnification/Bioconcentration

4.5.1 The Group recognized that, due to the very s hort half-life of ozone, it was not possible to generate any bioavailability/biomagnification/ bioconcentration data for this chemical.

3.6 Food web/Population Effects

3.6.1 The Group recognized that, due to the very short half -life of ozone, it would not have any adverse effect on the ecological communities.GESAMP-BWWG 3/9

ANNEX 6 Page 20

I:\MEPC\56\2-2.doc 3.7 Environmental Fate and Behaviour

3.7.1 An overview of the fate processes for oz one are presented in the following table:

Property Ozone Hydrolysis pH5 (seawater) ≤ 5 sec pH7 (seawater) ≤ 5 sec pH9 (seawater) ≤ 5 sec Photolysis NA Degradation in seawater NA Ready biodegradation 1 h Biodegradation NA Sorption (K

oc ) NA

Bioconcentration - 0.87 Anaerobic degradation NA

NA = not available

3.7.2 Although in the table several items are marked ìnot availableî the Group is of the opinion

that additional information on these items is not considered necessary because of the very low half life in the environment (ca. 5 sec).

3.7.3 Therefore it is expected that the Predic ted Environmental Concentration (PEC) was

assumed to be close to zero or the same as any naturally occurring ozone.

3.7.4 The Group agreed that as a result, the PEC/ PNEC ratio was assumed to be <<1 and as it was not defined as a PBT, the ozone itself would not present an environmental risk.

* * *GESAMP-BWWG 3/9

ANNEX 6 Page 21

I:\MEPC\56\2-2.doc Appendix 2

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF BROMATE ION

1 PHYSICOCHEMICAL PROPERTIES

1.1 The following table show the properties of th e Relevant Substance (Bromate ion) in the form of sodium bromate and potassium bromate.

Physical property Sodium
bromate Potassium
bromate

CAS number 7789-38-0 7758-01-2 Molecule weight 150.90 167.01 Melting point (°C) 381 350

Boiling point (°C) NA At 370°C decomposes Flash point NA NA Density (kg/dm 3 ) @ 20 °C 3.339 3.27 Vapour pressure (Pa) @ 20 °C NA NA Vapour density(air=1) NA NA

Water solubility (g/L) 275 @ 0 °C, 909 @ 100 °C 133 @ 40 °C, 497.5 @ 100 °C pH in solution NA NA Octanol / water partition coefficient (log Pow) NA NA Dissociation constant (pKa) NA NA Oxidation reduction potential NA NA Corrosivity to Material Non-corrosive NA Reactivity to container material NA NA Auto ignition temperature (°C) NA NA Explosive Properties NA NA Oxidizing properties NA NA Surface tension (dyne/cm) NA NA Viscosity (cP) @ 15°C NA 1.164 Thermal stability and breakdown product Missing NA Other physical and Chemical property Missing NA

Shaded areas indicate that the data are not required NA = not available or not applicable

2 MAMMALIAN TOXICITY

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group ar e summarized in the table below.

Bromate Exposure Route Value Species Reference

Oral LD 50 (mg/kg) 280 Rat, Mouse, and

Hamster WHO, 2005

Dermal LD 50 (mg/kg) Missing

Inhalation LC 50 (mg/l/4h) Missing Sub-acute toxicity NOAEL oral (mg/kg bw/day) 2 weeks 108 (based on changes in enzyme activities) SPF Mouse WHO, 2005GESAMP-BWWG 3/9

ANNEX 6 Page 22

I:\MEPC\56\2-2.doc 2.1.2 The Group noted that the inhalation and derm al toxicity data were missing and a short literature search suggested that they had not been determined.

2.1.3 It was also noted that the appl icant had indicated that ëthere is no scientific evidence that the bromate ion and compounds are absorbed th rough the skiní. In addition, the applicant indicated that ship safety regulations ensure that the crew does not enter a ballast water tank unless it is dry and has been pr operly ventilated thus minimizing any potential risk to the crew.

2.1.4 Notwithstanding this observat ion, the Group noted that the le thal doses of bromate seem to be very similar across rode nt species, and that the toxic signs and symptoms, observed at autopsy, included hyperaemia of the stomach and c ongestion of the lungs as well as damage to renal tubules including necrosis in the proximal tubular epithelium.

2.1.5 In addition, sub-acute adverse effects from bromate (potassium bromate) were reported in a two week oral study made with mice, as changes in enzyme activities, at doses of 270mg/kg bw/day and above.

2.1.6 Based on the available information, the Group agreed to use a NOAEL for bromate of 108mg/kg/day (WHO, 2005).

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritatio n data for bromate ions is shown in the

table below.

Species Method Results (including scores where available) Reference/Comments/Justification for missing data

Skin Not specified

Human Irritant

Irritant EEC Classification R36/37/38

RTECS Eye Not specified

Human Irritant

Irritant EEC Classification R36/37/38

RTECS

2.2.2 It was noted that there no i nhalation irritation data had been provided. It was also noted that the applicant had stated ì bromate compounds are not volatile. Therefore, there is no danger of them being inhaled î.

[2.2.3 Whilst the Group recognized that inhalation of bromat e vapours was not possible under normal conditions, inhalation of mists, vapours or sprays might be of some concern.]

2.3 Sensitization

2.3.1 The Group noted that sensitization data had not been provided for bromate ions. However, it was also noted that the EEC Cla ssification for bromate ions did not include R43 (May cause sensitization by skin contact).

2.4 Repeated dose toxicity

2.4.1 A summary of the available repeated dose toxi city data for bromate ions is shown in the

table below.GESAMP-BWWG 3/9

ANNEX 6 Page 23

I:\MEPC\56\2-2.doc Exposure Route Exposure Duration 15 weeks Exposure dose 30mg/kg/day Species Rats

Method

Results Observed adverse effects: signi ficant increases in blood serum parameters indicative of liv er and kidney toxicity

NOAEL 30mg/kg bw/day

NOEL

Reference/Comments/ Justification for missing

data

2.4.2 It was noted that exposure of rats to bromate for 15 weeks demonstrated a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg/day. One thirteen week rat oral exposure study, at a dose of 63 mg/kg/day, showed adverse effect s with significant incr eases in blood serum parameters indicative of liver and kidney toxicity (including glutamate oxaloacetate transaminase, lactate dehydrogenase, cho linesterase and blood urea nitrogen).

2.5 Chronic and long-term toxicity

2.5.1 The Group noted that the system ic toxicity of bromate (adm inistered as potassium salt) had been reported from long-term studies designed to evaluate bromate carcinogenicity in rats and 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.

2.5.2 Following 15 months exposure to 30mg/kg/day of bromate in drinking water, changes to the kidneys of the exposed rats were observe d along with increased blood urea nitrogen and

structural abnormalities of the co rtical tubules. Fr om these observations, the NOAEL could not be determined but a LOAEL of 30mg of bromate/ kg/day had been identified as part of the study.

2.6 Development and Reproductive Toxicity

Exposure Route Oral Exposure Duration 5 and 8 generations Exposure dose 15mg/kg/day Species Rat and Mouse

Method

Results No development of reproductive toxicity observed

NOAEL

NOEL

Reference/Comments/ Justification for missing

dataGESAMP-BWWG 3/9

ANNEX 6 Page 24

I:\MEPC\56\2-2.doc 2.6.1 The Group noted that no effects on reproduc tive performance had been observed in a study made with rats and mice fed with 15mg potassium br omate/kg 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.

2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the available car cinogenicity and mutagenicity data for bromate ions is

shown in the table below.

Species Method Details Results Reference/Comments/

Justification for

missing data Carcinogenicity Rats Possible human carcinogen LOEL=6mg/kgday IARC (Group 2B)

Mutagenicity Bacteria

Hamster Ames test Mutagenic Mutagenic

2.7.2 The Group noted that bromate ions are active oxidants in biological systems and have

been shown to cause an increase in renal tu mours, peritoneal mesotheliomas and thyroid follicular cell tumours in rats, and to a lesser exte nt in hamsters and mice. The lowest dose at

which an increased incidence of renal tum ours was observed in rats was 6mg/kg/day.

2.7.3 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.

2.7.4 In particular potassium bromate, 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 fibroblast cells, acute cytogenetic effects on rat bone marrow cells and

in the mouse micronucleus test.

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

2.8 Toxicokinetics

2.8.1 The Group noted that, following oral administra tion, bromate 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, kidneys, stomach, and small intestine.

2.8.2 It was noted that bromate can be converted into hypobromic acid by hypochloric acid in the stomach. liver and kidneys that may metabo lise bromate to bromide by a process involving glutathione, although only small amo unts appear to be reduced in th is way. Bromate is excreted mainly in the urine as bromate and bromide and some may also be eliminated in the faeces. Bromate concentrations in urine peak at abou t 1h, and bromate is not detectable in plasma

after 2 hours.GESAMP-BWWG 3/9

ANNEX 6 Page 25

I:\MEPC\56\2-2.doc 3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evaluation of the acute aquatic toxici ty of bromate ions in fish, crustaceans, algae and other organisms. The data on the acute toxicity of the Active

Substance and the Relevant Chemical are shown in Table T8.1.

Test

Substance F

C

A Species Effect Value

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 = Fish, C = Crustacea, A = Algae

3.1.2 Based on these data the 48-h EC 50 = 30 mg/L will be used as the value to take into

account in the further considera tions on the risk assessment.

3.1.3 No data waivers were considered necessary as all the required data had been provided.

3.2 Chronic Aquatic toxicity

3.2.1 The Group noted that no chronic aquatic t oxicity data had been provided for bromate

ions.

3.3 Information on Endocrine Disruption

3.3.1 The Group noted that there was no informa tion related to the endocrine disruption potential for this chemical.

3.4 Sediment Toxicity

3.4.1 The Group noted that there were not data on sediment toxicity.

3.5 Bioavailablity/Biomagnification /Bioconcentration

Log Pow BCF Koc Calculated

Environmental

Distribution

Ratio 1⁄2 life Reference

Assumed

<3

Based on

structure Assumed

<
Based on

structure

3.6 Food Web/Population Effects

3.6.1 The Group noted that there were no t data on food web/population effects.GESAMP-BWWG 3/9

ANNEX 6 Page 26

I:\MEPC\56\2-2.doc 3.7 Environmental fate

3.7.1 It was noted that no information on the fate and behaviour of bromate ions was presented to the Group. However, based on the nature of th ese substances this was considered justified.

