I:\MEPC\57\2-10.doc For reasons of economy, this document is pr inted in a limited number. Delegates are kindly asked to bring their copies to mee tings and not to request additional copies. INTERNATIONAL MARITIME ORGANIZATION

IMO 

# E

MARINE ENVIRONMENT PROTECTION
COMMITTEE
57th session Agenda item 2 MEPC 57/2/10 25 January 2008 Original: ENGLISH

HARMFUL AQUATIC ORGANI SMS IN BALLAST WATER

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

Note by the Secretariat

SUMMARY

Executive summary: This document contains the report of the fifth meeting of the GESAMP Ballast Water Working Group (GESAMP-BWWG) and includes the evaluation of proposals submitted for approval by South Africa, the Republic of Ko rea, Germany and Norway

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 5/9 (attached)

Introduction

1 The fifth meeting of the GESAMP-BWWG wa s held at IMO’s temporary headquarters from 14 to 18 January 2008 and its report is attached to this document as GESAMP-BWWG 5/9.

2 The main purpose of this meeting was to review the proposals for the approval of ballast water management systems (BWMS) that us e Active Substances to treat ballast water prior to discharge into the marine environment. The reviews of those proposals evaluated by the Group
are shown in annexes 5 to 8 of th e attached report. The present re port should be considered in conjunction with the fourth report of th e GESAMP-BWWG (docum ent MEPC 57/2).

3 Over the two meetings held between MEPC 56 and MEPC 57and covering seven proposals, the GESAMP-BWWG recommended that Basic Approval could be granted to four proposals taking into account the accompanying remarks contained in the reports. The Group was only able to recommend Final Approval to one out of the three proposals submitted for consideration prior to MEPC 57. It should be noted that the Group’s decision not to recommend Final Approval to two proposals was in both cases based on a wide range of considerations. These Applicants are advised to take all of the recommendations made by the Group, and contained in its reports, into account prior to re-submission.MEPC 57/2/10 - 2 -

I:\MEPC\57\2-10.doc 4 The GESAMP-BWWG noted that during its third, fourth and fifth meetings, it was necessary to request additional information from nearly all applicants, as the dossiers were incomplete or, more commonly, the informati on provided was unclear, so slowing down the evaluation process. Administrations have the res ponsibility to ensure th at Application dossiers are complete. They should check that all tec hnical descripti ons and specifica tions of the BWMS and, in particular those related to the operating conditions ar e included with each Application. Equally important, all data pertaining to the safety of the ship and crew, human health and environmental exposure and risk need to be submitted with each Application. Every Application has to be fully eval uated by the Group and whether it is recommended for approval or not, it takes the same amount of time. An Application that is not recommended for approval may, therefore, deny another potential applicant the chance of an early and possibly successful evaluation. Through MEPC, the GESAMP-B WWG would like to impress upon submitting
Administrations the need fo r a rigorous check of BWMSs applica tion dossiers prior
to submission.

5 The GESAMP-BWWG continued to work on its Methodology for information gathering and conduct of work (the Methodol ogy) and some improvements are proposed to
sections 7.2 and 10. The latest version of the Methodology is provided in annex 4 of the attached report.

Action requested of the Committee

6 The Committee is invited to:

.1 agree with the changes and additions included in sections 7.2 and 10 of the Methodology and to endorse the update d version of this Methodology as contained in annex 4 of the attached report;

.2 agree that Basic Approval should be granted to the Resource Ballast Technologies System as reported by South Africa in documen t MEPC 56/2/3 (see annex 5 of the current report);

.3 agree that Basic Approval should be granted to the GloEn-Patrol TM Ballast Water Management System as reported by the Republic of Korea in document MEPC 57/2/4 (see annex 6 of the current report);

.4 agree that Final Approva l should be granted to the SEDNA ® using PERACLEAN ® OCEAN Ballast Water Management System as reported by Germany in document MEPC 57/2/5 (see annex 7 of the current report);

.5 agree that Basic Approval should be granted to the OceanSaver ® Ballast Water Management System (OS BWMS) as reported by Norway in document MEPC 57/2/6 (see annex 8 of the current report);

.6 reiterate the need for a careful completeness check of the application dossiers by the Administrations submitting proposals fo r approval to IMO bearing in mind that according to Procedure (G9) onl y satisfactory applications should be forwarded to the Organization; and

.7 approve the report in general.

***I:\MEPC\57\2-10.doc GESAMP-BWWG
5th session Agenda item 9 GESAMP-BWWG 5/9 25 January2008 Original: ENGLISH

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

Table of Contents

Section Page Nos.

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

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

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

4 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR
INFORMATION GATHERING AND THE CONDUCT OF
WORK OF GESAMP-BWWG ........................................... 5

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

6 DATE FOR THE NEXT MEETING .................................... 6

7 CONSIDERATION AND ADOPTION OF THE REPORT .......... 6

ANNEXES

Annex 1 List of members who attended the fifth session of the GESAMP-Ballast Water Working Group

Annex 2 Agenda for the fifth session of the GESAMP-Ballast Water Working Group

Annex 3 Terms of referen ce for the Technical Group

Annex 4 Methodology for information ga thering and the conduct of work of GESAMP-BWWG – (Updated 18 January 2008)

Annex 5 Review of Proposal for Basic A pproval of Active Su bstance – ‘Resource Ballast Technologies System’, submitted by South Africa

Annex 6 Review of Proposal for Ba sic Approval of Active Substance
– ‘GloEn-Patrol TM Ballast Water Management System’, submitted by the Republic of Korea

Annex 7 Review of Proposal for Final Approval of the Ballast Water Management System
– ‘SEDNA ® using PERACLEAN ® OCEAN’, submitted by Germany

Annex 8 Review of Proposal for Basic Appr oval of Active Substance – ‘OceanSaver ® Ballast Water Management System’, submitted by NorwayGESAMP-BWWG 5/9 - 2 -

I:\MEPC\57\2-10.doc 1 INTRODUCTION

1.1 The fifth GESAMP Ballast Water Worki ng Group (GESAMP-BWWG) meeting was held at IMO Headquarters, London, from 14 to 18 January 2008, under the chairmanship of Dr. Tim Bowmer. This extraordinary meeting was held in addition to the fourth regular meeting in November 2007. A list of members attending this meeting is shown in annex 1, and the agenda, as adopted by the Group, is set out in annex 2.

1.2 The meeting was opened by Mr. Miguel Paloma res, Director of Marine Environment Division, who expressed his appreciation for the effort made by the members of the
GESAMP-BWWG to have this additional meetin g before MEPC 57. He informed the Group on
the volume of work for this sess ion and encouraged the participants to do their utmost to try to evaluate, if possible, all the submissions which had been submitted before the deadline for the regular meeting (i.e., 7 September 2007).

1.3 Mr. Palomares noted that in view of the rapidly increasing working load for the Group and the importance and need for timely review of the proposals for approval, IMO would approach GESAMP, with the view to e xpanding the number of members of the GESAMP-BWWG. In this resp ect, Mr. Palomares invited the members of the Group to propose
additional members that could be invited to participate the future sessions of the
GESAMP-BWWG.

1.4 Mr. Palomares informed the Group that Dr. Brigitte Behrends, who served as IMO consultant for the last two meetings of the GESAMP-BWWG, would not be available to continue to assist the Group and expressed his appreciation for her effort both during the preparatory phase and during the meeting, wishi ng her every success in her future career.

1.5 Finally, Mr. Palomares expressed his sinc ere appreciation for th e contribution of Dr. Tim Bowmer, who had chaired the Group for th e last three meetings, and who will not be
able to continue as chairman due to his new re sponsibilities as the Vice -Chairman of GESAMP.

1.6 Mr. Dandu Pughiuc, Head of the Marine Biosafety Section, Marine Environment Division, reported on the contractual arrangements and informed the Group on the logistics of the meeting. He also informed the Group that, at the request of Mr. Egil Dragsund, arrangements
had been made for him to be excused when the proposal for appr oval of the ‘OceanSaver ® Ballast Water Management System’ (Norway) was reviewe d, due to his involvement in the development of this technology. Mr. Dragsund took no part in this evaluation and his contract was consequently reduced to nine working days.- 3 - GESAMP-BWWG 5/9

I:\MEPC\57\2-10.doc 2 ISSUES OF CONFIDENTIALITY

2.1 Four proposals for approval of ballast water management systems submitted by the South Africa (Basic Approval), the Republic of Korea (Basic Approval), Germany (Final Approval) and Norway (Basic Appr oval) were reviewed at this meeting.

2.2 The Secretariat reminded the Group that the non-confidential parts of the submissions had been circulated as MEPC documents (MEPC 56/2/3 for South Africa; MEPC 57/2/4 for the Republic of Korea; MEPC 57/2/5 for Germany; and MEPC 57/2/6 for Norway) and emphasized that members of the Group were requested to keep the data contained in the application dossiers confidential to protect the commercial interests of the manufacturers.

2.3 Notwithstanding the above, the Group recall ed the agreement of MEPC 55 that all information related to safety and environmen tal protection, includi ng physical properties, environmental fate and toxicity, should be treate d as non-confidential. The Group noted that the Organization, prior to submission of the Group’s evaluation report to the MEPC, would consult with the respective Administrations/applicants to ensure that the report does not contain any
confidential information. In cases where the evaluation report is found to contain confidential information, the Organization would amend it accordingly, having taken the views of the respective manufacturer into account.

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

2.5 Mr. Pughiuc reported on the conclusion of the Statement of Acceptance of Access to
Confidential Information and reminded the Gr oup members of the n eed to hand over any documents, drafts, or any other asso ciated records and reports, for retention in confidence at the end of the meeting or when they are no longer necessary for the work of the Group. He also pointed out to the inventory lists prepared by the IMO Cons ultant for each submission and
confirmed that all the folders received from th e Member States concerned are made available to the Group.GESAMP-BWWG 5/9 - 4 -

I:\MEPC\57\2-10.doc 3 TERMS OF REFERENCE AND TIME FRAME

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

3.2 The Group agreed to use the table below to determine the timetable for activities related to its regular meetings and, on a case-by-case basis, to decide on the timing of additional meetings as appropriate.

TIMETABLE FOR ACTIVITIES RELA TED TO GESAMP-BWWG MEETINGS

Timeline Activity

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

(8 weeks) Preparation of the meeting, including circulation of any relevant information provided by other delegations

20 weeks before MEPC GESAMP-BWWG Meeting

(1 week) Editing and completion of the dr aft report of the meeting

(1 week) Administrations confirm that no confidential data are contained in the report

(3 weeks) Review and approval of the report by GESAMP

(1 week) Produce the final report addre ssing the comments by GESAMP

13 weeks before MEPC Submission of the report of the meeting of GESAMP-BWWG
in accordance with the 13-week deadline for MEPC- 5 - GESAMP-BWWG 5/9

I:\MEPC\57\2-10.doc 4 DEVELOPMENT OF THE DRAFT METHODOLOGY FOR INFORMATION
GATHERING AND THE CONDUCT OF WORK OF GESAMP-BWWG

4.1 Following the discussions regarding the further development of the Methodology conducted during its fourth meeting, the Group produced an updated vers ion of its Methodology including additional guidance on Human Exposure Scenario (see paragraphs from 7.2.3 to 7.2.7) and on the procedure for Final Approval (see paragraphs 10.1 and 10.2). Further guidance regarding the Human Exposure Assessment has b een incorporated as appendix 2 of the Methodology, which also contains in its secti on 6 a questionnaire on occupational exposure.

4.2 With regard to Final Approval, the Group noted that according to Procedure (G9) the discharge testing should be performed as part of land-based type-approval process using the treated ballast water discharge. According to Guidelines (G8) each test cy cle during the land-based testing should take place over a period of at least 5 days. The Group noted further 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 Guide lines (G8) to cover the possible re-growth of organisms is too long to allow representative sampling of water for eco toxicity testing, as toxic chemicals will be degraded during the 5 days’ storage period. Conse quently, the Group proposed that in the future “whole effluent” ecotoxicity testing and related an alytical chemistry of exposure conditions should be conducted immediately after treatment and after a 24 or 48 hours interval to provide meaningful information regarding the possible impact on the receiving environm ent. Paragraph 10.2.4 of the Methodology was modified to reflect this change.

4.3 The Group also discussed the structure a nd format of the Methodology, which differs from the reporting format used in the GESAMP-B WWG reports. This latter arrangement of the chapters has been adopted by the Group to improve the efficiency of the evaluation process. Although re-organizing the various sections of the Methodology according to the current reporting format is a laborious and time-consuming process, the Group agreed that it would save time in the long run and invited the Secretariat to explore the possibility of contracting the
Consultant to review the format and struct ure of the Methodology and harmonize it with the reporting format used in GESAMP-BWWG reports. Su ch a review would also ensure that all the provisions contained in Procedur e (G9) are adequately reflecte d in the Methodology and would
assist in the effort to formalize the Me thodology possibly as a technical circular.

5 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER
MANAGEMENT SYSTEMS

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

Annex 5 Review of Proposal for Basic Approval of Active Substance – ‘Resource Ballast Technologies System’, submitted by South Africa

Annex 6 Review of Proposal for Basic Approval of Active Substance
– ‘GloEn-Patrol TM Ballast Water Management System’, submitted by the Republic of Korea

Annex 7 Review of Proposal for Final A pproval of the Ballast Water Management System – ‘SEDNA ® using PERACLEAN ® OCEAN’, submitted by Germany

Annex 8 Review of Proposal for Ba sic Approval of Active Substance –
‘OceanSaver ® Ballast Water Management System’, submitted by NorwayGESAMP-BWWG 5/9 - 6 -

I:\MEPC\57\2-10.doc 5.2 Whilst it is recommended that the summary, results and discussion of each of the reviews are considered in detail, the Group recommended that:

.1 Basic Approval be granted to the Resource Ballast Technologies System,
submitted by South Africa;

.2 Basic Approval be granted to the GloEn-Patrol TM Ballast Water Management System, submitted by the Republic of Korea;

.3 Final Approval be granted to the SEDNA ® using PERACLEAN ® OCEAN Ballast Water Management System, submitted by Germany; and

.4 Basic Approval be granted to the OceanSaver ® Ballast Water Management System,
submitted by Norway.

6 DATE FOR THE NEXT MEETING

6.1 The Group noted the information contained in BWM.2/Circ.12 regarding the date for its sixth meeting tentatively scheduled for 19 to 23 May 2008, subject to submission of relevant documents and application dossiers by Member States. The Group will review the application dossiers received before 21 March 2008 and will further de velop its “Methodology for information gathering and the conduct of work” as necessary. The report of the Group will be approved by GESAMP itself and submitted to MEPC 58 (6-10 October 2008) for its
consideration.

7 CONSIDERATION AND ADOPTION OF THE REPORT

7.1 A draft report of the fifth meeting of the GESAMP-BWWG was produced on 18 January 2008, and, after a paragraph-by-p aragraph review, th e Group agreed on the final text and requested the Secretariat to make the necessary changes to ensure consistency with IMO documents format and style.

7.2 In his closing remarks, th e Chairman referred to the constantly increasing volume
of work and commended the Group for considerin g all the seven proposals submitted for MEPC 57. He emphasized the usefulness of the planning me eting held on Sunday, 13 January 2008, with the IMO Consultant a nd the Secretariat, and believed that further optimization of the work of the Group would be needed to cope with the future workload.

7.3 The Chairman expressed his appreciation fo r the long hours and substantial efforts made by the members of the Group throughout the week, valued the work done by the IMO consultant both in preparation and duri ng the meeting week and clos ed the meeting at 17.00 hrs.

***GESAMP-BWWG 5/9

I:\MEPC\57\2-10.doc ANNEX 1

LIST OF MEMBERS WHO ATTENDED THE FIFTH SESSION

OF THE GESAMP-BALLAST WATER WORKING GROUP

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

Fax:

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

+31 6 5318-1352

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

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

+351 9 1779 8048

Mr. Egil Dragsund Principal Marine Biologist
Environmental and 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 Toranomon
Minatoku-ku Tokyo 105-0001 Japan E-mail:
Tel:

Fax: s-hanayama@sof.or.jp
+81 3 3502 1886
+81 3 3502 2033

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

Sweden E-mail:
Tel:

Fax:

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

+46 70 483 11 23GESAMP-BWWG 5/9
ANNEX 1 Page 2

I:\MEPC\57\2-10.doc Mr. Jan Linders
Senior Risk Assessor
National Institute for Public Health and Environment Expert Centre on Substances
Anthonie van Leeuwenhoeklaan 9
RIVM-SEC
P.O. Box 1
NL-3720 BA Bilthoven
The Netherlands E-mail:
Tel:

Fax: jan.linders@rivm.nl
+31 30 274 3164
+31 30 274 4401

IMO-GESAMP CONSULTANT

Dr. Brigitte Behrends
Marine Environment Chemist
Marena Ltd.
St. Annenstr. 27
Jever
D-26441 Germany E-mail:
Tel:

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

+49 (0) 16 2244 3484

GESAMP

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

Fax: fhaag@imo.org +44 (0)20 7463 4139 (Direct) +44 (0)20 7587 3210

IMO SECRETARIAT

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

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

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

Fax: rcoenen@imo.org +44 (0)20 7587 3239 +44 (0)20 7587 3261GESAMP-BWWG 5/9
ANNEX 1 Page 3

I:\MEPC\57\2-10.doc 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 5/9

I:\MEPC\57\2-10.doc ANNEX 2

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

1 Introduction

2 Issues of confidentiality

3 Terms of reference and time frame

4 Review of proposals for a pproval of Active Substances

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

6 Future work programme

7 Consideration and adoption of the report

***GESAMP-BWWG 5/9

I:\MEPC\57\2-10.doc ANNEX 3

TERMS OF REFERENCE FOR THE TECHNICAL GROUP

1 Consideration of developmen t of necessary methodologies and information requirements
in accordance with G9 ∗ for consideration by MEPC 57.

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

In particular, the Group should undertake:

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

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

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

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

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

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

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

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

4 The Group 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 MEPC 53/2/1, annex, as amended: Procedure for approval of ballast water management systems that make use of Active Substances (G9).GESAMP-BWWG 5/9

I:\MEPC\57\2-10.doc ANNEX 4

METHODOLOGY FOR INFORMATION GATHERING AND THE
CONDUCT OF WORK OF GESAMP-BWWG

(Updated 18 January 2008)

Page

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

2 GENERAL............................................................................................................... 6 2.1 Legal provision......................................................................................... 6 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 a nd data protection........................................................ 8
2.5 Test Methods............................................................................................. 9
2.6 Altern atives to testing and non-submission of data....

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

3.0 APPLICATION DATA SET.................................................................................. 10
3.1 Identification of the Substan ce or Preparation (G9: 4.1).................... 10 3.1.1 Preparations.................................................................................. 10
3.1.2 Active Substa nces.................

.................. ............... ............... ........... 11 3.1.3 Relevant Chemicals (G9: 2.1.4).................................................. 11
3.1.4 Other Chemicals........................................................................... 11 3.2 Data on effects on aquatic plan ts, invertebrates and fish, and other biota, including sensitive a nd representative organisms (G9: 4.2.1.1).............................................................................................. 12 3.2.1 Acute aquatic toxicity................................................................... 12 3.2.2 Chronic aquatic toxicity............................................................... 12 3.2.3 Endocrine disruption................................................................... 13 3.2.4 Sediment toxicity.......................................................................... 13 3.2.5 Bioavailability/biomagni fication/bioconcentration................... 13 3.2.6 Food web/population effects........................................................ 14 3.3.0 Data on mammalian toxicity (G9: 4.2.1.2)............................................ 14 3.3.1 Acute toxicity................................................................................ 15 3.3.2 Effects on skin and eye................................................................. 15 3.3.3 Repeated-dose toxicity................................................................. 15 3.3.4 Chronic toxicity............................................................................ 16 3.3.5 Developmental and re productive toxicity.................................. 16 3.3.6 Carcinogenicity............................................................................. 16 3.3.7 Mutagenicity/genotoxicity........................................................... 17
3.3.8 Toxicokinetics............................................................................... 17
3.4.0 Data on environmental fate and effect under aerobic and
anaerobic conditions (G9: 4.2.1.3)......................................................... 17 3.4.1 Modes of degradation (biotic; abiotic)....................................... 18
3.4.2 Bio accumulation, partition coeffici ent, octanol/water partition
coefficient.............

.................. .................. ............... ............... ........... 18GESAMP-BWWG 5/9
ANNEX 4 Page 2

I:\MEPC\57\2-10.doc Page

3.4.3 Persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh waters)......... 19 3.4.4 Reaction with organic matter...................................................... 19 3.4.5 Potential physical effects on wildlife and benthic habitats....... 20
3.4.6 Potential residues in seafood....................................................... 20 3.4.7 Any known inter active effects..................................................... 20 3.5 Physical and chemical propert ies for the Active Substances and preparations and treated ballast wate r, if applicable (G9: 4.2.1.4).... 21 3.5.1 Melting point................................................................................. 21 3.5.2 Boiling point.................................................................................. 21 3.5.3 Flammability (flash point)........................................................... 21 3.5.4 Density (relative density)............................................................. 21 3.5.5 Vapour pressure, vapour density................................................ 21 3.5.6 Water solubility/d issociation constant........................................ 22
3.5.7 Oxidation/reduc tion potential..................................................... 22 3.5.8 Corrosivity to the materials or equipment of normal ship
construction................................................................................... 22 3.5.9 Auto-ignition temperature........................................................... 22 3.5.10 Explosive properties..................................................................... 22 3.5.11 Oxidizing properties..................................................................... 23
3.5.12 Surface tension.............................................................................. 23 3.5.13 Viscosity......................................................................................... 23 3.5.14 Thermal stability and iden tity of relevant breakdown products......................................................................................... 23 3.5.15 Reactivity towards container material....................................... 23 3.5.16 pH................................................................................................... 23 3.5.17 Salinity........................................................................................... 24 3.5.18 TOC, DOC, % particulate matter.............................................. 24 3.5.19 Other known relevant physical or chemical hazards................ 24 3.6 Analytical methods at environm entally relevant concentration (G9: 4.2.1.5) ......................................................................................................... 24

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

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

6 RISK CHARACTERIZATION............................................................................. 26 6.1 Screening for persistence, bioaccumulation and toxicity (G9: 5.1).................................................................................................... 26 6.1.1 Persistence (G9: 5.1.1.1).............................................................. 26 6.1.2 Bioaccumulation (G9: 5.1.1.2).................................................... 26 6.1.3 Toxicity tests (G9: 5.1.2.3).......................................................... 26
6.1.4 Does the Active Substance and/or preparation meet all
three criteria for PBT?................................................................ 26GESAMP-BWWG 5/9
ANNEX 4 Page 3

I:\MEPC\57\2-10.doc Page

6.2 Evaluation of the treated ballast water (G9: 5.2)................................. 27 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 2.4.4).............................................. 27 6.3.2 Characterization of degrada tion route and rate (G9: 5.3.5)... 27 6.3.3 Prediction of discharge and environmental concentrations..... 28 6.3.4 Assessment of potential for bioaccumulation............................ 28
6.3.5 Effects assessment........................................................................ 28 6.3.6 Effects on aquatic organisms....................................................... 29
6.3.7 Effects on sediment....................................................................... 30 6.3.8 Comparison of effect assessm ent with discharge toxicity......... 30

7 RISK ASSESSMENT.............................................................................................. 30 7.1 Risk to safety of ship................................................................................ 30
7.2 Risks to human health.............................................................................. 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 5/9
ANNEX 4 Page 4

I:\MEPC\57\2-10.doc 1 INTRODUCTION

This document contains methodology for informa tion gathering and the conduct of work by the GESAMP-BWWG when undertaking technical ev aluations in accordance with resolution MEPC.126(53) on the Procedure for the approval of ballast water management systems that make use of Active Substances (G9).

1.1 Terms and Definitions

For the purpose of this document, these defi nitions are intended to supplement those in
the Ballast Water Convention to facilitate a consistent evaluation of submissions:

.1 Ballast Water Convention means the International Convention for the Control and Management of 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 purpos es of Ballast Water Management and any relevant chemicals formed in the Ballast Water Management System that
make use of Active Substances to comply with the Convention.

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

.5 Other components of a preparation means any othe r substances in a preparation, other than the Active Substance(s) or subs tances, other than Relevant Chemicals, produced during the treatme nt of ballast water.

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

.7 Basic Approval means the approval of the use of Active Substances, according to their proposed manner of application, for prototype or type approval testing. The Basic Approval should confirm that the available information does not indicate possible unacceptable adverse e ffects or a potential for unreasonable risk of such a testing to environment, hum an health, property or resources. In recommending a Basic Approval, potential risks during full-scale deployment on commercial ships should be considered when possible.

.8 Final Approval means the approval of a Ballast Water Management System using an Active Substance or Preparati on to comply with the Convention and includes a review of the Type Approval te sts in accordance with Guidelines for Approval of Ballast Water Management Sy stems. The Final Approval shouldGESAMP-BWWG 5/9
ANNEX 4 Page 5

I:\MEPC\57\2-10.doc confirm that previous eval uations of risks to ship, crew and the environment including storage, handling and application of Active S ubstances or Preparations
remain valid and the concerns have been addressed, as well as that the residual toxicity of the discharge conforms to the evaluation undertaken for Basic Approval. The risk evalua tion at Final Approval shou ld take qualitatively into account cumulative effects that may occur due to the nature of shipping and port operations. It should consider the uncerta inties involved in the application for approval, and as appropriate, provide a dvice on how these uncertainties can be
dealt with.

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

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

1.2 Abbreviation used in the text

ABBREVIATIONS

< less than

< less than or equal to > greater than

> greater than or equal to μg microgram

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

°C degree Celsius (Centigrade)
CAS Chemical Abstract Service
Cc cubic centimetre

D day(s)

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

G gram GHS Globally Harmonized System G9 Procedure for approval of Ballast Water Management Systems that make use of Active Substances (G9) Resolution MEPC.126(53) adopted 22 July 2005GESAMP-BWWG 5/9
ANNEX 4 Page 6

I:\MEPC\57\2-10.doc

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

Pow octanol-water partition coefficient

TLV threshold limit value US EPA United States Environmental Protection Agency

WHO World Health Organization

wt weight

2 GENERAL

2.1 Legal provision

Regulation D-3.2 of the Internat ional Convention for the Contro l and Management of Ships’ Ballast Water and Sediments, 2004, stipulates th at Ballast Water Management Systems (BWMS)
that make use of Active Substances to co mply with the Convention shall be approved by the Organization. During its fifty-third session, the Marine Envi ronment Protection Committee (MEPC) adopted the Procedure for a pproval of Ballast Water Management Systems
that make use of Active Substances (G9) through resolution MEPC.126(53).GESAMP-BWWG 5/9
ANNEX 4 Page 7

I:\MEPC\57\2-10.doc 2.2 Principles of acceptability of BWMS that make use of Active Substances

A Ballast Water Management System that make s use of Active Substances accomplishes its intended purpose through action on Harmful Aquatic Organisms and Pathogens in ships’ ballast water and sediments. However, if the ballast water is still toxic at the time of discharge into the environment, the organisms in the receiving water may suffer unacceptable harm. Both the Active Substance itself or 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. Ballast Water Management Systems t hat make use of Active Substances and Preparations must be safe in terms of the sh ip, its equipment and the personnel to comply with
the Convention

.

2.3 Submission of an application for Basic Approval

2.3.1 The manufacturer of the Ballast Water Mana gement System should evaluate the Active Substance(s) or Preparation(s) a nd the potential discharge of treat ed ballast water in accordance with the approval criteria specified below (G9: 8.1.2.1). Upon comple tion, the manufacturer should prepare an Application Dossier for the Ba llast Water Management System that makes use
of Active Substances and submit it to the Ma ritime Administration of a Member of the Organization (G9: 8.1.2.2).

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

2.3.3 Applications for Basic Approval of the Ba llast Water Treatment System, associated with Active Substances, to be evaluated by the GESAMP Ballast Water Working Group should be addressed to: The Director, Marine E nvironment Division, International Maritime 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 versio n), including full study repo rts and full copies of literature. The complete Application Dossier should contain a contents list indicating the location of the information in the application. The order in which the information is presented, including ove rall structure such as how information is presented for the Active Substance, pr eparation, ballast water, risk assessment, assessment report, should follow this format, including its numbering, which is based on G9;

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

.3 a summary of the key 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 the G9 procedure (G9: 4.2.5).GESAMP-BWWG 5/9
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I:\MEPC\57\2-10.doc 2.4 Confidentiality and data protection

The confidential information of the submitted doc uments should clearly be identified. Once an approval procedure is completed and the 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;

.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 to establish the effects of the substance(s) or prep aration(s) on humans and the environment;

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

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

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

.11 Safety Data Sheets;

.12 methods of chemical analysis;

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

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

.15 First Aid and medical advice to be give n in the case of injury to persons;GESAMP-BWWG 5/9
ANNEX 4 Page 9

I:\MEPC\57\2-10.doc .16 all results of the PBT assessment and the risk characterization pursuant to sections 5.1 and 5.3 of Procedure G9; and

.17 the uncertainty analysis specified in chapter 6.4.3 of Procedure G9.

2.5 Test Methods

2.5.1 Tests should be carried out under 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., GLP). Information ma y be derived from existing data where an acceptable justification is provided. Full copies of sources of data (e.g., literature papers) should be provided.

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

2.5.3 Many substances have acquired large databa ses for many of the hazards concerned and a weight of evidence approach has become necessary to ensure that the ra ting reflects the body of data rather than simply using the most 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.

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

2.6 Alternatives to testing and non-submission of data

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

2.6.2 Information that is not necessary, owing to th e nature of the substan ce or of its proposed uses and taking into account al l proposed risk management measures, need not be supplied. The same applies where it is not scientifically necessary or technically possible to supply the information. In such cases, a justification should be submitted, which would help the Group’s evaluation of the Application Dossier.

2.7 Procedures and timelines

2.7.1 Procedures for the evaluation of the dossier are given in the Appendix to G9. If, in the course of the review by the Ballast Water Work ing Group, it becomes evident that additional data are found to be necessary in order to finalize th e evaluation, the Group may request that such data
are submitted.GESAMP-BWWG 5/9
ANNEX 4 Page 10

I:\MEPC\57\2-10.doc 2.7.2 The Administration will be informed, in wr iting, of the decision of the Organization. The Administration may appeal against a ny decision made by the Organization. The Organization will consider the appeal and respond in wr iting to the Member of the Organization.

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

3.0 APPLICATION DATA SET

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

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

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

3.0.4 For treated ballast water, the 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 include acute LC 50 values and chronic NOECs (G9: 5.2.5). Therefore, 100% concentrations of sample s of ballast water discharge should be tested (G9: 5.2.6), if appropriate.

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

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

3.1.1 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;GESAMP-BWWG 5/9
ANNEX 4 Page 11

I:\MEPC\57\2-10.doc .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.

3.1.2 Active Substance: For each Active Substance, the applicant should provide the following information:

.1 the Trade name (where relevant);

.2 the chemical (IUPAC) name;

.3 the CAS number;

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

.5 the Molar mass;

.6 the empirical formula;

.7 the structural formula;

.8 the classification in accordance with the UN GHS system;

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

.10 the identity of any stabil izers or necessary additives.

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

.1 the Chemical (IUPAC) name;

.2 the CAS number;

.3 the Molar mass;

.4 the empirical formula;

.5 the structural formula; and

.6 the classification in accordance with the GHS system.

3.1.4 Other Chemicals: Where the process might produce by-products not deemed to be Relevant Chemicals by the applic ant, a justification for such a conclusion should be provided.GESAMP-BWWG 5/9
ANNEX 4 Page 12

I:\MEPC\57\2-10.doc 3.2 Data on effects on aquatic plants, invert ebrates and fish, and other biota, including sensitive and representative organisms (G9: 4.2.1.1)

3.2.0 For every Active Substance or Preparation 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.

3.2.1 Acute aquatic toxicity

3.2.1.1 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 (A lgae, Growth Inhibition Test), 202 (Daphnia sp. Acute Immobilization Test), 203 (Fish, Acute Toxicity Test), Mysid shrimp ac ute 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).

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

3.2.1.3 Such acute aquatic toxicity data 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).

3.2.2 Chronic aquatic toxicity

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

3.2.2.2 In case of whole effluent testing, EPA 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.

3.2.2.3 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).GESAMP-BWWG 5/9
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I:\MEPC\57\2-10.doc 3.2.3 Endocrine disruption

3.2.3.1 Regarding the risks connected to endocrine disruption, non-standardized in vivo as well as in vitro tests may be conducted as long as no internationall y standardized tests are available (e.g., full-life-cycle test on fish or am phibian metamorphosis assay). When substantial evidence on such effects is available, this s hould be taken into account on a case-by-case basis and in the effect assessment for each compartmen t of relevance. If there is no indication for endocrine disruption – e.g., due to the structure of the substance or results of other available studies – these tests may be waived.

3.2.3.2 Such information on endocrine di sruption should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.2.4 Sediment toxicity

3.2.4.1 Substances that are potentially capable of depositing on or adsorbing to sediments to a significant extent 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.

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

3.2.4.3 Such information on sediment t oxicity should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.2.5 Bioavailability/biomagnification/bioconcentration

3.2.5.1 If log Pow >3, testing of the bioaccumul ation 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;GESAMP-BWWG 5/9
ANNEX 4 Page 14

I:\MEPC\57\2-10.doc .2 The biomagnification and persistence in the food web should be discussed based on the results from aquatic toxicity testing, mammalia n toxicity evaluation and bioaccumulation and biodegradation data; and

.3 There are no data 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.

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

.1 Active Substances;

.2 Any components of a preparation; and

.3 Relevant Chemicals.

3.2.6 Food web/population effects

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

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

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

.2 two NOECs from long-term studies with two mamm alian species (from section 2.3 below).

3.2.6.3 Such information related to the food web/ population effects should be provided for:

.1 Active substances; and

.2 Relevant Chemicals.

3.3.0 Data on mammalian toxicity (G9: 4.2.1.2)

3.3.0.1 Information that is deemed to be unnecessary need not be supplied. However, in such cases a scientific ju stification should be submitted in order to explain why the data have not been provided. In general, testing with vertebrate animals should be avoided if other type of
information is available that allows an 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.

3.3.0.2 In general, information should be provided on the Active Substance and the Preparation including any of its components, as appropriate. In formation on Relevant Chemicals formed during or after application of the BWMS should be provided as well.GESAMP-BWWG 5/9
ANNEX 4 Page 15

I:\MEPC\57\2-10.doc 3.3.1 Acute toxicity

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

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

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

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.3.2 Effects on skin and eye

3.3.2.1 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 cau se skin sensitization reactions. Animal testing should, whenever possibl e, be minimized. Tests should be performed with the Active Substance(s) or Preparation(s).

3.3.2.2 Testing of Active Substances or Preparat ion 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 Dermal Irritation/Corrosion) and 405 (Acute Eye Irritation/Corrosion). These tests need not be carried out on a strong acid or ba se (pH below 2 or above 11.5). Where the Active Substance or Prepar ation has shown to have potentially corrosive properties, or is a severe skin irritant, an eye irritation test should not be carried out. Results
from in vitro test methods, which are close to valida tion by recognized organizations, may be
submitted.

3.3.2.3 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.

3.3.2.4 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.

3.3.3 Repeated-dose toxicity

3.3.3.1 A 90-day sub-chronic toxicity study in two species, one rodent and another mammalian species, using the oral route unless another one is more appropriate.GESAMP-BWWG 5/9
ANNEX 4 Page 16

I:\MEPC\57\2-10.doc 3.3.3.2 Such information on repeated dose toxicity should be provided for:

.1 Preparation including any of its components;

.2 Active Substance; and

.3 Relevant Chemicals.

3.3.4 Chronic toxicity

3.3.4.1 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.

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

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

.1 Preparation including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.3.5 Developmental and reproductive toxicity

3.3.5.1 Testing should include:

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

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

3.3.5.2 However, these key data 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 patterns.

Such information on developmental and repr oductive toxicity shoul d be provided for:

.1 Preparation including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.3.6 Carcinogenicity

3.3.6.1 Carcinogenicity studies should be perf ormed with one rodent and one other mammalian species. The carcinogenicity testing of an Active Substance or preparation may not be needed where justification de monstrates that these tests are not necessary. Carcinogenicity studies may be combined with the chronic toxicity studies.GESAMP-BWWG 5/9
ANNEX 4 Page 17

I:\MEPC\57\2-10.doc 3.3.6.2 Such information on carcinogenicity should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.3.7 Mutagenicity/genotoxicity

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

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

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

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

.1 Preparations including a ny of its components; and

.2 Active Substances; and

.3 Relevant Chemicals.

3.3.8 Toxicokinetics

3.3.8.1 Basic data on the toxicokinetics of Ac tive Substances and 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.

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

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

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

3.4.0.3 The data submitted in accord ance with this paragraph shoul d 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.GESAMP-BWWG 5/9
ANNEX 4 Page 18

I:\MEPC\57\2-10.doc 3.4.1 Modes of degradation (biotic; abiotic)

3.4.1.1 Testing should include:

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

.2 a study on ready 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).

3.4.1.2 If the active Active Substance is not read ily biodegradable, then the following higher
tier studies should be conducted:

.1 a study on aerobic and anaerobic transfor mation in aquatic sediment systems according to OECD guideline 308 (Aerobic and Anaerobic Transformation 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 st udy on photo-transformati on in water e.g., US EPA OPPTS 835.2210 (1998) and/or OECD Guidance document on photo-transformation in water (1997).

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

.1 Active Substances;

.2 any other components of preparations; and

.3 Relevant Chemicals.

3.4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

3.4.2.1 Testing should include:

.1 data on bioconcentration and biomagnifi cation, which have already been detailed earlier in this document;GESAMP-BWWG 5/9
ANNEX 4 Page 19

I:\MEPC\57\2-10.doc .2 a study into the log Pow according to OECD 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 compounds, a slow stirring method is appropriate (e.g., OECD 123 (Par tition coefficient – slow stirring method)); and

.3 the partition coefficient betw een solids and liquids should be determined e.g., according to EU Technical Guidance Document on Risk Assessment (2003) for at least three i nocula, including freshwater sediment, marine sediment, and particulate matter (sludge) (OECD 106). If no measured data are available for a specific adsorb ing material, it is assumed that all adsorption can be related to the organic ma tter of the medium, vi z. standardization to Koc. This is only valid for non-ioni c substances. For ionic substances, the Kp values and the test characteristics (%clay, CEC, %o.c., pH) should be reported.

3.4.2.2 Such information on bi oaccumulation and partition coeffici ents should be provided for:

.1 Active Substances;

.2 any other components of preparations; and

.3 Relevant Chemicals.

3.4.3 Persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh waters)

3.4.3.1 The route of degradation in the highe r tier simulation tests specified under
section 3.4.1 of this document should be ch aracterized based on a mass balance, including
mineralization and formation of bound residues. Reaction or transforma tion products formed that may be considered as Relevant Chemicals should be identified.

3.4.3.2 Such information on persistence a nd metabolites should be provided for:

.1 Active Substances;

.2 any components of preparations; and

.3 Relevant Chemicals.

3.4.4 Reaction with organic matter

3.4.4.1 The reaction of radicals produced by the action of Active Substances 1 with organic matter 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.

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

1 MEPC 55/2/6, paragraph 33.GESAMP-BWWG 5/9
ANNEX 4 Page 20

I:\MEPC\57\2-10.doc 3.4.4.3 Such information on the reaction with organic matter should be provided for:

.1 Active Substances; and

.2 Relevant Chemicals.

