For reasons of economy, this document is pr inted in a limited number. Delegates are kindly asked to bring their copies to mee tings and not to request additional copies.

I:\MEPC\58\2-7.doc

INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION
COMMITTEE
58th session Agenda item 2 MEPC 58/2/7 14 July 2008 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

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

Note by the Secretariat

SUMMARY

Executive summary: This document contains the report of the sixth meeting of the
GESAMP-Ballast Water Work ing Group (GESAMP-BWWG) and includes the evaluation of proposals submitted for approval by Japan, the Netherlands and the Republic of Korea

Strategic direction: 7.1

High-level action: 7.1.2

Planned output: 7.1.2.4

Action to be taken: Paragraph 4

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

Introduction

1 The sixth meeting of the GESAMP-Ba llast Water Working Group (GESAMP-BWWG) was held at IMO Headquarters from 19 to 23 Ma y 2008 and its report is attached to this
document as GESAMP-BWWG 6/9.

2 The main purpose of this meetin g was to review the proposals for approval of ballast water management systems that make use of Active Subs tances to treat ballast water prior to discharge
into the marine environment. The reviews of th ose proposals evaluated by the Group are shown in annexes 5 to 7 of the attached report.

3 Following the adoption of the revised “Procedure for approval of ballast water management systems that make use of Ac tive Substances (G9)”, the GESAMP-BWWG developed an updated version of the Methodology for information gathering and the conduct of its work (the Methodology), as se t out at annex 4 of the attach ed report, to ensure that it accurately reflects the provisions of the revised Procedure (G9).MEPC 58/2/7 - 2 -

I:\MEPC\58\2-7.doc Action requested of the Committee

4 The Committee is invited to:

.1 endorse the updated version of th e Methodology contained in annex 4 * of the attached report;

.2 note the Group’s intention to further de velop the Methodology, in particular, on the aspect related to Human Exposure Scenario (HES), taking into account comments in document BLG 12/5/8 (Uni ted States) and the experience of other Administrations (paragraph 3.1.3);

.3 invite interested Administrations to send their comments and suggestions on Human Exposure Scenario (HES) to the IMO Secretariat with an understanding that they will be disseminated among th e members of the Gr oup to facilitate the Group’s considerat ion (paragraph 3.1.4);

.4 agree to the Group’s clarification on why analytic ballast water toxicity tests should be conducted immediately after treatm ent, at the middle, and at the end of the five-day period required in Guidelines (G8) and on how this information will be used in the evaluation (paragraphs 3.3.5 and 3.3.6);

.5 note that after consideration of the logistical costs and timing implication related to the proposals contained in document BLG 12/5/10 (Norway), the Group identified a number of aspects which did not support the approach proposed (paragraphs 3.4.1 and 3.4.2);

.6 note the Group’s willingness to designate its representatives to attend the proposed GloBallast Workshop on ball ast water treatment technology test facilities, to present the Group’s expectations regardi ng the testing facilities and their procedures and to assist in the de velopment of the rele vant Guidance Manual (paragraphs 3.4.3 and 3.4.4);

.7 invite Members to bring Procedure (G 9) and the Methodology to the attention
of concerned Administrations and to advi se the applicants to structure their applications in accordance with the Methodology (paragraph 5.1.3);

.8 request Administrations to evaluate the application dossier a nd confirm that it is satisfactory and complete before submitting to the Organization in accordance with Procedure (G9), bearing in mind that the Group might not be able to complete its evaluation if the data are not complete and presented in a clear and concise manner (paragraphs 5.1.4 and 5.1.5);

.9 agree to the Group’s proposal to devel op a database containing toxicological, ecotoxicological data and a ppropriate physical properties for chemical by-products produced by most of the systems, and to define one model with the same basic parameters when calculating Predicted Environmental Concentrations (PEC) (paragraphs 6.2 and 6.4);

* Paragraphs and annexes referred in this section are those of document GESAMP-BWWG 6/9.- 3 - MEPC 58/2/7

I:\MEPC\58\2-7.doc .10 agree that additional time should be allocated to disc uss the lessons learned and the general aspects related to the evaluati on process without the pressure of having to review specific submissions (paragraph 7.2);

.11 agree that Basic Approval should be granted to the TG Ballastcleaner and TG Environmentalguard system submitted by Japan in document MEPC 57/2/8 (annex 5);

.12 agree that Basic Approval should be gr anted to the Greenship’s Ballast Water Management System submitted by the Netherlands in document MEPC 57/2/7 (annex 6);

.13 agree that Final Approval should be granted to the Electro-Clean System (ESC) resubmitted by the Republic of Korea in document MEPC 58/2 (annex 7); and

.14 approve the report in general.

***I:\MEPC\58\2-7.DOC GESAMP-BWWG
6th session Agenda item 9 GESAMP-BWWG 6/9 23 May 2008 Original: ENGLISH

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

Table of Contents

Section Page Number

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

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

3 OUTCOME OF BLG 12 AND MEPC 57................................................. 4

4 TERMS OF REFERENCE AND TIME FRAME ............................ 8

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER
MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE
SUBSTANCES .......................................................................................... 9

6 FURTHER DEVELOPMENT OF THE METHODOLOGY FOR
INFORMATION GATHERING AND TH E CONDUCT OF WORK OF
THE GESAMP-BWWG ......................................................... 10

7 ANY OTHER BUSINESS .................................................... 11

8 CONSIDERATION AND ADOPTION OF THE REPORT .................. 11GESAMP-BWWG 6/9 - 2 -

I:\MEPC\58\2-7.doc ANNEXES

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

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

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

Annex 4 The Methodology for information ga thering and the conduct of work of the

GESAMP-BWWG

Annex 5 Review of proposals for appr oval of Ballast Water Management Systems that make
use of Active Substances – TG Balla stcleaner and TG Environmentalguard, submitted for Basic Approval by Japan

Annex 6 Review of proposals for appr oval of Ballast Water Management Systems that make
use of Active Substances – A Combined Ballast Water Management System Consisting of Sediment Removal and an El ectrolytic Process Using Seawater to Produce Active Substances, submitted for Basic Approval by the Netherlands

Annex 7 Review of proposals for appr oval of Ballast Water Management Systems that make use of Active Substances – Electro-Clean System (ECS), submitted for Final Approval by the Republic of Korea- 3 - GESAMP-BWWG 6/9

I:\MEPC\58\2-7.doc 1 INTRODUCTION

1.1 The sixth GESAMP-Ballast Water Wo rking Group (GESAMP-BWWG) meeting was held at IMO Headquarters, London, from 19 to 23 May 2008, under the chairmanship
of Mr. Jan Linders. A list of members attendi ng this meeting is show n in annex 1 and the agenda, as adopted by the Group, is set out in annex 2.

1.2 Mr. D. Pughiuc, Head, Marine Biosafety Section, welcomed members on behalf of
the Director of the Marine Environment Di vision, Mr. M. Palomares, and conveyed the appreciation of the Secretary-General and the Me mber States for the work being carried out by the Group.

1.3 Mr. Pughiuc indicated that there was a need to expand the membership of the Group and create a pool of experts in orde r to complete the difficult task of evaluating all of the proposals for approval of BWMS that make use of Active Substances in the limited time available between two subsequent sessions of MEPC. This task had been made more difficult by the need to have additional meetings, which not all members can al ways attend, as well as having to identify and invite members with very specific expertise. The Group was requested to recommend suitable experts that could be contacted by the Secretariat/GESAMP in this respect.

1.4 The Group was informed that, in addition to their task of evaluating three submissions, MEPC 57 had raised a number of pertinent issu es which the Group was being requested to
consider.

2 ISSUES OF CONFIDENTIALITY

2.1 Applications for Basic A pproval regarding the use of Active Substances had been submitted by Japan (MEPC 57/2/8) and the Ne therlands (MEPC 57/2/7). In addition, the Republic of Korea had re-submitted an application for Final Approval (MEPC 58/2). Two submissions were supplemented with addi tional and confidential supporting data, whereas
the submission from the Netherlands did not provide any confidential information.

2.2 The confidential nature of the additiona l data was recognized by the Group and was treated as such in order to protect the commer cial interests of the manufacturers concerned.
In order to ensure that the re port did not contain any confid ential information, the Group noted that the Secretariat would liaise with the relevant Administration prior to submitting the report

to MEPC.

2.3 Pursuant to paragraphs 4.2.2, 8.1.1 and 8.1.2.7 of the “Procedure for approval of ballast water management systems that ma ke use of Active Substances (G9)”, all information gathered, materials, notes and repor ts obtained or made out during the work of the GESAMP-BWWG Group, including the report, were , and will be, treated as confidential. In this respect all the members of the Group and the Consultant signed the Statements of Acceptance related to confidentiality.

2.4 The original copies of these Statements dul y signed and dated by all involved were filed with the Technical Secretary of the Group and wi ll be kept together with the submissions.

2.5 The submissions (dossiers) were deposit ed in a safe place in IMO Headquarters (strong-room) and made available to the Consultant, at his reque st, during the working hours. They were available for cons ultation by the members of the Group for the duration of the meeting in the meeting room and returned to the Organization’s strong-room after the working
hours.GESAMP-BWWG 6/9 - 4 -

I:\MEPC\58\2-7.doc 2.6 On completion of the work the Chairman of the GESAMP-BWWG obtained from the other members any documents, drafts and any othe r associated records and reports, which were transmitted to the Technical Secretary of the GESAMP-BWWG for retention in confidence.
All electronic records and data held on personal computers/laptops were destroyed when they were no longer necessary for the work of the GESAMP-BWWG.

3 OUTCOME OF BLG 12 AND MEPC 57

3.1 Outcome of BLG 12 concerning Human Exposure Scenario

3.1.1 The Group noted that BLG 12 had cont inued its work on ma tters related to the Methodology and, in particul ar, had addressed the aspects related to the Human Exposure Scenario (HES), safe handling a nd storage of chemicals used to treat ballast water and safety procedures for the resultant risk s to the ships crew from treatment process. The Group noted that, having considered documen t BLG 12/5/8 (United States), BLG 12 had recognized that the
information used in the technical comments re garding the Human Exposure Assessment (HEA) was based mainly on the experience of one country and so had recommended that other national regulations should be considered before incorp orating the suggested changes in the assessment outlined in the GESAMP-BWWG report (MEPC 57/2/10, annex 4).

3.1.2 It was also noted that BLG 12 had inv ited Administrations to provide their own experiences related to Huma n Exposure Assessment (HEA), currently being developed by GESAMP-BWWG, at their earlies t opportunity and had forwarded document BLG 12/5/8 to
the GESAMP-BWWG for considerati on, comment and ac tion. In add ition, BLG 12 had instructed the Secretariat to explore the possib ility of a more direct dialogue on this matter between interested Administrations and the GESAMP-BWWG at the earliest possible opportunity (BLG 12/17, para graphs 5.8, 5.11, 5.42.6 and 5.42.7).

3.1.3 The Group welcomed the comments made by th e United States in document BLG 12/5/8 and assigned two members to li aise directly with the United States to develop its proposals
further and also take into consideration the experience of other Admi nistrations when such
information will be made available.

3.1.4 In order to ensure a more direct dialogue regarding this particul ar aspect, the Group
invited interested Administrations to send their comments and suggestions to the IMO Secretariat with an understanding that they will be disseminated among the members of the Group as soon as possible.

3.1.5 The Group agreed to identify and reference the suggestions included in the HES for consideration by MEPC as appropriate. More te xt should be prepared on the outcome of the Group’s discussion.

3.1.6 The Group agreed to further develop the HES questionnaire.- 5 - GESAMP-BWWG 6/9

I:\MEPC\58\2-7.doc 3.2 Methodology for information gathering and the conduct of work of
GESAMP-BWWG and related issues

3.2.1 The Group noted that MEPC 57 adopted the revised “Procedure for approval of ballast water management systems that ma ke use of Active Substances (G9)” by resolution MEPC.169(57) and requested the GE SAMP-BWWG to review its Methodology for information gathering and the conduct of work to ensure it accurately reflects the provisions of the revised Procedure (G9). Consequently, the Group prepared anupdated version of the Methodology in light of the revised Procedure (G9), as set out at a nnex 4 of this report.

3.2.2 In this connection, the Gr oup noted that MEPC 57 had reque sted it, in particular, to replace the definitions for Basic Approval a nd Final Approval in the latest version of the Methodology with text which re fers directly to the revised Pr ocedure (G9). As a result, the Group amended the definition for Basic Approval to:

“ Basic Approval means the preliminary approval of Active Substances and the ballast water management system that uses them in order to comply with the Ballast Water Management Convention. Basic Approval should confirm that the available information does not indicate possible unacceptable advers e effects or a potential for unreasonable risk to the environment, human health, pr operty or resources. This should include consideration of potential ri sks associated with the Active Substance during full-scale deployment on commercial ships when possible.”

and Final Approval to:

“ Final Approval means the approval of a ballast water management system using an Active Substance or Preparation to comply with the Convention and includes a review of the Type Approval tests in accordance with Guidelines for approval of ballast water management systems (G8). The review does not include the re-evaluation of efficacy testing results conducted by Administ rations under the Guidelines (G8). The Final Approval should confirm that previo us evaluations of risks to ship, crew and the environment including storage, handlin g and application of Active Substances or Preparations remain valid and the c oncerns expressed during the Basic Approval process have been addressed, as well as that the residual toxicity of the discharge conforms to the evaluation undertaken for Basic Approval. The risk evaluation at Final Approval should take qualitatively into account cumulative effects that may occur due to the nature of shippi ng and port operations. The un certainties involved in the application for approval should be considered during the Final Appr oval process, and
advice on how these uncertainties can be deal t with should be provi ded as appropriate.”

3.3 Review of the relationship between Procedure (G9) and Guidelines (G8)

3.3.1 The Group recalled that it had previously cons idered that, if efficacy testing were required for two types of water then toxicity testing should be dealt with in a similar manner. It was thought that this was particular ly important because the various amounts of Dissolved Organic Carbon (DOC) and Total Suspended Solids (TSS) coul d have a marked effect on the quantities of by-products produced by the treatme nt process that, in turn, woul d affect the to xicity of the treated ballast water (MEPC 56/2/2, Report of the third meeting of the GESAMP-BWWG, paragraph 5.4.6).GESAMP-BWWG 6/9 - 6 -

I:\MEPC\58\2-7.doc 3.3.2 In this context, the Group had also recal led that the time-period between treatment and testing could also affect the toxicity of the treated ballast water 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 following an appropriate longer interval (MEPC 56/2/2, paragraph 5.4.7).

3.3.3 The Group recalled further that it had ag reed that for ballast water management systems that treat the water at the intake, a 5-day lag-time between treatment and discharge as recommended by Guidelines (G8) to cover the possible re-growth of organisms is too long to allow representative sampling of water for ecotoxicity testing, as toxic chemicals will be degraded during the 5 days’ storag e period. Consequentl y, the Group had proposed that in the future “whole effluent” ecotoxicity testing and related analytical chemistry of exposure conditions should be conduc ted immediately after treatment and after a 24 or 48 hours interval to provide meaningful information regarding the possible impact on the receiving envir onment. Paragraph 10.2.4 of the Methodology was modified to reflect this change. (MEPC 57/2/10, report of the fifth meeting of the GESAMP-BWWG, paragraph 4.2)

3

. 3.4 The Group noted that MEPC 57 considered its concerns expressed in the previous meetings, regarding the appropriateness of the discharge toxicity data being submitted from the land-based toxicity tests during Type Approval under Guidelines (G8). The Group further noted that MEPC 57 requested it to pr ovide additional clarification on why analytic ballast water toxicity tests should be conducted immediatel y after treatment, at the middle, and at the end of the five-day period require d in Guidelines (G8) and as to how this
information will be used in the evaluation.

3.3.5 In considering this issue further, the Group agreed that:

.1 levels of chemical by-products produced by a system could vary with time following treatment of ballast water. e.g., the levels of all halomethanes, haloacetic acids and chloroamines might be expected to rise initially, if residual TROs were present, but then might decline later due to degradation/evaporation etc;

.2 such variation could also occur below the levels of analytical detection with unpredictable environmental effects;

.3 whilst full chronic aquatic toxicity testi ng of treated ballast wa ter at various times following treatment would provide definitiv e data, such an approach would be expensive, time consuming and complex to perform; and

.4 sampling for whole effluent ecotoxicity testing and related analytical chemistry conducted prior to the completion of the five day storage pe riod, specified in Procedure (G8) and recomm ended by the Group in para graph 3.3.3 of this report, should only apply to systems which do no t include either a neutralization or treatment step upon discharge. However, in cases where a neutralization step forms an integral part of the treatment sy stem, it should be demonstrated that this step is capable of effectively neutralizi ng all levels of Active Substances which might be encountered in the system.- 7 - GESAMP-BWWG 6/9

I:\MEPC\58\2-7.doc 3.3.6 Having taken these aspects into account the Gr oup agreed that, in addition to the testing required by paragraphs 5.2.2, 5.2.3 and 5.2.4 of Proce dure (G9), from a pragmatic standpoint, the following information would provide ade quate safeguards for the environment:

.1 acute toxicity testing using fi sh, invertebrates and plants; or

.2 chemical analysis demonstrating that there is no signifi cant negative changes during the five day tank holding time in the chemical by-products; or

.3 both chemical analysis and acu te aquatic toxicity testing;

immediately after treatment and after 24 or 48 hours.

3.4 Logistical costs and timing implication of the proposal by Norway (BLG 12/5/10) for screening of ballast water treatment systems

3.4.1 After considering the proposals containe d in document BLG 12/5/10 (Norway), the Group identified a number of aspects that di d not support such an approach including:

.1 the Group noted that MEPC had alrea dy agreed that it would be for each
Administration to decide whether a balla st water management system requires Active Substances approval or not;

.2 the Group and GESAMP itself have onl y advisory roles and should not liaise directly with the Administrations with re gard to regulatory aspects which are the prerogatives of MEPC;

.3 the Group is an ad hoc body and has neither the admini strative infrastructure nor the ability to meet at a short notice, when ever a request for screening is forwarded by an administration;

.4 the Group agreed that conducting the ‘scr eening of applications’ during its regular meetings, as a pre-requisite for evaluati ons in accordance w ith Procedure (G9) or Guidelines (G8), would add to the already overwhelming workload, delay the availability of the ballast water technol ogies and impact on th e timely entry into force of the BWM Convention;

.5 notwithstanding this obs ervation, the Group agreed to contribute to the development of specific guidance for the Ad ministrations to ensure a uniform and rigorous assessment of all the proposed technologies should MEPC decide to develop such a guidance document. Furthe rmore, it was noted that paragraph 3.3 of the Revised Procedure (G9) indicates that:

“any system which makes use of, or generates, Active Substances,
Relevant Chemicals or free radicals during the treatment process to eliminate organisms in order to co mply with the Convention should be subject to this Procedure.”GESAMP-BWWG 6/9 - 8 -

I:\MEPC\58\2-7.doc .5.1 as a result, the Group believed that the in clusion of Relevant Chemicals and free radicals may address, to la rge extent, the concerns expr essed by Norway regarding whether a ballast water management system requires Active Substances approval;

.6 with regard to the suggested ‘pre-e valuation’ of the testing programmes and testing facilities, the Group was of the vi ew that, in addition to the difficulties identified in the paragraphs above, such a task would probably go beyond its area of expertise. The Group noted that th ere are well established organizations specialized in the evaluation and certification of the QMPs and QAPPs of the entities that may undertake type approval activities on behalf of the Administrations and that such organizations are, in most of the cases, recognized by the ISO.

3.4.2 Notwithstanding the above-mentioned consider ations, should MEPC be of the view that GESAMP-BWWG is the most appropriat e body to perform the tasks indicated in document BLG 12/5/10, the Group would be prepared to accept the additi onal responsibilities provided that it will work only during its regular meetings and th e resources will be increased to allow the assignment of additional experts to achieve a better division of the tasks.

3.4.3 The Group noted that the GloBallast Program me has among its strategic objectives the development of a "Guidance Manual for Ball ast Water Treatment Technology Test Facility” including recommended QMPs and QAPPs for testi ng procedures and is currently considering the possibility of organizing a workshop to addr ess this issue. Such a workshop would:

.1 provide a forum for technology test f acility developers, treatment technology developers, administrations and other inte rested parties to initiate a dialogue on the various aspects of this specific matter;

.2 facilitate the developmen t of a manual that could be made widely available to interested stakeholders; and

.3 contribute to the establishment of a gl obal network of test facilities that will promote continuous information ex change and experience sharing.

3.4.4 The Group recognized that the GloBallast a pproach proposed may be an appropriate means of addressing this issue and agreed that it would contribute to this process by designating its representatives to attend the workshop, pres ent the GESAMP-BWWG expectations regarding the testing facilities and procedures and assist in the development of the Guidance Manual if requested.

4 TERMS OF REFERENCE AND TIME FRAME

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

4.2 The Group used the table agreed at MEPC 56 and reproduced below to determine the timetable for activities related to its regular meetings and agreed to decide, on a case-by-case basis, on the timing of additi onal meetings as appropriate.- 9 - GESAMP-BWWG 6/9

I:\MEPC\58\2-7.doc TIMETABLE FOR ACTIVITIES RELA TED TO GESAMP-BWWG MEETINGS

Timeline Activity

28 weeks before MEPC Deadline for submission of applica tion dossiers and related documents to be reviewed by GESAMP-BWWG

(8 weeks) Preparation of the meeting, includ ing circulation of any relevant information provided by other delegations 20 weeks before MEPC GESAMP-BWWG Meeting (1 week) Editing and completion of the draft report of the meeting

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

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

4.3 The Group noted that MEPC 59 will be held from 6 to 10 July 2009 and, using the above timetable, agreed that the deadline for submissi on of application dossier s and related documents for consideration by MEPC 59 should be 19 December 2008.

4.4 The Group reconfirmed that its next meeting w ill take place from 30 June to 4 July 2008 to review the remaining three proposals received before the dead line of 21 July 2008 and agreed to tentatively schedule its 8th meeting from 16 to 20 February 2009 subject to the submission of the application dossiers in accordance with the deadline agreed in paragraph 4.3 above.

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

5.1 General review of the submissions

5.1.1 The Group noted that submissions for Basi c Approval had been received from Japan
and the Netherlands whilst a re-submission fo r Final Approval had been received from the Republic of Korea.

5.1.2 Once again, the Group noted that some submi ssions had not been presented in the clear and concise manner required to allow it to evaluate the applicant’s system in an efficient manner. As a result, the Group found it necessary to ask fo r a lot of clarifications from some of the applicants and, as a result, was ev aluating their responses as late as Friday of the meeting. It was
considered that this hindered the efficient working practice of the Group.

5.1.3 As a result, the Group requested MEPC to ur ge applicants and conc erned Administrations to note the Methodology and the requirements of Pro cedure (G9) so that th ey may construct their applications in an appropriate format before the submission.

5.1.4 The Group recalled that the Admi nistration is expected to revi ew any application prior to its submission to IMO (G9 8.1.2.3). However, the Group noted that so me of the applications had neither a complete dataset nor test results with adequate Quality Control and Quality Assurance. As a result, the Group requested to MEPC to urge Administration to recall their position and tasks under Procedure (G9) and to ma nage the application accordingly.GESAMP-BWWG 6/9 - 10 -

I:\MEPC\58\2-7.doc 5.1.5 In addition, MEPC was requested to convey to future applicants that the Group might not be able to complete its evaluation if the data are not complete and presented in a clear and
concise manner.

5.2 Detailed review of the submissions

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

.1 Annex 5 Review of the ballast water management system using “TG Ballastcleaner and TG Environmentalguard” as Active Substances, submitted by Japan;

.2 Annex 6 Review of a combined ballast water management system consisting
of sediment removal and an electro lytic process using seawater to produce Active Substances (Greenship Ltd), submitted for Basic Approval by the Netherlands; and

.3 Annex 7 Review of the ballast water management system using Active Substance (Electro-Clean Electrolytic Disinfection), submitted by the Republic of Korea.

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

.1 Basic Approval be granted to the “TG Ballastcleaner and TG Environmentalguard” system submitted by Japan;

.2 Basic Approval be granted to the Greenship Ltd system submitted by the Netherlands; and

.3 Final Approval be granted to the Electro-Clean system submitted by the Republic of Korea.

6 FURTHER DEVELOPMENT OF THE METHODOLOGY FOR INFORMATION
GATHERING AND CONDUC T OF THE WORK

6.1 Having considered a number of submissions dur ing the course of the first five meetings, the Group recognized that most of the systems tended to produce the same chemical by-products
in the treated ballast water.

6.2 As a result, the Group agreed that it would facilitate both the repor ting and evaluation of systems if the toxicological, ecotoxicological da ta and appropriate physi cal properties for such
chemicals were collected into a database a nd made available to all IMO Member States.

6.3 It was recognized that such an approach would allow the Predicted No Effect Concentrations (PNEC) of these chemicals to be used by all applicants, which would provide a consistent approach.

6.4 In addition, the Group rec ognized that the calculation of Predicted Environmental Concentrations (PEC) for those chemical by-pr oducts generated by the various systems have been generated by different models or by one model using different input parameters. In order to have a uniform approach to the generation of PECs , the Group agreed that it would be preferable to use one model with the same basic parameters in order to make comparisons of the results more meaningful.- 11 - GESAMP-BWWG 6/9

I:\MEPC\58\2-7.doc 6.5 Notwithstanding these observations, the Group recognized that each applicant would still be required to provide full chemical analysis of the chemicals produced in the ballast.

6.6 It was also agreed that fu ll mammalian toxicity data profile s for all of these chemicals would also be provided wher e data were available.

6.7 As a result, the Group requested MEPC to agr ee that this approach would facilitate the evaluation process and instruct the Secr etariat to generate such a database.

7 ANY OTHER BUSINESS

7.1 Having considered several general issues th at resulted from the review of the three specific applications for approva l of ballast water management systems, the Group recognized
the need to have time to consider mo re general aspects of the process.

7.2 As a result, the Group requested MEPC to ag ree that the Group shoul d meet for two days
in order to have the time to disc uss such issues without the pressu re of having to review specific
submissions.

8 CONSIDERATION AND ADOPTION OF THE REPORT

8.1 A draft report of the 6th meeti ng of the GESAMP-BWWG was produced on 23 May 2008, and, after a paragraph-by-paragraph 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.

8.2 In his closing remarks, Mr. M Palomares, Director, Marine Environment Division, acknowledged the hard work of the Group and congra tulated its member s for the results achieved. He also appreciated the work done on the Methodology for info rmation gathering
and conduct of work of the GESAMP-BWWG indicating that the Methodo logy will be
disseminated as an IMO technica l circular. With regard to the toxicity and hazards database proposed by the Group, Mr. Palomares informed that all the possibilities for developing such a tool will be explored and furt her advice will be sought from the Committee on this particular matter. A detailed briefing on the outcome of the recent annual meeting of GESAMP was provided by Mr. Palomares in his concluding re marks when he emphasized the need to expand the membership of the Group and to create a pool of experts to call upon as and when required.

8.3 The Chairman expressed his appreciation fo r the long hours and substantial efforts made by the members of the Group throughout the w eek and closed the meeting at 17 h 30.

***GESAMP-BWWG 6/9

I:\MEPC\58\2-7.DOC ANNEX 1

LIST OF MEMBERS WHO ATTENDED THE SIXTH SESSION
OF THE GESAMP-BWWG

Mr. Jan Linders (Chairman)
Senior Risk Assessor
National Institute for Public Health and Environment Expert Centre on Substances
Anthonie van Leeuwenhoeklaan 9

RIVM-SEC
P.O. Box 1
NL-3720 BA Bilthoven
The Netherlands E-mail:
Tel:

Fax: jan.linders@rivm.nl

+31 30 274 3164
+31 30 274 4401

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

+351 2 1843 0599
+351 9 1779 8048

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

Fax:
Mobile: egil.dragsund@dnv.com

+47 6757 8894
+47 6757 9911
+47 9702 6956

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

1-15-16 Toranomon
Minato-ku Tokyo 105-0001 Japan E-mail:
Tel:

Fax: s-hanayama@sof.or.jp

+81 3 3502 1886
+81 3 3502 2033

Ms. Annette Kronborg
Director Adalia Toxicology Consultants Runslingan 3E SE-187 72 TÄBY

Sweden E-mail:
Tel:

Fax:
Mobile: annette.kronborg@adalia.se

+46 8 510 149 36
+46 8 510 126 02
+46 70 483 11 23GESAMP-BWWG 6/9

ANNEX 1 Page 2

I:\MEPC\58\2-7.doc Dr. Brigitte Behrends
Marine Environment Chemist
Marena Ltd.

St. Annenstr. 27

Jever
D-26441 Germany E-mail:

Tel:
Mobile: brigitte.behrends@ belugagroup.com +49 (0) 4461 984 098 +49 (0) 16 2244 3484

Mr. Edward Lemieux Section Head, Corrosion Engineering, Code

6136 Centre for Corrosion Science & Engineering Naval Research Laboratory Key West, Florida

USA E-mail:
Tel:

Fax:
Mobile: edward.lemieux@nrl.navy.mil

+1-305-293-4214
+1-305-293-4217
+1-240-475-6918

Mr. David Tongue Marine Manager International Chamber of Shipping
12 Carthusian Street
London EC1M 6EZ United Kingdom E-mail:
Tel:

Fax:
Mobile David.tongue@marisec.org

+44 20 7417 2860
+44 20 7417 8877
+44 78 5539 1258

IMO-GESAMP CONSULTANT

Mr. John Crayford
2 Dunmow Hill
Fleet Hampshire

GU51 3AN United Kingdom E-mail:
Tel:
Mobile: j.crayford@ntlworld.com +44 (0)1252 672245 +44 (0)795 0894 244

GESAMP

Mr. Fredrik Haag
GESAMP Officer
Marine Environment Division International Maritime Organization
4 Albert Embankment
London SE1 7SR United Kingdom E-mail:
Tel:

Fax: fhaag@imo.org +44 (0)20 7463 4139 (Direct) +44 (0)20 7587 3210GESAMP-BWWG 6/9

ANNEX 1 Page 3

I:\MEPC\58\2-7.doc IMO SECRETARIAT

Mr. Dandu Pughiuc IMO Technical Secretary to GESAMP-BWWG
Marine Environment Division International Maritime Organization
4 Albert Embankment
London SE1 7SR United Kingdom E-mail:
Tel:

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

Mr. René Coenen IMO Technical Secretary to GESAMP
Marine Environment Division International Maritime Organization
4 Albert Embankment
London SE1 7SR United Kingdom E-mail:
Tel:

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

Mr. Huang Tianbing Technical Officer, Marine Biosafety Section
Marine Environment Division International Maritime Organization
4 Albert Embankment
London SE1 7SR United Kingdom E-mail:
Tel:

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

***GESAMP-BWWG 6/9

I:\MEPC\58\2-7.DOC ANNEX 2

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

1 Introduction

2 Issues of confidentiality

3 Outcome of MEPC 57 and BLG 12

4 Terms of reference and time frame

5 Review of proposals for a pproval of Active Substances

6 Further development of the Methodology for information gathering and
conduct of work

7 Any other business

8 Consideration and adoption of the report

***GESAMP-BWWG 6/9

I:\MEPC\58\2-7.DOC ANNEX 3

TERMS OF REFERENCE FOR THE TECHNICAL GROUP (GESAMP-BWWG)

1 Consideration of developmen t of necessary methodologies and information requirements

in accordance with G9 ∗ for consideration by MEPC 58.

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

In particular, the Group should undertake:

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

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

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

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

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

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

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

3 For Final Approval, the Gr oup should review the discharg e testing (field) data and
confirm that the residual toxi city of the discharge conforms to the evaluation undertaken for Basic Approval and that the previous eval uation of the risks to the ship and personnel including consideration of the st orage, handling and application of the active substance remains valid. The evaluation will be reported to MEPC (see paragraph 8.2 of G9).

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

***

∗ G9 stands equivalent for the Procedure for approval of ballast water management systems that make use of Active Substances (G9), adopted by resolution MEPC.126(53).GESAMP-BWWG 6/9

I:\MEPC\58\2-7.DOC ANNEX 4

METHODOLOGY FOR INFORMATION GATHERING AND THE
CONDUCT OF WORK OF GESAMP-BWWG (Updated 23 May 2008)

Page

1 INTRODUCTION................................................................................................... 4
1.1 Terms and definitions.............................................................................. 4
1.2 Abbreviations used in the text................................................................. 5

2 GENERAL............................................................................................................... 7 2.1 Legal provision......................................................................................... 7 2.2 Principles of acceptability of BWMS that make use of Active
Substances........

.................. ................. ................ ............... ............... ............ 7 2.3 Submission of an application for Basic Approval................................. 7 2.4 Confidentiality and data protection........................................................ 8
2.5 Test methods............................................................................................. 9
2.6 Altern atives to testing and non-submission of data.......... ....................... 10
2.7 Additional Data ....................................................................................... 10

3 APPLICATION DATA SET ................................................................................. 10
3.1 General ............................................................................ 10
3.2 Identification of the Substance or Preparation (G9: 4.1).................... 11
3.2.1 Preparations.................................................................................. 11
3.2.2 Active Substan ces.......................

............... .............. ................ ........ 11
3.2.3 Relevant Chemicals (G9: 2.1.4).................................................. 12
3.2.4 Other Chemicals........................................................................... 12 3.3 Data on effects on aquatic plan ts, invertebrates and fish, and other biota, including sensitiv e and representative organisms (G9: 4.2.1.1).............................................................................................. 12
3.3.2 Acute aquatic toxicity................................................................... 12
3.3.3 Chronic aquatic toxicity............................................................... 13
3.3.4 Endocrine disruption................................................................... 13
3.3.5 Sediment toxicity.......................................................................... 13
3.3.6 Bioavailability/biomagnification/bioconcentration................... 14
3.3.7 Food web/population effects........................................................ 14 3.4 Data on mammalian toxicity (G9: 4.2.1.2)............................................ 15
3.4.1
3.4.2 General.................................................................... Acute toxicity................................................................................ 15
15
3.4.3 Effects on skin and eye................................................................. 15
3.4.4 Repeated-dose toxicity................................................................. 16
3.4.5 Chronic toxicity............................................................................ 16
3.4.6 Developmental and repro ductive toxicity.................................. 17
3.4.7 Carcinogenicity............................................................................. 17
3.4.8 Mutagenicity/genotoxicity........................................................... 17
3.4.9 Toxicokinetics............................................................................... 18GESAMP-BWWG 6/9

ANNEX 4 Page 2

I:\MEPC\58\2-7.doc 3.5 Data on environmental fate and effect under aerobic and anaerobic conditions (G9: 4.2.1.3)......................................................... 18
3.5.1
3.5.2 General.................................................................... Modes of degradation (biotic; abiotic)....................................... 18
18
3.5.3 Bioaccumulation, partition coeffi cient, octanol/water partition
coefficient.............