3.7.2 The group concluded that bromate ions did not present a risk to the environment.

* * *GESAMP-BWWG 3/9

ANNEX 6 Page 27

I:\MEPC\56\2-2.doc Appendix 3

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF BROMOFORM

1 PHYSICOCHEMICAL PROPERTIES

1.1 The following table shows the physical properties of the Relevant Chemical (Bromoform):

Physical property Bromoform
CAS number 75-25-2 Molecule weight 252.77 Melting point (°C) 8.0-8.5
Boiling point (°C) 149.5 °C
Flash point NA Density (kg/dm 3 ) @ 20°C NA Vapour pressure (Pa) @ 20°C 667 Vapour density (air=1) 8.72 (calculated) Water solubility (mg/L) @ 25 °C 3100 pH in solution NA Octanol / water partition coefficient (log Pow) 0.38 Dissociation constant (pKa) 2.06 Oxidation reduction potential NA Corrosivity to Material Not corrosive Reactivity to container material NA Auto ignition temperature (°C) NA Explosive Properties NA Oxidizing properties NA Surface tension (mN/m) @ 15°C 46.18 Viscosity (cP) @ 10°C 2.217

Thermal stability and breakdown product Gradually decomposes at elevation of temperature Other physical and Chemical property Clear, colourless solution

Shaded areas indicate that the data are not required NA = not available or not applicable

2 MAMMALIAN TOXICITY

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group ar e summarized in the table below:

Value Species Reference /Comments/Justification for missing data

Oral LD 50 (mg/kg) 707-1550 Rat & Mouse EHC 216, 2000

Dermal LD 50 (mg/kg)

Inhalation LC 50 (μg/L/4h) 7000 Dog caused death after 1hGESAMP-BWWG 3/9

ANNEX 6 Page 28

I:\MEPC\56\2-2.doc 2.1.2 The Group noted that the applicant had neith er provided dermal nor inhalation toxicity data for bromoform. However, it was noted th at the EEC classify the product as R23 (Toxic by inhalation) and RAIS indicate that inhalation of >=7000μg/L caused deep anaesthesia in dogs

after 8min and death after 1h.

2.1.3 The Group agreed that the missing data s hould be provided by th e applicant for Final Approval as these effects were considered re levant for conducting the risk assessment.

2.2 Corrosion/Irritation

2.2.1 A summary of the available co rrosion/irritation data for brom oform is shown in the table

below:

Species Method Results (including

scores where

available) Reference/Comments/Justification for missing data

Skin Human Not specified Irritant MSDS Eye Human Not specified Irritant MSDS

Inhalation Human 0.03-1.2 μg/L Irritant MSDS

2.3 Sensitization

2.3.1 The Group noted that sensitization data had no t been provided for bromoform. However,

it was also noted that the EEC Classification for bromoform did not include R43 (May cause sensitization by skin contact).

2.4 Repeated dose toxicity

2.4.1 A summary of the repeated toxicity data evaluated by the Group fo r bromoform is shown

in the table below:

Exposure Route Oral Exposure Duration 13 weeks Exposure dose Missing Species Rats and Mouse

Method

Results

NOAEL 25mg/kg/day (rat), 100mg/kg/day(Mouse)

NOEL

Reference/Comments/ Justification for missing

data EHC 216(2000)

2.4.2 The Group noted a 13-week study, 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).GESAMP-BWWG 3/9

ANNEX 6 Page 29

I:\MEPC\56\2-2.doc 2.5 Chronic and long-term toxicity

2.5.1 A summary of the chronic toxicity data evaluated by the Group for bromoform is shown

in the table below:

Exposure Route Oral Exposure Duration 2 years Exposure dose 100 and 200 mg/kg/day Species Rat

Method

Results Small increase in tumours of the large intestine

NOAEL

NOEL

Reference/Comments/ Justification for missing

data EHC 216(2000)

2.5.2 The Group noted that no neoplastic effects were associated with th e exposure of mice to bromoform. However, adenocarcinomas of the col on or rectum were observed in 3/50 male rats dosed with 200mg/kg and 1/50 female rats dosed with 100mg/kg and 8/50 female rats dosed with 200mg/kg (c.f. 0/48 in female control rats).

2.6 Development and Reproductive Toxicity

2.6.1 A summary of the development and reproductiv e toxicity data evaluated by the Group for

bromoform is shown in the table below:

Exposure Route Oral Oral Exposure Duration At days 6-15 of gestation 105 days Exposure dose 50, 100 and 200 mg/kg/day Species Rat Rats (male and female pairs)

Method

Results Evidence of foetotoxic response.

No foetal malformations

observed No detectable effect on fertility, litters/pair, live pups/litter, proportion of pups born alive, sex or body weights

NOAEL

NOEL

Reference/Comments/ Justification for missing

data EHC 216 (2000) EHC 216 (2000)

2.6.2 It was noted that Ruddick et al. (1983) ha d conducted a teratologi cal 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. Ev idence 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 eff ects of bromoform on reproduction function. Bromoform was found to i nduce resorption in F344 pregnant rats, at higher doses (150 and 200mg/kg bw/day).GESAMP-BWWG 3/9

ANNEX 6 Page 30

I:\MEPC\56\2-2.doc 2.7 Carcinogenicity/Mutagenicity

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

Species Method Details Results Reference/Comments/

Justification for

missing data Carcinogenicity Rats 5 days exposure/week for 2 years No evidence

observed NTP, 1989a

Mutagenicity Bacteria

Not
identified (Ames test)

In vivo Mutagenic

Inconclusive

2.7.2 The Group noted that IARC had evaluated car cinogenicity of bromoform and concluded that there is inadequate eviden ce for its carcinogenicity in humans and limited evidence for its carcinogenicity in experimental animals. IARC classified bromoform in Group 3 (not classifiable as to its carcinogeni city to humans). EPA (2005) classified bromoform as possible human carcinogen (Group 2B).

2.7.3 In addition, the Group noted that bromoform is largely positive in bacterial assays of mutagenicity and appeared to be more potent than the other brominated THMs. In vivo studies have given contradictory results.

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

additional information was not essential.

2.8 Toxicokinetics

2.8.1 The Group noted that the applicant had indicate d that the limited data available indicates that bromoform is rapidly and e fficiently taken up from the Gastro Intestinal Tract (GIT). However, there were no data available for uptake through inhalation or dermal absorption.

2.8.2 It was also noted that, although bromoform has greater propensity for metabolism, it appears to be less potent toxicant and carcinogen than other brominated THM based on the NTP (1985, 1987) bioassays and numerous in vivo toxicity studies. A possible explanation is the less bioavailability resulting from the greater lipo philicity of this compound (logPow~240) that associated to greater reactivity of bromoform metabolites, may prevent it from reaching critical target sites.

2.8.3 Available toxicity data indicat e that target tissues are simila r in humans, rats and mice. Limited data suggest that effect levels are generally similar acr oss species (US Department of Health and Human Services, 2005).GESAMP-BWWG 3/9

ANNEX 6 Page 31

I:\MEPC\56\2-2.doc 3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evaluation of the acute aquatic toxi city of bromoform, made by the Group.

Species Effect Value

Fish Cyprinodon variegates 96-h LC 50 7.1 mg/L

Crustacea Americamysis bahia 96-h LC 50 24.4 mg/L Algae Skeletonema costatum 168-h IC 50 32 mg/L

3.2 Chronic aquatic toxicity

3.2.1 The table below summarizes the evaluation of the chronic toxicity of bromoform, made by the Group.

Species Effect Value

Fish Cyprinodon variegates 28-d NOEC 4.8 mg/L

Crustacea Algae

3.2.2 The Group agreed that the only value ava ilable for deriving a chronic PNEC for

bromoform was therefore 28d NOE C = 4.8 mg/L for the species Cyprinodon variegates . This

value was used in the further cons iderations on the risk assessment.

3.3 Information on Endocrine Disruption

3.4 Sediment Toxicity

3.5 Bioavailablity/Biomagnification /Bioconcentration

3.6 Food Web/Population Effects

3.7 Environmental Fate

3.7.1 In the following table an overview is given of the environmental fate and behaviour data

of bromoform.GESAMP-BWWG 3/9

ANNEX 6 Page 32

I:\MEPC\56\2-2.doc Property Bromoform Hydrolysis 686 y pH5 (seawater) pH7 (seawater) pH9 (seawater) Photolysis NA Degradation in seawater NA Ready biodegradation NA Biodegradation Water: 38 d

Soil: 75 d

Sediment: 340 d

Air: 380 d Sorption (K

oc ) (dm 3 /kg) 114.8 (62 ñ 126)

Bioconcentration 14 Anaerobic degradation 21 ñ 42 d
NA = not available or not applicable

3.7.2 The fate data on bromoform indicate that it is not clear on beforehand that there is no risk to the environment because of low exposures. Du e to the half lives of around 50 d substantial levels of bromoform may still occur after discharge of the ballast water into the receiving

environment.

3.7.3 Therefore the Predicted Environmental C oncentration (PEC) was calculated at the moment of discharge and after 28 days, being the duration of th e chronic toxicity study with Cyprinidon variegates

.

3.7.4 The Group agreed that as a result, the PEC/ PNEC ratio was assumed to be <<1 and as it was not defined as a PBT, the ozone itself would not present an environmental risk.

* * *GESAMP-BWWG 3/9

ANNEX 6 Page 33

I:\MEPC\56\2-2.doc Appendix 4

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF TOTAL RESIDUAL OXIDANTS (TRO)

1 PHYSICOCHEMICAL PROPERTIES

1.1 It was recognized that it was not possible to measure th e physical properties of the Relevant Chemical (TOR) due to it being a mixture of transient nature.

2 MAMMALIAN TOXICITY

2.1 Due to its very short life nature, the Group agr eed that it is plausible that no data related

to TRO would be available for t oxicological effects assessment.

3 ENVIRONMENTAL EFFECTS

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evaluation of th e acute aquatic toxicity of TOR, made by the Group.

Species Effect Value

Fish Morone saxatilis 96-h LC 50 0.08 mg/L as TRO

Crustacea Crab 48-h LC 50 0.08 mg/L as TRO Algae Skeletonema costatum 24-h E bg C

x <0.1 mg/L as TRO

3.2 Chronic aquatic toxicity

3.2.1 The table below summarizes the evaluation of the chronic toxicity of TOR, made by the Group.

Species Effect Value

Fish

Crustacea Algae

***GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc ANNEX 7

REVIEW OF PROPOSALS FOR APPR OVAL OF ACTIVE SUBSTANCES

Hybrid Ballast Water Treatment System using Seawater Electrolytic Process

Submitted by Japan as MEPC 56/2

0 SUMMARY

0.1 The BWM system envisages that a sidestream of the ballast inta ke is passed through a high output electrolytic cel l and then injected back into the ballast water line to create a Free Active Chlorine (FAC) concentration of 5 mg/L. This is considered by the applicant to be

sufficient for sterilization. Cont rol and measurement devices ar e still under development.

