For reasons of economy, this document is printed in a limited number. Delegates are 

kindly asked to bring their copies to meetings and not to request additional copies.

I:\MEPC\59\2-19.doc 

INTERNATIONAL MARITIME ORGANIZATION

IMO 

E

MARINE ENVIRONMENT PROTECTION 

COMMITTEE 

59th session 

Agenda item 2 

MEPC 59/2/19

 5 May 2009

 Original: ENGLISH

HARMFUL AQUATIC ORGANISMS IN BALLAST WATER 

Report of the ninth meeting of the GESAMP-Ballast Water Working Group 

Note by the Secretariat 

SUMMARY

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

the GESAMP-Ballast Water Working Group (GESAMP-BWWG) 

and includes the evaluation of proposals submitted for approval 

by Japan, the Netherlands and Germany. Following the decision 

of MEPC 58, only the main body of the GESAMP-BWWG’s reports 

is translated in all the three working languages with the annexes 

in English only. 

Strategic direction: 7.1 

High-level action: 7.1.2 

Planned output: 7.1.2.4 

Action to be taken: Paragraph 6 

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

Introduction

1 The ninth meeting of the GESAMP-Ballast Water Working Group (GESAMP-BWWG) 

was held at IMO Headquarters from 23 to 27 March 2009 and its report is attached to this 

document as GESAMP-BWWG 9/6. 

2 The main purpose of this meeting was to review the proposals for approval of ballast water 

management systems that make use of Active Substances to treat ballast water prior to discharge 

into the marine environment. The findings of the Group are contained in annexes 4 to 6 of the 

attached report. 

3 Due to the limited time between two consecutive sessions of the MEPC, 

the GESAMP-BWWG could only meet twice (GESAMP-BWWG 8 and GESAMP-BWWG 9) 

and was able to evaluate eight proposals for approval in their chronological order of submission. 

With a view to facilitating the consideration of as many ballast water management systems as
MEPC 59/2/19 - 2 - 

I:\MEPC\59\2-19.doc 

possible by the MEPC and in anticipation of an increasing workload for year 2010, the Group 

agreed to hold an extraordinary meeting (GESAMP-BWWG 10), tentatively scheduled 

from 14 to 18 September 2009, to evaluate the remaining four proposals submitted by the 

deadline of 19 December 2008 and report to MEPC 60. 

4 Since MEPC 60 will be held in March 2010, the Group agreed to tentatively schedule its 

next regular meeting (GESAMP-BWWG 11) from 19 to 23 October 2009, subject to submission 

of relevant documents and application dossiers by Member Governments. In accordance with the 

approved timetable for activities related to GESAMP-BWWG meetings, the deadline for 

submission of proposals to be considered by MEPC 60 is 28 August 2009. 

5 Recognizing the possibility that more than four proposals may be submitted for its review 

and approval by MEPC 60, the Group expressed its availability to have an additional meeting, 

in December 2009, to accommodate as many proposals as possible provided that all necessary 

conditions for organizing such a meeting are met. 

Action requested of the Committee

6 The Committee is invited to: 

 .1 agree that Final Approval is given to the Hitachi Ballast Water Purification System 

(ClearBallast) submitted by Japan in document MEPC 59/2/5 (see annex 4); 

 .2 agree that Final Approval is given to the Greenship Sedinox Ballast Water 

Management System submitted by the Netherlands in document MEPC 59/2/6 

(see annex 5); 

 .3 agree that Basic Approval is given to the AquaTriCombTM Ballast Water 

Treatment System submitted by Germany in document MEPC 59/2/8 

(see annex 6); 

 .4 note that the Group had agreed to hold an extraordinary meeting 

(GESAMP-BWWG 10), tentatively scheduled from 14 to 18 September 2009, to 

evaluate the remaining four proposals submitted by the deadline of 19 December 2008 

and report to MEPC 60; 

 .5 note the suggested time schedule for the eleventh meeting of the GESAMP-BWWG 

(19 to 23 October 2009) and invite Members to submit their proposals for approval 

(application dossiers) and the non-confidential description of their ballast 

water management systems to MEPC 60, as soon as possible but not later 

than 28 August 2009; and 

 .6 approve the report in general. 