.................. .................. ............... ............... ........... 19
3.5.4 Persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh waters)......... 20
3.5.5 Reaction with organic matter...................................................... 20
3.5.6 Potential physical effects on w ildlife and benthic habitats....... 20
3.5.7 Potential residues in seafood....................................................... 21
3.5.8 Any known interactive effects..................................................... 21 3.6 Physical and chemical propertie s for the Active Substances and preparations and treated ballast wa ter, if applicable (G9: 4.2.1.4).... 21
3.6.2 Melting point................................................................................. 21
3.6.3 Boiling point.................................................................................. 21
3.6.4 Flammability (flash point)........................................................... 21
3.6.5 Density (relative density)............................................................. 22
3.6.6 Vapour pressure, vapour density................................................ 22
3.6.7 Water solubility/dissociation constant........................................ 22
3.6.8 Oxidation/reduction potential..................................................... 22
3.6.9 Corrosivity to the materials or equipment of normal ship
construction................................................................................... 22
3.6.10 Auto-ignition temperature........................................................... 22
3.6.11 Explosive properties..................................................................... 23
3.6.12 Oxidizing properties..................................................................... 23
3.6.13 Surface tension.............................................................................. 23
3.6.14 Viscosity......................................................................................... 23
3.6.15 Thermal stability and identity of relevant breakdown products......................................................................................... 23
3.6.16 Reactivity towards container material....................................... 23
3.6.17 pH................................................................................................... 23
3.6.18 Salinity........................................................................................... 23
3.6.19 TOC, DOC, % particulate matter.............................................. 24
3.6.20 Other known relevant physical or chemical hazards................ 24 3.7 Analytical methods at environmentally relevant concentrations (G9: 4.2.1.5).......................................................................................................... 24

4 USE OF THE ACTIVE SUBSTANCE OR THE PREPARATION................... 24 4.1 The manner of application...................................................................... 24

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7)........................................... 25

6 RISK CHARACTERIZATION............................................................................. 25 6.1 Screening for persistence, bi oaccumulation and toxicity (G9: 5.1).................................................................................................... 25
6.1.1 Persistence (G9: 5.1.1.1).............................................................. 25
6.1.2 Bioaccumulation (G9: 5.1.1.2).................................................... 26
6.1.3 Toxicity tests (G9: 5.1.2.3).......................................................... 26GESAMP-BWWG 6/9

ANNEX 4 Page 3

I:\MEPC\58\2-7.doc 6.1.4 Does the Active Substance and/or preparation meet all
three criteria for PBT?................................................................ 26 6.2 Evaluation of the treated ballast water (G9: 5.2)................................. 26
6.2.1 Basic Approval.............................................................................. 27
6.2.2 Final Approval.............................................................................. 27
6.2.3 Determination of holding time.................................................... 27 6.3 Risk characterization and analysis......................................................... 27
6.3.1 Reaction with organic matter (see G9: 4.2.1.3; this report 3.5.5).............................................. 27
6.3.2 Characterization of degradation route and rate (G9: 5.3.5)... 27
6.3.3 Prediction of discharge and environmental concentrations..... 27
6.3.4 Assessment of potential for bioaccumulation............................ 28
6.3.5 Effects assessment........................................................................ 28
6.3.6 Effects on aquatic organisms....................................................... 28
6.3.7 Effects on sediment....................................................................... 29
6.3.8 Comparison of effect assessmen t with discharge toxicity......... 30

7 RISK ASSESSMENT.............................................................................................. 30 7.1 Risk to safety of ship................................................................................ 30
7.2 Risks to human health.............................................................................. 30
7.2.2 Health effects in humans............................................... 31
7.2.3 Human Exposure Scenario............................................ 31 7.3 Risks to the aquatic environment........................................................... 32

8 ASSESSMENT REPORT (G9: 4.3)...................................................................... 32

9 MODIFICATION TO THE APPLICATION...................................................... 33

10 FINAL APPROVAL............................................................................................... 33

APPENDIX 1 – KEY DATA SUMMARY FORM FOR GESAMP- BWWG
TECHNICAL EVALUATION OF BALLAST WATER
MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE
SUBSTANCES TO COMPLY WITH THE CONVENTION....... 35

APPENDIX 2 – HUMAN EXPOSURE ASSESSMENT................................... 41GESAMP-BWWG 6/9

ANNEX 4 Page 4

I:\MEPC\58\2-7.doc 1 INTRODUCTION

This document contains the Methodology for info rmation gathering and the conduct of work of the GESAMP-BWWG when undertaking techni cal evaluations in accordance with the “Procedure for the approval of ballast water management systems that make use of Active Substances (G9)”, as revise d (adopted by resolution MEPC.169(57)).

1.1 Terms and definitions

For the purpose of this paper, th ese definitions are intended to supplement those in the Ballast Water Management Convention to facilitate a consistent evaluation of submissions:

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

.2 Ballast Water Management means mechanical, physical, chemical and biological processes – either singularly or in combination – 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 on board for purposes of ballast water management and any relevant chemicals formed in the ballast water management system that makes 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 Relevant Chemicals, produced during the
treatment of ballast water.

.6 Relevant Chemicals means transformation or reacti on products that are produced during and after employment of the ballast water management system in the ballast water or in the receiving environm ent and that may be of concern to the ship’s safety, aquatic environment and/or human health.

.7 Basic Approval means the preliminary approval of Active Substances and the ballast water management system that uses them in order to comply with the Ballast Water Management Convention. Ba sic Approval should confirm that the available information does not indicate possible unacceptable adverse effects or a potential for unreasonable risk to envi ronment, human health, property or
resources. This should include considerati on of potential risks associated with the Active Substance during full-scale deployment on commercial ships when possible.GESAMP-BWWG 6/9

ANNEX 4 Page 5

I:\MEPC\58\2-7.doc .8 Final Approval means the approval of a ballast water management system using an Active Substance or Preparation to co mply with the Convention and includes a review of the Type Approval tests in accordance with Guidelines for approval of ballast water management systems (G 8). The review does not include the re-evaluation of efficacy te sting results conducted by Administrations under the Guidelines (G8). The Final Approval should confirm that previous evaluations of risks to ship, crew and the envir onment including storage, handling and application of Active Substances or Prep arations remain valid and the concerns expressed during the Basic Approval process have been addressed, as well as that the residual toxicity of the discharge c onforms to the evaluation undertaken for Basic Approval. The risk evaluation at Final Approval should take qualitatively into account cumulative effects that may o ccur due to the nature of shipping and port operations. The uncertainties involved in the application for approval should be considered during the Final Appr oval process, and advice on how these
uncertainties can be dealt with should be provided as appropriate.

.9 GESAMP–Ballast Water Worki ng Group (GESAMP-BWWG) means the Technical Group consisting of independent experts acting intheir individual capacity that review the proposals for approval of ballast water management systems that make use of Active Substances submitted by the Administration and report, through GESAMP, to MEPC. Wh en reviewing the proposals the Group
should take acc ount of any other relevant data as well as other relevant information
submitted to it.

GESAMP is the IMO/FAO/UN ESCO-IOC/WMO//IAEA/UN/UNEP/UNIDO Joint Group of Experts on the Scientif ic Aspects of Marine Environmental Protection, an advisory and multi-disc iplinary body consisting of specialized experts nominated by the s ponsoring 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) DOC dissolved organic carbonGESAMP-BWWG 6/9

ANNEX 4 Page 6

I:\MEPC\58\2-7.doc

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), as revised, adopted by resolution MEPC.169(57) in April 2008.

h hour

IARC International Agency for Research on Cancer

IC 50 inhibition concentration, 50% ISO International Organization 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 Organization for Economic Co-operation and Development Organization the Internati onal Maritime Organization

POC particulate organic carbon Pow Octanol/water partition coefficient

TLV threshold limit value US EPA United States Environmental Protection Agency

WHO World Health Organization

Wt weightGESAMP-BWWG 6/9

ANNEX 4 Page 7

I:\MEPC\58\2-7.doc 2 GENERAL

2.1 Legal provision

2.1.1 Regulation D-3.2 of the International Conve ntion for the Control and Management of Ships’ 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 Marine E nvironment Protection Committee (MEPC) adopted the “Procedure for a pproval of ballast water management systems
that make use of Active Substances (G9)” through resolution MEPC.126(53). Resolution MEPC.169(57) revoked the initial Procedure and provide d a revised version of it.

2.2 Principles of acceptability of BWMS that make use of Active Substances

2.2.1 A ballast water management system that ma kes use of Active Substances accomplishes its intended purpose through action on harmful aquatic organisms and pathogens in ships’ ballast water and sediments. However, if the ballast water is still toxic at the time of discharge into the environment, the organisms in the receiving water may suffer unacceptable harm. Both the Active Substance itself or Preparation, as well as the treated ballast water, should be subjected to toxicity testing in order to determine if an Ac tive Substance or Preparat ion can be used and under which conditions the potential for harming the receiving environment or human health is acceptably low (G9: 3.2).

2.2.2 Any system which makes use of , or generates, Active Substa nces, Relevant Chemicals or free radicals during the treatment process to elim inate organisms in order to comply with the Convention should be subject to Procedure (G9) (G9: 3.3).

2.2.3 Ballast water management systems that make use of Active Substances and Preparations
must be safe in terms of the sh ip, its equipment and the personne l to comply with the Convention (G9: 3.4).

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) a nd the potential discharge of treat ed ballast water in accordance with the approval criteria sp ecified below (G9: 8.1.2.1). Upon co mpletion, the manufacturer should prepare an application dossi er for the ballast water manageme nt system that makes use of
Active Substances and submit it to the maritime Administration of a Member of the Organization. An application should only be made once the ballast water management system, Active Substance or Preparation has been sufficien tly designed, progressed and tested to provide the full data necessary for a Basic Approval (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. Administrations should check the quality and completeness of any Basic or Final Approval submission, against the latest version of the Methodology for information gathering and the conduct work of the Technical Group agreed by the Organization, prior to its s ubmission to the MEPC (G9: 3.6).GESAMP-BWWG 6/9

ANNEX 4 Page 8

I:\MEPC\58\2-7.doc 2.3.3 Applications for Basic Approval of the ba llast water management system, associated with Active Substances, to be evaluated by the GESAMP-BWWG should be addressed to: Marine Environment Division, International Ma ritime Organization, 4 Albert Embankment, London SE1 7SR, United Kingdom.

2.3.4 Application contents:

.1 a complete application dossier including all documents identified in this paragraph (one paper version), including full study re ports and full copies of literature. The complete application dossier should contain a contents list indicating the location of the information in the applica tion. The order in which the information is presented, including overall structure su ch as how information is presented for the Active Substance, preparation, ballast water, risk assessment, assessment report, should follow this format, including its numbe ring, which is based on Procedure (G9);

.2 a non-confidential summary document, whic h would be circulated as an MEPC document to provide an overview of th e application (electronic version);

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

.4 the assessment report (e lectronic version); and

.5 dossiers already used for regi stration of chemicals can be used to satisfy the data provisions of Procedur e (G9) (G9: 4.2.5).

2.4 Confidentiality and data protection

The confidential information of the submitted documents should clearly be identified.
All information related to sa fety and environmental protec tion, including physical/chemical properties, environmental fate and toxicity, should be treate d as non-confidential (G9: 8.1.1). 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 Substan ce(s) in the prepara tions and the name of the preparation;

.4 the names of other components of prepar ations, in particul ar 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;GESAMP-BWWG 6/9

ANNEX 4 Page 9

I:\MEPC\58\2-7.doc .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 conducted pursuant to section 4.2 of the Procedure (G9) to establish the effects of the substance(s) or preparation(s) on humans and the environment;

.8 a summary of the results of the test s conducted on the treated ballast water pursuant to section 5.2 of Procedure (G9);

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

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

.11 Safety Data Sheets;

.12 methods of chemical analysis;

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

.14 procedures to be fo llowed and measures to be taken in the case of spilla ge or leakage;

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

.16 all results of the Persistence, Bioacc umulation and Toxic (PBT) assessment and the risk characterization pur suant to sections 5.1 and 5.3 of Procedure (G9); and

.17 the uncertainty analysis specified in paragraph 6.4.3 of Procedure (G9).

2.5 Test methods

2.5.1 Tests should be carried out under internationa lly recognized guidelines (preferably OECD or equivalent) (G9: 4.2.3), and according to an internationally recognized qual ity assurance system (G9: 4.2.4) (e.g., Good Laboratory Practice (GLP)). Information may 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 th e GESAMP-BWWG to c onduct a thorough risk

assessment.

2.5.3 Many substances have acquired large databa ses for many of the hazards concerned and a weight of evidence approach has become necessary to ensure that the ra ting reflects the body of data rather than simply using the most conserva tive value. This, however, means the submission of all available end-point data for Active Substa nces and Relevant Chemicals is necessary to enable a thorough review.GESAMP-BWWG 6/9

ANNEX 4 Page 10

I:\MEPC\58\2-7.doc 2.5.4 A list of test substances (for example, trade names) specified in study reports and literature data and an explanation of how the test ed substances relate to the current application should be provided.

2.6 Alternatives to testing and non-submission of data

2.6.1 Alternative methods to test ing on live organisms, e.g., in vitro testing methods, Quantitative structure-activity relationship (QSAR), extrapolation by analogy to known chemicals, or grouping of similar substan ces, may be used whenever justified.
Sufficient documentation or references to docum entation on the validity of the method should be provided, as well as documentation th at the substance or preparation lies within the applicability
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 al l proposed risk management measures, need not be supplied. The same applies where it is not scientifically necessary or technicall y possible to supply the information. In such cases, a justificati on should be submitted, which would help the
GESAMP BWWG’s evaluation of the application dossier.

2.7 Additional data

2.7.1 If, in the course of the review by th e GESAMP-BWWG, it becomes evident that additional data are found to be necessary in order to finalize the evaluation, the Group may request that such data are submitted.

2.7.2 It may be useful for a tech nical representative of the a pplicant to be available to
the GESAMP-BWWG for an hour or so to answer questions regarding the system.

3.0 APPLICATION DATA SET

3.1 General

3.1.1 The dossier should contain the information sp ecified in Procedure (G9). In cases where information requested in accordance with Procedure (G9) has not been submitted and no justification for non-submission is provided, the GESAMP-BWWG may not be able to judge the reasons for not submitting the information that ma y influence its evaluation and development of
recommendations.

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

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

3.1.4 For treated ballast water, the Administration should provide both 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 te st species (fish, invertebrate, algae) that address the sensitive life stage (G9: 5.2.4). The results should incl ude acute LC50 values andGESAMP-BWWG 6/9

ANNEX 4 Page 11

I:\MEPC\58\2-7.doc chronic NOECs (G9: 5.2.5). Therefore, 100% con centrations of samples of ballast water discharge should be tested (G9: 5.2.6), if appropriate.

3.1.5 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 recognized test me thod may also be used as well.

3.2 Identification of the Substa nce or Preparation (G9: 4.1)

3.2.1 Preparations: For each Preparation, the applic ation should include the following information (G9: 4.2.2):

.1 the Trade name;

.2 compositional information of the Preparation including:

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

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

.3 the CAS number of each component;

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

.5 an indication of whether the compone nt is an Active Substance (AS) or a
stabilizer or inhibito r or solvent, etc.

3.2.2 Active Substances: 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 and identification of impurities (chemical name and CAS-numbers, etc.); and

.10 the identity of any stabil izers or necessary additives.GESAMP-BWWG 6/9

ANNEX 4 Page 12

I:\MEPC\58\2-7.doc 3.2.3 Relevant Chemicals (G9: 2.1.4): Where the process might produce by-products when reacting with ballast water, the applicant shou ld provide the following information for those products deemed to be Relevant Chemicals:

.1 the Chemical (IUPAC) name;

.2 the CAS number;

.3 the Molar mass;

.4 the empirical formula;

.5 the structural formula; and

.6 the classification in accordance with the GHS system.

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

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

3.3.1 For every Active Substance or Preparation including 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.

3.3.2 Acute aquatic toxicity

3.3.2.1 Short-term L(E)Cx from freshwater or saltwater representatives of three taxonomic groups (algae, crustaceans and fish) representing three trophic levels (e.g., OECD guidelines 201 (Algae, Growth Inhibition Test), 20 2 (Daphnia sp. Acute Immobilization Test), 203 (Fish, Acute Toxi city Test), Mysid shrimp acute toxicity test (USEPA 850.1035) should be accepted. To reduce further any remaining uncertainty, Administrations should, preferabl y, also submit data for two a dditional marine taxonomic groups (e.g., echinoderms, molluscs).

3.3.2.2 In the case of whole effluent testing, US EPA or equivalent, short-term methods for estimating the acute toxicity of substances and discharge provide acceptable alternatives.

3.3.2.3 Such acute aquatic toxicity data should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water (G9: 5.2.3).GESAMP-BWWG 6/9

ANNEX 4 Page 13

I:\MEPC\58\2-7.doc 3.3.3 Chronic aquatic toxicity

3.3.3.1 Long-term NOECs or ECx from three fres hwater 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).

3.3.3.2 In case of whole efflue nt testing, US EPA short-term methods for estimating the chronic toxicity of substances and discha rge provide acceptable alternatives , since the identification of the sensitive sub-lethal endpoints and vulnerable life-sta ges is the ultimate aim of the long-term testing.

3.3.3.3 Such chronic aquatic toxicity data should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water (fish, i nvertebrate, plant) (G9: 5.2.3).

3.3.4 Endocrine disruption

3.3.4.1 Regarding the risks connected to endocrine disruption, non-standardized in vivo as well

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

3.3.4.2 Such information on endocrine disruption should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.3.5 Sediment toxicity

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

3.3.5.2 For substances that are persistent in mari ne waters or may accumulate in sediments, a specific marine sediment assessment is necessary.GESAMP-BWWG 6/9

ANNEX 4 Page 14

I:\MEPC\58\2-7.doc 3.3.5.3 Such information on sediment toxicity should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.3.6 Bioavailability/biomagnification/bioconcentration

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

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

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

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

3.3.6.2 Such information on bioavailability/b iomagnification/bioconcentration should be provided for :

.1 Active Substances;

.2 Any components of a preparation; and

.3 Relevant Chemicals.

3.3.7 Food web/population effects

3.3.7.1 The biomagnification and persistence in the food web should be discussed based on the results from aquatic toxicity testing, mamma lian toxicity evaluation and bioaccumulation and biodegradation data.

3.3.7.2 An assessment of secondary poisoning is redundant if for the substance of concern absence of bioaccumulation potential can be dem onstrated (BCF <500 L/kg wet weight for the whole organism at 6% fat). If not, testing should include:

.1 one long-term NOECs based on reproducti on studies with a bird species; andGESAMP-BWWG 6/9

ANNEX 4 Page 15

I:\MEPC\58\2-7.doc .2 two NOECs from long-term studies with two mamm alian species (from section 3.4 below).

3.3.7.3 Such information related to the food we b/population effects should be provided for:

.1 Active substances; and

.2 Relevant Chemicals.

3.4 Data on mammalian toxicity (G9: 4.2.1.2)

3.4.1 General

3.4.1.1 Information that is deemed to be unnecessa ry need not be supplie d. 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 assessment of hazards and risks to humans. Such alternative information may be obtained by validated in vitro methods, Quantitative Structure Activity Relationships (QSAR), and grouping or read-acros s with similar substances. If available, human experience or epidemiologi cal evidence should be presented and discussed.

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

3.4.2 Acute toxicity

3.4.2.1 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.

3.4.2.2 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 applica tion of the substance/products.

3.4.2.3 Such information on acute toxi city should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.4.3 Effects on skin and eye

3.4.3.1 The tests should provide information on the degree and nature of skin, eye and associated mucous membrane irritation, especially with regard to the reve rsibility of responses. The tests should provide sufficient information to assess the potential to ca use skin sensitization reactions. Animal testing should, whenever possibl e, be minimized. Tests should be performed with the Active Substance(s) or Preparation(s).GESAMP-BWWG 6/9

ANNEX 4 Page 16

I:\MEPC\58\2-7.doc 3.4.3.2 Testing of Active Substances or Prepar ation should include a study on acute dermal irritation/corrosion and a study on acute eye irritation/corrosion. The recommended tests are OECD guidelines 404 (Acute De rmal Irritation/Corrosion) and 405 (Acute Eye Irritation/Corrosion). These tests need not be carried out on a strong acid or base (pH below 2 or above 11.5). Where the Active Substance or Preparation has shown to have potentially corrosive properties, or is a severe skin irritant, an eye irritation test should not be
carried out. Results from in vitro test methods, which are clos e to validation by recognized organizations, may be submitted.

3.4.3.3 The recommended test for Skin Sensiti zation is OECD guide line 406. While the guinea-pig Maximization test is co nsidered to be the preferred adjuvant technique 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 ot herwise known as a sensitizer.

3.4.3.4 Such information related to the effects on skin and eyes should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.4.4 Repeated-dose toxicity

3.4.4.1 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.

3.4.4.2 Such information on repeated dose toxicity should be provided for:

.1 Preparation including any of its components;

.2 Active Substance; and

.3 Relevant Chemicals.

3.4.5 Chronic toxicity

3.4.5.1 There is a need for a chronic toxicity study of a minimum dur ation of 12 months in two species – one rodent and another ma mmalian species – unless a full justification demonstrates that this test is not necessary.

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

3.4.5.3 Such information on chronic t oxicity should be provided for:

.1 Preparation including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.GESAMP-BWWG 6/9

ANNEX 4 Page 17

I:\MEPC\58\2-7.doc 3.4.6 Developmental and reproductive toxicity

3.4.6.1 Testing should include:

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

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

3.4.6.2 However, these key data can be modified (either reduced or accelerated or extended) and influenced by factors such as structural re lationships with a known reproductive t oxicant, the results of other toxicity studies (including toxicokinetics), con cerns for endocrine disruption and anticipated use, and human exposure patter ns. Such information on developmental and reproductive toxicity should be provided for:

.1 Preparation including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.4.7 Carcinogenicity

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

3.4.7.2 Such information on carcinogenicity should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.4.8 Mutagenicity/genotoxicity

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

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

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

3.4.8.2 Such information on mutagenicity an d genotoxicity should be provided for:

.1 Preparations including a ny of its components; and

.2 Active Substances; and

.3 Relevant Chemicals.GESAMP-BWWG 6/9

ANNEX 4 Page 18

I:\MEPC\58\2-7.doc 3.4.9 Toxicokinetics

3.4.9.1 Basic data on the toxicokinetics of Activ e Substances and other components of a preparation as well as Relevant Chemicals should be included. Information 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.

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

3.5.1 General

3.5.1.1 The rate and route of abiotic and biotic de gradation of the Active Substances, components of a preparation and Relevant Chemicals unde r aerobic and anaerobic conditions should be assessed, resulting in the identification of relevant metabolites in the relevant media (ballast water, marine and fresh waters) (G9: 5.3.4).

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

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

3.5.2 Modes of degradation (biotic; abiotic)

3.5.2.1 Testing should include:

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

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

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

.4 studies on rea dy biodegradability according to OECD guideline 301 (or equivalent guidelines) and OECD guideline 306 (or equivalent guidelines) if the Active Substance is discharged in to estuarine water (e.g., inland harbour with contact to seawater).

3.5.2.2 If the Active Substance is not readily biodegradable, then the following higher tier
studies should be conducted:GESAMP-BWWG 6/9

ANNEX 4 Page 19

I:\MEPC\58\2-7.doc .1 a study on aerobic and anaerobic transfor mation 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 content should be tested (see above);

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

.3 where relevant, a study on p hoto-transformation in water e.g., US EPA OPPTS 835.2210 (1998) and/or OECD Guidance document on photo-transformation in water (1997).

3.5.2.3 Such information on the modes of degradation should be provided for:

.1 Active Substances;

.2 any other components of preparations; and

.3 Relevant Chemicals.

3.5.3 Bioaccumulation, partition coefficient, octanol/water partition coefficient

3.5.3.1 Testing should include:

.1 data on bioconcentration and biomagnificat ion, which have already been detailed earlier in this document;

.2 a study into the log Pow according to OE CD guideline 107 (Partition Coefficient (n-octanol/water): Shake Flask Method), OECD guideline 117 (Partition coefficient – n-octanol/water HPLC method) or equivalent test guidelines. For very hydrophobic compound s, a slow stirring method is appropriate (e.g., OECD 123 (Partition coe fficient – slow stirring method)); and

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

3.5.3.2 Such information on bioaccumulation and partition coefficients should be provided for:

.1 Active Substances;

.2 any other components of preparations; and

.3 Relevant Chemicals.GESAMP-BWWG 6/9

ANNEX 4 Page 20

I:\MEPC\58\2-7.doc 3.5.4 Persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh waters)

3.5.4.1 The route of degradation in the higher ti er simulation tests specified under section 3.5.2
of this document should be ch aracterized based on a mass balan ce, including mineralization and
formation of bound residues. Reaction or tr ansformation products formed that may be
considered as Relevant Chemicals should be identified.

3.5.4.2 Such information on persistence and metabolites should be provided for:

.1 Active Substances;

.2 any components of preparations; and

.3 Relevant Chemicals.

3.5.5 Reaction with organic matter

3.5.5.1 The reaction of radicals produced by the ac tion of Active Substances with organic matter should be addressed qualitati vely as to identify products of concern to the environment and, where possible, quantita tively as to identify envi ronmental concentrations.

3.5.5.2 Radical producing chemicals are capable of forming halogenated (chlorinated, brominated) hydrocarbons that ma y be of concern to environmental or human health, in the presence of organic matter. For these substances, the freely and otherwise reasonably available information should be presented and discusse d in relation to the proposed manner of application, since they are s ubject to the decision-making criteria.

3.5.5.3 Such information on the reaction with organic matter should be provided for:

.1 Active Substances; and

.2 Relevant Chemicals.

3.5.6 Potential physical effects on wildlife and benthic habitats

3.5.6.1 Data requirements consist of physical-c hemical properties also required later. Further guidance can be found in the MEPC-approved hazard evaluation procedure published as GESAMP Reports and Studies No.64.

3.5.6.2 Such data on the potential physical effect s on wildlife and benthic habitats should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.GESAMP-BWWG 6/9

ANNEX 4 Page 21

I:\MEPC\58\2-7.doc 3.5.7 Potential residues in seafood

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

3.5.7.2 Such data on potential residues in seafood should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.5.8 Any known interactive effects

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

3.5.8.2 Such information on known interact ive effects should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

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

3.6.1 Data should be submitted for the Active S ubstances, 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.

3.6.2 Melting point: Data on the melting point should be provided for:

.1 Preparations including a ny of its components; and

.2 Active substances.

3.6.3 Boiling point: Data on the boiling point should be provided for:

.1 Preparations including a ny of its components; and

.2 Active Substances.

3.6.4 Flammability (flash point): Data on the flash point should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; andGESAMP-BWWG 6/9

ANNEX 4 Page 22

I:\MEPC\58\2-7.doc .3 Relevant Chemicals.

3.6.5 Density (relative density): Data on the density should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Treated ballast water.

3.6.6 Vapour pressure, vapour density: Data on the vapour pre ssure and vapour density should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.6.7 Water solubility/dissociation constant: Data on the water solubility and dissociation constants should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.6.8 Oxidation/reduction potential: Data on the oxidation/reduction potentials should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.6.9 Corrosivity to the materials or equi pment of normal ship construction: Data on the corrosivity to materials of cons truction should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.6.10 Auto-ignition temperature: Data on the auto-ignition temp erature should be provided
for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.GESAMP-BWWG 6/9

ANNEX 4 Page 23

I:\MEPC\58\2-7.doc 3.6.11 Explosive properties: Data on the explosive properties should be provided for:

.1 Preparations;

.2 Active Substance; and

.3 Relevant Chemicals.

3.6.12 Oxidizing properties: Data on the oxidizing propertie s should be provided for:

.1 Preparations;

.2 Active Substances; and

.3 Relevant Chemicals.

3.6.13 Surface tension: Data on the surface tension should be provided for:

.1 Preparations; and

.2 Active Substances.

3.6.14 Viscosity: Data on the viscosity should be provided for:

.1 Preparations; and

.2 Active Substances.

3.6.15 Thermal stability and identity of relevant breakdown products: Data on thermal stability and identity of relevant br eakdown products should be provided for:

.1 Preparations including a ny of its components; and

.2 Active Substances.

3.6.16 Reactivity towards container material: Data on the reactivity towards container materials should be provided for:

.1 Preparations including any of its components;

.2 Active substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.6.17 pH: Data on the pH should be provided for:

.1 Preparations; and

.2 Treated ballast water.

3.6.18 Salinity: Data on the salinity should be provided for:

.1 Treated ballast water.GESAMP-BWWG 6/9

ANNEX 4 Page 24

I:\MEPC\58\2-7.doc 3.6.19 TOC, DOC, % particulate matter: Data on the TOC, DOC and % of particulate matter should be provided for:

.1 Treated ballast water.

3.6.20 Other known relevant physica l or chemical hazards: Data on the any other known relevant physical or chemical hazards should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

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

3.7.1 Recognizing that some methods may onl y cover a range of chemicals e.g., TRO, analytical methods at environmentally releva nt concentrations s hould be provided for:

.1 Preparations including 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 section 7 of Procedure (G9), the dossier shou ld 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 shoul d be provided, including quantity to be
added to ballast water and maximum c oncentration 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;GESAMP-BWWG 6/9

ANNEX 4 Page 25

I:\MEPC\58\2-7.doc .5 an indication of the possi bility of destruction or d econtamination following release in the marine environment;

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

.7 the possibility of reuse or recycling;

.8 the possibility of neutralization;

.9 conditions for controlled discharge; and

.10 the amount of substance on board 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 sy stem 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 DAT A SHEETS (G9: 4.2.7)

5.1 With respect to the classification of hazar ds, a detailed technical guidance document has been prepared for the United Nations Globall y Harmonized System of Classification and Labelling of Chemicals (GHS) to aid in interpreting data for classifying substances as dangerous. Reference is also made to the MEPC-approve d 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 Chemical s and other by-products produced by the system unless a cl ear justification is provided e.g., the half-life of the by-product
is so short that the hazards cannot be determine d. Key data for these should be summarized in the Key Data Summary Table.

6 RISK CHARACTERIZATION

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

6.1.1 Persistence (G9: 5.1.1.1)

6.1.1.1 Persistence is preferably assessed in simu lation test systems to determine the half-life under relevant conditions. Biodegradation screen ing tests may be used to show that the substances are readily biodegradable. The determination of the half-life should include
assessment of Relevant Chemicals.GESAMP-BWWG 6/9

ANNEX 4 Page 26

I:\MEPC\58\2-7.doc 6.1.1.2 For persistence and degradation data, se e sections 3.5.2 and 3.5.4 of this document.

6.1.2 Bioaccumulation (G9: 5.1.1.2)

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

For bioaccumulation data, see sections 3.3.6 and 3.5.3 of this document.

6.1.3 Toxicity tests (G9: 5.1.2.3)

6.1.3.1 Acute and/or chronic ecotoxicity data, id eally covering the sensitive life stages, should be used for the assessment of the toxicity criterion.

6.1.3.2 For ecotoxicity data, see section 3.3 of this document.

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

assessment.

6.1.4 Does the Active Substance and/or Prepar ation meet all three criteria for PBT?

See Procedure (G9): Table 1.

Criterion PBT criteria

Persistence Half-life: > 60 days in marine water, or > 40 days in fresh water, * 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 assessmen t half-life data in fresh water and freshwater sediment can be overruled by data obtained under marine conditions.

Active Substances or Preparations identified as PBT substances will not be recommended for approval in accordance with pa ragraph 6.4.1 of Procedure (G9).

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

The advantage of toxicity testing on the ballast wate r discharge is that it integrates and addresses the potential aquatic toxicity of the Active Substance, Preparation including any of its components and Relevant Chemicals formed during and after applic ation of the BWMS.GESAMP-BWWG 6/9

ANNEX 4 Page 27

I:\MEPC\58\2-7.doc 6.2.1 Basic Approval

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

6.2.1.2 A system using Active Substances or Prepar ations that have rece ived Basic Approval by the Organization may be used fo r evaluation of ballast water ma nagement systems using Active Substances or Preparations for Final Approval (G9: 8.2.1).

6.2.2 Final Approval

6.2.2.1 Toxicity tests with samples of ballast water treated with the BWMS down from the land-based test set-up should be conducted (G9: 5.2.1.2 and 5.2.3).

6.2.2.2 In accordance with regulation D-3.2, a ballast water management system using an Active Substance or Preparation to comply with the Convention (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-effect concentration upon discharge, i.e. the necessary dilution of the treated ballast water. The half-life, decay and dosage rates, system parameters and toxicity should be used to determine the amount of time needed to
hold the treated ballast water befo re discharge (G9: 5.2.7). An i ndication of the uncertainty of the holding time should be given, taking into acc ount variables (e.g., temp erature, pH, salinity and sediment loading).

6.3 Risk characterization and analysis

6.3.1 Reaction with organic matter (s ee G9: 4.2.1.3; this document: 3.5.5)

6.3.1.1 The reaction with organic matter of Active Substances and Preparations including any of its components should be addresse d qualitatively and quantitatively , so as to identify Relevant Chemicals that may be of c oncern to the environment.

6.3.2 Characterization of degradation route and rate (G9: 5.3.5)

6.3.2.1 The route and rate of abiotic and biot ic degradation of the Active Substances and Preparations, including any of its compone nts, under aerobic and anaerobic conditions (see 3.5.2 above) should be assessed, resulting in th e 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 s hould be predicted (G9: 5.3.8).GESAMP-BWWG 6/9

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I:\MEPC\58\2-7.doc 6.3.3.2 Environmental concentrations after discha rge of treated ballast water under controlled conditions during development and type approval tests should be estimated (e.g., by a suitable model simulating the test conditions) and provided in the application dossier for Basic Approval.
Concentrations of treated ball ast water, Active Substances, Relevant Chemicals and other components of Preparations, as a ppropriate, should be estimated.

6.3.3.3 Environmental concentrations, under suit able emission scenarios to be developed describing typical full-scale us e and discharge situations, s hould also be estimated for treated ballast water, Active Substances, Re levant Chemicals 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 components 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 prepared on secondary poisoning to mammalian and avian top-predators where relevant . Only toxicity studies reporti ng on dietary and oral exposure are relevant, as the pathway for secondary poi soning refers exclusively to the uptake of chemicals through the food chain. It might be n ecessary to extrapolate threshold levels for marine species from terrestrial species assumi ng there are interspecies correlations between laboratory bird species and ma rine predatory bird species and between laboratory mammals (e.g., rats) and the considerably larger marine predatory mammals . An assessment of secondary poisoning is redundant if the substance of con cern demonstrates a lack of bioaccumulation potential (e.g., BCF < 500 L/kg wet weight for the whole organism at 6% fat) (G9: 5.3.10).

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

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

6.3.6 Effects on aquatic organisms

6.3.6.1 For assessment of effects to the aquatic environment, appropriate Predicted No-Effect Concentrations (PNEC) should be derived. A PNEC is typically derived at a level that, when not exceeded, protects the aqua tic ecosystem against toxi c 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 short-term and/or long-term aqua tic toxicity results for relevant aquatic species by dividing the
lowest available effect concentration with an appropriate assessment f actor. For the aquatic effect assessment, the assessment factors, given in Table 2, should be gu iding although these may be altered on a case-by-case basis based on expe rt judgment. In case s where a comprehensiveGESAMP-BWWG 6/9

ANNEX 4 Page 29

I:\MEPC\58\2-7.doc data-set is available, the PNEC may be derive d with a mathematical model of the sensitivity distribution among species.

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

6.3.6.3 When aquatic toxicity data are available onl y for freshwater species but a PNEC for the marine environment (PNEC saltwater) is need ed, this may be derived by applying a higher
assessment factor than for the derivation of a PNEC fresh water to reflect the greater uncertainty in protecting sensitive species in saltwater enviro nments. 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 deriving PNECs for fresh water and saltwater

Assessment Factor Data-set PNEClong PNECshort

Freshwater assessment Lowest short-term L(E)C 50 from freshwater species representing three trophic levels 1000 10-100

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

Saltwater assessment Lowest short-term L(E)C 50 from marine species representing three trophic levels 1000 10-100

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

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

Lowest chronic NOEC from three freshwater or saltwater species 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 importa nt 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 meas ure long-term, sublethal endpoints. Only the latter tests are considered applicable to risk assessment because of the long-term exposure of benthic organisms to sediment-bound substances that occur under field c onditions. Due to the generally long-term exposure of benthic organi sms to sediment-bound substances, long-term tests with sub-lethal endpoints like reproduction, growth, emerge nce, sediment avoidance andGESAMP-BWWG 6/9

ANNEX 4 Page 30

I:\MEPC\58\2-7.doc burrowing activity are regarded as most relevant. It is recommended to use pooled marine and freshwater sediment toxicity data for effect asse ssment for the sediment compartment. However, when sufficient data for ecologically relevant sa ltwater species are available, lower assessment factors can be applied. Since there are no chronic marine se diment test methods that are internationally accepted, the results from any te sts should always be evaluated with caution.