0.2 Sterilization of the sea water during the labor atory testing seems to have been carried out with effluent produced by using ìa small device fitted with the same types of electrodes used for the actual seawater electrolytic processî. Th e system was run so as to generate an FAC concentration of 50(+ 3)mg/L and then apparently diluted down to 5 mg/L. The Group recognized that the applicant had used the term ëFAC í, for the initial dose, as theoretical rate and

the term ëTRCí as for the real concentration after some de gradation. The Group understood, from the submitted data, that the test water was ster ilized and then allowed to remain in the tank for 2 days before sampling for ecotoxicity testin g and analytical chemistr y. Ecotoxicity testing indicates that the treated test water was toxic to aquatic organisms.

0.3 The application intends to use a FAC va lue of 5 mg/L, i.e. a value apparently

consistent with WHO recommendations for disi nfection of drinking water. It describes the treatment of ballast water on uptake, with possib ilities for recirculation to maintain a TRC level of 0.1 to 3 mg/L during a voyage and/or on discha rge. However, the risk assessment appears to
have been carried out on the basis of treatment at simulated uptake only. Further treatment during a voyage and/or on discharge would lead to high er PEC values. Given the uncertainties in the description of the system, the reliability of the PE C values presented in the application is open to question. Furthermore, the levels of by-products su ch as tribromomethane are likely to increase if treatment during a voyage is carrie d out. A proper risk assessment cannot therefore be carried out until a clear description of the operation is provided.

0.4 Relevant substances/byproducts were measured at detection limits of 1 (trihalomethanes) to 10 μg/L (haloacetic acids). Th e majority of compounds were f ound to be below these detection limits. However, it was evident from a footnote on the analytical certificat es that six days had elapsed between sampling and analysis. For final approval, the group would like to evaluate the range of potential by-products at lower detectio n limits, e.g. similar to those used in routine surface water monitoring of 0.01-0.05 μg/L, with s upporting evidence of same day analysis and clear evidence of how sample ha ndling, storage and analysis we re achieved. The analytical measurements carried out during testing for basi c approval are summarized in the application, e.g. the maximum concentration of tribromomethane is reported as 160 μg/L but this was considered by the group to be an underestimate.

0.5 The system can only work properly when sali nity (chlorine ion con centration) is above certain levels. This level is not specified in th e dossier, nor is it stated how the power supply to the electrolytic cell is to be adju sted in such cases of differing salinities. Further, this will cause limitations to the effective use of the system onboard ships.GESAMP-BWWG 3/9

ANNEX 7 Page 2

I:\MEPC\56\2-2.doc 0.6 The Group identified various risks relative to ship and crew safe ty that are in need to be

addressed.

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 used to evaluate this system we re extracted from that supplied by Japan in submission MEPC 56/2 that was supported by additional confidential information provided to the

GESAMP-BWWG Secretariat.

2 COMPLETENESS OF THE DOSSIER

2.1 The application dossier was not considered to be complete for the following reasons:

.1 the dossier is considered to describe a conceptual treatment of ballast water with electrolysis of seawater. It describes th ree means of treatments; at uptake, during voyage and at discharge. The dossier give s only information about environmental and safety aspects based on a simulation of the treatment on uptake;

.2 experimental results presented in the dossier are only based on small-scale laboratory experiments (capacity of the electrolytic cell=500 ml) and did not use flow through electrolytic cells such as would be installed on ships;

.3 the dossier gives no information on the intended control scheme. An automatic monitoring sensor for residual chlorine is said to be under development;

.4 calculation of the predicted environmenta l concentration (PEC) in the dossier is based on the CHEMMAP model using a con centration of active substance found in treated water two days after treatmen t. This scenario assumes that all discharged ballast water is kept at least tw o days in ballast tank s before discharge.

This is in conflict with the three alternat ives for treatment. PEC values from the modelling are not therefore considered reliable enough to carry out the risk

assessment.

3 DESCRIPTION OF THE BWMS

3.1 Overview of the system

3.1.1 The submission indicates that the system propos ed utilises a mechani cal filtration system to remove or deactivate large organisms of > 50μm followed by a seawater electrolytic process producing active chlorine to treat the ballast water. The chlorine is produced by the seawater electrolytic process at a compara tively high concentration in a side-stream from the shipsí ballast system that is then injected back into the ballas t main where the concentration of chlorine is then

diluted to the intended dose level. The submi ssion indicates that the in tended application would normally be during ballast water uptake, but also that the system can be applied during navigation or ballast water disc harge should this be required to maintain the treated water

minimum TRC disinfection levels recommended by the manufacturer.GESAMP-BWWG 3/9

ANNEX 7 Page 3

I:\MEPC\56\2-2.doc 3.1.2 It was noted that the submi ssion indicates the electrolytic process proposed is a further application development of the marine-Growth-Prevention System (MGPS Æ ) developed by Mitsubishi Heavy Industries Ltd. The MGPS system has used chlorine generated from seawater by electrolysis to control the problems associated with the establishment and growth of marine species in ships seawater coo ling systems for many years.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 The Group noted that the appl icant had identified chlorine gas as the primary Active Substance that is generated by the electrolysis of seawater onboard. However, it was also noted that the chlorine gas rapidly dissolves in seawat er to form free active ch lorine as a mixture of hypochlorous acid (HClO) a nd hypochlorite ion (ClO - ) that should be re garded as Active

Substances also.

3.2.2 The Group agreed that the use of information on sodium hypochlorite (NaClO) as surrogate data for hypochlorite ion was acceptable for the evaluation.

3.2.3 The Group also noted that, whilst it is this free active chlorine that has the disinfectant properties, it also reacts with naturally occu rring nitrogen compounds and organic compounds to form chloramines. The applicant had indicated th at the resultant mixture of free active chlorine and chloramines were referred to as Total Residual Chlorine (TRC) or Total Residual Oxidant (TRO).

3.2.4 The Group noted that, due to the naturally occurring presence of bromine in seawater (~65mg/L), an equilibrium exists between chlo rine and bromine containing compounds. As a result, when chlorine reacts with seawater to form hypochl orous acid and chlorite ions, hypobromous acid and bromite ions are also form ed. These react with naturally occurring organic compounds, inorganic nitrog en compounds and carboxylic acids, examples of which are shown below as being relevant to this application:

.1 Chlorine gas reacts with water to form the Active Substances (TRO)

Cl 2 + water → HClO + ClO - (TRO) (Equation not balanced)

.2 Hypochlorous acid can then react with nitrogen compounds such as ammonia, as

shown below:

NH 3 + HClO → NH 2 Cl + H 2 O

NH 2 Cl + HXO → NHCl 2 + H 2 O

NHX 2 + HClO → NX 3 + H 2 O

However, at the pH of seawater (pH8 ), monohaloamines are produced which, for practical reasons are deemed to be included in the definition of TRO

.3 Hypochlorous acid can also react with naturally occurring organic compounds to form trihalomethanes, such as:

RCOCH 3 + 3HOCl → CHCl 3 + RCOOH + 2H 2 OGESAMP-BWWG 3/9

ANNEX 7 Page 4

I:\MEPC\56\2-2.doc .4 In addition, hypochlorous acid can also react with naturally occurring carboxylic acids to generate halogenated acetic acids as shown below:

RCHO + HOX → RCOOH + H + + X -

RCOOH + HOX → RXCOOH + H 2 O

RXCOOH + HOX → RX 2 COOH + H 2 O

RX 2 COOH + HOX → RX 3 COOH + H 2 O

Where X = Cl or Br

3.2.5 The Group noted that, having identified thes e reactions, the applicant had analysed

chlorine treated seawater with the results shown below:

Item Analysis value (mg/l) Detection limit (mg/l) Sample Condition Sampling Point

Sampling Date

Initial chlorine concentration (FAC)

POC

DOC TOC (=DOC+POC) pH Tokyo Bay

2006.7 (5.0) a,b

2.49 b

0.82 b

3.31 b
8.3 (21°C) Oigawa Port

2006.9 (5.0) a,c

0.1 c

1.0 c

1.1 c 8.1 (19°C) 0.05 2( μ g)

0.05

-

-

Trihalomethanes trichloromethane (CHCl 3 ) bromodichloromethane (CHBrCl 2 ) dibromochloromethane (CHBr 2 Cl) tribromomethane(CHBr 3 ) (bromoform) N.D.

N.D.

0.006

0.16 N.D. c

N.D. c

0.003 c

0.15 c 0.001

0.001

0.001

0.001

Haloacetic acids 2-monochloroacetic acid (CH 2 ClCOOH) 2,2-dichloroacetic acid (CHCl 2 COOH) 2,2,2-trichloroacetic acid (CCl 3 COOH) 2-monobromoacetic acid (CH 2 BrCOOH) 2,2-dibromoacetic acid (CHBr 2 COOH) 2,2,2-tribromoacetic acid (CBr 3 COOH) 2,2-bromochloroacetic acid (CHBrClCOOH) 2,2,2-bromodichloroacetic acid (CBrCl 2 COOH) 2,2,2-dibromochloroacetic acid (CBr 2 ClCOOH) N.D.

N.D.

N.D.

N.D.

0.02

0.03

N.D.

N.D.

N.D. N.D. c

N.D. c

N.D. c

N.D. c

N.D. c

0.01 c

N.D. c

N.D. c

N.D. c 0.01

0.004

0.02

0.01

0.01

0.01

0.01

0.01

0.01

Where:

a: Test seawater was electr olyzed to prepare an electrol ytic solution containing about 50 mg of TRC/l. TRC was quantitativel y determined by iodometry followed by mixing of the electrolytic so lution with test seawater.

b: Results of analysis carried out by the applicantGESAMP-BWWG 3/9

ANNEX 7 Page 5

I:\MEPC\56\2-2.doc c: Results of analysis carri ed out by the appli cantís laboratory in chemical tests on treated seawater (see paragraph 5.2), with six day old samples N.D.: Not Detectable.

3.2.6 The Group noted that, based on this analysis and, in addition to the Active Substances (Chlorine and TRO), the applican t identified the following by-produc ts as Relevant chemicals, some of which are produced by the interacti on with naturally occu rring bromide ions:

Maximum concentration identified (mg/L)

tribromomethane 0.16

dibromochloromethane 0.006 2,2-dibromoacetic acid 0.02 2,2,2-tribromoacetic acid 0.03

3.2.7 The Group noted that analyses had only been carried out using samples from laboratory scale experiments where still water had been el ectrolysed in a 500 ml ce ll and diluted manually with untreated water. The Group considered that results from su ch small scale experiments were

of limited value for evaluati on of full scale systems.

3.2.8 It was also noted that the dossier did not include information about other relevant halogenated chemicals that may be produced because they were not detected in the chemical analysis. As a result, the Group recommended that additional analysis be included in the further testing both onboard ships and in land-based test s and that these data are submitted in the application for final approval.

3.2.9 In addition, the Group agreed that the Level of Quantificat ion (LOQ) of the analytical methods used for the potential by-products measured should be at a level th at will confirm that the potential amount of by-products produced by the system is sufficiently low and meets

the international standards on these substances. The Group considered that the LOQs generally used to be too high. It is common to determine these contaminants in surface waters at levels of 0.01 ñ 0.05 μg/L.