3.4.5 Potential physical effects on wildlife and benthic habitats

3.4.5.1 Data requirements consist of physical-chemical properties also required later. Further guidance can be found in th e MEPC-approved hazard evalua tion procedure published as GESAMP Reports and Studies No.64.

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

.1 Preparations including any of its components;

.2 Active Substance;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.4.6 Potential residues in seafood

3.4.6.1 As appropriate, data 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.

3.4.6.2 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.

3.4.7 Any known interactive effects

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

3.4.7.2 Such information on known interactive effects should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.GESAMP-BWWG 5/9
ANNEX 4 Page 21

I:\MEPC\57\2-10.doc 3.5 Physical and chemical properties for th e Active Substances and preparations and treated ballast water, if applicable (G9: 4.2.1.4)

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

3.5.1 Melting point

Data on the melting point should be provided for:

.1 Preparations including a ny of its components; and

.2 Active substances.

3.5.2 Boiling point

Data on the boiling point should be provided for:

.1 Preparations including a ny of its components; and

.2 Active Substances.

3.5.3 Flammability (flashpoint)

Data on the flash point should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.5.4 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.

3.5.5 Vapour pressure, vapour density

Data on the vapour pressure and vapour density should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.GESAMP-BWWG 5/9
ANNEX 4 Page 22

I:\MEPC\57\2-10.doc 3.5.6 Water solubility/dissociation constant

Data on the water solubility and dissocia tion constants should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.5.7 Oxidation/reduction potential

Data on the oxidation/reduction poten tials should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.5.8 Corrosivity to the mate rials or equipment of no rmal ship construction

Data on the corrosivity to materials of construction should be provided for:

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.5.9 Auto-ignition temperature

Data on the auto-ignition temper ature should be provided for:

.1 Preparations including any of its components;

.2 Active Substances; and

.3 Relevant Chemicals.

3.5.10 Explosive properties

Data on the explosive properties should be provided for:

.1 Preparations; 2

.2 Active Substance; and

.3 Relevant Chemicals.

2 MEPC 55/2/6, paragraph 34.GESAMP-BWWG 5/9
ANNEX 4 Page 23

I:\MEPC\57\2-10.doc 3.5.11 Oxidizing properties

Data on the oxidizing propertie s should be provided for:

.1 Preparations;

.2 Active Substances; and

.3 Relevant Chemicals.

3.5.12 Surface tension

Data on the surface tension should be provided for:

.1 Preparations; and

.2 Active Substances.

3.5.13 Viscosity

Data on the viscosity should be provided for:

.1 Preparations; and

.2 Active Substances.

3.5.14 Thermal stability and identity of relevant breakdown products

Data on the melting point should be provided for:

.1 Preparations including a ny of its components; and

.2 Active Substances.

3.5.15 Reactivity towards container material

Data on the reactivity towards containe r materials should be provided for:

.1 Preparations including any of its components;

.2 Active substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

3.5.16 pH

Data on the pH should be provided for:

.1 Preparations; and

.2 Treated ballast water.GESAMP-BWWG 5/9
ANNEX 4 Page 24

I:\MEPC\57\2-10.doc 3.5.17 Salinity

Data on the salinity should be provided for:

.1 Treated ballast water.

3.5.18 TOC, DOC, % particulate matter

Data on the TOC, DOC and % of partic ulate matter should be provided for:

.1 Treated ballast water.

3.5.19 Other known relevant physi cal or chemical hazards

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

.1 Preparations including any of its components;

.2 Active Substances;

.3 Relevant Chemicals; and

.4 Treated ballast water.

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

Recognizing that some methods may only cover a range of ch emicals e.g., TRO, analytical methods at environmentally relevant c oncentrations should 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 point 7 of the Procedure, the dossier should contain the necessary data addressing the following items:

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

.2 recommended methods and precautions concerning handling, use, storage, and transport;GESAMP-BWWG 5/9
ANNEX 4 Page 25

I:\MEPC\57\2-10.doc .3 procedures to be followed in case of fire, and the nature of reaction products, combustion gases, etc.;

.4 emergency measures in case of an accident;

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

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

.7 the possibility of reuse or recycling;

.8 the possibility of neutralization;

.9 conditions for controlled discharge; and

.10 the amount of substance 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 System and should be evaluated
in the assessment.

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

5 MATERIAL SAFETY DATA SHEETS (G9: 4.2.7)

5.1 With respect to the classification of hazar ds, a detailed technical guidance document has been prepared for the United Nations Globall y Harmonized System of Classification and Labelling of Chemicals (GHS) to aid in interpreting data for classifying substances as dangerous. Reference is also made to the MEPC-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.GESAMP-BWWG 5/9
ANNEX 4 Page 26

I:\MEPC\57\2-10.doc 6 RISK CHARACTERIZATION

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

6.1.1 Persistence (G9: 5.1.1.1)

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

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

6.1.2 Bioaccumulation (G9: 5.1.1.2)

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

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

6.1.3 Toxicity tests (G9: 5.1.2.3)

6.1.3.1 Acute and/or chronic ecotoxicity data, ideally covering the sensitive life stages,
should be used for the assessmen t of the toxicity criterion.

6.1.3.2 For ecotoxicity data, see 3.2 of this document.

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

assessment.

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

See G9: Table 1.

Criterion PBT criteria
Persistence Half-life: > 60 days in marine water, or > 40 days in 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 the Procedure.GESAMP-BWWG 5/9
ANNEX 4 Page 27

I:\MEPC\57\2-10.doc 6.2 Evaluation of the treated ballast water (G9: 5.2)

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

6.2.1 Basic Approval

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

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

6.2.2 Final Approval

6.2.2.1 Full-scale land-based toxicity tests with samples of ballast water treated with the
BWMS under test conditions and a scale as defi ned in Guidelines (G8) during on-board testing should be conducted (G9: 5.2.2).

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

6.2.3 Determination of holding time

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

6.3 Risk characterization and analysis

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

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

6.3.2 Characterization of degradat ion route and rate (G9: 5.3.5)

6.3.2.1 The route and rate of abiotic and bio tic degradation of the Active Substances and Preparations, including any of its compone nts, under aerobic and anaerobic conditions (see 2.4.1 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).GESAMP-BWWG 5/9
ANNEX 4 Page 28

I:\MEPC\57\2-10.doc 6.3.3 Prediction of discharge and environmental concentrations

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

6.3.3.2 Environmental concentrations after discharg e of treated ballast water under controlled conditions during development and 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 com ponents and Relevant Chemicals, the potential for bioaccumulation s hould be assessed in ma rine or freshwater organisms (fish or bivalves) if the logarithm octanol/water partition coefficient (log Pow) is >3 (G9: 5.3.7).

6.3.5 Effects assessment

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

6.3.5.2 An effect assessment could also be prep ared on secondary poisoning to mammalian and avian top-predators where relevant. Only toxicity studies reporting on dietary and oral exposure are relevant, as the pathway for secondary poisoning 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 sp ecies should be conducted unless the potential
of the substance of concern to partition into the sediment is low (e.g., Koc < 500 L/kg) (G9: 5.3.11).

6.3.5.4 The effect assessment of the Active Substan ces, Preparations and Relevant Chemicals, taking the indicated information into account, should be based on internationally recognized guidance (e.g., OECD) (G9: 5.3.13).GESAMP-BWWG 5/9
ANNEX 4 Page 29

I:\MEPC\57\2-10.doc 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 ba sis based on expert judgement. In cases where a comprehensive 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 f ound 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 only 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 th e 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 10GESAMP-BWWG 5/9
ANNEX 4 Page 30

I:\MEPC\57\2-10.doc 6.3.7 Effects on sediment

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

Table 3 – Effect assessment for deriving PNECs for sediment

Data-set Assessment factor
Freshwater assessment Three chronic sediment tests with species representing different living and feeding conditions 10

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

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

6.3.8 Comparison of effect assessm ent with discharge toxicity

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

7 RISK ASSESSMENT

7.1 Risk to safety of ship

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

.1 increased corrosion;

.2 fire and explosion;

.3 storage and handling of the substances;GESAMP-BWWG 5/9
ANNEX 4 Page 31

I:\MEPC\57\2-10.doc .4 contact with, or inhala tion of, process products; and

.5 noise.

7.2 Risks to human health

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

Health effects in humans

7.2.2 The effect assessment of the Active Substances, 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).

Human Exposure Scenario

7.2.3 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 1 of this document.

7.2.4 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?

7.2.5 The identification of ‘unit operations’ in the whole BWM process 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 sim ilar approach is proposed with regard to
BWMS evaluations.GESAMP-BWWG 5/9
ANNEX 4 Page 32

I:\MEPC\57\2-10.doc 7.2.6 The risk assessment should include a descrip tion of the ballast water 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 uni t operations, i.e., stating clear Personal Protective Equipment requireme nts for each step in the process.

7.2.7 Maintenance, equipment failure and accident si tuations 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. The specific assessment might await fu rther development of an appropriate Emission Scenario Document for discharge of treated ballast water.

8 ASSESSMENT REPORT (G9: 4.3)

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

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

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

.3 if any monitoring has been conducted, a summary of the results of that monitoring, including information on the analytical methodology used, ship movements and a general descri ption of the area monitored;GESAMP-BWWG 5/9
ANNEX 4 Page 33

I:\MEPC\57\2-10.doc .4 a summary of the available data on e nvironmental exposure and any estimates of environmental concentrations developed th rough the applicati on of mathematical models, using all available environmental fate parameters, preferably those that were determined experimentally, along with an identification or description of the modelling methodology;

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

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

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

9 MODIFICATION TO THE APPLICATION

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

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

10 FINAL APPROVAL

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

, the discharge testing should be perf ormed as part of the land-based type approval process using the treated ballast water discharge.

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

.1 Basic Approval has to be given first;

.2 the Member of the Organization, submitting an application should conduct the Type Approval tests in accordance with Guidelines for Approval of Ballast Water Management Systems (G8). Although Guidel ines (G8) are concerned with efficacy testing, paragraph 1.6.4 of part 1 of its annex provides the link between the Guidelines (G8) and the Procedure (G9) a nd consequently the test results from both Guidelines (G8) and Procedure (G9) would be used by MEPC to grant Final Approval . This would then allow the Administration to issue a Type Approval Certificate as shown in the appendix to Guidelines (G8). In this context Type Approval of any equipment us ed onboard ship should be given when the relevant approval body is satisfied that the Quality Assurance programmeGESAMP-BWWG 5/9
ANNEX 4 Page 34

I:\MEPC\57\2-10.doc employed by the manufacturer will ensure that the equipment can be produced consistently to the required specification and the risks to the ship and crew have been adequately addressed;

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

.4 toxicity testing should be done on two t ypes of seawater at two appropriate time intervals after treatment (preferably im mediately after treatment and after a 24 or 48-hour interval), and organisms normally found in the selected types of
seawater should be used in the toxicity testing;

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

.6 in addition to the basic data set 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

.7 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 ot hers both acute and chronic data might be required.

* * *GESAMP-BWWG 5/9
ANNEX 4 Page 35

I:\MEPC\57\2-10.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-products 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 treatment , that the analysis was carried out. It
is recommended that there should be:

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

.2 one analysis carried out [5] five days later.GESAMP-BWWG 5/9
ANNEX 4 Page 36

I:\MEPC\57\2-10.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 5/9
ANNEX 4 Page 37

I:\MEPC\57\2-10.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/4h)

3.2 Corrosion/Irritation

Species Method Results (including
scores where

available) Reference/Comments/Justification for missing data

Skin Eye

3.3 Sensitization

Species Method (e.g., Buehler, M&K) Results (Sensitizer Y/N) Reference/Comments/Justification for missing data

Skin

Inhalation

3.4 Repeated-Dose Toxicity

Exposure Route Exposure Duration Exposure dose Species
Method
Results

NOAEL
NOEL
Reference/Comments/ Justification for missing dataGESAMP-BWWG 5/9
ANNEX 4 Page 38

I:\MEPC\57\2-10.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 /Comments/Justification for missing data Log Pow

KocGESAMP-BWWG 5/9
ANNEX 4 Page 39

I:\MEPC\57\2-10.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 Oxidising properties

Surface tension Viscosity Thermal stability and identity of breakdown products Other physical or chemical propertiesGESAMP-BWWG 5/9
ANNEX 4 Page 40

I:\MEPC\57\2-10.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 5/9
ANNEX 4 Page 41

I:\MEPC\57\2-10.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.

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

1.3 In assessing an acceptable leve l of a particular substance, the procedure usually follows moving from an experiment database of animal or preferably human data (e.g., epidemiological studies) giving a No Observed Adverse Effect Level (NOAEL) or a Lowest Observed Adverse Effect Level (LOAEL) to deriving exposure limit at a lower exposure valu e, to allow for the uncertainties in the data. Comparison of this exposure limit with a measured or estimated exposure level is then used to judge whether the situation is satisfactory or whether risk management measures are required.

2 THE MARGIN OF SAF ETY (MOS) OR MARGIN OF EXPOSURE (MOE)
APPROACH

2.1 In this procedure the ratio of NOAEL determin ed in the animal studies and expressed in mg/kg/day is compared with the level to which a human may be exposed:

MOS or MOE = NOAEL mg/kg/d Exposure mg/kg/d

2.2 Assuming that the exposure of a human population to a substan ce in drinking water is 1 mg/L, for 60 kg woman consuming on average 2 L of water/day, then:

Exposure= 1mg/L x 2 L/day = 0.03 mg/kg/day 60 kgGESAMP-BWWG 5/9
ANNEX 4 Page 42

I:\MEPC\57\2-10.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 comparing to MOSr ef (100). However, if this value was much lower or lower than MOSref, it would indicate an inadequate MOS value over the NOAEL and a unacceptable human risk towards this adverse effect.

2.5 The selection of the critical NOAEL for RA will depend on the extent, duration and route of human exposure and the selection of the most critical adverse effect

.

3 EXPOSURE ASSESSMENT

3.1 The aim of assessing human exposure is to obtain a realistic es timate of total human exposure, expressed in terms of dose per unit weight, e.g., mg/kg.

3.2 In principle, the exposure of a human population could be assessed by representative monitoring data and/or model calculations base d on available information on substances with analogous uses and exposure patterns or properties.

3.3 The predictions of exposure levels should de scribe a reasonable worst case situation, covering normal use patterns and where general pub lic or workers may be exposed to the same substance. It is important to assess the reliability and the representativeness of the exposure

measurements.

3.4 Where data are of an unsatisfactory qualit y, it is useful to conduct an assessment using “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 worki ng week – 8h day, 5 days per week;

.1.2 relatively healthy part of general population; and

.1.3 exposure routes: norma lly inhalation and dermal.

.2 General public/Human exposure via environment – Users of coastal amenities,
beach coastlines and offshore installations and harbours:

.2.1 exposure intermittent – needs to be estimated;GESAMP-BWWG 5/9
ANNEX 4 Page 43

I:\MEPC\57\2-10.doc .2.2 exposures may not be controlled;

.2.3 exposure routes: oral, in halation and/or dermal; and

.2.4 includes vulnerable groups, e.g., children and elderly people.

3.6 Normally occupational exposure will be an ex ternal 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 assessmen t, should be made taking PPE (p ersonal protective equipment)
into account.

4.3 Of primary importance in developing the a ssessment of occupationa l exposure is a full understanding of the processes and unit operations in which exposure occurs, and of the actual
work activities resulting in expo sure. With this background know ledge, the following questions
have to be answered:

.1 what is the population of potentially exposed individuals?

.2 what are the magnitude, frequency and duration of inhalation and dermal exposures?

.3 what personal protective equipment and control measures are used to reduce or mitigate exposure? and

.4 how effective are they in reducing exposure?

4.4 The overall assessment of each type of expos ure should be repeated for all the various production processes and uses made for the chos en chemical, and from a knowledge of the frequency and duration of exposur e the “worst case” highlighted.

4.5 If “real” data are missing for a chosen substanc e, as an alternative to modelling it may be possible to substitute data from another chem ical with a similar pattern of exposure.GESAMP-BWWG 5/9
ANNEX 4 Page 44

I:\MEPC\57\2-10.doc 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 5/9
ANNEX 4 Page 45

I:\MEPC\57\2-10.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 5/9

I:\MEPC\57\2-10.doc ANNEX 5

REVIEW OF PROPOSAL FOR BASIC APPROVAL OF ACTIVE SUBSTANCE

Resource Ballast Technologies System

Submitted by South Africa

0 SUMMARY

0.1 The Group agreed to recommend that Basic Approval be given to the Resource Ballast Technologies System submitted by South Africa.

0.2 The Group noted that the Resource Ball ast Technologies System (RBT) uses electro-chemical treatment, ozonation cavitation and filtration to treat ballast water. The dossier
states that the electrochemical unit produces the Active Substance hypochlorite in the ballast water stream up to a maximum allowable concen tration of 1 mg/L, while the Active Substance

ozone is generated separately on board and injected into the ballast pipe up to an allowable concentration of 1 mg/L. The Group noted that ballast water is tr eated on uptake only.

0.3 The Group noted that the active substances identified by the dossier were ozone and hydroxyl radicals, while relevant chemicals we re chlorine gas, hydrogen gas and hypobromous acid. Hypobromite ions, bromate ions and bromoform are the resultant by-products of the system
when used under seawater conditio ns. Resultant by-products and re levant chemicals when used
in fresh water ballast situations are not identified and information should be provided in the Final Approval application.

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

.1 due to its very short half-life, ozone does not present any en vironmental threat and whilst it is very toxic by inhalation, it shou ld be safe to use providing that strict control measures are app lied to ensure that human exposure is prevented;

.2 the concentration of bromate ions in the treated ballast water is unknown. Bromate ions are deemed to be genotoxi c/carcinogenic and in formation regarding human exposure (HES, MEPC 56/2/2, a nnex 9) should be provided in the application for Final Approval.

.3 bromoform is relatively persistent and is bot h toxic and irritant to mammals. Chemical analysis of the treated ballast water showed that bromoform was found in concentrations of 0 – 9 μg/L. More detailed chemical analysis should be provided in the Final Approval application.

0.5 The Group concluded that chlorinated and brominated disinfection by-products are the toxicologically relevant compounds generated by the process as they have a potential for human genotoxicity/carcinogenicity. Therefore they will ha ve to be kept below toxicologically critical levels (bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L, WHO Guidelines for Drinking Water Quality, 2003).GESAMP-BWWG 5/9
ANNEX 5 Page 2

I:\MEPC\57\2-10.doc 0.6 The Group noted that the applicant did not provide information concerning the Human Exposure Scenario (MEPC 56/2/2, annex 9) and th erefore the risk char acterization for human health could not be adequately performed. Th is should be included in an application for Final Approval.

0.7 The lowest explosion limit for hydrogen gas is 4% under standard conditions. The amount of hydrogen gas produced by the electro-chemical un it should be documented in the application for Final Approval. The same applies to chlori ne gas. The Group recomme nds that a de-aeration component is added immediately following the el ectrolytic unit and that a hydrogen gas monitor is included in the system.

0.8 The Group noted that the applicant did not ca rry out chronic ecotoxicity studies, which is normally unacceptable. However, the Group also noted that the acute ecotoxicity data was quite extensive and generated under flow-through cond itions covering six species from four groups, including three trophic levels.

0.9 The applicant should carefully consider th e effect of organic matter levels on the production of by-products for the final operational m ode(s) of the system and demonstrate this by appropriate measurements.

0.10 The applicant indicates that the filter system is located downstream of the ballast water pumps and the treatment reactor, as opposed to many other systems where filtration is carried out directly on uptake. The Group considered that the filter cake could contain treatment by-products
and should therefore be considered as a waste stream warranting further investigation as part of the Final Approval process.

0.11 The application indicated that ozone would be dosed at 1 μg/L during treatment, however subsequent correspondence with th e applicant confirmed that, in fact, this is 1 mg/L. The Group will evaluate any application for Final A pproval on the basis of this latter value.

0.12 As there is currently no information on the estimated Predicted Environmental Concentration it is required that the applicant establishes a PEC estimation in order to determine a PEC/PNEC ratio to identify a possible risk for th e environment for the relevant chemicals in the application.

1 INTRODUCTION

1.1 The data for this product were extracted fr om original data supp lied by South Africa to support its submission MEPC 56/2/3 and the confid ential dossier issued to the Organization.

2 COMPLETENESS OF THE DOSSIER

2.1 The Group noted that information about the following subjects had been included in the application dossier:

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

.2 ecotoxicity tests with seawater treated with the Resource BWMS; and

.3 results of chemical analysis of treated water.GESAMP-BWWG 5/9
ANNEX 5 Page 3

I:\MEPC\57\2-10.doc 2.2 The description and diagram of the system are insufficiently clear regarding the sequence and the conditions (e.g., seawater, freshwater) in which the treatment technologies are to be used, including how the reactor is operated. Clear information on the operation of the entire system is required in order to be able to assess the hazards and risks in the application for Final Approval.

2.3 The control system should be described in detail including the sensors for ozone and chlorine monitoring.

2.4 The Group does not consider that the list of possible disinfection by- products provided by the applicant is complete, not does it cove r the possible operating modes of the system, e.g., ozonation alone, electrochemical tr eatment alone or both together.

2.5 A more comprehensive, measured datase t on both the electr ochemical and ozone generation systems plus a thor ough evaluation of Active Substa nces, Relevant Chemicals and by-products should be provided in th e application for Final Approval.

2.6 It was noted that the Applicant did not carry out chronic aquatic toxicity tests; this should be included in the dossier for final approval.

2.7 The Group noted that several valu es for ozone dosage were pr ovided and that some of the
values were lower than natural levels of ozone in the environment. Only the highest value (1 mg/L) was considered by the Group to be correct and therefore included in this summary dossier.

3 DESCRIPTION OF RESOURCE BA LLAST TECHNOLOGIES SYSTEM

3.1 Overview of the system

3.1.1 The Group noted that the RBTS treats ballast water by filtration, cavitation,
electro-chemical treatmen t (Chlorine) and ozone.

3.1.2 Ozone is injected in to the ballast water by utilizing a Venturi system to promote the
cavitational effect and to ensure the disinfection performance, wh en operating in fresh water. The maximum level of ozone after treatment is 1 mg/L . The ozone gas is produced by two generators that only become operational onc e the RBT Reactor is powered.

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

.1 a description of the ozone generator and safety aspects;

.2 a general description of the electro-chemical treatment; and

.3 a general descri ption of cavitation.

3.1.4 It was further noted that the electro-chemical treatment consists of electrodes, which create sodium hypochlorite (<1 mg/L) to ad ditionally support the cavitational effect.

3.1.5 The sequence of the treatment is unclear to the Group.GESAMP-BWWG 5/9
ANNEX 5 Page 4

I:\MEPC\57\2-10.doc 3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 The Group noted that Active Substances used for treatment of ballast water with the RBT Reactor include ozone, which is produced by a generator provided on board, and an electrochemical system producing disinfecta nts such as hydroxyl ra dicals and hypochlorite
in situ. The submission indicates that it is the in tention to dose ozone to result in a concentration of 1 mg/L ballast water.

3.2.2 Whilst recognizing that ozone is routinely used to disinfec t drinking wate r when it is injected into seawater, the following Relevant Ch emicals will be formed due to the presence of bromide ions that are not pr esent in drinking water:

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

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

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

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

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

Chemical

name CAS
number Molecular
Mass Empirical
formula Structural
formula Maximum
concentration
in treated
ballast water AS
RC
other

Ozone 10028-15-6 48 O 3 O=O–O 1 mg/L AS

Bromate ion 7758-01-2 167 KBrO 3 RC

Bromoform 75-25-2 252.73 CHBr 3 0 - 9 μg/L RC Hydroxyl
radical 3352-57-6 17.01 HO O*H AS

Chlorine gas 7782-50-5 70.9 Cl 2 Cl–Cl RC

Sodium hypochlorite 7681-52-9 74.4 NaClO Na–OCl 1 mg/L RC

Total residual
oxidants - - - - RC

Hydrogen gas 01333-74-0 2.015 H 2 H – H RCGESAMP-BWWG 5/9
ANNEX 5 Page 5

I:\MEPC\57\2-10.doc 3.2.5 The Group noted the following chemical reactions associated with the treatment of ballast water with ozone by the proposed system:

.1 O 3 + Br - Æ O 2 + OBr -

.2 O 3 + OBr - Æ 2 O 3 + Br -

.3 2 O 3 + OBr - Æ 2 O 2 + BrO 3 –

.4 Br - + O 3 ÅÆ OBr - + O 2

.5 OBr - + H + ÅÆ HOBr

.6 HOBr + Organic Matter Æ CHBr 3

.7 HOBr + NH 3 ÅÆ NH 2 Br

where O 3 and OBr - are considered the real Active Substances.

3.2.6 The Applicant states that reactions 6 a nd 7 do not occur in wa ter with a pH higher than 8 or in water with high contents of bromium compounds.

3.2.7 Reactions of ozone with organic matt er are described in appendix 1, 4.4.

3.2.8 The Group noted that a normal operation pr ocedure would result in a concentration of 1 μg O 3 /L, which is very low, compared to ot her BWTS making use of ozone as Active Substance. Later corresponde nce with the manufactur er confirmed that this was in fact 1 mg/L and this was used by the Group to evaluate the ozone generation part of the system.

3.2.9 The Group noted that the ozone generator used in this system creates ozone from ambient air, so that maximum gas concentration of ozone is limited to 12% by weight.

3.2.10 In addition, it was noted that ozone inter acts with naturally occurring bromide ions to produce very low quantities of bromoform, hypobromous acid/hypobrom ite and bromate ion together with other halogenated compounds. Thes e bromide ions break down slowly in the dark (half life of 1-2 d) but react quicker with seawater under the influence of UV radiation.

3.2.11 The Group concluded that the main comp onents to take into account for the risk assessment would be bromate, Total Residua l Oxidants (TRO), bromoform and other halogenated compounds.

3.2.12 Details of the evaluation of each chemical employed or generated by this system are shown in the appendices as indicated below:

.1 Ozone – Appendix 1

.2 Bromate ions – Appendix 2

.3 Bromoform – Appendix 3

.4 Free Active Chlorine – Appendix 4

.5 Hydrogen – Appendix 5GESAMP-BWWG 5/9
ANNEX 5 Page 6

I:\MEPC\57\2-10.doc 4 HUMAN HEALTH ASSESSMENT

4.1 Taking into consideration the concentrations of Active Subs tance and Relevant Chemicals
associated with the disinfection process described in the South Af rica’s Application Dossier, the Group was able to reach the following conclusions:

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

.2 The applicant claims that in the RBT system ozone is only generated when the ballast water pumps are running. Ozone gas is sucked directly into the ballast water being treated. A non-return/one way valve, situated on the corona reactor ensures that no ozone gas escapes.

.3 Bromate (potassium bromate): e xhibits a high potential for mutagenicity/carcinogenicity in humans . It is classified under the Globally Harmonized System as a carcinogen – may cause cancer category 1 B. The current MCL (Maximum Contaminant Level) in the United States is 10 μg/L and the maximum contaminant level is zero, because of the possibility that bromate may be a genotoxic carcinogen. No data about bromate concentrations were provided by the applicant, but the formation of bromate is very likely. The Group
considered that the risks to human health could be of concer n and therefore risk mitigation measures should be put in place in order to minimize occupational exposure.

.3.1 It was noted that the applicant claimed th at bromate ions will form in the ballast water. The water is pumped into the ship’s ballast tanks mechanically and
therefore there will be no human contact on board the ship with treated ballast water. Providing the treated water is releas ed more than 12 hours (the half life of a bromate ion) after it was treated, bromate i ons will pose no threat to human health outside of the ship. The applicant should c onsider the practicality of this, as it would imply that ballast water tanks could not be inspected before 12 h have elapsed and that de-ballasting operati ons may be necessary on the time
scale-scales shorter than 12 h.

.3.2 However, the Group recognized that, apar t from the crew, members of the public
need to be taken into co nsideration as exposure coul d occur both by ingestion and inhalation when swimming in the sea. In this context, it was noted that the U.S.EPA regulates the level of brom ate in drinking water to 10 μg/L (WHO, Guidelines for Drinking water Quality, 2003).

.4 Bromoform is toxic both by oral ingestion and inhalation as well as being irritant to skin, eyes and the respiratory tract. It is classified under GHS as toxic if inhaled (Acute tox 3), causes serious eye irritation (Eye irrit. 2) and causes skin irritation (Skin irrit 2). The primary routes of exposure are ingestion and inhalation (from volatilized compounds) and dermal exposure during bathing. Bromoform is readily absorbed from the gastrointestin al tract and may be absorbed through the respiratory tract and skin. They ar e rapidly distributed throughout the body.GESAMP-BWWG 5/9
ANNEX 5 Page 7

I:\MEPC\57\2-10.doc Principal health effects associated with inhalation or oral e xposure to bromoform are central nervous system depression and liver and kidney damage. The Group considered that bromoform represents a potential risk for human health.

.4.1 There is strong evidence that the hepa totoxicity of bromof orm is due to its metabolism into reactive intermediates and highly reactive trihalomethyl free
radicals.

.4.2 Oral MRL (Minimal Risk Levels) have been derived for:

- acute-duration oral exposure (14 days or less) of 0.7 mg/kg/d; - intermediate-duration expos ure (15-364 days) of 0.2 mg/kg/d;
- chronic-duration exposure (365 days or more) of 0.02 mg/kg/d.

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

.4.3 Bromoform concentrations in the treated ballast water ranged from 0 – 9 μg/L. However the applicant should carry out fu rther testing with seawater from a variety of sources, whic h will clarify the range of bromoform concentrations to be generated by the system.

.5 Free Active Chlorine (FAC, from hypochlorite) can cause irritation, pain and
inflammation of mucoses when swallowed. In severe cases it can cause ulceration and perforation of the gastro intestinal tract. Vapours are not easily formed although under certain conditions, high con centration solutions in low pH mixed with acids, may produce chlorine gas whic h can cause severe irritation of the nose and throat. The Group recommends measuri ng the concentration of chlorine gas
emitted from the treated ballast water tank.

.5.1 The Applicant states that sodium hypochl orite will be produced in situ and will be pumped directly into the ballast tanks . Chlorine has a rapid half life and presumably does not pose a risk to huma ns once the treated ballast water has
been released.

.5.2 The Gr oup considered that the cr itical health effects related to FAC exposure are mostly acute in nature; however, so me concerns are also addressed in literature (EHC 216, WHO, 2000) related to toxicity to respiratory, developmental/reproductive function and carcinogenicity, depending on the severity of exposure and presumably under long term exposures (e.g., occupational scenarios). Therefore, the Group recommended measuring the concentration of chlorine gas emitted from the treated ballast water tank.

.6 Hydrogen is not toxic, but if released in large enough quantities it may displace oxygen leading to unconsciousness or asphyxiat ion. It is also highly explosive in high concentrations. The Group recomme nds measuring the concentration of hydrogen gas emitted from the treated ballast water tank.GESAMP-BWWG 5/9
ANNEX 5 Page 8

I:\MEPC\57\2-10.doc .6.1 The Applicant states that th e amount of hydrogen produced by the
electro-chemical electrodes is minuscule small and would not reach any dangerous levels. Any excess that is not already ab sorbed/dissolved into the ballast water would be vented into the atmosphere via the vents in the ballast tanks.

.7 As a result of the above evaluation, the Group considered that, from the human health perspective provided the above recommendations are taken into account, the system may be recommended for Basic Approval.

5 RISK TO SAFETY OF SHIP

5.1 It was noted that there is an increased ri sk of corrosion arisi ng from the oxidizing properties of ozone and hypochlorite produced in the RBT reactor. The applicant should carry out appropriate corrosion tests for Final Approval.

5.2 The Applicant states that it will be ensure d that the machinery producing the ozone and the piping leading into the ballast water is coated with a ceramic coating and/or constructed of and appropriate non-corrosive material.

5.3 The Group noted that with systems using elec trochemical treatment there is an increased risk of explosion following the potential accumu lation of hydrogen gas generated by the system. The hazards associated with the potential for gene ration of chlorine gas during the process is also
in need of a further evaluation. Monitoring of levels of these substances and additional appropriate safety procedures s hould be required as a minimum for the opening of treated ballast tanks and personnel tank entry until it has been verified that such precautions are unnecessary.

5.4 The Applicant claims that there are no ri sks associated with the handling of active
chemical as the Active Substances and the rele vant chemicals are produced in situ and are
therefore not handled.

5.5 It had been noted that the application for Basic Approval on ly described generic safety requirements for an ozone system and that no indication had been given on how these requirements will be applied when such a system would be used on board a ship.

5.6 As a result, the Group considered that, from the ship perspectiv e provided the above recommendations are taken into account, the sy stem may be recommended for Basic Approval.GESAMP-BWWG 5/9
ANNEX 5 Page 9

I:\MEPC\57\2-10.doc 6 RISKS TO THE AQ UATIC ENVIRONMENT

6.1 Assessment Of Persistence (P), Bi oaccumulation (B) And Toxicity (T)

6.1.1 The products identified as Active Substances were assessed regarding their Persistence (P), Bioaccumulation potential (B) and their Toxicity (T). The a ssessment of these products is
shown below:

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

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

Bromate ion No? No (Log Pow=-7.18) No

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

Chlorine (Cl 2 ) No No Yes

FAC No No Yes Hydrogen No No No

6.1.2 The Group agreed that, although no inform ation was available on the Bioaccumulation characteristics of ozone, it was not expected that any of these substances would meet the criteria
and therefore none of these substances s hould be classified as a PBT substance.

7 ASSESSMENT OF TREATED BALLAST WATER

7.1 The Group noted that experiments to determin e the concentrations of Active Substances (Chlorine) and Relevant Chem icals (THM) in freshly treated ballast water yielded the following results:

Concentration (mg/L) References

Ozone N.D.
Total Residual Oxidant as
Free Chlorine
Total Chlorine 0.32 – 0.57
0.08 – 0.32
0.12 – 0.35 Appendix 1 Application Dossier Appendix 3 Application Dossier Appendix 3 Application Dossier
Bromate ion N.D.
Chloroform <0.0008 Appendix 4 Application Dossier
Bromodichloromethane <0.0001 Appendix 4 Application Dossier
Dibromochloromethane <0.0001 Appendix 4 Application Dossier
Bromoform 0 – 0.009 Appendix 1 Application DossierGESAMP-BWWG 5/9
ANNEX 5 Page 10

I:\MEPC\57\2-10.doc 7.2 From these data the Group concludes that the maximum concentration relevant for the
environment would be TRO and bromoform. Th e maximum concentratio n for TRO of 0.57 mg/L and for bromoform 0.009 mg/L would be relevant to take into acc ount for further exposure of the aquatic environment.

7.3 In this context, it was noted that the a pplicant recommended carry ing out further tests
with different waters to ascertain the results.

7.4 Acute toxicity of treated ballast water

7.4.1 Six local marine and/or estuarine species, a marine sea weed, a crus tacean, two species of gastropod mollusc and two species of fish were expos ed to treated ballast water. The results are listed in the following table (Ref erence MEPC 56/2/3, appendix 1):

Species LC 50 at TBW%
Seaweed Gracilaria verrucosa Ca. 50% no consistent results
Crustacean Diogenes brevirostris 100%

Mollusc Bullia digitalis 100%

Mollusc Haliotis midae 100%
Fish Liza richardsonii 72%
Fish Psammogobius knysnaensis 35%

7.4.2 Immediately after treatment, the total chlo rine levels in the si mulation ballast tanks were 0.99 mg/L and bromoform levels measured ~4 hours after treatment were 5.5 μ g/L.

7.5 Chronic toxicity

7.5.1 The Group noted that the appl icant did not carry out chroni c toxicity studies, which is normally unacceptable. However, the Group also noted that the acute toxicity studies were carried out under flow-through conditions and covere d six species including three trophic levels. It is recommended to carry ou t chronic toxicity studies for the full-scale testing for Final Approval.

8 ENVIRONMENTAL RISK ASSESSMENT

The Group noted that the half life for ozone in seawater was reported as only 5 s in
seawater and 30 min in fresh water and so would be degraded prior to be ing released into the
marine environment.

8.1 Derivation of a Predicted No Effect Concentration (PNEC)

8.1.1 The Applicant claims that it is only relevant to evaluate PN EC values for ozone in fresh water and bromoform in seawater for this study.

8.1.2 For ozone there is only one chronic value availa ble, which is 5 μg/L. An assessment factor of 100 is applied to this va lue resulting in a PNEC chronic = 0.05 μ g/L. There are 2 values available for acute data, the lowest of which is 60 μ g/L. Apply a factor of 1000 to this yields a
PNECacute = 0.06 μ g/L. Of these two data the lowest value is taken as the resulting PNEC:
PNEC = 0.05 μ g/L as ozone. In the case of ozone introduced to fresh water a total time of at least 8 hours is required before the ba llast water can safe ly be discharged.GESAMP-BWWG 5/9
ANNEX 5 Page 11

I:\MEPC\57\2-10.doc 8.1.3 For bromoform there is one chronic value available. An assessment factor of 100 is applied to this value resulting in a PNEC chronic = 48 μ g/L and 3 for the acute data, the lowest of which is 7.1 mg/L. Using an assessment factor of 1000 the PNEC acute is established at 7.1 μ g/L.
Of these two data the lowe st value is taken as the resulting PNEC: PNEC = 7.1 μ g/L as
bromoform. The half life of bromoform is in the order of 1-2 month and delaying release of
ballast water is not considered feasible.

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

8.2.1 The Group noted that the applicant had not used any model to calculate the predicted
environmental concentrations of Active substances or Relevant Chemicals.

8.2.2 The Applicant uses the concentration of bromoform in the treated ballast water (19.6 μ g/L) and concludes that this is only marginally higher than the PNEC value (7.1 μ g/L) and hence no major risk to the environment is expected.

8.2.3 The Group realizes that the resulting PEC/PNEC >1. Howe ver, taking initial dilution rates into account, the PEC/PNEC could be sign ificantly lower. The Group recommends applying a ballast water discharge model for Final Approval.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

9.1.1 It was agreed that there is a potential risk of explos ion due to the possible excess hydrogen being produced. There is al so a potential risk of corrosion to parts of the ship caused by the possible high levels of ch lorine generated by the system.

9.2 Risks to the crew and general public

9.2.1 The Group concluded that chlorinated and brominated disinfection by-products are the toxicologically relevant com pounds generated by the RBT as they have a potential for human genotoxicity/carcinogeni city; therefore they will have to be kept below toxicological critical levels (bromate <10μg/L; bromoform <100μg/L; chloroform <200 μg/L, WHO Guidelines for Drinking Water Quality, 2003).

9.2.2 The Group noted that the applicant did not provide information concerning the Human Exposure Scenario (MEPC 56/2/2, annex 9) of the RBT. This information has to be provided to the Group for Final Approval in order to en able an appropriate human health risk
characterization.

9.3 Risks to the environment

9.3.1 The Group noted that the applicant did not ca rry out chronic ecotoxicity studies, which is normally unacceptable. However the Group also no ted that the acute ecotoxicity data was generated under flow-through conditions and cove red six species from four groups, including three trophic levels. Due to the lack of data on chronic aquatic toxicity, the PEC/PNEC was based on acute toxicity data only.GESAMP-BWWG 5/9
ANNEX 5 Page 12

I:\MEPC\57\2-10.doc 9.3.2 The applicant should carefully consider th e effect of organic matter levels on the production of by-products and demonstrate this by appropriate measurements.