*** 
I:\MEPC\59\2-19.doc 

GESAMP-BALLAST WATER WORKING 

GROUP (GESAMP-BWWG) 

Agenda item 9 

GESAMP-BWWG 9/6

 27 March 2009

 Original: ENGLISH

REPORT OF THE NINTH MEETING OF THE GESAMP-BALLAST WATER 

WORKING GROUP (GESAMP-BWWG) 

Table of Contents 

Section Page Nos. 

 

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

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

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

4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS .................................................................... 5 

5 ANY OTHER BUSINESS......................................................... 7 

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

 

I:\MEPC\59\2-19.doc 

ANNEXES 

Annex 1 List of members who attended the Ninth Meeting of the GESAMP-BWWG 

Annex 2 Agenda for the Ninth Meeting of the GESAMP-BWWG 

Annex 3 Terms of reference for the Technical Group 

Annex 4 Review of proposals for approval of ballast water management systems that make 

use of Active Substances – Hitachi Ballast Water Purification System (ClearBallast) 

(Japan) 

Annex 5 Review of proposals for approval of ballast water management systems that make 

use of Active Substances – Greenship Sedinox Ballast Water Management System 

(the Netherlands) 

Annex 6 Review of proposals for approval of ballast water management systems that make 

use of Active Substances – AquaTriCombTM Ballast Water Treatment System 

(Germany) 
 - 3 - GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

1 INTRODUCTION 

1.1 The ninth GESAMP-Ballast Water Working Group (GESAMP-BWWG) meeting was 

held at IMO Headquarters, London, from 23 to 27 March 2009, under the chairmanship 

of Mr. Jan Linders. 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. Dandu Pughiuc, Head, Marine Biosafety Section, who 

conveyed the appreciation of the Director of Marine Environment Division for the effort made by 

the members of the GESAMP-BWWG to have this additional meeting before MEPC 59 in an 

attempt to review as many as possible of the remaining proposals which had been submitted 

before the deadline established for MEPC 59 (i.e. 19 December 2008). Mr. Pughiuc informed 

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 is prepared to take all the possible actions 

to maximize the effectiveness and efficiency of the Group in the common effort to respond to the 

growing number of proposals for approval. Also on this subject, Mr. Pughiuc emphasized the 

need to continue the work on adapting the MAMPEC model to the specificity of ballast water 

discharges and invited the members of the Group advice on the next steps in this respect. 

1.3 The Group was also informed a new link for approved ballast water management systems 

on the IMO’s website and agreed that a clear distinction between systems that have undergone 

evaluations according to Procedure (G9) and systems approved in accordance with Guidelines (G8) 

needs to be made. 

1.4 Mr. Pughiuc expressed his appreciation for the effort made by the IMO consultant, 

Dr. Andrew Craven, for his hard work in preparing this meeting and for reviewing a large 

amount of documentation in a relatively short period of time. 

1.5 Finally, Mr. Dandu Pughiuc 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 Dr. Stephan Gollasch, arrangements had been made for him to be excused when the proposal 

for approval of the AquaTriCombTM Ballast Water Treatment System (Germany) is reviewed, 

due to his involvement in the development of this technology. Dr. Gollasch took no part in this 

evaluation and his contract was consequently reduced to ten working days. 

2 ISSUES OF CONFIDENTIALITY 

2.1 One proposal for Basic Approval of ballast water management systems that make use 

of Active Substances had been submitted by Germany (MEPC 59/2/8) and two proposals for 

Final Approval had been submitted by Japan (MEPC 59/2/5) and the Netherlands 

(MEPC 59/2/6). All three submissions contained confidential supporting data. 

2.2 The confidential nature of the information was recognized by the Group and was treated 

as such in order to protect the commercial interests of the manufacturers concerned. In order to 

ensure that the report did not contain any confidential information, the Group noted that 

the Secretariat would liaise with the relevant Administrations prior to submitting the report 

to MEPC. 