3.2.10 The Group noted that the applicant had al so indicated that hydrogen gas is also generated by the system but, as th ere were no reported ( eco-)toxicity data for this chemical, only its safety hazards were consid ered and the product was not rega rded as a Relevant Chemical.

3.2.11 The evaluation of the Active Substances and Relevant Chemicals are shown in the appendices as indicated below:

.1 free active chlorine (TRO) Appendix 1;

.2 monochloramine Appendix 2;

.3 tribromomethane Appendix 3;

.4 dibromochloromethane Appendix 4;GESAMP-BWWG 3/9

ANNEX 7 Page 6

I:\MEPC\56\2-2.doc .5 2,2-dibromoacetic acid Appendix 5;

.6 2,2,2-tribromoacetic acid Appendix 6.

4 HUMAN HEALTH ASSESSMENT

4.1 The seawater electrolysis generates in situ chlorine gas (Cl 2 ) that rapidly dissolves to form free active chlorine (FAC ), a mixture of hypochlorous aci d (HOCl) and hypochlorite ion (OCl - ) that is expected to have a very short-life. Subsequently, free chlori ne reacts with nitrogen compounds existing in the biological materials forming chloramines that act as secondary

disinfectants. This constitutes to tal residual chlorine (TOC) or to tal residual oxidant (TRO) used to assess FAC, considered to be the Active Substance.

4.2 It was acknowledged that chlorine in th e form of hypochlorous acid/hypochlorite ion (HOCl/ClO - ) is able to react with bromide ion, oxidizing it to hypobromous acid/hypobromite ion (HOBr/OBr-). Hypochlorous acid and hypobromous ac id react collectively with natural organic matter (NOM) to form chlorine DBPs, in cluding THM, haloacetic acids (HAAs), haloacetonitriles (HANs). The relative amounts of TOC

, bromide and chlorine will affect the species distribution of THMs (four species: ch loroform, bromoform, bromodichloromethane (BDCM) and dibromochloromet hane (DBCM)), HAAs and HANs.

4.3 The Group considered the disinfection by-produ cts (DBP) to be relevant chemicals, not only the compounds referred in the application but others, as above menti oned, expected to be produced in such an electrolytic system. The ex isting weight of evidence associated with the potential for human toxicity of these compounds makes this a majo r concern and requires strict mitigation measures namely for occupational exposure.

4.4 The presence of bromine in the seawater e nhances lipid solubility of the halomethanes and consequently, uptake into the tissues, increas ing the capacity of their chemical reactivity and

the likelihood of biotransformation to more toxi c metabolites. According to existing information (EPA 216, 2000), cancer following chronic exposur e is the primary hazard of concern for

brominated THMs.

4.5 Most of the experimental toxicity data on chlorine are found under the WHO drinkingwater disinfectants and disinfect ant by-products research program where evidence is normally

associated to chlorine administ ered via drinking-water. Although being aware that such exposure is not particularly relevant to exposures in the Ballast Water Treatment Systems, the Group consider these data to substantiate the qualitative assessment.

4.6 From the information presented it is conclude d that the critical he alth effect s resulting from human exposure to the active substances a nd relevant chemicals generated by the system are mostly acute in nature (corrosiveness, irri tancy to skin and eyes, and respiratory tract); however, and this mostly applies do DBPs, concerns are also addressed in literature related to genotoxicity and carcin ogenicity to humans, depending on th e severity of exposure and under long term exposures (e.g. occupational scenarios).

4.7 Other relevant factors have also to be ta ken into account when assessing human exposure towards chemicals include, inter alia :GESAMP-BWWG 3/9

ANNEX 7 Page 7

I:\MEPC\56\2-2.doc .1 the variability in human individual sensitivity (e.g. genetic polymorphism);

.2 the fact that most of these compounds are volatile liquids atroom temperature, therefore inhalation becomes an importan t exposure route in addition to dermal;

.3 the fact that complex mixt ures of disinfectants and DB Ps, according to the actual knowledge, interact in an additive way, leading to cumulative effects at low concentration (EHC 216, 2000).

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

PUBLIC

5.1 The Group noted that the applicant had indicate d that there are risks associated with the excessive production of the Active Substance that might leak from the equipment. However, the electrolytic cell is turned off automatically if ther e is leakage or if the se awater flow rate to the electrolytic cell falls below a pres et level. It is recommended that confirmation is obtained that the shut down parameters include chlorine gas detection in the vicinity of the chlorine generator and chlorine injection piping to the ballast system to minimise the possibility of unacceptable personnel exposure. The Group considered that this was particularly relevant as the electrolytic cell produces relatively high chlorine concentrations.

5.2 It was noted that the system is a developm ent of an existing appl ication in which the initial dosing rate may not be of particular concern due to the normal operating procedures for that particular system. Whilst recognizing that the TRC discharge level would be monitored to keep it within acceptable limits, the Group was concerned that the subm ission did not clearly

indicate that the TRC or other relevant parameters in the treat ed water would be adequately monitored. In addition, the Group noted that the sensor for such m onitoring is still under development and that the chlorine levels report ed were derived from theoretical calculations based on the electric current to be applied to th e electrolytic cell. It is recommended for the purpose of further approval that the TRC concentr ation following injection in the ballast line is also appropriately monitored to ensure the leve ls of TRC in the treated ballast tanks do not exceed the anticipated levels.

5.3 The Group noted that the applicant had indicat ed that the free active chlorine, generated by the system reacts with organic matter to form DBPs such as trihalomethane and halogenated acetic acids. However, the analysis of some of these products was not always sensitive enough to show whether they had been produced or not. Ot her studies have suggested that THM generation increases with pH, time, temperature and the am ount of organic matter present. It has been suggested that TRC levels above 1 mg/L can produce unacceptable THM levels. As with other systems, unless it can be demonstrated that the levels of these compounds produced do not present an unacceptable human health risk, appr opriate mitigation measure must be used to prevent human contact with the treated ballast wa ter. Such measure might include the use of Personal Protective Equipment (PPE) when entering ballast water tanks. The Group agreed that this view emphasized the need for a quantitati ve human exposure risk assessment system if meaningful recommendations are to be made to MEPC. The formation of DBPs in the ballast tanks may be greatly increased if the on passage re-chlorination option described is followed, due

to the fresh influx of available TRC.GESAMP

- BWWG 3/9

ANNEX 7 Page 8

I: \ MEPC \ 56 \ 2

- 2.doc 5.4 The Group noted that the submission had identified an increased risk of corrosion to piping and the ballast tank structure that may be anticipated with the use of chlorine. However, it

was stated tha t there is only a low risk of corrosion due to the “low” concentration of 5 mg FAC/l measured during treatment and the use of lined piping. The Group noted that other studies of the corrosive effect experienced with the use of chlorine had indicated a 100 % corrosion effect increase with the use of a 5 mg/L chlorine solution and that the effectiveness of any typical onboard seawater piping or ballast tank protective coating system could not be guaranteed in all cases. The Group, therefore, recommended that the corrosive effect caused by use of the proposed system is verified during further testing, and that when initial trials take place onboard a ship, the suitability of the ships corrosion protection coatings is verified and that conditions are

checked re gularly to avoid the possibility of piping and/or structural failure. The degradation effect that the treatment may have on the tank coatings should also to be assessed.

5.5 The Group noted that the submission had indicated that there is an increased ris k of explosion following the potential accumulation of hydrogen gas generated by the system. However, the applicant suggested that, due to its high water solubility, most of the generated hydrogen gas would be dissolved. Furthermore, it was indicated tha t the hydrogen gas would be discharged from the ventilation hole of the ballast tank. However, the Group agreed that there might be serious safety concerns with this system and so recommended that this risk be further evaluated before accepting that no ad ditional precautionary measures are necessary. This will be especially relevant when opening ballast tanks and monitoring of the condition of the air exiting the tank vent system during treated water uptake or recirculation for re

- chlorination. The hazar ds associated with the potential for generation of chlorine gas during the process is also in need of a further equivalent evaluation. Monitoring of levels of these substances and additional appropriate safety procedures should be required as a minimum fo r the opening of treated ballast tanks and personnel tank entry until it has been verified that such precautions are unnecessary.

5.6 The Group noted that the submission indicated that the ballast water treatment system proposed was in an early stage of d evelopment, and that operation of the system would appear to be very labour intensive and time consuming until appropriate automation and controls were developed and incorporated.

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

6. 1 The Group noted that the following classifications could be made on the PBT

- criteria as presented in the table.

Substance Persistence Bioaccumulation Toxicity

FAC No No No

monochloramine No No No

tribromomethane Yes (half

- life 340d in sediment) No N o

dibromochloromethane No No No
2,2

- dibromoacetic acid No No ND
2,2,2

- tribromoacetic acid No No NDGESAMP-BWWG 3/9

ANNEX 7 Page 9

I:\MEPC\56\2-2.doc 6.2 Based on these results, none of the substances should be classified as a PBT-substance.

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 Based on the available ecotoxicity data the Group derived a predicted no-effect concentration (PNEC) for the substa nces as indicated in the table.

Substance Lowest L(E)C 50 (mg/L) Lowest

NOEC (mg/L) AF PNEC (μg/L)

TRO 0.005 0.007 100 0.07

monochloramine 0.079 NA 1000 0.079

tribromomethane 7.1 4.8 1000 7.1

dibromochloromethane 27 2.9 1000 27 2,2-dibromoacetic acid 6.9 NA 1000 6.9 2,2,2-tribromoacetic acid NA NA - NA

7.2 Given the uncertainties in the establishment (estimation) of th e PEC, as the description of the BWMS is considered not sufficient by the Group, it was noted that carrying out of a real risk assessment based on these data is not possible. First a clear indication of the possible PEC is required.

7.3 It was recognized that, due to the inadequa te description of this system, it was not possible to measure a Predicted Environmenta l Concentration (PEC) of possible chemicals

released into the sea.

8 CONCLUSIONS AND RECOMMENDATIONS

8.1 Risks to safety of the ship

8.1.1 It was agreed that there is a potential risk of explos ion due to the possible excess hydrogen being produced. There is al so a potential risk of corrosion to parts of the ship caused by the possible high levels of ch lorine generated by the system.

8.2 Risks to the crew and the public

8.2.1 In addition to those points identified in pa ragraph 8.1.1, which pose a potential risk to the crew as well, the Group were conc erned that the types and levels of by-products generated by the system might also present an unacceptable huma n health risk if the crew or the public are exposed to treated ballast wate r. As a result, the Group reco mmended that, until it can be demonstrated that these concerns are unfounded, a ppropriate mitigation meas ures must be used to prevent human contact w ith treated ballast water.

8.3 Risks to the environment

8.3.1 As it was not possible to generate a value for the Predicted Environmental Concentration of products released into the sea, the Group could not evaluate the potential risks to the

environment.