9.3.3 As there is currently no information on the estimated Predicted Environmental Concentration it is required that the applicant establishes a PEC estimation in order to determine a PEC/PNEC ratio to identify a possible risk for th e environment for the relevant chemicals in the application.

9.4 Conclusions

After critical review of the submission, the Gro up agreed to recommend that Basic Approval be given to the Resource Ballast Technologies System submitted by South Africa.

* * *GESAMP-BWWG 5/9
ANNEX 5 Page 13

I:\MEPC\57\2-10.doc APPENDIX 1

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION
AND BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: OZONE

2 EFFECTS ON AQUATIC ORGANISMS

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

A summary of the acute aquatic toxicity data for ozone is shown in the table below:

Species LC 50 (mg/l/duration) Reference/Comments/Justification for missing data
Fish Lepomis macrochirus Bluegill 0.06
24 h Paller and Heidinger (1979)

Fish Morone saxatilis Striped bass 0.15
6 h Hall et al. (1981)

Fish Pimephales promelas
Fathead minnow 0.1
0.03 h Asbury and Coler (1980)

Mollusc Dreissena polymorpha
Zebra Mussel 0.52-0.54
5.78 h Harrington et al. (1997)

The acute toxicity of ozone (LC 50 ) used as an Active Substance for this system is 8.1 μ g/L in
fresh water and 50 μ g/L in seawater (PAN pesticides database).

2.2 Chronic Aquatic Toxicity Data

The concentration of ozone will break down to <11 μ g/L (NOEC for Daphnia magna , Leynan

et al . 1997) within 40 seconds in seawater and w ithin 3.5 hours in fresh water, and to <0.14 μ g/L (natural background levels) within 75 seconds in seawater and 6.5 hours in fresh water. Thus, it is supposed that ozone has no chronic aquatic toxicity.

2.3 Information on Endocrine Disruption

There have been no documented studies on the endoc rine disruptive properties of ozone. Due to its rapid dissolution, it is considered not to be an endocrine disruptor.

2.4 Sediment Toxicity

The decomposition speed of ozone is high enough so that there is no concern of toxicity to benthic organisms.GESAMP-BWWG 5/9
ANNEX 5 Page 14

I:\MEPC\57\2-10.doc 2.5 Bioavailability/Biomagnification/Bioconcentration

Ozone decomposes very rapidly in natural water. Therefore th ere is no risk that ozone may concentrate in organisms.

2.6 Food Web/Population Effects

Ozone does not persist or concentr ate in organisms therefore there is no concern of effect on any animal high up the food chain.

3 MAMMALIAN TOXICITY

The toxicity of ozone to mammals is based on its strong oxidizing property. Ozone causes irritation to the eyes and to the pharynx, trachea, bronchi a nd bronchiole when inhaled.

3.1 Acute mammalian Toxicity

A summary of the mammalian toxicity data for ozone is shown in the table below:

Value [ppm] Species Reference/Co mments/Justification for missing data

Inhalation LC 50 (mg/L; 4 h) 5.9-6.8 Mice Cheminfo by Canadian Centre for Occupational Health and Safety (CCOHS)

The Group considers that ozone is very toxic by inhalation.

Inhalation LC 50 (mg/L; 4 h) 5.9-6.8 mice Cheminfo by Canadian Centre for Occupational Health and Safety

3.2 Corrosion/Irritation

3.2.1 Effects on skin and eye

Ozone gas can probably cause skin irritation in humans due to it s oxidizing ability, but only at concentrations capable of causing seve re respiratory inju ry (CCOHS, 2007). Ozone concentrations greater than 2 mg/L can be irritating to human eyes within minutes (CCOHS, 2007). Based on existing information, the prim ary site of acute effects is considered to be the lung causing pulmonary congestion and incr easing its sensitivity to other irritants.GESAMP-BWWG 5/9
ANNEX 5 Page 15

I:\MEPC\57\2-10.doc 3.3 Sensitization

3.4 Repeated-Dose Toxicity

A summary of the repeated dose toxicity data for ozone is shown in the table below:

Exposure Route Inhalation Exposure Duration a) 105 to 130 weeks b) 3-18 months Exposure dose a) 0.01-0.02 mg/kg bw/d b) 0.003-0.013 mg/kg bw/d Species a) Mice b) Monkeys

Method
Results a) increased incidence of non-carcinogenic lesions of the nose and lungs b) alterations to lungs, many changes seemed irreversible six months after exposure had stopped

NOAEL

NOEL
Reference/Comments/ Justification for missing data a) NTP, 1994

Although the reference NTP, 1994 was not submitted, the Group concluded that the observed critical effects in the repeated toxicity studies mentioned by the applicant (MEPC 56/2/3) were mainly non-carcinogenic lesions in the respiratory tract (nose and lungs).

The Group was unable to find the reference referred to above.GESAMP-BWWG 5/9
ANNEX 5 Page 16

I:\MEPC\57\2-10.doc 3.5 Development and Reproductive Toxicity

3.5.1 A summary of the development and reproductive toxicity data for ozone is shown in the
table below:

Exposure Route Inhalation Exposure Duration a) 4 d in middle or late pregnancy b) d 7 -17 of pregnancy c) not stated d) from six days prior to mating to postnatal day 22 Exposure dose a) continuously 0.020 or 0.03 mg/kg bw b) 0.024 mg/kg bw c) 0.03 and 0.04 mg/kg bw, d) not referred Species a) rat b) mouse c) rat d) mouse

Method
Results
observed adverse effects a) reduced growth rates after birth and delayed behavioural development, no maternal toxicity b) decrease in fetal body we ight gain and signs of maternal toxicity were observed c) Embryo toxicity in the form of increased resorption. Maternal to xicity was not reported. d) reduced body weight in the offspring and slight effects in neurobehaviour development of the offspring; maternal tox. Not evaluated
NOAEL a) not referred b) not referred c) not referred d) not referred
NOEL
Reference/Comments/ Justification for missing data a), b), c), d) – CCOHS

The Group considers that there are some concerns of reprotoxicity effects by inhalation exposure, namely neurobehavioural development, in the submitted studies.GESAMP-BWWG 5/9
ANNEX 5 Page 17

I:\MEPC\57\2-10.doc 3.6 Carcinogenicity/Mutagenicity

3.6.1 A summary of the Carcinogenic ity/Mutagenicity toxicity data for ozone is shown in the
table below:

Species Method Details Results (Yes/No) Reference

Carcinogenicity a) rats Rats b) mice 0.0021, 0.01 and 0.02 mg/kg bw
105-130 weeks a) no evidence for carcinogenicity in rats b) no evidence as tumor promoterMutagenicity a) lymphocytes of
hamsters b) lung macrophages
female rats c) bacteria, mammalian, and
human cells a) 0.0048-0.086 mg/kg bw for 5 h b) 0.0024-0.016 mg/kg bw for
6 hours a) cytogenetic aberrations b) cytogenetic aberrations c) evidence for mutagenicity in bacteria, mammalian
and human cells NTP, 1994
Mutation Research,
1992

The Group concluded that there is evidence of mutagenicity concern, in line with existing
scientific literature.

3.7 Toxicokinetics

Ozone is absorbed in both the upper and lower respir atory tract. It is a pote nt oxidant that reacts with protein and lipids, particul arly within biological membranes. A small amount of ozone is absorbed into the blood. The Group considers th at due to the short life and the high reactivity, Ozone has low potential for bioaccumulation of ozone limits its ability to accumulate.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

A summary of the modes of degradation data for ozone is shown in the table below:

Seawater or
Fresh Water Test
Duration Results Breakdown products Reference/Comments/ Justification for missing
data
1⁄2 - Life FW 10-30min O 2 MEPC 56/2/3, 3.1
1⁄2 - Life SW 5 s O 2 MEPC 56/2/3, 3.1

4.1.1 The Group recognized that ozone breaks dow n in an abiotic process into oxygen (O 2 ). In pure (fresh) water ozone has a half life of 10- 30 minutes. In seawater th e half-life is reduced
to 5.3 seconds.GESAMP-BWWG 5/9
ANNEX 5 Page 18

I:\MEPC\57\2-10.doc 4.2 Partition Coefficients

Method Results Reference/Comments/ Justification for missing data Log Pow
Koc <1 MEPC 56/2/3, 3.1.7.2

4.3 Persistence and Identifica tion of Main Metabolites

Method Results Reference/Comments/ Justification for missing data

Persistence N.D.

4.4 Reaction with Organic Matter

Cyclo addition (Criegee mechanism )

Consequentially to its dipolar structure, an ozone molecule can undergo a 1-3 dipolar cyclo-addition with satura ted compounds (double or triple bonds). This leads to the formation of a compound called ozonide.

Dipolar cyclo-addition (Lenntech database)

In a protonic solution, such as wa ter, primary ozonide disintegrates into an aldehyde, a keton or a
zwitter ion. The zwitter ion will even tually be disintegrated furt her into hydrogen peroxide and carboxyl compounds.

Disintegration of ozonide (Lenntech database)GESAMP-BWWG 5/9
ANNEX 5 Page 19

I:\MEPC\57\2-10.doc Electrophilic reactions

Electrophilic reactions occur in molecular soluti ons that have a high electronic density and mainly in solutions that contain a high level of aromatic compounds. Aromatic compounds that are substituted by electr on donors (such as OH and NH 2 ), have a high electronic density on the carbon compounds in ortho and para position. C onsequentially, in these positions aromatic compounds react actively with ozone. Is an ex ample of a reaction between ozone and Phenol. Phenol groups react with ozone relatively quickly.

Reaction between phenol and ozone (Lenntech database)

Nucleophilic reactions

Nucleophilic reactions mainly take place where there is a shortage of electrons and particularly at carbon compounds that contain electron-retr eating groups, such as –COOH and –NO 2

. For electron-retreating groups, the reaction speed is much lower.

From the above-mentioned data, it appears that di rect oxidation of organic matter by ozone is a selective reaction mechanism, during which ozone reacts quickly with organic matter that contains double bonds, activated aroma tic groups or amines. It is also stated that ozone reacts quicker with ionized and dissociated or ganic compounds than with the neutral (non-dissociated) type.

For most inorganic compounds in drinking water, th e reaction speed is relati vely high. The main
reaction mechanism for oxidation of inorganic compounds is determined by transfer of the extra oxygen atom of ozone to the inorganic compounds . For inorganic compounds, reaction speed is also higher for ionized and dissociated compounds.

In summary, ozone oxidizes organic compounds se lectively and partly. A large number of inorganic compounds are oxidized fast and completely.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

As the half life of ozone is 5 seconds in seawat er and 30 minutes in fresh water, it decomposes too quickly for the treated ballast water to have any potential effects on wildlife and
benthic habitats.

4.6 Potential Residues in Seafood

As ozone is not accumulated, there w ill be no risk of residue in seafood.GESAMP-BWWG 5/9
ANNEX 5 Page 20

I:\MEPC\57\2-10.doc 4.7 Any Known Interactive Effects

Ozone produces oxygen when decomposed in water. As a result it in creases the amount of oxygen dissolved in the water which helps aquatic organisms. In a closed system, such as a seawater aquaculture system, ozone removes nitrogen in the form of ammonia that is discharged
from fish.

5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES,
PREPARATIONS AND TREATED BALLA ST WATER IF APPLICABLE (Ref. MEPC 56/2/3, 2.3, table 2)

Physical property Value

Name Ozone
CAS number 10028-15-6 Molecular weight (g/Mol) 48 Melting point (°C) -193 Boiling point (°C) -112 Flash point (C°) Non-combustible but promotes burning of other substances Density (g/mL at 20 o C) N.D. (1.5 at -183 °C) Vapour pressure (Pa at 20°C) >100,000 Vapour Density (air=1) 1.6 Water solubility/dissociation constant (pKa) Definition for liquid; no relation with

gas pH Not Required Octanol/water partition coefficient (log P
ow ) see p.22 N.D. (-0.87)

Dissociation constant (pKa) N.A. Oxidation/reduction potential (V) 2.07 Corrosivity to the materials Yes Autoignition temperature ( o C) Non-combustible but promotes burning of other substances Explosive properties May cause fire or explosion when heated or coming into contact with a combustible material (alkene, ether) Oxidizing properties Yes Surface tension (N/mm at -183 o C) 3.84 x 10 -2
Viscosity (Pa.s at -183 o C) 1.5 x 10 -3
Thermal stability and identity of relevant breakdown products Oxygen

Other known relevant physical or chemical
hazards Reactivity towards container materialGESAMP-BWWG 5/9
ANNEX 5 Page 21

I:\MEPC\57\2-10.doc 6 OTHER INFORMATION

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

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification: Not classified under GHS classification, Annex VI, COM (2007) 355 final.

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data No No Yes MEPC 56/2/3, 7.1, table 7

* * *GESAMP-BWWG 5/9
ANNEX 5 Page 22

I:\MEPC\57\2-10.doc APPENDIX 2

DATA REQUIRED FOR EACH COMPON ENT OF THE PREPARATION AND
BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: BROMATE

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data (Ref. MEPC 56/2/3, 3.2.1, table 4)

A summary of the acute aquatic dose toxicity da ta for bromate is shown in the table below:

Species LC 50 (mg/l/; duration) Reference

Fish Cymatogaster aggregater
Shiner Perch 880
72 h Crecelius (1979)

Fish OncorhynchusKeta
Chum salmon 512
96 h Crecelius (1979)

Mollusc Crassostrea gigas Pacific oyster 30
48 h Crecelius, 1979

Mollusc Macoma inquinata
Bent-nosed clam 880
72 h Crecelius (1979)

Mollusc Protothaca staminea
Littleneck clam 880
72 h Crecelius (1979)

Mollusc Crassostrea virginica American oyster 1
48 h Stewart et al . (1979)

Crustacean Pandalus danae Coon stripe shrimp 880
72 h Crecelius (1979)

Crustacean Neomysis awatschnsis Opossum shrimp 176
24 h Crecelius (1979)

2.1.1 Ozone reacts with bromide in seaw ater to form the bromate ion (BrO 3 - ). The half life of the bromate ion is approximately 12 hours. Fresh water typically contains a very low
concentration of the bromide ion and therefore the production of the bromate ion does not occur
in fresh water.

2.2 Chronic Aquatic Toxicity Data

No chronic toxicity data were de livered, probably due to the short half life of bromate, which is approximately 12 h.

2.3 Information on Endocrine Disruption

No instances have been reported for the endoc rine disruptive properties of bromate ions.GESAMP-BWWG 5/9
ANNEX 5 Page 23

I:\MEPC\57\2-10.doc 2.4 Sediment Toxicity

Soil adsorption factor of bromate ion is estimated as follows from the relation with the octanol/water partition coefficient, P
ow :

Based on the following (QSAR):

K oc = 0.41 x log (P
ow ) 8

And using a log P
ow of -7.18 a K
oc = 2.8 L/kg is calculated. This value will be used in
further calculations if needed.

This estimate of K
oc : 2.8 L/kg is below the value of anticip ated toxicity to benthic organisms and
there is therefore no risk of t oxicity to benthic organisms.

The Group recommends that the applican t checks and re-considers the above.

2.5 Bioavailability/Biomagnification/Bioconcentration

The octanol/water partition coefficient log va lue of bromate ion is -7.18 and is therefore considered not to pose a risk of concentration in organisms.

Log Pow: -7.18 Reference/Comments/Justific ation for missing data
BCF: No risk MEPC 56/2/3, 3.2.4

2.6 Food Web/Population Effects

The bromate ion does not accumulate and there w ill therefore be no effect on organisms high in
the food chain.

3 MAMMALIAN TOXICITY

The toxicity of the bromate ion to mammals is based on its strong oxidizing properties. Bromate ions may affect the skin and eyes by exposure and cause coughing, pharynx pain, nausea, vomiting, abdominal pain, diarrh ea or central nervous system disturbance if taken orally.

3.1 Acute mammalian Toxicity

Value (mg/kg) Species Reference/Co mments/Justification for missing data

Oral LD 50 321 Rat Sinochem chemical data sheet

Bromate (potassium bromate) is toxic if swallowed (GHS clas sification, Annex VI, COM (2007) 355 final).

3.2 Corrosion/Irritation

Bromate (potassium bromate) is irritati ng to eyes, skin and mucous membranes (MSDS Sinochem).GESAMP-BWWG 5/9
ANNEX 5 Page 24

I:\MEPC\57\2-10.doc 3.3 Sensitization

No information available.

3.4 Repeated-Dose Toxicity

The exposure of rats to bromate for 15 weeks dem onstrated a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg bw/d.

3.4.1 Chronic toxicity

A summary of the chronic mammalian toxicity data for bromate (potassium bromate) is shown in
the table below:

Species Dose Effect Reference/Comments
/Justification for missing data

Male
B6C3F 1 mice 0, 0.08, 0.4, or 0.8g/L
KBrO 3 , drinking water, 100 weeks No effects observed on incidence on non-neoplastic lesions NOAEL of 0.8g/L De Angelo, 1998 (WHO, 2005)

Male F344

rats 0, 0.02, 0.1, 0.2, or 0.4 g/L KBrO 3 NOAEL of 0.02g/L based on kidney effects De Angelo, 1998 (WHO, 2005)

The Group concluded that from existing and submitted information (WHO, 2005) there are concerns related to nephropathy under long term exposure to potassium bromate.

3.5 Development and Reproductive Toxicity

A summary of the development and reproductive toxi city data for bromate (sodium bromate) is
shown in the table below:

Exposure Route Oral Exposure Duration 35 d Exposure dose 0, 2.2, 7.7 and 22 mg of bromate/kg bw/d

Species Rat
Method
Results Decrease in epididymal sperm density (at 22 mg/kg bw/d),
otherwise no indication of the developmental endpoints or any
effects were observed.
NOAEL 7.7 mg/kg/d
LOAEL 22 mg/kg/d
NOEL
Reference/Comments/ Justification for missing data Wolf and Kaiser, 1996 in WHO, 2005

From the submitted information, the Group conclude d that there are some fertility concerns related to exposure of rats to sodium bromate.GESAMP-BWWG 5/9
ANNEX 5 Page 25

I:\MEPC\57\2-10.doc 3.6 Carcinogenicity/Mutagenicity

A summary of the Carcinogenicity /Mutagenicity data for bromate (potassium bromate) is shown
in the table below:

Species Method
Details
Bromate

alone Results Reference/Comments
/ Justification for missing data

Carcinogenicity Rat Oral 32.3 mg KBrO3/kg average daily consumption
104 weeks (drinking water) Increased dysplastic foci, renal adenomas, adenocarcinomas, thyroid follicular cell tumors, peritoneal
mesotheliomas Kurata et al. 1992 in (WHO, 2005)

Mutagenicity V79
chinese
hamster
cells Micronucleus, CA, HPRT

gene mutation,
alkaline comet assay cytotoxic, increased the frequency of cells with micronuclei,
chromosome aberrations, DNA migration, increased
levels of 8 oxodeoxyguanosine, gene mutations and gene mutation at
HPRT locus Speit et al. 1999 in (WHO, 2005)

From the submitted and existing information (WHO, 2005), bromate (potassium bromate) produces tumours at multiple sites in rats, incl uding the kidney (adenomas and carcinomas), the thyroid gland (follicular cell adenomas and carcinomas) and the peritoneum (mesotheliomas) (Kurokawa et al. , 1986 a,b, 1987; Kurata et al. 1992; DeAngelo et al ., 1998). Further, a clear dose-response relationship exists in tumour incidence and the se verity/progression of tumours. The weight of evidence from the rat bioassays clear ly indicates that bromate (potassium bromate) has the potential to be a human carcinogen.

Bromate (potassium bromate) is classified as carcinogen – may cause cancer category 1 B (GHS classification, Annex VI, COM (2007) 355 final)

In addition, and according to existin g literature, the Group considered that the weight of evidence demonstrates that bromate (potassium bromate) is clearly mutagenic in in vitro assays. These positive findings show that this mutagenicity is also expressed in vivo . Thus, bromate (potassium bromate) should be considered a mutagenic disinfection by-product.

3.7 Toxicokinetics

3.7.1 Bromate may be converted into hypobromic acid by hypochloric acid in the stomach. Liver and kidney tissues may degrade bromate to bromide by a process involving glutathione, although only a small amount appears to be reduced in this way. Bromate is excreted mainly by
urine as bromate and bromide and so me may also be eliminated by faeces. Bromate concentrations in urine peak at about 1 hour, and bromate is not detectable in plasma after 2 hours.GESAMP-BWWG 5/9
ANNEX 5 Page 26

I:\MEPC\57\2-10.doc 4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

The Group noted that Bromine is removed fr om seawater by several mechanisms (Perrins et al. 2006). HOBr/OBr_OBr - reacts with natural organic matter to form bromoform (CHBr 3 ) by the haloform reaction. In th e presence of ammonia, HOBr/OBr - will react rapidly to form monobromamine, which can subs equently disproportionate to NHBr 2 and NH 3 or with
excess HOBr/OBr - it can react further to form N 2 and bromide. The rate of these reactions varies light and salinity concentration.

4.2 Bioaccumulation/Partition Coefficients

The established octanol/water pa rtition coefficient of bromate (Log Pow=-7.18) is very low. Therefore, the Group concludes that br omate has no risk of bioconcentration.

4.3 Persistence and Identifica tion of Main Metabolites

Compare 4.1.

4.4 Reaction with Organic Matter

Bromate does not volatilize and is on ly slightly adsorbed onto soil or sediment. Because it is a strong oxidant, its most likely fa te is reaction with organic matte r, leading to the formation of bromide ion (WHO, 2005).

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

The Group noted that the half life of the br omate ion in seawater is fairly short (~12 hours) and its estimated adsorption coefficient is very low (2.8). Ther e is no potential of effects on benthic organisms. The bromate ion is not accumulated and therefore will not affect high-order organisms in a food chain.

4.6 Potential Residues in Seafood

The bromate ion is not accumulated and therefor e there will be no potenti al residues in seafood.

4.7 Any Known Interactive Effects

Under normal environmental conditions, it is di fficult for the bromate ion to be reduced. However, it may be reduced to the bromide i on where ferrous ions, activated carbon or other
carbonaceous substances exist.GESAMP-BWWG 5/9
ANNEX 5 Page 27

I:\MEPC\57\2-10.doc 5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES,
PREPARATIONS AND TREATED BALLA ST WATER IF APPLICABLE (Ref. MEPC 56/2/3, 2.3, table 2)

Ph y sical p ro p ert y Value
Name Potassium bromate

CAS number 7758-01-2

Molecular wei g ht ( g /Mol) 167
Meltin g p oint (°C) 350
Boilin g p oint (°C) 370
Flash p oint (C°) N/A
Densit y ( g /mL at 20 o C) 3.27
Va p our p ressure (Pa at 20°C)
Va p our Densit y (air=1) 5.8
Water solubilit y ( g /L) Dissociation constant ( p Ka) 8.62

p H
Octanol/water p artition coefficient (lo g P ow ) -7.18
Oxidation/reduction p otential (V)
Corrosivit y to the materials Yes
Autoi g nition tem p erature ( o C)

Ex p losive p ro p erties
Oxidizin g p ro p erties Yes Surface tension (N/mm at -183 o C)
Viscosit y (Pa.s at -183 o C) 66.6-67.6
Thermal stabilit y and identit y of relevant breakdown p roducts
Other known relevant p h y sical or chemical hazards

6 OTHER INFORMATION

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

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

Carc 1B, Acute Tox. 3 (hazard statement codes: H350, H301)

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data No No Yes MEPC 56/2/3, 7.1, table 7

* * *GESAMP-BWWG 5/9
ANNEX 5 Page 28

I:\MEPC\57\2-10.doc APPENDIX 3

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION
AND BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: BROMOFORM

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

2.1.1 A summary of the acute aquatic toxicity data for bromoform is shown in the table below:

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

Fish Brevoortia tyrannus
Atlantic menhaden 9
96 h Anderson (1979)

Fish Cyprinodon variegates Sheepshead minnow 16
48 h Heitmuller et al . (1981)

Fish Lepomis macrochirus
Blue Gill 33
24 h Buccafusco et al . (1981)

Mollusc Crassostrea virginica American oyster 40
96 h Gibson et al . (1981)

Mollusc Mercenaria
mercenaria
Hard clam 140
96 h Gibson et al . (1981)

Crustacea Penaeus aztecus Brown shrimp 20
96 h Gibson et al . 1981

Algae Selenastrum capricornutum Green algae 18.7
24 h US EPA, 1978

Algae Selenastrum capricornutum Green algae 28.2
96 h US EPA, 1978

2.2 Chronic Aquatic Toxicity Data

2.3 Information on Endocrine Disruption

No information is available on disrupti on of endocrine functions by bromoform.GESAMP-BWWG 5/9
ANNEX 5 Page 29

I:\MEPC\57\2-10.doc 2.4 Sediment Toxicity

Bromoform and dibromochloromet hane have a minor tendency to be adsorbed by soils
and sediments. Calculated and measured values of K
oc (the organic carbon/water partition coefficient, an index of the relative mobilit y of a material in wa ter-soil systems) for bromoform range from 62 to 126 (Hassett et al . 1983; Hutzler et al . 1986; Mabey et al . 1982 in U.S. Agency for Toxic Substances and Dise ase Registry, 2005). These relatively low values imply that bromoform will exhibit only a minor affinity for soil ma terials and will tend to be highly mobile (Roy and Griffin 1985 in U. S. Agency for Toxic Substances and Disease Registry, 2005). This low tendency for adsorp tion to soil has been confirmed in laboratory studies (Curtis et al . 1986 in U.S. Agency for To xic Substances and Disease Re gistry, 2005) and in field studies by (Roberts et al ., 1986 in U.S. Agency fo r Toxic Substances and Di sease Registry, 2005).

2.5 Bioavailability/Biomagnification/Bioconcentration

Reference/Comments/Justific ation for missing data Log Pow -
BCF: between <1 and 10
times the water
concentration Gibson et al 1979; 28 day uptake and depuration tests with shrimps and fish

BCF: 7.6 Oyster ( Crassostrea virginica ) 90 μg/L

It was concluded that the rate of uptake and depuration was dependent on the individual, the species and the concentration of bromoform in the water.

2.6 Food Web/Population Effects

There is inconclusive evidence as to whether br omoform is concentrated up the food chain but it appears unlikely that bromof orm persists in organisms.

3 MAMMALIAN TOXICITY

3.1 Acute mammalian Toxicity

A summary of the acute mammalian toxicity data for bromoform is shown in the table below:

Value Species Reference /Comments/Justification for missing data

Oral LD 50 (mg/kg) 1475 Mouse Bowman et al ., 1978 in Melnick, 1989
1268 Rat Chu et al ., 1980 in Melnick, 1989

3.1.1 The LD 50 values presented in subm itted studies, indicate that bromoform is harmful if swallowed. In addition and according to GHS cla ssification, bromoform is toxic if inhaled.

3.2 Corrosion/Irritation

3.2.1 Bromoform is classified under GHS as an eye irrita nt (Eye irrit 2) and skin irritant (Skin irrt 2).GESAMP-BWWG 5/9
ANNEX 5 Page 30

I:\MEPC\57\2-10.doc 3.3 Sensitization

3.3.1 The Group noted that sensitization data had no t been provided for bromoform. However, the Applicant states that direct contact with bromoform in liq uid form causes redness and pain.

3.4 Repeated-Dose Toxicity

A summary of the repeated toxicity data eval uated by the Group for bromoform is shown in the
table below:

Exposure

Route a) Oral (gavage) b) Oral (gavage) c) Oral (gavage) Exposure
Duration a) 5 times weekly for 13 weeks b) 14 d c) 14 d Exposure
dose a) 0, 12, 25, 50, 100, or 200 mg/kg (rat), 0, 25, 50, 100, 200, or 400 mg/kg (mouse) b) 50, 125, or 250 mg/kg d c) 72, 145, or 289 mg/kg d Species a) Rat and Mouse b) Mouse c) Mouse

Method
Results a) All male rats treated with 100 or 200 mg/kg and all female rats treated with 200 mg/kg were lethargi c. Dose-related increases of cytoplasmic vacuolization of hepato cytes were observed in males of both species, but not in females. b) depressed humoral and cellular immunity in male mice only. Liver

weights and serum glutamate oxaloacet ate transaminase levels were increased and serum glucose and blood urea nitrogen levels were decreased in the high-dose animals. c) Elevated serum glutamate-pyruvate transaminase in high dose animals. Histological changes in the ki dneys and liver incl uding hyperplasia of tubular epithelial ce lls, hypertrophy and degenerative changes of the glomeruli in the kidney, and cen trilobular cytoplasmic pallor and slight focal inflammation of the liver.
NOAEL N.D.

NOEL N.D.
Reference/
Comments a) NTP, 1989 in Faust, 1995 b) Munson et al . 1982 in Faust, 1995 c) Condie et al . 1983 in Fasut, 1995

The Group concluded that from existing and submitted information there are concerns related to nephropathy and hepatopathy under repeated exposure to bromoform.GESAMP-BWWG 5/9
ANNEX 5 Page 31

I:\MEPC\57\2-10.doc 3.4.1 Chronic toxicity

3.4.1.1 The Group considered the study subm itted by the applicant (90d study) to be a sub-chronic test. A summary of the chronic toxi city data evaluated by the Group for bromoform
is shown in the table below:

Exposure Route Oral

Exposure Duration 90 d

Exposure dose 5,50, 500, 2500 mg/L

Species Rat
Method
Results Liver lesions (male rats 2,500 mg/L, in female rats 500
and 2500 mg/L).
NOAEL

NOEL
Reference/Comments/ Justification for missing
data Chu et al ., 1982 in Melnick, 1989

The Group concluded that from existing and submitted information there are concerns related to hepatopathy under sub-chronic exposure (90 days) to bromoform with gende r specific effects.

3.5 Development and Reproductive Toxicity

3.5.1 A summary of the development and reproductiv e toxicity data evaluated by the Group for
bromoform is shown in the table below:

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

Method
Results Evidence of foetotoxic

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

NOEL
Reference Ruddick et al . 1983 EHC 216 (2000)

The Group concluded from the submitted and existing information (EHC 216, 2000) that there may be some reprotox concerns (f etotoxicity) related to exposure to bromoform. No effects were observed on fertility parameters.GESAMP-BWWG 5/9
ANNEX 5 Page 32

I:\MEPC\57\2-10.doc 3.6 Carcinogenicity/Mutagenicity

The Group evaluated the carcinogenicity and muta genicity data submitted for bromoform and concluded that there are positive animal data indicating that bromoform can cause liver and
intestinal tumours.

3.7 Toxicokinetics

3.7.1 The Group noted that bromoform can be ab sorbed by inhalation, ingestion and dermal routes of exposure. In humans and laboratory an imals, bromoform is generally absorbed quickly (Backer et al . 2000). Although bromoform is lipophilic, it does not appear to accumulate in adipose tissue (Stanley 1986).

3.7.2 Bromoform is primarily excreted via e xhalation as the parent compound or carbon dioxide (Mink et al . 1986 in U.S. Agency for Toxic S ubstances and Disease Registry, 2005).

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

In the following table an overview is given of the environmental fate and behaviour data of
bromoform:

Seawater
or Fresh

water Test
Duration

DT50 Results Breakdown products Reference/Comme
nts/ Justification for missing data Biodegradatio

n N.D.

1/2 – Life Air N.D. 1-2
months concentration in
air indicate that
levels are <10 ppt). ATSDR, 1990
volatilization

4.1.1 The Group noted that bromoform tends to volatilize from water when exposed to the air, where it is relatively stable with a half life of 1-2 months. Most measurements of the
concentration of bromoform in air indicat e that levels are quite low (<10 ppt).

4.2 Partition Coefficients

4.2.1 In the following table an overview is given of the partition coefficients of bromoform:

Method Results Reference /Comments/Justification for missing data Log Pow
Koc range from 62
to 126 Mabey et al . 1982 in U.S. Agency for Toxic Substances and Disease Registry,
2005GESAMP-BWWG 5/9
ANNEX 5 Page 33

I:\MEPC\57\2-10.doc 4.2.2 The Group noted that bromoform may be sligh tly bioconcentrated by aquatic organisms. The magnitudes of the K
ow value suggest that the chemicals w ill tend to partition to fat tissues of aquatic organisms (U.S. Agency for Toxi c Substances and Disease Registry, 2005).

4.3 Persistence and Identifica tion of Main Metabolites

4.4 Reaction with Organic Matter

4.4.1 It was noted by the Group that trihalometha nes such as bromoform are formed as a by-product when chlorine or bromine are used to treat ballast water by reaction with organic matter in the water. However, once the bromofor m is formed it does not appear to have any further reactions with organic matter.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

No information is available on the effects of bromoform on wildlife or benthic habitats.

4.6 Potential Residues in Seafood

No information is available on bromoform residues in seafood.GESAMP-BWWG 5/9
ANNEX 5 Page 34

I:\MEPC\57\2-10.doc 5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES,
PREPARATIONS AND TREATED BALLA ST WATER IF APPLICABLE (Ref. MEPC 56/2/3, 2.3, table 2)

Property Value

Name bromoform

CAS number 75-25-2 Molecular weight (g/Mol) 252.73 Melting point (°C) 8.3 Boiling point (°C) 150 Flash point (°C) >107 Density (g/mL at 20 o C) Vapour pressure (Pa at 20°C) 640 Vapour Density (air=1) 8.7 Water solubility (g/L) Dissociation constant (pKa) pH - Octanol/water partition coefficient (log P
ow ) Oxidation/reduction potential (V) 2.06 Corrosivity to the materials Yes Autoignition temperature ( o C) Explosive properties Oxidizing properties Surface tension (N/mm at -183 o C) Viscosity (Pa.s at -183 o C) Thermal stability and identity of relevant breakdown products Other known relevant physical or chemical hazards

6 OTHER INFORMATION

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

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification ......... Acute Tox. 3, Eye i rritation 2, Skin irritation 2 (hazard statement codes: H331, H319, H315)

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data Yes No Yes MEPC 56/2/3, 7.1, table 7

* * *GESAMP-BWWG 5/9
ANNEX 5 Page 35

I:\MEPC\57\2-10.doc APPENDIX 4

DATA REQUIRED FOR EACH COMPON ENT OF THE PREPARATION AND
BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: FR EE ACTIVE CHLORINE

The following compounds are all treated under this heading:

- Chlorine gas (Cl 2 )

- HOCl and ClO- (Sodium hypochlorite)

- Total Residual Oxidants (TRO)

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data (Ref. MEPC 56/2/3, 3.4.1, Table 6)

2.1.1 A summary of the acute aquatic toxicity data for Free Activ e Chlorine is shown in the
table below:

Organism Species LC 50 (mg/l/dur

ation) Reference/Comments/Justification for missing data

Chlorine
Fish Salvelinus fontinalis
Brook trout 0.35
9h Dandy, (1972)

Fish Morone saxatilis Striped bass 0.61
6 h Bills et al . (1992)

Mollusc Crassostrea gigas Pacific oyster 0.556
1 h Chien and Chow, 1989

Mollusc Mercenaria mercenaria
Hard Clam 0.05
48 h Bellanca and Bailey, 1977

Crustaceans Asellus aquaticus Aquatic sowbug 0.754
24 h Kaniewska-Prus, 1982

Crustaceans Callinectus sapidus
Blue crab 0.75
48 h Vreenegoor et al . 1977

Algae Chlorophyceae Green Algae 0.1
24 h static Toetz et al . 1977

Sodium hypolchlorite
Fish Clupea pallasii Pacific herring 0.065
96 h Thatcher, 1978

Mollusc Lepomis macrochirus Bluegill 0.58
96 h Office of pesticide programs, 2000

Mollusc Dreissena polymorpha
Zebra mussel 0.090
17.7 h Harrington et al ., 1997

Mollusc Crassostrea virginica American oyster 0.12
0.5 Capuzzo, 1979

Crustaceans Clibanarius humilis
Hermit crab 2.5
96 h Best, 1991GESAMP-BWWG 5/9
ANNEX 5 Page 36

I:\MEPC\57\2-10.doc Organism Species LC 50 (mg/l/dur

ation) Reference/Comments/Justification for missing data

Crustaceans Hemigrapsus nudus
Shore crab 1.418
96 h Thatcher, 1978

Algae Chlorella sorokiniana Green algae 0.2
20 h Kott and Edlis, 1969

Algae Plankton 0.09
96 h Best, 1991

2.2 Chronic Aquatic Toxicity Data

2.3 Information on Endocrine Disruption

No information is available on endocrine disruption by chlorine

2.4 Sediment Toxicity

2.4.1 The Group noted that chlorine may react w ith soil and sediment components to form chlorides, which, depending on their water so lubility, are easily washed out. (Seiler et al . 1988).

2.5 Bioavailability/Biomagnification/Bioconcentration

2.5.1 It was noted that there is no potential fo r the bioaccumulation or bioconcentration of chlorine (HSDB, 1994).

2.6 Food Web/Population Effects

2.6.1 The Group noted that that as there is no potential for bioconcen tration of chlorine, animals high in the food chain will not be affected.

3 MAMMALIAN TOXICITY

3.1 Acute Toxicity

The acute toxicity effects of Free active chlorine (FAC) are ir ritation, pain, inflammation of
mucoses. In severe cases causes ulceration a nd perforation of gastro intestinal tract.
Mild irritation to corros ive injury by dermal route dependi ng on the concentration. Vapours are not easily formed however with more concentrated solutions and high pH or if mixed with acids higher % of chlorine may be released causing mild to severe irritation of nose and throat. Lethal effects can also occur, derived from aspiratio n of sodium hypochlorite solution into the lungs. Health effects depend on concentr ation and pH of the solution.

Chlorine has irritant effects on mucoses and skin. Acute inflam atory effects of chlorine gas towards the respiratory tract are also well reported and seem to be reversible in 1-4 weeks after exposure. The severity of the h ealth effects will depend on concen tration of chlorine and pH of
the solution. Chlorine is cl assified under GHS as toxic if inhaled (Acute tox 3).GESAMP-BWWG 5/9
ANNEX 5 Page 37

I:\MEPC\57\2-10.doc 3.2 Corrosion/Irritation

3.2.1 Effects on skin and eye

Free active chlorine (NaClO - ) can cause mild skin irritation to corrosive injury depending on the duration of contact, concentrati on and pH of the solution. Sodium hypochlorite does not easily form vapours however in more concentrated soluti ons and at high pH, form mists that can cause
mild to severe irritati on of the nose and throat.

Sodium hypochlorite is classified under GHS as skin corrosive 1B.

Chlorine is considered a primary irritant to th e mucous membranes of the eyes, nose, and throat and to the linings of the entire respiratory trac t (Stokinger 1982). Acute inflammatory effects to exposed skin are reported. The extent of acute injury to humans depends on the concentration and duration of exposure as well as the water conten t of the tissue involved and the presence of underlying cardiopulmonary disease (HSDB 1994).

Chlorine is classified under GHS as eye irritant (Eye irr 2) and skin irritant (Skin irr 2).

3.3 Repeated dose toxicity

Several rodent studies with administered sodium hypochlorite in drinking-water have suggested immunological changes. Exon et al. (1987) exam ined immunotoxicological effects of sodium hypochlorite at 5, 15 or 30mg/litre (0.7, 2.1 or 4.2.mg/kg bw per da y) in the drinking water of male Sprague-Dawley rats for 9 weeks. The ef fects on macrophage activit y suggest that some impairment does occur at relatively low levels of sodium hypochlorite although the significance
of which is still unknown. Modification of macr ophage function seems to be one of the most sensitive responses identified in studies of ch lorine or hypochlorite in experimental animals (EHC 216, WHO, 2000).