Table 3 – Effect assessment for deriving PNECs for sediment

Data-set Assessment factor

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

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

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

6.3.8 Comparison of effect assessment with discharge toxicity

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

7 RISK ASSESSMENT

7.1 Risk to safety of ship

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

.1 increased corrosion;

.2 fire and explosion;

.3 storage and handling of the substances;

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

.5 noise.

7.2 Risks to human health

7.2.1 The human health risk assessment should follow generally accepted guidelines including acute and long-term exposure situations. The ri sk assessment should entail hazard identification and, as appropriate, dose (concentration) – re sponse (effect) assessment, exposure assessment and risk characterization. The population groups d eemed to be at risk a nd so to be examined should include crew, passengers and all personnel, including the public, in por ts. Potential health risks connected to the exposure of consumers vi a seafood or persons at the coast (e.g., beach)GESAMP-BWWG 6/9

ANNEX 4 Page 31

I:\MEPC\58\2-7.doc after discharge should be evaluated. Special attention shou ld be given to servic e and repair of the system by technicians and accidental situatio ns on board (e.g., specific personal protection equipment). The evaluation of the risks to human health should include risk reduction (risk management) by regulations based on the SO LAS 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.

7.2.2 Health effects in humans

7.2.2.1 The effect assessment of the Active Subs tances, Preparations and Relevant Chemicals should include a screening on carcinogenic, muta genic 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).

7.2.3 Human Exposure Scenario

7.2.3.1 A Human Exposure Scenario (HES) should be provided by the applicant as part of the risk assessment procedure for ballast water mana gement systems, using the guidance contained in appendix 2 of this document (G9: 6.3.3).

7.2.3.2 There are normally four stages when carrying a quantitative risk assessment:

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

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

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

.4 Risk characterization – how to qua ntify the risk from the above data?

7.2.3.3 The identification of “unit operations” in the whole BWM proce ss of each system is important to the understanding human exposures. Th e term “unit operation” is used in chemical process engineering to describe a basic st ep in a process. A chemical or other manufacturing/treatment process may have many unit operations. Occupational hygienists depend on knowledge of such unit operations to be able to determine exposure to chemicals involved in each step of a process. A simila r approach is proposed with regard to BWMS
evaluations.

7.2.3.4 The risk assessment should include a descri ption of the ballast wa ter treatment process associated with their system as a set of unit ope rations, i.e. in doing so, identifying clearly which individual system components of a BWMS are likely to lead to hu man exposure to Active Substances, Relevant Substances and by-pro ducts. For each system component, including connecting piping, a description of such exposures needs to be provided, e.g., chemical storage, chemical application, processing of treated ballast water, ball ast tank operations, including associated piping, as well as discharge operation s. The risk assessment should also include the risk reduction measures envisaged for all of the above-defined unit operations, i.e. stating clear Personal Protective Equipment requireme nts for each step in the process.GESAMP-BWWG 6/9

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I:\MEPC\58\2-7.doc 7.2.3.5 Maintenance, equipment failure and accident situations should be considered separately from conditions of normal operation.

7.3 Risks to the aquatic environment

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

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

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

7.3.4 The potential risks to the aquatic environm ent resulting from full-scale deployment on board ships and discharge of treated ballas t water under representative conditions should be
assessed. An Emission Scenario Do cument (ESD) should be provided by the applicant as part of the Risk Assessment procedure for ballast water management systems. The ESD should be based on the worst case discharge scenario and should be regarded as the first stage of a stepped approach to the development of a full ESD, when more data on potential discharges and technologies becomes available (G9: 6.4.4).

8 ASSESSMENT REPORT (G9: 4.3)

8.1 The Assessment report referred to in sec tion 4.3 of Procedure (G9) should at least provide:

.1 an overview of the data and endpoint s on which the risk characterization according to section 6 of Procedure (G9) 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., fisherie s) in accordance with section 6 of Procedure (G9);

.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;GESAMP-BWWG 6/9

ANNEX 4 Page 33

I:\MEPC\58\2-7.doc .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 Convention in question, the related adverse effects and the environmental concentrations, eith er observed or expected based on the risk assessment and the effluent testing;

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

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

9 MODIFICATION TO THE APPLICATION

9.1 Manufacturers should report an y modifications 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 acco rdingly (G9: 8.4.1).

9.2 Manufacturers intending to significantly change any part of a ballast water management system that has been approved by the Organization or the Active Substances and Preparations used in it should submit a new application (G9: 8.4.2).

10 FINAL APPROVAL

10.1 In accordance with paragraph 5.2.1 of Procedur e (G9) for Final Approval, the discharge testing should be performed as part of the land-bas ed type approval pro cess using the treated ballast water discharge.

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

.1 Basic Approval has to be given first;

.2 the Member of the Organization, submitting an application should conduct the Type Approval tests in accordance with Guidelines for approval of ballast water management systems (G8). The results s hould be conveyed to the Organization for
confirmation that the residual toxicity of the discharge conforms to the evaluation undertaken for Basic Approval. This would result in Final Approval of the ballast water management system in accordance with regulation D-3.2. Active Substances or Preparations that have re ceived 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);

.3 it is to be noted that from the Guide lines (G8) land-based te sting only the results of the residual toxicity tests should be included in the proposal for Final Approval in accordance with Procedure (G9). All othe r Guidelines (G8) testing remains for
the assessment and attention of the Administration. Although Basic Approval under Procedure (G9) should not be a pre -requisite of Type Approval testing, as an Administration can regu late discharges from its own ships in its ownGESAMP-BWWG 6/9

ANNEX 4 Page 34

I:\MEPC\58\2-7.doc jurisdiction. Basic Approva l would still be require d, and the specific technology
could not be used in vessels in anot her jurisdiction without Basic Approval (G9: 8.2.2);

.4 it should be noted that once a syst em has received Fi nal Approval under Procedure, then the respective applicant s hould not have to re trospectively submit new data if there is a change in th e Methodology agreed by the Organization (G9: 8.2.3);

.5 toxicity testing should be done on two t ypes of seawater at two appropriate time intervals after treatment (preferabl y immediately after treatment and after a 24 or 48 hours interval), and or ganisms normally found in the selected types of seawater should be us ed in the toxicity testing;

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

.7 in addition to the basic data set needed for the treated ballast water and the individual chemicals produced by the sy stem – as identified in the Methodology for Basic Approval – a generated meaningf ul PEC/PNEC ratio would be required for Final Approval; and

.8 the application for Final Approval shoul d reflect the concerns identified during consideration of Basic Approva l. This would mean that in some cases only acute toxicity testing would be needed for Fi nal Approval and in some cases chronic toxicity might be needed whilst in othe rs both acute and chronic data might be required.

* * *GESAMP-BWWG 6/9

ANNEX 4 Page 35

I:\MEPC\58\2-7.doc APPENDIX 1

KEY DATA SUMMARY FORM FOR GESAMP-BWWG TECHNICAL EVALUATION

OF BALLAST WATER MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE
SUBSTANCES TO COMPLY WITH THE CONVENTION

(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 a ppendix e.g., if the Summary Form includes an
Acute Oral LD 50 for a Rat, the appendix should include the complete list of values identified in
the literature from which this value was chosen 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-product s should be created unless a scientific explanation is pr ovided to justify not including them.

2 A chemical analysis should also be provi ded 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 treatmen t, 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 6/9

ANNEX 4 Page 36

I:\MEPC\58\2-7.doc Data on each component of the preparation and by-product produced in ballast water

Chemical Name

................................................................................................. Where the applicant considers that it is not necessary to complete the data form for a given chemical, a full justifica tion should be given (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 Algae

2.5 Bioavailability/Biomagnification/Bioconcentration

Log Pow Reference/Comments/Justification for missing data

BCFGESAMP-BWWG 6/9

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I:\MEPC\58\2-7.doc 2.6 Food Web/Population Effects

A description of potential food web and popul ation effects should be provided 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/4 h)

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 6/9

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I:\MEPC\58\2-7.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 EFFECT 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/C omments/Justification for missing data Log Pow

KocGESAMP-BWWG 6/9

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I:\MEPC\58\2-7.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-reduction potential Corrosivity to material or equipment Reactivity to container material Auto-ignition temperature (°C) Explosive properties Oxidizing properties

Surface tension Viscosity Thermal stability and identity of breakdown products Other physical or chemical propertiesGESAMP-BWWG 6/9

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I:\MEPC\58\2-7.doc 6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Con centration at environmentally Relevant
Concentrations

Method Applicability Sensitivity

Reference/Comments/Justification for missing data

6.2 Material Safety Data Sheet provided (Yes/No) ................................................

6.3 GHS Classification ..................................................................................

6.4 Risk Characterization

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

* * *GESAMP-BWWG 6/9

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I:\MEPC\58\2-7.doc APPENDIX 2

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 normally four stages when carrying a quantitative risk assessment:

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

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

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

.4 Risk characterization – how to qua ntify the risk from the above data.

1.3 The greatest part of information about the potential human toxic effects of chemical
substances is obtained from studies on animals.

1.4 In assessing an acceptable leve l of a particular substance, the procedure usually follows moving from an experiment database of animal or preferably human da ta (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= 1 mg/L x 2 L/day = 0.03 mg/kg/day 60 kgGESAMP-BWWG 6/9

ANNEX 4 Page 42

I:\MEPC\58\2-7.doc 2.3 The next step in the MOS approach is to derive and apply a so-called “reference MOS” (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 – between animals and hu mans – and 10 for intraspecies variability – among humans).

2.4 Example: taking into account the exposure value referred in 2.2. (0.03mg/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 co mparing to MOSref (100). Howe ver, if this value was much lower or lower than MOSref, it would indicate an inadequate MOS value over the NOAEL and an 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 “worst case” 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 working week – 8-hour day, 5 days per week;

.1.2 relatively healthy part of general population; and

.1.3 exposure routes: norma lly inhalation and dermal.GESAMP-BWWG 6/9

ANNEX 4 Page 43

I:\MEPC\58\2-7.doc .2 General public/Human exposure via environment – Users of coastal amenities,
beach coastlines and offshore installations and harbours:

.2.1 exposure intermittent – needs to be estimated;

.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 “is of concern”, 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 assessment should be made taking PPE (personal 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 “worst case” highlighted.GESAMP-BWWG 6/9

ANNEX 4 Page 44

I:\MEPC\58\2-7.doc 4.5 If “real” 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.

4.6 The following major factors can affect exposure potential:

.1 size of activity – the greater the quantity of the 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 – 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 time of exposure – the duration and frequency of exposure to an activity will also be a factor – 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 characterization phase these estim ates 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 6/9

ANNEX 4 Page 45

I:\MEPC\58\2-7.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 OCCUPATIONAL EXPOSURE QUESTIONS

6.1 Questions need to be addre ssed by the applicant in the Appl ication for Basic Approval of
a BWMS are as follows:

.1 What are the chemical substances/produc ts used/generated at the workplace and what is their physical-state (gas, liquid or solid) and concentration?

.2 Where and how the substances/products are used/generated at the workplace?

.3 By whom the substances/products will be directly used (primary exposure)?

.4 Description of the operator tasks, fre quency and duration at each operation unit – please include the relevant task s in the process flow chart.

.5 What are the expected measures to reduce worker exposure (PPE, RPE)?

.6 Who else may be exposed (secondary exposure)?

7 REFERENCES

.1 Chemical Risk Assessmen t – UNEP/IPCS, WHO, 1999; and

.2 Technical Guidance Document on Risk Assessment, European Chemicals Bureau (ECB) – Part I, European Communities, 2003.

***GESAMP-BWWG 6/9

I:\MEPC\58\2-7.DOC ANNEX 5

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

TG Ballastcleaner and TG Environmentalguard

Submitted for Basic Approval by Japan

0 SUMMARY

0.1 The Group noted that the TG Ballastcleaner /TG Environmentalguard system uses a combination of filtration and chemical treatment to treat the ballast water followed by further
chemical treatment to neutralize the Active Substance.

0.2 The Group noted that this system requires th e onboard storage of chem icals used in this system. To address the hazards associated w ith the release in the environment and human exposure, the Group used the highest concentra tion levels of the chemicals present in the
mixtures and therefore the outcome represented a worst-case scenario.

0.3 With the additional information received during the meeting of the GESAMP-BWWG, the Group was of the opinion that Basic Approval should be granted to the BMWS that makes use of TG Ballastwater and TG Environmentalguard submitted by Japan.

0.4 When applying for Final Approval in the fu ture the following subjects need to be addressed carefully:

.1 Considering corrosion, the Group agr eed that the applicant’s response was insufficient to quantitatively assess the corrosion impact to relevant metallic and non-metallic materials likely to be used in ballast water tanks, piping and fixtures. For non-metallic gasket materials, the applicant responded that tests were not started since they have sufficient information for suitable materials but no details or data were provide.

.2 The applicant should provide appropriat e QAs and QCs and indicate why there are
different detection limits for the same substance being analysed.

.3 Further measurement and analysis of discharge concentration of THMs and HAAs with adequate QA/QC should be taken durin g the full scale land- based test before the submission of final approval.

.4 The chemical analyses for THMs were not performed under adequate QAPPs and so recommended that all chemical measurement and analyses should be performed under QAPPs.

.5 Final Approval submission should provide full details of the dosing control arrangements so as to ensure certainty of maintaining specified dosage levels of
Active Substances.GESAMP-BWWG 6/9

ANNEX 5 Page 2

I:\MEPC\58\2-7.doc .6 The Group was satisfied that the fl ow diagram, provided, was suitable for Basic Approval. It is appreciated that fu rther details for evaluation be supplied for review during any Final Approval.

.7 The applicant indicated to continue gathering information related to the two chemicals, bromochloroacetic acid and bromodichloroacetic acid and, if no additional data were to be found, they would carry out further algal tests as required.

.8 The Group was satisfied that the applicant had given due preliminary
consideration to the concerns concerni ng temperature control put forward but requested that these safety mitigation m easures and requirements should be fully detailed in the operating manual pr esented for any Final Approval.

.9 Whilst recognizing the validity of the pressure monitoring/control, the Group
considered that further veri fication of this should be made during the ship board testing and included in the doc umentation for Final Approval.

.10 The Group is of the opinion that the acute toxicity testing for treated ballast water is needed and that the information for acute toxicity testing by simulated ballast water in a laboratory scal e and full scale land-based system for evaluation. In addition the Group requested that quantif ication analysis a nd degradation rates of sodium sulphite in various conditions should be carried out for the submission for Final Approval.

.11 The Group recommended that the follo wing human exposure information related
to TG BallastCleaner should be addressed:

.1 in advance identification of all leak ing points; these are to be considered critical points for the HSE (due to the corrosive properties of the preparation);

.2 foreseen safety measures for spills/ leaks in the waste wa ter collection tank;
and

.3 manual handheld (residual chlorine meter) measurements of residual
chlorine concentration in the waste water tank.

1 INTRODUCTION

1.1 The data used to evaluate th is system were extracted from that supplied by the Japanese document MEPC 57/2/8 which was supplemente d by additional confid ential information provided by the applicant. Further informati on was provided by the a pplicant in response to specific questions posed.

2 COMPLETENESS OF DOSSIER

2.1 The Group agreed that further informa tion should have been provided and so clarifications were requested. The queries (Q ) put to the applicant, its answers (A) and the Group’s reaction (R) are summarised in the rest of this section.GESAMP-BWWG 6/9

ANNEX 5 Page 3

I:\MEPC\58\2-7.doc 2.2 (Q) Corrosion – While several references are made within the dossier regarding the corrosiveness of the treatment the anticipated seve rity is not estimated. Mitigation measures of epoxy coatings or linings are also identified, but it is not clear what the corrosion rate within coatings defects or uncoated materials may be. Ar e there any quantitative test or literature data available which characterize the corrosivity of TG Ballast Cleaner on steel, galvanized steel, zinc anode materials used in cathodic prot ection systems or common gasket materials (e.g., EPDM rubber)?

2.2.1(A) In response to this question, the applicant stated that it had comp ared the differences of
corrosion under the seawater with and without s odium hypochlorite at the available chlorine concentration of 20 mg/L.

2.2.2 There were no differences between the epo xy coated steel and galvanized steel. For uncoated steel, there were some differences in the corrosion rates a nd we are continuing to collect the quantitative data. For coating defect , small differences were observed so far and we are still continuing to collect more data. For zi nc anode materials used in cathodic protection systems, we have not started the corrosion test yet but we will start the test to evaluate the effectiveness of the cathodic prot ection systems. For gasket mate rials we have not started the corrosion test yet, because we have enough information of the suitable materials for gasket even at higher concentration of sodium hypochlorite such as TG Ballastcleaner.

2.2.3 (R) With respect to the effect of TG Balla stCleaner on tank and pipe coatings, the Group considered the applicant’s response to be thorou gh since a substantive te st report was provided,
but that these results were onl y indicative of performance usi ng the proposed Active Substance
since the tests were conducted at a reduced concentration. The applicant did answer the Group’s query sufficiently regarding acceptable materials for Active substance storage and distribution piping. Finally, with respect to corrosion, the Group agreed that the applicant’s response was insufficient to quantitatively assess the corrosio n impact to relevant metallic and non-metallic materials likely to be used in ballast water tanks, piping and fixtures. For non-metallic gasket materials, the applicant responded that tests were not started since they have sufficient
information for suitable materials bu t no details or data were provide.

2.3 (Q) Representative concen tration of bromoform - The highest disc harge concentration for the Bromoform was measured during the early life stage toxic ity testing against Java Medaka (ref. 14-5(2)). During the same test period, the variation in the concentration was measured (ref. 14-5(1) and (ref. 14-5(3)). The Group c onsidered that the QA and number of samples analysed fell far short of a representative values for THMs and HAAs and so requested an explanation of why there was such a huge varia tion observed during the same toxicity testing period.

2.3.1 (A) The applicant stated that the certificated reference 14-5(2) clearly states that sampling timing was on 27th October and sample is moved to laboratory on 1st November.

2.3.2 (R) The Group concluded that as this sample was four days old, it was possible that volatile organic compounds such as THMs were not represen tative of the true con centrations which were expected to be higher and so as ked how can this old sample be regarded as representative? Furthermore the certification pape r does not include the procedur es for analysis methods, and storage conditions during the movement and repeat ability results. The applicant should provide appropriate QAs and QCs and in dicate why there are different detection limits for the same substance being analysed.GESAMP-BWWG 6/9

ANNEX 5 Page 4

I:\MEPC\58\2-7.doc 2.3.3 (A) In answering this que ry, the applicant stated:

.1 the variation of bromoform concentrations shown in Table 4-1-1 is possibly due to the differences in temperature as th e experiment was not conducted in the temperature controlled room, which may be e quivalent to the actua l ballast water. Furthermore, this experiment was inte nded to examine the toxicity of the simulated ballast water and the analysis of THMs is conducted as references. The reason why the concentrations of HAAs were not measured was that at the time of this experiment we did not pay attention to HAAs as referenced substances. If it is required, we are ready to conduct the experiments again and analyse HAAs along with more data for THMs formed in seawater from the Port of Oigawa, for example;

.2 for the storage condition, “Samples are s ealed after sodium sulphite is added, and are kept in a cool and dark place until quantitative analys is.” as stated in the note of Table 4-1-1 on page 67 of the “Report on Assessment”, which is in accordance with JIS K 0102, “Testing methods for i ndustrial wastewater” published by Japanese Industrial Standards Committee. Therefore, we consider THMs were preserved until analysis;

.3 the analysis method of THMs in th e Reference 14-4(1) was headspace GC with ECD. Since we failed to clarify as GC with ECD in this reference, we would
like to add this information at the time wh en we are allowed to apply for the final approval;

.4 the analysis method of THMs in the References 14-5(1), (2) and (3) was HS (Headspace)-GC/MS as stated in those test reports;

.5 regarding the QAs and QCs of these experiments they were conducted in accordance with the standard analysis methods of JWWA (Japan Water Works Association); and

.6 the differences in the Detection limits come from the differences in the
laboratories that we used for convenience s. We will try to keep conformity in
the Detection limits hereafter.

2.3.4 (R) Having considered these additional clarific ations, the Group considered that the further measurement and analysis of discharge concen tration of THMs and HAAs with adequate QA/QC should be taken during the full scale land-based te st before the submission of final approval.

2.3.5 The Group noted that, from the response of the applicant, the maximum discharge concentrations of THMs (i.e . bromoform ) had been measur ed during the laboratory-scale toxicity testing. The Group recognized that the si mulation procedure for treated ballast water in laboratory-scale tests had signifi cant differences between that of onboard testing. The Group noted that after adding the neutralizer, the stir ring process was performed in 20 minutes. Such a long stirring process could reduc e the concentration of volatile by-products and so might not be representative of those in discharged ballast water.GESAMP-BWWG 6/9

ANNEX 5 Page 5

I:\MEPC\58\2-7.doc 2.3.6 For the QA/QC, the Group noted that th e applicant had not provided QAPPs for chemical analysis which had been performed in se veral laboratories and also noted that some of the certificated reports for volat ile THMs stated that the sampling date and person in charge of sampling were “unknown”. The Group strongly recommended that all chemical measurement and analyses should be performe d under QAPPs and result of DQOs also should be included in the certificated reports.

The Group strongly recommended that all chemi cal measurement and analyses should be performed under QAPPs and result of DQOs also should be included in the certificated reports.

2.4 (Q) Dose - It was noted that the s ubmission indicated that a dose rate of 20 mg/L FAC is required to ensure efficacy and that the ma ximum intended dosage to the ballast water is 30 mg/L FAC. It was also noted that the concentration of free active chlorine
in TG Ballastwater is 5–13 wt%.

2.4.1 With the large variation in the concentra tion of FAC that may be available, the Group wanted to know how the dosing rate to ballast wate r is to be monitored and controlled to ensure the required levels are obtained and not exceeded.

2.4.2 (A) The applicant indicated that sin ce the concentration of sodium hypochlorite in TG Ballastcleaner is explicitly known fo r each delivery, the concentration of FAC is controlled at a specified level using information from Flow Meter and chlo rine sensor as shown in Figure 2-1 on page 6 of the “Report on Assessment”.

2.4.3 (R) The Group accepted that the applicants’ response was sufficient for the purposes of a Basic Approval evaluation. Ho wever, any Final Approval submission should provide full details of the dosing control arrangements so as to ensure certainty of maintaining specified dosage levels of Active Substances.

2.5 Coating system of stor age equipment and piping - The Group noted that appropriate materials for the storage tank of TG Ballastcleaner are stated in paragraph 5-2-3 on page 107 of the “Report on Assessment” . The Group noted that:

.1 the internal surfaces of piping and valves running from storage tank to injection nozzle which come into contact with the chemical are made of titanium, steel with lining or a coating of polypropylene, pol yethylene, or pol yvinyl chloride;

.2 the internal surfaces of chemical inj ection pump and nozzles which contact with
the chemical are made of the sa me materials described above;

.3 appropriate materials for the storage ta nk of TG Environmenta lguard are stainless steel or steel with lining or coating of polypropylene, polyet hylene, or polyvinyl chloride; and

.4 the chemical injection sy stem designed for onboard tests are shown in appendix 2, as an example.

2.6 The Group agreed that appropria te initial considerat ion had been given to the selection of coatings and materials for the storage tank a nd injection piping. The application for final approval should further specify the detailed requir ements for corrosion protection for all parts of the treatment system.GESAMP-BWWG 6/9

ANNEX 5 Page 6

I:\MEPC\58\2-7.doc 2.7 Dissimilar metals, galvanized piping/zinc anodes – The Group started to examine the
effect of ballast water treated with TG Ballastcl eaner on dissimilar metals, galvanized piping zinc anodes with limited results. However, this will be fully examined during consideration of the application for Final Approval.

2.8 (Q) Schematic of system/monitoring/control/saf ety (gas detection/al arms/protection of

crew – The Group requested a detailed schematic di agram of the intended plant showing valve positioning, monitoring and control func tions, and alarm detector sites.

2.8.1 (A) The applicant provided a system fl ow diagram and the list of equipment.

2.8.2 (R) The Group was satisfied that the flow diagram, provided, was suitable for Basic Approval but more details should be supplie d for review during any Final Approval.

2.9 (Q) SDS & Classification and Labelling - The Group noted that, according to the SDS for TG Ballastcleaner this prepar ation is classified according to European regulations (section 15) as Irritant with risk phrases R31 and R36/37/38. However the pH is stated to be above 11.5 (section 9), which would justify a classification of R34 (Corrosive, Causes burns). As a result, the Group asked if the data under s ection 11 relate to the preparat ion or to sodium hypochlorite.

2.9.1 In addition, it was noted that TG Environmental guard is classified in the same way as TG Ballastcleaner and so requested justification for this as, according to European regulations, both sodium sulphite and sodium sulphate are non-cla ssified (The information in section 15 appeared to be a copy of the same section in TG Ballastcleaner).

2.9.2 Furthermore, the Group noted some inconsiste ncies in the SDS since the data presented
under section 11 is not in accordance with the classification as presented under section 15, and the symptoms described under section 3.

2.9.3 The Group also noted that there was no correl ation between the concentration of sodium hypochlorite in TG Ballastcleaner and the data under section 11 of the corresponding SDS. The applicant was asked to comment on these apparent discrepancies.

2.9.4 (A) In response, the applicant i ndicated that section 15 of the SDS for TG Environmentalguard was deliberately take n from that of TG Balla stcleaner to provide a safer operation.

2.9.5 (R) The Group was concerned about the answer s to these queries and so, to assist the applicant, referred to the re gulations according to GHS (UNE CE, second revised edition, 2007) where the following is said under A4.3.11.2 about the informati on required for section 11 of
the SDS:

“The data included in this subsection should apply to the substance or mixture as used. The toxicological data should describe the mixt ure. If that information is not available,
the classification under GHS and the toxicological properties of the hazardous ingredients should be provided.”GESAMP-BWWG 6/9

ANNEX 5 Page 7

I:\MEPC\58\2-7.doc 2.9.6 The Group agreed that all information in a Safety Data Sheet has to be in line, if a preparation is unclassified then the recommendati ons for e g measures for First Aid have to be made accordingly. It is not acceptable to deliberat ely over-classify a substance or a preparation, that is, to “upgrade” the inform ation in section 15 (which shoul d reflect the information on the label).

2.9.7 The applicant indicated that there are tw o versions of the TG Ballastcleaner, one with 5-6% of sodium hypochlorite and one with 12-13% of sodium hypochlorite. In accordance with current European regulations (directive 19 99/45/EC) for classificati on this would result in the two different preparations of TG Ballastcl eaner requiring two differe nt classifications, the first is an Irritant (R31-36/38) and the second one is Corrosive (R31-34) (since the classification limit of 10% is exceeded). The Group decide d, for its work, to use the 13% of sodium hypochlorite as a worst-case scenario.

2.9.8 (Q) Details of the composition of TG Ballastcleaner and TG Environmentalguard
– The Group requested more precise information about the amount of s odium hypochlorite in the TG Ballastcleaner. In particular, it want ed to know whether the amount was above 10%, or
below as the submission indicated a concentration range that straddles this classification limit, i.e. 5-13%. (Classification limit for classifying as corrosive according to European regulations is 10%).

2.9.9 (A) In response, the applican t indicated that there were tw o types of TG Ballastcleaner,
one with concentrations ra nging from 5.5-6% and the ot her with concentrations ranging from 12.5-13%. In addition the appli cant stated that th e concentration of TG Environmentalguard was normally a bove and around 10% and at the most 22%.

2.9.10 (R) The Group noted this response which was regarded as acceptable for Basic Approval.

2.10 (Q) Bromodichloroacetic acid and di bromochloroacetic acid data – It was noted that in the dossier presented to the Group, there was no information on the potential Relevant Chemicals, bromochloroace tic acid and bromodichloroacetic acid.

2.10.1 (A) The applicant indicated that analyses for both chemicals had been carried out but the
substances were below the limit of detection. In addition the applicant was of the opinion that only trace amounts would be formed during the fo rmation of disinfection by-products (DBP).

2.10.2 (R) The Group agreed with the applicant that both substances should be exempt from a detailed risk assessment. Nevertheless, the Gr oup indicated that it woul d appreciate being kept informed of any newly established (eco)toxicol ogical information. However, the Group did not agree with the statement of the applicant that a risk assessment is not needed because of missing
information.

2.10.3 In this context, the Group no ted that the applicant was cont inuing to gather information related to these two chemicals and, if no additiona l data were to be found, they would carry out further algal tests as required.

2.11 (Q) Oxygen deficiency in discharged water – Recognizing that th e neutralizing agent, sodium sulphite, causes oxygen deficiency when adde d to the discharge ballast water and that the limit for chronic oxygen deficiency is 4.8 mg/L, th e Group asked if there were plans to monitor the dissolved oxygen (DO) concentrati on in the treated ballast water to ensure that it is above this limit prior to discharge. Are there any plans to ra ise the DO by e.g., aeration?GESAMP-BWWG 6/9

ANNEX 5 Page 8

I:\MEPC\58\2-7.doc 2.11.1 (A) In response, the applicant indicated th at there is no intention to use equipment to increase the DO as there is no significant defici ency of oxygen in discharged water with normal dosage of sodium sulphite. It was also indicate d that, in practical expe riments it was shown that unless the concentration of sodium sulphite is over 40mg/L, no oxygen defi ciency was created. Therefore, the discharged water does not have an y effects on the survival of marine organisms.

2.11.2(R) The Group accepted the explanation of the applicant that the cal culated concentration of sodium sulphite would not cause any signifi cant oxygen deficiency in the discharged ballast

water.

2.12 (Q) Temperature control – It was noted that TG Ballast cleaner has to be kept in the temperature range 0 o C – 20 o C and that lagging of piping betw een storage tank and injection unit may be necessary to avoid freezing. However, the Group recognized that the environment that ships operate in frequently exceeds 20 o C especially in the engine room where the injection equipment will be usually installed. As a result , the applicant was asked what provisions were being taken to ensure the maxi mum temperature of storage ta nk and piping remains below 20 o C?

2.12.1(A) The applicant informed the Group that TG Ballastcleaner is to be chilled by the electrical chilling system as shown in Figure 4-1-1 on page 65 of the “Report on Assessment”. Chilled TG Ballastcleaner is supplied from storage tank into piping during the operation of the system. After the operation TG Ballastcleaner in the piping is replaced with water.

2.12.2(R) The Group was satisfied that the applican t had given due preliminary consideration to the concerns put forward but requested that th ese safety mitigation measures and requirements should be fully detailed in the operating manual presented for any Final Approval.

2.13 (Q) Pressure monitoring/control – The Group noted that when treatment stops, the storage tank outlet and injection unit inlet valves are to be shut simultaneously by remote control for safety and crew protection. However, the Group requested information on what detectors and alarms are intended to be fitted for leakage detection of chemicals and/or gases (chlorine) in the event of storage tank/system overpressure or excessive temperatures. In particular, information was requested on how the supply pipe is to be protected against overpressure if temperature
exceeds 20 o C.

2.13.1(A).2 In response, the applicant indicated that even if the temperature of TG Ballastcleaner in storage tank exceeds 20 o C, no chlorine gas is generated and only slig ht amount of oxygen gas is generated as stated in 4-1 on page 65 of th e “Report on Assessment”. Each of the storage tanks are equipped with two pre ssure/vacuum vent valves, respect ively. One of these valves opens when tank’s internal pressure exceeds the set pressure value and the other does when the internal pressure drops below the set pressure valu e. In order to avoid overflow from the tank in filling TG Ballastcleaner and manage the supply of chemicals, the tank system is equipped with a high-level alarm and liquid surface level gaze.

2.13.2(R) Whilst recognizing the valid ity of this response, the Group considered that further verification of this should be made during the ship board testing and included in the documentation for Final Approval.

2.14(Q) Missing toxicity data for treated ballast water – The Group noted that, for the toxicity testing of the treated ba llast water, only of Early Life St age for fish and chronic toxicity testing for invertebrate and phyt oplankton were reported. As G9 clearly requests both acute and chronic toxicity testing (5.2.2 of G9), the applic ant was asked if there were any additional data for toxicity testing.GESAMP-BWWG 6/9

ANNEX 5 Page 9

I:\MEPC\58\2-7.doc 2.14.1 The Group agreed that, as this system in cludes a neutralization process just before discharge using sodium sulphite, which, although it has a short life has a high toxicity to marine organisms but the toxicity testing does not appear to reflect such a potential short-term risk. Also the application did not include the results fr om the simulation model for short term or even for the real measurement of degr adation rates in natural seawater for sodium sulphite. As a result, the applicant was asked how the risk analys is for sodium sulphite can be evaluated without
these data.

2.14.2(A) In response, the applicant stated that it did not have any additional data for toxicity tests, because the early life stages of fish an d chronic toxicity testing for invertebrate and phytoplankton are most sensitive organisms. IDEA consultants Inc. unde rstand that the result satisfies the G9 guideline. IDEA stated that “Combining the toxicity results on the test organisms, the simulated ballast water to which the test group treated with 30mg/L of residual chlorine was exposed had no lethal or sublethal effects in the early life stages of Java medaka and on the bodies of juvenile marine gammarids ( Hyale barbicornis ).” on page 97 of the “Report

on Assessment”

2.14.3 The degradation rate is the very important parameter. If a low degradation rate is assumed, the PEC/PNEC ratio exceeds 1.0 but accord ing to our experiments, sodium sulphite becomes sodium sulphate in the treated ballast wa ter within 15 minutes as stated on page 85 of the “Report on Assessment”.

2.14.4 The most sensitive data, EC 50 of 16 – 32 mg/l in 6.4 – 8.9h on page 90 of the “Report on
Assessment” was taken from IUCLID DATASET. Bu t we consider that th ese data have been obtained in an irregular pro cedure, so we are searching for the original literature.

2.14.5 The additional tests regarding the DO decr ease due to sodium sulph ite and its biological effect have been planned and already started. So far we have obtained data those show no effects

on DO.

2.14.6(R) Having considered these additional clarifications, the Group was still of the opinion that the acute toxicity testing for treated ballast water is needed and that the information for acute toxicity testing by simulated ballast water was not provided in the dossier.

2.14.7 The Group recalled that G9 clearly requests both the acute and chronic toxicity testing and in this particularly system, there is potential short-term risk from sodium sulphite just around the discharge point which the a pplicant had already recognized. Furthermore, the Group recalled that the procedure to control th e dose of neutralizer (sodium sulphite) had not been clearly described in the dossier, so there were possibilities that the neutra lizer was dosed at higher levels than required to neutralize the TRC. This woul d result in residual sodium sulphite being discharged to the receiving wa ter before efficient degradati on (i.e. 15 minutes). The Group recommended that acute toxicity testing using with adequate simulation procedure should be performed in a laboratory scale and full scale la nd-based system for evaluation. In addition, the Group requested that quantific ation analysis and degradation rates of sodium sulphite in
various conditions should be carried out for the submission for Final Approval.GESAMP-BWWG 6/9

ANNEX 5 Page 10

I:\MEPC\58\2-7.doc 2.15(Q) HES The Group drew the applicant’s attenti on to the fact that the Human Exposure Scenario (HES) had not been completed.

2.15.1(A) The applicant indicated that, if allowed to proceed to the application for Final Approval, then the following scenario s would be provided in accordance with the methodology of specific operation procedure of the ballast water management system:

.1 Loading of chemicals .2 Ballasting operation .3 De-ballasting operation .4 Inspection and mainte nance of storage tanks .5 Inspection and maintenance of ballast tank .6 Measures for trouble and emergency

2.15.2(R) The Group encouraged the applicant to develop the relevant human exposure scenarios according to HSE methodology. In this context, and in addition to the information already provided (e-mail 21/05/08), the Group r ecommended that the following human exposure
information related to TG Balla stcleaner should be addressed:

.1 in advance identification of all leaking poi nts; these are to be considered critical points for the HES (due to the corrosi ve properties of the preparation);

.2 foreseen safety measures for spills/l eaks in the waste water collection tank; and

.3 manual handheld (residual chlorine me ter) measurements of residual chlorine
concentration in the waste water tank.