2.3 Pursuant to paragraphs 4.2.2, 8.1.1 and 8.1.2.7 of the “Procedure for approval of ballast 

water management systems that make use of Active Substances (G9)”, all information gathered, 

materials, notes and reports obtained or made out during the work of the GESAMP-BWWG, 
GESAMP-BWWG 9/6 - 4 - 

 

I:\MEPC\59\2-19.doc 

were, and will be, treated as confidential. In this respect all the members of the Group and the 

Consultants signed the Statements of Acceptance related to confidentiality. 

2.4 The original copies of these Statements, duly signed and dated by all involved, were filed 

with the Technical Secretary of the Group and will be kept together with the submissions. 

2.5 The submissions (dossiers) were deposited in a safe place in the IMO Headquarters and 

made available to the Consultant, at his request, during the working hours. They were available 

for consultation by the members of the Group for the duration of the meeting in the meeting 

room and returned to the Organization’s designated room after the working hours. 

2.6 On completion of the work, the Chairman of the GESAMP-BWWG obtained from the 

other members all the documents, drafts and any other associated records and reports, which 

were transmitted to the Technical Secretary of the GESAMP-BWWG for retention in confidence. 

All electronic records and data held on personal computers/laptops were destroyed when they 

were no longer necessary for the work of the GESAMP-BWWG. 

3 TERMS OF REFERENCE AND TIME FRAME 

3.1 The Group continued to conduct its work in accordance with the Terms of Reference 

approved by the MEPC as contained in annex 3 of this report. 

3.2 The Group used the table below to determine the timetable for activities related to its 

regular meetings and agreed to decide, on a case-by-case basis, on the timing of additional 

meetings as appropriate. 

TIMETABLE FOR ACTIVITIES RELATED TO GESAMP-BWWG MEETINGS 

Timeline Activity 

28 weeks before MEPC Deadline for submission of application dossiers and related 

documents to be reviewed by the GESAMP-BWWG 

(8 weeks) Preparation of the meeting, including circulation of any relevant 

information provided by other delegations 

20 weeks before MEPC GESAMP-BWWG Meeting 

(1 week) Editing and completion of the draft report of the meeting 

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

response/clarification by the working group 

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

the report 

(1 week) Produce the final report addressing the comments by GESAMP 

13 weeks before MEPC Submission of the report of the meeting of the GESAMP-BWWG in 

accordance with the 13-week deadline (bulk documents) for MEPC 
 - 5 - GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

3.3 Due to the limited time between two consecutive sessions of the MEPC, the Group could 

only meet twice (GESAMP-BWWG 8 and GESAMP-BWWG 9) and was able to evaluate eight 

proposals for approval in their chronological order of submission. With a view to facilitating the 

consideration of as many ballast water management systems as possible by the MEPC and in 

anticipation of an increasing workload for year 2010, the Group agreed to hold an extraordinary 

meeting (GESAMP-BWWG 10), tentatively scheduled from 14 to 18 September 2009, to 

evaluate the remaining four proposals submitted by the deadline of 19 December 2008 and to 

report to MEPC 60. 

3.4 Since MEPC 60 will be held in March 2010, the Group noted that the deadline for 

submission of proposals for approval to be considered by MEPC 60 is 28 august 2009 and agreed 

to tentatively schedule its eleventh meeting for 19 to 23 October 2009, subject to submission of 

relevant documents and application dossiers by Member Governments. The Group will review 

the application dossiers received before 28 August 2009 and will further develop its 

“Methodology for information gathering and the conduct of work” as necessary. 

3.5 Recognizing the possibility that more than four proposals may be submitted for its review 

and approval by MEPC 60, the Group expressed its availability to have an additional meeting to 

accommodate as many proposals as possible provided that all necessary conditions for organizing 

such a meeting are met. 

4 REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS 

4.1 General review of the submissions

4.1.1 The Group noted that submissions for Final Approval had been received from Japan 

and the Netherlands whilst a submission for Basic Approval had been received from Germany. 

4.1.2 Having reviewed all of the submissions, the Group agreed that there are a number of 

points arising which it wished to bring to the attention of the MEPC. These are addressed in the 

rest of this section. 