A study from Daniel et al . (1990a) evaluated th e toxicity of chlorine prepared by bubbling chlorine gas into distilled water and adjustin g pH to 9.4. The nominal concentrations of chlorine were approx im. 0, 3, 10, 16 or 21 mg/kg bw per day, administered as drinking-water to both male and female Sprague-Dawley rats (10 per sex per dose) for 90 days. No deat hs occurred in any treatment group. A NOEL (No Observed Effect Level) of 10 mg/kg bw pe r day was identified by the authors based on reduced body weight gain however this cannot be considered a tr ue toxicological end-point as can be associated to a reduced pala tability of the drinking-water.

3.4 Chronic toxicity

In a 2-year study (NTP, 1992) usi ng chlorine up to 14 mg/kg bw/d in drinking-water of F344 rats and B6C3F1 mice. The only treatment-related non -tumour pathology was found to be a dilatation of renal tubules in male mices at the highest dose level (14mg/kg bw/d ). No non-neoplasic
lesions were observed in either male or female rats. A NOAEL could be derived of approximately 15 mg/kg bw per day in th e 2-year studies in rats and mice.

Chronic exposure to chlorine gas may cause dy spnea, palpitations, chest pain reactive, upper airways dysfunction syndrome. It is one of the most frequent causes of occupational asthma.GESAMP-BWWG 5/9
ANNEX 5 Page 38

I:\MEPC\57\2-10.doc 3.5 Carcinogenicity/Mutagenicity

In most animal studies available for carcinogen icity evaluation (EHC 216, WHO, 2000) there is a
lack of statistical evaluation of the results and lack of dose-response relationship. Sodium hypochlorite is not classified by IARC as to their carcinogenicity to humans (Group 3).

Several studies have shown that sodium hypochlor ite produces mutagenic responses in bacterial systems and mammalian cells in vitro . However, there is no evidence of activity in mammalian test systems in vivo . It is not clear to what extent th is is influenced by the formation of mutagenic by-products as a result of reactio ns with components of the incubation media (Rosenkranz et al ., 1976).

3.6 Developmental and reproductive toxicity

Some indicative effects of altered sperm shape have been detected in several studies with chlorinated drinking-water. Meier et al . (1985b) reported that oral administration of sodium hypochlorite (pH 8.5) prepared from chlorine gas and administered at 4 or 8 mg/kg bw per day for 5 weeks incr eased the incidence of sperm abnormalities in
B6C3F1 mice.

Some animal studies have demonstrated no repr oductive or teratogenic effects of chlorine (Druckrey, 1968). A number of s ubsequent studies have studied the effects of chlorine or hypochlorite however there is insuffi cient information to draw conc lusions about the potential for developmental toxicity (EHC 216, WHO, 2000).

3.7 Toxicokinetics

Hypochlorite does not accumulate in the body; it re acts with tissues and apparently is readily absorbed in serum and eliminated from plasma with a half-life of 44 h (EHC 216, WHO, 2000).

Chlorine is a strong oxidi zing agent, and it must be presum ed that the toxicological mode of action induced at high doses by ei ther gaseous chlorine or solutio ns of hypochlorite is at least partially related to this property.

In conclusion, from the above information, the Gr oup considers that the critical health effects related to FAC exposure are mostly acute in nature; however, some concerns are also addressed in literature (EHC 216, 2000; WHO, 2000) related to toxi city to respiratory and developmental/reproductive function and carcinoge nicity, depending on the severity of exposure and presumably under long term expos ures (e.g., occupational scenarios).GESAMP-BWWG 5/9
ANNEX 5 Page 39

I:\MEPC\57\2-10.doc 4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

4.1.1 The following table summarizes the resu lts for development and carcinogenicity mutagenicity and reprotoxicity of FAC:

Seawater or
Fresh
Water Test
Dura
tion Results Break-down products Reference

Hydrolysis at pH 7 Fresh and

waste-water Rate constants range: 1.5 x 10 -4 at 0 °C to 4.0 x 10-4
at 25 °C hypochlorous
acid and
chloride ion hypochlorite
and H + U.S. EPA
1989

1/2 - Life natural
waters, 0.005 s NR U.S. EPA
1989

4.1.2 The Group notes that at pH values >5, OC l- predominates; at pH values <5, HOCl predominates (U.S. EPA 1989). Free active chlori ne (Cl2, HOCl, and OCl -) reacts rapidly with inorganics such as bromide and more slowly with organic material present in natural waters. These reactions yield chloride, oxidized organi cs, chlorooganics (including trihalomethanes), oxygen, nitrogen, chlorate, bromate and bromoorganics.

4.2 Partition Coefficients

There is no potential for the bioaccumulation or bioconcentration of chlorine (HSDB 1994).

4.3 Persistence and Identifica tion of Main Metabolites

4.4 Reaction with Organic Matter

The Group noted that chlorine reacts slowly with organic material present in natural waters. These reactions yield chloride, oxi dized organics, chloroganics (including trihalomethanes), oxygen, nitroge n, chlorate, bromate and bromoorganics.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.5.1 The following table summarizes the result for poten tial physical effects on wildlife and
benthic habitats of FAC:

Species Method
Details Results Reference

Phytoplankton Salmonella typhimurium
strains TA1530
and TA100 chlorination
of 0.05 to 0.15 mg/L shifts in the species composition of marine phytoplankton
communities U.S. EPA,
1994GESAMP-BWWG 5/9
ANNEX 5 Page 40

I:\MEPC\57\2-10.doc 4.5.2 The Group recognized that chlorine has been shown to have high acute toxicity to many organisms (U.S. EPA, 1994). Chlorine is phytotoxi c but is also essential to plant growth; crops need around 5 pounds or more of chlorine per acre. Acute toxicity to plants is characterized by defoliation with no leaf symptoms and, in highe r plant forms, by spotting of the leaves (at 1.5 mg/m 3 ) and marginal and interveinal injury (at 150-300 mg/m 3 ) (Seiler et al . 1988 in U.S. EPA, 1994).

4.5.3 No data were available regardi ng the toxicity of chlorine to terrestrial animal s. However, the data from experimental studi es indicate that injury to animals would occur only in the presence of high concentrations of chlorine, eith er in drinking water or the ambient atmosphere (U.S. EPA, 1994).

4.5.4 As chlorine and chlorine compounds do not pe rsist in sediments, it is not expected to
affect benthic habitats unless direc tly applied in high concentrations.

4.6 Potential Residues in Seafood

As there is no potential for the bioaccumulation or bioconcentration of chlo rine, there is no risk of potential resi dues 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 (Ref. MEPC 56/2/3, 2.3, table 2)

Property Value Value
Name Chlorine gas Sodium hypochlorite
CAS number 7782-50-5 7681-52-9 Molecular weight (g/Mol) 70.9 74.4 Melting point (°C) N/A -20 to -30 o C Boiling point (°C) N/A 96-120 o C Flash point (°C) Nonflammable N/A

Density (g/mL at 20 o C) 1.1 (relative density) Vapour pressure (Pa at 20°C) 780 000 Pa Vapour Density (air=1) Water solubility (g/L) Dissociation constant (pKa) pH - - Octanol/water partition coefficient (log P
ow ) Oxidation/reduction potential (V) 1.5V 1.7V Corrosivity to the materials Yes Yes Autoignition temperature ( o C) Forms explosive
mixtures with
flammable gases and
mixturesGESAMP-BWWG 5/9
ANNEX 5 Page 41

I:\MEPC\57\2-10.doc Explosive properties Anhydrous sodium hypochlorite is explosive Oxidizing properties Yes Surface tension (N/mm at -183 o C) Viscosity (Pa.s at -183 o C) Thermal stability and identity of relevant breakdown products Other known relevant physical or
chemical hazards Incompatibility with Nitrogen compounds, ammonium salts, acids, methanol. Copper, Nickel and cobalt speed up decomposition of NaOCl

6 OTHER INFORMATION

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

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification

Chlorine: Acute tox 3, Eye ir r 2, Skin irr 2, STOT single 3 (H azard statements codes: H331; H319; H315; H335)

Sodium hypochlorite: Skin corr 1B (Hazard statement code: H314).

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data No No Yes MEPC 56/2/3, 7.1, table 7

* * *GESAMP-BWWG 5/9
ANNEX 5 Page 42

I:\MEPC\57\2-10.doc APPENDIX 5

DATA REQUIRED FOR EACH COMPON ENT OF THE PREPARATION AND
BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: HYDROGEN

The Group noted that hydrogen gas is produced in th e electrochemical cell of the RBT reactor as a byproduct of hydroxyl radicals.

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

There is no data on acute aquatic toxicity of hydrogen.

2.2 Chronic Aquatic Toxicity Data

2.3 Information on Endocrine Disruption

None of the available data indicate to xicity for exposures of any duration.

2.4 Sediment Toxicity

There is no data on sediment toxicity of hydrogen.

2.5 Bioavailability/Biomagnification/Bioconcentration

Hydrogen does not bioconcentrate in the tissues of organisms.

2.6 Food Web/Population Effects

Hydrogen does not bioconcentrate or accumulate in th e tissues of organisms therefore there is no risk to organisms up the food chain.

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic) Hydrogen exists naturally in the atmosphere and will be dissipat ed rapidly in well
ventilated areas.

4.2 Partition Coefficients Hydrogen rapidly dissipates so there is no bioaccumulation.

4.3 Persistence and Identifica tion of Main MetabolitesGESAMP-BWWG 5/9
ANNEX 5 Page 43

I:\MEPC\57\2-10.doc 4.4 Reaction with Organic Matter

Hydrogen is not known to r eact with organic matter.

4.5 Potential Physical Effects on Wildlife and Benthic Habitats

4.5.1 The Group noted that no adverse ecologica l effects are expected. Hydrogen does not contain any Class I or Class II ozone depleting chemicals (40 CF R Part 82). Hydrogen is not listed as a marine pollutant by DOT (49 CFR Part 171).

4.6 Potential Residues in Seafood

Hydrogen does not bioaccumulate so there is no risk of hydrogen re sidues 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 (Ref. MEPC 56/2/3, 2.3, table 2)

Pro p ert y Value
Name Hydrogen gas
CAS number 01333-74-0
Molecular wei g ht ( g /Mol) 2.015
Meltin g p oint (°C) -259
Boilin g p oint (°C) -253
Flash p oint (°C) N/A
Densit y ( g /mL at 20 o C) 0.0899x10 -3

Va p our p ressure (Pa at 20 o C)
Va p our Densit y (air=1) 0.0695
Water solubilit y ( g /L) Dissociation constant ( p Ka)

p H

- Octanol/water p artition coefficient (lo g P ow )
Oxidation/reduction p otential (V)
Corrosivit y to the materials
Autoi g nition tem p erature ( o C) 565.5 Explosive properties Extremely especially at high temperatures
Oxidizin g p ro p erties Yes Surface tension (N/mm at -183 o C)

- Viscosit y (Pa.s at -183 o C)

- Thermal stabilit y and identit y of relevant breakdown
Other known relevant p h y sical or chemical hazardsGESAMP-BWWG 5/9
ANNEX 5 Page 44

I:\MEPC\57\2-10.doc 6 OTHER INFORMATION

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

6.2 Material Safety Data Sheet provided: Yes

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

6.4 Risk Characterization

Persistent (y/n) Bioaccumulative (y/n) Toxic (y/n) Reference/Comments/Justification for missing data No No No MEPC 56/2/3, 7.1, table 7

***GESAMP-BWWG 5/9

I:\MEPC\57\2-10.doc ANNEX 6

REVIEW OF PROPOSAL FOR BASIC APPROVAL OF ACTIVE SUBSTANCE

GloEn-Patrol TM Ballast Water Management System

Submitted by the Republic of Korea

0 SUMMARY

0.1 The Group recommends that Basic Appr oval be granted to the GloEn-Patrol TM Ballast Water Management System. Despite the many probl ems encountered in evaluating this dossier, the Group decided to recommend approval as the sy stem, should it be shown to be efficacious, would have a high degree of environmental acceptability.

0.2 The decision to approve the system was ba sed primarily on the expertise within the Group itself and knowledge available in the public literatu re, rather than on the information contained in the submission. Although UV treatment of ballast water on uptake (fo llowing filtration) and discharge would be unlikely to cause any harm to the environment and providing precautions are taken to prevent UV radiation esca ping from the system, is expect ed to have little impact on human health, it is still the re sponsibility of the applicant to demonstrate clearly that it is harmless in the Final application

.

0.3 The Group noted that the proposed system is based on a technology using filtration followed by high intensity medium pressure ul tra violet (MPUV) light for disinfection of micro-organisms and operates in situ during ballast water uptake and discharge. The Group recognized that this system is not augmented by the use of titanium dioxide or any other catalyst to increase efficacy. Should any other treatment mechanism, e.g., a titanium dioxide catalyst,
ozonation or electrochemical treatment be needed to boost the efficacy of the current system, then the whole system would need to be re-evaluated for Basic Approval.

0.4 The Group emphasizes that the ballast water tr eatment system presented here has been
evaluated on the basis of its current capacity, i.e., MPUV treatment of 50 m 3 /h with a maximum
UV dose of 300 mJ/cm 2 at wavelengths of 200 – 400 nm. Any other specifications would require
re-evaluation.

0.5 The Group noted that the dossier identified photons as the Active Substance and hydroxyl
radicals as Relevant Chemicals. In addition , a number of by-products from reactions between hydroxyl radicals and naturally o ccurring compounds in the treate d water were analysed but not detected. However, it was not possible to check the validity of the analytical chemistry in the dossier.

0.6 The Group noted that no ecotoxicity tests had been carried out by the applicant. In this particular case the lack of ecotoxicity data in the dossier is not a reason for refusal of Basic Approval, as UV treatment is often used in the aquaculture industry to sterilize water for rearing sensitive marine organisms for human consumption. The Group considered that the applicant had made insufficient effort to review such data from the literature.

0.7 The Group strongly recommends that whole effluent ecotoxicity testing and related chemical analysis of the exposure conditions be carried out for Final Approval as with any other system. Samples should be taken during efficacy tests to meet G8 standards (Ref. G9, 5.2.1). The purpose is to demonstrate conclu sively both the lack of any ecotoxicity and the lack of any disinfection by-products.GESAMP-BWWG 5/9
ANNEX 6 Page 2

I:\MEPC\57\2-10.doc 0.8 The Group noted that the submission identified that the only poten tial for human health
risk in the GloEn-Patrol TM system was related to exposure to UV irradiation from the treatment unit. The Group recommends that appropriate risk mitigation measure be put in place.

1 INTRODUCTION

1.1 The data for this product were extracted from the submission of the Republic of Korea to MEPC (MEPC 57/2/4) and the application dossier.

2 COMPLETENESS OF THE DOSSIER

2.1 The Group noted that the following documents have been included in the application dossier for Basic Approval: Qual ity Assurance Project Plan (QAPP) for anal ytical methods and sampling procedures, physical properties of the UV lamp, studies on degradation of hydrogen peroxide and a GloEn-Patrol TM instruction manual.

2.2 The Applicant submitted background info rmation on the possible formation of by-products in UV treatment, which are H 2 O 2 , HOCl/OCl - , HOBr/OBr - , THMs, HAAs and other halogenated organics.

2.3 The following information was identified by the Group as missing:

.1 The Group noted that a QAPP had been submitted, but the exact procedures for e.g., sampling and handling of the samp les for chemical analysis were not included. The Group was therefore not able to evaluate the reliability of the low detection limits reported by the applicant.

.2 Furthermore, the origin of the sample s taken for chemical analysis, the ballast water treatment conditions applied in the test and the water quality parameters pertaining were also not included.

.3 No ecotoxicity tests with the treated ballast water were carried out by the applicant. In this particular case the lack of ecotoxicity data in the dossier is not a reason for refusal of Basic Approval, as UV treatment is often used in other applications such as aquaculture to ster ilize water for rearing sensitive organisms. However, the Group considered that the applican t had made insufficient effort to
review data from the literature to support their contention.

.4 No information about th e potential risk of gas produc tion such as hydrogen or hydrogen in situ was delivered by the app licant. After request of the Group, the applicant explained that MPUV light th eoretically does not produce hydrogen gas, as it is not a photo-catalytic process.

.5 The Group noted that Material Safety Da ta Sheets would not be required for this particular application.GESAMP-BWWG 5/9
ANNEX 6 Page 3

I:\MEPC\57\2-10.doc 3 DESCRIPTION OF GloEn-Patrol TM BALLAST WATER MANAGEMENT SYSTEM

3.1 Overview of the system

3.1.1 GloEn-Patrol TM Ballast Water Management System uses medium-pressure ultra violet (MPUV) light for disinfection of micro-orga nisms and operates in situ during uptake and discharge of the ballast water. The ballast water treatment system consists of the following components:

.1 A filter unit runs automatically but only during uptake of ballast water as a pre-treatment. The filtered material is flushed with water and returned to the

seawater.

• Maximum flow rate: 300 m 3 /h • Filtration degree: 50 μm

.2 A UV unit, which employs high-intensity , medium-pressure ultra violet (MPUV) lamps in the wavelength range of 200 - 400 nm to destroy living micro-organisms present in the liquid being treated. UV Di sinfection system as a main treatment
installed with:

• UV Reactor (SS316L, flow rate: 50-65 m 3 /h) • Medium pressure UV lamps
• UV monitor • Temperature sensor • Automatic washing wiper for quartz sleeves

3.1.2 The Group emphasizes that the ballast water treatment system presented here has been
evaluated on the basis of its current capacity (filtration 300 m 3 /h and MPUV treatment 50 m 3 /h)
and maximum UV dose of 300 mJ/cm 2 . To meet the 300 m 3 /h as treatments rated capacity defined in G8, several MPUV treatment units have to be combined.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 Active Substances

3.2.1.1 It was noted that the proposed system involves filtration followed by a system for producing free radicals in situ with the aid of UV li ght. As a result, chemi cals are neither stored on board nor generated on demand.

3.2.1.2 The Applicant defines Photons as the Active Substance in the GloEn-Patrol TM Ballast Water Management System.

3.2.2 Relevant chemical (•OH)

3.2.2.1 The submission states that the MPUV light generates hydroxyl radicals (•OH). Therefore, hydroxyl radicals are defined as the “Relevant Ch emical” in the GloEn-Patrol TM Ballast Water Management System.GESAMP-BWWG 5/9
ANNEX 6 Page 4

I:\MEPC\57\2-10.doc Chemical name CAS
number Molecular
Mass [g/mol] Empirical
formula Structural
formula Max. initial
concentration anticipated in
ballast water AS
RC
other

Hydroxyl radical 3352-57-6 17.01 HO HO Not detected RC

3.2.3 Other Chemicals, by-products

3.2.3.1 The Group noted that both the Active S ubstance (Photon) and Rele vant Chemical (•OH)
are not residual in both of treated ballast water.

3.2.3.2 The Group noted that the MPUV-based GloEn-Patrol TM system might produce other
chemicals such as H 2 O 2 , HOCl/OCl - , HOBr/OBr, which could reac t with dissolved organic matters (DOM) in seawater, forming severa l harmful halogenated organics such as Thrihalomethanes (THMs), Haloacetic acid (HAAs) and other halogenated organics. To investigate the possibility of their producti on, halogenated organic compounds were analysed
in the treated ballast water.

3.2.3.3 The Group noted that experiments to determ ine the concentrations of Active Substances and Relevant Chemicals in the single treate d ballast water yielded the following results:

Compound Concentration (mg/L) Detection limit (mg/L)
Chloroform N.D. 0.0001
dibromochloromethane N.D. 0.001
bromodichloromethane N.D. 0.001
Bromoform N.D. 0.001
chloroacetic acid N.D. 0.005
bromoacetic acid N.D. 0.005
dichloroacetic acid N.D. 0.005
trichloroacetic acid N.D. 0.005
bromochloroacetic acid N.D. 0.005
dibromoacetic acid N.D. 0.005 1,1,1-trochloroethene N.D. 0.001

Tetrachloroethane N.D. 0.001 1,2-dibromo-3- chloropropane N.D. 0.001

N.D. = not detected.

3.2.3.4 It was not possible for the Group to evalua te the chemical analys is due to lack of supporting information.

3.2.3.5 The submission further states that the main UV spectra emitted from MPUV lamps used
in GloEn-Patrol TM system are in the range of 200 - 400 nm . Hydrogen gas can be produced in the photo-catalysis process such as TiO 2 /UV, but the MPUV system is not a photo-cataly sis process. Therefore, hydrogen or oxygen gas is not expe cted to be produced in the GloEn-Patrol TM system.GESAMP-BWWG 5/9
ANNEX 6 Page 5

I:\MEPC\57\2-10.doc 4 HUMAN HEALTH ASSESSMENT

4.1 The Group noted that the submission identified that the only poten tial for human health
risk in the GloEn-Patrol TM system was related to exposure to UV irradiation from the treatment unit. The Group recommends that all operators fo llow the safety instruction manuals provided by the manufacturer.

4.2 In addition the applicant states that there ar e no detectable concentrations of disinfection by-products by the GloEn-Patrol TM system. Therefore, the Group considers that at this stage there seems to be no risk resulting from human exposure to these compounds.

5 RISK TO SAFETY OF SHIP

5.1 The submission states that GloEn-Patrol TM does not create any corrosive by-products, such as TRO or acidic compounds. Further, the ORP value does not change during ballast water treatment (378 mV).

5.2 The Group noted that the electric power re quirement of the system will not be an insignificant additional ship service demand. Th e applicant states that the electric power consumption is not of any concern in relati on to normal ship operations. The applicant confirmed that the equipment meets regulatory st andards, but this needs to be documented, both with regard to construction and the prev ention of electric shock to personnel.

5.3 The Group raised some concerns regardin g overheating of the treatment unit from the MPUV lamps, which is designed to be monitored and equipped with an alarm system. However, the Group recommends that an automa tic shut-down system in case of overheating
should be considered.

6 RISKS TO THE AQ UATIC ENVIRONMENT

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

6.1.1 The Group recognized that it was not possible to evaluate the persistency, bioaccumulation and toxicity of any chemicals produced by the sy stem as they were either short-lived or not
detectable. Assessment of the PBT-criteri a is therefore considered not required.

6.1.2 Due to fact that chemical analysis for di sinfection by-products (DBP ) could not be fully evaluated, the Group could not assess PBT criteria for DBP.

7 ASSESSMENT OF TREATED BALLAST WATER

7.1 Chemical analysis

7.1.1 The Group noted that chemical analysis was car ried out with filtered natural seawater and single treated seawater collected from the pilot plant. The Group regards the single treated water as not representative for treated ballast water disc harge, as the submission informs that the ballast water would undergo a second treatment during the discharge process.GESAMP-BWWG 5/9
ANNEX 6 Page 6

I:\MEPC\57\2-10.doc 7.1.2 The Applicant investigated HOCl/OCl - , HOBr/OBr - and H 2 O 2 concentrations in the treated water, but only a some residual H 2 O 2 was detected, which was very close to the detection limit LOQ = 10 μg/L. Due to lack of the documentation of QA, the Group was not able to
evaluate this.

7.1.3 The Group noted that experiments to dete rmine the concentrations of disinfection by-products yielded the results described in se ction 3.2.3.3. However, it was not possible to check the validity of the analytical chemistry in the dossier.

7.2 Acute and chronic toxicity of treated ballast water

7.2.1 The Group noted that due to their short lifet ime, photons and also hydroxyl radicals will not be present in the di scharged ballast water.

7.2.2 The Group noted that no ecotoxicity tests we re carried out by the applicant. The Group noted that the Applicant st ates that the GloEn-Patrol TM treated water does not contain any toxic matter. This fact was used by the applican t to justify not submitting ecotoxicity studies. The Group cannot agree to this approach and for Final Approval therefore strongly recommends that whole effluent ecotoxicity testing should be undertaken with samples taken during efficacy tests to meet G8 standards (Ref. G9, 5.2.1).

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Derivation of a Predicted No Effect Concentration (PNEC)

8.1.1 The Group noted that no data or analysis of PNEC were delivered with the submission. Due to the lack of toxicity testi ng the Group can not evaluate a PNEC.

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

8.2.1 The Group noted that no PEC was found by th e applicant. Howeve r the Group requests
confirmation that a 100% concentr ation of treated ballast water discharge would be acceptable under any situation.

8.3 Calculation of the PEC/PNEC ratios

8.3.1 The Group noted that neither the PEC nor the PNEC had been derived.

9 CONCLUSIONS AND RECOMMENDATIONS

The information received for th e evaluation of the proposed BWMS under G9 was not considered sufficient for a Basic Approval und er normal circumstances. Based on the expertise of the Group and available knowledge in the public literature only could Basic Approval be granted.

The following information is missing in the dossier and should be provid ed for Final Approval:

- chemical analysis of treated ballast water with appropriate QA
- identification of relevant substance re sulted from chemical analysis above - results of toxicity testing of the treated ballast water described in sec. 5.2 in G9GESAMP-BWWG 5/9
ANNEX 6 Page 7

I:\MEPC\57\2-10.doc 9.1 Risks to the safety of the ship

The Group recommends that an automatic shut- down system in case of overheating should be
considered.

9.2 Risks to the crew and general public

The Group recommends that appropriate risk mitig ation measures be put in place to minimize human exposure to UV irradiation from the treatmen t unit. Furthermore, no other risk to human
health was identified.

9.3 Risks to the environment

The submission did not contain any ecotoxicity data. Therefore a full evaluation of the risk to the environment was not possible. However, base d on existing knowledge, the Group concluded that there was no risk or only a minor risk deriving from the proposed BWMS.

9.4 Conclusions

The Group recommends Basic Approval to be granted to the GloEn-Patrol TM Ballast Water Management System.

The Group emphasized to MEPC that the standard for a dossier submitted for Basic Approval is generally insufficient as the submission l acks much of the required information.

The Group noted that no ecotoxicity tests were ca rried out by the applicant and considered that the applicant had made insufficient effort to review data from the literature to support their case. The Group strongly recommends that whole effluent ecotoxicity testing and appropriate chemical analysis of samples taken during efficacy tests to meet G8 standa rds (Ref. G9, 5. 2.1) are strongly recommended as part of the Final Approval application.

The Group emphasizes that the ballast water treatm ent system presented here has been evaluated
on the basis of its current capacity (filtration 250 m 3 /h and MPUV treatment 50 m 3 /h) and
maximum UV dose of 300 mJ/cm 2

.

* * *GESAMP-BWWG 5/9
ANNEX 6 Page 8

I:\MEPC\57\2-10.doc APPENDIX 1

DATA REQUIRED FOR EACH COMPONENT OF THE PREPARATION
AND BY-PRODUCT PRODUCED IN BALLAST WATER

2 EFFECTS ON AQUATIC ORGANISMS

For the “Active Substance”, “Relevant Chemical” and “Treated Water”, data are presented and
discussed either on the basis of toxicological tests or existing toxicological knowledge for each end point listed.

Required data Active substance (Photon) Relevant chemicals (•OH)

2.1 Acute aquatic toxicity

2.2 Chronic aquatic toxicity

2.3 Endocrine disruption

2.4 Sediment toxicity

2.5 Bioavailability/biomagnification/
bioconcentration

2.6 Food web/population effects N.A. a N.A. a

N.A.: Not applicable. a. Photons and hydroxyl radicals will not be pres ent at the time of ballast water discharge.

3 MAMMALIAN TOXICITY

Required data Active substance (Photon) Relevantchemicals (•OH)

3.1 Acute toxicity

3.2 Corrosion/Irritation

3.3 Sensitization

3.4 Repeated-dose toxicity/chronic toxicity

3.5 Developmental and reproductive Toxicity N.A. a N.A. aGESAMP-BWWG 5/9
ANNEX 6 Page 9

I:\MEPC\57\2-10.doc

3.6 Carcinogenicity/Mutag enicity/genotoxicity

3.7 Toxicokinetics

N.A.: Not applicable.

a. Since photons and hydroxyl radicals genera ted in the MPUV reac tor, mammalians will not be exposed.

4 ENVIRONMENTAL FATE AND EFFE CT UNDER AEROBIC AND ANAEROBIC
CONDITIONS

4.1 Modes of degradation (biotic; abiotic)

Hydroxyl radicals can be formed during the UV process. However, the formed •OH is instantaneously scavenged by several specific chemical reactions with basic components present in seawater as described below (Jayson and Parsons, 1973; Zehavi and Rabani, 1972;

Buxton et al ., 1988; Hoigne and Bader, 1979).

4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

Not applicable.

4.3 Persistence and identification of the main metabolites in the relevant media

The half-life of •OH is close to 10 -9 sec in water.

4.4 Reaction with organic matter

4.4.1 The Active Substance (Photon) and Relevant Chemical (•OH) can react with organic matter, but this will only occur in the MPUV react or, and not in the ballast water and the ballast water discharge due to their high reactivity.

4.4.2 Hydroxyl radicals react with organics at extremely high rates ranging 10 8 ~10 10 M -1 s -1 (Buxton et al., 1988). These reactio ns of •OH with organics ar e possible under the continuously •OH-produced condition, which can be provided by advanced oxidation processes (AOPs), such as ozone/high pH, ozone/H 2 O 2 , UV/H 2 O 2 , ozone/UV, UV/TiO 2 , gamma-ray, sonication, (Photo) Fenton, etc. (Arbon et al., 1994; Kang and Ho ffmann, 1998; Park et al., 2001; Moraes
et al ., 2004; Garoma and Gurol, 2005; Oh et al, 2005; Chen et al., 2006). In general, these AOPs can produce high amounts (10 -9 ~10 -11 M) of •OH. So, it should be noted that the amount of •OH produced from the MPUV irradiation of seaw ater is significantly low, at most 10 -13 ~10 -15 M, which is not a significant level to affect any ch ange in background organics present in seawater.

4.5 Potential physical effects on wildlife and benthic habitats

Not applicable.

4.6 Potential residues in seafood

Not applicable.GESAMP-BWWG 5/9
ANNEX 6 Page 10

I:\MEPC\57\2-10.doc 4.7 Any known interactive effects

Not applicable.

5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES,
PREPARATIONS AND TREATED BALL AST WATER IF APPLICABLE (Ref. MEPC 56/2/3, 2.3, table 2)

Physical property Active
substance (Photon) Relevant
chemicals

(•OH)

CAS number - 3352-57-6
Molecular weight (g/Mol) - 17.01
Melting point (°C) N.A. -
Boiling point (°C) N.A. -
Flash point (°C) N.A. N.A.
Density (g/mL at 20°C) N.A. N.A.
Vapour pressure (Pa at 20°C) N.A. N.A. Vapour Density (air=1) N.A. N.A.
Water solubility/dissociation constant (pKa) N.A. N.A./11.9

pH - - Octanol/water partition coefficient (log P
ow ) N.D. N.D.

Oxidation/reduction potential (V) N.A. 2.7
Corrosivity to the materials N.A. N.A.
Autoignition temperature (°C) N.A. N.A.
Explosive properties N.A. N.A.

Oxidizing properties N.A. Non-selective a

, Various routes

Surface tension (N/mm at -183°C) N.A. -

Viscosity (Pa.s at -183°C) N.A. -

Thermal stability and identity of relevant breakdown products N.A b

-

Other known relevant physical or
chemical hazards N.A. N.A.

N.A.: Not applicable.

a. The hydroxyl radical (•OH) is one of the most powerful oxidi zing agents known (E  ̊ = +2.7 V in acid solution) and reacts wi th most organic compounds at almost
diffusion- controlled rates (Letterman, 1999; Bolton, 2001).GESAMP-BWWG 5/9
ANNEX 6 Page 11

I:\MEPC\57\2-10.doc b. The applied UV dose in the MPUV system is 300 mJ/cm 2 as a maximum condition. It is too small to break down any dissolved or ganics. Buchanan et al (2004) reported that
more than 10000 mJ/cm 2 is required for just 5% reduc tion of DOC. It should be noted that photonated by-products are not produced under the c ondition of the MPUV radiation in the system.

6 OTHER INFORMATION

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

Not delivered.

6.2 Material Safety Data Sheet provided: N.A.

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

***GESAMP-BWWG 5/9

I:\MEPC\57\2-10.doc ANNEX 7

REVIEW OF PROPOSAL FOR FINAL APPROVAL OF THE BALLAST WATER
MANAGEMENT SYSTEM

SEDNA ® using PERACLEAN ® OCEAN

Submitted by Germany

0 SUMMARY

0.1 Final Approval of the SEDNA ® using PERACLEAN ® OCEAN Ballast Water Management System is recommended, base d on the submission provided by Germany.

0.2 The Group noted that the proposed system treats the ballast water on uptake only.
The ballast water is filtered and then treated by injection of PERACLEAN ® Ocean into the ballast line from a storage tank. Chemicals are st ored in a container on board but the quantities required are not indicated in the dossier. The Group considers that the preparation
PERACLEAN ® Ocean contains the Active Substances peracetic acid and hydrogen peroxide.

0.3 The required concentration of PERACLEAN ® Ocean to achieve Regulation D-2 compliance is given by the submission as 150 mg/L . The Group therefore considers 150 mg/L as the Maximum Dosage for the purpose of this evaluation.

0.4 The Group considered that the use of PERACLEAN ® Ocean in the treatment of ballast water was unlikely to produce any unacceptabl e quantities of disinfection by-products.

0.5 The Group noted that the dossier only contai ned a generic descrip tion of the monitoring and control system to ensure that the maximu m designed concentration is maintained for a sufficient period of. The control system was based on monitoring of flow rates and did not include information about different dosing de pending on varying water qualities. The Group recommends that such a safeguard be includ ed in the system prior to the granting of Type Approval by the Administration.

0.6 Careful consideration should be given by the applicant to safe condi tions of storage and the location of tanks containing PERACLEAN ® Ocean on board. The Administration is strongly advised to pay special attention to ensure that adequate safety conditions for a range of potential locations and storage situations are met prior to granting Type Approval. In the absence of other guidance on safe storage, th e IMDG code and the PERACLEAN ® Ocean manufacturers land-based requirements for safe storage should be employed.

0.7 The PEC and PNEC calculations provided by th e applicant rely on a worst case for the dissipation of PAA and H 2 O 2 concentrations on board and in one harbour, used as an example. Accepting the applicants’ contention that there are no tailor-made models available for assessing
the risks from ballast water di scharges, the Group nonetheless stressed the importance for applicants of providing adequate examples to illustrate the potential risk to the marine environment, which should in clude any relevant models.

0.8 The Group accepts that PAA dissipates sufficien tly rapidly as not to be of concern and
therefore focused on the risks of H 2 O 2 . The selection of the PNEC then becomes critical: the Group felt that the PNEC value of 10 μg/L chosen in the EU risk assessment (2003) may be more representative than the PNEC deri ved by the applicant from one of the chronic fish tests, as the background levels in seawater may be high in any case.GESAMP-BWWG 5/9
ANNEX 7 Page 2

I:\MEPC\57\2-10.doc 0.9 Using the above PNEC, and the PEC calculation provided by the applicant for Richards Bay harbour in South Africa, plus an additional calcu lation based on the port characteristics of Rotterdam, representing a more enclosed harbour, the group concluded that the
PEC/PNEC ratios would remain below 1.

0.10 Approval is granted to the SEDNA ® using PERACLEAN ® Ocean Ballast Water Management System on the understanding that the system will not be operated at dosed concentrations of greater than 150 mg/L. I mmediate discharge of ballast water following treatment is not acceptable, as PAA, the main component of PERACLEAN ® Ocean, will not yet have dissipated sufficiently. The group considered a 24-h delay before discharge of treated
ballast water would therefore be essentia l to avoid any environmental effects.

0.11 The Group recommends that an occupational health medical surveillance plan according
to the Guidelines on the Basic Elements of a Shipboard Occupationa l Health and Safety Programme (SOHSP), IMO, May 2006 should be put in place to a ddress possible inhalation and dermal toxicity under occupa tional exposure situations.

0.12 The Group considers that a cooling system for the storage tanks in case temperatures exceed the 35oC limit should be pa rt of a multi level risk mitiga tion scheme. The Administration should ensure that such a system be impl emented, including at least the following:

- an active cooling syst em (air-conditioning)

- separate temperature sensors monito r the temperature of the PERACLEAN ® Ocean
inside of the tank as well as the air temperature in the tank room.

- an active ventilation system

- a tank spraying device (sprinkl er) in case the temperature reaches critical levels

- a signal is given to the vessels central alarm system via potential-free contact.

0.13 Prior to granting Type Approval, the Administration is recommended to check documentation on corrosion and tank coating compatib ility referred to in the application but for which no reports were in cluded in the dossier.

1 INTRODUCTION

1.1 The data for this product were extrac ted from the submission of Germany to MEPC (MEPC 57/2/5), the confidential applicati on dossier and additional information received following request of the Group to the applicant.

2 COMPLETENESS OF THE DOSSIER

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

.1 A general report with summaries of studies carried out with PERACLEAN ®

Ocean and ballast water treated with the SEDNA ® System according to Guidelines (G8) and Procedure (G9);

.2 A Germanischer Lloyd certificate confirmi ng appropriate safety management of
the installed SEDNA ® system as required by GESAMP-BWWG in document MEPC 54/2/12;GESAMP-BWWG 5/9
ANNEX 7 Page 3

I:\MEPC\57\2-10.doc .3 A Germanischer Lloyd certificate confir ming compatibility, i.e., non-corrosivity, to ballast water tank coating;

.4 An extract of the Quality Assurance Project Plan for full scale type approval testing according to Guidelines for approva l of ballast water management systems (G8) and the Procedures (G9); and

.5 An assessment report of full scale land-based testing.

2.2 The Group noted that the App licant has carried out extensiv e ecotoxicity studies on both,
the Active Substances and treated ballast water.

2.3 Furthermore, for the purpose of human health assessment, the Applicant submitted studies on skin irritation and acute oral exposure to PERACLEAN ® Ocean.

2.4 Corrosion tests on coated and uncoated steel pa nels were carried ou t under aeration and
with artificial seawater. Both conditions do not represent the typical situ ation in ballast water
tanks. Under these circumstances , no anaerobic corrosion will take place, and the typical marine bacteria being responsible for corrosion ar e not present in arti ficial seawater.

2.5 No model for environmental exposure was applied. The calculations proposed by
BLG 11/4/11 and BLG 11/4/15 were submitted.

2.6 The Group identified the following inform ation and documentation as missing in
the Dossier:

- Description of the control and monitoring system to be applied on board ships. A conceptual description is provided.

- Operational manual.

- BWMS Drawings and instructions for installation on board ships.

- Maximum level of dosage.

- Maximum allowable discharge level.

2.7 Questions and answers plus missing inform ation asked for at Basic Approval by the Group can be found in appendix 3.

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

3.1 Description of the ballast water management system

3.1.1 The submission informs that PERACLEAN ® Ocean is applied to the ballast water at uptake only by an automated dosing system that addr esses the variations in flow rates of ballast pumps. The chemicals are dosed after a two-stage filtration process designed for pre-separation of solids above 50 μm.

3.1.2 PERACLEAN ® Ocean is specified as scheduled in the IMDG Code under UN No. 3109, organic peroxide Type F, liquid, with a classification of 5.2. It is stored onboard in special designed containers. Due to its explosive nature the temperature is monitored in the containers and a sprinkler system is installed in case the temperature exceeds 35oC.GESAMP-BWWG 5/9
ANNEX 7 Page 4

I:\MEPC\57\2-10.doc 3.1.3 The recommended application of PERACLEAN ® Ocean is a concentration of 150 mg/L in the ballast water. This corresponds to initial concentrations of peracetic acid of around 23 mg/L, hydrogen peroxide of around 21 mg/L and acetic acid of around 38 mg/L.