2.16 Q) Lower LODs for disinfection by-products – The Group considered that the Level of Quantification (LOQ) for the met hods used in the anal yses of disinfection by-products in treated ballast wa ter were too high. It was point ed out that it is common to
determine these contaminants in surface waters at levels of 0.1 μg/L. The potential levels may therefore be understated, but may as well remain within acceptable limits. Therefore, it remains to be confirmed that the poten tial amount of by-products produced by the system is sufficiently
low and meets the international standards on thes e substances. The applicant was requested to clarify this uncertainty with additional analys es during the full scale testing on land and/or on board ships by the applicant.

2.16.1(A) .15.1 The applicant indicated that it agreed with these concerns and so would ask the certified laboratories of chemical analysis to quantify these contaminants in surface water at levels of 0.1μg/L hereafter.

2.16.2(R) The Group noted this response.

2.17 In addition to these concerns, the Group noted that the applicant had identified a number of chemicals which might be produced by the system . Of these, eleven had been identified as potentially requiring aquatic toxicity evaluati on one of which (sodium sulphite) was also identified as requiring mammalian toxicity ev aluation. However, the Group noted that the applicant did not provide any information on dihalogenated hydrocarbons and chloroamines potentially formed during treatment. In addition , the applicant had indicated that two chemicals (sodium hypochlorite and sodium sulphate) require d mammalian toxicity evaluation only because these would be neutralized by sodium sulphite prior to being released in the environment.GESAMP-BWWG 6/9

ANNEX 5 Page 11

I:\MEPC\58\2-7.doc 2.18 The Group expressed the following concerns related to the applicant’s d ecisions to select
chemicals for evaluation:

.1 sodium sulphite: The applicant indicated that it wa s not necessary to test this for chronic aquatic toxicity as it reacts w ith residual chlorine and dissolved oxygen;

However, it was noted that the applicant had indicated that the theoretical
maximum concentration in treated ballast water was 22 mg/L. However, it was also noted (MEPC 57/2/8, annex, para. 4.6) that residual sodium sulphite reacts with naturally occurring dissolved oxygen to beco me sodium sulphate within 10 minutes and so the Group accepted that chronic aquatic toxicity testing for this product was not necessary;

.2 sodium hypochlorite: The applicant indicated that this was reduced by aquatic organisms, organic matter and sodium sulphite. Whilst no indication of the completeness and speed of this reacti on was given in MEPC 57/2/8, the Group noted that the reaction was complete (Report on Assessment of Ballast Water Management System that makes use of TG Ballastcleaner and TG Environmentalguard, table 3-9-2);

.3 residual chlorine: The Group recognized that th is would be reduced, during discharge by sodium sulphite, as part of the treatment. Whilst no indication of the completeness and speed of this reacti on was given in MEPC 57/2/8, the Group noted that the process was complete (Report on Assessment of Ballast Water Management System that makes use of TG Ballastcleaner and TG Environmentalguard, table 3-9-2);

.4 bromochloroacetic acid: The applicant indicated th at this was only generated in trace amounts. However, the Group noted that this had been measured at 0.007 mg/L and so should be evaluated as an Active Substance or Relevant Chemical;

.5 other haloacetic acids: The Group noted that these had been detected at levels up to 0.03 mg/L in treated ballast wa ter and so should be evaluated as Active Substances or Relevant Chemicals; and

.6 haloacetonitriles: The Group accepted that these chemicals had not been detected at levels up to 0.001 or 0.004 mg/L and so need not be evaluated as an
Active Substance or Relevant Chemical.

2.19 The Group noted that the fo llowing chemicals would be stor ed onboard as components of
either TG Ballastcleaner or TC Environmentalguard and should be regarded as Active Substances:

.1 sodium hypochlorite (5-13%);

.2 sodium hydroxide (<1%);

.3 sodium chloride (<13%);

.4 sodium sulphite; and

.5 sodium sulphate.GESAMP-BWWG 6/9

ANNEX 5 Page 12

I:\MEPC\58\2-7.doc 2.20 However, the Group:

.1 recognized that sodium hypochlorite w ould be neutralized by sodium sulphite prior to discharge to sea and so only re quired evaluation of the risks to ship’s crews and ship safety;

.2 agreed that sodium chloride would not present any hazards in storage and would
be diluted to 0.2% natural seawater concen trations and so need not be subject to Risk Assessment;

.3 noted that the applicant had provid ed both aquatic toxicity and mammalian toxicity data for evaluation as part of the Risk Assessment; and

.4 agreed that sodium sulphate need only be evaluated for its risks to the crew and safety of the ship as, when discharged to sea it is at 1% of natural seawater
concentration.

3 DESCRIPTION OF THE SYSTEM

3.1 Overview

3.1.1 This Ballast Water Management System (BWMS) comprises the following modular
components:

.1 the filtration of suspended particles >50μm, during ballasting operations, which are then returned to the sea in backwash water;

.2 TG Ballastcleaner is added to the balla st water during uptake as a preparation. The dosage level of Active Substance was reported as 30mg/l of Free Active Chlorine (FAC); and

.3 during deballasting, residual chlorine cont ained in the disinfected ballast water is reduced and eliminated by adding TG Enviro nmentalguard (sodium sulphite in the ratio of 0.021% to seawater) in order to protect marine habitats in the surrounding
seawater where the treated ballast wate r is discharged. The Group expressed concern that it was not clear whether the dose rate for the neutralizing solution
was fixed or could be varied to reflect the level of TRC in the ballast water. This
issue should be clarif ied for Final Approval.GESAMP-BWWG 6/9

ANNEX 5 Page 13

I:\MEPC\58\2-7.doc 3.1.2 A schematic representation of the system, provide by the applicant, is shown below:

3.1.3 Further details of the system, including re ference to a cavitation generator, and its installation onboard were provided to the Gr oup as confidential information. The Group considered that the cavitation phase might affect the composition of chemicals in the ballast water and so, in the application for Final Approval, the applicant should indicate that all tests were carried out following treatment by ALL parts of the treatment system.

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

3.2.1 It was recognized that the Active Substan ce (sodium hypochlorite), used by this system, can react with inherently occurring chemicals to produce by-products, some of which might be regarded as Relevant Chemicals.

3.2.2 However, it was noted that some of these we re not detected in th e treated ballast water and so it was agreed that these need not be evaluated. In add ition, it was noted that:

.1 the concentration of sodium chloride produced by the system was only 0.2% of the natural background c oncentration in sea wate r (Section 4-4-1 of the confidential “Report on Assessment of Ba llast Water Management System that
Make Use of TG Ballastcleaner and TG Environmentalguard”);

.2 the concentration of sodium sulpha te produced by the system was 1% of the natural background leve l in seawater (Section 4- 4-1 of the confidential “Report on Assessment of Ballast Water Ma nagement Systems that Make Use of TG Ballastcleaner and TG Environmentalguard”);

.3 the reactions associated with the degr adation of sodium hypochlorite and sodium sulphite were as shown below:

NaClO + Na 2 SO 3 → NaCl + 2Na 2 SO 4

The excess of sodium sulphite becomes sodium sulfate by reacting with dissolved oxygen in ballast water by the following reaction:

2Na 2 SO 3 + O 2 → Na 2 SO 4 NaClO ... TG Ballastcleaner TG Environmentalguard

Ballast

NaClO

Na 2 SO 3 Na 2 SO 4

Seawater

Freshwater BALLASTING DEBALLASTING

Disinfected
Ballast Water Treated Ballast Water Ballast Line

Water Environment NaClO Na 2 SO 3

Filter

Back
Wash
WaterGESAMP-BWWG 6/9

ANNEX 5 Page 14

I:\MEPC\58\2-7.doc .4 Hypochlorous acid (See also MEPC 57/ 2/8, annex, para. 3.1.1): The applicant indicated that this was readily reduced with sodium sulphite, as shown in the reaction below, and so the Group agreed that this chemical need not be subject to a complete Risk Assessment:

Na 2 SO 3 + HClO → Na 2 SO 4 + HCl

.5 Hypobromous acid (See also MEPC 57/ 2/8, annex, para. 3.1.1): The applicant indicated that this was readily reduced with sodium sulphite, as shown in the reaction below, and so the Group agreed that this chemical need not be subject to a complete Risk Assessment:

Na 2 SO 3 + HBrO → Na 2 SO 4 + HBr

.6 Sodium hypobromate (See also MEPC 57/2/8, annex, para. 3.1.1): The applicant
indicated that this was reduced with s odium sulphite, as shown in the reaction below, and so the Group agreed that this chemical need not be subject to a complete Risk Assessment:

Na 2 SO 3 + NaBrO → Na 2 SO 4 + NaBr

3.2.3 Such chemicals are shown in the table below as shaded

Substance Chemical

Formula Identification no. Concentration Proposed Status by applicant

Sodium hypochlorite

described as

FAC NaClO CAS no. 7681-52-9

EINECS no. 231-668-3

UN no. 1791

IMCO Class 8.0 5–13 wt% (as FAC) AS

Sodium hydroxide NaOH CAS no. 1310-73-2

EINECS no.215-185-5

UN no. UN1824

IMCO Class 8.0 <1 wt% in TG
Ballastcleaner corresponding
to 12% FAC OC

Sodium
chloride NaCl CAS no. 7647-14-5 Less than 13
wt% corresponding
to 12% FAC OC

Sodium sulphite Na 2 SO 3 22 mg/L (calculated
maximum concentration) OC*

Sodium sulphate Na 2 SO 4

Hypochlorous
acid HClO CAS no. 7790-92-3
--- RCGESAMP-BWWG 6/9

ANNEX 5 Page 15

I:\MEPC\58\2-7.doc Substance Chemical

Formula Identification no. Concentration Proposed Status by applicant

Chloroform CHCl 3 CAS no. 67-66-3 0.04 mg/l RC

Bromodichloro

methane CHBrCl 2 CAS no. 75-27-4 0.015 mg/l RC*

Dibromochloro

methane CHBr 2 Cl CAS no. 124-48-1 0.012 mg/l RC*

Bromoform CHBr 3 CAS no. 75-25-2 0.47 mg/l RC*

Hypobromous
acid HBrO CAS no. 13517-11-8
--- RC

Sodium hypobromite NaBrO CAS no. 13824-96-9
--- RC

Sodium

bromate NaBrO 3 CAS no. 7789-38-0 0.0094 mg/l RC*

Monochloroacetic acid CH 2 ClCOO

H CAS no. 79-11-8 0.002 mg/l RC*

Dichloroacetic
acid CHCl 2 COO

H CAS no. 79-43-6 0.022 mg/l RC*

Trichloroacetic
acid CCl 3 COOH CAS no. 76-03-9 0.03 mg/l RC*

Bromochloroacetic acid CHBrClCO

OH CAS no. 5689-96-8 0.003 mg/l RC

Bromodichloro
acetic acid CBrCl 2 COO

H CAS no. 71133-14-7 <0.01 mg/l RC

Dibromochloro
acetic acid CBr 2 ClCOO

H CAS no. 5278-95-5 <0.03 mg/l RC

Bromoacetic
acid CH 2 BrCOO

H CAS no. 79-08-3 0.007 mg/L RC

Dibromoacetic
acid CHBr 2 COO

H CAS no. 631-64-1 0.055 mg/L RC*

Tribromoacetic
acid CBr 3 COOH CAS no. 75-96-7 <0.05 mg/l RC

Chloroacetonitrile CH 2 ClCN CAS no. 107-14-2 <0.001 mg/l RC

Dichloroacetonitrile CHCl 2 CN CAS no. 3018-12-0 <0.004 mg/l RC

Trichloroacetonitrile CCl 3 CN CAS no. 545-06-2 <0.001 mg/l RC

Dibromoacetonitrile CHBr 2 CN CAS no. 3252-43-5 <0.001 mg/l RC

Bromochloroacetonitrile CHBrClCN CAS no. 83463-62-1 <0.001 mg/l RCGESAMP-BWWG 6/9

ANNEX 5 Page 16

I:\MEPC\58\2-7.doc Substance Chemical

Formula Identification no. Concentration Proposed Status by applicant

Monochloramine NH 2 Cl CAS no. 10599-90-3 --- RC

* = Identified by the applicant for risk evaluation

3.2.4 The Group noted that the applicant had iden tified the following eleven chemicals as
either Active Substances or Relevant Chemi cals possibly requiring ev aluation (MEPC 57/2/8, annex, Summary):

.1 sodium sulphite (acute toxicity only);

.2 sodium bromate;

.3 chloroform;

.4 bromodichloromethane;

.5 dibromochloromethane;

.6 bromoform;

.7 monochloroacetic acid;

.8 dichloroacetic acid;

.9 trichloroacetic acid;

.10 bromoacetic acid; and

.11 dibromoacetic acid.

3.2.5 However, the Group noted that bromochloroace tic acid might also require some degree of
evaluation.

3.2.6 The Group also noted that the applicant:

.1 had grouped data on some of the products under halomethanes and haloacetic acids;

.2 had concluded that only mammalian toxicity data were needed for sodium hypochlorite, sodium sulphite and sodium sulphate

3.2.7 An indication of the data provided by the a pplicant for various chemicals is shown in the
table below:GESAMP-BWWG 6/9

ANNEX 5 Page 17

I:\MEPC\58\2-7.doc Data provided for or referenced for chemicals associated with the BWMS

Chemical Aquatic Ecotoxicity Mammalian Toxicity

AE CE ED ST B AMT C/I CT D/R C/M
Sodium hypochlorite √ √ √ √ √

F √ R

C √ Sodium sulphite

A √ R √ √ √ √ √

Sodium sulphate √ √ √ √ √Active Substances

Sodium hydroxide

Sodium bromate M √

N √ R R √

Chloroform F √ √

C √ √

A √ √ R R √

Bromodichloromet
hane F √

C √

A R R √

Dibromochloromet
hane F √

C √

AHalomethanes

Bromoform F √ √

C √

A √ √ R R √

Monochloroacetic
acid √ √ R R √

Dichloroacetic acid √ R R √

Trichloroacetic acid √ R R √

Bromoacetic acid √ √ R R √

Bromochloroacetic
acidHaloacetic acids

Dibromoacetic acid √ R R √

Dibromoacetonitril

e √ R R √

AE = Acute Ecotoxicity CE = Chronic Ecotoxicity ED = Endocrine Disruption ST = Sediment Toxicity B = Bioavailability/biomagnification/bioconcentration AMT = Acute Mammalian Toxicity C/I = Skin/Eye Corrosion/Irritation CT = Chronic and Long-term ToxicityGESAMP-BWWG 6/9

ANNEX 5 Page 18

I:\MEPC\58\2-7.doc D/R = Developmental and Reproductive Toxicity C/M = Carcinogenicity and Mutagenicity
F = Fish

C = Crustacea A = Algae R = Property referenced but no data provided √ = Data provided

4 HUMAN HEALTH ASSESSMENT

4.1 TG Ballastcleaner

4.1.1 The Group considered sodium hypochlorite to be the critical toxicant in terms of human
health effects and therefore used this Active Subs tance to address the hazards of the preparation
and to further its risk assessment. In this context the Group noted the classification of this preparation as shown in the MS DS provided by the applicant:

Xi; R36/37/38, R31

4.1.2 The applicant indicated that there are tw o versions of the TG Ballastcleaner, one with 5-6% of sodium hypochlorite and one with 12-13% of sodium hypochlorite. In accordance with current European regulations (directive 19 99/45/EC) for classificati on this would result in the two different preparations of TG Ballastcleane r driving two different classifications, the first is an Irritant (R31-36/38) and th e second one is Corrosive (R31- 34) (since the classification limit of 10% is exceeded) and so two different SDSs ar e needed to reflect this. The Group decided for
its work to use the 13% of sodium h ypochlorite as a worst-case scenario.

4.1.3 For clarification the Group re ferred to the regulations acco rding to GHS (UNECE, second revised edition, 2007) where the following is sa id under A4.3.11.2 about th e information required
for section 11 of the SDS which states:

“The data included in this subsection should apply to the substance or mixture as used. The toxicological data should describe the mixt ure. If that information is not available,
the classification under GHS and the toxicological properties of the hazardous ingredients should be provided.”

4.1.4 The Group noted that, according to the presented data, as shown in the table below, the acute toxicity of sodium hypoc hlorite is low by the oral, dermal a nd inhalation rout es of exposure.

Acute toxicity

Route of exposure Species Effect Reference
Oral (12.5% sodium hypochlorite) Rat LD50> 5.8 g/kg bw RAR EC, 2007

Dermal (unspecified concentration sodium hypochlorite) Rabbit LD 0 > 10 g/kg bw () RAR EC, 2007

Inhalation (unspecified concentration sodium hypochlorite) Rat LC 0 >10.5 mg/l (1h) RAR EC, 2007GESAMP-BWWG 6/9

ANNEX 5 Page 19

I:\MEPC\58\2-7.doc 4.1.5 The Group noted that, according to the presen ted data, shown in the following two tables, sodium hypochlorite (12.7%) a moderate skin irritant and a se vere eye irritant

4.1.6 The Group also noted that, ac cording to RAR EC (2007), corro sivity from animal studies show that 12.7% of hypochlorite solution produced severely irritant or corrosive effects to the eye. However the same concentration applied to rabbit skin does not s how corrosive effects, only moderate irritation was observed. Sodium hypochlorite aerosols may be irritant to the respiratory tract.

4.1.7 The Group agreed that the ove rall evaluation of both animal and human data supports the
current EU classification as irritant above 5% a nd as corrosive above 10% which is pertinent to the hazards to be expected with TG Ballastcleaner.

Skin irritation

Substance Species Exposure
duration Effect Reference

Sodium hypochlorite

12.7%
(as FAC) Rabbit 24 hours Intact skin and abraded skin. Result: Moderately irritating RAR EC, 2007

Eye Irritation

Substance Species Exposure
duration Method Effect Reference

Sodium hypochlorite

12.7%
(as FAC) Rabbit 14days Draize
method Severely irritating. Recovery not complete at 14 days RAR EC, 2007

4.1.8 Sensitization – The Group noted that, according to existing data, sodium hypochlorite does not show a potentia l to cause delayed contact hypersen sitivity (draft Risk Assessment Report (RAR) on sodium hypochlorite, EU Assessment 793/93).

4.1.9 Repeated Dose Toxicity – The Group noted the repeated dose toxicity data shown in the table below and the NTP, 1992 which is consider ed to be the key study for deriving a NOEL for
risk characterization for the oral route.

4.1.10 Concerning the repeated exposure by derm al route, EC (RAR, 2007), the NTP concluded that no systemic effects were seen following dermal exposure to 10000mg/L NaClO. A NOEL of 1% from the study of Kurokawa (1984) is ch osen to evaluate the local dermal effects.GESAMP-BWWG 6/9

ANNEX 5 Page 20

I:\MEPC\58\2-7.doc 4.1.11 For the evaluation of the effects of inhala tion exposure, it is propos ed to use data from chlorine gas. The NOAEL for repeated exposure to chlorine gas is 0.5 ppm in studies performed with rhesus monkeys and human volunteers.

Substance Species Dose/route of

exposure Duration
of

treatment Effects Reference

Sodium hypochlorite SpragueDawley

rats Drinking-water 0, 3, 10, 16 or 21 mg/kg bw per day as FAC 90 days NOEL of 10 mg/kg
bw based on reduced body weight gain Daniel et al.

, 1990 (EHC, 2000)

Sodium hypochlorite B6C3F1

Mice Drinking water 0, 70, 140 and 275 mg/L as

FAC 2 years NOEL 13.75 mg/kg bw (or 275 mg/l as FAC)

No treatment
related adverse
effects were
observed NTP, 1992

4.1.12 Carcinogenicity/Mutagenicity – The Group noted that s odium hypochlorite is not classified by IARC as to its ca rcinogenicity to humans (Group 3) . Several studies have shown that sodium hypochlorite produces mutagenic responses in b acterial systems and mammalian
cells in vitro . However, there is no evidence of activity in mammalian test systems in vivo

.

4.1.13 In conclusion, based on the results of th e effects assessment of sodium hypochlorite, the Group considered that the human health hazard s of TG Ballastcleaner (up to 13% NaClO) are due to its corrosive properties.

4.1.14 Therefore, the Group recommended that engineering measures are put in place in
addition to the use of PPE/RPE in order to minimise human exposure.

4.2 THM generation in conjunction with TG Ballastcleaner

4.2.1 The Group considered that chlorinated a nd brominated disinfection by-products (THM) are the toxicological relevant compounds generate d by the preparation as they have a potential for human genotoxicity/carcinogeni city. According to WHO Guidelines for Drinking Water Quality, 2003, these compounds have to be ke pt under toxicological critical levels (e.g., bromate <10μg/L; bromoform < 100μg/L; chloroform <200 μg/L).

4.2.2 Acute toxicity of trihalomethanes – The Group noted that the Acute toxicity (LD 50 ) of trihalomethanes (Chloroform, Bromodichloromethane, dibromochloromethane and bromoform) on rats has been found to be in the range of 848-1388 mg/kg (Chu et al., 1980). Clinical effects following single oral doses were sedation, ataxia, piloerection, and prostration.

4.2.3 The Group also noted that chloroform (GHS classifica tion, Annex VI, COM (2007) 355 final), bromodichloromethane and chlorodibrom omethane (self classification by commercial suppliers) are all classifi ed as harmful if swallowed. Howeve r, it was noted that bromoform is classified as toxicant by inhalation (GHS cla ssification, Annex VI, COM (2007) 355 final) and bromate (as potassium bromate) is classified as toxic if swallowed (GHS classification, Annex VI, COM (2007) 355 final).GESAMP-BWWG 6/9

ANNEX 5 Page 21

I:\MEPC\58\2-7.doc 4.2.4 Genotoxicity/Carcinogenicity – The Group noted that chlo roform and other THMs have
been shown to increase tumours of the liver, kidney or large intestine in rats and mice. The weight of evidence suggests that chloroform is non-genotoxic and there are data, to indicate that tumours only occur at high doses where th ere is also tissue damage (Fawell, 2000).

4.2.5 The evidence suggests that th e use of a threshold approach , based on the tolerable daily intake (TDI) would be the most appropriate way of determining safe levels in drinking water (WHO, 1998).

4.2.6 Chloroform is classified acco rding to its carcinogenic proper ties (suspected of causing cancer) (GHS classification, Annex VI, COM (2007) 355 final), this conclusion also applies for bromodichloromethane (self classification by comm ercial suppliers). Bromate (as potassium bromate) is classified according to its ca rcinogenic properties (may cause cancer) (GHS classification, Annex VI, COM (2007) 355 final).

4.3 HAA generation in conjunction with TG Ballastcleaner

4.3.1 The Group noted that:

.1 monochloroacetic acid is classified acco rding to GHS as acute tox 3 (ingestion), and as skin corr 1 B (hazar d statements; H301 and H314);

.2 dichloroacetic acid is classified according to GHS as skin corr 1 A (hazard statement; H314);

.3 trichloroacetic acid is classified according to GHS as skin corr 1 A (hazard statement; H314);

.4 monobromoacetic acid is classified accord ing to GHS as acute tox 3 (inhalation, skin contact, ingestion, and as skin corr 1 A (hazard statements; H331, H311, H301 and H314); and

.5 dibromoacetic acid is classified accord ing to GHS (self-classification according to supplier) as acute tox 3 (inhalation, skin contact, ingestion, a nd as skin corr 1 B (hazard statements; H331, H311, H301 and H314).

4.4 TG Environmentalguard

4.4.1 The Group noted that the cla ssification of the preparation which was stated to be in accordance with the current European system for classification and labelling, according to the MSDS (TG Environmentalguar d, first issue May 1, 2007), provi ded by the applicant was:

Xi; R36/37/38, R31

4.4.2 However, the Group also noted that the SDS presented by the applicant for the TG Environmentalguard is not accurate since th e basis for classification as Irritant is lacking. (The Group noted that according to self-classif ication by major suppliers in Europe the two active substances in TG Environmentalguard ar e regarded as non-classified and only slightly irritating by oral route, skin contact as well as by inhalation). Sectio n 11 of the supplier SDS confirms that this preparation is to be regarded as slightly irritating. Yet, in section 15, the above-mentioned classification is pr esented without any justification.GESAMP-BWWG 6/9

ANNEX 5 Page 22

I:\MEPC\58\2-7.doc 4.4.3 According to the presented data, the Group agre ed that sodium sulphite is not an acute toxicant by oral route, neith er is it considered to be an eye or skin irritant. Furthermore there seemed to be neither any relevant toxicological concerns towards repeated exposure to sodium sulphite nor to its developmental toxicity or mutagenicity.

4.4.4 In addition, the Group noted that sodium sulphite is classified as IARC group 3 (Not classifiable as to its carci nogenicity) since no data were av ailable on the carcinogenicity in experimental animals of sulphites. Evaluation by IARC states that there is inadequate evidence for the carcinogenicity in experi mental animals of sulphites.

4.4.5 According to the presented data, sodium sulpha te is not considered to be an acute toxicant by oral route, neither is it considered to be an ey e or skin irritant. Furthermore there seemed to be neither any relevant toxicological concerns towards repeated expos ure to sodium sulfate nor to developmental toxicity, mutage nicity or carcinogenicity.

4.4.6 In conclusion, based on the results of the effects assessment of sodium sulphite and sodium sulphate, the Group considers that the hazardous properties of TG Environmentalguard are slight irritation. Therefor e, the Group recommended that engi neering measures are put in place in addition to the use of PPE/RPE in order to minimize human exposure.

4.5 Human Exposure Assessment based on HES

4.5.1 The Group encourages the appl icant to proceed the building up of the HES for the BWTS according to human exposure assessment methodology, therefore being able to identify the tasks that may pose a risk to human health and if necessary to elaborate a proposal for RMM.

4.5.2 In this context, and in addition to the information already forwarded by the Applicant (e-mail 21/05/08), the Group added the following requirements for TG Ballastcleaner when being submitted for Final Approval:

.1 all leaking points should be identified in advance and considered critical points for the HES (due to the corrosive properties of th e preparation);

.2 foreseen safety measures for spills /leaks in the waste water collection tank (2.5 parts of TG Environmentalguard a nd 1 part of TG Ballastcleaner); and

.3 manual handheld (residual chlorine me ter) measurements of residual chlorine
concentration in the waste water tank.GESAMP-BWWG 6/9

ANNEX 5 Page 23

I:\MEPC\58\2-7.doc 5 RISKS TO THE SAFETY OF THE SHIP, ITS CREW AND THE GENERAL
PUBLIC

5.1 Storage and handling of preparations

5.1.1 The Group considered that the most relevant risk to human health associated with the onboard storage of the preparation TG Ballastcleane r (up to 13% NaClO) is due to its corrosive properties. Therefore, the Group recommended that , in addition to the use of PPE/RPE, risk reduction features should be incorporated into th e system design specification so as to minimize the possibilities of human exposure..

5.1.2 The Group considered that the hazardous properties of TG E nvironmentalguard are slight irritation based on the results of the toxicologi cal evaluation of sodium sulphite and sodium sulphate. Therefore, the Group recommended that engineering measures are put in place in
addition to the use of PPE/RPE in order to minimise human exposure.

5.1.3 The Group recommended that the storage ar rangements for the substances involved are verified as fully compliant with all relevant maritime regulations and Codes for the storage and carriage of such preparations, including the loca tion of the storage facilities and PPE and risk mitigation measures required.

5.1.4 The Group further recommends that the proced ures for the loading and handling of the preparations are fully detailed in the ope rations manual, including all PPE and safety
considerations necessa ry for safe handling.

5.2 Chlorine Gas

5.2.1 The Group considered that there is a small po ssibility that the use of this ballast water treatment system may result in an accumulation of chlorine gas in the treated ballast tanks. This possibility should be considered and mon itored during onboard testing to ensure that chlorine gas accumulation in the ballast ta nks will not raise a risk to the crew.

5.3 Corrosion

5.3.1 The Group considered that the data submitted regarding TG Ballastcleaner indicate it to
be corrosive to steel both in the concentrate and the treated ballast water concentrations. The Group noted that the supplem ental material stated that:

.1 the treatment with TG Ballastcleaner is corrosive to steel, ballast and supply piping and storage tanks;

.2 such treatment contact surfaces should be coated (tanks) with an epoxy resin coating system or lined (pipes) with polypropylene, polyvinylchloride or polyethylene or constructed of Titanium or its alloys; and

.3 the Handling Manual additionally recognizes that gasket materials used in the injection piping must be sufficiently resistant.GESAMP-BWWG 6/9

ANNEX 5 Page 24

I:\MEPC\58\2-7.doc 5.3.2 At the request of the Group regarding long -term corrosion evaluations, the applicant submitted additional data regarding long term coati ngs studies reported in appendixes 1-2 of the supplemental material, entitled ”Endurance Tests of Epoxy coated steel with Simulated Fault”.
This effort evaluated the effect s of sodium hypochlorite and hydr ogen peroxide on coated steel coatings adhesion. The relevant portion of the document reports:

.1 a 100-day, ten-cycle alternate immersio n study of coal ta r epoxy and modified epoxy coated steel substrates conducted;

.2 each sample was tested in duplicate and was applied with a 40 mm cross-cut scribe which penetrated the coating;

.3 each cycle included a 7-day immersion period and a 3-day dry period;

.4 the immersion portion of the cycle included a either artificial seaw ater or artificial
seawater with an initial dose of either 20 mg/L sodi um hypochlorite or a 50 mg/L dose of hydrogen peroxide or a natural seawater. The test solution was newly prepared for each cycle;

.5 the TRO was recorded at the beginning and end of each test cycle, TRO concentrations varied from 18-23 mg/L a nd generally < 1 mg/L at the beginning and end of the cycle, respectively;

.6 the samples were evaluated for appearan ce, coatings adhesion of the scribed area and the unperturbed coating according to JIS K 5400 and coating hardness according to pencil hardness test, JIS K 5600;

.7 from the visual appearance of sample s coated with a modified epoxy coating (typical for use in the marine vessel industry), samples exposed to sodium hypochlorite had more apparent corrosion, judged by the presence of corrosion products, and some discoloration of th e coating had occurred. However, the applicant notes that no blistering or exfo liation of the scribed area and the coating remained intact. No penetration depths or corrosion rates were measured to assess
the relative increase in corrosion rate in 20 mg/L TRC seawater . The Group noted from the provided photographs that the scribed area of the coating exhibited substantially more corrosion products a nd rust staining, as compared to the artificial seawater exposure which reflect ed only discrete corrosion products along the scribe;

.8 regarding coatings adhesion testing subsequent to testing in the respective test conditions, the adhesion strength deterior ated about 3.4% for the condition in which 20 mg/L of sodium hypochlorite was added versus a deterioration of
about 1.9% in artificial seawater. As a resu lt, the applicant concluded that although there was a tendency towards deterioration there were no significant differences;

.9 evaluation of the scribed area coating a dhesion through a cellophane tape peel test revealed no coatings exfoliation in any case;

.10 with the modified epoxy paint, lower (sof ter) results were obtained compared to the untested material for all test solution conditions, but the results were similar for the artificial sea water. In other words, with the modified epoxy paint, there was a tendency towards softening with the passing of test time regardless of sodium hypochlorite presence;GESAMP-BWWG 6/9

ANNEX 5 Page 25

I:\MEPC\58\2-7.doc .11 From these test data, the a pplicant concluded the following:

.11.1 For the modified epoxy paint, discol oration occurred for the condition in which 20 mg/L of sodium hypochlorite was added;

.11.2 Although there were differences in th e degree of rusting for the cross cut parts of the modified epoxy paint, the co at film in the vicinity of the cross cut was in sound condition;

.11.3 For the adhesion strength of the cross cut parts after the tests no peeling of the coat film could be noticed; and

.11.4 from the pencil hardness test and the adhesion strength test no significant
differences could be noticed between th e artificial seawater solutions with and without 20 mg/L sodi um hypochlorite was added.

5.3.3 The Group agreed that:

.1 the marine coatings evaluation study conducted by the applicant was useful and significant in evaluating the impact of 20 mg/L TRO concentration seawater on conventional marine epoxy coatings. In addition, the Group accepted from these
studies the conclusion that conventiona l epoxy systems shall be sufficiently protective in 20 mg/L TRO concentration treated seawater. However, as the proposed treatment concentration of the TG Ballastcleaner is 30 mg/L, these data may only be indicative of likely performance;

.2 with regards to corrosion of carbon steel , the applicants results and conclusions make it apparent that increased corrosion rate may be expected, but their studies did not sufficiently assess or quantify the expected corrosion ra te of carbon steel. Also, as the proposed treatment con centration of the TG Ballastcleaner is 30 mg/L TRO, these data may only be indicative of likely substrate corrosion effects since they were ca rried out at 20 mg/L TRO;

.3 the applicant did not provide either literature or test data which quantify the extent
of corrosion on either relevant metallic or non-metallic materials. While the need for epoxy coatings within the ballast tank s is recognized, it cannot be expected that ballast tanks will be maintained with a defect free coating systems as ship tanks can be expected to have exposed s ubstrates of up to 15% of the coated surface; and

.4 with respect to non-metallic materials, it is known that TRO exceeding 1 mg/l can cause degradation of some non-metallic materials commonly used as gaskets or sealing materials, but the applican t does not address this concern.

5.3.4 The Group recommended that the long term st udies, as appropriate, be carried out or otherwise documented from literature to quantify, at the treatment concentration, the expected uniform or localized corrosion rates on typical marine vessel metallic (e.g., steel, galvanized steel, zinc, stainless steel, et c...) and non-metallic materials (e .g., EPDM rubber) used for ballast tanks, fixtures and piping. Studies of the same rigor and approach of those submitted for the coatings effects are encouraged using methods wh ich are applicable for the direct measurement and quantification of corrosion rates or material degradation.GESAMP-BWWG 6/9

ANNEX 5 Page 26

I:\MEPC\58\2-7.doc 5.4 Other concerns

5.4.1 The Group noted that this system requires the onboard storage of solutions containing sodium hypochlorite, sodium hydroxide, sodium ch loride, sodium sulphite and sodium sulphate.

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

6.1 The Group noted that the following classificat ions could be made on the PBT-Criteria as presented in the table below:

Substance for PBT criteria Persistence (P)
( Yes or No ) Bioaccumulation (B)
( Yes or No ) Toxicity (T)
( Yes or No )

Trihalomethanes Yes No No

Sodium bromate Yes No No

Haloacetic acids Yes No No

Haloacetonitoriles Yes No No
Sodium sulphite No No No

6.2 Based on the results of tabl e 6.1 the Group concluded that th ese chemicals should not be
classified as PBT-substances.

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 The Group noted that the applicant had us ed the MAM-PEC model to estimate the
Predicted Environmental Concentrations of the va rious chemicals in the Port of Rotterdam.

7.2 From the data generated by the MAM-PEC model a nd the aquatic toxicity data associated with various Relevant Chemicals, the Group agreed on the PEC/PNEC ratios shown in the table below.

Calculation of the PEC/PNEC Ratios

Toxicity Value PNEC BW

conc. Dil.

factor PEC PEC/P
NEC Chemical substance

Endpoint Conc. (mg/l) Assess

ment

factor (μg/l) (μg/l)

Chloroform (freshwater) EC 50 72h 13.3 1000 13.3 40 58 0.69 0.052

Chloroform (seawater) LC 50 96h 28 1000 28 40 58 0.69 0.025

Bromoform (freshwater) LC 50 96h 29 1000 29 470 145 3.24 0.11

Bromoform (seawater) LC 50 96h 7.1 1000 7.1 470 145 3.24 0.46

Monochloroacetic acid EC 50 48h 0.028 1000 0.028 2 252 0.008 0.28

Trichloroacetic acid EC 50 96h 0.3 1000 0.3 30 102 0.294 0.98

Bromoacetic acid EC 50 72h 0.2 1000 0.2 7 58 0.121 0.61

Sodium sulphite EC 50 6.4-
8.9h 25.2 100 252 22000 67600 0.33 0.0013GESAMP-BWWG 6/9

ANNEX 5 Page 27

I:\MEPC\58\2-7.doc 7.3 The Group found that the assessment factor of 100 for the acute aq uatic toxicity of sodium sulphite was not regarded as sufficient and the lowest EC 50 was found to be 16 instead of 25.2 mg/L (Table 3.2.1.6, MEPC 57/2/8). Accordi ng to the Methodology an assessment factor of 1000 would have to be applied for an acute aqua tic toxicity value. However, even with an
assessment factor of 1000 an d application of the lower EC 50 the PEC/PNEC remains well below 1.