* * *GESAMP-BWWG 3/9

ANNEX 7 Page 10

I:\MEPC\56\2-2.doc Appendix 1

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF FREE ACTIVE

CHLORINE (FAC) DESCRIBED AS TOTAL RESIDUAL OXIDANT (TRO)

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group recognized that as TRO was a mixt ure of chemicals (deem ed to be chlorine, hypochlorous acid and chlorite ion, it was not possi ble to identify all of the physical properties accurately. However, the Group noted the following physical properties associ ated with some of the TRO components.

Physical property Chlorine Hypochlorous
acid Sodium hypochlorite

CAS number 7782-50-5 7790-92-3 7681-52-0
Molecule weight 70.906 52.46 74.44
Melting point (°C) -101 - 25

Boiling point (°C) -34.6 107

Flash point (°C) Nonflammable

Density (kg/dm 3 ) @ 20 °C 3.214 at 0°C/101.3kPa 1.21*10 3

Vapour pressure @ 20°C (Pa) 7.77*10 5 1740-2000
Vapour density (air=1) 2.5 @ -34.6°C

Water solubility (g/L) 14.6 @ 0°C 5.7 @ 30°C 293

pH in solution
Octanol / water partition coefficient (log Pow)
Dissociation constant (pKa) 3.4 7.5
Oxidation reduction potential
Corrosivity to Material
Reactivity to container material
Auto-ignition temperature (°C) NA
Explosive Properties
Oxidizing properties

Surface tension NA
Viscosity (mPa.s) NA 2.6
Thermal stability and breakdown product
Other physical and Chemical property

2 MAMMALIAN TOXICITY (based on calcium and sodium hypochlorite data)

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group ar e summarized in the table below.GESAMP-BWWG 3/9

ANNEX 7 Page 11

I:\MEPC\56\2-2.doc Exposure Route Value Species Reference

Oral LD 50 (mg/kg) 850 WHO 2003 (Calcium hypochlorite

Dermal LD 50 (mg/kg)

Inhalation LC 50 (mg/l/4h)

2.2 Corrosion/Irritation

2.2.1 A summary of the available co rrosion/irritation data for TRO is shown in the table below.

Species Method Results (including scores where available) Reference/Comments/Justification for missing data

Skin Rabbit OECD 404 2% slight (1.2) 20% severe (5.2) IUCLID 2000 sodium hypochlorite

Eye Rabbit 5.25% irritant 0.5% slight irritant

0.05% NOEC IUCLID 2000 sodium hypochlorite

2.3 Sensitization

2.3.1 The Group noted that a 2.8% solution of s odium hypochlorite solution was not found to be a skin sensitizer in Guinea pigs (IUCLID 2000).

2.4 Repeated dose toxicity

2.4.1 A summary of the available repeated dose to xicity data for TRO is shown in the table

below.

Exposure Route Oral Exposure Duration 90 days Exposure dose 200mg/l TRO in drinking water Species Mouse

Method

Results

NOAEL 50 mg/l (10-12 mg/kg/day)

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2 para. 2.3.3.1 (Daniel et al 1991)

2.5 Chronic and long-term toxicity

2.5.1 A summary of the available chronic and long- term data for TRO is shown in the table

below.GESAMP-BWWG 3/9

ANNEX 7 Page 12

I:\MEPC\56\2-2.doc Exposure Route Oral Exposure Duration 2 years Exposure dose Up to 24.2 mg/kg/day (14.4 in rats, 24.2 in Mouse) Species Rat and Mouse

Method

Results

NOAEL 14.4 mg/kg/day

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.4.1 (NTP 1992)

2.6 Development and Reproductive Toxicity

2.6.1 The Group noted that the applicant had repor ted that no information was available for

tests carried out in accordance with OECD Guid elines 414 or 416. A summary of the available development and reproductive toxicity data for TRO is shown in the table below.

Exposure Route Oral Exposure Duration 7 generations Exposure dose 100mg TRO/l (drinking water tr eated with sodium hypochlorite) Species Rat

Method

Results

NOAEL

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.5.1

2.7 Carcinogenicity/Mutagenicity

2.7.1 The Group noted that the applicant had repor ted that rats exposed to drinking water treated with up to 14.4 mg/kg/day sodium hypochlorite for 104 weeks showed no effects that were deemed to be carcinogenic. Similar resu lts were shown in mice exposed to 24.2 mg/kg/d

for 104 weeks.

2.7.2 The Group noted that sodium hypochlorite pro duced mutations in an Ames test and in human embryo stem cells in vitro . However, no mutagenicity wa s observed in either a mouse micronucleus assay or a mouse chromosomal aberration test.

2.7.3 A summary of the available carcinogenicity/ mutagenicity data for TRO is shown in the

table below.GESAMP-BWWG 3/9

ANNEX 7 Page 13

I:\MEPC\56\2-2.doc Species Method

Details Results Reference/Comments/ Justification for missing data Carcinogenicity Not carcinogenic IARC Gr oup D (not classifiable as human carcinogen). MEPC 56/2, paragraph 2.3.6.1 Mutagenicity (Not) mutagenic MEPC 56/2, paragraph 2.3.7.1

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evaluation of the acute aquatic toxic ity of TRO based on data provided by the applicant.

F

C

A Species Effect Value (mg/L) Reference/Comments

F Oncorhynchus kisutch 96h LC 50 0.032

C Ceriodaphnia dubia 24h LC 50 0.005

A Thalassiosira pseudonana 24h IC 50 0.075

M Crassostrea virginica 96h EC 50 0.023 MEPC 56/2 para.2.2.1.1

F = Fish, C = Crustacea, A = Algae, Mollusc

3.2 Chronic Aquatic toxicity

3.2.1 The table below summarizes the evaluation of the chronic aquatic t oxicity of TRO based on data provided by the applicant.

F

C

A Species Effect Value (mg/L) Reference/Comments

F Menidia peninsulae 28d NOEC 0.04 Chlorine-produced

oxidant

C Pandalus danae 28d NOEC 0.05mg/l Free

Active Chlorine

A Unknown species 7d NOEC 0.0027 mg/l

TRO

M Crassostrea virginica 15d NOEC 0.007mg/l

TRO MEPC 56/2 para.2.2.2.1

F = Fish, C = Crustacea, A = Algae, Mollusc

3.3 Information on Endocrine Disruption

3.3.1 The Group noted that th e applicant had indicated that ther e were no reports indicating that TRO might have any endocrine effects on aquatic organisms.GESAMP-BWWG 3/9

ANNEX 7 Page 14

I:\MEPC\56\2-2.doc [3.3.2 However, the Group considered data on endocrine disruption fo r this substance not relevant because of the nature of the substance.]

3.4 Sediment Toxicity

3.4.1 The Group [agreed] with the applicantís view that, due to the estimated low Koc of TRO (see 3.7) it is unlikely that these will partition into sediment and cause further adverse effects to organisms in this area.

3.5 Bioavailability/Biomagnification/Bioconcentration

3.5.1 A summary of the pertinent data relate d to bioavailability, biomagnification and

bioconcentration for TRO is shown in the table below.

Log Pow Hypochlorous acid -0. 87 Sodium hypochlorite -3.42

Based on these values the Group did not c onsider the substan ces bioaccumulative.

3.6 Food Web/Population Effects

3.6.1 The Group [agreed] with the applicantís view that, due to the estimated low Log Pow of TRO, it is unlikely that these will be accumulated through the food chain.

3.7 Environmental Fate

3.7.1 The Group noted that only few environmental fate data were available in the notifying dossier. The table gives the data available.

Koc (l/kg) half life (h) Hypochlorous acid 14.3 0.8 Sodium hypochlorite 14.3 1.4

3.7.2 As these chemicals have oxidizing prope rties in the BWMS unde r consideration the Group does expect that the amount available of th ese chemicals will disappear rapidly during the oxidizing activity. Therefore the resulting TRO in the receiving water will be very low.

* * *GESAMP-BWWG 3/9

ANNEX 7 Page 15

I:\MEPC\56\2-2.doc Appendix 2

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF MONOCHLORAMINE

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were not any physical properties provided for monochloramine. The following data may be found in the open literature:

Molecular formula NH 2 Cl Molecular weight 51.48

CAS-number 10599-90-3 Appearance Colourless Density NA Water Solubility (mg/L) Soluble Melting Point (°C) - 66 Boiling Point (°C) NA

2 MAMMALIAN TOXICITY

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group for monochl oramine are summarized in the table below.

Exposure Route Value Species Reference

Oral LD 50 (mg/kg) >0.8 Rat MEPC 56/2, paragraph 2.3.1.2 (not really an AT test)

Dermal LD 50 (mg/kg) Missing

Inhalation LC 50 (mg/l/4h) Missing Sub-acute toxicity NOAEL oral (mg/kg bw/day) 2 weeks Missing

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritati on data for monochloramine is shown in the

table below.

Species Method Results (including scores where available) Reference/Comments/Justification for missing data

Skin Missing Eye Missing Lung Irritant MEPC 56/2, paragraph 2.3.2.2GESAMP-BWWG 3/9

ANNEX 7 Page 16

I:\MEPC\56\2-2.doc 2.3 Sensitization

2.3.1 The Group noted that there was no indi cation of sensitization potential of monochloramine provided.

2.4 Repeated dose toxicity

2.4.1 The Group noted that data had been provided fo r repeated dose toxicity studies using both

rats and mice. As the rat data indicated a lower NOAEL, these were selected as the most appropriate data for use and are summarized in the table below.

Exposure Route Oral Exposure Duration 90 days Exposure dose 0-200mg/l in drinking water = 11.6 mg/kg/day Species

Method

Results

NOAEL 5.8 mg/kg/day

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.3.1

2.5 Chronic and long-term toxicity

2.5.1 A summary of the chronic and long-term toxi city data evaluated by the Group is shown in

the table below:

Exposure Route Oral Exposure Duration 2 years Exposure dose 0 - 9.5 mg/kg/day (Rat) 0 - 17.2 (Mouse) Species Rats and Mouse

Method

Results

NOAEL 9.5 mg/kg bw/day (rat); 17.2 mg/kg bw/day (Mouse)

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.4.2

2.6 Development and Reproductive Toxicity

2.6.1 A summary of the development and reproductiv e toxicity data eval uated by the Group is

shown in the table below.GESAMP-BWWG 3/9

ANNEX 7 Page 17

I:\MEPC\56\2-2.doc Exposure Route Oral Exposure Duration 66-76 days Exposure dose 0-10mg/kg/day Species Rat

Method

Results

NOAEL 10mg/kg/day

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.5.2

2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the carcinogenicity and muta genicity data evalua ted by the Group is

shown in the table below.

Species Method Details Results Reference/Comments/ Justification for missing

data

Carcinogenicity Not carcinogenic IARC Group D (MEPC 56/2, paragraph 2.3.6.2)

Mutagenicity Mouse Micronucleus assay.