3.1.4 The Group noted that the control system wa s based on monitoring flow rates of ballast
water and automatic PERACLEAN ® Ocean dosage.

3.2 Identification of Active Substances , Relevant Chemicals and Other Chemicals

3.2.1 The Group noted that the product PERACLEAN ® Ocean was defined as the Active Substance in the dossier. This is a proprieta ry formulation based on peroxygen chemistry. The main components are:

• peracetic acid (PAA) [79-21-0] H 3 C–C(=O) –O–OH 14 - <17%

• hydrogen peroxide [7722-84-1] H–O–O–H 13 - <15%

• acetic acid [64-19-7] CH 3 –COOH 24 - <29%

• stabilizer (acidic) < 1%

• water H 2 O <39 - 49%

3.2.2 At the request of the Group, the applicant reported that th e stabilizer consisted of a mixture of acids .............. (Section deemed to be conf idential and removed at the request of the submitting Administration).................... The total conc entration of additives is below 1%.

3.2.3 The Group noted that per acetic acid is produced by reacting hydrogen peroxide (H 2 O 2 ) with acetic acid in aqueous solution. In this pr ocess, peracetic acid is not obtained as a pure substance but in the form of aqueous equilibriu m solutions containing peracetic acid, acetic acid, hydrogen peroxide and water:

CH 3 COOH + H 2 O 2 CH 3 CO(O 2 )H + H 2 O

3.2.4 The Group noted that the Relevant Chemi cals were principally those listed above. The applicant further describes the measuremen t of a range of disinfection by-products in samples from the land-based testing.

3.2.5 The assessment of the treated ballast wate r regarding Active Substances and Relevant
chemicals is described under 7.1.4.

4 HUMAN HEALTH ASSESSMENT

4.1 The submission indicates that when us ing the system following the recommended operating and maintenance instructions, workers a nd ship crew will not be directly exposed to
PERACLEAN ® Ocean during the regular ballas t water treatment, since the SEDNA ® system runs in a separated room or compartment via an automated, closed dosing system (Evonik Degussa Gmb H, 2007n).

4.2 The applicant informs that (re)filling of the PERACLEAN ® Ocean storage tank on board is the same or a similar procedure to picking up other consumables such as bunkers or lubricants.
PERACLEAN ® Ocean is delivered as a typical bu lk chemical. The product is pumped for maximum 2 hours, e.g., from a large storage tank on the pier or from a tank truck, to a smaller storage tank on board the ship. Leakage-free couplings are used for hose connections. After filling of the PERACLEAN ® Ocean tank, residual product in the hose is removed by a pressured air device or ot her appropriate equipment.GESAMP-BWWG 5/9
ANNEX 7 Page 5

I:\MEPC\57\2-10.doc 4.3 The Group noted that possible fumes (e.g., a vinegar smell from acetic acid) developed during the (re)filling pr ocess of the PERACLEAN ® Ocean tank are removed by a ventilation
extraction unit.

4.4 The Group noted that incidental exposure can occur for a short time during connecting and disconnecting the hose pipe, in case of spillage or for maintenance works. In these cases, the recommended personal protection equipment cons ists of coverall, gloves, goggles, boots and, if required, respiratory protection.

4.5 The submission informs that the SEDNA ® system including the PERACLEAN ® Ocean dosing system and the storage tank on board a ne wly-built container vesse l have been checked regarding safety aspects and accident preventi on and received approval by Germanischer Lloyd (Germanischer Lloyd 2006) and by the Federal Ma ritime and Hydrographic Agency (BSH 2006).

4.6 The Applicant stated th at during Basic Approval the (MEPC 54/2/12) the Group recommended to perform a chronic inhalation st udy in rats however the Group noted that this
was not the case as it was recommended then “ that the irritation effects in the respiratory tract triggered in some inhalation studies (Jansse n, 1989; Janssen and Van Doorn, 1994) should be further investigated in a repeat ed dose inhalation study in order to assess the to xicity of the substance at lower dose exposure. Additionally, a dermal absorption study in vitro with non damaged skin at lower doses (diluted concentrati ons) should be conducted to anticipate the risk of occupational exposure in non accidental situations ”

.

4.7 Human exposure calculations were submitted subsequently by the Applicant, for pouring of the liquid which is considered to be the task of concern in te rms of human exposure, using the Manual Mixing and Loading model (EU, TnG, 2002, Model 7), thereby estimating exposure to the active substance at maximum of 7% of the TLV 0.6 mg/m 3 based on Gagnaire et al , 2002 study. The Group accepted the indicative values as s upporting information for a risk assessment.

4.8 In conclusion, the Group considers that further animal testing is not necessary but recommends that an occupational health medical surveillance plan according to the Guidelines on the Basic Elements of a Shipboard Occupational Health and Safety Programme (SOHSP), IMO, May 2006, should be put in place to address possibl e inhalation and dermal toxicity under occupational exposure situations (irr itation at the site of contact namely the respiratory tract and skin and secondary systemic effects namely impairment of lung and liver functions).

5 RISK TO SAFETY OF SHIP

5.1 Corrosivity

5.1.1 The Group noted that PERACLEAN ® Ocean is classified as corrosive and oxidizing.

5.1.2 The Group noted that a number of corrosion tests were included in the dossier using
artificial seawater that was ch anged daily. The tests included the determination of resistance against liquids according to ISO 2812-2 and the determ ination of extent of blistering according to ISO 4628-2. Duration was 120 days. Further tests were done on cathodic disbonding according to ASTM G8-96 (duration 30 days) (Evonik Degussa GmbH 2007g). In the tests no effect on the coating system was found, but for uncoated stee l plates the corrosion rates increased by 10-25%
in water treated with PERACLEAN ® Ocean.GESAMP-BWWG 5/9
ANNEX 7 Page 6

I:\MEPC\57\2-10.doc 5.1.3 In addition to the aforementioned studies on corrosion (MEPC 53/2/ 12), a major supplier of ballast tank coatings conducte d tests in their own laboratory and confirmed that the common Epoxy-based coatings are compatib le with the use of PERACLEAN ® Ocean (Jotun 2005).
The test documentation was however not included in the dossier and should be checked by the Administration prior to granting type approval.

5.2 Explosive properties

5.2.1 The Group noted that PERACLEAN ® Ocean under the influence of heat or catalytically active substances is liable to rapid exothe rmic decomposition. A general description of a mitigating scheme was given in the application dossier.

5.2.2 After an additional request of the Group the Applicant informed that a cooling system for the storage tanks in case temperatures exceed the 35oC limit is part of a multi level risk mitigation scheme, which has been approved by Germanischer Lloyd for this specific ballast water treatment system. The risk mitigation measures include, but are not limited to, the following points:

.1 The Applicant submitted an operating manual of the SEDNA ® System including detailed risk mitigation measures for the storage and handling of PERACLEAN ®

Ocean which are based on the Guid eline for storage of PERACLEAN ® Ocean that has been developed by Evonik Degussa GmbH.

2. As a standard feature of all SEDNA ® Systems, the PERACLEAN ® Ocean tank room is equipped with an active cooli ng system (air-conditioning). Separate temperature sensors monitor the temperature of the PERACLEAN ® Ocean inside of the tank as well as the air temperature in the tank room. The air-conditioning and the temperature sensors are fully implemented in the PLC steering of the
SEDNA ® system.

5.2.3 Furthermore, the applicant informed that:

.1 an active ventilation system allows a minimum of 10-fold exchange of the tank room volume per hour, which is installed with every PERACLEAN ® Ocean tank system;

2. the ventilation system will start automatically, when a temperature of 35°C is reached in the tank room;

.3 the air from the tank room is released in places where they can not harm crew members. The exact location depends on the installation details of the specific ship and is subject to plan approval of the class as it is a mandatory part of the risk mitigation system; and

4. if the tank temperature reaches 40°C a ta nk spraying device (sprinkler) is started to condense vapors and cool down the tank. Furthermore, a signal is given to the vessels central alarm system via potential-free contact.

5.2.4 The applicant describes the general design of the tank and dosing facilities, the location and the safety features depend on the conditions of the individual vessel and they have to be decided in co-operation with the relevant authorities and the classification society.GESAMP-BWWG 5/9
ANNEX 7 Page 7

I:\MEPC\57\2-10.doc 5.3 Storage of PERACLEAN ® Ocean on board

5.3.1 With regard to the safety considerations of chemicals stored on board ships for the purpose of ballast water treatment , the Group considered that re gulations for the transport of Packaged Goods by Sea are relevant, i.e., the IMDG code. However, best practice in the storage of PAA on land, e.g., at manufacturing sites will al so be very important. The applicant has outlined a series of safety measures applicable to a range of potential storage situations on board ship.

5.3.2 The IMDG code indicates that PAA falls unde r Class 5.2, i.e., Organi c Peroxides (liquid) and tanks containing PAA should therefore be st ored on deck when carried as packaged goods cargo. The application indicates a variety of possible storage lo cations depending on the design of the ship, including on-deck and below deck.

5.3.3 Careful consideration should be given by the applicant to safe conditions of storage and location, should they decide to deviate from th e guidance of the IMDG c ode. The Administration is strongly advised to pay special attention to ensure that adequa te safety conditions for a range of potential tank sizes, locations a nd storage situations are met pr ior to granting Type Approval.

6 RISKS TO THE AQ UATIC ENVIRONMENT

6.1 Assessment of Persistence (P), Bi oaccumulation (B) and Toxicity (T)

The active components of PERACLEAN ® Ocean do not fulfill the PB T criteria as outlined in Methodology (MEPC 56/2/2, annex 4) and Pr ocedure (G9) (MEPC 53/24/Add.1, annex 4):

Persistence (P) Due to the ready biodegradability and the abio tic degradation of the active components of
PERACLEAN ® Ocean, it can be concluded that it is not persistent in the environment.
Environmental half-lives are in the order of hours or a few days at the maximum.

Bioaccumulation (B) Due to the high water solubility and the low octanol water partition coefficients of the active components of PERACLEAN ® Ocean, there is no concern for a possible bioaccumulation potential of the product. (log Kow below 0).

Toxicity (T) One active component of PERACLEAN ® Ocean has a NOEC level below 0.01 mg/L. However, no indications for relevant effects concerning carcinogenicity, mutagenicity or reproductive toxicity as well endocrine disruption are found.

The Group agrees that none of the ingredients of PERACLEAN ® Ocean are considered to be
PBT substances.GESAMP-BWWG 5/9
ANNEX 7 Page 8

I:\MEPC\57\2-10.doc 7 ASSESSMENT OF TREATED BALLAST WATER

7.1 Chemical analysis of treated ballast water

7.1.1 The Group noted that die-away or dissipa tion tests with peracetic acid and hydrogen peroxide were carried out by the applicant during the land-based G8 efficacy tests. In all tests peracetic acid was completely degraded within less than 20 h. In brackish water, the half-life was about 4.5 h, in high saline water 3.5 h, respectively.

7.1.2 Hydrogen peroxide was found to degrade slower than peracetic acid. It took on average four days (96 h) until hydrogen peroxide had completely disappeared. In the test runs 7 to 12, the
detection limit of H 2 O 2 was reached after about three days. The estimated half-lives found were 24 h in brackish water and 19.5 h in high saline water, respec tively (NIOZ 2007b).

Landbased Testing at NIOZ / Texel, testrun 5, start on 10th of May 2007

0 2 4 6 8 10 12 14 16 18 20 22 24

0 12 24 36 48 60 72 84 96 108 120 132 144

time ( h )content (ppm) PAA

H2O2

detection limit Landbased Testing at NIOZ / Texel, testrun 10,
start on 14th of June 2007

0 2 4 6 8 10 12 14 16 18 20 22 24

0 12 24 36 48 60 72 84 96 108 120 132 144

time ( h )content (ppm) PAA

H2O2

detection limit

Figure 1: Die-away of PERACLEAN ® Ocean components in the land -based tests at NIOZ. Left figure: salinity 22 PSU, rightfigure: salinity 33 PSU

7.1.3 The Group noted that the die-away of PA A and H2O2 observed in fresh water is generally slower.GESAMP-BWWG 5/9
ANNEX 7 Page 9

I:\MEPC\57\2-10.doc 7.1.4 The Group noted that one analysis of treat ed ballast water was provided with samples
collected from land-based G8 test no. 11 with high salinity water and low organic loading (<2 mg TOC/L). The analysis yielded th e following results (Evonik Degussa GmbH, 2007k):

Untreated BW [μg/L] Treated BW [μg/L]
AOX n.d. n.d. AOX solid phase extraction < 20 28

EOX < 0.01 <0.01 Chlorophenols 2,3,4,5-tetrachlorophenol <0.1 <0.1 phenol <0.1 <0.1 pentachlorophenol <0.1 <0.1 4-chlorophenol <0.1 <0.1 3-chlorophenol <0.1 <0.1 3,5- dichlorophenol <0.1 <0.1 3,4-cichlorophenol <0.1 <0.1 3,4,5-trichlorophenol <0.1 <0.1 2-chlorophenol <0.1 <0.1 2,6-dichlorophenol <0.1 <0.1 2,4- u. 2,5-dichlorophenol <0.1 <0.1 2,4,6-trichlorophenol <0.1 <0.1 2,4,5-trichlorophenol <0.1 <0.1 2,3-dichlorophenol <0.1 <0.1 2,3,6-trichlorophenol <0.1 <0.1 2,3,5-trichlorophenol <0.1 <0.1 2,3,5,6-tetrachlorophenol <0.1 <0.1 2,3,4-trichlorophenol <0.1 <0.1 2,3,4,6-tetrachlorphenol <0.1 <0.1 Highly volatile halogenated hydrocarbons
trichloromethane <0.3 <0.3
dibromochloromethane <0.1 0.2
bromodichloromethane <0.1 <0.1
tribromomethane <0.2 1.5
total of determined LHKW -/- 1.7

n.d: Not determined (if amount of chlo ride is >15 g/L, th e SPE-AOX has to be determined).

7.1.5 From the tested compounds, only slightly increased amounts of AOX, bromoform and
dibromochloromethane could be detected in the ballast water treated with PERACLEAN ® Ocean (Evonik Degussa GmbH 2007e). These results are contradictory to previ ous findings showing
that trihalomethanes were not formed even unde r extreme conditions. Nevertheless, since these values are potencies below recent limit values in drinking water, they can be considered as negligible. The Group could accept the above argumentation.GESAMP-BWWG 5/9
ANNEX 7 Page 10

I:\MEPC\57\2-10.doc 7.2 Acute toxicity of treated ballast water

7.2.1 Low Salinity

7.2.1.1 The Group noted that acute ecotoxic ity tests were carried out with ROTOX ® , Microtox basic test, algae and oyster larv ae using ballast water, which had been stored for 5 days. An acute fish test was not performed due to the low sensitivity towards hydrogen peroxide. The results on the toxicity of ballast water of low salinity (22 PSU) are summarized in the following table:

Trophic
level Species Endpoint Storage in
the ballast
water tank [d] Result [% treated
ballast water 1 ] Reference

Rotifer Brachionus plicatilis 24 h EC 50 , static, mortality 5 Undiluted: no
effects (Evonik Degussa
GmbH 2007d)
Bacteria Vibrio fischeri 5 min EC 50 , luminescence 5 17.94%
inhibition with
50% treated
ballast water 2 (Evonik Degussa
GmbH 2007c) Algae Skeletonema

costatum 72 h chronic study growth rate (limit test) 5 Undiluted: no
effects (Evonik Degussa
GmbH 2007m) Oyster Crassostrea gigas 48 h EC 50 , static development 5 Restrictedly
usable (Sneekes 2007)

1 treated ballast water: treated ballast water.

2 Based on the given method of the Microtox basic test, the highest test concentration is 50% (1:1 dilution)

.

All tests performed at low salinity showed no adverse effects related to the treated ballast water. Only in the MICROTOX basic as say, some inhibitory effects (17.94%) were detected at the highest treated ballast wate r solution (Evonik Degussa GmbH 2007c; Evonik Degussa GmbH 2007d; Evonik Degussa GmbH 2007m). The oys ter larvae, which were also investigated, showed a very low development rate in the contro l and the test is considered as restrictedly usable. In undiluted treated ballast water, the development was again similar to the control (Sneekes 2007).GESAMP-BWWG 5/9
ANNEX 7 Page 11

I:\MEPC\57\2-10.doc 7.2.2 High salinity

7.2.2.1 The effects of treated ba llast water with high salinity (>31 PSU) are described in the following table:

Trophic
level Species Storage in the
ballast water tank [days] Endpoint Result [% treated
ballast water 1 ] Reference

Acute

Rotifer Brachionus plicatilis 1
5 EC 50 (24 h), static, mortality 58.8%
Undiluted:
no effects (Evonik Degussa
GmbH 2007d)
Bacteria Vibrio
Fischeri 1

5 EC 50 (5 min),
luminescence 11.95% inhibition
with 50% treated
ballast water 2

Hormesis (Evonik Degussa
GmbH 2007c)
Fish Solea solea
Juvenile 5 LC 50 (96 h), static, mortality Undiluted:
no effects (Evonik Degussa
GmbH 2007b) Oyster Crassostrea gigas 1 EC 50 (48 h),
static development aerated: 36.0%
unaerated: 35.7% (Evonik Degussa
GmbH 2007a) Oyster Crassostrea gigas 5 EC 50 (48 h),
static development 41.5% (Evonik Degussa
GmbH 2007a) Algae Skeletonema

costatum 1
2
3 3

5 EC 50 (72 h) growth rate 31.6%
35.4%
Undiluted:
no effects
Undiluted:
no effects (Evonik Degussa
GmbH 2007m)

Oyster Crassostrea gigas 1 NOEC (48 h), development
static aerated: 31.6%
unaerated: 31.6% Evonik Degussa GmbH,
2007f Oyster Crassostrea gigas 5 NOEC (48 h), development
static 31.6 (Evonik Degussa
GmbH 2007a) Algae Skeletonema

costatum 1
2
3 3

5 NOEC (72 h) growth rate 17.8%
17.8%
Undiluted:
no effects
Undiluted:
no effects (Evonik Degussa
GmbH 2007m)GESAMP-BWWG 5/9
ANNEX 7 Page 12

I:\MEPC\57\2-10.doc Trophic
level Species Storage in the
ballast water tank [days] Endpoint Result [% treated
ballast water 1 ] Reference

Fish Solea solea 5 NOEC (6 days) Egg hatch

success Mortality 31.6%

31.6% (Evonik Degussa
GmbH 2007l)

7.2.3 Bacterial Screening assays

The EC 50 value found in the ROTOX ® test kit of the day-1 treat ed ballast water was 58.8% treated ballast water, whereas the day-5 treated ballast water did not sh ow increased mortality, compared to the untreated ballast water contro l. (Evonik Degussa GmbH 2007d). Peracetic acid was degraded completely. Therefore, the toxicity of day-1 treated ballast water correlates to the hydrogen peroxide concentration found.

In the MICROTOX basic assay, no EC 50 values could be calculate d. While for the day-1 treated ballast water the highest treated ballast water solu tions showed slight inhi bitory effects (11.95%), incubation of the day-5 water resulted in increas ing hormesis effect with increased amounts treated ballast water compared to the NaCl control or untreated ballast water controls, respectively (Evonik Degussa GmbH 2007c).

7.2.4 Acute fish test

In an acute toxicity study in juvenile fish ( 96 h, static conditions) with day-5 treated ballast water, no mortality occurred up 100% treated ballast water. (Evonik Degussa GmbH 2007b).

7.2.5 Oyster larvae development test

7.2.5.1 The Group noted that development tests with oyster larvae were car ried out. Some of the test vessels were additionally aerated during incubati on, as a rapid decrease of oxygen in tests with oysters was measured in former tests.

7.2.5.2 The treated ballast water (day 1) did not affect the development of oyster larvae in concentrations up to 31.6% treated ballast wa ter (NOEC), regardless whether aeration was performed or not. In higher treated ballast wate r concentrations, the development of larvae was influenced resulting in EC 50 values of 36.0% treated ballast water for aerated samples and 35.7% for the unaerated samples, respectively. With a concentration of 5.9 mg H 2 O 2 /L found in the treated ballast water sample at test start, the EC 50 and NOEC of treated ba llast water correspond to 2.1 and 1.86 mg H 2 O 2 , respectively. These values are in th e range of the effect and no effect concentrations of pure hydrogen pe roxide solutions determined in parallel as toxicant control (EC 50 2.6 mg H 2 O 2 /L; NOEC: < 2.4 mg/L).

7.2.5.3 The Group noted that the day-5 treated ba llast water showed inhibitory effects in a similar concentration range (EC 50 41.5%, NOEC: 31.6%; Evonik Degussa GmbH, 2007a) The Applicant assumes a different reason, other th an Active Substance con centrations, since the peracetic acid and hydrogen peroxide levels were below the detection limit in the 5-day treated ballast water. Oyster larvae are known to be very sensitive towards even slight changes of environmental conditions like pH or te mperature or other water parameters (Douillet and Langdon 1993). It ca n not be excluded, that the obs erved bacteria re-growth (see also NIOZ 2007b) might also play a role in th e development of D-Larvae. Therefore, results from the performed tests with ballast wate r and oyster larvae might be questionable.GESAMP-BWWG 5/9
ANNEX 7 Page 13

I:\MEPC\57\2-10.doc 7.2.6 Algal growth inhibition test

7.2.6.1 The Group noted that the algae Skeletonema costatum was used for toxicity testing of treated ballast water day-1, -2, -3 and -5. Day-1 and da y-2 treated ballast wa ter did not contain peracetic acid any more, but had hydrogen pe roxide concentrations of 5.9 and 6.0 mg H 2 O 2 /L, respectively. The treated ballast water related EC 50 values for both treate d ballast waters were quite similar (31.6 and 35.4% respectively), as well as the NOECs (17.8% for both).

7.2.6.2 Further it was recognized that the day-3 and day-5 treated ballast water (no peracetic acid and hydrogen peroxide detect able), did not show any growth inhibition compared to the control (Evonik Degussa Gm bH 2007m). Therefore, it can be assumed, that the main toxicity of
treated ballast water is due to hydrogen peroxide.

7.3 Long-term Fish test

7.3.1 A fish early life stage test, according to OE CD 210 adapted for Sole, did not meet valid
criteria because the untreated ballast water control had a mortality of 100% after 18 days. This might have happened due to the aeration syst em installed during the test. Despite of that, during the egg and early larvae stage, the survival rate (up to test day 6) was high enough that
some observations could be used for further hazard assessment. Fu rthermore, unaerated controls were also tested (untreated ballast water and und iluted treated ballast water) and in this case, the
survival rate of the untreated ballast water c ontrol was 77.5% after 18 days, the treated ballast water-treated fish eggs died up to test day 6.

7.3.2 The egg hatch success and early mortality of the aerated samples were only affected above 31.6% treated ballast water (NOE C) (Evonik Degussa GmbH 2007l).

7.3.3 The applicant states that base d on existing findings, it might be concluded that fish is not the most sensitive species.

7.4 Conclusions on aquatic toxicity

7.4.1 Treated ballast water was tested in various species. The observed toxi city of the day-1 and day-2 treated ballast water correlates well with the hydroge n peroxide level in the water sample, observed for rotifer, algae and oyster, leading to an overall NOEC of 17.8% treated
ballast water.

7.4.2 With the algae, the toxicity decreased with increasing storage time of the ballast water indicating that no secondary toxicity is present. However, treated ball ast water on day-5 caused some toxic effects towards oyster and fish larvae suggesting that either ba cteria re-growth, a well known phenomenon (Douillet and Langdon 1993; Vaughn 2006), was responsible for the toxicity or other water parameters like pH or oxygen level di sturbing oyster larvae a nd fish eggs in their development.

7.4.3 The most sensitive species found were the oyster and fish larvae yielding a NOEC
of 31.6% treated ballast water.

7.4.4 No adverse effects were observed in the low saline environmen t under tested conditions

, but this might be restricted due to the limited number of results. Because of the extreme algae bloom in May, no further tests could be performed under low saline conditions.GESAMP-BWWG 5/9
ANNEX 7 Page 14

I:\MEPC\57\2-10.doc 7.4.5 The Group can generally accept the above arguments, but wishes to note that the guidance given in G8 for using a 5-day delay be fore testing ballast water may be too long.

8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Derivation of a Predicted No Effect Concentration (PNEC)

8.1.1 The Group noted that the results for marine algae indicate that marine algae are less
sensitive towards PERACLEAN ® Ocean than fresh water spec ies (refer to MEPC 53/2/12). All mentioned studies indicate a very steep dose response curve. However, fish larvae were
much more sensitive than Daphnia magna (long-term NOEC of 0.05 mg/L) leading to an overall NOEC of 2.25 μg PAA/L based on the results of the fish test. Using an assessment factor of 10, a PNEC of 0.225 μg/L can be derived corr esponding to a PNEC of 1.5 μg PERACLEAN ®

Ocean/L.

8.1.2 The Group also noted that the EU also es tablished a PNEC value of 10 μg/L for H 2 O 2

. Despite this value the Group will us e a value of 1.5 μg/L PERACLEAN ® Ocean as the
PNEC value in the risk assessment below.

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

First case

8.2.1 The Group noted that the Maximum A llowable Discharge Concentration for
PERACLEAN ® Ocean was not clearly stated in th e submission. However, based on the
PEC calculations and information received in the application the Group considers 21 mg/L of residual hydrogen peroxide as the Maxi mum Allowable Discharge Concentration.

8.2.2 The applicant states th at release of PERACLEAN ® Ocean into the aquatic environment during ballast water treatment is considered unlikel y due to the short degrad ation time. Peracetic acid degrades within 12 - 24 h. Therefore, it is unlikely that considerable amounts will attain to the aquatic environm ent if PERACLEAN ® Ocean is used in recommended manner. Even if the ship has to discharge all ballast water immediatel y after treatment, there will be no build-up of this component. However, measurable hydr ogen peroxide might be released into the environment, when ballast water is discharged 24 to 96 h after treatment. The Group generally
concurs with this assessment.

8.2.3 After confirmation by the Ballast Water Re view Group at MEPC 56 that none of the software currently available meets the requ irements for modeling an Emission Scenario, calculations were carried out based upon in formation provided by documents BLG 11/4/11
and BLG 11/4/15.

8.2.4 The Group would have preferre d somewhat wider interpretati on of the BLG advice cited above with some more examples.

8.2.5 The Group noted that the harbor of Richards Bay, SA has been used to calculate the total
release of H 2 O 2 , which was 434 t/a (assuming that all the ballast water contains 21 mg H 2 O 2 /L). This would generate a concentration of 1.66 mg H 2 O 2 /L, if no degradation at all took place. Considering just one day with 4.75 incoming ships and 56,616 tons ballast wa ter on average, the resulting H 2 O 2 concentration in the port ar ea would be 0.0045 mg/L (=PEC).GESAMP-BWWG 5/9
ANNEX 7 Page 15

I:\MEPC\57\2-10.doc Second case

8.2.6 The Applicant also describes a s econd case, where the build-up of H 2 O 2 in the harbor water was calculated. According to the results of the land-based tes ting (salinity 22 PSU, temperature 15.6°C), the half-life of H 2 O 2 is estimated to be 24 h. This approach can be
considered as conservative sin ce the trials at NIOZ were conduc ted in cleaned tanks and after filtration of the water by the SEDNA ® system. Under realistic harbor area conditions the degradation is significantly accelerated by suspende d solids, sediments and sunlight. Even after one year, the build-up of the peroxide concen tration in the harbor does not exceed a level of 0.009 mg/L.

8.2.7 Calculations disregarding a ny means of degradation at the time of release demonstrated that even if instantaneously discharged at bert h the concentration of th e Active Substance under
consideration is 3 orders of magnitude lower than the acute NOEC of the most sensitive species.

8.2.8 It could be demonstrated that even after continuous release of ba llast water immediately
after treatment with PERACLEAN ® Ocean from all incoming ships after 365 days, the PEC value in the receiving waters remained one order of magnitude below the PNEC.

8.2.9 The Group concluded that the estimated build-up of the concentration of H 2 O 2 to a level of 0.009 mg/L can be considered acceptable as a reasonable estimate. The Group adopts this value of 0.009 mg H 2 O 2 /L as a worst case e xposure concentration.

8.3 Calculation of PEC/PNEC ratios

The Group considered the PNEC of 0.010 mg/L for H 2 O 2 as sufficiently conservative (related to continuous long term exposures) and is adopted from the EU Risk Assessment in 2003 (see Chapter 2.5.3 of the submission for Final Appr oval). In consequence, the PEC/PNEC ratio after one day is 0.0045/0.01 = 0.45.

Using the PEC of the s econd case (0.009 mg/L H 2 O 2 ), the PEC/PNEC ratio will
be 0.009/0.010 = 0.9.

Comparing the cumulative value of 9 μ g/L with naturally occurring hydrogen peroxide found in seawater (0.5 to 14 μg/L, see EU Risk A ssessment, 2003), they are in the same range.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

Careful consideration should be given by the app licant to safe conditions of storage and the location of tanks containing PERACLEAN ® Ocean. The Administration is strongly advised to pay special attention to ensure that adequate safe ty conditions for a range of potential tank sizes, locations and storage situations are met prior to granting Type Approval.

The Group considers that a cooling system for th e storage tanks in case temperatures exceed the 35oC limit should be part of a multi-level risk mitigation scheme. The Administration should ensure that such a system be implemented:

- an active cooling syst em (air-conditioning)

- separate temperature sensors monito r the temperature of the PERACLEAN ® Ocean
inside of the tank as well as the air temperature in the tank roomGESAMP-BWWG 5/9
ANNEX 7 Page 16

I:\MEPC\57\2-10.doc - an active ventilation system

- a tank spraying device (sprinkler) in case the temperature reaches 40°C

- a signal is given to the vessels central alarm system via potential-free contact.

9.2 Risks to the crew and general public

Being severely corrosive to skin and eyes and severely irritating to mucous membranes of the respiratory tract, the Group considered that direct contact to PERACLEAN ® Ocean during system operations should be minimized by the recommended handling procedures that include the appropriate personal protec tive equipment, gloves, goggles and respiratory protection.

In addition, the Group considers that PERACLEAN ® Ocean due to its toxicokinetic properties is unlikely to be systemically av ailable beyond the site of contact , showing also a low genotoxic concern. However, according to existing and su bmitted information (JACC No40) there is some concern related to the carcinoge nicity potential of PAA ac ting as a tumour promoter.
The observed effects are considered to be secondary to local irritation (Greaves and Barsoum, 1990).

The Group recommends that a human health surv eillance program according to the Guidelines on the Basic Elements of a Shipboard Occupational Health and Safety Programme (SOHSP), IMO, May 2006, should be put in place to address possibl e inhalation and dermal toxicity under occupational exposure situations (irr itation at the site of contact in particular skin and respiratory tract and secondary systemic effects as impairment of the lung function).

9.3 Risks to the environment

Exposure modeling has been performed base d upon information provided by documents BLG 11/4/11 and BLG 11/4/15. However, the outcome of the calculations was not presented,
which hinders the evaluation of the reliability of the model results.

The PEC and PNEC calculations provided by the applicant rely on a worst case for the dissipation of PAA and H 2 O 2 concentrations on board and in one harbour, used as an example. Accepting the applicants’ contention that there are no tailor-made models available for assessing
the risks from ballast water di scharges, the Group nonetheless stressed the importance for applicants of providing adequate examples to illu strate the potential ri sk, which should include any relevant models.

The Group accepts that PAA dissipates sufficiently ra pidly as not to be of concern and therefore
focussed on the risks of H 2 O 2 . The selection of the PNEC th en becomes critical: the Group felt
that the PNEC value chosen in the EU risk assessment of H 2 O 2 (10 μg/L) completed in 2003 may be more representative than the PNEC derived by the applicant from one of the chronic fish tests, as the background in seawater may be high in any case.

Using the above PNEC, and the PEC calculation provided by the applicant for Richards Bay harbour in South Africa, plus an additional calculation based on the port characteristics of Rotterdam, representing a more en closed harbour, the group concl uded that the PEC/PNEC ratios
would remain below 1.

Based on the assumptions made in the application (e.g., example harbor) and by the Group (i.e., PNEC) it can be concluded that the discharg e of the treated ballast water is not likely to present an environmental risk to the receiving waters.GESAMP-BWWG 5/9
ANNEX 7 Page 17

I:\MEPC\57\2-10.doc 9.4 Conclusions

Approval is granted to the SEDNA ® using PERACLEAN ® OCEAN Ballast Water Management System on the understanding that the system will not be operated at dosed concentrations of greater than 150 mg/L. Immediate discharge of ballast water following treatment is not acceptable, as PAA, the main component of PERACLEAN ® Ocean, will not yet have dissipated sufficiently. The group considered a 24-h delay before discharge of treated ballast water would
therefore be essential.

The Group noted that the proposed system treats the ballast water on uptake only. The ballast water is filtered and then treated by injection of PERACLEAN ® Ocean into the ballast line from a storage tank. Chemicals are stored in a cont ainer onboard, but the quantities are not indicated by the dossier. The Group considers that the preparation PERACLEAN ® Ocean contains the Active Substances peracetic acid and hydrogen peroxide.

The required concentration of PERACLEAN ® Ocean to achieve Regulation D-2 compliance is given by the submission as 150 mg/L. The Group therefore considers 150 mg/L as the Maximum Dosage.

The Group considered that the use of PERACLEAN ® Ocean in the treatment of ballast water was unlikely to produce any unacceptable quant ities of disinfect ion by-products.

The Group noted that only a generic description of the monitoring and control system which could ensure that the maximum designed concentra tion is maintained for a sufficient period of time was included in the dossier. The control sy stem was based on monitoring of flow rates and
did not include information about different dosing depending on varying water qualities. The Group recommends that such a safeguard be in cluded in the system pr ior to the granting of Type Approval by the Administration.

* * *GESAMP-BWWG 5/9
ANNEX 7 Page 18

I:\MEPC\57\2-10.doc APPENDIX 1

DATA REQUIRED FOR EACH COMPON ENT OF THE PREPARATION AND
BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: PERACLEAN ® Ocean

2 EFFECTS ON AQUATIC ORGANISMS

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

2.1.1 Fresh water species

2.1.1.1 A summary of the acute aqua tic toxicity data for PERACLEAN ® Ocean on fresh water species is shown in the table below:

Result
EC 50 [mg PAA/L] 1 Trophic

level Species Endpoint

100 ppm
PERACLEAN ®

Ocean 200 ppm
PERACLEAN ®

Ocean 300 ppm
PERACLEAN

® Ocean

Product 0.74 0.46 0.42

Bacteria Vibrio fischeri light
inhibition (15 min)
Microtox TM PAA 0.111 0.069 0.063

Product 1.4 1.5 < 1.5 Algae Selenastrum capricornutum Growth
inhibition (72 h) PAA 0.21 0.225 < 0.225

Product 7.1 7.0 7.8Cladoceran Daphnia magna Immobilisation (48 h) PAA 1.065 1.17 1.05

Product < 0.78 1.22 < 2.34Microcrustacea Thamnocephalu s platyurus Acute mortality (24 h) PAA < 0.112 0.183 < 0.351

Product > 12.5 38.4 31.8 Hydra Hydra attenuata Acute mortality/
Submortality PAA > 1.5 5.76 3.96

Product 16.2 14.2 13.2

Fish Oncorhynchus mykiss Acute mortality PAA 2.43 2.16 1.98

These values were calculated on the basis of th e values given in Table 7 for the 2 h treated
ballast water.GESAMP-BWWG 5/9
ANNEX 7 Page 19

I:\MEPC\57\2-10.doc The results of the toxicity tests for different fres h water species show diffe rences in sensitivity. Small organisms are more sensitive towards PERACLEAN ® Ocean than higher organisms, except for the Microcrustacea, which was also found very sensitive. This ranking is not surprising since the active compound peracetic aci d is a well known bactericide. Comparing the results of daphnia, fish and algae with recent findings (ECETOC 2001), the now presented values correspond very well.

2.1.2 Marine species

2.1.2.1 Additional studies for marine wate r species, requested by and conducted under supervision of Washington State Department of Ecology, USA, are summarized in Table 2.

2.1.2.2 A summary of the acute aqua tic toxicity data for PERACLEAN ® Ocean on fresh water species is shown in the table below:

Trophic
level Species Method Endpoint Results
EC 50 (PERACLEA
N ® Ocean) Results
EC 50 (PAA) Reference

Algae Macrocy
stis pyrifera EPA/600/
R-95/136
static EC 50 Germination
EC 50 Germ tube length 48 h 7.91 mg/L

4 mg/L 1.19 mg/L

0.6 mg/L (Evonik Degussa
GmbH 2005a)

Algae Skeletone

ma

costatum E1218-97a
static EC 50 Growth inhibition,
96 h > 16 mg/L > 2.4 mg/L (Evonik Degussa
GmbH 2005a)
Fish
16 PSU Clupea pallasi Not stated
Semistatic EC 50 96 h > 16 mg/L > 2.4 mg/L (Evonik Degussa
GmbH 2005b)

2.1.2.3 All tests were performed according to gui delines and protocols of Washington State Department of Ecology without GLP.

2.1.2.4 The acute effects of PERACLEAN ® Ocean were investigated in two marine algae species, Macroystis pyrifera and Skeletonema costatum . The EC 50 values (48 h) in Macroystis pyrifera were 7.91 mg PERACLEAN ® Ocean /L for germination and 10.9 mg PERACLEAN ® Ocean/L for germ tube length, corresponding to 1.19 and 1.64 mg PAA/L, respectively. The species Skeletonema costatum , exposed for 96 h, was found less sensitive with an EC 50 value
of EC 50 > 16 mg PERACLEAN ® Ocean/L, corresponding to 2.4 mg PAA/L (Evonik Degussa GmbH 2005a).

2.1.2.5 In an additional acute t oxicity test with PERACLEAN ® Ocean (test duration 96 h, water renewal after 48 h), using the pacific herring ( Clupea pallasi ), no toxic effects were observed up to the highest test concentration of 16 mg PERACLEAN ® Ocean/L. Therefore, the LC 50 is > 16 mg PERACLEAN ® Ocean/L, which corresponds to > 2.4 mg PAA/L. (Evonik Degussa GmbH 2005b).GESAMP-BWWG 5/9
ANNEX 7 Page 20

I:\MEPC\57\2-10.doc 2.1.3 Conclusions on acute toxicity

2.1.3.1 All findings are in the same range of previous data alread y presented in the application for Basic Approval (MEPC 53/2/12). Compared to the results obtained in fresh water, the sensitivity of marine fish is similar.

2.1.3.2 Comparing available results obtained for th e three trophic levels (not restricted to
PERACLEAN ® Ocean), fish was found less sensitive (lowest acute LC 50 is 1.6 mg PAA/L).
For invertebrates the lowest EC 50 was obtained for Daphnia ma gna, with 0.5 mg PAA/L. The acute toxicity appears to be relate d to the size of the test organism.

2.1.3.3 Embryonic stages of oysters and musse ls were found most sensitive with 48 h EC 50 values of 0.27 to 0.54 mg PAA/L.

2.2 Chronic Aquatic Toxicity Data

2.2.1 Further new reports on chronic aquatic toxicity of PERACLEAN ® Ocean were obtained
which are summarized in Table 3.