8 CONCLUSIONS AND RECOMMENDATIONS

8.1 Risks to the safety of the ship

8.1.1 The Group agreed that providi ng the precautions referred to under section 5, are adhered to, there should be no undue safety concerns for the ship while the additional work is carried out to allow an application for Final Approval to be made.

8.2 Risks to the crew and general public

8.2.1 Having considered the hazards and risk s associated with the onboard storage
of TG Ballastcleaner and TG E nvironmentalguard, the Group c oncluded that the major human health risk associated with the system is relate d to the corrosive properties of TG Ballastcleaner (up to 13% NaClO). Therefore, the Group recommended that engi neering measures are put in place in addition to the use of PPE/RPE in order to minimise human exposure.

8.2.2 The Group encouraged the app licant to proceed in the building up of the relevant human exposure scenarios according to HES methodology. In this context and in addition to the information already provided (e-mail 21/05/08 ), the Group recommended that following human exposure information related to TG Ballastcleaner should be addressed:

.1 in advance identification of all leaking poi nts; these are to be considered critical points for the HES (due to the corrosi ve properties of the preparation);

.2 foreseen safety measures for spills/l eaks in the waste water collection tank; and

.3 manual handheld (residual chlorine me ter) measurements of residual chlorine
concentration in the waste water tank.

8.3 Risks to the environment

8.3.1 Based on the information provided, the Group agreed that there would be no undue risks to the environment while the necessary work is being undertaken to make an application for Final Approval.

8.4 Recommendations

8.4.1 Having considered all of the data submitted for Basic Approval, the Group agreed to recommend to MEPC that Basic Appr oval be granted to this system.GESAMP-BWWG 6/9

ANNEX 5 Page 28

I:\MEPC\58\2-7.doc 8.4.2 When applying for Final Approval in the future, the following subjects need to be addressed carefully:

.1 Considering corrosion, the Group agr eed that the applicant’s response was insufficient to quantitatively assess the corrosion impact to relevant metallic and non-metallic materials likely to be used in ballast water tanks, piping and fixtures. For non-metallic gasket materials, the applicant responded that tests were not started since they have sufficient information for suitable materials but no details or data were provide.

.2 The applicant should provide appropriat e QAs and QCs and indicate why there are
different detection limits for the same substance being analysed.

.3 Further measurement and analysis of discharge concentration of THMs and HAAs with adequate QA/QC should be taken durin g the full scale land- based test before the submission of final approval.

.4 The chemical analyses for THMs were not performed under adequate QAPPs and so recommended that all chemical measurement and analyses should be performed under QAPPs.

.5 Final Approval submission should provide full details of the dosing control arrangements so as to ensure certainty of maintaining specified dosage levels of
Active Substances.

.6 The Group was satisfied that the fl ow diagram, provided, was suitable for Basic Approval. It is appreciated that fu rther details for evaluation be supplied for review during any Final Approval.

.7 The applicant indicated to continue gathering information related to the two chemicals, bromochloroacetic acid and bromodichloroacetic acid and, if no additional data were to be found, they would carry out further algal tests as required.

.8 The Group was satisfied that the applicant had given due preliminary
consideration to the concerns concerni ng temperature control put forward but requested that these safety mitigation m easures and requirements should be fully detailed in the operating manual pr esented for any Final Approval.

.9 Whilst recognizing the validity of the pressure monitoring/control, the Group
considered that further veri fication of this should be made during the ship board testing and included in the doc umentation for Final Approval.

.10 The Group is of the opinion that the acute toxicity testing for treated ballast water is needed and that the information for acute toxicity testing by simulated ballast water in a laboratory scal e and full scale land-based system for evaluation. In addition the Group requested that quantif ication analysis a nd degradation rates of sodium sulphite in various conditions should be carried out for the submission for Final Approval.GESAMP-BWWG 6/9

ANNEX 5 Page 29

I:\MEPC\58\2-7.doc .11 The Group recommended that the follo wing human exposure information related
to TG BallastCleaner should be addressed:

.1 in advance identification of all leak ing points; these are to be considered critical points for the HSE (due to the corrosive properties of the preparation);

.2 foreseen safety measures for spills/ leaks in the waste wa ter collection tank;
and

.3 manual handheld (residual chlorine meter) measurements of residual
chlorine concentration in the waste water tank.

* * *GESAMP-BWWG 6/9

ANNEX 5 Page 30

I:\MEPC\58\2-7.doc Appendix 5.1

Chemical and biological prop erties of Trihalomethanes

1 CHEMICAL IDENTIFICATION

1.1 Various data were presented on the follo wing chemicals included in this group:

.1 chloroform;

.2 bromodichloromethane;

.3 dibromochloromethane; and

.4 bromoform.

1.2 However, it was noted that no data had b een provided for dibromochloromethane which
had been identified in concentrations si milar to that of bromodichloromethane.

1.3 The chemical formulae and identification numbers are shown in paragraph 3.2.5 of the main section of this report.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Substance Type/Organism Endpoint Concentration (mg/l) Reference

Fish (Freshwater) ( Lepomis macrochirus ) LC 50 96h 18 IUCLID

Fish (seawater) ( Limanda limanda) LC 50 96h 28 as above

Crustacean (Freshwater) (Daphnia magna) EC 50 48h 29 as above

Crustacean (seawater) Brine shrimp ( Artemia salina ) EC 50 24h 30.37 G.D. Foster et al. (1984)

Phytoplankton (Freshwater) ( Chlamydomonas reinhardtii ) EC 50 72h 13.3 IUCLID Chloroform

Aquatic Plant (seawater) Diatom ( Skeletonema
costatum ) EC 50 120h 437 as above

Fish Common carp ( Cyprinus carpio ) egg EC 50
72-120h 67.4 J.S. Mattice et al. (1981)Bromodichloromethane

Crustacean
Ciliate ( Tetrahymena pyriformis ) EC 50 24h 240 Y. Yoshioka et al. (1985)

Dibromochloromethane Fish Common carp ( Cyprinus carpio ) egg LC 50 72-
120h 33.5 J.S. Mattice et al. (1981)GESAMP-BWWG 6/9

ANNEX 5 Page 31

I:\MEPC\58\2-7.doc

Substance Type/Organism Endpoint Concentration (mg/l) Reference

Crustacean
Ciliate ( Tetrahymena pyriformis ) EC 50 24h 65 Y. Yoshioka et al. (1985)

Fish (Freshwater)
Bluegill ( Lepomis
macrochirus ) LC 50 96h 29 R.J. Buccafusco et al. (1985)

Fish (Seawater) Sheepshead minnows ( Cyprinodon variegatus ) LC 50 96h 7.1 G.S. Ward et al. (1981)

Crustacean (Freshwater) Water flea ( Daphnia pulex ) LC 50 96h 44 J.R. Trabalka et al. (1977)

Crustacean (Seawater) Brown Shrimp ( Peaneus aziecus ) LC 50 96h 26 ECOTOX

Phytoplankton (Freshwater) Green algae ( Selenastrum capricornutum ) EC 50 96h 38.6 PAN Pesticides
Database Bromoform

Phytoplankton (Seawater)
Diatom ( Skeletonema costatum ) EC 50 96h 12.3 ECOTOX

2.2 Chronic Aquatic Toxicity Data

2.2.1 The Group noted that the applicant had identifi ed the species which was most sensitive to each of the chemicals and had provided chroni c toxicity data for each species/chemical
combination.

Substance Type/Organism Endpoint Conc. (mg/l) Reference

Chloroform Fish ( Oncorhynchus mykiss ) LC 50 27d 2.03 IUCLID

Crustacean ( Daphnia magna ) NOEC
21d 13 as above

Phytoplankton
Diatom ( Skeletonema costatum ) NOEC 5d 216 U.M. Cowgill
et al. (1989)

Bromoform Fish Sheepshead minnow ( Cyprinodon variegatus ) NOEC 4d 2.9 P.T. Heitmuller
et al. (1981)

Mollusk Littleneck clam ( Protothaca
staminea ) Not reported 7 C.I. Gibson et al. (1979)
NUREG/CR0835 PNL-3023 Phytoplankton Green algae ( Selenastrum capricornutum ) NOEC 4d 10 Pan Pesticides
Database Bromodichloromethane No data provided Dibromochloromethane No data providedGESAMP-BWWG 6/9

ANNEX 5 Page 32

I:\MEPC\58\2-7.doc 2.3 Information on Endocrine Disruption

2.3.1 The Group noted that the applicant had b een unable to find a ny information on the endocrine disruption poten tial of trihalomethanes.

2.4 Sediment Toxicity

2.4.1 The Group [noted][concurred with the applican t] that the evaluation of the effects on benthic organisms was unnecessary for trihalomethanes as the absorption coefficient of all chemicals in this group are <500 l/kg.

2.4.2 However, the Group indicated that it woul d have preferred to see specific values
identified rather than be described as “<500 l/kg”.

2.5 Bioavailability/Biomagnification/bioconcentration

2.5.1 The Group noted the following log Pow and cal culated BCF values for trihalomethanes and recognized that, as they were all <3, th e bioaccumulation potential of these compounds is expected to be low.

Chemical substance Log Pow BCF (l/kg) Reference

Relevant Chemicals
Chloroform 1.52 1.7 Syracuse Research Corporation,
Bromodichloromethane 1.61 2.0 Syra cuse Research Corporation,

Dibromochloromethane 1.70 2.4 Syra cuse Research Corporation,
Bromoform 1.79 2.8 Syracuse Research Corporation,

3 MAMMALIAN TOXICITY

3.1 The Group noted that no mammalian toxicity data had been provided for the group
of Trihalomethanes.

3.2 However, the Group recalled that it had be en considered necessary to review the toxicology of some THM generate d by other systems and consider ed that such a review was necessary for this system (pleas e see section 4 of the Report).

4 ENVIRONMENTAL FATE AND EFFECT 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

1/2-Life Seawater NR >60days MEPC 57/2/8, annex, para. 4.3GESAMP-BWWG 6/9

ANNEX 5 Page 33

I:\MEPC\58\2-7.doc 4.2 Partition Coefficients

Chemical substance log Pow BCF (l/kg) Reference

Relevant Chemicals
Chloroform 1.52 1.7 Syracuse Research Corporation
Bromodichloromethane 1.61 2.0 Sy racuse Research Corporation

Dibromochloromethane 1.70 2.4 Sy racuse Research Corporation
Bromoform 1.79 2.8 Syracuse Research Corporation

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 No information provided.

4.4 Reaction with Organic Matter

4.4.1 No information provided.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.5.1 No information provided.

4.6 Potential Residues in Seafood

4.6.1 No information provided.

5 PHYSICAL PROPERTIES

5.1 No physical property data were prov ided for this group of chemicals.

6 OTHER INFORMATION

6.1 Analytical Methods for Measuring the Co ncentration at Environmentally Relevant
Concentrations

6.1.1 No information provided.

6.2 Material Safety Data Sheet provided: No

6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P)
( Yes or No ) Bioaccumulation (B)
(Yes or No ) Toxicity (T)
( Yes or No )

Trihalomethanes Yes No No

* * *GESAMP-BWWG 6/9

ANNEX 5 Page 34

I:\MEPC\58\2-7.doc Appendix 5.2

Chemical and biological properties of Haloacetic acids and Haloacetonitriles

1 CHEMICAL IDENTIFICATION

1.1 Various data were presented on the follo wing chemicals included in this group:

.1 monochloroacetic acid;

.2 dichloroacetic acid;

.3 trichloroacetic acid;

.4 bromoacetic acid; and

.5 dibromoacetic acid.

1.2 The chemical formulae and identification numbers are shown in paragraph 3.2.5 of the main section of this report.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Substance Type Organism Endpoint Concentration (mg/l) Reference

Rotifera (monochloroacetic acid) Rotifer ( Brachionus calyciforus ) EC 50 48h 68.9 P. Radix et al. (1999)

Phytoplankton algae
(monochloroacetic

acid) Green algae ( Scenedesmus subspicatus ) EC 50 48h 0.028 R. Kuhn et al. (1990)

Others Amphibian
(dichloroacetic acid) African clawed frog ( Xenopus laevis ) EC 50 96h 3,560 D.J. Fort et al. (1993)

Fish
(trichloroacetic acid) Fathead minnow ( Pimephales promelas ) LC 50 96h 2,000 W.H. Dennis
Jr. et al. (1979)

Others Amphibian
(trichloroacetic acid) African clawed flog ( Xenopus laevis ) EC 50 96h 1,740 D.J. Fort et al. (1993)

Phytoplankton algae (trichloroacetic acid) Green algae ( Chlorella pyrenoidos a) LC 50 14d 0.3 T. Bednarz (1981)

Crustacean (bromoacetic acid) Water flea ( Daphnia

magna ) EC 50 24h 65 R. Kuhn et al. (1989)

Phytoplankton
(bromoacetic acid) Green algae ( Scenedesmus subspicatus ) EC 50 72h 0.2 as above (1990)Haloacetic
acids

Fish (dibromoacetic acid) Fathead minnow ( Pimephales promela s) LC 50 96h 69 M.A. Mayes
et al . (1985)
ECOTOXGESAMP-BWWG 6/9

ANNEX 5 Page 35

I:\MEPC\58\2-7.doc

Substance Type Organism Endpoint Concentration (mg/l) Reference

Haloacetonitriles Fish (dibromoacetonitrile) Fathead minnow ( Pimephales promelas ) LC 50 96h 0.55 M.A. Mayes
et al. (1985)

2.2 Chronic Aquatic Toxicity Data

Substance Type/Organism Endpoint Concentration
(mg/l) Reference

Chloroacetic acid Crustacean Water flea ( Daphnia magna ) NOEC 21d 32 R. Kuhn et al. (1989)

Bromoacetic acid Crustacean Water flea ( Daphnia magna ) NOEC 21d 3.2 as above

2.3 Information on Endocrine Disruption

2.3.1 The Group noted that the applicant had b een unable to find a ny information on the endocrine disruption potential of ha loacetic acids or haloacetonitriles.

2.4 Sediment Toxicity

2.4.1 The Group noted that the eval uation of the effects on bent hic organisms was unnecessary
for haloacetic acids and haloacetonitriles as the absorption coefficient of all chemicals in this group are <500 l/kg.

2.4.2 However, the Group indicated that it woul d have preferred to see specific values
identified rather than be described as “<500 l/kg”.

2.5 Bioavailability/Biomagnification/bioconcentration

2.5.1 The Group noted the following log Pow and ca lculated BCF values for the haloacetic acids and haloacetonitriles and recognized that , as they were all <3, the bioaccumulation potential of these compounds is expected to be low.

Chemical substance logPow BCF (l/kg) Reference

Relevant Chemicals

Chloroacetic acid 0.34 2.1×10 -1 Syracuse Research Corporation,

Dichloroacetic acid 0.52 3.0×10 -1 Syracuse Research Corporation,

Trichloroacetic acid 1.44 1.5 Syracuse Research Corporation,

Bromochloroacetic acid 0.61 3.5×10 -1 Syracuse Research Corporation,

Bromoacetic acid 0.43 2.5×10 -1 Syracuse Research Corporation,

Dibromoacetic acid 0.70 4.1×10 -1 Syracuse Research Corporation,

Chloroacetonitrile 0.11 1.4×10 -1 Syracuse Research Corporation,

Dichloroacetonitrile 0.29 2.0×10 -1 Syracuse Research Corporation,
Trichloroacetonitrile 1.21 1.0 Syracuse Research Corporation,

Bromoacetonitrile 0.20 1.7×10 -1 Syracuse Research Corporation,

Dibromoacetonitrile 0.47 2.7×10 -1 Syracuse Research Corporation,

Monochloramine -1.19 1.4×10 -2 Syracuse Research Corporation,GESAMP-BWWG 6/9

ANNEX 5 Page 36

I:\MEPC\58\2-7.doc 3 MAMMALIAN TOXICITY

3.1 The Group noted that no mammalian toxicity data had been provided for the group of
haloacetic acids haloacetonitrils and haloamines.

3.2 However, the Group recalled that it had be en considered necessary to review the toxicology of some HAA generated by other systems and cons idered that such a review was necessary for this system (section 4 of the Report).

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

1/2-Life Seawater NR >60days MEPC 57/2/8, annex, para. 4.3

4.2 Partition Coefficients

Chemical substance logPow BCF (l/kg) Reference

Relevant Chemicals

Chloroacetic acid 0.34 2.1×10 -1 Syracuse Research Corporation,

Dichloroacetic acid 0.52 3.0×10 -1 Syracuse Research Corporation,

Trichloroacetic acid 1.44 1.5 Syracuse Research Corporation,

Bromochloroacetic acid 0.61 3.5×10 -1 Syracuse Research Corporation,

Bromoacetic acid 0.43 2.5×10 -1 Syracuse Research Corporation,

Dibromoacetic acid 0.70 4.1×10 -1 Syracuse Research Corporation,

Chloroacetonitrile 0.11 1.4×10 -1 Syracuse Research Corporation,

Dichloroacetonitrile 0.29 2.0×10 -1 Syracuse Research Corporation,
Trichloroacetonitrile 1.21 1.0 Syracuse Research Corporation,

Bromoacetonitrile 0.20 1.7×10 -1 Syracuse Research Corporation,

Dibromoacetonitrile 0.47 2.7×10 -1 Syracuse Research Corporation,

Monochloramine -1.19 1.4×10 -2 Syracuse Research Corporation,

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 No information provided.

4.4 Reaction with Organic Matter

4.4.1 No information provided.GESAMP-BWWG 6/9

ANNEX 5 Page 37

I:\MEPC\58\2-7.doc 4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.5.1 No information provided.

4.6 Potential Residues in Seafood

4.6.1 No information provided.

5 PHYSICAL PROPERTIES

5.1 No physical property data were prov ided for this group of chemicals.

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Co ncentration at Environmentally Relevant
Concentrations

6.1.1 No information provided.

6.2 Material Safety Data Sheets provided No

6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P)
( Yes or No ) Bioaccumulation (B)
( Yes or No ) Toxicity (T)
( Yes or No )

Haloacetic acids Yes No No

Haloacetonitoriles Yes No No

* * *GESAMP-BWWG 6/9

ANNEX 5 Page 38

I:\MEPC\58\2-7.doc Appendix 5.3

Chemical and biological prop erties of Sodium bromate

1 CHEMICAL IDENTIFICATION

1.1 The chemical formula and identification numbers are shown in paragraph 3.2.5 of the main section of this report.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

2.2 Chronic Aquatic Toxicity Data

2.2.1 The Group noted that no chronic aquatic toxi city data had been supplied for sodium
bromate.

2.3 Information on Endocrine Disruption

2.3.1 The Group noted that the applicant had b een unable to find a ny information on the endocrine disruption potential of sodium bromate.

2.4 Sediment Toxicity

2.4.1 The Group noted that the eval uation of the effects on bent hic organisms was unnecessary for sodium bromate as its absorption coefficient is <500 l/kg.

2.5 Bioavailability/Biomagnification/bioconcentration

2.5.1 The Group noted that no data had been provi ded for sodium bromate but as an inherent component of seawater agreed that it was unnecessary to provide it.

3 MAMMALIAN TOXICITY

3.1 The Group noted that no mammalian toxicity data had been provided for sodium bromate.

3.2 However, the Group recalled that bromate ions are deemed to be genotoxic/carcinogenic and information should be provided in the application for Final Approval. Type Organism Endpoint Concentration (mg/L) Reference

Mollusk Pacific oyster ( Crassostrea gigas ) EC 50 96h > 30 E.A. Crecelius (1979)

Nematodes &
Flatworms Planarian ( Polycelis nigra ) LT 50 48h 3,018 J.R. Erichsen
Jones (1941)GESAMP-BWWG 6/9

ANNEX 5 Page 39

I:\MEPC\58\2-7.doc 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

1/2-Life Seawater NR >60days MEPC 57/2/8, annex, para. 4.3

4.2 Partition Coefficients

Chemical substance log Pow BCF (l/kg) Reference

Relevant Chemicals

Sodium bromate -7.18 3.7×10 -7 Syracuse Research Corporation,

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 No information provided.

4.4 Reaction with Organic Matter

4.4.1 No information provided.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.5.1 No information provided.

4.6 Potential Residues in Seafood

4.6.1 No information provided.

5 PHYSICAL PROPERTIES

5.1 No physical property data were prov ided for this group of chemicals.

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Co ncentration at Environmentally Relevant
Concentrations

6.1.1 No information provided.

6.2 Material Safety Data Sheets provided No

6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P)
( Yes or No ) Bioaccumulation (B)
( Yes or No ) Toxicity (T)
( Yes or No )

Sodium bromate Yes No No

* * *GESAMP-BWWG 6/9

ANNEX 5 Page 40

I:\MEPC\58\2-7.doc Appendix 5.4

Chemical and biological prop erties of Sodium sulphite

1 CHEMICAL IDENTIFICATION

1.1 The chemical formula and identifica tion numbers are shown in paragraph 3.2.5.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Type Organism Endpoint Concentration (mg/l) Reference

Fish Leuciscus idus NOEC 96h
LC 50 96h 220
220-460 IUCLID

Crustacean Daphnia magna TL
m 100h 203 as above

Mollusk Buccinum undatum LC 50 24h 400 as above

Echinoderm Psammechinus miliaris LC 50 24h 330(as SO 3 ) as above

Phytoplankton Green algae ( Chlamydomonas reinhardtii ) ( Chlorella vulgaris ) ( Scenedesmus basiliensis ) EC 50 8.9h
EC 50 6.4h
EC 50 8.2h 16-32 (as SO 3 )
as above
as above as above

A. STAMM (1980)

2.2 Chronic Aquatic Toxicity Data

2.2.1 The Group noted that no chronic toxicity da ta had been provided for sodium sulphite.

2.3 Information on Endocrine Disruption

2.3.1 The Group noted that the applicant had b een unable to find a ny information on the endocrine disruption poten tial of sodium sulphite.

2.4 Sediment Toxicity

2.4.1 The Group noted that the eval uation of the effects on bent hic organisms was unnecessary for sodium sulphite as its ab sorption coefficient is<500 l/kg.

2.5 Bioavailability/Biomagnification/bioconcentration

2.5.1 The Group noted the following log Pow and cal culated BCF values sodium sulphite and recognized that, as it is <3, th e bioaccumulation potential of it is expected to be low.

Chemical substance log Pow BCF (l/kg) Reference

Active substance
Sodium Sulphite -7.78 1.3×10 -7 Syracuse Research Corporation,GESAMP-BWWG 6/9

ANNEX 5 Page 41

I:\MEPC\58\2-7.doc 3 MAMMALIAN TOXICITY

3.1 Oral Toxicity

Substance Species (animal) LD 50 Reference

Sodium sulphite Rat 2.61 g/kg bw IUCLID, Na 2 SO 3, (2000)

3.1.1 According to the presented data, sodium sulphite is not considered to be an acute toxicant by oral route.

3.2 Dermal Toxicity

3.2.1 No data provided.

3.3 Inhalation Toxicity

3.3.1 No data provided.

3.4 Corrosion/Irritation

3.4.1 Skin irritation data

Substance Species (animal) Exposure
duration Concentration Observation and
remark Reference

Sodium sulphite Rabbit Not reported Not reported Not irritating

Draize IUCLID,
Na 2 SO 3, (2000)

3.4.1.1 According to the presented data, sodium sulph ite is not considered to be a skin irritant.

3.4.2 Eye Irritation data

Substance Species (animal) Exposure
duration &
concentration Method Observation and
remark Reference

Sodium sulphite Rabbit Not reported BASF-test Not irritating IUCLID,

Na 2 SO 3, (2000)

3.4.2.1 According to the presented data, sodium sulph ite is not considered to be an eye irritant.

3.5 Sensitization

3.5.1 No data provided.

3.6 Repeated Dose Toxicity

Substance Species (animal) Dosage route &
concentration Duration of
treatment Observation and
remark Reference

Sodium sulphite No data.
WHO has recognized as non toxic. WHO Food
Additives
Series21 IPCS
INCHEM HomeGESAMP-BWWG 6/9

ANNEX 5 Page 42

I:\MEPC\58\2-7.doc 3.6.1 According to the presented data, there seemed to be no relevant toxicological concerns towards repeated exposure to sodium sulphite.

3.7 Developmental toxicity data

Substance Species (animal) Dosage route &
concentration Duration of
treatment Observation
and remark Reference

Sodium sulphite Rat
Wistar Oral Feed 0.32; 0.63; 1.25; 2.5 and,5% (300, 1100, 2100 and 3300 mg/kg) 8-20 days of gestation, daily 20 days and
after birth. No significant
effect IUCLID Na 2 SO 3 (55)(56)(57)

3.7.1 From the submitted data there seems to be no relevant toxicological concerns towards developmental toxicity.

3.8 Reproductive Toxicity Data

Substance Species (animal) Dosage route &
concentration Duration of
treatment Observation
and remark Reference

Sodium sulphite No data With WHO’s recognition testing for reproductive toxicity is deemed

unnecessary. WHO Food
Additives
Series 21 IPCS
INCHEM Home

3.9 Carcinogenicity

Substance Species (animal) Type of test,
duration Doses (mg/L, FAC) Observation and
remark Reference

Sodium sulphite No specific data IARC designates as “group 3”. Pan
Pesticides

Database

3.9.1 Sodium sulphite is classified as IARC group 3 (Not classifiable as to its carcinogenicity) since no data were available on the carcinogeni city in experimental animals of sulphites. Evaluation by IARC states that there is inadequate evidence for the carcinogenicity in experimental animals of sulphites.

3.10 Mutagenicity

Substance Species Type of test Concentration (mg/l) Observation
and remark Reference

Sodium sulphite In vitro : Salmonella typhimurium OECD
Guide-line
471 “Genetic Toxicology:
Salmonella typhimurium
Reverse
Mutation Assay” 20-500 μg/ plate
Metabolic activation:
with and without Negative IUCLID
Na 2 SO 3 (2000)GESAMP-BWWG 6/9

ANNEX 5 Page 43

I:\MEPC\58\2-7.doc 3.10.1 From the submitted data on Ames test th ere seems to be no relevant toxicological concerns towards mutagenicity.

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

1/2-Life Seawater NR >60days MEPC 57/2/8, annex, para. 4.3

4.2 Partition Coefficients

Chemical substance log Pow BCF (l/kg) Reference

Relevant Chemicals

Sodium bromate -7.18 3.7×10 -7 Syracuse Research Corporation,

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 No information provided.

4.4 Reaction with Organic Matter

4.4.1 No information provided.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.5.1 No information provided.

4.6 Potential Residues in Seafood

4.6.1 No information provided.

5 PHYSICAL PROPERTIES

5.1 No physical property data were prov ided for this group of chemicals.

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Co ncentration at Environmentally Relevant
Concentrations

6.1.1 No information provided.

6.2 Material Safety Data Sheets provided NoGESAMP-BWWG 6/9

ANNEX 5 Page 44

I:\MEPC\58\2-7.doc 6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P)
(Yes or No ) Bioaccumulation (B)
( Yes or No ) Toxicity (T)
( Yes or No )

Sodium sulphite No No No

* * *GESAMP-BWWG 6/9

ANNEX 5 Page 45

I:\MEPC\58\2-7.doc Appendix 5.5

Chemical and biological propert ies of Sodium hypochlorite

1 CHEMICAL IDENTIFICATION

1.1 The chemical formula and identification num bers for sodium hypochlorite are shown in paragraph 3.2.5 of the main section of this report.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 The Group noted that no data had been provi ded for the effects of sodium hypochlorite on aquatic organisms.

2.2 However, the Group recognized that as th is Active Substance employed as part of the BWMS is degraded by the use of sodium sulphi te before being released into the sea, such information was unnecessary.

3 MAMMALIAN TOXICITY

Regarding the toxicological eval uation of sodium hypochlorite pleas e see section 4 of the Report.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

4.1.1 The Group noted that such information was not necessary as the product is denatured with sodium sulphite prior to the ballast water being released into the sea.

4.2 Partition Coefficients

4.2.1 The Group noted that such information was not necessary as the product is denatured with sodium sulphite prior to the ballast water being released into the sea.

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 No information provided but none necessary.

4.4 Reaction with Organic Matter

4.4.1 No information provided but none necessary.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.5.1 No information provided but none necessary.GESAMP-BWWG 6/9

ANNEX 5 Page 46

I:\MEPC\58\2-7.doc 4.6 Potential Residues in Seafood

4.6.1 No information provided but none necessary.

5 PHYSICAL PROPERTIES

5.1 The Group noted the physical properties of sodium hypochlorite, as provided by the applicant, and shown in the table below:

Chemical name Sodium hypochlorite

Molar mass 74.44 g/mol

Formula NaClO

Melting point -20 to -30oC

Boiling point 96 to 120oC at 1013 hPa

Specific gravity 1.15 (13.1wt% as FAC) aqueous solution at 25oC

Vapor Pressure 17.4 – 20 kPa at 20oC

Aqueous solubility 29.3 g/100g at 0oC

PH >11.5

Octanol-water partition coefficient log Pow=-3.42

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Co ncentration at Environmentally Relevant
Concentrations

6.1.1 No information provided.

6.2 Material Safety Data Sheets provided No

6.3 GHS Classification Not provided

6.4 Risk Characterization

Substance for PBT criteria Persistence (P)
( Yes or No ) Bioaccumulation (B)
( Yes or No ) Toxicity (T)
( Yes or No )

* * *GESAMP-BWWG 6/9

ANNEX 5 Page 47

I:\MEPC\58\2-7.doc Appendix 5.6

Chemical and biological prop erties of sodium sulphate

1 CHEMICAL IDENTIFICATION

1.1 The chemical formula and identification num bers for sodium sulphate are shown in paragraph 3.2.5 of the main section of this report.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 The Group noted that the applicant had not provided any data on the effects of sodium hypochlorite on aquatic organisms.

2.2 However, the Group agreed that, as this w ould be discharged to sea at 1% of the concentration of natural seawater, such data would not be required.

3 MAMMALIAN TOXICITY

3.1 Oral Toxicity

Substance Species (animal) LD 50 Reference

Sodium sulfate Mouse 5.99 g/kg bw OECD SIDS,
Okahara, (2005)

3.3.1 According to the presented data , sodium sulfate is not consid ered to be an acute toxicant by oral route.

3.2 Dermal Toxicity

2.2.1 No data provided.

3.3 Inhalation Toxicity

2.2.2 No data provided.

3.4 Skin irritation data

Substance Species (animal) Exposure
duration Concentration Observation and
remark Reference

Sodium
sulfate Rabbit 4 hours

Occlusive 500 mg Slightly irritating

EC classification-not irritating OECD 404,
Draize OECD SIDS,
Na 2 SO 4, (2005)

3.4.1 According to the presented data, sodium sulph ite is not considered to be a skin irritant.GESAMP-BWWG 6/9

ANNEX 5 Page 48

I:\MEPC\58\2-7.doc 3.5 Eye Irritation data

Substance Species (animal) Exposure
duration &
concentration Method Observation and
remark Reference

Sodium
sulfate Rabbit 90 mg, pulverized

into conjunctival

sac OECD guideline
405 Slight irritating
redness of the conjunctiva
observed. The
redness was
reversible within 7 days. OECD SIDS,

Na 2 SO 4, (2005)

3.5.1 According to the presented data, sodium sulfat e is not considered to be an eye irritant.

3.6 Sensitization

3.6.1 No data provided

3.7 Repeated Dose Toxicity

Substance Species (animal) Dosage route &
concentration Duration of
treatment Observation and
remark Reference

Sodium
sulfate Rats Sprague Dawley In food 0.84% in
diet 27 and 44 weeks daily NOAEL 320-400 mg/kg/day

Mortality, tumor, Body weight, food
and water consumption OECD SIDS,
Na 2 SO 4, (2005)

3.7.1 According to the presented data, there seemed to be no relevant toxicological concerns towards repeated exposure to sodium sulfate.

3.8 Developmental toxicity data

Substance Species (animal) Dosage route &
concentration Duration of
treatment Observation
and remark Reference

Sodium
sulfate The limited available data give no indication that sodium sulfate is toxic for development. OECD SIDS (2005)

3.8.1 From the submitted data there seems to be no relevant toxicological concerns towards developmental toxicity.GESAMP-BWWG 6/9

ANNEX 5 Page 49

I:\MEPC\58\2-7.doc 3.9 Reproductive Toxicity Data

Substance Species (animal) Dosage route &
concentration Duration of
treatment Observation
and remark Reference

Sodium
sulfate The available data on fertility are quite limited but in view of the fact that the substance is abundantly oc curring in the body, toxicity for reproduction is unlikely. OECD SIDS (2005)

3.9.1 From the submitted data there seems to be no relevant toxicological concerns towards reproductive toxicity.

3.10 Carcinogenicity

Substance Species (animal) Type of test,
duration Doses (mg/l, FAC) Observation and
remark Reference

Sodium
sulfate Swiss
albino
mice Carcinogenicity 26 weeks, daily 31 μg in 0.01 ml (0.9%) per g body weight, s.c. injected Tumor of subcutis
and/or skin in 1%
of the female and
4% in male (normal for this strain in this lab). OECD SIDS (2005)

3.10.1 From the submitted data there seems to be no relevant toxicological concerns towards carcinogenicity.

3.11 Mutagenicity

Substance Species Type of test Concentration (mg/l) Observation
and remark Reference

Sodium
sulfate In vitro : Salmonella typhimurium Ames test
under GLP

Salmonella
Microsome
test 312-5,000μg
Metabolic S-9
activation: with and
without Negative OECD SIDS (2005)

3.11.1 From the submitted data on Ames test th ere seems to be no relevant toxicological concerns towards mutagenicity.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

4.1.1 The Group noted that such information was not necessary as the product is denatured with sodium sulphite prior to the ballast water being released into the sea.

4.2 Partition Coefficients

4.2.1 The Group noted that such information was not necessary as the product is denatured with sodium sulphite prior to the ballast water being released into the sea.GESAMP-BWWG 6/9

ANNEX 5 Page 50

I:\MEPC\58\2-7.doc 4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 No information provided but none necessary.

4.4 Reaction with Organic Matter

4.4.1 No information provided but none necessary.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.5.1 No information provided but none necessary.

4.6 Potential Residues in Seafood

4.6.1 No information provided but none necessary.

5 PHYSICAL PROPERTIES

Chemical name Sodium sulfate

Molar mass 142.05 g/mol

Formula Na 2 SO 4
Melting point 888oC

Boiling point 1429 oC

Specific gravity 1.10 g/cm3 (10wt%) at 27oC

Vapor Pressure Substantially 0 mm Hg at ambient temperature

Aqueous solubility 19.5 g/100g at 0oC

PH Neutral

Octanol-water partition coefficient logPow=-4.4

6 OTHER INFORMATION

6.1 Analytical Methods for measuring the Co ncentration at Environmentally Relevant
Concentrations

6.1.1 No information provided.

6.2 Material Safety Data Sheet No

6.3 GHS Classification No

6.4 Risk Characterization

***GESAMP-BWWG 6/9

I:\MEPC\58\2-7.DOC ANNEX 6

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

A Combined Ballast Water Management System consisting of Sediment Removal and an Electrolytic Process using Seawater to produce Active Substances

Submitted for Basic Approval by the Netherlands

0 SUMMARY

0.1 The Group noted that the Combined Ball ast Water Management System uses a combination of filtration and electrolysis to treat the ballast water.