Chromosomal

aberration test Not mutagenic MEPC 56/2, paragraph 2.3.6.2)

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evaluati on of the acute aqua tic toxicity of

monochloramine.

F

C

A Species Effect Value Reference/Comments/ Justification for missing data

F Oncorhynchus kisutch 96h LC 50 0.079 mg/l

C Gammarus pseudolimnaeus 96h LC 50 0.22 mg/l

A Missing MEPC 56/2, paragraph 2.2.1.2

F = Fish, C = Crustacea, A = Algae

3.2 Chronic Aquatic toxicity

3.2.1 The Group noted that there were no availabl e data on the chronic aquatic toxicity of

monochloramine.GESAMP-BWWG 3/9

ANNEX 7 Page 18

I:\MEPC\56\2-2.doc 3.3 Information on Endocrine Disruption

3.3.1 The Group noted that there was no informa tion related to the potential endocrine disruption effect of monochloramine.

3.4 Sediment Toxicity

3.4.1 The Group agreed with the vi ew of the applicant that, du e to the low Koc (see 3.7), monochloramine was unlikely to be adsorbed into the sediment su fficiently to cause any adverse effects in that compartment.

3.5 Bioavailability/Biomagnification/Bioconcentration

3.5.1 A summary of the pertinent data relate d to bioavailability, biomagnification and

bioconcentration for monochloramine is shown in the table below.

Log Pow BCF Reference monochloramine -1.19 MEPC 56/2, paragraph 2.2.5.2

3.6 Food Web/Population Effects

3.6.1 The Group agreed with the vi ew of the applicant that, due to the low Log Pow of monochloramine, it was unlikely to accumulate in the food chain.

3.7 Environmental Fate

3.7.1 The Group noted that no information ha s been provided on the degradation of monochloramine whilst the sorption of monochl oramine was estimated using a QSAR (EPI Suite). It was concluded that these data are sufficient to estimate the rapid removal of

monochloramine from seawater if discharde.

* * *GESAMP-BWWG 3/9

ANNEX 7 Page 19

I:\MEPC\56\2-2.doc Appendix 3

PHYSICOCHEMICAL AND BIOLOGICAL PR OPERTIES OF TRIBROMOMETHANE

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were no physi cal properties provided for tribromomethane (bromoform), although some data could be retrieve d from other sources as shown in the table.

Molecular formula CHBr 3 Molecular weight 253.73

CAS-number 75-25-2 Appearance Colourless to yellow liquid Density (air = 1) 8.7 Vapour pressure (Pa) @ 20 oC 665 Water Solubility (mg/L) Slightly Melting Point (°C) 9 Boiling Point (°C) 150

2 MAMMALIAN TOXICITY

2.1 Acute mammalian toxicity

2.1.1 A summary of the acute mammalian toxicity data for tribromomethane, evaluated by the Group, is summarized in the table below.

Exposure Route Value Species Reference

Oral LD 50 (mg/kg) 1147 Rat MEPC 56/2, paragraph 2.3.1.2

Dermal LD 50 (mg/kg) Missing

Inhalation LC 50 (mg/l/4h) <7000ppm/1h Dog MEPC 56/2, paragraph 2.3.2.2 Sub-acute toxicity NOAEL oral (mg/kg bw/day) 2 weeks Missing

2.2 Corrosion/Irritation

2.2.1 A summary of the corrosion/ irritation data for tribromothane evaluated by the Group is

summarized in the table below.GESAMP-BWWG 3/9

ANNEX 7 Page 20

I:\MEPC\56\2-2.doc Species Method Results (including

scores where

available) Reference/Comments/Justification for missing data

Skin Rabbit Moderately irritating Eye Rabbit Moderately irritating Respiratory system Moderately irritating MEPC 56/2, paragraph 2.3.2.2

2.3 Sensitization

2.3.1 The Group noted that no sensitization da ta were reported for tribromomethane.

2.4 Repeated dose toxicity

2.4.1 A summary of the repeated dose toxicity da ta for tribromomethane, evaluated by the Group is shown in the table below.

Exposure Route Oral Exposure Duration 13 weeks Exposure dose 50 mg/kg/day Species Rat

Method

Results

NOAEL 25 mg/kg/d

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.3.2

2.5 Chronic and long-term toxicity

2.5.1 A summary of the data evaluated by the Group for tribromomethane, is shown in the table

below.

Exposure Route 1 year Exposure Duration Exposure dose 6.2-57 mg/kg/d (Rat) 8.3-73 mg/kg/d (Mouse) Species Rat and Mouse

Method

Results

NOAEL <6.2 mg/kg/d

NOEL <6.2 mg/kg/d

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.4.2GESAMP-BWWG 3/9

ANNEX 7 Page 21

I:\MEPC\56\2-2.doc 2.6 Development and Reproductive Toxicity

2.6.1 A summary of the development and reproductiv e toxicity data evaluated by the Group for

tribromomethane is shown in the table below.

Exposure Route Exposure Duration Not given for rat study 105 d for Mouse study Exposure dose 50-200 mg/kg Species Rat and Mouse

Method

Results foetotoxicity observed in rats No fertility effects seen in Mouse study

NOAEL ?

NOEL ?

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.5.2

2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the carcinogenicity and muta genicity data evaluated by the Group for

tribromomethane is shown in the table below.

Species Method

Details Results Reference/Comments/ Justification for missing

data Carcinogenicity Human Probable

Human Carcinogen U.S. EPA (IRIS) MEPC 56/2, paragraph 2.3.6.2 Mutagenicity Salmonella.

Mammalian

cells Ames test Mixed

Mixed MEPC 56/2, paragraph 2.3.7.2

2.7.2 As the mutagenicity data reported were variable, the Group could not come to a conclusion regarding the mutagenic ity potential of tribromomethane

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evalua tion of the acute a quatic toxicity for

tribromomethane.GESAMP-BWWG 3/9

ANNEX 7 Page 22

I:\MEPC\56\2-2.doc

F

C

A Species Effect Value (mg/L) Calculated

NOEC (mg/L) Reference/Comments

F Cyprinodon variegatus 96h LC 50 7.1 2.9

C Daphnia magna 24-48h LC 50 46 <7.8

A Skeletonema costatum 96h EC 50 12.3 MEPC 56/2, paragraph 2.2.1.2

F = Fish, C = Crustacea, A = Algae

3.2 Chronic Aquatic toxicity

F

C

A Species Effect Value Reference/Comments

F Cyprinodon variegatus 28d NOEC 4.8mg/l

C

A MEPC 56/2, paragraph 2.2.2.2

3.3 Information on Endocrine Disruption

3.3.1 The Group noted that there were no availabl e data on the chronic aquatic toxicity of

tribromomethane.

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the ap plicant that, due to its low Koc value, tribromomethane was unlikely to be adsorbed into the sediment sufficiently to cause any adverse effects in that compartment.

3.5 Bioavailability/Biomagnification/Bioconcentration

3.5.1 A summary of the pertinent data related to the bioavail ability, biomagnification and

bioconcentration of tribromomethane is shown in the table below.

Log Pow BCF Reference

CHBr 3 2.4 MEPC 56/2, paragraph 2.2.4.2

3.5.2 Based on this information the Group concluded that br omoform was not a bioaccumulating substance.

3.6 Food Web/Population Effects

3.6.1 The Group agreed with the vi ew of the applicant that, due to the low Log Pow of tribromomethane, it was unlikely to accumulate in the food chain.

3.7 Environmental Fate

3.7.1 In the following table an overview is given of the environmental fate and behaviour data

of bromoform.GESAMP-BWWG 3/9

ANNEX 7 Page 23

I:\MEPC\56\2-2.doc Hydrolysis 686 y pH5 (seawater) pH7 (seawater) pH9 (seawater) Photolysis NA Degradation in seawater NA Ready biodegradation NA Biodegradation Water: 38 d

Soil: 75 d

Sediment: 340 d

Air: 380 d Sorption (K

oc ) (dm 3 /kg) 114.8 (62 ñ 126)

Bioconcentration 14 Anaerobic degradation 21 ñ 42 d NA = not available or not applicable

3.7.2 The fate data on bromoform indicate that it is not clear on beforehand that there is no risk to the environment because of low exposures. Du e to the half lives of around 50 d substantial levels of bromoform may still occur after discharge of the ballast water into the receiving

environment.

3.7.3 Therefore the Predicted Environmental C oncentration (PEC) was calculated at the moment of discharge and after 28 days, being the duration of th e chronic toxicity study with Cyprinodon variegatus

.

* * *GESAMP-BWWG 3/9

ANNEX 7 Page 24

I:\MEPC\56\2-2.doc Appendix 4

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF

DIBROMOCHLOROMETHANE

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were not any physical properties provided for dibromochloromethane. However, the Group was able to draw some properties from other sources. An overview is pr ovide din the table below.

Molecular formula CHClBr 2 Molecular weight 208.28

CAS-number 124-48-1 Appearance Colourless to yellow liquid Density (air = 1) 2.451 Vapour pressure (Pa) @ 20 oC NA Water Solubility (mg/L) Slightly Melting Point (°C) < - 20 Boiling Point (°C) 119 ñ 120

2 MAMMALIAN TOXICITY

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group for dibromoc hloromethane are summarized in the table

below.

Exposure Route Value Species Reference

Oral LD 50 (mg/kg) 800 Mouse MEPC 56/2, paragraph 2.3.1.2

Dermal LD 50 (mg/kg) Missing

Inhalation LC 50 (mg/l/4h) Missing

2.2 Corrosion/Irritation

2.2.1 A summary of the available corrosion/irritati on data for dibromochloromethane is shown

in the table below.

Species Method Results (including scores where available) Reference/Comments/Justification for missing data

Skin Irritating MEPC 56/2, paragraph 2.3.2.2 Eye Irritating MEPC 56/2, paragraph 2.3.2.2 Lung Irritating MEPC 56/2, paragraph 2.3.2.2GESAMP-BWWG 3/9

ANNEX 7 Page 25

I:\MEPC\56\2-2.doc 2.3 Sensitization

2.3.1 The Group noted that no data had been pr ovided on the sensitiz ation potential of

dibromochloromethane.

2.4 Repeated dose toxicity

2.4.1 A summary of the available repeated dose to xicity data for dibromochloromethane is

shown in the table below.

Exposure Route Oral Exposure Duration 90 days Exposure dose 0-200mg/kg/d Species Rat

Method

Results Decrease in body weight at 200mg/kg/d

NOAEL 50mg/kg/d

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2 para. 2.3.3.2

2.5 Chronic and long-term toxicity

2.5.1 A summary of the chronic and long-term t oxicity data for dibromochloromethane is

shown in the table below.