2.2.2 A summary of the chronic aquati c toxicity data for PERACLEAN ® Ocean on fresh water species is shown in the table below:

Trophic
level Species Method Endpoint Results (NOEC) (PERACLEAN ®
Ocean) Results (NOEC) (PAA) Reference

Fresh wate r Fish Danio
rerio OECD 210
Flow through
conditions (GLP) Hatch

success, Development

Mortality 15 μg/L 2.25 μg/L (Evonik Degussa
GmbH 2007j)

Seawater
Fish (16 PSU) Clupea pallasi Not stated
Semi-static Hatching

success 16 days 1.9 mg/L 29 mg/L (Evonik Degussa
GmbH 2005b) Algae Macroc ystis pyrifera EPA/600/
R-95/136
static Germ tube length
48 h 4 mg/L 6 mg/L (Evonik Degussa
GmbH 2005a) Algae Skeleton

ema

costatum E1218-97a
static Growth inhibition,
96 h 8 mg/L 2 mg/L (Evonik Degussa
GmbH 2005a)

2.2.3 A fish early life stage test with the fresh water fish Danio rerio was performed according to OECD 210. Neither effects on hatching success no r behavioral and morphological changes were observed. Surprisingly, the only effect was a reduced survival in the two highest concentrations (50 and 150 μg/L PERACLEAN ® Ocean) in a time range 5 to 12 days post hatching which is considered to be a rather insensitive life stage of fish larvae. No dose dependency was observed.
The overall NOEC is consid ered to be 2.25 μg PAA/ L (Evonik Degussa GmbH 2007j).GESAMP-BWWG 5/9
ANNEX 7 Page 21

I:\MEPC\57\2-10.doc 2.2.4 Based on a specific study protocol (non-GLP), reco mmended by Washington State Department of Ecology, a 16-d ay fish embryo development test using pacific herring ( Clupea pallasi ) gametes with PERACLEAN ® Ocean was performed. The NOEC (e ndpoint: percentage of hatched larvae) was 1.9 mg PERACLEAN ® Ocean /L (0.29 mg PAA /L) (Evonik Degussa GmbH 2005b).

2.2.5 The NOEC for Macroystis pyrifera ( germination tube length) was 4 mg PERACLEAN ® Ocean /L (0.6 mg PAA/L). The species Skeletonema costatum was found less sensitive with an NOEC of 8 mg PERACLEAN ® Ocean/L (1.2 mg PAA/L) (Evonik Degussa GmbH 2005a).

2.3 – 2.6

No new information (refer to MEPC 53/2/12).

3 MAMMALIAN TOXICITY

3.1 Acute mammalian Toxicity

3.1.1 The Group noted that no additional informa tion for the acute mammalian toxicity of PAA 15% was submitted for Final Approval.

3.1.2 The predominant effect in all acu te toxicity studies is local irritation at th e site of contact. The extent depends on the concentration and the composition of the applied test solution.

3.2 Corrosion/Irritation

3.2.1 The Group noted that no additional info rmation for the corro sion/irritation of PAA 15% was submitted for Final Approval.

3.2.2 PERACLEAN ® Ocean should be considered severely corrosive to skin and eyes and severely irritating to mucous membra nes of the respiratory tract. The RD 50 for an aerosol generated from a product with a similar composition was 21.5 to 24.1 mg/m 3

.

3.3 Sensitization

3.3.1 The submitted information in Basic Approval showed that PAA 15% is not a sensitizer.

3.4 Repeated-Dose Toxicity

3.4.1 The Applicant stated that repeated dose st udies with diluted equilibrium PAA solutions
are relevant for PERACLEAN ® Ocean to which the Group is in agreement.

3.4.2 The Group considers that there are still concer ns to be clarified re lated to human exposure to PAA by inhalation under occupationa l situations (repeated exposure).

3.4.3 However, the Group is of the opinion that further animal testing are not required and therefore recommends that an occupational health medical surveillance plan according to the Guidelines on the Basic Elements of a Shipbo ard Occupational Health and Safety Programme (SOHSP), IMO, May 2006 should be implemented to address possible inhalation and dermal toxicity (irritation at the site of contact namely the resp iratory tract and sk in and secondary systemic effects namely impairment of lung and liver functions).GESAMP-BWWG 5/9
ANNEX 7 Page 22

I:\MEPC\57\2-10.doc 3.5 Developmental and reproductive toxicity

3.5.1 The Group evaluated a developmental toxic ity study performed according to OECD 414 (Müller 2005) submitted by the Applicant, in rats with 35% peracetic acid solution administered in drinking water and concluded th at the observed liver effects in fetuses were shown to be dose dependent (12.5, 30.4 and 48.1mg/kg bw/d ). No NOEL was derived as th ere was a slight effect at the lowest dose group.

3.6 Carcinogenicity

3.6.1 The Applicant states that due to the toxicoki netics, it is unlik ely that PERACLEAN ® Ocean is systemically available and the absence of a genotoxic potential in the majority of the genotoxicity studies, it is unlikely that the pro duct has a relevant carcinogenic potential for humans, and further testing is not warranted. However, according to existing and submitted information (JACC No40) there is still some con cern related to th e carcinogenicity potential of PAA acting as a tumor promoter. The observed eff ects are considered to be secondary to local irritation (Greaves and Barsoum, 1990).

3.7 Mutagenicity

3.7.1 The weight of evidence, in particular in the more recent studies in in vitro experiments in mammalian cell cultures, indicates that equilibri um peracetic acid does not have a significant genotoxic potential and does not cause gene muta tions and chromosomal ab errations both in the presence and absence of a metabolic activation system. Only in one chromosomal aberration

assay in vitro a positive result was obtained at highly cytotoxic concentrations. However, a

recent in vitro chromosomal aberration assay (JACC No40) did not show such an effect even at cytotoxic concentrations suggesti ng that the earlier findings may ha ve been an artifact. PAA did
not induce micronuclei in in vivo mouse micronucleus tests (Wallat Dr., 1984b) when administered by gavage up to the maximum tolera ted dose levels and did not induce unscheduled DNA synthesis in a recent rat in vivo UDS assays when administ ered by gavage up to the maximum tolerated dose level (Haddouck, 2002).

According to the above information, the Group concluded that PERACLEAN ® Ocean is unlikely to have a genotoxic or mutagenic potential.

3.8 Toxicokinetics

3.8.1 As it was referred in Basic Approval it is considered that PAA due to its intrinsic physical-chemical properties and in case of damage d skin can efficiently diffuse and be absorbed
in the cells of mucous membranes lining the gastrointestinal and resp iratory tract. This process is assumed not to induce target or gan toxicity, perhaps with excep tion of stomach – where pH is
around 2 and PAA can be stable – nor bioaccumu late as the parent compound will rapidly be absorbed, distributed in the body fluids and metabolized by catalases into HOAc and H2O and O2, being further eliminated by the differe nt routes (urine, faeces and exhaled air).

The Group concluded that the short rapid degrada tion limits the systemic availability of both peracetic acid and hydrogen peroxide.GESAMP-BWWG 5/9
ANNEX 7 Page 23

I:\MEPC\57\2-10.doc 4 ENVIRONMENTAL FATE AND EFFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

It has been already shown and discussed in th e application for Basic Approval (MEPC 53/2/12), that both active ingr edients of PERACLEAN ® Ocean, peracetic acid and hydrogen peroxide rapidly degrade under abiotic as well as under biotic conditions. Therefore, only some recently performed studies will be discussed here.

4.1.1 Degradation of PERACLEAN ® Ocean

4.1.1.1 The primary and ultimate biodegradability in seawater in the Shake Flask Test (OECD Guideline 306) was determined for PERACLEAN ® Ocean over a period of 28 days. Beginning of biodegradation (10% level) was observed after 10 days of adaptation time and the pass level (>50%) was reached after 12 days. Afte r 21 days, there was an almost complete mineralization. The elimination/primary degradati on of peracetic acid was rapid (after two days below limit of detection) corresponding with an elimination rate of >94%. The elimination of hydrogen peroxide reached 71% after 7 days and came to >88% (limit of detection) on day 14. Therefore, PERACLEAN ® Ocean is considered as ultimately biodegradable in seawater (Evonik Degussa GmbH 2007i).

4.1.1.2 In a non-guideline study performed by E nvironment Canada, degr adation of peracetic acid and hydrogen peroxide over 7 days at 6 °C wa s analytically investigated in dependence of salinity (0 - 27 PSU) and presence or absence of se diment taken from a ballast tank aboard the ship Canadian Provider . This sediment contained large amounts of rust particles and debris
from ballast tank corrosion. In unfiltered fr esh water, the concentration of PAA and H 2 O 2 was reduced by 30% and 12.5% after 7 days.

4.1.1.3 In the presence of sediment, PAA was degraded by 91% and H 2 O 2 by 62% after 7 days, respectively. In salt water (> 7 PSU), PAA and H 2 O 2 were degraded by 92 and 52%, respectively. In the presence of sediments, PA A became undetectable (< 0.5 mg/L) after 3 days and the degradation rate of H 2 O 2 was 93%. (DeLafontaine and Despatie 2006).

4.1.1.4 Large-volume (4.5 m 3 ) experiments with PERACLAEN ® Ocean were also conducted at very cold water temperatures (1 - 2 °C) in salt and fresh water. In the fresh water experiment, PAA degraded gradually down to 51 to 66% over the course of the test. In salt water, the detection limit was very high (10 mg/L) and de gradation could not been properly monitored. However, only at concentra tion of 300 mg/L PERACLEAN ® Ocean, levels above 10 mg/L were
observed. Levels of H 2 O 2 remained more or less stable in fresh and salt water over time until catalase was added which dropped the H 2 O 2 level down to zero under bo th, fresh and salt water
conditions. The levels found in fresh water were al ways higher than in salt water (DeLafontaine and Despatie 2006).

4.1.1.5 After addition of PERACLEAN ® Ocean, the average pH immediately dropped from 7.5 (fresh water control) to 6.7, 6.16 a nd 5.56 in the 100, 200 and 300 mg/L treated tanks, respectively. The average pH in salt wate r dropped from 8.2 (contr ol tank) to 7.3, 6.75 and 6.2 with the addition of 100, 200 and 400 mg/L PERACLEAN ® Ocean. The pH of the
treated waters remained stable over time and did not vary significantly. Very high levels of dissolved Oxygen were noted in all treated tanks acr oss both experiments. Furthermore, a concentration dependent increase of dissolved organic Carbon (DOC) wa s found, which can beGESAMP-BWWG 5/9
ANNEX 7 Page 24

I:\MEPC\57\2-10.doc ascribed to the Carbon introduced by peracetic acid and Acetic acid. However, that increase was
found less in salt water than in fresh wate r at the 100 and 200 mg/L treatment level (DeLafontaine and Despatie 2006).

4.1.1.6 Gregg and Hallegraeff inves tigated the degradation of PERACLEAN ® Ocean in filtered seawater (28.6 PSU and 23.7 PSU) at 17°C storage temperature using an indirect method by testing the effectiveness against vegetative microalgae in different seawater samples and different light
conditions. At concentrati ons of 200 mg/L PERACLEAN ® Ocean, PERACLEAN ® Ocean samples were found to degrade to a level non-toxic to marine microalgae with in 2-6 weeks. In the dark, degradation rate was lower even in pres ence of sediment (Gregg and Hallegraeff 2007).

4.1.1.7 The viability of the micr oalgae re-increased up to >90% within one (high salinity) or two weeks (lower salinity) post tr eatment. With sediment, the c ontrol level (100% viability) was achieved within one week. The performance of th e degradation test is not usual and questionable
because the authors did not measure the actual content of PAA and H 2 O 2 , e.g., by photometric determination. Therefore, it is not sure whether PAA and H 2 O 2 were actually still present or
whether the effects found were cau sed by other influences, e.g., th e pH-level, the presence of
nutrients or bacteria or the Oxygen content.

4.1.2 Conclusion

4.1.2.1 PERACLEAN ® Ocean is readily (bio)degradabl e under conditions according to the OECD guidelines. Peracetic acid showed a rapi d degradation especially in salt water and presence of sediment and light. Hydrogen peroxide degraded slower but, in presence of sediment and salt water, degradati on significantly increased.

4.1.2.2 In fresh water, both components are more stable especially under extremely cold conditions. Also, the presence of peracetic acid can be observed over a longer period of time. The presence of sediments facilitate s degradation in fresh water, too.

4.1.2.3 Under realistic conditions, it can be assumed that sediment, which is usually present in ships’ ballast water tanks, enhances degradat ion. When the ballast water is discharged, photo-degradation additionally occurs. Therefore, the actual environmental concentrations are most probably lower than measur ed under laborato ry conditions.

4.2 Partition Coefficients

4.2.1 From the n-octanol-water partition coeffi cients of the Active Substances PAA and hydrogen peroxide, the organic ca rbon normalized distribution coe fficient can be derived using the following equations according to the EU technical guidance document on risk assessment (EC, 2003).

For organic acids, the follo wing equation can be used:

log Koc = 0.6 log Kow + 0.32

For peracetic acid with a log Kow of -0.26 at pH 7 (Evonik Degussa GmbH 2007h), a log Koc of 0.164 (Koc = 1.45 L/kg) is derived.GESAMP-BWWG 5/9
ANNEX 7 Page 25

I:\MEPC\57\2-10.doc The following equation for non-hydrophobics may be used for hydrogen peroxide:

log Koc = 0.52 log Kow + 1.02

Using that equation, a log Ko c of 0.2 (Koc = 1.58 L/kg) was de rived for hydrogen peroxide (EU, 2003).

4.2.2 Both Koc values indicate a negligible ab sorption to organic matter which would also indicate a very low adsorption potential to soil a nd sediment. This is confirmed by the Mackay level equilibrium distribution (see docume nt for Basic Approval, MEPC 53/2/12).

Furthermore, it can be assumed that bioaccumulation for PERACLEAN ® Ocean is negligible.

4.3 Persistence and Identifica tion of Main Metabolites

No new information (MEPC 53/2/12).

4.4 Reaction with Organic Matter

4.4.1 In addition to the presented studies on disi nfectant by-products of peracetic acid in water treatment (see MEPC 53/2/12), Nurizzo et al . (2005) has published inve stigations of effluents from municipal wastewater treatm ent plant and surface water.

4.4.2 Only under extreme high bromide content (0.9 mg/L) and a high content of oxidizable organic carbon (3.2 - 4.9 mg/L), a distinct amount of aldehyde s was observed. No formation of
total tribromomethanes was obser ved under any condition (Nurizzo et al . 2005).

4.4.3 Additional laboratory findings indicate that no brominated and chlorinated phenol will be formed during waste water disinfecti on with peracetic acid (Dell’Erba et al. 2007; Kitis 2004).

4.4.4 For that reason, peracetic acid is gaining mo re and more interest as an alternative to replace other Active Substances in municipal waste water treatment plants.

4.5 – 4.7 Potential Physical Effects on Wildlife and Benthic Habitats

No new information (MEPC 53/2/12).GESAMP-BWWG 5/9
ANNEX 7 Page 26

I:\MEPC\57\2-10.doc 5 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES,
PREPARATIONS AND TREATED BALLA ST WATER IF APPLICABLE (Ref. MEPC 56/2/3, 2.3, table 2)

The relevant physical chemical properties were already presented in the application for Basic Approval (see MEPC 53/2/12). Some ne w data were determined in the meantime,
summarized in table 6.

Table 1: Physical chemic al properties of PERACLEAN ® Ocean

Property Value Reference/comment pH value (23°C) 0.39 (Evonik Degussa GmbH 2006a) relative density 1.122 (20°C) (Evonik Degussa GmbH 2006a) Kinematic viscosity at 20°C 1.77 mm 2 /s (Evonik Degussa GmbH 2006a) Kinematic viscosity at 40°C 1.13 mm 2 /s (Evonik Degussa GmbH 2006a)

6 OTHER INFORMATION

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

6.1.1 The quantitative reaction of peracetic acid (PAA) with met hyl ptolyl sulphide (MTS) yields the corresponding sulfoxide (MTSO). To prevent the react ion of the active ingredient hydrogen peroxide (H 2 O 2 ) with MTS, triphenylphosphine (TPP) is added. Analytical evaluation
of MTSO is carried out via LC-MS/MS on a reversed-phase column (C8) using acetic acid/methanol as mobile phase in gradient mode. Detection is carried out with an electrospray tandem mass spectrometer in positive mode using an external standard.

6.2 Material Safety Data Sheet provided: Yes

6.3 GHS Classification:

Acute tox 4 (inhalation, dermal, i ngestion), skin corrosion 1A (Hazard statement codes: H332, H312, H302, H314).

6.4 Risk Characterization

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ANNEX 7 Page 27

I:\MEPC\57\2-10.doc APPENDIX 2

DATA REQUIRED FOR EACH COMPON ENT OF THE PREPARATION AND
BY-PRODUCT PRODUCED IN BALLAST WATER

1 Chemical Name: HYDROGEN PEROXIDE

2 EFFECTS ON AQUATIC ORGANISMS

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

2.1.1 The aquatic toxicity data of hydrogen peroxide were alrea dy summarized in the application for Basic Approval (MEPC 53/2/12). No new information on acute aquatic toxicity on fresh water species (refer to MEPC 53/2/12).

2.1.2 Based on the intended use, some additiona l marine species were tested and the corresponding results on the effects of H 2 O 2 are summarized in Table 4.

2.1.3 A summary of the acute aquatic toxicity da ta for hydrogen peroxide on marine species is
shown in the table below:

Trophic
level Species Guideline Endpoint Result [mg/L] Reference

Rotifer Brachionus plicatilis Rotox ®

Manual EC 50 (24 h), static, mortality 4.8 (Evonik Degussa GmbH 2007k)
Bacteria Vibrio fischeri. MICROTOX
basic manual EC 50 (15 min),
luminescence 20.6 (Evonik Degussa GmbH 2007k)
Fish Solea solea
larvae OECD 203 LC 50 (96 h), static, mortality > 151 < 268 (Evonik Degussa GmbH 2007k)
Fish Solea solea juvenile OECD 203 LC 50 (96 h), static, mortality > 84 < 150 (Evonik Degussa GmbH 2007b) Oyster Crassostrea gigas EPA/600/R95/136 EC 50 (48 h),
static development 3.2 (Evonik Degussa GmbH 2007k)
Chaetocaros gracilis OECD 201 EC 50 (72 h) growth rate 3.2 (Evonik Degussa GmbH 2007k) Algae

Skeletonema

costatum OECD 201 EC 50 (72 h) growth rate 2.7 - 3.4 (Evonik Degussa GmbH 2007m)

2.1.4 The same study (Evonik Degussa GmbH 200 7k) informs about NOECs of the same organisms with lowest NOEC = 1.9 mg/L for algae.

2.1.5 In the ROTOX ® test kit, the EC 50 value was 4.8 mg/L. In the MICROTOX basic assay the
EC 50 found was 20.6 mg/L (Evonik Degussa GmbH 2007k).GESAMP-BWWG 5/9
ANNEX 7 Page 28

I:\MEPC\57\2-10.doc 2.1.6 In an acute toxicity study in fish la rvae, no mortality occurred up to 151 mg/L H 2 O 2

. But with a concentration of 268 mg/L, all larvae were found dead (Evonik Degussa GmbH 2007k). The juvenile fish ( Solea solea) was found more sensitive under same conditions
with a LC 50 between 84 and 150 mg H 2 O 2 /L (Evonik Degussa GmbH 2007b).

2.1.7 The development into D-larvae wa s inhibited with a corresponding EC 50 value of 3.2 mg

H 2 O 2 /L (Evonik Degussa GmbH 2007k). The two algal species – Chaetocaros gracilis and
Skeletonema costatum – showed comparable sensitivity towards hydrogen peroxide, resulting in
an EC 50 value of approximately 3 mg/L (Degussa 2007k; Degussa 2007m).

2.2 Chronic Aquatic Toxicity Data

2.2.1 In a 21-day continuous exposure study on Daphnia magna conducted by the USGS (United States Geological Survey, USA), the chr onic no observable effect concentration (NOEC) for reproduction was 0.63 mg H 2 O 2 /L and for mortal ity it was 1.25 mg H 2 O 2 /L (Meinertz et al. 2007; Vaughn 2006).

2.2.2 The results of toxici ty tests performed in different ma rine species are summarized in the following table:

Trophic
level Species Guideline Endpoint Results
NOEC [mg/L] Reference

Oyster Crassostrea gigas EPA/600/R95/136 NOEC (48 h), static development 2.8 (Evonik Degussa
GmbH 2007k)
Chaetocaros gracilis OECD 201 72 h chronic study, growth rate 1.9 (Evonik Degussa
GmbH 2007k) Algae

Skeletonema

costatum OECD 201 72 h chronic study growth rate 1 (Evonik Degussa
GmbH 2007m)
Fish Solea solea
larvae OECD 210 (adapted) 18 days, semi-static mortality, egg hatch, development 48 (Evonik Degussa
GmbH 2007l)

2.2.3 Hydrogen peroxide did not aff ect the development of oyster la rvae, in concentrations up to 2.8 mg/L (NOEC) (Evonik Degussa GmbH 2007k).

Of the two tested algal species – Chaetocaros gracilis and Skeletonema costatum – the latter showed sensitivity slightly towards hydrogen pe roxide, resulting in an NOEC of 1 mg/L (Evonik Degussa GmbH 2007k; Evonik Degussa GmbH 2007m).

2.2.4 In an 18-day fish embryo development test (Solea solea) with water renewal every 2 days, mortality, behavior, hatching suc cess and development were observed during the course of the test. In the highest concen tration of 148 mg/L no egg survived (day 6). At concentrations of 98 mg/L, hatching was not affected, but only 25% of the larvae survivedGESAMP-BWWG 5/9
ANNEX 7 Page 29

I:\MEPC\57\2-10.doc into free-swimming stage (day 6 to 10) and nearly all larvae died until day 18. Lower concentrations of hydrogen peroxide did not show any effects. Therefore, the NOEC can be set to 48 mg/L under conditions test ed (Evonik Degussa GmbH 2007l).

2.3 Conclusion

2.3.1 Algae were found as the most sensitive species towards hydrogen peroxide. These findings confirm previous studie s (e.g., EU Risk Assessment, 2003) . The toxicity of the oyster larvae was slightly lower than that of algae. This is in accordance with the results of fresh water invertebrates, already discussed in the applic ation for Basic Approval (MEPC 53/2/12). With a view to the test kits used, the sensitivity of the ROTOX ® assay is more comparable to that of the oyster larvae and algae than that of the MICROT OX basic assay. The fish larvae and juveniles were the less sensitive species, as expect ed, even in the long term study performed.

2.3.2 In the EU Risk Assessment (2003), a PN EC of 10 μg/L for hydrogen peroxide was derived. However, this value appears to be very conservative and is related to continuous long-term exposures. When deriving a tolerabl e level for hydrogen peroxi de in ballast water applications, some considerations about the chem istry and occurrence of the substance should be taken into account, already di scussed in the application fo r Basic Approval (MEPC 53/2/12).

H 2 O 2 acts as an oxidant and, therefore, its a dverse effects are only local and short term. Hydrogen peroxide is a normal metabolite in n early all organisms and naturally produced by sunlight in water. Therefore, almost all or ganisms are particularly well equipped in defense mechanisms against hydrogen peroxi de and other Active Oxygen species.

2.3.3 In seawater, the available natural concen trations – ranged from 0.5 to 14 μg hydrogen peroxide/L, in lakes values > 100 μg/L – were reported.

2.4 – 2.5: No information

3 MAMMALIAN TOXICITY

3.1 The Group considered that mammalian toxi city data concerning Hydrogen peroxide individually was not relevant for Huma n Health Risk Assessment of PERACLEAN ® Ocean as a full toxicological dataset was provided for the ch emical preparation as generated by the system.

4 OTHER INFORMATION

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

4.1.1 The quantitative reaction of hydrogen Peroxide (H 2 O 2 ) with potassium bis (oxalato) oxotitanate (IV) yields a yellowish peroxidet itan-complex with a maximum of absorption at 385 nm. Analytical evaluation of the complex is done spectro-photometrically using external standard (Evonik Degussa GmbH 2007i).

* * *GESAMP-BWWG 5/9
ANNEX 7 Page 30

I:\MEPC\57\2-10.doc APPENDIX 3

ADDITIONAL INFORMATION REGARDING THE SEDNA ® USING PERACLEAN ®

OCEAN BALLAST WATER MANAGEMENT SYSTEM (EVONIK DEGUSSA GmbH)

During the fifth GESAMP BWWG meeting, the Group had the followi ng questions to the applicant:

1 Active Substance, Relevant Chemicals

1.1 Does the preparation contain any stabilizers?

“ YES, PERACLEAN ® Ocean contains a mix of acids as stabilizers......... (Section deemed to be confidential and removed at the request of the submitting Administration.) ......... The total concentration of additives is below 1% .”

1.2 How do you maintain a concen tration of 150 mg/L PERACLEAN ® Ocean in the tanks? Is there any monitoring device? Please deliver information.

“ The concentration of Peraclean Ocean in the st orage tank is stable (15% PAA + 14.3% H2O2) throughout at least one year. After that a slow loss of activity occurs

. The ballast Water is mixed with 150 mg/L Peraclean Ocean at uptake via the described automated volumetric dosing

unit

. The dosing of Peraclean Ocean is adjusted to the actual flow of the ballast water at any time during the entire ballast water operati on (see pages 21 to 26 of the Technical Manual)

. Once the treated ballast water entered the ballast water tank the active components are degraded as described in the application for Final Approval .”

1.3 Is 150 mg/L the maximum allowable discharge concentration?

“ The addition of 150 mg/L PERACLEAN ® Ocean during ballast water uptake means a concentration of 22.5 PAA and 21.5 mg/L H2O2, respectively

. The concentration of the main active ingredient Peracetic Acid at discharge s hould be <1 mg/L

. Half-life was 3.5 and 4.5 hrs depending on the salinity.

As measured during the land based testing at NIOZ, PAA could no longer be detected after less
than 20 hrs

. For H2O2, the bacteriostatic com pound, the half-life were 19.5 and 24 hrs, respectively

. At discharge the concentration of Hy drogen peroxide should not exceed 12 ppm

.

These concentrations provide that the PNEC values confirmed by GESAMP in
document MEPC 54/2/12 are not exceeded taki ng into account dilution an instantaneous degradation. ”GESAMP-BWWG 5/9
ANNEX 7 Page 31

I:\MEPC\57\2-10.doc 2 Human Health

2.1 The Group wants to understand where hum an exposure could occur, even though the system is fully automated.

“ The risk of any human exposure is minimized by multi level Risk Mitigation Measures (RMM ; see pages 27 to 32 of the Technical Manual). Even the filling of the Peraclean Ocean storage tank is fully automated (see pages 43 to 46 of the Technical Manual). Furthermore, the valve between the supply hose and the storage tank is especially designed for this purpose and prevents even dropping when the hose is disconnected after discharge. The storage tank itself is in a separate room which must not be entere d by crew members or other human beings (see additional information provided by attached manual extract). ”

2.2 Exposure assessment: What were the input parameters and which model was used for human exposure, as we cannot trace TnG, 2002, Model 7?

“ The highest inhalation expos ure expressed as mg Pera cetic acid/m3 was found during mixing/loading, i.e

., during pouring and filling procedures. The estimated amount was 0.0435 mg/m3 without respiratory protection. The inhalation exposure during this operation is, thus, well below the propos ed occupational exposure limit of 0.6 mg Peracetic acid/m3 and corresponds to about 7.25% of the OEL if no respir atory protective equipment (RPE) is used. For the use of diluted disinfection solutions during the application, inhalation exposure of workers/operators towards Peracetic acid dur ing application and post-appl ication of diluted Peracetic acid does not occur the exposure and accompanying risk assessments performed for industrial uses of Peracetic acid as a disinfect ant demonstrated that the proposed OEL of 0.6 mg/m3 which was derived from a se nsory irritation study performed by Gagnaire et al (2002), is not exceeded for the intended industrial use without taking into consideration any form of respiratory protection .”

2.3 Could we have any available sub-chronic inhalation toxicity studies e.g., 28 or 90 days please?

No answer.

3 Ship safety

3.1 The Group strongly requests drawings of th e system for further consideration of the
submission. These should cover:

- An overall drawing showing the installation components
- Installation of the tanks - Piping and venting - Possibly you have an installation manual, which you can deliver.

“

A 3-D drawing of the installation on the test sh ip is attached. Furthe rmore, the attached extractions of the Technical Manual contain more de tailed descriptions of individual sections of
the SEDNA ® System, especially the PERACLEAN ® Ocean section. All of this information has to be treated strictly confidential. The drawing of the installation as approved by the competent authority “ Germanischer Lloyd ” follows ASAP but has to be treated absolutely confidential. ”GESAMP-BWWG 5/9
ANNEX 7 Page 32

I:\MEPC\57\2-10.doc 3.2 Did you plan to install a cooling system for the storage tanks, in case temperatures exceed
the 35oC limit?

“ YES, the control of the temperature is part of a multi level risk mitigation scheme, which has been approved by Germanischer Lloyd for this specific BWT system. The risk mitigation measures include, but are not li mited to, the following points:

(1) The operating manual of the SEDNA ® System includes detailed risk mitigation measures for the storage and handling of PERACLEAN ® Ocean which are based on the Guideline for storage of PERACLEAN ® Ocean that has been developed by Evonik Degussa GmbH (see attached “ Evonik Degussa GmbH 2007n Concept for storage onboard ships ” ).

(2) As a standard feature of ALL SEDNA ® Systems, the PREACLEAN ® Ocean tank room is equipped with an active coolin g system (air-conditioning). Separate temperature sensors monitor the temperature of the PERACLEAN ® Ocean inside of the tank as well as the air temperatur e in the tank room. The air-conditioning and the temperature sensors are fully implemented in the PLC steering of the
SEDNA ® system. ”

3.3 In case of toxic fumes development, how are the aeration and de-aeration valves regulated (e.g., by pressure) and where will the gases be released?

(1) “ Moreover the above risk mitigation measures, an active ventilation system that allows a minimum of 10-folt exchange of the tank room volume per hour is installed with every PERACLEAN ® Ocean tank system.

(2) The ventilation system will start automatically, when a temperature of 35°C is
reached in the tank room.

(3) The air from the tank room is released in places where they can not harm crew members. The exact location depends on the installation details of the specific ship and is subject to plan approval of the class as it is a mandatory part of the risk mitigation system.

(4) If the tank temperature re aches 40 °C a tank spraying de vice (sprinkler) is started to condense vapors and cool down the tank. Furthermore, a signal is given to the vessels central alarm system via potential- free contact. Generally, the design of the tank and dosing facilities, the locati on and the safety features depend on the conditions of the individual vessel and they have to be decided in co-operation
with the relevant authorities and the classification society. ”

3.4 Corrosion test: Was PERACLEAN ® Ocean also added to the s eawater at a concentration of 200 mg/L daily?

“ Yes, PERACLEAN ® Ocean was added daily (working days) at a concentration of 200 ppm. ”GESAMP-BWWG 5/9
ANNEX 7 Page 33

I:\MEPC\57\2-10.doc 3.5 Why were the immersion tests carried out under aeration and with artificial seawater?

Answered by Germanischer Lloyd :

“

Artificial seawater according to ASTM D 1141-98 has been used to have a standardized test solution, since in both test solutions (with and without PERACLEAN ® ) the same test conditions are needed to compare them. Ae ration has been used because it is stated in ISO 2812-2 and to accelerate the amount of oxygen, which leads to stricter test conditions due to higher corrosion. Accord ing to our experience anaerobic corrosion is not the dominant type of corrosion in ballast tanks .”

3.6 The Group has concerns regarding the layer formation and shallow pit formation of the uncoated steel panels especially in the gas phase, plus the increased corrosion rate after addition
of PERACLEAN ® Ocean. One of the results was that PERACLEAN ® increases the corrosion rate of uncoated steel especially of the test panels in the gas pha se, which were immersed in the test solution (with and without PERACLEAN ® ). Can you please explain?

“ Generally, it should be considered that PERACLEAN ® Ocean is a strong oxidant. Therefore the main concern was to check whether there could be an oxidative break-down of common ballast tank coatings or any other any negative effect such as on blistering, corrosion, discoloration,
adhesion or hardness.

Regarding aeration and the use of artificial seawater, here is a comment from Dr. Marcel Veldhuis, Royal Netherlands Inst itute for Sea Research (NIOZ):

“ This answer to the above indicated question relate to additional exp eriments conducted during the G9 and G8 certification procedure as conducted in the harbor of NIOZ under the supervision of th e BSH in spring and early summer of 2007. Experiment conducted at NIOZ showed that the addition of 150 mg/L of PERACLEAN ® Ocean significantly increased the concentration of dissolved oxyg en in the treated ballast water. When the active ingredients (Peracetic acid and Hydroge n peroxide) were degraded, the growth of heterotrophic bacteria started. As a result of bacterial growth, the oxygen concentration started to decline. Extreme low oxygen levels, resulting in anoxic conditions, can only be expected after >> 5 days of retention time. Ty pical anoxic conditions are accompanied by the production of the gas H2S, which has a typical smell. But during the tests we did observe this only in the contro l tank which contained a high sediment load. In contrast, the treated tanks were almost free of sedi ment and the oxygen level never dropped to <10% of the saturation value. Considering th e elevated oxygen level in the treated water and the fact that PERACLEAN ® Ocean eliminates almost all the natural bacterial population, it is highly unlikely that there will be an anaerobic corrosion or a growth of bacteria responsible for corrosion. ””

4 Risk to the aquatic environment (PEC/PNEC)

4.1 Can you please deliver more de tails about your PEC calculations?

“ Carrying out the emission scenario the applicant used the principle described in BLG 11/4/15. In order to also satisfy the recommendations provided in document BLG/11/4/11 the Port of Richards bay was chosen allowing to also descri be an acute scenario. All details were sent to GESAMP for consideration and are attached as annex 1. ”GESAMP-BWWG 5/9
ANNEX 7 Page 34

I:\MEPC\57\2-10.doc Worst Case Scenario Calculation :

Calculating the figures for the harbor of Ric hards Bay the total release of H2O2 is 434 tons/year (assuming that all the ballast wate r contains 21 mg H2 O2/L). This would generate a concentration of 1.66 mg H2O2/L, if no degrada tion at all took place. Considering just one day with 4.75 incoming ships and 56,616 tons ballast water on average, the resulting H2O2 concentrati on in the port area would be 0.0045 mg/L (=PEC). The PNEC of 0.010 mg/L for H2O2 is very conservative (related to continuous long term exposures) and derived from the EU Risk Assessment in 2003 (see Chapter 2.5.3, page 10 of th e submission for Final Appr oval) In consequence the PEC/PNEC ratio after one day is 0.0045/0.01 = 0.45. The following calculation describes the build-up of H2O2 in the harbor water. According to the results of the land-based testing (salinity 22 PSU, temperature 15.6°C), the half-life of H2O2 is estimated at 24 hrs. This approach can be consid ered as conservative since the trials at
NIOZ were conducted in cleaned tanks and a fter filtration of the water by the SEDNA ® system. Under realistic har bor area conditions the degradation is significantly accelerated by suspended solids, sediment s and sunlight. The following figure on page 3 of Annex 1 illustrates that even after one year, the build-up of the peroxide concentration in the harbor does not exceed a level of 0.009 mg/L. Using that level as PEC, the
PEC/PNEC ratio will be 0.009 / 0.010 = 0.9. Comparing the cu mulative value of 9 μg/L with naturally occurring Hydrogen peroxide found in seawater (0.5 to 14 μg/L, see EU Risk Assessment, 2003), they are in the same range. ”

4.2 The Group has concerns regarding the envir onmental exposure scenario (PEC). Did you run a model for the discharge of ballast water like MAM-PEC?

“

A model for discharge using MAM-PEC was r un in connection with the application for Basic Approval. Since several experts confirmed that this or other existing models are not appropriate for Ballast Water Emission Scenar ios (see BLG 11/16 §4.26) the applicant drafted an ESD along ideas developed and adopted at BLG 11 and MEPC 56.

The ESD provided for the Basic Approval dossier is calculated as daily instantaneous discharge of treated Ballast Water just treated without any degradation of the Ac tive Substance by various ship types throughout one year. In order to fulfill the requirements to also consider an acute ES from one ship along the berth as well as possibl e chronic emission by la rge bulk carriers (see attached BLG 11/4/11), the port of Richards Bay was chosen for the ESD in the current application for Final Approval. ”

4.3 The Group does not understand the units being used in tables 1 and 7 of your application
dossier. Is it % treated BALLAS T WATER or mg PAA/L in table 7, or is mg PAA/L in table 1 correct? Is there any relati on between table 1 an d 7? And if yes, how do they relate?

“ There is a direct correlation between the tabl es 1 and 7 in the Final Approval document. The data figures for table 7 ar e directly taken from the “ deLafontaine 2006 ” publication (Tables in appendix) or table 1 the figures for 2 h reten tion time were used (assumi ng that there is no or only very low degradation in fresh water in the first 2 h at this low temperature) and transformed from %TBW to mg PAA/L .”

***GESAMP-BWWG 5

I:\MEPC\57\2-10.doc ANNEX 8

REVIEW OF PROPOSAL FOR BASIC APPROVAL OF ACTIVE SUBSTANCE

OceanSaver ® Ballast Water Management System

Submitted by Norway

0 SUMMARY

0.1 The Group agreed to recommend that Basi c Approval be granted to the OceanSaver ® Ballast Water Treatment System submitted by Norway.

0.2 The group noted that the OceanSaver ® Ballast Water Treatment System comprises a number of different processe s, which include cavitation, ni trogen super-s aturation and disinfection by electrochemical tr eatment. The application indicates that the sequence of the different treatment elements may be varied. In any application for final approval, the Group would require a definite configurat ion to be submitted for evaluation.

0.3 The group is mainly concerned with any configuration in which the system uses electrochemical treatment, as this would produc e Active Substances and by-products, as well as the nitrogen treatment which reduces oxygen con centration in the ballast water and requires mitigation procedures prior to discharge.

0.4 If the original intention of the applican t was to apply physical treatment (filtration, cavitation, and nitrogen purging) to reduce the need for st erilization through electrochemical treatment, this is not reflected in lower chlorine concentrations dosed to the ballast water with this system, which are within the range of those used by other electrochemical systems submitted for Basic Approval.

0.5 Where the use of Nitrogen is concerned, the Group considers that hi gh nitrogen levels and subsequent oxygen depletion in the headspace of ballast tanks could form a hazard to human health and that deoxygenated ballast water co uld form a hazard to the environment unless adequately oxygenated prior to discharge.

0.6 Bromoform concentrations as representative of disinfection by-products and measured in
fresh and stored ballast water were at levels similar to those observed in other ballast water management systems based on electrolysis.

0.7 The applicant claims that TRO had disappeared in less than 24 h. However it needs to be explained why the reported ecotoxicity tests all showed toxicity even 5 days after treatment.

0.8 The applicant provided information on an initial dilution model as part of the
environmental risk assessment but was unable to calculate a PEC value. The Group strongly recommends that the applicant wi ll provide a complete environmen tal risk assessment as part of an application for Final Approval.

0.9 The Group considered that the mitigation steps included in the applica tion i.e., re-aeration prior to discharge would be an important factor , in reducing the discharge concentrations of a variety of Active Substances and by-products.GESAMP-BWWG 5/9
ANNEX 8 Page 2

I:\MEPC\57\2-10.doc 1 INTRODUCTION

1.1 The data for this product were extracted from the submission of Norway to MEPC (MEPC 57/2/5) and the application dossier.