0.2 The Group was satisfied that, as the system do es not involve the storage or generation of chemicals to treat ballast water, there were no associated storage safety problems.

0.3 However, it was recognized that the system produces vari ous Relevant Chemicals with safety and environmental concerns.

0.4 The Group reviewed the hazards and risk s associated with each of the Relevant Chemicals, as shown in appendices 1-3.

0.5 The Group concluded that chlorinated and brominated disinfection by-products are the toxicological relevant compounds generated by the process as they have a potential for human genotoxicity/carcinogeni city; therefore they will have to be kept below toxicological critical levels (bromoform <100 μg/L, WHO Guidelin es for Drinking Water Quality, 2003). The Group noted that the applicant didn’t provide information concerning the Human Exposure Scenario (MEPC 56/2/2, annex 9) and theref ore the risk characterization for human health could not be adequately performed.

0.6 Having reviewed all the information in the non-confidential submission and all information received from the Applicant during the GESAMP-BWWG meeting the Group decided to propose to MEPC to grant Ba sic Approval to the BWMS submitted by the Netherlands with the following considerations if the system has to be reviewed for Final Approval in the future:

.1 All the topics addressed under Chapte r 2 (Completeness of the Dossier as mentioned below) have to be a ddressed by the Applicant carefully.

.2 The Group noted that the applicant did not provide information concerning the Human Exposure Scenario (MEPC 56/2/2, annex 9) a nd therefore the risk
characterization for human health co uld not be adequately performed.

.3 The Group considered that the organic c ontent of the test water with treated
natural seawater should be provided for Final Approval.

.4 The Group considered that the Level of Quantification (LOQ) for the haloacetic acids were too high. This may lead to unders tatement of the potential levels in the
treated ballast water. This uncertainty should be clarif ied in additional analyses during the full scale test ing on land and/or onboard ships by the applicant.GESAMP-BWWG 6/9

ANNEX 6 Page 2

I:\MEPC\58\2-7.doc 1 INTRODUCTION

1.1 The data used to evaluate this syst em were extracted from that supplied by the Netherlands in document MEPC 57/2/7, whic h was supplemented by additional confidential information provided by the applicant after a re quest for further information by the Group during its meeting. The Group recognized by that the su bmission by the Netherlands did not contain any confidential information.

2 COMPLETENESS OF DOSSIER

2.1 The Group had the following concerns which it considered should be addressed prior to application for Final Approval. Having put such concerns to the applicant, the Group’s reaction to the responses received are also shown below:

.1 a more detailed description of the sy stem needs to be provided to include
inter alia:

.1 system layout – the Group agreed th at the additional information provided was acceptable for Basic Approval;

.2 details of the protection devices an d failsafe controls incorporated – the Group agreed that the additional in formation provided was acceptable for Basic Approval;

.3 specific details of the treatmen t (e.g., is treatment upon intake and/or treatment upon discharge) – the Gr oup agreed that the additional information provided was acceptable;

.4 maximum dose concentration – the Group noted that this was stated as 2mg/L but not consistently repor ted throughout the documentation;

.5 maximum allowable discharge co ncentration – Having received the response from the applicant, the Gro up still wanted to know the maximum discharge concentration that the system would produce NOT what is allowable; and

.6 means of determining and contro lling dosage rates (including differing salinity of uptake water) – Having received the response from the applicant, the Group was sa tisfied that the additi onal information provided was acceptable for Basic Approval noting that it was not sufficient for Final Approval;

.2 it was noted that the tests referred to in the submission had been carried out with a single dose of 10 mg/L sodium hypochlorite and this resulted in table 2.4 where different disinfection by-products had been determined. It was not clear what would happen if the system had been a pplied at both ballasti ng and deballasting – the response satisfied the Group but it sti ll wanted to know the concentration of by-products at the point of discharge;GESAMP-BWWG 6/9

ANNEX 6 Page 3

I:\MEPC\58\2-7.doc .3 the quantification of THMs and HAAs for salted fresh water maybe completely
different from those obtained from na tural seawater or brackish water – the applicant indicated that tests had be en carried out in natural seawater;

.4 the Group needed clarification of whether the doses are for both ballast intake and discharge and how it is ensured that the maximum concentration of FAC is environmentally acceptable at the time of discharge – the Group was not entirely satisfied with the response and agreed th at a complete descri ption of monitoring and control systems would be needed for Final Approval;

.5 the Group noted that the application, i ndicated that the generation of free hydrogen gas does not pose risk to the sh ip or crew but requested further
verification of this statement – Based on the response, the Group recognized that
the theoretical calculati ons indicated little risk, however, as hydrogen will be
entrained in solution and the treated ballast water in the tank will have little free volume then this risk will require furthe r evaluation during full scale testing to verify the calculated no risk indicated;

.6 results of the corrosion monitoring need to be presented – the Group agreed that the information provided was acceptable for Basic Approval but more information would be required for Final Approval;

.7 the risks associated with the additional known by-products may need to be quantified e.g., dibromochloromethane and bromochloroacetic acid. The additional data provided to the Group were acceptable for Basic Approval;

.8 references 1 and 10-18 had not been included on the CD - these were subsequently sent; and

.9 the Group requested the input parameters used to run the MAMPEC model for all substances – these data were provided and the Group noted that the calculated PEC had been made using a degradation ra te for FAC but if this was not applied the resultant PEC produces a PEC/PNEC ra tio of 70 and 110. Whilst recognizing that the PEC is a long term steady state value, some concern was still expressed that the short term exposure had not been taken properly into account. It was also agreed that this treatment system require d further development and refinement as system discharging this le vel of FAC would probably not be recommended, by the Group, for Final Approval.

3 DESCRIPTION OF THE SYSTEM

3.1 Overview

3.1.1 The Group noted that this Ba llast Water Management System (BWMS) consists of two modular components:

.1 the Sedimentor , a multi-hydrocyclone unit, which is reported as being capable of removing particles >20 μm with an effici ency of 100% and particles of >10 μm with an efficiency of > 80%; andGESAMP-BWWG 6/9

ANNEX 6 Page 4

I:\MEPC\58\2-7.doc .2 the Termanox, which electrolyses the ballast water producing Active Substances including Free Active Chlorine (FAC) fo r the deactivation of biota, at both ballasting and de-ballasting.

3.1.2 In addition it was noted that both the Sedi mentor and the Termanox comprise modular components to handle ballast wa ter flows ranging from 50 m 3 /h to >5,000 m 3 /h.

3.1.3 The applicant indicated that the type of elec trolytic cell employed in this system has a long-lasting coating that requires maintenance (cl eaning) once a year for approximately three to five years.

3.1.4 The Group noted that no chemicals are st ored onboard as the FAC is generated in situ

.

3.2 Chemical reactions involved in the electrolysis of seawater (provided by the applicant)

An idealized drawing of a cell in which an aqueous solution of sodium ch loride is electrolysed

NaCl (s) + H2O (l) Æ Na + (aq)+ Cl - (aq)

3.2.1 The Na + ions migrate toward the negative electrode and the Cl - ions migrate toward the positive electrode. There are two substances that can be reduced at the cathode: Na + ions and
water molecules.

Cathode (-):

Na + + e - Na E o red = -2.71 V

2 H 2 O + 2 e - H 2 + 2 OH - E o red = -0.83 V

3.2.2 Because it is much easier to reduce water than Na + ions, the only product formed at the cathode is hydrogen gas.

3.2.3 There are also two substances th at can be oxidized at the anode: Cl - ions and water
molecules.

Anode (+):

2 Cl - Cl 2 + 2 e - E o

ox = -1.36 V

2 H 2 O O 2 + 4 H + + 4 e - E o

ox = -1.23 VGESAMP-BWWG 6/9

ANNEX 6 Page 5

I:\MEPC\58\2-7.doc 3.2.4 The standard-state potentials for these half-r eactions are so close to each other that we might expect to see a mixture of Cl 2 and O 2 gas collect at the anode. In practice, the only product
of this reaction is Cl 2

.

3.2.5 In summary, electrolysis of aqueous Na Cl solutions gives a mixture of hydrogen and chlorine gas and an aqueous sodium hydroxide solution.

2 NaCl( aq ) + 2 H 2 O( l ) 2 Na + ( aq ) + 2 OH - ( aq ) + H 2 ( g ) + Cl 2 ( g )

3.2.6 The products of the electrolysis of aqueous sodium chloride react with water to form sodium hypo-chlorite.

Cl 2 ( g ) + H2O( l ) HOCl( aq ) + H + (aq) + Cl - ( aq )

HOCl (aq) H + (aq) + ClO - (aq)

3.2.7 The Group noted that the applicant did not in clude or consider the bromide analogues of
these reactions in natural seawater.

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

3.3.1 It was recognized that the generation of Free Active Chlorine (FAC), by electrolysis, leads to the formation of other halogenated by-p roducts in seawater du e to the reaction with organic compounds and other components in seawater such as ammonia.

3.3.2 The applicant identified Free Active Chlorine (FAC) and Total Residual Chlorine
as Active Substances and measured their concen trations in seawater taken from the harbour of Harlingen (the Netherlands) and treated with the system at a rate of 100 m 3 /h. It was noted that neither the initial dose leading to the concentration of TRC and FAC shown below nor the organic content of the test water, was indicated. Th e results are shown below:

Active Substance Sampling time (minutes after treatment)

Control (Untreated water) 0 30 120

TRC mg/L <0.01 2.38 1.83 1.15

FAC mg/L <0.01 1.67 1.25 0.51

3.3.3 The Group noted that the applicant had id entified the following potential Relevant Chemicals which might be formed as a result of the treatment process and which had been the quantifiably analysed in the treated ballast water. The results of the analyses provide are shown
in the table below:GESAMP-BWWG 6/9

ANNEX 6 Page 6

I:\MEPC\58\2-7.doc Concentrations (μg/L) of potential Relevant Chemicals in treated natural seawater samples

Compound Time of Sampling After Treatment

Units Control 0 min 30 min 12 h 24 h

Halomethanes
dichloromethane μ g/L <1.0 <1.0 <1.0 <1.0 <1.0 1,1-dichloroethane μ g/L <0.5 <0.5 <0.5 <0.5 <0.5 1,2-dichloroethane μ g/L <0.5 <0.5 <0.5 <0.5 <0.5 trans-1,2-dichloroethene μ g/L <0.5 <0.5 <0.5 <0.5 <0.5 cis-1,2-dichloroethene μ g/L <0.5 <0.5 <0.5 <0.5 <0.5 1,2-dichloropropane μ g/L <0.5 <0.5 <0.5 <0.5 <0.5

trichloromethane μ g/L <0.1 <0.1 <0.1 <0.1 <0.1

tetrachloromethane μ g/L <0.1 <0.1 <0.1 <0.1 <0.1 1,1,1-trichloroethane μ g/L <0.1 <0.1 <0.1 <0.1 <0.1 1,1,2-trichloroethane μ g/L <0.1 <0.1 <0.1 <0.1 <0.1

trichloroethene μ g/L <0.1 <0.1 <0.1 <0.1 <0.1

tetrachloroethene μ g/L <0.1 <0.1 <0.1 <0.1 <0.1

sum C/T dichloroethene μ g/L <0.5 <0.5 <0.5 <0.5 <0.5 sum chloroaliphatics μ g/L <2.1 <2.1 <2.1 <2.1 <2.1

dibromomethane μ g/L <0.5 <0.5 <0.5 <0.5 <1.2

tribromomethane μ g/L <0.5 200 200 280 290

bromodichloromethane μ g/L <0.5 1.3 <0.5 <0.5 <0.5

dibromochloromethane μ g/L <0.5 9.5 9.1 12 13

Haloacetic acids
Chloroacetic Acid μ g/L <1 <1 <1 <1 <1

Dichloroacetic acid μ g/L <1 <1 <1 <1 <1

Trichloroacetic acid μ g/L <1 <1 <1 <1 <1

Bromoacetic acid μ g/L <1 <1 <1 <1 <1

Dibromoacetic acid μ g/L <1 62 50 64 <1

tribromoacetic acid μ g/L <1 <1 <1 <1 <1

Bromochloroacetic acid μ g/L <1 1.3 1.6 2.1 <1

Dibromochloroacetic acid μ g/L <1 <1 <1 <1 <1

Bromodichloroacetic acid μ g/L <1 <1 <1 <1 <1

3.3.4 It was noted that the halomethanes had been analysed according to NEN/ISO 15680 and that the haloacetic acids had been analysed using GC-MS, all analyses being performed at accredited laboratories. However, it was also noted that the applicant had not reported the organic content of the test water wh ich had yielded the above results.

3.3.5 The Group also noted that, in a separate test , using fresh surface water, to which salt had been added, chloroamines had been analysed. Wh ilst it was noted that no chloroamines had been detected in this test, concern was expressed th at the fresh water might not contain sufficient organic compounds, to produce measurable quantities of chloroamines as a result of the treatment process. As a result, the Group considered that the organic content of the test water should be provided for Final Approval.GESAMP-BWWG 6/9

ANNEX 6 Page 7

I:\MEPC\58\2-7.doc 3.3.6 Based on the analytical data shown in the table above an d general information about electrolysis, the Group concurred with the views of th e applicant that:

.1 Free Active Chlorine should be tr eated as an Active Substance;

.2 the hydroxyl radicals formed during the electrolytic process should not be regarded as Relevant Chemicals due to their very short half-lives; and

.3 the formation of hydrogen and chlorine, dur ing the process, shoul d be regarded as a potential safety hazard which needs to be evaluated further.

3.3.7 In addition, the Group considered that all identified by- products including dibromochloromethane, tribromomethane, dibr omoacetic acid and bromochloroacetic acid
should be treated as Relevant Chemicals and shoul d be analysed for in samples from the land based tests. The Group consid ered further that the Levels of Quantification (LOQ) for the haloacetic acids were too high and that this may lead to an undere stimation of the levels in the treated ballast water. This uncertainty should be clarified in additional analyses during the full scale testing on land and/or onboa rd ships by the applicant.

3.3.8 The physicochemical and biol ogical properties of the Active Substance and Relevant Chemicals are shown in appendices 1-3.

4 HUMAN HEALTH ASSESSMENT

4.1. The Group considered that the human health risk assessment had not been satisfactorily provided. Therefore, the Group recommended that for Final Approval th e following information
should be submitted:

.1 an (M)SDS of the active substances and relevant chemicals generated by the system (5. Methodology (G9));

.2 a description and full unde rstanding of the processes and unit operations in which human exposure may occur; and

.3 a human health risk assessment base d on the human exposure scenario – HES (7.2.3. Methodology, appendix 2 (G9)).

4.2 The Group noted that, accord ing to the presented data (Appendix I, part 3, Mammalian toxicity), tribromomethane is considered to be harmful by oral exposure. Furthermore,
tribromomethane is classified as toxic by inhalation (GHS classification, Annex VI, COM (2007) 355 final). However, dibromo acetic acid, is not consider ed to be an acute oral toxicant. Furthermore the Group co ncluded that the acute toxicity of sodium hypochlorite is low by the oral, dermal and inhalation routes of exposure.

4.3 It was also noted that hypochlorite is classi fied as a skin and eye irritant. Additionally, tribromo-acetic acid is considered to be corrosive to skin and eye. Tribromo-methane is classified as skin and eye irri tant, causing serious eye irritati on (GHS classification, Annex VI, COM (2007) 355 final).GESAMP-BWWG 6/9

ANNEX 6 Page 8

I:\MEPC\58\2-7.doc 4.4 From the submitted data, the Group noted that some reproductive toxicological effects were observed associated with exposure to dibromoacetic acid and tribromomethane to rodents at high doses.

4.5 Based on the overall information, the Group agreed that the relevant toxicological concerns related to human exposure towards hy pochlorite, tribromomethane and dibromoacetic acid were mostly acute in nature and should be addressed by the appropriate risk mitigation measures put in place.

4.6 In addition, Chlorinated and Brominated DP B have demonstrated a potential for human genotoxicity/carcinogenicity therefore the Group recommended that these relevant chemicals will have to be kept below toxicological critical levels (e.g., bromate <10 μg/L; bromoform <100 μg/L; chloroform <200 μg/L) WHO Guidelines for Drinking Water Quality, 2003).

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

5.1 The Group recognized that as the Active Subs tance and Relevant Chemicals are generated

in situ , there were not any storage ha zards or risks. Whilst recogni zing the irritancy potential to skin eyes and the respiratory system of FAC, at the concentrations, indica ted by the applicant, in
the treated ballast water or released into the e nvironment, the Group agreed that these chemicals were unlikely to pose any threat to people.

5.2 However, the Group agreed that additiona l safety precautions should be specified following further evaluation of the risks pos ed by the system, particularly including precautionary measures to be taken when entering ballast water tanks.

5.3 The Group noted that whilst the applicant stated that the electrolytic cells and connecting pipes were fully protected by spec ial coatings, no data or descri ptions were provided of these coatings and their resistant to highly oxidative solutions.

5.4 The Group also noted that ap plicant considers FA C corrosive but that its disappearance will be rapid and that tank coatings will be suffi cient corrosion mitigation. The Group noted that the applicant did not provide either literature or test data which quantify the extent of corrosion
on either relevant metallic or non-metallic mate rials at the treatment concentration or possible exposure concentration. While th e need for coatings within the ballast tanks is recognized, it cannot be expected that ballast tanks will be ma intained with a defect free coating systems as ship tanks can be expected to have exposed substr ates of up to 15% of the coated surface. With respect to non-metallic materials, it is known that TRC exceedi ng 1 mg/L can cause degradation of some non-metallic materials commonly used as gaskets or sealing materials requiring the use of fluorinated polymer materials.

5.5 Finally the Group recognized that the applican t did not provide either literature or test data which quantify the extent of corrosion on either relevant me tallic or non-metallic materials. While the need for epoxy coatings within the balla st tanks is recognize d, it cannot be expected
that ballast tanks will be maintained with a de fect free coating systems as ship tanks can be expected to have exposed substrates of up to 15% of the coated surface.

5.6 With respect to non-metallic materials, it is known that TRO exceeding 1 mg/L can cause degradation of some non-metallic materials commonly used as gaskets or sealing materials, but the applicant does not address this concern.GESAMP-BWWG 6/9

ANNEX 6 Page 9

I:\MEPC\58\2-7.doc 5.7 The Group recommends that long-term studies, as appropriate, be carried out or otherwise documented from literature to quantify, at the treatment and possible exposure concentrations, resultant ballast tank coatings degradation and th e expected uniform and localized corrosion rates on typical marine vessel metallic (e.g., steel, galvan ized steel, zinc, stainless steel, etc.) and non-metallic materials (e.g., EPDM rubber) materials us ed for ballast tanks, fixtures and piping.

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

6.1 The Group agreed on the following PBT characte ristics of the AS and RC associated with this system:

Chemical Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n)

Sodium hypochlorite (FAC) No No Yes

Tribromomethane Yes No No 2,2-Dibromoacetic acid No No No

6.2 Based on the results of tabl e 6.1 the Group concluded that th ese chemicals should not be
classified as PBT-substances.

7 ENVIRONMENTAL RISK ASSESSMENT

7.1 Calculation of the predicted environmenta l concentrations of the Active Substance
and the Relevant Chemicals

7.1.1 The Group noted that for the calculation of the Predicted Environmental Concentration (PEC), the model MAM-PEC, version 2.0, had been applied. This model is freely available and
can be downloaded. The model has been deve loped by Delft Hydraulic s (now DELTARES) and the Free University, Amsterdam. The model was developed to calculate leaching of anti-fouling paints from ships. It is ba sed on the assumption that a perman ent source of the pollutant is present in the harbour and casualt ies a steady state concentration f the pollutant. Calculations can
be done for different harbours with different di mensions and “surroundings”, which in practice
means the channel to which the harbour is connecte d. It also has the possibility for calculations in a shipping lane of 200 km 2 . In this application, a standard OECD-EU harbour has been used with an exchange volume of 51,117,000 m 3 per tidal period of 12.1 ho urs. The daily volume of discharged treated ballast water and the concen tration of the Active Substance and Relevant Chemicals are critical input data. The Group rec ognized that reliable data on daily discharge of
ballast water is difficult to obtain and that other applicant had used volumes varying between 396,000 m 3 /day (Republic of (Korea) and 50,000 m 3 /day (Sweden).

7.1.2 The Group also noted that, ac cording to the authoriti es of the Port of Rotterdam, the real
value will be closer to 50,000 than 396,000. It depends on the type of harbour and in Rotterdam the intake of ballast water is higher than the discharge, since the majority of ships arrive laden. A port that hand les mainly tankers that arrive unloaded, may have a higher daily discharge than the Port of Rotterdam. The Group noted that this applican t had used the figure of 200,000 m 3 /day.GESAMP-BWWG 6/9

ANNEX 6 Page 10

I:\MEPC\58\2-7.doc 7.2 Calculation of PEC/PNEC ratios

7.2.1 After request of the Group the Applicant de livered information about the input data for the MAM-PEC model, which enabled the Group to re-calculate the PEC data delivered by the applicant presented in the table below.

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

1.25

0.06 Free Active Chlorine 0.34 (harbour) 0.017 (Surroundings) 0.014 (Shipping Lane) 2.7 10 0.27

0.05

0.03

0.0008 Tribromomethane 1.28 (Harbour) 0.036 (Surroundings) 0.005 (Shipping lane) 4800 100 48

0.0001

0.003

0.0001 2,2-Dibromoacetic
acid 0.019 (Harbour) 0.001 (Surroundings) 0.0007 (Shipping lane) 6900 1000 6.9

0.0001

7.2.2 Based on the delivered information, a fina l worst case discharge concentration of 2.6 mg/L for FAC and under a llowance of a degradation rate , the PEC was found to be 0.218.
This results in a PEC/PNEC of 0.8 and slightly lower PEC/PNEC values for the other substances. Based on this, the Group has no co ncerns regarding long- term environmental aquatic risk of the relevant substances. However, the short-term lo cal impact at the point of discharge could be significant.

7.2.3 Further, the Group has concerns regarding tr eatment of ballast water during discharge with max 2 mg/L. With some residual FAC in the ballast water this could well exceed the
allowable PEC/PNEC.

7.2.4 The Group requested the measurements of FAC and relevant by-products after storage of
the treated ballast water for a maximum of two days and a sec ond treatment during discharge.

7.2.5 For better comparability, the Group would be in favour of the application of the
commercial harbour scenario within the MAM-PE C model until a better scenario or model is available for the application of ballast water discharge.

8 CONCLUSIONS AND RECOMMENDATIONS

8.1 Risks to safety of the ship

8.1.1 The Group agreed that the information submitted by the applicant was insufficient to
characterize the effect of treatme nt with the proposed electrolytic process and Active Substances on the degradation of coatings or the corrosion of materials associated ballast tank, piping and
fixtures.

8.1.2 The Group recommends that long term studies, as appropriate, be carried out or otherwise documented from literature to quantify, at the treatment and possible exposure concentrations, resultant ballast tank coatings degradation and th e expected uniform and localized corrosion rates on typical marine vessel metallic (e.g., steel, galvan ized steel, zinc, stainless steel, etc.) and non-metallic materials (e.g., EPDM rubber) materials used for ballast tanks, fixtures and piping.GESAMP-BWWG 6/9

ANNEX 6 Page 11

I:\MEPC\58\2-7.doc 8.2 Risks to the crew and general public

8.2.1 The Group concluded that chlorinated and brominated disinfection by-products are the toxicological relevant compounds generated by the electrochemical process as they have a potential for uptake and human ge notoxicity/carcinogenicity concerns ; therefore they will have to be kept below toxicological critical levels (e.g., bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L) WHO Guidelines for Drinking Water Quality, 2003).

8.2.2 The Group agreed that the human health ri sk assessment had not been satisfactorily provided. Therefore, the Group recommended that for Final Approval, information should be submitted concerning:

.1 the (M)SDS of the Active Substances and Relevant Chemicals generated by the system; and

.2 the description and full understanding of the processes and unit operations in which human exposure may occur and the human health risk assessment based on the human exposure scenario (HES).

8.3 Risks to the environment

8.3.1 Having reviewed all of the information subm itted with this application, the Group agreed that this system will not cause any harm to the environment when carrying the further work which is necessary to apply for Final Approval.

8.4 Recommendations

8.4.1 Having considered all of the data submitted for Basic Approval, the Group agreed to recommend to MEPC that Basic Appr oval be granted to this system.

8.4.2 However, the Group wished to inform MEPC that, in order to make such a recommendation, it was necessary to make referen ce to information gained through experience of evaluating previous applications as the data submitted with this application were regarded as inadequate. The Group recommended that the following aspects should be given due consideration if the system has to be reviewed for Fina l Approval in the future:

.1 All the topics addressed under Chapte r 2 (Completeness of the Dossier as mentioned above) have to be addr essed by the Applicant carefully.

.2 The Group noted that the applicant did not provide information concerning the Human Exposure Scenario (MEPC 56/2/2, annex 9) a nd therefore the risk
characterization for human health co uld not be adequately performed.

.3 The Group considered that the organic c ontent of the test water with treated
natural seawater should be provided for Final Approval.

.4 The Group considered that the Level of Quantification (LOQ) for the haloacetic acids were too high. This may lead to unders tatement of the potential levels in the
treated ballast water. This uncertainty should be clarif ied in additional analyses during the full scale test ing on land and/or onboard ships by the applicant.

* * *GESAMP-BWWG 6/9

ANNEX 6 Page 12

I:\MEPC\58\2-7.doc Appendix 6.1

Physical and biological properties of Free Active Chlorine (FAC) in the form of hypochlorite ions (primarily sodium hypochlorite)

1 CHEMICAL IDENTIFICATION

1.1 The Group recognized that this was the Activ e Substance generated by the system (paragraph 3.3.7 of this report).

1.2 The Group accepted that the FAC is present as hypochlorite in seaw ater and would be interpreted as Total Residual Oxidants (TRO).

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute aquatic toxicity

Species Effect Value (mg/L) References

F Oncorhynchus kisutch 96 h LC 50 0.032

C Ceriodaphnia dubia 24 h LC 50 0.005

A Thalassiosira pseudonana 24 h IC 50 0.075

M Crassostrea virginica 96 h EC 50 0.023 RAR Hypochlorite (Ref. 33); Thatcher, 1978; Taylor, 1993; Gentile et al. , 1979; Roberts and Gleeson, 1978

MEPC 57/2/7, annex, p.14, para. 3.1.1 F = Fish, C = Crustacea, A = Algae, M = Mollusc

2.2 Chronic aquatic toxicity

Species Effect Value (mg/L) References

F Menidia peninsulae 28d NOEC 0.04
Chlorineproduced

oxidant

C Pandalus danae 28d NOEC 0.05 mg/L Free
Active Chlorine

A Unknown species 7d NOEC 0.0027 mg/L

TRO

M Crassostrea virginica 15d NOEC 0.007 mg/L

TRO RAR Hypochlorite (Ref. 33); Goodman, 1983; Gibson, 1976; Cairns, 1990; Liden,

1980.

MEPC 57/2/7, annex, p.14, para. 3.1.1

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

2.3 Information on Endocrine Disruption

The Group noted that no reports indicating that FAC might have any endoc rine effects on aquatic organisms had been found. The Group agreed that, as with other similar applications there was no reason to suspect that the Relevant Chemical s would have any endocrine disrupting effects.GESAMP-BWWG 6/9

ANNEX 6 Page 13

I:\MEPC\58\2-7.doc 2.4 Sediment toxicity/bioavaila bility/biomagnification/bioconce ntration/foodweb-population
effects

2.4.1 It was noted that the Log Po w value of hypochlorou s acid is -0.87 (estimated) and that of sodium hypochlorite -3.42 (estimated), which are both smaller than the criteria of Log Pow=3. The Koc value of sodium hypochlorite is 14.3 l/kg (estimated by EPI Suite TM ), which is smaller than 500 l/kg.

2.4.2 The Group, therefore, agreed that FAC was neith er expected to absorb to sediment nor to accumulate in the food web (see also results of MAM-PEC).

3 MAMMALIAN TOXICITY

3.1 Acute mammalian toxicity

Exposure Route Value Species References

Oral LD 50 (mg/kg) 850 rat WHO 2000 (Calcium hypochlorite

Dermal LD 50 (mg/kg) > 10000 rabbit MEPC 57/2/1

Inhalation LC 50 (mg/l/4h) > 10.5 rat MEPC 57/2/1

3.1.1 The Group agreed that, according to subm itted and existing data (RAR EC, 2007), the Group concluded that the acute toxicity of sodium hypochlorite is low by the oral, dermal and inhalation routes of exposure.

3.2 Corrosion/irritation

Species Method Results (including scores where available) References

Skin Rabbit OECD 404 2% slight (1.2) 20% severe (5.2) IUCLID 2000

Eye Rabbit 5.25% irritant 0.5% slight irritant
0.05% NOEC Pashley, 1985

3.2.1 The Group agreed that, according to the pres ented data, sodium hypochlorite is to be regarded as a skin and eye irritant and is classified under GHS as skin corrosive 1B (GHS classification, Annex VI, COM (2007) 355 final).

3.3 Sensitization

3.3.1 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). According to existing data sodium hypochlorite does not show a potential to cau se delayed contact hypersensitivity (draft Risk Assessment Report (RAR) on sodium hypochlorite, EU Assessment 793/93).GESAMP-BWWG 6/9

ANNEX 6 Page 14

I:\MEPC\58\2-7.doc 3.4 Repeated dose toxicity

Exposure Route Oral Exposure Duration 90 days Exposure dose 200 mg/l TRO in drinking water Species Mouse

Method

Results

NOAEL 50 mg/l (10-12 mg/kg/day)

NOEL

Reference Daniel et al . (1991)

3.5 Chronic and long-term toxicity

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 NTP, 1992

3.5.1 The Group noted the existing and submitted data and concluded that:

.1 the NTP, 1992 is considered to be the key study for deriving a NOEL for risk characterization for the oral route;

.2 concerning the repeated exposure by de rmal route, EC (RAR, 2007), no systemic effects were had been seen following de rmal exposure to 10000mg/L NaClO. As a result, the NOEL of 1% from the study of Kurokawa (1984) was chosen to evaluate the local dermal effects; and

.3 in evaluating the effects of inhalation exposure, it wa s proposed to use data from chlorine gas. The NOAEL for repeated exposure to chlorine gas is 0.5 ppm in studies performed with rhesus monkeys and human volunteers.

3.6 Development and reproductive toxicity

Exposure Route Oral Exposure Duration 7 generations Exposure dose 100 mg TRO/l (drinking water treated with sodium hypochlorite) Species Rat

Method

Results

NOAEL 14.4 mg/kg/day

NOEL

Reference Druckrey, 1968GESAMP-BWWG 6/9

ANNEX 6 Page 15

I:\MEPC\58\2-7.doc 3.6.1 The Group noted that the submitted study (Druckrey, 1968) showed no reproductive or teratogenic effects of chlorine . In addition, and according to existing and submitted data, the Group concluded that there was insufficient inform ation to draw conclusions about the potential for developmental toxicity (EHC 216, WHO, 2000).

3.7 Carcinogenicity/mutagenicity

Species Method
Details Results Reference

Carcinogenicity Not carcinogenic NTP, 1992

Mutagenicity Not mutagenic Hayashi, 1988; Meier et al.

, 1985

3.7.1 From the available data the Group concluded that:

.1 sodium hypochlorite is not classified by IARC as to its carci nogenicity to humans (Group 3); and

.2 whilst several studies have shown th at sodium hypochlorite produces mutagenic responses in bacterial systems and mammalian cells in vitro , there is no evidence of activity in mammalian test systems in vivo

.

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC
CONDITIONS

4.1 Environmental fate

4.1.1 The Group noted that the hal f-life of hypochlorous acid an d hypochlorite ions at pH 7.0 (main formula is HClO) is about 0.8 hour and the half-life at pH 8.0 (main formula is ClO - ) is about 1.4 hour. The A.I.S.E. document (ref .1) reports a half-life of 45-60 minutes.

4.1.2 In addition, it was noted that, in the presen ce of organic material , FAC disappears very quickly, due to its oxidizing property. The Group, therefore, agreed that the resulting TRO in the receiving water is expected to be very low.

4.2 Partition coefficients

Method Results Reference Log Pow estimated -3.42 EPI Suite TM

Koc estimated 14.3 l/kg EPI Suite TM

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 The Group noted that Free Active Chlorine degrades in less th an an hour and so is not expected to be persistent on rele ase into the marine environment.GESAMP-BWWG 6/9

ANNEX 6 Page 16

I:\MEPC\58\2-7.doc 4.4 Reaction with organic matter

4.4.1 The Group recognized that when FAC reacts w ith organic material in water, by-products such as halomethanes and haloge nated acetic acids are formed and that this was consistent with the chemical analysis carried out on sea water treated by this system.

4.5 Potential physical effects on wildlife and benthic habitats

4.5.1 The Group noted that FAC are highly water- soluble inorganic chemicals (IUCLID, 2000)
which do not float on the surface or sediment to the bottom. As a result, the Group agreed that these are unlikely to have any physical e ffects on wildlife or benthic habitats.

4.6 Potential Residues in Seafood

4.6.1 The Group noted that no reports concerning the persistence of FA C in seafood were available. However, due to its low Log Pow, th ese chemicals are not expected to bioaccumulate
in seafood.

4.7 Any known interactive effects

4.7.1 The Group noted that FAC may generate co rrosive gas including gaseous chlorine under high temperature or low pH condition (<pH 4) but that these conditions will not occur in the environment [or in the ballast water tanks].

5 PHYSICAL AND CHEMICAL PROPERTIES

Physical property Sodium hypochlorite

CAS number 7681-52-9 Molecule weight 74.44 Melting point (°C) -25 Boiling point (°C) 107 Flash point (°C) Density (kg/dm 3 ) at 25°C 1.23*103 Vapour pressure @ 20°C (Pa) 1740-2000 Water solubility (g/L) miscible(293) pH in solution 14 Octanol/water partition coefficient (log Pow) -0.87

Dissociation constant (pKa) 7.63 Corrosivity to material or equipment Reactivity to container material Auto ignition temperature (oC) Explosive properties

Surface tension Viscosity Oxidation reduction potential 1.7 Oxidizing properties Strong oxidizing agent Viscosity (mPa.s) 2.6GESAMP-BWWG 6/9

ANNEX 6 Page 17

I:\MEPC\58\2-7.doc 6 OTHER INFORMATION

6.1 PH, salinity, TSS, POC, DOC

6.1.1 The Group noted that the pH and salinity of the treated ballast water was the same as the natural values of the uptake water. The pH varied from 7.4 to 8.0. Salinity varied from 22-34 PSU. TSS, DOC and POC were analysed in samples taken during the test on killing rates in the summer of 2007. All parameters varied highly due to conditions in the harb our through tidal movements and ship movements. TSS va ried between 20 and 100 mg/l. POC values were in the range 0.5 – 29 mg/l and DOC valu es were in the range of 1.0–52 mg/l.

6.2 Material Safety Data Sheet provided: No

6.3 GHS Classification: No

6.4 Risk Characterization

6.4.1 Characteristics of the Active Substance

6.4.1.1 The Group agreed that the Active Substan ce (Free Active Chlorine ) has the following
characteristics

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference

No No Yes MEPC 57/2/7

6.4.2 Data Input

6.4.2.1 The Group agreed with the applicant that the following data used to calculate the
Predicted Environmental Concen tration (PEC) was appropriate:

.1 Load: 334 kg/day (based on 200,000m 3 /day and maximum of 1.67 mg/l);

.2 Half-life : 0.041 days in water; and

.3 The MAM-PEC model calculates for FAC a st eady state situation (= PEC) in the
harbour of 0.34 μ g/l and of 0.017 μ g/l in the surroundings. The model calculates a steady state situation in the shipping lane of 0.014 μ g/l.