Exposure Route Oral Exposure Duration ? Exposure dose 0-100mg/kg/d Species Rat and Mouse

Method

Results Liver lesions seen in all test groups

Liver necrosis and calcification seen at 100mg/kg/d female Mouse

NOAEL

NOEL Not reported

Reference/Comments/ Justification for missing

data

2.6 Development and Reproductive Toxicity

2.6.1 A summary of the development and reproductiv e toxicity data for dibromochloromethane

is shown in the table below.GESAMP-BWWG 3/9

ANNEX 7 Page 26

I:\MEPC\56\2-2.doc Exposure Route Oral Exposure Duration 2-generations Exposure dose 0-4mg/l Species Mouse

Method

Results At 4mg/l decreased fertility and ge stational index in F1 generation. At 4mg/l only decreased fer tility in F2 generation.

No dominant lethal or te ratogenic effects observed.

NOAEL Not reported

NOEL Not reported

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.5.2

2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the carcinogenicity and mutage nicity data for dibromochloromethane is

shown in the table below.

Species Method

Details Results Reference/Comments/ Justification for missing

data Carcinogenicity Human Probable human carcinogen U.S. EPA (IRIS) MEPC 56/2, paragraph 2.3.6.2 Mutagenicity Salmonella typhimurium Ames +ve and -ve results MEPC 56/2, paragraph 2.3.7.2

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the evaluati on of the acute aqua tic toxicity of

dibromochloromethane.

F

C

A Species Effect Value Reference/Comments

F Oryzia latipes 96h LC 50 79mg/l

C Daphnia magna 48h EC 50 27mg/l

A Selenastrum capricornutum 72h EC 50 72h NOEC 6.1mg/l 2.9mg/l MEPC 56/2, paragraph 2.2.1.2

F = Fish, C = Crustacea, A = AlgaeGESAMP-BWWG 3/9

ANNEX 7 Page 27

I:\MEPC\56\2-2.doc 3.2 Chronic Aquatic toxicity

3.2.1 The Group noted that no chronic aquati c toxicity data had been reported on

dibromochloromethane.

3.3 Information on Endocrine Disruption

3.3.1 The Group noted that there was no informa tion related to the potential endocrine disruption effect of dibromochloromethane.

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the ap plicant that, due to its low Koc value, dibromochloromethane was unlikely to be adsorb ed in the sediment sufficiently to cause any adverse effects in that compartment.

3.5 Bioavailability/Biomagnification/Bioconcentration

3.5.1 A summary of the pertinent data relate d to bioavailability, biomagnification and

bioconcentration for dibromochlorometha ne is shown in the table below.

Log Pow BCF Reference 2.16 MEPC 56/2, paragraph 2.2.5.2

Based on this value the Group does not consider dibromochloromethane to be a bioaccumulative

substance.

3.6 Food Web/Population Effects

3.6.1 The Group agreed with the vi ew of the applicant that, due to the low Log Pow of dibromochloromethane, it was unlikely to accumulate in the food chain.

3.7 Environmental Fate

3.7.1 The main process taking place if the substa nce has been released to surface water is volatilisation. This process will typically occur with a half life of 46 hours and a range of 43 min to 16.6 d. The sorption constant of the subs tance is established at Koc = 84 l/kg.

3.7.2 Based on these values the substance may be of concer n in the risk evaluation.

* * *GESAMP-BWWG 3/9

ANNEX 7 Page 28

I:\MEPC\56\2-2.doc Appendix 5

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF 2,2-DIBROMOACETIC ACID

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were not any physical properties provided for 2,2-dibromoacetic acid.

2 MAMMALIAN TOXICITY

2.1 Acute mammalian toxicity

2.1.1 The data available to the Group on the acute toxicity of 2,2-dibromoacetic acid are

summarized in the table below.

Exposure Route Value Species Reference

Oral LD 50 (mg/kg) 1737 Rat MEPC 56/2, paragraph 2.3.1.2

Dermal LD 50 (mg/kg) Missing

Inhalation LC 50 (mg/l/4h) Missing

2.2 Corrosion/Irritation

2.2.1 A summary of the available co rrosion/irritation data for is shown in the table below.

Species Method Results (including scores where available) Reference/Comments/Justification for missing data

Skin Corrosive Eye Severe Lung Severe Assumed as a strong acid

2.3 Sensitization

2.3.1 The Group noted that there were no data related to the se nsitization potential of 2,2-dibromoacetic acid.

2.4 Repeated dose toxicity

2.4.1 A summary of the available repeated dose toxicity data for 2,2-dibromoacetic acid is

shown in the table below.GESAMP-BWWG 3/9

ANNEX 7 Page 29

I:\MEPC\56\2-2.doc Exposure Route Oral Oral Exposure Duration 28d 3 months Exposure dose 0-2000mg/l Species Mouse Mouse

Method

Results No deaths but various effects seen at

>500m/l

NOAEL 38mg/kg/d Not reported

NOEL Not reported

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.3.2

2.5 Chronic and long-term toxicity

2.5.1 A summary of the available chronic and long- term toxicity data for 2,2-dibromoacetic

acid is shown in the table below.

Exposure Route Oral Oral Exposure Duration 2 years 2 years Exposure dose 0-1000mg/l Species Mouse Rat

Method

Results Increased body weights at 50 and 500mg/l in males only Decrease body weights at 500 and 1000mg/l

NOAEL Not reported Not reported

NOEL Not reported Not reported

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.4.2

2.6 Development and Reproductive Toxicity

2.6.1 A summary of the available devel opment and reproductiv e toxicity data for 2,2-dibromoacetic acid is shown in the table below.

Exposure Route Oral Exposure Duration Exposure dose 0-250 mg/kg/d Species Rat

Method

Results Increased E2 at 250 mg/kg/d

NOAEL 125 mg/kg/d

NOEL

Reference/Comments/ Justification for missing

data MEPC 56/2, paragraph 2.3.5.2GESAMP-BWWG 3/9

ANNEX 7 Page 30

I:\MEPC\56\2-2.doc 2.7 Carcinogenicity/Mutagenicity

2.7.1 A summary of the available ca rcinogenicity and mutagenicity data for 2,2-dibromoacetic

acid is shown in the table below

.

Species Method

Details Results Reference/Comments/

Justification for

missing data Carcinogenicity Mouse and

rat Carcinogenic (tumours/cancers observed) MEPC 56/2, paragraph 2.3.6.2

Mutagenicity Salmonella typhimurium Ames

test Positive at 10mg/l MEPC 56/2, paragraph 2.3.7.2

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute aquatic toxicity

3.1.1 The table below summarizes the eval uation of the acute aquatic toxicity of 2,2-dibr o m oacetic acid

.

F

C

A Species Effect Value Reference/Comments

F Pimephales promelas 96h LC 50 6.9 mg/l MEPC 56/2, paragraph 2.2.1.2

C Missing

A Missing

F = Fish, C = Crustacea, A = Algae

3.2 Chronic Aquatic toxicity

3.2.1 The Group noted that there were not availa ble data on the chr onic aquatic toxicity of 2,2-dibromoacetic acid.

3.3 Information on Endocrine Disruption

3.3.1 The Group noted that there was no informa tion related to the potential endocrine disruption effect of 2,2-dibromoacetic acid.

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the applicant that, due to its low Koc value, 2,2-dibromoacetic acid was unlikely to be adsorbed into the sediment sufficiently to cause any adverse effects in that compartment.GESAMP-BWWG 3/9

ANNEX 7 Page 31

I:\MEPC\56\2-2.doc 3.5 Bioavailability/Biomagnification/Bioconcentration

3.5.1 A summary of the pertinent data relate d to bioavailability, biomagnification and

bioconcentration is show n in the table below

Log Pow BCF Reference 1.22 MEPC 56/2, paragraph 2.2.5.2

3.5.2 Based on this value the Group does not consid er the substance to be bioaccumulative.

3.6 Food Web/Population Effects

3.6.1 The Group agreed with the view of the applicant that, due to the low Log Pow of 2,2-dibromoacetic acid, it was unlikel y to accumulate in the food chain.

3.7 Environmental Fate

3.7.1 No information is provided on the degradat ion of 2,2-dibromoacetic acid. The Group was also not able to find any data on this item. A sorption constant was available of Koc = 1.9 l/kg.

* * *GESAMP-BWWG 3/9

ANNEX 7 Page 32

I:\MEPC\56\2-2.doc Appendix 6

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF 2,2,2-TRIBROMOACETIC ACID

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group noted that there were not any physical properties provided for 2,2,2-tribromoacetic acid.

2 MAMMALIAN TOXICITY

2.1 Acute mammalian toxicity

2.1.1 The Group noted that there were no acute ma mmalian toxicity data for this chemical.

2.2 Corrosion/Irritation

2.2.1 A summary of the available co rrosion/irritation data for:

Species Method Results (including scores where available) Reference/Comments/Justification for missing data

Skin Corrosive Eye Severe Lungs Severe Assumed because a strong acid

2.3 Sensitization

2.3.1 The Group noted that there were no data re lated to the sensitizati on potential of this

chemical.

2.4 Repeated dose toxicity

2.4.1 The Group noted that there were no data rela ted to the repeated dose toxicity of this

chemical.

2.5 Chronic and long-term toxicity

2.5.1 The Group noted that there were no data rela ted to the chronic and long-term toxicity of

this chemical.

2.6 Development and Reproductive Toxicity

2.6.1 The Group noted that there were no data related to the devel opment and reproductive toxicity of this chemical.GESAMP-BWWG 3/9

ANNEX 7 Page 33

I:\MEPC\56\2-2.doc 2.7 Carcinogenicity/Mutagenicity

2.7 A summary of the evaluated carcinogenicity an d mutagenicity data is shown in the table

below.

Species Method

Details Results Reference/Comments/

Justification for

missing data Carcinogenicity Missing Mutagenicity Salmonella typhimurium Ames

test mutagenicity seen at 2000mg/l Inconclusive in relation

to humans

2.8 Toxicokinetics

3 ENVIRONMENTAL EFFECTS AND FATE

3.1 Acute aquatic toxicity

3.1.1 The Group noted that there were no acute aquatic toxicity data availa ble for this chemical.

3.2 Chronic Aquatic toxicity

3.2.1 The Group noted that there were no chronic aquatic toxicity data available for this

chemical.

3.3 Information on Endocrine Disruption

3.3.1 The Group noted that there was no informa tion related to the endocrine disruption potential for this chemical.

3.4 Sediment Toxicity

3.4.1 The Group agreed with the view of the appl icant that, due to its low Koc value, this chemical was unlikely to be adsorbed into the se diment sufficiently to cause any adverse effects in that compartment.