2 COMPLETENESS OF THE DOSSIER

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

.1 Technical information about the nitrog en generator, ballast water filter, C3T Hydro Cavitation unit, C2E Elect rolyte unit including drawings. Furthermore, the submission included specifications for prototype operation, a safety manual, installation procedures, a ballast water management plan and additional background information re garding hydrodynamic cavitation.

.2 The applicant submitted test results for acute ecotoxicity on one marine algae and fish larvae. A test using a simila r electrochemical unit to OceanSaver ® was used to assess chronic toxicity to Daphnia.

.3 Furthermore, the submission includes a de tailed chemical analysis of Active and
Relevant chemicals created by electrolytic disinfection.

2.2 However, the Group noted that some information was not submitted:

.1 The Group found that the applicant had not performed an appropriate human health risk assessment taking into account the Human Exposure Scenario (MEPC 56/2/2, annex 9; GESAMP B WWG 4, 7.1), having only submitted
information related to hazards iden tification (Active Substances and Relevant Chemicals).

.2 No information was delivered about the gas sensors and the possible development of hydrogen and chlorine gas by the electrochemical system.

.3 Corrosion tests were carried out with the nitrogen saturated water; no information was provided for the system as a whole.

.4 The Group noted that no Quality Assurance Project Plan for chemical analysis and ecotoxicity testing was available.

.5 The applicant provided no estimate of the PEC.GESAMP-BWWG 5/9
ANNEX 8 Page 3

I:\MEPC\57\2-10.doc 3 DESCRIPTION OF OCEANSAVER ® BALLAST WATER MANAGEMENT SYSTEM

3.1 Overview of the system

3.1.1 The applicant proposes a combined ballast water management system (BWMS) that applies pre-filtration, cavitation, n itrogen super-saturation and elec trochemical disinfection as its main working principles.

3.1.2 The Mechanical Filtration Un it used includes an automatic back flushing process, which removes trapped residue (particles, organisms) >50 μ m. Discharge following back-flushing takes place only when the filter is in use at the location of ballast water uptake.

3.1.3 The hydrodynamic cavitation unit (C3T Unit) is a specia lly designed ci rcumferential hydrodynamic cavitation chamber which is able to generate, harness and control intense pressure pulses arising from cavitation. The cavitation involves formation and implosion of cavitation bubbles and thereby generates forces and shockwaves, whic h affect particles and or ganisms in the water.
The dimensions of the cavitat ion unit have been optimized to effectively break down micro-organisms having a size of larger than 10 μm, but also organism s outside this range
will be affected.

3.1.4 The electrochemical disinfection unit (C2E Unit) produces electrochemically activated water by generating controlled am ounts and variations of Active S ubstances in situ in a side stream of the main ballast water stream (t ypically <0.5% by volume) without adding any additional chemicals to the water. The Group not ed that the prototype was operated at 0.2% by volume. The treated water is re-injected into th e ballast water line. Other than the main ballast water stream there is also a possibility of using other sources of water like an external source of brine or saltwater or bypasse d water, presumably for operation in fresh water.

3.1.5 The nitrogen (N 2 ) super-saturation unit is provided for the injection of nitrogen (N 2 ) gas into the ballast water. Nitrogen may be injected in to all or a part of the water flow (typically less than 15% of the total water flow) with the main criteria being that the nitrogen is injected in
sufficient amounts to ensure that the treated water when reaching the ballast tanks is super-saturated with nitrogen to a level of around 120-135%. This way dissolved oxygen is reduced in the ballast water down to <2.5 mg/L leading to hypoxic conditions and preventing re-growth of organisms that are dependent on ox ygen for their survival. The Group noted that a side stream for nitrogen inj ection was not indicated in the system specification and that
furthermore there was an indication in the dossier of applying nitrogen gas directly into the
ballast water tanks. Th is needs further clarification. The Group noted that the positioning and exhausting of the nitrogen gene rator might require attention.

3.1.6 The Group noted that the system may be run in different configura tions depending on the level of treatment required and the particular pr operties of the ballast water. For example:

.1 Filter/C3T/C2E/N 2 Super-Saturation

.2 Filter/C2E/N 2 Super-Saturation

.3 Filter/C3T/N 2 Super-Saturation

.4 Filter/C3T/C2E (or C2E/ C3T).GESAMP-BWWG 5/9
ANNEX 8 Page 4

I:\MEPC\57\2-10.doc However, for the evaluation of the system the Group is only concerned with the functioning of the electrochemical unit, as this is the only pa rt using Active Substances . In considering an application for Final Approval the Group would also consider the e ffects of discharging de-oxygenated ballast water on the environment.

Figure 2: The OceanSaver ® BWMS main Components: Water flow at uptake of Ballast Water. (Mechanical filter, C2E unit and nitrogen super-sa turation are not used at ballast water discharge)

3.1.7 The Group noted that the treated water is ae rated during ballast water discharge to avoid discharge of hypoxic water and that the discharge water is also treated with the C3T cavitation unit. The Group was unable however to find details and data on either of the above statements.

3.1.8 The submission informs that the principle pro cess of the electrochemi cal activation unit is that of applying an electric potential differen ce between two electrodes to the water flow separated by a membrane/diaphragm (electrodial ytic process). The ion selective membrane separates the anolyte and the catholyte flows and forms metastable ions and free radicals. In conventional electrolysis, hypochlorous acid is the dominant stable constituent formed. In this application the anolyte has superior sterilizing and disinfectant propert ies, since the reactive species present in the solution are more effective in destroyi ng micro-organisms and organic molecules than chlorine alone. The catholyte e ffluent is alkaline (pH ~10-12) and the anolyte effluent is acidic (pH ~ 2.4-4). The pH in the anolyte may be adjusted by mixing some or all of the catholyte into the effluent. In the C2E unit a pproximately 50% of the catholyte is mixed with the anolyte resulting in a pH aroun d 3 before the side stream is injected into the ballast line. Catholyte is re-circulated in th e cell avoiding waste issues. Fr om the point of view of the production of by-products the Gro up could see no distinction betw een this system and others using electrolytic disinfection. If this unit is i ndeed more efficient, then the Group would have expected to see lower dosing levels.GESAMP-BWWG 5/9
ANNEX 8 Page 5

I:\MEPC\57\2-10.doc 3.1.9 The submission informs that th e ratio between the overall amou nt of water and the amount of water flowing into and out of the electrochemical ac tivation cell is nearly constant, th us the dosage of the C2E disinfectant by volume is constant. Any necessary alterati ons regarding the concentration of Active Substances in the disinfectant produced ov er the cells are achieved by changing the level of applied electrical current (amper age) and adjusting the injection of catholyte. Changes to the necessary settings ar e indicated by comparing the O xygen Reduction Potential (ORP), Free Available Chlorine levels and pH measured in a calibration loop to measurements taken from a monitoring point downstream of the injection point (main ballast line). The ranges for desired values of ORP and FAC may be 350 – 800 mV and 0.05 – 2 mg/L, respectively, but more preferably 350 – 550 mV and 0.5 – 1.5 mg/L.

As the ballast water is stored for a period of time after treatment, this allows for the Active Substances from the product of the electrochemi cal activation cell to have full effect on any micro-organisms and other unwanted matter in the water. Experience ha s verified the short duration in which these characteristic values (O RP/ FAC) are elevated. FA C levels are typically
halved within 6 – 8 hours.

3.2 Active Substances, Relevant Chemicals and Other Chemicals

3.2.1 Active Substances

Treated water Hi g h salinit y 34 PSU Brackish water
17 PSU Surface water
20 PSU total chlorine (Cl 2 ) mg/L 1010 870 970 free chlorine (Cl 2 ) mg/L 980 800 930 combined chlorine (Cl 2 ) mg/L 30 70 40 ozone (O 3 ) mg/L 13.7 5.4 10.9 hydrogen peroxide (H 2 O 2 ) mg/L 2.7 2.1 3.6

3.2.2 Other Active Substances

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

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

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

ozone 10028-15-6 47.998 O 3

chlorine dioxide 10049-04-4 9191 69.5 ClO 2GESAMP-BWWG 5/9
ANNEX 8 Page 6

I:\MEPC\57\2-10.doc 3.2.3 Relevant chemicals

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

bromoform 75-25-2 2515 252.731 CHBr 3

dibromochloromethane 124-48-1 2810 208.290 CHBr 2 Cl

dichlorobromomethane 75-27-4 8027 163.83 CHBrCl 2

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

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

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

3.2.4 Other chemicals

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

nitrogen gas 7727-37-9 1066 28.013 N 2

4 HUMAN HEALTH ASSESSMENT

4.1 The Group noted that the Active Substances and Relevant Chemicals produced in the
OCEANSAVER ® BWMS can be toxic to humans. The liquid solution produced by the C2E unit
contains chemical formulations that can be irritating to eyes, skin and digestive tract.

4.2 In many electrochemical processes involving saline water, hydrogen gas may be formed. There is no release of any produced gas from the process to the atmosphere. The unit is ventilated as a safety precaution in case of leak age and also due to cool ing purposes. Integrated gas detectors will detect any gas leakage. In th e case of gas detection or pressure loss in the pressurized system, the electrical supply will be disconnected auto matically and thus, the system
will shut down.GESAMP-BWWG 5/9
ANNEX 8 Page 7

I:\MEPC\57\2-10.doc 4.3 The Group noted that the system is further protected by limiting the electrical supply to the electrodialytic cell as a function of thei r flow capacity making it impossible to build up explosive atmospheres (concentrations above 4% hydrogen). Note also that the tanks when filled
are also inerted due to the nitr ogen super-saturation feature.

4.4 The applicant states that the C2E unit produ ces disinfectant on dema nd in a pressurized enclosed closed circuit; therefore there are no handling or storage issues. There are safety measures built into the system in case of failure causing leakage and thus the potential exposure to humans. In case of leakage, th e system will automatically shut down.

4.5 The Group noted that the appl icant had delivered a list of safety precautions, hazard identifications, emergency measures and first aid instructions.

4.6 The Applicant informs that there is a danger to ship, crew and shore personal of nitrogen gas escaping or migrating into spaces as follows : ballast tanks, air ventilation pipes from tanks, cable trunks, nitrogen generating area, pi ping and electrical cable penetrations.

Taking the above into consideration, the Group recommends that for Final Approval, the Applicant should submit the BW TS Human Exposure Scenario (HES), namely to address nitrogen exposure as there is an identified risk in several areas adjacent to a nitrogen-filled space.

4.7 The Group concluded that chlorinated and brominated disinfection by-products are the toxicologically relevant compounds generated by the electrochemical process (C2E unit) as they have a potential for uptake an d human genotoxicity/carcinogenici ty concerns; therefore they will have to be kept below toxicological cri tical levels (bromoform <100 μg/L, Ref. WHO, Guidelines for drinking water quality, 2003).

4.8 The Group recommends that for Final Approva l description of the operation units where human exposure can take place should be subm itted according to HES (MEPC 56/2/2, annex 9).

5 RISK TO SAFETY OF SHIP

5.1 The Group noted that two different corrosi on tests for nitrogen saturated water were carried out by the applicant: one co ated test panel exposure in a ballast tank on bo ard of a ship,
and a lab test. Both tests were carried out with de-oxygenated water (nitrogen saturation) and
untreated seawater. In the lab test no differe nce between de-oxygenated and untreated seawater regarding coating performance has been observed. The untreated s eawater test showed a higher anode consumption and elec trical current demand.

5.2 The Group noted that results from indepe ndent full scale testing suggest that the
OCEANSAVER ® BWMS largely eliminates potential creep corrosion in ballast tanks.

5.3 The Group noted that no corrosion tests were carried out with the complete OceanSaver ®
treated ballast water, which would include electrochemical activation and cavitation.GESAMP-BWWG 5/9
ANNEX 8 Page 8

I:\MEPC\57\2-10.doc 6 RISKS TO THE AQ UATIC ENVIRONMENT

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

6.1.1 The P criterion

None of the Active Substances or the Relevant Chemicals has a half-life exceeding 60 days in marine water. Subsequently, there is no Active Substance or Relevant Chemical within the
OCEANSAVER ® BWMS that fulfils the P criterion for being persistent.

6.1.2 The B criterion

6.1.2.1 Based on the log K
ow values provided in the appendix (section 4.2.2) it may be concluded that only for the substance 2,4,6-tribromophenol a slight bioaccumulation potential may be expected.

6.1.2.2 The Group concluded that none of the chos en Active Substances or Relevant Chemicals can be addressed as being bio accumulative.

6.1.3 The T criterion

To fulfill the T criterion the NOEC value of the s ubstance shall be <0.01 mg/L. According to the ECOTOX database search presented in Section 4, only chlorine fits that criterion with an LC 50 for the Acartia tonsa of 5 μg/L.

6.1.4 Conclusion

The Group concluded that none of the Active S ubstances or Relevant Chemicals should be classified as a PBT compound.

7 ASSESSMENT OF TREATED BALLAST WATER

7.1 Concentrations of Active Substances and Relevant chemicals in the treated ballast

water

7.1.1 Residual oxidant level

7.1.1.1 The Applicant has carried out measuremen ts of free and total re sidual oxidants in the treated ballast directly after treatment and at discharge (5 days) from a small-scale installation (35 m 3 /h). Oxidant decay was monitored followi ng treatment of seawater with water qualities corresponding to the requirements in the G8 guideline (int ermediate salinity). Three tests were carried out with varyin g dosages of anolyte of 3, 6, and 9 L/m 3 , whereas the latter two correspond to the dosage that is used in the full-scale version. No TRO and Free
oxidant was detectable after <24 hours.

7.1.1.2 Further tests carried out showed simila r results with rapid decay of TRO and Free oxidants in less than 6 hours. In water samples from the surface layer of the Oslo fjord and low content of organic compounds and particles, low le vels of oxidants were detectable after more
than 24 hours.GESAMP-BWWG 5/9
ANNEX 8 Page 9

I:\MEPC\57\2-10.doc 7.1.2 Measurement of by-products and relevant chemicals

7.1.2.1 The Group noted that the applicant has determined the formation of disinfection by-products and relevant chemicals in a land-based installation (>200 m 3 /h) directly after treatment and after 5 days of storage. The following table shows the results of treated and
untreated water:

Chemical Name Control day 0 Control day 5 Test day 0 Test day 5 μg/L μg/L μg/L μg/L

AOX 29 <500 386 1290
EOX <50 <50 <50 <50 2-monochlorophenol <0.1 <0.1 <0.1 <0.1 3- monochlorophenol <0.1 <0.1 <0.1 <0.1 4- monochlorophenol <0.1 <0.1 <0.1 <0.1 2,3-dichlorophenol <0.1 <0.1 <0.1 <0.1 2,4+2,5-dichlorophenol <0.2 <0.2 <0.2 <0.2 2,6-dichlorophenol <0.1 <0.1 <0.1 <0.1 3,4-dichlorophenol <0.1 <0.1 <0.1 <0.1 3,5-dichlorophenol <0.1 <0.1 <0.1 <0.1 2,3,4-trichlorophenol <0.1 <0.1 <0.1 <0.1 2,3,5-trichlorophenol <0.1 <0.1 <0.1 <0.1 2,3,6-trichlorophenol <0.1 <0.1 <0.1 <0.1 2,4,5-trichlorophenol <0.1 <0.1 <0.1 <0.1 2,4,6-trichlorophenol <0.1 <0.1 <0.1 <0.1 3,4,5-trichlorophenol <0.1 <0.1 <0.1 <0.1 2,3,4,5-tetrachlorophenol <0.1 <0.1 <0.1 <0.1 2,3,4,6-tetrachlorophenol <0.1 <0.1 <0.1 <0.1 2,3,5,6-tetrachlorophenol <0.1 <0.1 <0.1 <0.1 pentachlorophenol <0.1 <0.1 <0.1 <0.1
trichloromethane/chloroform <0.3 <0.3 <0.3 <0.3
tribromomethane/bromoform <0.2 0.822 385 398
dibromochloromethane <0.1 <0.1 14.7 17.8
dichlorobromomethane <0.1 <0.1 0.297 0.337
tetrachloromethane <0.05 <0.05 <0.05 <0.05
tribromomethane 0.03 0.29 170 170
trichloromethane <0.05 <0.05 <0.05 <0.05
dibromochloromethane <0.02 0.02 4.2 4.5
dichlobromomethane <0.05 <0.05 0.13 0.11
trichlorethane <0.3 <0.3 <0.3 <0.3
tetrachloroethane <0.05 <0.05 <0.05 <0.05
tribromoethane? <0.05 <0.05 1.5 1.4GESAMP-BWWG 5/9
ANNEX 8 Page 10

I:\MEPC\57\2-10.doc 7.2 Acute and chronic toxicity of treated ballast water

7.2.1 The Group noted that initial ac ute toxicity tests w ith C2E unit (electrochemically) treated ballast water was carried out by th e applicant. Four tests with Skeletonema costatum and
two tests with Scophthalmus maximus were carried out. The applicant states that acute toxicity
tests were carried out from full scale la nd-based tests with a salinity of 35 PSU.

FCA Species Salinity [PSU] Days
after

treatment Concentration of
treated water References/
Comments

A Skeletonema

costatum 35 0 NOEC: <10%
EC 50 : 18% NIVA 2007, reports 502 File 2 chapter 1

A Skeletonema

costatum 35 5 NOEC: 32%
EC 50 : 55% NIVA 2007, reports 500 File 2 chapter 2

A Skeletonema

costatum 35 0 NOEC: 3.2%
EC 50 : 11% NIVA 2007, reports 499 File 2 chapter 5

A Skeletonema

costatum 35 5 NOEC: 56%
EC 50 : >100% NIVA 2007, reports 501 File 2 chapter 4

F Scophthalmus

maximus 32 0 96 h, semi-static 1)

NOEC: 10%
LC 50 : 13.4% NIVA 2007, report 499; File 2 chapter 3

F Scophthalmus

maximus 32 1 96 h, semi-static 1)

NOEC: 18%
LC 50 : 32% NIVA 2007, report 499B; File 2 chapter 6

1) semi-static: 1 complete water exchange per day

7.2.2 The Group noted that samples taken imme diately after electrochemical treatment (C2E unit, day 0) show aquatic toxi city as do samples after 5 days.

7.2.3 The applicant further states that full toxicity assessment will be provided for the final approval.

7.2.4 The applicant further submitted acute toxicity studies with Daphnia magna of a similar system comparable to the C2E unit in the OCEANSAVER ® BWMS, which has been performed by the Institute of Chemistry at Ta llinn Technical University (Munter et al. 1999). Initial free
active chlorine concentr ations were ~350 and ~500 mg/L anol yte. No acute effects were found for the anolyte diluted by 1:500 or more and no significant differences between the two anolyte qualities were observed. The Group was unable to interpret the above data in the context of the proposed bw treatment system and the same a pplies to the chronic aq uatic toxicity test.GESAMP-BWWG 5/9
ANNEX 8 Page 11

I:\MEPC\57\2-10.doc 8 ENVIRONMENTAL RISK ASSESSMENT

8.1 Derivation of a Predicted No Effect Concentration (PNEC)

8.1.1 The Group noted that not for all Active Substances and Relevant Chemicals sufficient data were available for estimating PNEC values. Derived PNEC values are given in the
table below:

Toxic substance Available data Assessment
factor PNEC

hypochlorous acid Two long-term NOECs from freshwater or salt-water species representing two trophic levels 500 0.096 μg/L

bromoacetic acid Two long-term NOECs from freshwater or salt water species representing two trophic levels 500 0.12 μg/L

tribromomethane One short-term EC 50 from each of three trophic levels of the base set (fish, Daphnia and algae), but where at least the acute toxicity for Daphnia is determined. 10 000 0.29 μg/L

2-bromophenol One long-term NOEC from freshwater or salt water crustacean reproduction 1000 0.22 μg/L

chlorine dioxide LC 50 values from two freshwater fish species, marine crustacean and marine algae 10 000 0.25 μg/L

ozone LC 50 values from 6 freshwater fish 10 000 0.93 ng/L

bromoform LC 50 from two freshwater fish, one
freshwater and one marine crustacean and one freshwater algae 1000 0.29 μg/L

dibromochlorometh

ane LC 50 from one fish species 10 000 5.2 μg/L

2,4,6 tribromophenol LC 50 from one fish species (3 studies), one crustacean and one algae. Chronic effects from one algae 1000 0.5 μg/L

dibromoacetonitrile LC 50 from one fish species, chronic effects from two algae 10 000 0.055 μg/L

monobromoacetic
acid LC 50 from 2 fish species and one
crustacean. Chronic effects on one crustacean and one algae 1000 1.6 μg/L

8.1.2 The Group further noted that the lowest PNEC value is derived for ozone (0.93 ng/L), but
ozone has a half-life around 5 seconds in seawater and is produced in low concentrations of the C2E unit. Ozone was therefore not regarded as relevant in the PNEC assessment. The most relevant chemical compound has been decide d to be hypochlorous acid with a PNEC value of 0.096 μg/L.GESAMP-BWWG 5/9
ANNEX 8 Page 12

I:\MEPC\57\2-10.doc 8.2 Calculation of the Predicted Environmental Concentration (PEC) for the
Active Substance and Relevant Chemicals

8.2.1 The Applicant claims that predicted e nvironmental concentration (PEC) of Active Substances and relevant chemicals in discharged ballast water from ships can be estimated from direct measurements of chemicals in treated sea water or estimated indirectly by measuring the
oxidant level in the treated water (see chapters 7.1.1 and 7.1.2). However, no PEC data were
estimated. The Free Chlorine in the treated BW has been found to be >3 mg/L, which is higher than it will be in normal operation (approx. 2 mg/L). Further tests will be carried out by the applicant.

8.2.2 The Group noted that initial dilution calc ulations had been carried out with the
US-EPA Visual Plume model. Initial dilution of the effluent in a ne ar-zone (300 m along the quay and 200 m from the ship side will be > 20 times at a BW discharge rate of 6,000 m 3 /h and a total ballast water volume of 50,000 m 3 . Further, the flux out of this near-zone is minimal with 0.42 m/h without any the wate r currents in the harbor. No PE C data were concluded from this study.

8.2.3 The Group emphasizes that for Final Approva l a reasoned PEC value will be required for
the environmental risk assessment.

8.3 Calculation of PEC/PNEC ratios

8.3.1 The applicant informs that the preliminary re sults based on available data from pre-tests with higher oxidant levels than in normal operati on indicate that several of the chemicals in paragraph 8.1.1 may have a PEC/PNEC ratio larger than 1 in treated balla st water discharge. With a dilution factor around 100 the discharged ballast water will have PEC/PNEC below 1.

8.3.2 The Group was not able to calculate a provisi onal PEC and therefore the establishment of a PEC/PNEC ratio was not possible.

9 CONCLUSIONS AND RECOMMENDATIONS

9.1 Risks to the safety of the ship

The Group noted that no corrosion tests were carried out with the complete OceanSaver ® treated ballast water, which would include el ectrochemical activation and cavitation.

9.2 Risks to the crew and general public

The Group recommended that for Final Approval , the Applicant should submit a BWTS HES where unit operations for the nitrogen system and electrochemical system are described in terms of where, when and how human e xposure can take place (please see HES, MEPC 56/2/2, annex 9).

The Group concluded that chlorinated and br ominated disinfection by-products are the toxicological relevant compounds generated by th e electrochemical process (C2E unit) as they have a potential for uptake and human genotoxicity/carcinogenicity concerns; therefore they will have to be kept below toxicological cr itical levels (bromoform <100 μg/L, Ref. WHO, Guidelines fo r drinking water quality, 2003).GESAMP-BWWG 5/9
ANNEX 8 Page 13

I:\MEPC\57\2-10.doc In addition, the Group c onsidered that high nitrogen levels and consequent oxygen depletion in the headspace of ballast tanks could form a hazard to human health therefore aeration procedures or other risk mitigation measur es should be put in place.

9.3 Risks to the environment

The group is mainly concerned with a configura tion in which the system uses electrochemical treatment, as this would produ ce Active Substances and by-produc ts, as well as the nitrogen treatment which reduces oxygen concentration in the ballast water and requires mitigation prior to discharge.

Bromoform concentrations as re presentative of disinfection by- products and measured in fresh
and stored ballast water were at levels sim ilar to those observed in other ballast water management systems based on chlorine.

The applicant claims that TRO had disappeared in less than 24 h. However it requires explanation why the ecotoxicity tests carried out all showed ecotoxicity even 5 days after

treatment.

The applicant provided information on an initial d ilution model as part of the risk assessment but was unable calculate a PEC value. The Group exp ects that the applicant will provide a complete environmental risk assessment as part of an application for Final Approval.

The Group considered that the mitigation steps incl uded in the application i.e., re-aeration prior to discharge would be an important factor, in re ducing the discharge concentrations of a variety of Active Substances and by-products.

9.4 Conclusions

The group noted that the OceanSaver ® ballast water management system comprises a number of different processes, which include cavitation, nitrogen super-saturation and disinfection by an electrochemical activation. The ap plication indicates that the seque nce of the different treatment elements may be varied. In any application for final approval, the Group w ould require a definite configuration to be submitted for evaluation.

If the original inte ntion of the applicant was to apply phys ical treatment (fi ltration, cavitation, and nitrogen purging) to reduce th e need for steriliza tion through electrochemi cal treatment, this
is not reflected in lower chlorine concentrations dosed to the ballast water with this system, which are within the range of those used by other electrochemical systems submitted for Basic Approval.

* * *GESAMP-BWWG 5/9
ANNEX 8 Page 14

I:\MEPC\57\2-10.doc APPENDIX 1

DATA REQUIRED FOR EACH COMPON ENT OF THE PREPARATION AND
BY-PRODUCT PRODUCED IN BALLAST WATER

1 PHYSICAL AND CHEMICAL PROPER TIES FOR THE ACTIVE SUBSTANCES,
PREPARATIONS AND TREATED BALLA ST WATER IF APPLICABLE

Available data describing the properties of the chemicals is highly variable and when sufficient data have not been obtainable, the chemical is not presented.

1.1 Active Substances

Property hypochlorous
acid sodium hypochlorite hydrogen peroxide ozone chlorine
dioxide

Melting point (  ̊ C) - -25 -33
35% w/w in water -526.5 -59

Boiling point (  ̊ C) - 107 108 at 1013 hPa
35% w/w in water -112 11

Flash point (  ̊ C) - N/A Density kg/m 3 at 20  ̊ C - 1.21 1.1-1.2
35% w/w in water 2.144 (0 o C) 1.01 (4 o C)

Vapor pressure at
20  ̊ C (hPa) - 17.4-20 0.48 at 30°C 5.5E4 (-12 ° C) 1420

Vapor density (air = 1) - - - - 2,3 Water solubility (g/L) Soluble 293 100% miscibility at any ratio 7.5

pH in solution - - - - 2-3 (8 g/L)
Dissociation constant (pKa) 7.5 - - - -

Octanol/water partition constant (log K
ow ) -0.87 -3.42 -0.296 - -

Corrosivity to
material or equipment - - Reacts with rust, brass, zinc, nickel , copper , iron and their alloys - -

Explosive properties - - Vapor in equilibrium with aqueous solutions above 70% by weight can explode - Explosive
with or
without
contact with
air

Oxidizing properties - One of the

more commonly
used oxidizing agent Classified as oxidizing agent for transport - Strong oxidizing agentGESAMP-BWWG 5/9
ANNEX 8 Page 15

I:\MEPC\57\2-10.doc 1.2 Relevant chemicals

Property bromoform Dibromochloromethane Bromodichloromethane 2,4,6 - tribromophenol dibromo
acetonitrile Bromo
acetic
acid Melting point (  ̊ C) 8.0-8.5 -20 -55 93 67 49

Boiling point (  ̊ C) 149.5 119-120 90.1 290 at 994.58
hPa 67 at
3.2E3 Pa 206

Flammability (  ̊ C) N/A - - non-flammable. >93 -

Density (kg/m 3 ) 2.89 - - 2.55 - -

Vapor pressure at
20  ̊ C (hPa) 667 7.4 66.7 - 2.6 at 50°C ; 20 at 70°C;
17.8 at 95°C -

Vapor density (air = 1) 8.72 (calculated) 2.451 - - - -

Water solubility (g/L) Slight 4 5-10 at 19°C 50 at 20 °C 5-10 at
21.5°C miscible

Octanol/water partition
coefficient (log K
ow ) 0.38 2.08 1.88 4.02 N/A 0.295

Dissociation constant pKa 2.06 2.16 - - - -

Corrosivity to
material or equipment Not
corrosive - - - - -

2 EFFECTS ON AQUATIC ORGANISMS

2.1 Acute Aquatic Toxicity Data

Ecotoxicological data have not been found for all substances, and not all da ta can be considered relevant for estimating the short- and long-term e ffects. n/a indicates that sufficient data was not
available.

2.1.1 Hypochlorous acid

FCA Species End point Reference

F Oncorhynchus kisutch , Coho
salmon LC 50 : 32 μg/L/4 d Thatcher 1978

C Acartia tonsa, Calanoid copepop LC 50 : 403 μg/L/1 d Bradley et al. 1997

C Americamysis bahia, Opossum shrimp LC 50 : 143.6 μg/L/7 d Fischer et al. 1994GESAMP-BWWG 5/9
ANNEX 8 Page 16

I:\MEPC\57\2-10.doc 

### 2.1.2 Hydrogen peroxide

FCA Species End point Reference
Oncorhynchus mykiss , Rainbow

trout LC 50 : 10 000 μg/L/4 d Office of Pesticide Programs,
2000 F

Lepomis macrochirus, Bluegill LC 50 : 18 000 μg/L/4 d Office of Pesticide Programs,
2000

A Alexandrium

tamarense, Dinoflagellate LC 50 : 10 000-50 000 μg/L/0-3 d, reproductionGermination Ichikawa, S, Wakao, Y, Fukuyo, Y. 1993

2.1.3 Ozone

FCA Species End point Reference
Lepomis macrochirus, Bluegill LC 50 : 60 μg/L/24 h Paller & Heidinger 1979 Morone saxatilis, Striped bass LC 50 : 150 μg/L/6 h Hall et al., 1981 Pimephales promelas, Fathead
minnow LC 50 : 100 μg/L/0.03h Asbury & Coler 1980

Salmo gairdneri, Rainbow trout LC 50 : 9.3 μg/L/96 h Wedemaier et al. , 1979

Perca flavescens, Yellow perch LC 50 : 210 μg/L/24 h/embryo Coler & Asbury 1980 F

Salmo gairdneri, Rainbow trout LC 50 : 190-310 μg/L/ embryo

2.1.4 Chlorine dioxide

FCA Species End point Reference

Salmo trutta , Brown trout LC 50 : 10 000 000 μg/L/48 h Woodiwiss, FS, Fretwell, G. 1974 F

Rasbora heteromorpha

, Harlequinfish, red rasbora LC 50 : 7 000 000 μg/L/24 h Tooby, TE, Hursey, PA, Alabaster,
JS. 1975.
C Carcinus maenas , Green/ European shore crab LC 50 : 500 000 μg/L/48 h Portmann, JE, Wilson, KW, 1971

C Crangon crangon , Common shrimp LC 50 : 500 000 μg/L/48 h Portmann, JE, Wilson, KW, 1971

A Macrocystis pyrifera, Giant kelp LC 50 : 2500 μg/L/48 h Hose, JE, Fiore Di, D, Parker, HS, Sciarrotta, T. 1989GESAMP-BWWG 5/9
ANNEX 8 Page 17

I:\MEPC\57\2-10.doc 2.1.5 Bromoform

FCA Species End point Reference
Cyprinodon variegates, Sheapshead minnow NOEC: 2900 μg/L/ 4 d Heitmuller PT.
et al. , 1981 Cyprinodon variegates, Sheapshead minnow LC 50 : 18000 μg/L/96 h

Lepomis macrochirus

, Bluegill LC 50 : 29000 μg/L/96 h Boccafusco et al., 1981 F

Oryzias latipes, Japanese
killifish/Medaka LC 50 : 40400 μg/L/48 h MITI 1992

C Penaeus aztecus , Brown shrimp LC 50 : 20000 μg/L/4 d Gibson, CI.
et al. , 1981 Daphnia magna,
Water flea LC 50 : 46000 μg/L/48 h LeBlanc 1980

A Selenastrum capricornutum, Green algae LC 50 : 18.7 μg/L/24 h Chlorophyll US EPA 1978

A Selenastrum capricornutum, Green algae LC 50 : 28.1 μg/L/96 h Population changes, general US EPA 1978

2.1.6 Dibromochloromethane

FCA Species End point Reference

F Cyprinus carpio , Common camp LC 50 : 52 000 μg/L/45 min Mattie, JS. et al. ,1981

2.1.7 2,4,6-Tribromophenol

FCA Species End point Reference
Pimephales promelas

, Feathered minnow LC 50 : 6250 μg/L/96 h, Broderius, SJ, Kahl, MD, Hoglund, MD, 1995 Pimephales promelas

, Feathered minnow LC 50 : 6540 μg/L/96 h Geiger, DL, Northcott, CE, Call, DJ, Brooke, LT. 1985 F

Pimephales promelas

, Feathered minnow LC 50 : 4500 μg/L/ 8 d Phipps, GL. et al. , 1981

C Daphnia magna
Water flea LC 50 : 1290 μg/L/2 d Carlson, R. M, Caple, R. 1977

A Bacillariophyceae

, Diatom LC 50 : 500 μg/L/48 h, Physiology Erickson, SJ, Hawkins, CE,
1980

2.1.8 Dibromoacetonitrile

FCA Species End point Reference

F Pimephales promelas

, Feathered minnow LC 50 : 710 μg/L/24 h 550 μg/L/96 h Mayes, MA, Blanchard FA, Hopkins, DL, Takahashi, IT, 1985GESAMP-BWWG 5/9
ANNEX 8 Page 18

I:\MEPC\57\2-10.doc 2.1.9 Monobromoacetic acid

FCA Species End point Reference
Cyprinus carpio

, Common carp LC 50 : 326 mg/kg (100% mortality after 1.5 h, force-fed), 222 mg/kg LT100 (100% mortality after 5 h, force-fed) Loeb, HA, Kelly, WH,
1963 F

Lepomis
macrochirus

, Bluegill LC 50 : 5 mg/L/24 h (Solvents: Ethanol, 2-Propanone, Multiple effects reported as one result) Applegate, VC, Howell, JH, Hall Jr. AE, Smith, MA, 1957
C Daphnia magna,
Water flea EC 50 : 65 000 μg/L/24 h, behaviorequilibrium, intoxication-immobile) Kuhn, R. 1988, Kuhn, R. Pattard, M, Pernak K-D, Winter, A,
1989

2.2 Chronic Aquatic Toxicity Data

2.2.1 Hypochlorous acid

FCA Species End point Reference

F Oncorhynchus gorbuscha,
Pink salmon NOEC: 42 μg/L/23 d, mortality Holland et al. , 1960

Americamysis bahia

, Opossum shrimp NOEC: 47.8 μg/L/7 d, reproduction Fischer et al. , 1994

Americamysis bahia

, Opossum shrimp NOEC: 65.5 μg/L/7 d, Development Fischer et al. , 1994 C

Americamysis bahia

, Opossum shrimp NOEC: 81.2 μg/L/7 d,
Growth Fischer et al. , 1994

A Porphyra yezoensis , Red algae EC 50 : 1400 μg/L/10 d,
Growth Maruyama et al. , 1988

2.2.2 Hydrogen peroxide

FCA Species End point Reference

C Americamysis bahia, Opossum shrimp LC 50 : 47.8 μg/L/7 d, reproduction Fischer et al. , 1994

A Porphyra yezoensis, Red algae LC 50 : 1400 μg/L/10 d, Growth Maruyama, T et al.

, 1988

2.2.3 Bromoform

FCA Species End point Reference

F Cyprinodon variegatus, Sheepshead minnow LC 50 : >4800<8500 μg/L/>28 d, Mortality, maximum acceptable
Toxicant Concentration Ward, GS. Parrish, PR, Rigby, RA, 1981 Daphnia magna,
Water flea EC 50 : 5400 μg/L/15 d, Reproduction Canton, JH.
et al. , 1983 C

Penaeus aztecus, Brown shrimp LC 50 : 30-290 μg/L 1-28 d, Accumulation, general Gibson, CI.
et al. , 1981GESAMP-BWWG 5/9
ANNEX 8 Page 19

I:\MEPC\57\2-10.doc 2.2.4 2,4,6-Tribromophenol

FCA Species End point Reference

A Thalassiosira pseudonana,
Diatom LC 50 : 16 000 μg/L/7 d, population changes, general Erickson, SJ, Freeman, AE, 1978

2.2.5 Dibromoacetonitrile

FCA Species End point Reference

Glenodinium halli, Dinoflagellate LC 50 : 16 000 μg/L/7 d, Population changes, general Erickson, SJ, Freeman, AE, 1978 A

Scenedesmus subspicatus, Green algae EC 50 : 1400 μg/L/72h, (Population changes, general) Kuhn, R, Pattard, M,
1990

2.2.6 Monobromoacetic acid

FCA Species End point Reference

C Daphnia magna,
Water flea NOEC: 1600 μg/L/21 d, Reproduction Kuhn, R. et al. , 1989

A Monoraphidium griffithii, Green algae EC 50 : 60 μg/L/4 d, growth Eloranta, V 1982

2.3 Information on Endocrine Disruption: N.D.

2.4 Sediment Toxicity: N.D.

2.5 Bioavailability/Biomagnification/Bioconcentration: N.D.

2.6 Food Web/Population Effects: ND

3 MAMMALIAN TOXICITY

3.1 Sodium hypochlorite

3.1.1 Corrosion/irritation

Exp. route Species Method Results Reference Skin Rabbit OECD 404 2% slight
20% severe Sodium hypochlorite IUCLID
2000 GESAMP-BWWG 3/9 Eye Rabbit n/a 5.25% irritant 0.5% slight irritant
0.05% NOEC Sodium hypochlorite IUCLID
2000 GESAMP-BWWG 3/9

According to the presented data, sodium hypochlorite is to be regarded as a skin and eye irritant. Sodium hypochlorite is classi fied under GHS as skin corrosi ve 1B (GHS classification, Annex VI, COM (2007) 355 final).GESAMP-BWWG 5/9
ANNEX 8 Page 20

I:\MEPC\57\2-10.doc 3.1.2 Repeated-dose toxicity

Exp

route Exp
duration Exp dose Species NOAEL Reference

Oral 90 d 200 mg/L in drinking
water Sodium hypochlorite Mouse 50 mg/L (10-12 mg/kg/d) MEPC 56/2 para. 2.3.3.1 (Daniel
et al. , 1991)

According to existing and submitted data, the Group concluded the following:

Several rodent studies with administered sodium hypochlorite in drinking-water have suggested immunological changes. Exon et al . (1987) examined immunotoxicological effects of sodium hypochlorite at 5, 15 or 30mg/litre (0.7, 2.1 or 4.2.mg/kg bw per day) in the drinking water of male Sprague-Dawley rats for 9 weeks. The effects on macrophage activity suggest that some impairment does oc cur at relatively low levels of sodium hypochlorite although the significance of whic h is still unknown. Modification of macrophage function seems to be one of the mo st sensitive responses identified in studies of chlorine or hypochlorite in experi mental animals (EHC 216, WHO, 2000).