6.4.3 Aquatic Toxicity Risk Assessment

6.4.3.1 Using the results from the environmenta l modelling and the es timated PNEC values obtained from the aquatic toxicity testing, th e Group agreed on the following PEC/PNEC ratios for the Active Substance, Free Active Chlorine:

PEC (μg/L) Toxicity (μg/L) Factor applied PNEC (μg/L) PEC/PNEC

0.34 (harbour) 0.017 (Surroundings) 0.014 (Shipping Lane) 2.7 10 0.27 1.25
0.06
0.05GESAMP-BWWG 6/9

ANNEX 6 Page 18

I:\MEPC\58\2-7.doc 6.4.3.2 In calculating the above PEC/PNEC ratio for Free Active Chlorine, the Group also recalled the following estimati ons which had been made:

.1 0.07 μg/L (MEPC 56/2/2)

.2 0.04 μg/L (MEPC 57/2/7, ref. 33)

.3 8 μg/L (MEPC 57/2/1)

* * *GESAMP-BWWG 6/9

ANNEX 6 Page 19

I:\MEPC\58\2-7.doc Appendix 6.2

Physical and biological prop erties of Tribromomethane

1 CHEMICAL IDENTIFICATION

1.1 As shown in section 3.4 of the main report.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute aquatic toxicity

Species Effect Value (mg/L) Calculated
NOEC (mg/L) References

F Cyprinodon variegates 96 h LC 50 7.1 2.9

C Daphnia magna 24-48 h LC 50 46 <7.8

A Skeletonema costatum 96 h EC 50 12.3 Ward et al ., 1981;
Heitmuller et al ., 1981; Ecotox, 2005; LeBlanc, 1980

MEPC 57/2/7, annex, p.19, para. 3.2.1 F = Fish, C = Crustacea, A = Algae

2.2 Chronic aquatic toxicity

Species Effect Value Reference

F Cyprinodon variegatus 28d NOEC 4.8 mg/l

C

A Ward et al ., 1981

MEPC 57/2/7, annex, p.19, para. 3.2.1

2.3 Information on endocrine disruption

2.3.1 The Group noted that no reports had been found, indicating that tribromomethane might have any endocrine effects on aquatic organisms.

2.4 Sediment toxicity/bioavaila bility/biomagnification/biocon centration/food web-population
effects

2.4.1 The Group noted that the Log Pow value of tribromomethane is 2.4 (ATDSR, 2005), which is smaller than the criteria of Log Pow = 3. The Koc value of tribromomethane is 114.8 l/kg (annex 7 to MEPC 56/2/2), which is smaller than 500 l/kg. As a result, the Group agreed that tribromomethane is not expected to absorb to sediment or to accumulate in the food
web.GESAMP-BWWG 6/9

ANNEX 6 Page 20

I:\MEPC\58\2-7.doc 3 MAMMALIAN TOXICITY

3.1 Acute mammalian toxicity

Exposure Route Value Species References

Oral LD 50 (mg/kg) 1147 Rat Chu et al ., 1980

MEPC 57/2/7, annex, p.19, para. 3.2.2

Dermal LD 50 (mg/kg)

Inhalation LC 50 (mg/l/4 h) >7000 ppm/1/h Dog MEPC 56/2, para 2.3.2.2

MEPC 57/2/7, annex, p.19, para. 3.2.1 Sub-acute toxicity NOAEL oral (mg/kg bw/day) 2 weeks

3.1.1 The Group agreed that the LD50 values presen ted in the submitted studies, indicate that
bromoform is harmful if swallowed. In a ddition, and according to GHS classification,
bromoform is toxic if inhaled.

3.2 Corrosion/irritation

Species Method Results Reference

Skin Rabbit Moderately irritating Eye Rabbit Moderately irritating Respiratory system Unspecified Moderately irritating Torkelson et al ., 1994

MEPC 57/2/7, annex, p.19, para. 3.2.2

3.2.1 According to the data in the above table, the Group noted that bromoform is classified under GHS as an eye irritant (e ye irritant 2) and a skin irritant (skin irritant 2).

3.3 Sensitization

The Group noted that no sensitization data had been reported for tribromomethane.GESAMP-BWWG 6/9

ANNEX 6 Page 21

I:\MEPC\58\2-7.doc 3.4 Repeated dose toxicity

Exposure Route Oral Exposure Duration 13 weeks Exposure dose 50 mg/kg/day Species Rat

Method

Results

NOAEL 25 mg/kg/d

NOEL

Reference NTP, 1989

3.5 Chronic and long-term toxicity

Exposure Route ? Exposure Duration 1 year 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 Moore et al ., 1994

MEPC 57/2/7, annex, para. 3.2.2

3.5.1 From the existing and submitted data, the Group concluded that there are concerns related to nephropathy and hepatopathy under repeated exposure to bromoform.

3.6 Development and reproductive toxicity

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 WHO, 2000

3.6.1 The Group concluded from the submitted and existing information (EHC 216, 2000) that, although there were no observed effects on fertilit y parameters, there may be some reprotoxicity concerns (foetotoxicity) relate d to exposure to bromoform.GESAMP-BWWG 6/9

ANNEX 6 Page 22

I:\MEPC\58\2-7.doc 3.7 Carcinogenicity/mutagenicity

Species Method
Details Results References

Carcinogenicity Human Probable

Human Carcinogen U.S. EPA (IRIS)

MEPC 56/2/7, annex, para. 3.2.2 Mutagenicity Salmonella.
Mammalian
cells Ames test Mixed
Mixed Simmon et al ., 1978;
Simmon et al ., 1979; NTP, 1989; Rapson
et al ., 1980; Varma
et al. , 1988; Morimoto, 1983; Fuji et al ., 1993; Galloways et al ., 1985

3.7.1 The Group evaluated the carcinogenicity and mutagenicity data submitted for bromoform and concluded that there are positive animal data indicating that bromoform can cause liver and
intestinal tumours.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROVIC CONDITIONS

4.1 Modes of degradation (abiotic) and persistence

4.1.1 The Group noted that the rate constant of hydrolysis for tribromomethane is estimated

at 3.2x10 -11 /sec (Mabey, W. et al., 1978).

4.2 Partition coefficients

Method Results Reference Log Pow observed 2.4 CITI, 1992; Sangster, 1994

Koc observed 114.8 l/kg MEPC 56/2/2, annex 7

4.3 Persistence and Identifica tion of Main Metabolites

4.3.1 The Group noted that tribromomethane is a st able compound in water with an estimated half-life of 686 years.

4.4 Reaction with Organic Matter

4.4.1 The Group noted that no reports on the reaction of tribro momethane with organic matter
had been found.

4.5 Potential physical effects on wildlife and Benthic Habitats

4.5.1 The Group noted that Tribromomethane has a higher specific gravity than seawater (2.890 at 20°C) and a low solubility (3.1 g/l (20°C)). Therefor e, according to an evaluation based on the GESAMP hazard evaluation (GES AMP, 2002), the compound is classified as Rating S (substances having a potenti al effect on benthic habitats).GESAMP-BWWG 6/9

ANNEX 6 Page 23

I:\MEPC\58\2-7.doc 4.6 Potential Residues in Seafood

Tribromomethane has a low bioaccumulation potentia l and therefore it is unlikely that residues
will be found in seaf ood (see paragraph 3.2.1).

5 PHYSICAL AND CHEMICAL PROPERTIES

Property Value Reference/Comments/Justification for missing data

Melting point (°C) Boiling point (°C) Flammability (flash point for liquids; °C) Nonflammable MEPC

Density (20°C; kg/m 3 ) Vapour pressure (20°C; Pa) 534 Vapour density (air = 1) Water solubility (temp; effect of pH; mg/l) Slightly
soluble pH in solution Dissociation constant (pKa) Oxidation-reduction potential Corrosivity to material 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 method for measuring the conc entration at environmentally relevant
concentrations:

Method GC-MS Applicability salt water Sensitivity < 0.5 – 0.1 μ g/l

Reference NEN/EN/ISO 15680

6.2 Material Safety Data Sheet provided: No

6.3 GHS Classification: NoGESAMP-BWWG 6/9

ANNEX 6 Page 24

I:\MEPC\58\2-7.doc 6.4 Environmental Risk Characterization

6.4.1 Characterization of the Rele vant Chemical (Tribromomethane)

6.4.1.1 The Group agreed that the Relevant Chemical (Tribromomethane) has the following
characteristics:

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference
Yes No No MEPC 57/2/7

6.4.2 Data Input

6.4.2.1 The Group agreed with the applicant that the following data us ed to calculate the
Predicted Environmental Con centration were appropriate:

.1 Load: 58 kg/day (based on 200.000 m 3 /day and maximum of 0.290 mg/l)

.2 Half-life: 340 days in sediment

.3 The MAM-PEC model calculates for tr ibromomethane a steady state situation (PEC) in the harbour of 1.28 μ g/l and of 0.036 μ g/l in the surroundings. The model calculates a steady state si tuation in the sh ipping lane of 0.005 μ g/l.

6.4.3 Aquatic Toxicity Risk Assessment

6.4.3.1 Using the results from the environmen tal modeling and the estimated PNEC values obtained from the aquatic toxici ty testing, the Group agreed ton the following PEC/PNEC ratios for the Relevant Chemical, Tribromomethane:

PEC (μg/L) Toxicity (μg/L) Factor applied PNEC (μg/L) PEC/PNEC

1.28 (Harbour) 0.036 (Surroundings) 0.005 (Shipping Lane) 4800 100 48 0.03
0.0008
0.0001

6.4.3.2 In calculating the above PEC/PNEC ratio for tribromomethane, the Group also recalled the following estimations for PNEC which had been made:

.1 7.1 μg/L (MEPC 56/2/2)

.2 146 μg/L (MEPC 57/2/7, ref. 33)

.3 1.5 μg/L (RIVM, 2005)

* * *GESAMP-BWWG 6/9

ANNEX 6 Page 25

I:\MEPC\58\2-7.doc Appendix 6.3

Physical and biological propert ies of 2,2 Dibromoacetic Acid

1 CHEMICAL IDENTIFICATION

1.1 As shown in section 3.4 of the main report.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute aquatic toxicity data

Species Effect Value Reference

F Pimephales promelas 96 h LC 50 6.9 mg/l Mayes et al , 1985

C

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

2.2 Chronic aquatic toxicity

The Group noted that no data were available on the chronic aquati c toxicity of 2,2-dibromoacetic
acid.

2.3 Information on endocrine disruption

The Group noted that no reports had been foun d, indicating that 2,2 dibromoacetic acid might have any endocrine effects on aquatic organisms.

2.4 Sediment toxicity/bioavaila bility/biomagnification/biocon centration/food web-population
effects

The Log Pow value of 2,2 dibromoacetic acid is 1.22 (observed), which is smaller than the criteria of log Pow = 3. The Koc value of 2,2 dibromoacetic is 1.90 l/kg (), which is smaller than 500 l/kg.

The Group, therefore, agreed that 2,2 dibromoacetic acid is not expected to be absorbed onto
sediment or be accumulated in the food web.

3 MAMMALIAN TOXICITY

3.1 Acute mammalian toxicity

Exposure Route Value Species Reference

Oral LD 50 (mg/kg) 1737 Rat Linder et al ., 1994

Dermal LD 50 (mg/kg)

Inhalation LC 50 (mg/l/4 h)GESAMP-BWWG 6/9

ANNEX 6 Page 26

I:\MEPC\58\2-7.doc 3.2 Corrosion/irritation

Species Method Results Reference

Skin Corrosive Eye Severe Lung Severe Assumed as a strong acid

3.2.1 The Group noted that, according to the presen ted data, dibromoacetic acid is considered
to be corrosive to skin and a sever irri tant to the respiratory system and eyes.

3.3 Sensitization

3.3.1 The Group noted that no sensitization data had been reported for 2,2 dibromoacetic acid.

3.4 Repeated dose toxicity

Exposure Route Oral Oral Exposure Duration 28d 3 months Exposure dose 0-2000 mg/l Species Mouse Mouse

Method

Results No deaths but various effects seen at >500 mg/l

NOAEL 38 mg/kg/d Not reported

NOEL Not reported

Reference WHO, 2004

3.5 Chronic and long-term toxicity

Exposure Route Oral Oral Exposure Duration 2 years 2 years Exposure dose 0-1000 mg/l Species Mouse Rat

Method

Results Increased body weights at 50 and 500 mg/l in males only Decrease body weights at 500 and 1000 mg/l

NOAEL Not reported Not reported

NOEL Not reported Not reported

Reference NTP, 2005

3.5.1 From the above data, the Gr oup concluded that there wa s no relevant toxicological concern regarding the repeated e xposure to dibromoacetic acid.GESAMP-BWWG 6/9

ANNEX 6 Page 27

I:\MEPC\58\2-7.doc 3.6 Development and reproductive toxicity

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 Cummings et al . (1998)

3.6.1 The Group noted, from the submitted data, that whilst some repr oductive toxicological effects were observed, these were asso ciated with exposure to high doses.

3.7 Carcinogenicity/mutagenicity

Species Method
Details Results Reference

Carcinogenicity Mouse and

Rat Carcinogenic (tumours/cancers observed) NTP, 2007

Mutagenicity Salmonella typhimurium Ames

test Positive at 10 mg/l NTP, 2007; Giller
et al. , 1997

3.7.1 Relevant adverse effects relate d to target organs (liver a nd testes) were observed in the presented data. Chlorinated and Brominated DPB, have a potential for bioaccumulation and human genotoxicity/carcinogenicity therefore will have to be kept below toxicological critical levels (WHO Guidelines for Drinking Water Quality, 2003).

4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND ANAEROBIC
CONDITIONS

4.1 Environmental fate

4.1 The Group noted that Holmes et al. (2001) had measured the decay rate of 2,2 dibromoacetic acid with in vivo and vitro t oxicity tests and that th ey reported a half-life
of 1.5 hours.

4.2 Partition coefficients

Method Results Reference Log Pow estimated 1.22 EPI Suite TM

Koc estimated 1.90 l/kg EPI Suite TM

4.3 Persistence and Identification of Main metabolites

4.3.1 No data.GESAMP-BWWG 6/9

ANNEX 6 Page 28

I:\MEPC\58\2-7.doc 4.4 Reaction with Organic Matter

4.4.1 The Group noted The 2,2 dibromoacetic acid is highly soluble in water; actually it is highly hygroscopic. It, therefore, is not expected to react substantially with organic matter nor will it precipitate in wildlife or benthic habitats or accumulate in seafood.

5 PHYSICAL AND CHEMICAL PROPERTIES

Property Value Reference/Comments/Justification for missing data

Melting point (°C) Boiling point (°C) Flammability (flash point for liquids; °C) Nonflammable MEPC 57/2/7, annex, para. 3.3.4

Density (20°C; kg/m 3 ) Vapour pressure (20°C; Pa) 0.023 MEPC 57/2/7, annex, para. 3.3.4 Vapour density (air = 1) Water solubility (temp; effect of pH; mg/l) Highly
soluble MEPC 57/2/7, annex, para. 3.3.4

pH in solution Dissociation constant (pKa) Oxidation-reduction potential Corrosivity to material 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 me asuring the concentration at environmentally relevant
concentrations

Method GC-MS Applicability salt water Sensitivity < 1 μ g/l

Reference RPS Laboratories: Halacet_V1 methodology

6.2 Material Safety Data Sheet provided: No

6.3 GHS Classification: NoGESAMP-BWWG 6/9

ANNEX 6 Page 29

I:\MEPC\58\2-7.doc 6.4 EnvironmentaL Risk Characterization

6.4.1 Characteristics of the Relevant Chemical (2,2-Dibromoacetic Acid)

6.4.1.1 The Group agreed that the Relevant Chemical (2,2-Dibromoacetic Acid) has the following characteristics:

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference

No No No MEPC 57/2/7

6.4.2 Data Input

6.4.2.1 The Group agreed with the applicant that the following data, used to calculate the
Predicted Environmental Concentr ation (PEC) were appropriate:

.1 Load: 13 kg/day (based on 200.000 m 3 /day and maximum of 0.064 mg/L)

.2 Half-life: 0.0625 day in water

.3 The MAM-PEC model calculates for 2,2 dibromoacetic acid a steady state situation (PEC) in the harbour of 0.019 μ g/l and of 0.001 μ g/l in the surroundings. The model calculates a steady state si tuation in the sh ipping lane of 0.0007 μ g/l.

6.4.3 Aquatic Toxicity Risk Assessment

6.4.3.1 Using the results from the environmenta l modelling and the es timated PNEC values obtained from the aquatic toxici ty testing, the Group agreed ton the following PEC/PNEC ratios for the Relevant Chemical, 2,2-dibromoaceti acid:

PEC (μg/L) Toxicity (μg/L) Factor applied PNEC (μg/L) PEC/PNEC

0.019 (Harbour) 0.001 (Surroundings) 0.0007 (Shipping Lane) 6900 1000 6.9 0.003
0.0001
0.0001

6.4.3.2 In calculating the above PEC/PNEC ratio for 2,2-dibromoacetic acid, the Group also recalled the following estimations for PNEC which had been made:

.1 6.9 μg/L (MEPC 56/2/2); and

.2 0.72 μg/L (MEPC 57/2/7, ref. 33)

***GESAMP-BWWG 6/9

I:\MEPC\58\2-7.DOC ANNEX 7

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

Electro-Clean System (ECS)

Submitted for Final Approval by the Republic of Korea

0 SUMMARY

0.1 The Group noted that the Electro-Clean Syst em (ECS) uses an electrolytic process to effect disinfection. The syst em produces Active Substances in situ which are neutralized by sodium thiosulphate to demand. The Group r ecognized the importance of the neutralization process as an environmental risk mitigation measure.

0.2 The Group also noted that hydrogen and chlori ne gases are produced by the system and that the risks associated with these products have been recognized and mitigated by the inclusion of monitoring, alarm and shut- down functions to the system.

0.3 The Group was pleased to find the additional information, provided by the applicant, in response to the remarks made in the report of the last evaluation of this system. For example the Group noted that this was the first application which it had reviewed which included some quantitative human risk assessment.

0.4 The Group appreciated the attempts by the appl icant to provide details of evaluations of the various chemicals by employing EUSES 2.1 and MAM-PEC 1.6. Although these tools have not been adopted by the Group, it was considered useful to review the results provided.

0.5 However, the Group expressed its concern that the many data changes and additional information provided after the application dossier for Final Approval had been received, made review very difficult.

0.6 The Group noted some deficienci es regarding the compliance w ith test guidelines of one specific part of the toxicity tests (algae) whic h were possibly due to a lack of consistent Quality Assurance. However, taking all of the tests (fish, Daphnids and algae) into account, it was agreed that the system would not produce an unreasonable risk to the receiving environment.

0.7 Having reviewed the additional informa tion provided since th e last application for Final Approval, the Group agreed to re commend to MEPC that Final Approval of the ECS system should be granted subject to the following:

.1 maximum allowable dosage of Active Substances 10 mg/ L as TRO which should be monito red and recorded during uptake by TRO sensors maintained adequately;

.2 maximum allowable discharge concentrations of Active Substances <0.02 mg/ L as TRO which should be monitored and recorded during discharge by TRO sensors maintained adequately; and

.3 further corrosion tests being carried out – see section 4.7.GESAMP-BWWG 6/9

ANNEX 7 Page 2

I:\MEPC\58\2-7.doc 1 INTRODUCTION

1.1 The data used to evaluate this syst em were extracted from that supplied by the Republic of Korea in document MEPC 58/2 which was supplemented by additional confidential information provide d by the applicant. Further information was provided by the applicant in response to specific questi ons posed before a nd during the meeting.

1.2 It was noted that Basic Approval for the ECS had been granted by MEPC 54 based on the recommendations made by the Group in MEPC 54/2/12.

1.3 It was recalled that an application for Fina l Approval of this system had been rejected by MEPC 57 based on the Group’s recommendation (MEPC 57/2).

2 COMPLETENESS OF THE DOSSIER

2.1 The Group recalled that, at its fourth mee ting, it had recommended that Final Approval should not be granted to ECS as it had identified important in formation was missing from the application.

2.2 Confidential information supplied in a ddition to that included in MEPC 58/2

2.2.1 The Group noted that the applicant had provided the following manuals:

.1 Cover Manual .2 Non-Confidential Report .3 Appendix I – Recommendations of BE SAMP-BWWG and concerns of KOREA that submitted the dossier for Final Approval .4 Appendix II – Preliminary report for the Type Approval Test Used by Electro-clean Ballast Water Management System .5 Appendix III – Analysis of Active Substances and Relevant Chemicals .6 Appendix IV – Key data summary of Active Substances , Relevant Chemicals and Other Components .7 Appendix V – Installation & Opera tion Manual of Electro-Clean System .8 Appendix VI – MSDS of Active Subs tances, Relevant Chemicals and Other Components .9 Appendix VII-1 – Toxicity Test Report .10 Appendix VII-2 – Toxicity Test Report .11 Appendix VIII – Corrosivity Test Report .12 Appendix 8-I – Corrosivity Test Report .13 Appendix 8-II – Corrosivity Test Report .14 Appendix IX – Data sheet of MAM-PEC and EUSES for Risk Assessment .15 Appendix X – Quality Assurance Project Pl an (QAPP) for the full scale testing of the Electro-Clean ballast water management system of Techcross Inc. .16 Appendix X, Annex A – References – Volume 1 (A1: bio-Efficacy, A2: Active Substances) .17 Appendix X, Annex A – Referen ces – Volume 2 (A3: Toxicity) .18 Appendix X, Annex B – Quality Manua l of ISO/IEC 17025 System at the South
Sea Institute of KORDI .19 Appendix XI – Estimated results fo r ECS treated water by EPI and TOPKATGESAMP-BWWG 6/9

ANNEX 7 Page 3

I:\MEPC\58\2-7.doc .20 Reference 1 (A-C) .21 Reference 2 (E-1) .22 Reference 3 (E-2) .23 Reference 4 (E-3) .24 Reference 5 (E-4) .25 Reference 6 (H) .26 Reference 7 (I-N) .27 Reference 8-I (O) .28 Reference 8-II (O) .29 Reference 9 (R-T) .30 Reference 10 (U-W) .31 Reference 11 (Estimated results fo r ECS treated water by EPI and TOPKAT) .32 Reference 11-2 (Estimated results for ECS treated water by EPI and TOPKAT) .33 Reference 11-3 (Estimated results for ECS treated water by EPI and TOPKAT)

3 DESCRIPTION OF THE BWMS

3.1 Overview of the system

3.1.1 The Group noted that the application for Final Approval described the system as consisting of:

.1 an electrolysis module;

.2 a rectifier;

.3 a heat-exchanger;

.4 a power distributor;

.5 a control PC;

.6 a neutraliser; and

.7 several sensors.

3.1.2 It was noted that the electrolysis module is installed in the middle of the ballast pipe and disinfects micro-organisms in the ballast water. The Rectifier receives AC power from MCC and supplies DC power to the electrolysis m odule while periodically ch anging the polarity of electrodes by the timer setting. When the rec tifier is operated, it generates heat, and so

a Heat-exchanger is used to cool it. The Power distributor supplies power to the ECS with 3-phase 440V input power and electricity is supplied to the c ontrol PC, rectifier and sensor units by the magnet. The cont roller unit on the distributor switches on the magnet in an emergency to prevent problems that may occur in the system. A Control PC is installed in ballast room or on the distributor panel and contro ls ECS. It collects all data-from sensor units and all components of ECS- through RTU and controls the ECS with these data.GESAMP-BWWG 6/9

ANNEX 7 Page 4

I:\MEPC\58\2-7.doc 3.1.3 The Neutralisation system is installed in order to d ecrease TRO concentration by ECS before discharging the treated wa ter in ballast tanks. It is c onnected to inflow neutraliser automatically into ballast pipe. The Programma ble Logic Controller (PLC) would automatically
control the amount of neutralizer according to the TRO concentra tion. ECS is designed to be operated automatically, reflecting data from the following sensor units:

.1 conductivity sensor;

.2 pH sensor;

.3 Temperature sensor;

.4 TRO sensor; and

.5 Gas sensor and Flow meter for H 2 and Cl 2

.

3.2 Electro-Clean System Process

3.2.1 The Group noted that the ball ast water treatment process of the Electro-Clean System (ECS) comprises a series of processe s as outlined in the diagram below:

3.2.2 It was noted that the conductivity of the ba llast water is measured at uptake and the
results sent to the Control PC. The Control PC us es this information to adjust the current needed to be supplied to electrolysis module in order to generate a TRO of 10 mg/L to disinfect the ballast water. In addition, a TRO sensor is located after the trea tment prior to the ballast tank, which supplies a feedback control signal to the cont rol PC to further adjust the current needed to maintain the TRO concentration at 10 mg/L. This disinfection process includes the part that supplies current to the electrodes in the ECS module and the cooler unit (rectifier, power distributor and heat-exchanger) th at is controlled by the onlin e TRO sensor and control PC.GESAMP-BWWG 6/9

ANNEX 7 Page 5

I:\MEPC\58\2-7.doc 3.2.3 In order to minimize the toxi c effects of TRO, the treate d water is neutralised, at discharge, by sodium thiosulphate and the TRO concentration of neutra lised water is checked again using the online TRO sensor.

Note: sodium bisulphite was reported in the previous applicati on for Final Approval as the neutralizing agent. This has been replaced by sodium thiosulphate.

3.2.4 The Group noted that for the reliability of th e systems, all the TRO sensors are located in parallel so that the PLC can easily detect the lack of signal or sensor’s malfunctions.

3.3 Gas detection and hazard mitigation functions

3.3.1 The Group noted that the ECS included the following safety features:

.1 a water leakage detector, which is in stalled on electrolysis module which, in the event of any detected water leakage, operates the alarm sy stem and shuts the system down;

.2 gas separators are installed on ballast pipe to remove chlorine and hydrogen;

.2.1 the Group considered that this facili ty might also release bromoform to the atmosphere thus reducing the level of bromoform in the discharge water;

.3 an on-line gas-detector activates an alarm system when the level of hydrogen exceeds 3% and activates system shut down at levels exceeding 4%;

.3.1 additional information provided by the applicant (e-mail 11/04/08) indicated that the system had been changed so that the alarm system is activated at 2% hydrogen and the system is shut down automatically when the concentration reaches 3%;

.4 on-line gas-detector activates an alar m system when the level of chlorine exceeds 0.8 ppm and causes the ECS to shut down at levels exceeding 1 ppm; and

.4.1 additional information provided by the applicant (e-mail 11/04/08) indicated that the system had been changed so that th e alarm system is activated at 0.6 ppm chlorine and the system is shut down automatically when the concentration reaches 0.8 ppm.

3.4 Identification of Active Substance (A S), Relevant Chemicals (RC) and Other Chemicals (OC)

3.4.1 The Group noted that the applicant had id entified the following chemicals as AS, RC

or OC:

Chemical name Control

water (μg/L) Treated water (μg /L) before
neutralization Treated water (μg /L) after
neutralization LOD* (μg /L) LOQ* (μg /L) History

HOCl (OCl
- ) N.D. 1400 N.D. 10 40 A

HOBr (OBr
- ) N.D. 6390 N.D. 2 6 A Active
Substances

O 3 (H 2 O 2 ) N.D. 478 N.D. 20 60GESAMP-BWWG 6/9

ANNEX 7 Page 6

I:\MEPC\58\2-7.doc Chemical name Control

water (μg/L) Treated water (μg /L) before
neutralization Treated water (μg /L) after
neutralization LOD* (μg /L) LOQ* (μg /L) History

2,3-dihydroxybenzoic acid N.D. N.D. N.D. 10 20

OH 2,5-dihydroxybenzoic acid N.D. N.D. N.D. 20 50

Trichloromethane 0.20 0.12 0.13 0.006 0.02 A

Dibromomethane N.D. 0.07 0.06 0.006 0.02

Bromodichloromethane 0.02 0.31 0.12 0.008 0.03 A

Dibromochloromethane 0.02 14.35 8.04 0.006 0.02 A

Tribromomethane 0.10 481.67 373.96 0.005 0.02 A

1,2,3-Trichloropropane N.D. N.D. N.D. 0.006 0.02

2-Chlorotoluene N.D. N.D. N.D. 0.006 0.02

4-Chlorotoluene N.D. N.D. N.D. 0.006 0.02

1,2-Dibromo-3-Chloropropane N.D. N.D. N.D. 0.009 0.03

1,3,5-Tribromobenzene N.D. N.D. N.D. 0.011 0.03

1,2,4-Tribromobenzene N.D. N.D. N.D. 0.011 0.03

Trichloroacetonitrile N.D. N.D. N.D. 0.004 0.01

Dichloroacetonitrile N.D. N.D. N.D. 0.003 0.01

Bromochloroacetonitrile N.D. N.D. N.D. 0.004 0.01

Dibromoacetonitrile 0.16 36.84 21.49 0.003 0.01

2,4-Dibromophenol 0.01 0.02 0.02 0.002 0.01

2,6-Dibromophenol 0.01 0.02 0.01 0.002 0.01

2,4,6-Tribromophenol 0.01 0.28 0.38 0.002 0.01

2-Chlorophenol N.D. N.D. N.D. 0.003 0.01

2,4-Dichlorophenol N.D. N.D. N.D. 0.002 0.01

2,4,6-Trichlorophenol N.D. N.D. N.D. 0.004 0.01

Pentachlorophenol N.D. N.D. N.D. 0.002 0.01

Monochloroacetic acid 0.19 1.31 1.26 0.005 0.02 A

Monobromoacetic acid N.D. 26.33 22.98 0.006 0.02 A Relevant
Chemicals

Dichloroacetic acid 0.06 0.88 ≤ 0.74 0.010 0.03 AGESAMP-BWWG 6/9

ANNEX 7 Page 7

I:\MEPC\58\2-7.doc Chemical name Control

water (μg/L) Treated water (μg /L) before
neutralization Treated water (μg /L) after
neutralization LOD* (μg /L) LOQ* (μg /L) History

Trichloroacetic acid N.D. N.D. N.D. 0.011 0.03 A

Bromochloroacetic acid N.D. 11.59 7.87 0.011 0.03 A

Dibromoacetic acid N.D. 270.96 163.38 0.011 0.03 A

Bromodichloroacetic acid N.D. N.D. N.D. 0.010 0.03 A

Dibromochloroacetic acid N.D. ≤ 5.61 ≤ 7.00 0.009 0.03 A

Tribromoacetic acid N.D. ≤ 289.67 183.41 0.011 0.03 A

Bromate ion N.D. 41.21 26.18 0.11 0.37 A

Other
component Sodium thiosulphate N.A. N.A. 1633 - -

* LOQ: Limit of Quantification (SD*10, n=7), *LOD: Limit of Detection (SD*3.14, n=7) = MDL History: A = Identified in la st application for Final Approval
Shaded chemicals are those which could be de tected in the treated ballast water and so were considered as potential Relative Chemicals.

3.4.2 The Group recognized that those chemicals wh ich were deemed to be Active Substances
could not be identified within the limits of det ection, in the treated/neut ralized ballast water and so did not require a complete Risk Assessment. In addition, it was agreed that the other chemicals which could be identified as being present in the treated ballast water above the limits of detection (shaded in the above table) should be regarded as Relevant Chemicals which would need to be subject to a complete Risk Assessment.

4 THE APPLICANT’S RESPONSES TO THE CONCERNS OF THE GROUP
EXPRESSED AT ITS FOURTH MEETING

4.1 Storage of the neutralizing agent and the co ntrol of its addition to the ballast water (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 2.3.1)

4.1.1 The Group noted that the applicant had pr ovided details of how the neutralizing agent is stored onboard and is dosed automatically in to the ballast pipe under the control of the Programmable Logic Controlle r (PLC) according to the concentration of TRO (MEPC 58/2, annex, paragraphs 3.1 and 3.2.1).

4.2 Had the discharge toxicity tests been conducted on samples drawn from the G8 land-based efficacy tests as required by G9 (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.4).

4.2.1 The Group noted that the discharge toxicity tests had been conducted on samples drawn from the G8 land-based efficacy tests (Data supplied by the applican t: Appendix I Folder,

GESAMP REVIEW , section 1).GESAMP-BWWG 6/9

ANNEX 7 Page 8

I:\MEPC\58\2-7.doc 4.2.2 However, the Group considered that thes e tests had not been carried out under adequate Quality Control for the whole effluent toxicity testing, so th at the resultant PNEC values calculate from these data could have larg e uncertainties. It was noted that this comment had been made when the previous submission fo r FA had been considered (MEPC 57/2, annex 7, section 7.1.1.1.).

4.2.3 The Group also recognized that, notwithstanding the test deficiencies of the algal test, the fish and daphnia tests were sati sfactory and clearly showed no ecotoxicological effects to the organisms tested. As the tests were expected to be negative, because of the neutralizing agent, the Group decided to accept all of the whole effluent tests as a basis for making its
recommendations.

4.3 Concentration of organic matter and salinity of the test samples

4.3.1 The Group recalled that it had c onsidered the concentration of organic matter in the water
used in the land-based tests to be too low and that this would lead to a reduction in the levels of by-products generated by the system (MEP C 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.5).

4.3.2 In addition, it was recalled that the salini ty of the test water samples were not in
accordance with the standards defined in G9.

4.3.3 However, it was noted that the applicant ha d conducted further tests using more realistic concentrations of Particulate Organic Conten t (POC), Dissolved Organic Content (DOC) and Total Suspended Solids (TSS) (Data supp lied by the applicant: Appendix I Folder,

GESAMP REVIEW , section 1).

4.3.4 Details of the salinity an d organic content of the te st water are shown below:

Water quality of seawater (Masan Bay)

Date Sample pH Temp.

(°C) Salinity

(PSU) DO

(mg/L) TSS

(mg/L) DOC

(mg/L) POC

(mg/L)

06-06-2007 Test

water 8.0 19.8 33.4 6.9 48.8 1.6 3.3

20-06-2007 Test

water 8.2 20.5 33.2 7.0 90.3 1.7 10.1

07-12-2007 Test

water 8.1 9.5 32.7 9.3 40.4 1.6 2.9

17-12-2007 Test

water 7.9 9.3 32.1 10.1 63.1 2.0 1.7

16-01-2008 Test

water 8.1 6.9 32.9 10.2 58.5 1.8 1.1GESAMP-BWWG 6/9

ANNEX 7 Page 9

I:\MEPC\58\2-7.doc Water quality of brackish water (Sumjin Estuary)

Date Sample pH Temp.

(°C) Salinity

(PSU) DO

(mg/L) TSS

(mg/L) DOC

(mg/L) POC

(mg/L)

01-08-2007 Test

water 7.9 27.0 19.3 6.5 52.9 5.4 6.2

22-08-2007 Test

water 8.3 27.9 18.2 8.5 60.3 6.7 6.0

29-08-2007 Test

water 7.9 26.5 18.6 7.8 60.3 6.5 5.5

10-09-2007 Test

water 8.0 23.9 19.2 8.9 63.5 5.7 6.3

22-10-2007 Test

water 8.0 21.6 20.1 19.1 57.9 6.1 5.8

20-02-2008 Test

water 8.5 5.9 16.8 11.7 59.5 5.4 6.1

Additionally, toxicity tests were conduc ted on 22nd October 2007 and 17th December 2007 with discharged water treated with ECS during land-based tests. (Refer to Appendix 7: Toxicity Test Report.)

4.4 Lack of information associated with by-p roducts potentially produced by the system

4.4.1 It was recalled that, previously, the app licant had only identifie d a limited number of by-products which the system could potentially generate compared with similar systems considered by the Group and data found in the open literature. In addition, it was recalled that the applicant had not provided any information regarding the potential reaction between chlorine gas and bromide ions which are an inherent constituent of seawater (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.6).