3.5 Bioavailability/Biomagnification/Bioconcentration

3.5.1 A summary of the pertinent data relate d to bioavailability, biomagnification and

bioconcentration for:

Log Pow BCF Koc Calculated

Environmental

Distribution

Ratio 1⁄2 life Reference

2.07 2.741 l/kg 0.0715% MEPC 56/2, paragraph 2.2.5.2GESAMP-BWWG 3/9

ANNEX 7 Page 34

I:\MEPC\56\2-2.doc 3.6 Food Web/Population Effects

3.6.1 The Group agreed with the view of the appl icant that, due to the low Log Pow of this chemical, it was unlikely to accumulate in the food chain.

3.7 Environmental Fate

3.7.1 The group noted that no data were available in the notifying dossier on degradation of this substance. A sorption value of Koc = 2.741 l/kg was presented.

* * *GESAMP-BWWG 3/9

ANNEX 7 Page 35

I:\MEPC\56\2-2.doc Appendix 7

AQUATIC TOXICITY DATA FO R TREATED BALLAST WATER

1 Introduction

1.1 The Group recognized that it was inappropriate to provide data on the physical properties of treated ballast water and agreed that it wa s unnecessary to provide mammalian toxicity data

either.

2 Chronic Aquatic Toxicity Data

2.1 A summary of the chronic toxic ity data from the testing of treated ballast water is shown

in the table below.

Dilution (v/v) required to

observe the effect F

C

A Species Exposure

Duration NOEC LOEC Reference/Comments

F Oryzia javanicus 40 days 10% 31%

C Hyale barbicornis 21 days 10% 31%

A Skeletonema

costatum 72 hrs 3.1% 10% MEPC 56/2, paragraph 5.2.3

The starting point was a con centration of 50 mg FAC/L.

***GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc ANNEX 8

TIMETABLE FOR ACTIVITI ES RELATED TO THE 4 TH MEETING

OF THE GESAMP-BWWG

Date Activity

31 August 2007 Deadline for submission of application dossiers and related documents to be reviewed by GESAMP-BWWG (4).

31 August 2007 ñ 26 October

2007 Preparation of the meeting, including circulation of any relevant information provi ded by other delegations.

29 October ñ 2 November 2007 4 th Meeting of the GESAMP-BWWG.

5-9 November 2007 Editing and completion of th e draft report of the 4 th meeting.

12-18 November 2007 Administrations confirm that no confidential data are contained in the report.

19 November ñ 14 December

2007 Review and approval of the report by GESAMP.

17-21 December 2007 Produce the final report addr essing the comments by

GESAMP.

21 December 2007 Submission of the report on the 4 th meeting of

GESAMP-BWWG in accordance with the 13 weeks deadline

for MEPC 57 documents.

***GESAMP-BWWG 3/9

I:\MEPC\56\2-2.doc ANNEX 9

GESAMP BWWG ñ HUMAN EXPOSURE ASSESSMENT

1 INTRODUCTION

1.1 In risk assessment for human health, the nor mal procedure is to compare the exposure levels to which the population is exposed or likel y to be exposed with those levels at which no toxic effects are expected to occur.

1.2 There are nor m ally four stages when carrying a quantitative risk assess m ent:

.1 Hazard identification ñ what are the substances of concern and what are their

effects.

.2 Dose (concentration) ñ response (eff ect) relation ñ what is the relationship

between the dose and either the sever ity or the frequency of the effect.

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

.4 Risk characterisation ñ how to qua ntify the risk from the above data.

1.2 The greatest part of information about the potential human toxic effects of chemical

substances is obtained from studies on animals.

1.3 In assessing an acceptable leve l of a particular substance, the procedure usually follows moving from an experiment database of animal or preferably human data (e.g. epidemiological studies) giving a No Observed Adverse Effect Level (NOAEL) or a Lowest Observed Adverse Effect Level (LOAEL) to deriving exposure limit at a lower exposure valu e, to allow for the uncertainties in the data. Comparison of this exposure limit with a measured or estimated exposure level is then used to judge whether the situation is satisfactory or whether risk management measures are required.

2 The Margin of Safety (MOS) or Margin of Exposure (MOE) Approach

2.1 In this procedure the ratio of NOAEL determin ed in the animal studies and expressed in mg/kg/day is compared with the level to which a human may be exposed:

MOS or MOE = NOAEL mg/kg/d Exposure mg/kg/d

2.2 Assuming that the exposure of a human population to a substan ce in drinking water is 1 mg/L, for 60 kg woman consuming on average 2 L of water/day, then:

Exposure= 1mg/L x 2 L/day = 0.03 mg/kg/day 60 kgGESAMP-BWWG 3/9

ANNEX 8 Page 2

I:\MEPC\56\2-2.doc 2.3 The next step in the MOS approach is to derive and apply a so- called ìreference MOSî (MOSref). The MOSref is an overall assessment factor (AF) addressing differences between animal experimental data and real human exposur e situation, taking into account variability and uncertainty. Normally, the value for each AF is based on substance-specific information or, if missing, on default values. It is common in Human Risk Assessment to use an MOSref of 100 (10 for interspecies vari ability ñ between animals and hu mans ñ and 10 for intraspecies variability ñ among humans).

2.4 Exa m ple: taking into account the exposure value referred in 2.2. (0.03 m g/kg/day) and, for instances, a NOAEL for developmental toxi city of 100 mg/kg/day, the MOS will be 100/0.03, i.e. 3333, a reassuring large value comparing to MOSr ef (100). However, if this value was much lower or lower than MOSref, it would indicate an inadequate MOS value over the NOAEL and a unacceptable human risk towards this adverse effect.

2.5 The selection of the critical NOAEL for RA will depend on the extent, duration and route of human exposure and the selection of the most critical adverse effect

.

3 EXPOSURE ASSESSMENT

3.1 The aim of assessing human exposure is to obtain a realistic es timate of total human exposure, expressed in terms of dose per unit weight, e.g. mg/kg.

3.2 In principle, the exposure of a human population could be assessed by representative monitoring data and/or model calculations base d on available information on substances with analogous uses and exposure patterns or properties.

3.3 The predictions of exposure levels should de scribe a reasonable worst case situation, covering normal use patterns and where general pub lic or workers may be exposed to the same substance. It is important to assess the reliability and the representativeness of the exposure

measurements.

3.4 Where data are of an unsatisfactory qualit y, it is useful to conduct an assessment using ìworst caseî assumptions. If this indicates a ri sk of no concern, the assessment needs no further

refinement.

3.5 The most probable scenarios for human expos ure to BWMS still ne ed to be properly identified. However, one can assume two potential groups, with some characteristics of each and expected route of exposure as follows:

.1 Crew (exposed occupationally):

.1.1 exposure assumed during worki ng week ñ 8h day, 5 days per week;

.1.2 relatively healthy part of general population; and

.1.3 exposure routes: norma lly inhalation and dermal.

.2 General public/Human exposure via environment ñ users of coastal amenities,

beach coastlines and offshore installations and harbours:

.2.1 exposure intermittent ñ needs to be estimated;GESAMP-BWWG 3/9

ANNEX 8 Page 3

I:\MEPC\56\2-2.doc .2.2 exposures may not be controlled;

.2.3 exposure routes: oral, in halation and/or dermal; and

.2.4 includes vulnerable groups e .g. children and elderly people.

3.6 Normally occupational exposure will be an external exposure, i.e. the amount in contact with the skin, inhaled, or the concentration in th e atmosphere. Where the conclusion is that this level ìis of concernî, it may be necessary to de termine internal exposure, i.e. the amount taken

into the tissues of the body, or its bioavailability.

3.7 The predictions of the consequences of expos ure have to be carried out for each exposed human population (e.g. workers, gene ral public) and for each effect.

4 OCCUPATIONAL EXPOSURE

4.1 The most common routes of exposure in th e workplace are by inhalation or by absorption through intact skin. Dermal exposure may also resu lt in local effects, such as irritation or

dermatitis.

4.2 Exposure should always be assessed in the fi rst instance for the unprotected worker and, if appropriate, a second assessmen t, should be made taking PPE (p ersonal protective equipment)

into account.

4.3 Of primary importance in developing the a ssessment of occupationa l exposure is a full understanding of the processes and unit operations in which exposure occurs, and of the actual

work activities resulting in expo sure. With this background know ledge, the following questions

have to be answered:

.1 what is the population of potentially exposed individuals?

.2 what are the magnitude, frequency and duration of inhalation and dermal exposures?

.3 what personal protective equipment and control measures are used to reduce or mitigate exposure? and

.4 how effective are they in reducing exposure?

4.4 The overall assessment of each type of expos ure should be repeated for all the various production processes and uses made for the chos en chemical, and from a knowledge of the frequency and duration of exposur e the ìworst caseî highlighted.

4.5 If ìrealî data are missing for a chosen substan ce, as an alternative to modelling it may be possible to substitute data from another chem ical with a similar pattern of exposure.GESAMP-BWWG 3/9

ANNEX 8 Page 4

I:\MEPC\56\2-2.doc 4.6 The following major factors can affect exposure potential:

.1 size of activity ñ the greater the quantity of th e substance involved or the higher the concentration in solution, the greater the potential for exposure is likely to be. Any potential hazard from 10 tons is likely to be much greater than that of 10 mg;

.2 physical characteristics of the activity ñ particle size of a solid or volatility of a liquid are also likely to a ffect the exposure, as is th e presence of barriers to the exposure and containment of the substance away from human contact. Procedures involving elevated temperatur e, particularly with substances with significant vapour pressures, may engender an enhanced inhalation exposure; and

.3 t ime of exposure ñ the duration and frequency of exposure to an activity will also be a factor ñ the longer the time of e xposure the higher the exposure potential.

4.7 The quantitative human exposure assessment re sults in a reasonable worst-case estimate for external exposure via the inhalation and derm al route (the main ro utes of concern for occupational exposure) that are taken forward to the risk characterization.

4.8 These estimates are obtained for all relevant scenarios that have b een identified taking

into account all relevant available information.

4.9 In the risk characterisation phase these esti mates are combined with the results of the

effects assessment and conclusions are drawn whet her or not there is a concern for any scenarios

assessed.

5 CONTROL OF THE RISK

5.1 When a risk assessment results in the conclu sion that the risk is too high, consideration has to be given to introducing the following controls that will lower this risk to acceptable levels:

.1 prevention that includes:

.1.1 elimination;

.1.2 substitution; and

.1.3 good hygiene practice.

.2 Physical segregation that includes:

.2.1 complete enclosure with extraction;

.2.2 local exhaust ventilation with or without partial enclosure; and

.2.3 screening.GESAMP-BWWG 3/9

ANNEX 8 Page 5

I:\MEPC\56\2-2.doc .3 Personal protection that includes:

.3.1 respiratory protective equipment including respirators and self-contained breathing apparatus; and

.3.2 protective clothing (eye and head protection, gloves, shoes, etc.).

6 REFERENCES

.1 Chemical Risk Assessmen t ñ UNEP/IPCS, WHO, 1999; and

.2 Technical Guidance Document on Risk Assessment, European Chemicals Bureau (ECB) ñ Part I, European Communities, 2003.

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