A study from Daniel et al . (1990a) evaluated the toxicity of chlorine prepared by bubbling chlorine gas into di stilled water and adjusting pH to 9.4. The nominal
concentrations of chlorine were approximately 0, 3, 10, 16 or 21 mg/kg bw per day, administered as drinking-water to both male and female Sprague-Dawley rats (10 per sex per dose) for 90 days. No deaths occurred in any treatment group. A NOEL (No Observed Effect Level) of 10 mg/kg bw per day was identified by the authors based on reduced body weight gain however this can not be considered a true toxicological end-point as can be associated to a redu ced palatability of the drinking-water.

3.1.3 Sensitization data

Exp route Species Method Results Reference Skin Guinea pig n/a 2.8% NOEC Sodium hypochlorite
IUCLID 2000 GESAMPBWWG 3/9

According to existing data sodium hypochlorite does not show a poten tial to cause delayed contact hypersensitiv ity (draft Risk Assessment Re port (RAR) on sodium hypochlorite, EU Assessment 793/93).

3.1.4 Developmental and reproductive toxicity

Exp route Exp duration Exp dose Species NOAEL Reference
Oral 7 generations 100 mg sodium hypochlorite/L Rats 100 mg/L GESAMP
BWWTGESAMP-BWWG 5/9
ANNEX 8 Page 21

I:\MEPC\57\2-10.doc According to existing and submitted data the Group concluded the following:

Some indicative effects of altered sperm shape have been detected in several studies with chlorinated drinking-water. Meier et al . (1985b) reported that oral administration of sodium hypochlorite (pH 8.5) prepared from chlorine gas and administered at 4 or 8 mg/kg bw per day for 5 weeks increased the incidence of sperm abnormalities in B6C3F1 mice.

Some animal studies have demonstrated no repr oductive or teratogenic effects of chlorine (Druckrey, 1968). A number of s ubsequent studies have studied the effects of chlorine or hypochlorite however there is insuffi cient information to draw conc lusions about the potential for developmental toxicity (EHC 216, WHO, 2000).

3.1.5 Carcinogenicity

Effect Species Method Results Reference Carcinogenicity Not carcinogenetic GESAMP BWWT MEPC 56/2, para. 2.3.7.1 Mutagenicity Not mutagenic GESAMP BWWT MEPC 56/2, para. 2.3.7.1

According to existing and submitted data the Group concludes the following:

In most animal studies available for carcinogenic ity evaluation (EHC 216, WHO, 2000) there is a
lack of statistical evaluation of the results and lack of dose-response relationship. Sodium hypochlorite is not classi fied by IARC as to their carcinogenicity to humans (Group 3).

Several studies have shown that sodium hypochlor ite produces mutagenic responses in bacterial systems and mammalian cells in vitro . However, there is no evidence of activity in mammalian test systems in vivo . It is not clear to what extent th is is influenced by the formation of mutagenic by-products as a result of reactio ns with components of the incubation media (Rosenkranz et al. , 1976).

3.2 Hydrogen peroxide

Source: EU-risk assessment re port – Hydrogen Peroxide

3.2.1 Acute Toxicity

Exp route Species Method Results Reference Dermal Rat Whole body, 4 hours LC 50 : 2000 mg/m 3 Kondrashov
1977 Inhalation Mouse Aerosols (70% H 2 O 2 ), 5 min -2 h, exp at 12 000-13 000 mg/m 3 50% lethality after
10-15 min Punte et al.

, 1953

Hydrogen peroxide is classi fied under GHS as harmful if inhaled or swallowed (GHS classification, Annex VI, COM (2007) 355 final).GESAMP-BWWG 5/9
ANNEX 8 Page 22

I:\MEPC\57\2-10.doc 3.2.2 Repeated dose toxicity

Exp

route Exp
duration Exp
dose Species Method Results NOAEL NOEL Reference

Inhalation 28 d 0-33 mg/m 3 Rat 6 h daily
for 5 d per week Respiratory

tract irritation,
necrosis and
inflammation
of nasal cavity epithelium 2.9 mg/m 3 14.6 mg/m 3 CEFIC Peroxygen
Sector Group
2002

Oral 12
weeks 0-506 mg/kg
bw/d Rat Stomach
tube 6 d per week Decreased bw gain, erythrocyte
count, hemoglobin

conc. Gastric
mucosal erosions,
eschars and
round cell
infiltration 56.2 mg/kg
bw/d Ito et al.

, 1976

Oral 0-90 d 0-3000 mg/L Mouse Drinking

water Decreased bw gain,
reduced
blood total protein,
reduced
food and

water consumption,
duodenal
mucosal hyperplasia 100 mg/L 300 mg/L FMC
1997

According to the presented data, there seemed to be relevant toxicol ogical concerns towards repeated exposure to hydrogen peroxide. This is also confirmed in the RAR on hydrogen peroxide (EU Assessment).

3.2.3 Sensitization

Exp route Species Method Results Reference Skin Human Vapor, 5 min-4 h

exposure NOAEL: 10 mg/m 3 , Effect conc/dose: 20 mg/m 3 Kondrashov
1977 Inhalation Human Face mask (nose inhalation) NOAEL: 5 mg/m 3 , Effect conc/dose: 10 mg/m 3 Kondrashov
1977GESAMP-BWWG 5/9
ANNEX 8 Page 23

I:\MEPC\57\2-10.doc According to existing data (RAR , hydrogen peroxide), there is not enough evidence to classify hydrogen peroxide as a sensitizer. The potential of hydrogen peroxide to cause skin sensitization is extremely low (there are two reported cases of positive patch tests as well as uncertainty surrounding an outdated animal st udy, with a negative result).

3.2.4 Developmental and reproductive toxicity

Exp

route Exp duration Species Method Results Reference

Oral 90 d Mouse Drinking water No effects FMC 1997

According to existing data ((RAR, hydrogen per oxide) there are no appropr iate animal studies available for a complete evaluation of reproduc tive and developmental toxicity. Two limited studies with mice and rats exposed to hydrogen peroxide in drinking water suggested no grave
disturbances on the male or fema le reproductive functions (Wales et al , 1959, Hankin, 1958). With regards to developmental toxicity a decision was reached on the presumption that conventional study protocols (e.g., administration in drinking water) we re unlikely to show specific embryonal or fetal effect s firstly, because it is doubt ful whether hydrogen peroxide (as opposed to its degradation products oxygen and water) would reach the fetus and secondly, because local effects in the mother, possibly causi ng nutritional disturbances and general toxicity, are expected.

3.2.5 Carcinogenicity

Species Method Results Reference

Mouse Drinking water Increased incidence of erosions and ulcer in the glandular
stomach and duodenal hyperplasia Ito et al.

, 1981a, Ito et al., 1982b

Hamster Painting of left buccal pouch twice weekly with
DMBA * and H 2 O 2 Development of carcinomas, hyperkeratosis and hyperplasia Weitzman
et al. , 1986

Mouse Dermal, treatment on
dorsal skin with DMB * A
and H 2 O 2 and/or acetone twice weekly H 2 O 2 functioned as an extremely weak tumor promoter Klein-Szanto and Slaga
1982

* 9, 10-dimethyl-1,2-bentzanthracene

According to existing data (RAR, hydrogen peroxide ) it can be concluded th at the special nature of demonstrated carcinogenicity of hydrogen per oxide, and the overall evid ence available, cast some doubt on whether hydrogen peroxide should be regarded as a carcinogen of practical significance. The weak effect f ound in complete carcinogenesis studies in mice as well as in some promotion studies suggest promotion type of activity and possi ble underlying genotoxic
mechanisms. Given the fact that mammalian cells have of necessity built defences against reactive oxygen species arisi ng in endogenous metabolism, th e injuries caused by hydrogen peroxide may well be non-stochastic, i.e., have a dose/dose rate threshold. This evidence
however is not sufficient to trigger classification.GESAMP-BWWG 5/9
ANNEX 8 Page 24

I:\MEPC\57\2-10.doc 3.2.6 Mutagenicity/genotoxicity

Species Strain Measured endpoint Test
conditions Results
without
activation Results
with
activation Reference

Escherichia
coli WP2 (uvrA) Ames test H 2 O 2 , 1.0-3333.3 μg/plate - - SRI
International
1980
Salmonella typhimurium TA1535 /pS
K1002 DNA damage and repair H 2 O 2 , 45 μg/mL + NT Nakamura
et al. , 1987

African green monkey Kidney
cells (CV-1) Mammalian
cell-line
mutation – (supF locus of the pZ189 plasmid mutations) H 2 O 2 , 0.5-
10 mM + NT Moraes
et al. , 1990

Chinese
hamster V79-
379A
cells DNA damage and repair– DNA single
and doublestrand breaks H 2 O 2 , 10- 1000 μM + NT Prise
et al. , 1989

According to a conclusion in existing literatu re (RAR on hydrogen pero xide) hydrogen peroxide is a mutagen and genotoxicant in a variety of in vitro test systems.

3.3 Ozone

3.3.1 Acute mammalian Toxicity

Exp route Species Method Results Reference
Oral Human Inhalation 0.021-0.124 mg/m 3 /29 min Decremented FVC,

FEV 1 , PEFR Spektor et al.

, 1988

Oral Human Inhalation 0.08 mg/m 3 /6.6 h Decremented FVC,

FEV 1 Increased SRaw McDonnell et al.

, 1991

The Group considers that ozone is very toxic by inhalation.GESAMP-BWWG 5/9
ANNEX 8 Page 25

I:\MEPC\57\2-10.doc 3.3.2 Developmental and reproductive toxicity

Exp
duration Exp
dose Species Results Reference

8 h/d day 6-9, 9-
12 and 6-15 of gestation 1.97 mg/m 3 Rat Increased resorption rate Kavlock
et al.

, 1979 day 17-20 of gestation 1.0 or 1.5 mg/m 3 Rat Offspring with retarded of reflex development and slowing in open field behavior Kavlock
et al.

, 1980

Exp
duration Exp
dose Species Method Results Reference

Day 17-20 of gestation 2 and 2.9 mg/m 3 Rat (offspring) Maternal

exposure Retarded reflex development, slowing open field behavior Kavlock
et al.

, 1980 7 h/d, 5
d/week 0.4 mg/m 3 Mouse (fetus) Maternal

exposure Blepharophimosis and jaw anomalies Veninga
1967 6 h 2 mg/m 3 Rat (pregnant/lacta ting) Enhanced sensitivity to o3 pulmonary
inflammation Gunnison
et al.

, 1992

The Group considers that there are some concerns of reprotoxicity effects by inhalation exposure, namely neuro-behavioural development, in the submitted studies.

3.3.3 Carcinogenicity/Mutagenicity

Ozone is not considered as carcinogenic ( The American Conference of Governmental Industrial Hygienists (ACGIH)), however, t he Group concluded that there is evidence of mutagenicity concern, in line with existing scientific literature.

3.4 Chlorine dioxide

Very limited data available, probably due to the f act that chlorine dioxide is readily decomposed to chlorine and oxygen in the environment.

3.4.1 Acute toxicity

Species Exp route Type Value Reference

Rat Oral LD 50 292 mg/kg bw Finnish Chemicals Oy Äetsä

Rat Inhalation LC 50 500 mg/kg Finnish Chemicals Oy Äetsä

The Group noted that according to GHS classifi cation (GHS, Annex VI, COM (2007) 355 final)
chlorine dioxide is fatal if inhaled.GESAMP-BWWG 5/9
ANNEX 8 Page 26

I:\MEPC\57\2-10.doc 3.4.2 Skin and eye irritation

Organ Species Remark Reference

Skin Human May irritate skin very slightly Finnish Chemicals Oy Äetsä

Eye Human Vapours may irritate eyes Finnish Chemicals Oy Äetsä

Chlorine dioxide is classified under GHS as sk in corrosive 1B (GHS classification, Annex VI, COM (2007) 355 final).

3.4.3 Carcinogenicity

Chlorine dioxide is not classified as a carcinogenic (Finnish Chemicals Oy Äetsä).

3.5 Bromoform

3.5.1 Acute toxicity

Exp route Value Species Reference/comments
Oral LD 50 (mg/L) 707-1550 Rats & Mice EHC 216, 2000 GESAMP

BWWT
Inhalation LC 50 (mg/L/4h) 7000 μ/L Dogs Death after 1 h GESAMP

BWWT

The LD 50 values presented in submitted studies, i ndicate that bromoform is harmful if swallowed. In addition and according to GHS cl assification, bromoform is toxic if inhaled.

3.5.2 Repeated dose toxicity

Exp

route Exp
duration Exp
dose Species NOAEL Reference

Oral 13 weeks 25 mg/kg/d (rat), 100 mg/kg/d (mice) Rats and
Mice 25 mg/kg/d (rat), 100 mg/kg/d (mice) EHC 216 (2000)

The Group concluded that from existing and submitted information there are concerns related to nephropathy and hepatopathy under repeated exposure to bromoform.

3.5.3 Corrosion/Irritation

Exp route Species Method Results Reference Skin Human Not specified Irritant MSDS GESAMP BWWT Eye Human Not specified Irritant MSDS GESAMP BWWT
Inhalation LC 50 (mg/L/4h) Human 0.03-1.2 μg/L Irritant MSDS GESAMP BWWT

Bromoform is classified under GHS as an eye irritant (Eye irrit 2) and skin irritant (Skin irrit 2).GESAMP-BWWG 5/9
ANNEX 8 Page 27

I:\MEPC\57\2-10.doc 3.5.4 Developmental and reproductive toxicity

Exp100

route Exp
duration Exp
dose Species Results Reference

Oral At days
6-15 of gestation 50, 100
and 200 mg/kg/d Rats Evidence of foetotoxic response. No foetal
malformations observed EHC 216 (2000)

Oral 105 d Rats (male and
female pairs) No detectable effect on fertility, litte rs/pair, live pups/litter, proportion of pups born alive, sex or body weights EHC 216 (2000)

The Group concluded from the submitted and existing information (EHC 216, 2000) that although there were no observed effects on fertil ity parameters, there may be some reprotox concerns (fetotoxicity) related to exposure to bromoform.

3.5.5 Carcinogenicity/Mutagenicity

Effect Species Method Results Reference Carcinogenicity Rats 5 d exposure/week for 2 years No evidence
observed NTP,
1989a Mutagenicity Bacteria
Not identified (Ames test) In vivo Mutagenic
Inconclusive

The Group evaluated the carcinogenicity and muta genicity data submitted for bromoform and concluded that there are positive animal data indicating that bromoform can cause liver and
intestinal tumours.

3.6 Dibromochloromethane

Trihalomethanes in drinking wa ter (Ref. WHO/SDE/WSH/05.08/64).

3.6.1 Acute toxicity

Exp route Value Species Reference 800 Mouse MEPC 56/2, para. 2.3.1.2,
GESAMP BWWT Oral

LD 50 (mg/L)
1186/848 (male/female) Rat Chu et al. , 1980

The LD 50 values presented in submitted studies, indi cate that dibromochloromethane is harmful
if swallowed.GESAMP-BWWG 5/9
ANNEX 8 Page 28

I:\MEPC\57\2-10.doc 3.6.2 Repeated dose toxicity

Exp

route Exp
duration Exp
dose Species Method Results NOAEL Reference

Oral 90 d 0-200 mg/kg/d Rat Solved
in corn oil,

gavage Decrease in body weight at 200 mg/kg/d,
elevated alanine
aminotransferas e, centrilobular hepatic necrosis, kidney proximals
tubule cell degeneration 50 mg/kg/d MEPC 56/2, para. 2.3.1.2
GESAMP BWWT,
Daniel
et al ., 1990

Oral 90 d 0-250 mg/kg
bw/d Rat Solved
in corn oil,

gavage Depressed body weight,
increased hepatic vacuolation, kidney and liver toxicity 30 mg/kg
bw NTP 1985

Oral 90 d 0-250 mg/kg
bw/d Mouse Solved
in corn oil,

gavage Kidney and liver toxicity 125 mg/kg
bw NTP 1985

The Group concluded that from existing and submitted information there are concerns related to nephropathy and hepatopathy under repeated exposure to dibromochloromethane.GESAMP-BWWG 5/9
ANNEX 8 Page 29

I:\MEPC\57\2-10.doc 3.6.3 Developmental and reproductive toxicity

Exp

route Exp
duration Exp
dose Species Method Results NOAEL NOEL Reference

Oral 2 generations 0.4 mg/L Mice At 4 mg/L
decreased fertility.
No dominant
lethal or teratogenic
effects
observed. n/a n/a MEPC 56/2, para. 2.3.5.2,
GESAMP
BWWT

Oral 35 d/ generation 0-685 mg/kg
bw (0-
4000 mg/L) Mice Ad libitum, multigen
erational Decreased body weight, enlarged
livers with

gross morphological changes,
decreased litter size, decreased pup viability,
reduced fertility and
reduced F 1 generation
survival 17 mg/kg
bw/d n/a Borzelleca
&
Carchman
1982

The Group concluded from the submitted and existi ng information that there are observed effects on fertility parameters, as well as some reprotox concerns (fetot oxicity) related to exposure to
dibromochloromethane.

3.6.4 Carcinogenicity/Mutagenicity

Effect Species Method Results ReferenceCarcinogenicity Human Probable
human carcinogen US EPA (Iris) MEPC 56/2, para. 2.3.6.2, GESAMP
BWWT Mutagenicity Salmonella typhimurium Ames Positive and negative
results MEPC 56/2, para. 2.3.7.2, GESAMP
BWWT Genotoxicity Chinese hamster ovary cells

Human lyphocytes Chromosomal
aberration test
SCE-test Positive

Positive Ishidate et al. , 1982

Morimoto & Koizumi
1983

The Group noted that the carcinogenicity and mutage nicity data submitted for suggests that there are positive data indicating that dibromochlor omethane may act as a mutagen as well as a carcinogen.GESAMP-BWWG 5/9
ANNEX 8 Page 30

I:\MEPC\57\2-10.doc 3.7 Dichlorobromomethane

Trihalomethanes in drinking wa ter (Ref. WHO/SDE/WSH/05.08/64).

3.7.1 Acute toxicity

Exposure route Value Species Reference
Oral LD 50 (mg/L) 916/969 (male/female) Rat Chu et al. , 1980

The LD 50 values presented in submitted studies, indi cate that dichlorobrom omethane is harmful
if swallowed.

3.7.2 Repeated dose toxicity

Exp

route Exp
duration Exp
dose Species Method Results NOAEL Ref.

Oral 90 d 0-300 mg/kg
bw/d Rat Gavage Decreased body weight,
centrilobular degeneration of liver, degeneration
and necrosis of kidney 75 and 150 mg/kg bw/d (bw reduction
and hepatic/renal
lesions respectively) NTP
1987

Oral 90 d 0-100 (m) /0- 400 (f) Mouse (m/f) Gavage Centrilobular degeneration of liver (f), degeneration
and necrosis of kidney (m) 50 mg/kg
bw/d NTP
1987

The Group concluded that from existing and submitted information there are concerns related to nephropathy and hepatopathy under repeated exposure to dichlorobromomethane.GESAMP-BWWG 5/9
ANNEX 8 Page 31

I:\MEPC\57\2-10.doc 3.7.3 Developmental and reproductive toxicity

Exp

route Exp
duration Exp
dose Species Method Results NOAEL Reference

Oral 15 d (d 6-21 of gestation) 0-82 mg/kg
bw/d Rat Ad
libitum Water consumption, body weight gain and feed consumption
reduced 18.4 mg/kg
bw/d (maternal) 45 mg/kg
bw/d(developmental) Christian et al.,
2001

Oral 23 d (d6-29 of gestation) 0-55.3 mg/kg
bw/d Rabbit Ad
libitum Body weight gain and feed consumption
reduced 13.4 mg/kg
bw/d (maternal) 55.3 mg/kg
bw/d(developmental) Christian
et al.

, 2001

Oral 52 weeks 22 and
39 mg/kg
bw/d Rats Ad
libitum Decreased mean straight line average path
and curvilinear
velocities of

sperm IPCS
2000

From the submitted data, some reproduction t oxicological concern was observed regarding fertility parameters.

3.8 2,4,6-Tribromophenol

3.8.1 Acute mammalian toxicity

Exp route Species Method Results Reference Skin (LD 50 ) Rabbit
Rabbit >2000 mg/kg
bw >8000 mg/kg
bw IRDC 1973
IRDC 1974a

Inhalation LC 50 (mg/L/4h) Rat
Rat 4 h
1 h 50 000 mg/m 3 200 000 mg/m 3 IRDC 1974a
IRDC 1973

The LD 50 values presented in submitted studies, indicate that 2,4,6-tribromophenol is not classified according to its acute toxic properties. However self -classification by a major supplier (Great Lakes, UK) suggests that 2,4,6-tr ibromophenol is harmful if swallowed.GESAMP-BWWG 5/9
ANNEX 8 Page 32

I:\MEPC\57\2-10.doc 3.8.2 Repeated dose toxicity

Exp

route Exp
duration Exp
Dose Species Method Results NOAEL Reference

Oral 48 d 100-
1000 mg/kg
bw/d Rat Gavage Salivation, suppressed bw gain,
decreased food consumption,
increased liver weight, increased kidney weight,
increased total protein, decreased
bilirubin and potassium in blood, decreased thymus weight, hepatocyte hypertrophy, decreased hepatic fatty change, renal papillary necrosis and dilatation of tubules, lymphocyte
infiltration 100 mg/kg
bw Tanaka
et al. , 1999

The Group concluded that from existing and submitted information there are concerns related to nephropathy and hepatopathy under repeat ed exposure to 2,4,6-tribromophenol.

3.8.3 Corrosion/irritation

Exp route Species Method Results Reference
Skin Rabbit OECD TG 404 One dosage (0.5g)
24h Not irritating DSBG/BCL (1985b)

Eye Rabbit OECDTG 405 One dosage (100mg) Moderately irritating DSBG/BCL (1997b)

The Group noted that the presente d data suggests that 2,4,6-tribr omophenol is irri tation to eyes (self-classification made by a major supplier (Great Lakes, UK) also suggests that it is irritating to skin).GESAMP-BWWG 5/9
ANNEX 8 Page 33

I:\MEPC\57\2-10.doc 3.8.4 Developmental and reproductive toxicity

Exp

route Exp
duration Exp
dose Species Method Results NOAEL NOEL Reference

Oral Day 0 and day 4 100,
300 and
1000 mg/kg/d Rat Repeated
dose toxicity,

reproduction/development Reduced viability and body weight 1000 mg/kg/
d
mother
300 mg/kg/ d pups Tanaka
et al. , 1999

Oral 20 d 10-3000 mg/kg/d Rat Decreased weight gain,
increased postimplantation loss,
decreased
fetus viability 1000 mg/kg/
d
mother
300 mg/kg/ d pups IRDC,
1978b

Inhalation 21 d of gestation 0.03-1.0 mg/m 3 Rat Whole body
inhalation Pre and postimplantation embryo losses,
decreased fetal body weight <0.03m g/m 3 Lyubimov
et al. , 1998

From the submitted data, some reproduction t oxicological concern was observed regarding developmental parameters.

3.8.5 Carcinogenicity

No long-term exposure or carcinogenicity stud ies on brominated pheno ls were identified.

3.8.6 Genotoxicity

Effect Species Method Dose Results Reference Genotoxicity CHL/IU
cells Chromosomal
aberration test ( in vitro ) 1.6 mg/ml Positive Sasaki
et al. , 1999

Genotoxicity Mouse,
bone

marrow Micronucleus test ( in vivo ) 75-300 mg/kg intraperitoneally Negative DSBG/BCL (2002)GESAMP-BWWG 5/9
ANNEX 8 Page 34

I:\MEPC\57\2-10.doc 3.9 Dibromoacetonitrile

Halogenated Acetonitriles in Drinking-water (R ef: WHO/SDE/WSH/03.04/98)

3.9.1 Repeated dose toxicity

Exp

route Exp
duration Exp
dose Species Method Results NOAEL Reference

Oral 13 weeks 0.9-12.6 mg/kg
bw/d Rat Drinking

water ad libitum Decreased

water consumption,
decreased body weight 11.3 (females)
and 12.6 (males) mg/kg
bw/d NTP, 2001b
and 2002 a,b

Oral 14 d 23-280 mg/kg
bw Rat Gavage Decreased body weight in males,
increased liver weight in
females 23 mg/kg
bw/d Hayes et al.

, 1986

The Group concluded that from submitted informati on apparently there are no concerns related to repeated exposure to dibromoacetonitrile.

3.9.2 Developmental and reproductive toxicity

Exp

route Exp
duration Exp
dose Species Method Results NOAEL Reference

Oral 14 d 2-18 mg/kg
bw/d Rat Drinking
water, ad libitum Decreased

testes weight and
testicular atrophy 12 mg/kg
bw/d NTP,
2000c

14 d (gestation d 7-21) 50mg/kg
bw/d Rat Intubation Decreased
maternal weight gain,
decreased
birth weight * 50 mg/kg
bw/d ** Smith
et al.

, 1987

* Dibromoacetonitrile were solved in tricaprylin which is proven to be a development toxicant and hence possibility of potentiating developmen tal effects of trihaloacetonitriles an d probably other haloacetonitriles.

** Only one dose administered.

From the submitted data, some reproduction t oxicological concern was observed regarding fertility parameters.GESAMP-BWWG 5/9
ANNEX 8 Page 35

I:\MEPC\57\2-10.doc 3.9.3 Genotoxicity

Effect Species Method Results Reference| DNA damage Escherichia coli SOS chromotest Weakly positive (without metabolic activation) Le Curieux et al.

, 1995

Sister
chromatid exchange Chinese hamster ovary
cells Exogenous
metabolic
activation Induction Bull et al. , 1985

Human lymphoblastic
cells DNA strand breaks Daniel et al.

, 1986

The Group noted that the mutagenicity data su bmitted suggests that there are positive data indicating that dibromoacetoni trile may act as a mutagen.

3.10 Monobromoacetic acid

No data on mammalian toxicology for monobrom oacetic acid from the current databases is
available.

The Group noted that monobromoacetic acid is classified according to GHS as acute tox 3 (inhalation, skin contact, ingestion, and as skin corr. 1 A (hazard statements; H332, H312, H302 and H314).

4 ENVIRONMENTAL FATE AND E FFECT UNDER AEROBIC AND
ANAEROBIC CONDITIONS

4.1 Modes of degradation (biotic and abiotic)

4.1.1 Bromoform

In air, brominated trihalomethanes (THMs) may be degraded by photo-oxidative interaction with atmospheric hydroxyl radicals; thei r typical atmospheric half-life is about 2 months. The main
route of loss of THMs from the water phase has been reported to be through volatilization, with a
recorded volatilization half- life ranging from 0.5 hour s to 24 days. (WHO, 1996, Taylor 2006). The reported biodegradation half-life under aerobic conditions has been reported to around 1 month (Taylor, 2006). Under anaerobic conditions, brominated trihalomethanes are readily bio-degraded within days in the presence of methane-producing bacteria and under denitrifying and sulfate-re ducing conditions (Taylor, 1996) . Adsorption to suspended matter and abiotic degradation (e.g., via hydrol ysis) have been reported as negligible (Taylor, 2006); the estimated half-life through hydrolysis in aqueous media is 686 years for bromoform, (WHO, 1996).

During experiments in open (air exposed) reac tion vessels (150 L) conc entrations of THMs in
chlorinated seawater decreased from 15 mg/L to <0.25 mg/L over 7 days (In closed reaction vessels only a small decrease of THMs in chlorina ted water was observed). The following first
order rate constant (k) and half-life (t 0.5 ) were determined for Bromoform:

Total loss: k = 0.027 h -1 t 0.5 = 26 h;
Net volatilization loss: k = 0.024 h -1 t 0.5 = 28 h.GESAMP-BWWG 5/9
ANNEX 8 Page 36

I:\MEPC\57\2-10.doc The potential toxicity (pT) of open vessels of chlorinated seawat er declined to non-chlorinated intake levels within 2–3 days. Thereafter the pT remained relatively constant. In a closed system no significant decrease in pT was observed. Al though samples were tested for genotoxicity the results were equivocal: local i nputs, probably from other industria l activities, were sufficient to mask any influence of low-le vel chlorination (Taylor 2006).

Bromoform should be regarded relatively pers istent once rel eased into the environment (also stated in GESAMP-BWWG 3/9 draft).

4.1.2 Dibromochloromethane

(As for Bromoform; THMs in general).

In Taylor (2006), the following first or der rate constant (k) and half-live (t 0.5 ) were determined for DBCM (in sea water):

Total loss: k = 0.040 h -1 t 0.5 = 17 h;
Net volatilization loss: k = 0.031 h -1 t 0.5 = 22 h.

Adsorption to suspended matter and abiotic degrad ation (e.g., via hydrolysis) have been reported as negligible (Taylor, 2006); estimated half-live through hydrolysis in aqueous media is 274 years for DBCM (WHO, 1996), (See also MEPC 56/2), thus DBCM should be regarded relatively persistent once released into the environment.

4.1.3 Dichlorobromomethane

(As for Bromoform; THMs in general).

In Taylor (2006), the following first or der rate constant (k) and half-life (t 0.5 ) were determined for DCBM (in sea water):

Total loss: k = 0.080 h -1 t 0.5 = 9 h.

Adsorption to suspended matter and abiotic degrad ation (e.g., via hydrolysis) have been reported as negligible (Taylor, 2006); estimated ha lf-life through hydrolysis in aqueous media is 1000 years for DCBM (WHO, 1996), t hus DCBM should be regarded relatively persistent once released into the environment.

4.1.4 Tribromophenol

Halophenols have been known to be partially ioni zed at ambient pH valu es. The volatilization half-lives of 2,4-dichlorophenol and 2,4,6-trichlorophenol have been reported as 2 weeks. Halophenols have been known to be susceptibl e to photo-degradation and this has been understood to be the major fate process, with a half-life of several days (Taylor 2006). Volatilization of non-dissociated 2,4,6-TBP from water surfaces is not expected to be an important fate process (Dan ske Miljøministeriet, 2000).GESAMP-BWWG 5/9
ANNEX 8 Page 37

I:\MEPC\57\2-10.doc Tribromophenol is not regarded as readily biodegradable (49% of BOD, 4w, 100 mg/L substance, 30 mg/L sludge) (Danske Miljømini steriet, 2000), however, adapted communities of microorganisms and specialist communities (such as anaerobic or sulfidogenic) may degrade the compounds (WHO, 2005). Biodegradati on half-lives have been reported as being 7 days and the degree of adsorption to suspende d solids and sediments (and biocon centration) has been reported as moderate (Taylor, 2006, WHO, 2005).

4.1.5 Dibromoacetonitrile

The half-lives of dihaloacetonitriles such as di bromoacetonitrile (DBAN) have been reported as being of the order of several days, dependent on pH, with the primary route being gradual hydrolysis into dihaloacetic acids. Adsorption to solids has been reported as negligible (Taylor, 2006).

In Taylor (2006) for both open and closed reaction vessels (sea wa ter), >90% dibr omoacetonitrile was lost in 40 h giving k = 0.050 h -1 and t 0.5 = 14 h. The potential toxi city (pT) of open vessels
of chlorinated seawater declined to non-chlorinated intake levels within 2–3 days. Thereafter the pT remained relatively constant. In a cl osed system no significant decrease in pT was observed. Although samples were tested for genotoxi city the results were equivocal: local inputs, probably from other industrial activities, were su fficient to mask any influence of low-level chlorination (Taylor 2006).

4.2 Bioaccumulation, partition coefficient, octanol/water partition coefficient

4.2.1 Hypochlorous acid

Results Log Kow -0.87 hypochlorous acid -3.42 sodium hypochlorite Koc 14.3 hypochlorous acid 14.3 sodium hypochlorite 1⁄2-life 0.8 h hypochlorous acid 1.4 h sodium hypochlorite

Hypochlorous acid and sodium hypochlorite can not be considered as bioaccumulative based on given data. As the log K
ow values for sodium hypochlorite a nd hypochlorous acid are very low, it is considered unlikely that these substances should accumulate through the food chain.

4.2.2 Hydrogen peroxide

Results Reference Log K ow H 2 O 2 does not accumulate in cells of living organisms IUCLID 2000GESAMP-BWWG 5/9
ANNEX 8 Page 38

I:\MEPC\57\2-10.doc 4.2.3 Bromoform, Dibromochloromet hane, Dichlorobromomethane

Log
K ow Results Reference

Bomoform
Dibromochloromethane
Dichlorobromomethane 2.38
2.08

1.88 Some bioaccumulation of bromoform in sea bass was noted, but this accumulation rapidly dissipated. No impacts on growth were observed and no damage to liver tissues was
observed. Taylor (2006)

4.2.4 2,4,6-Tribromophenol

Measured values suggest that the potential for bioconcentr ation of 2,4,6-TBP in aquatic organisms is moderate to high. Octanol/wat er partition coeffici ent (log Kow) is 4.02.

Exposure of bluegills ( Lepomis macrochirus ) to 14C-labelled 2,4,6- TB P for 28 days resulted
in 20-fold bioaccumulation in edible tissue and 140-fold bioconcentration in viscera. Plateau levels were reached by 3–7 days of e xposure. The half-life for residues was less than 24 h following termination of exposure (WHO, 2005).

As described in Taylor (2006) for coastal and estuarine power stations cooling water, the influence of long-term exposure by chlorina tion residues (including 2,4,6-Tribromophenol) on sea bass ( Dicentrarchus labrax ) was found to be very lim ited. Although some bromoform bioaccumulation was noted during annual chlorination seasons, this accumulation rapidly dissipated thereafter. No impacts on growth were observed and no damage to liver tissues.

4.2.5 Dibromoacetonitrile

Adsorption to sediment and bioconcentration in aquatic organisms is stated in WHO (2004) stated as “not expected”.

As described in Taylor (2006) for coastal and estuarine power stations cooling water, the influence of long-term exposure by chlorination residues (including dibromoacetonitrile) on sea bass ( Dicentrarchus labrax ) was found to be very limited. Although some bromoform bioaccumulation was noted during annual chlorination seasons, this accumulation rapidly dissipated thereafter. No impacts on growth were observed and no damage to liver tissues.

4.3 Persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh waters)

4.3.1 Bromoform, Dibromochloromet hane, Bromodichloromethane

Bromodichloromethane (BDCM) is metabolized to phosgene, whereas dibromochloromethane (DBCM) and bromoform are metabolized to brom inated analogues of phosgene. The rate of metabolism of these compounds to carbon monoxide both in vivo and in vitro generally follows the halide order: namely, bromoform >> DBCM > BDCM >> chloroform. IPCS (2000) postulated that the brominated THMs may be mo re rapidly and more extensively metabolized than their chlorinated counterpa rts. Although this may be true for BDCM, support for this statement, as it pertains to DBCM or bromof orm, is difficult to determine from the limited literature currently available. The majority of the comparative metabolism studies conducted to
date are limited to chloroform or BDCM. Nonetheless, it would appear that the toxicity of BDCM and likely other brominat ed THMs is mediated through a bioactivation pathway (from WHO, 2005).GESAMP-BWWG 5/9
ANNEX 8 Page 39

I:\MEPC\57\2-10.doc No information on persistence of metabolite s has been found. According to MEPC 56-2, no persistent substance is formed by DBCM.

4.3.2 2,4,6-Tribromophenol

TBP is in itself a natural metabolite from infauna in marine pristine soft bottom habitats (for example from Acorn worms (enteropneusta )). However, no information was found on the metabolites of TBP (same conclusion in WHO, 2005).

4.3.3 Dibromoacetonitrile

Halogenated acetonitriles are metabolized via oxidative de halogenation and dehydration to carbon dioxide and cyanide, which is then further me tabolized to thiocyanate. The first step in this reaction is catalysed by a mixed-function ox idase (such as a cytoch rome P-450) and results in production of a halocyanomethanol. It is proposed that the halocyanomethanols then dehydrate to form halocyanoformaldehydes or lose cyanide to form haloformaldehydes, including phosgene. The cyanide ca rbon group is more readily excret ed in the urine, whereas the halomethyl carbon group is excreted nearly equally in expired air and in urine; excretion in faeces is low (WHO 2004).

Data on persistence of main me tabolites have not been found.

4.4 Reaction with organic matter

4.4.1 Bromoform

When chlorine or bromine is used to treat balla st water, trihalomethanes such as bromoform are formed as a by-product. They result from the r eaction of chlorine and/or bromine with organic matter in the water being treated. However, once the bromoform is formed it does not appear to have any further reactions with organic matter (MEPC 56/2/3).

4.4.2 Dibromochloromethane

When chlorine or bromine is used to treat ba llast water, THMs are formed as a by-product. They result from the reaction of chlorine and/or bromine with organic matter in the water being treated. However, once the THM is formed it does not appear to have any further reactions with organic matter.

4.4.3 Dichlorobromomethane

When chlorine or bromine is used to treat ballast water, THMs are formed as a by-product. They result from the reaction of chlorine and/or bromine with organic matter in the water being treated. However, once the THM is formed it does not appear to have any further reactions with organic matter.

4.4.4 2,4,6-Tribromophenol

Bromophenols can be formed during the chlorinati on of natural water and wastewater containing phenol and bromide ions. No information has been found on further reactions with organic matter.GESAMP-BWWG 5/9
ANNEX 8 Page 40

I:\MEPC\57\2-10.doc 4.5 Potential physical effects on wildlife and benthic habitats

4.5.1 Bromoform

No information is available on the effects on wildlife or benthic ha bitats (MEPC 56/2/3), however significant physical eff ects have not been considered relevant for this substance.

4.5.2 Dibromochloromethane

DBCM has a higher specific gravity than seaw ater (2.451 (20°C)) a nd a low solubility (2.7g/L (20°C)). Therefore, according to evaluation based on GESA MP hazard evaluation (GESAMP (2002)), the compound is classified as Rating S (substances having a potential effect on benthic habitats) (MEPC 56/2).

4.5.3 Dichlorobromomethane

No information has been available on physical e ffects on wildlife and benthic habitats, however, significant physical effects ha ve not been considered rele vant for this substance.

4.5.4 2,4,6-Tribromophenol

No information has been available on physical e ffects on wildlife and benthic habitats, however, significant physical effects ha ve not been considered rele vant for this substance.

4.6 Potential residues in seafood

4.6.1 Bromoform

No information has been found on bromoform residues in seafood (see also MEPC 56/2/3).

4.6.2 Dibromochloromethane

As DBCM is considered to have low bioaccumu lation potential, its persistence in seafood is expected to be low. Accordi ng to studies, DBCM was not dete cted in oysters, clam and the
sediment of the Ariho River and the Yoshinaga River (MEPC 56/2).

4.6.3 Dichlorobromomethane

DBCM is not a common food contaminant but has been found in trace amounts in some samples: 1.2 μ g/kg in one dairy composite and 7 μ g/kg in butter (WHO, 1996). However, information on potential residue s in seafood has not been found.

4.6.4 2,4,6-Tribromophenol

2, 4, 6-tribromophenol has been measured in wild-harvested prawns, and ocean fish, Eastern Australia. The levels ranged from 0.1 to 230 ng/g in fish (gut, flesh) and 0.12-460 ng/g in prawns (head, tail) (Danske Mi ljøministeriet, 2000). In biota likely to form part of human diets, edible portions contain mean 2,4,6-TBP concentrations up to 198 and 2360 μ g/kg dry weight in molluscs and crustaceans, respectively, and up to 39 μ g/kg dry weight in marine fish. Brominated phenols have been detected in hum an milk, blood, and adipose tissue (WHO, 2005).GESAMP-BWWG 5/9
ANNEX 8 Page 41

I:\MEPC\57\2-10.doc 4.7 Interactive effects

No information has been f ound on interactive effects.

Physical and chemical properties for the Actives Substances and preparations and treated ballast water (G9: 4.2.1.4).

____________