4.4.2 However, the Group noted that the applicant had identified more potential by-products as shown under paragraph 4.3 and had also provided the following information related to the
reaction mechanisms of chloride and bromide ions:

.1 active substances like HOCl (OCl – ), HOBr (OBr – ), O 3 , H 2 O 2 and OH - radicals are generated by the ECS during its operation. The synergisti c effect of these Active Substances efficiently re moves various micro-organisms in ballast water;GESAMP-BWWG 6/9

ANNEX 7 Page 10

I:\MEPC\58\2-7.doc .2 HOCl and OCl – are generated at electrolysis pro cedure. Chlorine and water react to form hypochlorous acid (HOCl) and hydr ochloric acid (HCl ). In turn, the HOCl dissociates into the hypochlorite ion (OCl – ) and the hydrogen ion (H + ), according to the following reactions:

Cl 2 + H 2 O Q HOCl + HCl

HOCl Q H + + OCl –

.3 hypochlorous acid is weak acid (pKa of a bout 7.5), meaning it dissociates slightly into hydrogen and hypochl orite ions. Between a pH of 6.5 and 8.5 this dissociation is incomplete and both HOCl and OCl – species are present to some extent. Below a pH of 6.5, no dissociation of HOCl occurs, while above a pH of 8.5, complete dissociation to OCl – occurs. As the germicidal effects of HOCl are much higher than that of OCl - , chlorination at a lower pH is preferred (Alternative Disinfectant EPA, 1999). The OCl – and HOCl species are commonly referred to as free chlorine, which is extremely reactive with cell components of numerous micro-organisms;

.4 bromine occurs naturally in sea water where it is present as bromide salts or organic bromine substances. These s ubstances are produced by several sea organisms. Bromine is present mostly in th e form of soluble salts in seawater, salt
lakes and brine. Chlorine will also oxidise bromide to form hypobromous acids
shown in the reactions below:

Cl 2 + H 2 O Q HClO + H + + Cl -
HOCl + Br - Q HOBr + Cl -

.5 hypobromous acid (HOBr) is an effective biocide. The rate of hypobromous acid and hypobromite ions is determined by the pH value of the water. When the pH
value is a between 6.5 and 9 both hypobromous acid and hypobromite ions can be found in water (Lenntech, Disinfectants Bromine, Water treatment & air purification Holding B.V.);

.6 ozone is a stronger and faster-acting oxidiser. Because ozone is an unstable molecule, it should be generated at the point of application for use in water treatment. It is genera lly formed by, combining an oxygen atom with an oxygen
molecule. Ozone is far more efficient in ki lling bacteria, viruse s, spores and cysts (Muhammad Arif Malik, Abdul Gha ffar & Salman Akbar Malik, 2000);

.7 hydrogen peroxide (H 2 O 2 ) is a very unstable oxidant. In general these can adequately remove micro-organisms. H 2 O 2 is non-persistent, has innocuous or even beneficial degradation products, and does not accumulate. Hydrogen peroxide is a normal metabolite in nearly all organisms and naturally produced by sunlight in water; and

.8 the OH - radical is a very reactive oxidative sp ecies with half-life in the order of milliseconds, thus never leaving the reactor. OH - radical, through the exchange of ions, instantaneously disinfect the bact eria and aquatic micro-organisms around it (Glaze et al ., 1987; Alternative Disinfectant EPA, 1999).GESAMP-BWWG 6/9

ANNEX 7 Page 11

I:\MEPC\58\2-7.doc 4.5 Human exposure to brominated by-pro ducts and other volatile substances potentially generated by the system

4.5.1 The Group recalled that the previous submissi on had lacked any data related to the risks to humans who might be exposed to brominated by-products and other volatile substances (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.7 ). As a result, th e Group was unable to carry out a full Human Risk Assessment and c ould only make recommendations to mitigate any risks to humans based on a precautionary approach.

4.5.2 In addition, the Group recalled that, in co nsidering the previous submission by this applicant, it had expressed concern that the concentrations of Total Residual Chlorine (TRC), formed by this system, largely ex ceed the limit values establis hed for the discharge of waste water from land-based point sources. As the degradation rate of the TRC is so low, substantial concentrations of TRC might be exp ected in the discharged ballast water which is of concern as the potential health risks ha ve not been sufficiently characterized (MEPC 57/2, GESAMP-BWWG 4/9, Annex 4, para. 9.4.1).

4.5.3 However, the Group noted that the applicant had prepared various exposure scenarios for individual Active Substances, Relevant Chemicals and Other Components. Such scenarios assumed that the crew might be exposed to tr eated ballast water whilst the public might be exposed to treated ballast water which had firs t been neutralized using sodium thiosulphate.

4.5.4 The Group accepted the results of the EASE/EUSES 2.1 Risk Assessments made by the applicant. However, the Group noted that a co mprehensive justificati on for the selection of the N(L)OAEL values used in the Risk Assessme nt (which study, critical effect, etc.) and MOE
calculations used in the risk characterization were not provi ded. The Group also recommended that the applicant could elaborate further on th e relevant human exposure scenarios associated with the system through an adequate descript ion of the processes and unit operations where worker exposure may occur.

4.6 Measurement and control mechanisms for hydrogen and chlorine

4.6.1 It was recalled that, whilst the applicant had indicated that the highest levels of hydrogen and chlorine measured during tests were 4% a nd 0.9 ppm respectively, the Group considered that adequate measurement and control mechanisms fo r these chemicals needs to be put in place (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, paras. 0.8, 0.12 and 0.13).

4.6.2 In making such recommendations, the Group had taken into account that the Lower Explosion Limit for hydrogen is 4% and the published fifteen minute acute human exposure limit for chlorine is 1 ppm and the workplace exposure limit is 0.5 ppm (8-hr weighted average).

4.6.3 The Group noted that the applicant had indi cated that monitoring alarm and shut-down functions had been included in the system to miti gate the potential risks, details, of which, were described in section 4 of appendi x 1 of confidential documentation.

4.6.4 However, it was noted that, for hydrogen, the al arm system was designed to operate at 2% and the system would shut down if the level ex ceeded 3%. In addition, it was noted that, for chlorine, the alarm system would operate at 0.6 ppm and the system would shut down at 0.8 ppm.GESAMP-BWWG 6/9

ANNEX 7 Page 12

I:\MEPC\58\2-7.doc 4.6.5 Having taken these factors into account, th e Group was satisfied that these facilities provided adequate safeguards to ensure that the crew were not exposed to hazardous levels of chlorine and the levels of hydrogen would not be hazardous to the ship.

4.7 Corrosivity testing

4.7.1 The Group recalled that it had, noted that, previously, the appli cant had carried out corrosion tests using coated test samples and so it was only the coating being tested. This led to
the concern that the Active Subs tances, such as chlorine, genera ted by the system, might lead to increased corrosion of the tank and pipi ng (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, paragraphs 0.9, 0.14 and 9.4).

4.7.2 The Group noted, that, in res ponse to these con cerns, the applicant had provided the following information (Section 5 of Appe ndix I to supplementary information):

.1 electrochemical studies (e.g., potentiost atic tests, potentio dynamic polarization, Tafel plot analyses and pot ential vs. Time studies) on uncoated/coated samples, pipe materials, and ballast tank samples were conducted from 10th January
to 2nd March 2008 with various initial TRO concentrations up to 10 ppm. In addition, the ballast tanks in the test barge were inspecte d after 2 years of undefined usage rate to assess the relative coatings damage in the seawater and
chlorinated seawater. Detailed test report is provided as appendix 8 of the application dossier;

.2 the uncoated test samples are the substa ntial materials for ballast tanks and the coated test samples are the materials pa sted with Zn primer, which was assumed to be a zinc rich epoxy primer as opposed to a galvanized coating;

.3 the applicant conducted a visual assessment of the corrosion condition of barge
ballast tanks used to conduc t the land based testing. Th e applicant indicates that these tanks were coated with a typical epoxy amine coating 150-200 μm thick, operated for two years throughout the test ing of their treatment system, but the Group noted that no details regard ing the cumulative time of exposure to treated or control waters were provided nor the corrosion condition of these tanks prior to testing. The app licant determined from the inspection of these tanks resulted in comparable corrosion on overhead and vertical bulkhead surfaces, but
that the tank bottom of the control/natu ral seawater exposed tank had more sever corrosion than the chlorinated seawater tanks. The applicant concludes from this inspection that chlorination was benefici al to corrosion of the substrate;

.4 the applicant conducted Tafel plot analyses of polarizat ion curves generated with an initial 600 s lag time and subsequent 2 mV/s scan rate on uncoated steel samples. From these corrosion potentia ls and corrosion current densities were determined, though the calculation of Tafel slopes were not provided. In this case, the corrosion current density is proportio nal to the corrosion rate as dictated by Faraday’s Law. The applicant concl uded from these analyses that when TRO was 2 ppm, the corrosion current density was rather lower than in seawater, but when TRO was 6 and 10 ppm, it was almost same as in seawater. Thus, under 10 ppm TRO, corrosivity would be similar or lower than in seawater. However, the Group noted that, Tafel analys es are not advisable for assessment of long term corrosion rates or in-service performance (note that these were conducted in a period of minut es). These are ideal for rudimentary or preliminary
evaluations of material beha viour or relative corrosivity;GESAMP-BWWG 6/9

ANNEX 7 Page 13

I:\MEPC\58\2-7.doc .5 Tafel analyses were repeated for samples with a zinc primer. These data exhibited the lowest corrosion current density at TRO 2mg/L whereas the highest corrosion current density was shown in natural s eawater. TRO 6mg/L and 10mg/L have
lowe r or similar corrosion current density to natural seawater. Consequently, the reaction between Zn primer and TRO causes less remarkable corrosion than natural seawater. However, the Group wa s concerned that th ese conclusions are largely based on averaged polarization cu rves which exhibited highly disparate data. Polarization curves generated with identical conditions resulted in corrosion potentials distributed over 200-300 mV vs . Ag/AgCl, likewise corrosion current
densities are distributed over an order of magnitude. These results are irregular and are cause for concern regarding either the experimental procedure or the presence of other uncontrolled variables;

.6 in Tafel analysis of pipe material s by TRO concentrations generated by ECS, corrosion potential and corrosion current de nsity have been calculated. Natural seawater shows the highest corrosion potential than seawater with TRO concentrations. On the other hand, na tural seawater and seawater with TRO
concentrations show almost similar results on corrosion current density. Therefore, the applicant considers that TR O has only little effect on corrosivity. The Group noted that this conclusion is not in keeping with published long term
corrosion rates for steel in chlorinated seawater; and

.7 in summary, the applicant concluded th at, TRO does not cause corrosion as severe
as natural seawater because seawater with TRO concentrations shows less or
similar corrosion to natural seawater in electrochemical experiments and Tafel analysis. In addition, comparing floors of ballast tanks on the test barge during the internal inspection, the tanks with ECS treated water shows even less corrosivity than the tanks with natural seawater.

4.7.3 Having considered this additional informa tion, the Group recognized that the applicant
had concluded that treatment with the Electro-C lean system would result in comparable or reduced corrosion rates on steel and zinc primer coat ed steel relative to e quivalent exposures in
natural seawater.

4.7.4 However, the Group determined that this conclusion could not be accepted since it contradicts known and published data regarding increased co rrosion of carbon steel in chlorinated seawater. Furthermore, the electroch emical data are not considered of sufficient length or uniformity to support this conclusion.

4.7.5 The Group noted that the appli cant attempted to evaluate lo ng term performance based on the inspection of barge ballast tanks used duri ng testing, but the Group agreed that visual examination of such broad areas was insufficient, alone, without further detail and usage history. The Group recommends a monitoring programme be instigated to provide for the long-term inspection of ballast systems using the ECS tr eatment to ensure that no common obvious or
extensive corrosion failures occur as a result of usi ng the ballast water treatment system. As this type of inspection is difficult to perform properly and quantitativ ely, it is recommended that such inspections should be conducted by trained inspection personnel. The Group further recommended that longer term studies on both uniform and localized corrosion rate
determination of corrosion of car bon steel be performed at the TRO levels in ballast water applied by the treatment system.GESAMP-BWWG 6/9

ANNEX 7 Page 14

I:\MEPC\58\2-7.doc 4.8 Neutralization System

4.8.1 It was recalled that, at the time of the previous submission, the applicant had not tested the neutralization system under operational conditions and so the Group had
considered that effective neutralization of TRO in the discharge water could not be ensured (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 0.1).

Note: In the previous submission the applicant used “TRC” as the parameters for Active Substance. However, the Group agre ed that the applicant now used “TRO” parameters measured by TRO sensors instead of TRC in this FA.

4.8.2 In addition, the Group recalled that it had obser ved that mitigation procedures should be
established to reduce the TRO to levels acce ptable to the environment in the case of short trips and during the treatment of fr esh waters (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 9.3).

4.8.3 Furthermore, it was recalled that it had b een of the opinion that the amounts of total residual oxidant (TRO) formed duri ng the electrolytic process could result in concentrations in the treated ballast water which exceed the limit values established for discharge of waste water from land-based point sources. The Group had agreed that, as the degradation rate of TRO is not fast enough (1/2 life = 1 day) in ballast tanks to avoid substantia l concentrations of TRO in the receiving environment for short voyages (1-2 days) and the health risks had not been characterized sufficiently.

4.8.4 The Group noted that, having considered th ese points, the applicant had provided the following information:

.1 the initial concentration of TRO produced by the ECS had been reduced from 20-30 mg/L to 10 mg/L and, followi ng neutralization process just before discharge, TRO is mitigated in the discharged water;

.2 the neutralizing agent had been changed from sodium bisulphite, which was stated at the previous submission, to sodium thiosulphate;

.3 an automatic process, which will be operated at all discharge operation, had been installed in order to neutralize any TR O produced by the disi nfection process. This neutralization process is controlled by the PLC which, automatically controls the volume of sodium thiosulphate adde d according to the actual level of TRO determined; and

.4 concentrations of TRO present in the discharged ballast water, following this automated treatment, were <0.02 mg/L in various TRC range (2.1 -8.2 mg/L) both
in land-based test and on- board test as shown below:GESAMP-BWWG 6/9

ANNEX 7 Page 15

I:\MEPC\58\2-7.doc TRO concentration changes through neutrali zation system after at land-based test

TRO concentration
before
neutralization (mg/L) Automatic
neutralization system 300m 3 /hr fixed pump flow rate (L/h) Amount of Neutralizer (kg/m 3 ) TRO concentration
after neutralization (mg/L)

2.3 15.0 0.0082 <0.02

4.3 36.0 0.0196 <0.02

5.8 39.0 0.0212 <0.02

8.2 42.0 0.0228 <0.02

TRO concentration changes through neutra lization system at shipboard test

TRO concentration
before
neutralization (mg/L) Automatic
neutralization system 300m 3 /hr fixed pump flow rate (L/h) Amount of Neutralizer (kg/m 3 ) TRO concentration (mg/L) after
neutralization

2.1 14.4 0.0078 <0.02

4.1 33.6 0.0183 <0.02

5.8 37.8 0.0203 <0.02

7.8 41.1 0.0223 <0.02

Refer to Appendix 5: Installation & Opera tion Manual of Electro-C lean System (ECS).

4.8.5 Having considered this information, the Gr oup concluded that by installation of this neutralization process, the system could mitigate the risk to marine ecosystem significantly not only against short voyages. The Group also noted th at the reliability of control system including that of TRC sensors is important to gua rantee the maximum discharge concentration of TRC (< 0.02 mg/L).

4.9 Acute and Chronic Aquatic Toxicity Tests on ECS Treated Ballast Water

4.9.1 The Group recalled that the acute tests, carried out using seaw ater treated with the ECS,
had shown that a dilution of more than 100 times had been required in order to remove its acute aquatic toxicity properties (MEPC 57/2, GESAMP-BWWG 4/9, a nnex 4, para. 9.4.2).GESAMP-BWWG 6/9

ANNEX 7 Page 16

I:\MEPC\58\2-7.doc 4.9.2 The Group noted that the applicant had made the following points in relation to this
observation:

.1 further toxicity tests had been carried out using ECS treated and neutralized water:

.1 immediately after treatment; and

.2 after 72-hour storag e in the ballast tank.

.2 as neutralization is part of the ECS system, TRO was not detected in the treated water which is used for toxicity testing.

4.9.3 The Group noted that the aquatic toxicity test results, shown in table 5/4 of section 5.2.2.1 of MEPC 58/2, show that the tr eated brackish water does not show any acute or chronic toxicity.

4.10 Risk Assessment Related to Environmental Exposure with an Adequate Model

4.10.1 The Group recalled th at it had noticed, in the previous application, that the environmental exposure concentrations had, apparently, been based on MAMPEC model calculations submitted by a previous applicant. As a result, the Group had requested that the input data and model parameters be made availa ble to ascertain the validity of the results (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 9.4.3).

4.10.2 The Group noted that, in response, the applicant had indicated that:

.1 as the Active Substances were not detected in the discharged ballast water after neutralization, Risk Assessment for such substances were not considered; and

.2 the PEC/PNEC ratio for the by-pr oducts, after neut ralization was <1.

4.11 Operation of ECS system on Fresh Water

4.11.1 The Group recalled that the previous submission did not include documentation on the Active Substance which may be produced by the ECS system in fresh water and so it had requested full documentation of the properties of such AS (MEPC 57/2, GESAMP-BWWG 4/9, annex 4, para. 9.4.5).

4.11.2 The Group noted that, in response to this request, the applicant had provided the following information:

Analytical result of Active substances in fresh water

Chemical name Control

water (mg/L) Treated water (mg/L) before
neutralisation Treated water (mg/L) after
neutralisation LOD* (mg/L) LOQ* (mg/L)

0.86 N.D.

0.80 N.D. Active
substances HOCl(OCl - ) N.D.

0.82 N.D. 0.01 0.04GESAMP-BWWG 6/9

ANNEX 7 Page 17

I:\MEPC\58\2-7.doc Chemical name Control

water (mg/L) Treated water (mg/L) before
neutralisation Treated water (mg/L) after
neutralisation LOD* (mg/L) LOQ* (mg/L)

0.722 N.D.

0.635 N.D. HOBr(OBr - ) N.D.

0.582 N.D. 0.002 0.006

2.49 N.D.

2.32 N.D. O 3 (H 2 O 2 ) N.D.

2.46 N.D. 0.02 0.06

N.D. N.D.

N.D. N.D. 2,3-dihydroxybenzoic acid N.D.

N.D. N.D. 0.01 0.02

N.D. N.D.

N.D. N.D. OH 2,5-dihydroxybenzoic
acid N.D.

N.D. N.D. 0.02 0.05

Operating condition of rectifier at 200 ton/h

Condition Salinity Conductivity Ampere of rec tifier Voltage of rectifier

2.8‰ 4 mS 3000A 12V

18‰ 25 mS 1980A 5.2V

20‰ 28 mS 1950A 4.8V Treatment

capacity:

200 ton/h

TRO: 10mg/L 32‰ 45 mS 1950A 4.5V

Operating condition of rectifier at 300 ton/hr

Condition Salinity Conductivity Ampere of rectifier Voltage of rectifier

2.8‰ 4 mS 4500A 14V

18‰ 25 mS 2950A 6.5V

20‰ 28 mS 2900A 5.9V Treatment capacity:
300 ton/h TRO: 10 mg/L 32‰ 45 mS 2900A 5.5V

The applicant indicated that the ECS generated TR O 10mg/L successfully in saline concentration
of 2.8‰.

4.11.3 Having considered this additional information, the Group was satisfied with the information provided.GESAMP-BWWG 6/9

ANNEX 7 Page 18

I:\MEPC\58\2-7.doc 4.12 Quality Assurance Plan

4.12.1 The Group recalled that the previous a pplication did not include documentation of the Quality Control/Quality Assurance Programme as requested in G9:4.2.4.

4.12.2 The Group noted that the QAPP for the full-scale testing was provided (Additional Data, appendix 10). Also, the Group noted that for the chemical analysis, there are adequate data quantity objectives (DQOs) and the results report incl ude the attainment against DQOs, such as repeatability for zero blank and calibration control for GC-MS.

4.12.3 Having considered this information, the Gr oup concluded that, for the toxicity testing, the applicant did not provide bot h adequate QA and QC. As a re sult, the Group requested MEPC to recommend that, for future applications, a thorough review of the QA PP is conducted by the appropriate authorities in the Republic of Korea.

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

5.1 The Group recognized that the Active Substanc es and Relevant Chemicals are generated

in situ and so there were not any associated storage hazards or risks. Nevertheless, it was agreed
that there are risks associated w ith the potential exposure of the crew to such products from the
treated ballast water which n eed to be taken into account.

5.2 In addition, it was noted that the neutralizing agent, sodium thiosulphate does need to be
stored on board and so its hazards and associated risks need to be taken into consideration.

5.3 In this context the Group recognized that, with the exception of sodium thiosulphate,
none of the Relevant Chemicals exceeded a con centration of 0.11 mg/L in the treated ballast
water either before or after ne utralization of the Active Substan ces. Taking this into account and being aware that the chemicals have different volatilities, th e Group noted that the potential
health hazards associated to this system would be:

.1 acute effects: inhalation toxicity (T ROs); corrosiveness (hypochlorite); and

.2 long-term effects: mutagenicity/carcin ogenicity (brominated an d chlorinated DBP).

5.4 Recognizing that sodium thiosulphate is to be stored on board ship, the Group took account of its human toxicological h azards as an undiluted chemical. In this respect, it was noted
that:

.1 the oral toxicity of sodium thiosulphate is low (>2500 mg/kg);

.2 no dermal toxicity for sodium thiosu lphate was provided. However, the Group considered that, based on the oral toxicit y, this was expected to be low also; and

.3 sodium thiosulphate has irritative prope rties towards the respiratory tract (MSDS).

5.5 Notwithstanding these observations, the Group recommended that all normal safety and hygiene standards are applied to mitigate th e risks of exposure to such chemicals.GESAMP-BWWG 6/9

ANNEX 7 Page 19

I:\MEPC\58\2-7.doc 5.6 Whilst recognizing the lack of real data asso ciated with sodium thiosulphate, the Group agreed that the risks to the crew would require m itigating by the inclusion of detailed procedures and PPE requirements for the handling and loading of this chemical in the operational manual.

5.7 Recognizing that there are potential hazards a ssociated with the exposure of the crew to treated ballast water, the Group not ed that the applicant had app lied the European Union System for the Evaluation of Substances (EUSES) for estim ating the potential risk to both the crew and general population who might become exposed to the treated ballast water. The results of this application are shown below:

Risk assessment results for crew

Potential by-products Ratio MOS/Ref-MOS for vapour
inhalation

Hypochlorite 1.29

Hypobromite
-

Ozone -

Dibromochloromethane 121

Tribromomethane 333

Dibromoacetonitrile -

2,4,6-Tribromophenol 127

Monochloroacetic acid 33.4

Monobromoacetic acid 8.82

Dichloroacetic acid 19.3

Dibromoacetic acid 38.4

Bromochloroacetic acid 18.2

Tribromoacetic acid 88.3

Bromate ion 2.77GESAMP-BWWG 6/9

ANNEX 7 Page 20

I:\MEPC\58\2-7.doc Risk assessment results for general population

Ratio MOS/Ref-MOS

Local Regional Potential by products

Inhalatory Total Exposure Inhalatory Total Exposure

Dibromochloromethane 2.25E+09 5.34E+03 1.02E+12 9.31E+09

Tribromomethane 2.23E+06 2.12E+06 6.41E+06 1.28E+07

Dibromoacetonitrile - - - -

2,4,6-Tribromophenol 2.59E+10 5.77E+03 1.57E+13 1.6E+10

Monochloroacetic acid 9.44E+06 4.5E+04 1.56E+11 1.76E+10

Monobromoacetic acid 1.11E+07 4.69E+03 2.09E+11 2.27E+09

Dichloroacetic acid 1.46E+08 5.97E+03 8.73E+11 3.37E+09

Dibromoacetic acid 1.53E+08 2.18E+03 6.68E+11 3.29E+08

Bromochloroacetic acid 9.31E+06 3.74E+04 1.47E+11 1.87E+10

Tribromoacetic acid 9.6E+08 1.84E+03 1E+12 1.49E+08

Sodium thiosulphate - - - -

Ref: Additional data, Appendix 9: Data sh eet of MAM-PEC and EUSES for risk assessment.

5.8 Being aware that the results of EUSES risk assessment showed some level of uncertainty due to insufficient background calculations provided, the Group noted, however, that
the Risk Characterization Ratios (RCR) for the Releva nt Chemicals identified were above 1 therefore showing limited risk. However, bromate ions produc ed values close to 1 in
the Risk Assessment for the crew and therefore the Group recommended that all the normal safety practices should be employed by th e crew when entering the ballast tanks. In addition, the Group
considered that ECS treated ballast water woul d not pose an undue risk to the general public.

5.9 With regard to the risk to the crew and the ship from th e potential generation of hydrogen and/or chlorine gases, the Group was satisfied that the alarm/shut -down facilities built into the system were adequate. However, the Group considered that there is a potent ial for the crew to be exposed to THMs in the air emitting from the gas venting system, ther efore, the siting of the vent outlet requires careful consideration to mitigate this potential risk.

6 RISKS TO TH E ENVIRONMENT

6.1 Persistence (P), Bioaccumulation (B) and Toxicity (T)

6.1.1 The Group noted that none of the Active S ubstances or Relevant Chemicals should be considered as meeting the PBT criteria defined in G9.

Ref: Additional information, Appendix IV.GESAMP-BWWG 6/9

ANNEX 7 Page 21

I:\MEPC\58\2-7.doc PBT character of Active Substances and Relevant Chemicals

Chemical Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n)

Hypochlorous acid (No) 1/2-Life: Not reported No Log Pow= -2.46 Yes

133d NOEC for Ictalurus punctatus

, 0.005mg/l

Hypobromous acid/hypobromite No 1/2-Life: 10.5days No Log Pow = 1.03

BCF = 1.236 (No)

NOEC = No data

Hydrogen peroxide No Anticipated 1/2-Life is

from hours to a few days No Log Pow <-1.5 No NOEC = 2mg/l ( zebra mussel )

Ozone No Decomposes very rapidly in natural

water (No) (No)

NOEC = No data

Hydroxyl radical No Evaluated as hydrogen No

Evaluated as hydrogen No Evaluated as hydrogen peroxide

Trichloromethane Yes BOD=0% (14days) No LogPow= 2

BCF= 1.4-13 No Ceriodaphnia dubia NOEC= 3.4 mg/l/11 days

Dibromomethane Yes

1/2 – Life = 22years No Log Pow = 1.7

BCF = 4.06 No Cyprinodon variegates NOEC= 4.8 mg/l/28 days (Tribromomethane)

Bromodichloromethane Yes

BOD=51-59% (28days) No LogPow= 2

BCF= 7 No Oryzias latipes NOEC= 0.78 mg/l/21days

Dibromochloromethane Yes Biowin2 (Non-Linear Biodeg Probability) =

0.0000 : Does Not Biodegrade Fast / Appendix 11, page
106, 107 No Log Pow = 2.16

BCF = 9.188 No Daphnia magna NOEC = 0.063 mg/l/21days (GLP)

Tribromomethane Yes Biowin2 (Non-Linear Biodeg Probability) =

0.0000 : Does Not Biodegrade Fast / Appendix 11, page
125, 126 No Log Pow = 2.4

BCF = 14.06 No Cyprinodon variegates NOEC= 4.8 mg/l/28 daysGESAMP-BWWG 6/9

ANNEX 7 Page 22

I:\MEPC\58\2-7.doc Dibromoacetonitrile Yes Aquatic fate: 5% and

20% of

dibromoacetonitrile are lost via hydrolysis in 10 days at pH 6 and 8, respectively Biowin2 (Non-Linear Biodeg Probability) =

0.0170 : Does Not Biodegrade Fast / Appendix 11, page
144, 145 No Log Pow = 0.47

BCF = 1.34 No Pimephales promelas LC50= 0.55 (mg/l/96 h)

2,4-Dibromophenol Yes BOD=0% (28days) No Log Pow =3.29

BCF = 12-40 No Oryzias latipes LC 50 = 12mg/l/96 h

2,6-Dibromophenol Yes Biowin2 (Non-Linear Biodeg Probability) =

0.0467 : Does Not Biodegrade Fast / Appendix 11, page
182, 183 No Log Pow =3.29

BCF = 30.7 No Oryzias latipes LC 50 = 12mg/l/96 h (2,4-dibromophenol)

2,4,6-Tribromophenol Yes

BOD = 49 % (28 days) 1/2 – Life >32 days (Fresh water) Biowin2 (Non-Linear Biodeg Probability) =

0.0030 : Does Not Biodegrade Fast/ Appendix 11, page
202, 203 No Log Pow =3.89

BCF = 513 No Daphnia magna NOEC= 0.1 (mg/l/21 days) (GLP)

Monochloroacetic acid No

BOD = 100 % (28 days) Biowin2 (Non-Linear Biodeg Probability) = 0.6123 : Biodegrades Fast / page 221, 222 No Log Pow = 0.22

BCF = 3.162 No Brachydanio rerio LOEC= 25 (mg/l/28 days)

Monobromoacetic acid No BOD=73% 8-10days No Log Pow = 0.41

BCF = 3.162 No Daphnia magna NOEC= 1.6 (mg/l/21days)

Dichloroacetic acid Yes Biowin2 (Non-Linear Biodeg Probability) =

0.1318 : Does Not Biodegrade Fast / Appendix 11, page
260, 261 No Log Pow = 0.92

BCF = 3.162 No Nitocra spinipes LC50= 23 (mg/l/96 h)GESAMP-BWWG 6/9

ANNEX 7 Page 23

I:\MEPC\58\2-7.doc

Bromochloroacetic acid Yes

Biowin2: 0.5801 NonLinear Model =

0.0060 : Does Not Biodegrade Fast / Appendix 11, page
279, 280 No Log Pow = 0.61

BCF = 3.162 No Brachydanio rerio LOEC=
25 (mg/ l /28 days) (Monobromoacetic
acid)

Dibromoacetic acid No Biowin2 (Non-Linear Biodeg Probability) =

0.0002 : Does Not Biodegrade Fast / Appendix 11, page
298, 299 No Log Pow = 0.70

BCF = 3.162 (No) Pimephales promelas LC50=
69 (mg/ l /96 h)

Tribromoacetic acid Yes Biowin2 (Non-Linear Biodeg Probability) =

0.0000 : Does Not Biodegrade Fast No Log Pow = 1.71

BCF = 3.162 (No) Pimephales promelas LC50=
69 (mg/ l /96 h) (Dibromoacetic acid)

Bromate ion No Biowin2 (Non-Linear Biodeg Probability) = 0.6541 : Biodegrades Fast / Appendix 11, page 336, 337 No Log Pow = -7.18

BCF = 3.162 (No)

Morone saxatilis LC50= 404 (mg/l/96 h)

Sodium thiosulphate No Biowin2 (Non-Linear Biodeg Probability) = 0.6822 : Biodegrades Fast / Appendix 11, page 354, 355 No Log Pow = -2.32

BCF = 3.162 Yes Oncorhynchus mykiss NOEC= 600 (mg/l/18 months)

6.1.2 The Group concluded based on the Table of section 6.1.1 that none of the Relevant Chemicals defined in this appl ication should be consid ered as a PBT-compound.

6.2 Calculation of PEC/PNEC Ratios

6.2.1 The Group noted the revised data in th e table below provided by the applicant
on 12/05/08.

Chemical PEC (Max) (mg/L) Toxicity (mg/L) Factor Applied PNEC (mg/L) PEC/PNEC (Max)

Trichloromethane 2.42E-08 3.4 100 Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + Three long-term NOEC from fresh water (algae, crustaceans and fish) 0.034 7.12E-07

Dibromomethane 1.47E-08 2.9 100 Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + Three long-term NOEC from fresh water (algae, crustaceans and fish) 0.029 5.07E-07GESAMP-BWWG 6/9

ANNEX 7 Page 24

I:\MEPC\58\2-7.doc Bromodichlorometh

ane 2.60E-08 0.79 500 Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + Two long-term NOEC from fresh water (crustaceans and fish) 0.00158 1.65E-05

Dibromochlorometh

ane 2.31E-06 0.063 500 Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + Two long-term NOEC from fresh water (fish and crustaceans) 0.000126 1.83E-02

Tribromomethane 1.34E-04 2.9 100 Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + Three long-term NOEC from fresh water (algae, crustaceans and fish) 0.029 4.62E-03

Dibromoacetonitrile 3.96E-06 0.55 10,000 One L(E)C50 from fresh water or sea water (fish) 0.000055 7.20E-02

2,4-Dibromophenol 9.06E-08 12 10,000 Two L(E)C50 from fresh water or sea water (fish and algae) 0.0012 7.55E-05

2,6-Dibromophenol 4.76E-08 12 10,000 Two L(E)C50 from fresh water or sea water (fish and algae) 0.0012 3.97E-05

2,4,6- Tribromophenol 4.28E-06 0.1 1,000 Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + One long-term NOEC from fresh water (crustaceans) 0.0001 4.28E-02

Monochloroacetic

acid 2.04E-07 0.033 500 Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + Two long-term NOEC from fresh water (crustaceans and fish) 0.000066 3.09E-03

Monobromoacetic

acid 4.08E-06 1.4 500 One L(E)C50 from fresh water or sea water (algae) + One long-term NOEC from fresh water (crustaceans) 0.0028 1.46E-03

Dichloroacetic acid 1.97E-07 23 1,000 One L(E)C50 from fresh water or sea water (fish) + One long-term LC50 from fresh water (crustaceans) 0.023 8.57E-06

Bromochloroacetic

acid 1.59E-06 0.033 500 Three L(E)C50 from fresh water or sea water (algae, crustaceans and fish) + Two long-term NOEC from fresh water (crustaceans and fish) 0.000066 2.41E-02

Dibromoacetic acid 1.28E-03 69 10,000 One L(E)C50 from fresh water or sea water (fish) 0.0069 1.86E-01

Tribromoacetic acid 1.69E-03 69 10,000 One L(E)C50 from fresh water or sea water (fish) 0.0069 2.45E-01

Bromate ion 6.40E-04 13.6 10,000 Two L(E)C50 from fresh water or sea water (algae and fish) 0.00136 4.71E-01

Sodium thiosulphate 3.99E-02 600 1,000 Two L(E)C50 from fresh water or sea water (crustaceans and fish) + One long-term NOEC from fresh water (fish) 0.6 6.65E-02

6.2.2 The Group disagreed with some of the assessm ent factors of the table in section 6.2.1. An assessment factor of 10,000 is not needed in these cases. Also the assessment factor
of 500 lacks a basis as it is not used in the TGD. However, considering that the valid assessment
factor to be chosen should be less than the fact or applied by the applicant the resulting PNEC will be higher and therefore, the PEC/PNEC ratio lower than presented in table of section 6.2.1.GESAMP-BWWG 6/9

ANNEX 7 Page 25

I:\MEPC\58\2-7.doc 6.3 MAM-PEC Model

6.3.1 The Group welcomed the quantity of input data, which allowed evaluation of the PEC data for the relevant by-products. However, some problems arose from the large variety of basic physical and chemical data and some errors by the Applicant in transfe rring the data into the model. Degradation rates taken from the EPI suite, for example, were reported as daily degradation, whereas they were given an hourly degradation rates from the EPI study. Yet, the
PEC/PNEC ratios were not affect ed significantly by these errors.

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to the safety of the ship

7.2 Risks to the crew and the general public

7.2.1 The Group agreed that the human health risk assessment provided by the applicant
showed limited risk towards active substances and relevant chemicals generated by the system. However, bromate ions produced values close to 1 in the Ri sk Assessment for the crew and therefore the Group recommended that all the no rmal safety practices should be employed by the crew when entering the ballast tanks. In additio n, the Group considered that ECS treated ballast water would not pose an undue ri sk to the general public.

7.2.2 The Group also recommended that when opera ting the ECS, the applicant could further elaborate on the relevant human exposure scenario s associated to the system through an adequate description of the processes and unit operations where worker exposure may occur.

7.3 Risks to the environment

7.3.1 Having considered all of the information provided, the Group agreed that this system would not pose any undue risk to the environment.

7.4 Recommendations

7.4.1 Having reviewed the additional informa tion provided since th e last application for Final Approval, the Group agreed to re commend to MEPC that Final Approval of the ECS system should be granted.

___________