4.1.3 During a general discussion on the possibility of requesting the manufacturers to address 

additional aspects to the ones identified during the evaluation for Basic Approval, the Group was 

of the view that aspects posing a risk to the environment or human health not raised during the 

initial evaluations could still be questioned, particularly when the systems or the Methodology 

have changed. 

4.1.4 The Group recommended that Administrations, before submitting a Final Approval dossier 

to MEPC, should check and confirm whether or not the ecotoxicity testing required by Procedure 

(G9) is performed as part of the Type Approval testing in accordance with the requirements for the 

whole effluent tests, as this has implications for the dossier review required under Procedure (G9). 

4.1.5 The Group agreed that each applicant should make a clear reference to the Methodology 

version being followed in the preparation of their application. 

4.1.6 The Group noted that, during this meeting, it was necessary to request additional 

information or clarification from all the applicants, as the dossiers were incomplete or, more 

commonly, the information provided was unclear, so slowing down the evaluation process. 
GESAMP-BWWG 9/6 - 6 - 

 

I:\MEPC\59\2-19.doc 

4.1.7 In this context, the Group invited MEPC to note that time spent evaluating inadequate 

dossiers prevented it from evaluating those that were complete and likely to be recommended for 

approval. 

4.2 Detailed review of the submissions

4.2.1 Details of the submissions reviewed by the Group can be seen in: 

Annex BWMS Administration 

4 Hitachi Ballast Water Purification System (ClearBallast) Japan 

5 Greenship Sedinox Ballast Water Management System the Netherlands 

6 AquaTriCombTM Ballast Water Treatment System Germany 

4.2.2 With regard to the criteria associated with Procedure (G9), having reviewed all of the 

information associated with these submissions, the Group recommended that: 

 .1 Final Approval be given to the Hitachi Ballast Water Purification System 

(ClearBallast) (Japan); 

 .2 Final Approval be given to the Greenship Sedinox Ballast Water Management 

System (the Netherlands); and 

 .3 Basic Approval be given to the AquaTriCombTM Ballast Water Treatment System 

(Germany). 

4.3 Specific comments related to the Hitachi Ballast Water Management System 

(ClearBallast)

4.3.1 The Group noted that the Hitachi Ballast Water Management System (ClearBallast) is a 

system consisting of coagulation and magnetic separation, with removal of the resulting 

flocculated material from the ballast water. 

4.3.2 The Group recommended to MEPC that Final Approval be given to the Hitachi BWMS 

(ClearBallast) provided that the concerns and issues raised in the review are addressed by the 

Applicant and this is confirmed by the Administration during Type Approval procedures under 

Guidelines (G8). 

4.3.3 The Group, having reviewed the dossier and additional responses requested of the 

applicant, was of the opinion that although generally safe, this system remains under 

development. The Group agreed that when this BWMS is correctly operated it will present no 

unacceptable risks to the environment, and when all the risk mitigation measures that have been 

identified as necessary in this review are developed in detail and implemented, 

the ClearBallast BWMS will present no unacceptable risks to the safety of the ship, its crew or 

human health. To this end, the Group strongly recommended that the MEPC requests 

the Administration undertaking the Type Approval testing under Guidelines (G8) to inform 

the Committee that all issues and concerns have been addressed prior to issuing a Type Approval 

Certificate for this system. 
 - 7 - GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

4.4 Specific comments related to the Greenship Sedinox Ballast Water Management 

System 

4.4.1 The Group noted that the Greenship Sedinox Combined Ballast Water Management System 

consists of sediment removal and in situ electrolysis using seawater to produce Active Substance 

for biocidal treatment of ballast water. 

4.4.2 The Group noted that in response to the comment of the GESAMP-BWWG that the 

system needed refinement (MEPC 58/2/7, annex 6, paragraph 2.1.9), the Applicant had 

significantly refined the system without changing the principles of the treatment. The refinement 

consisted of three main adjustments: (1) lowering the maximum dose concentration 

of Active Substance at uptake, (2) removal of the disinfection at ballast water discharge and (3) 

installing online continuous monitoring of Active Substance during uptake with continuous feedback to the electrolytic cells to maintain an optimum dose concentration of Active Substance. 

The Group reviewed these modifications in detail and noted that significant improvements to the 

BWMS have resulted, and in view of all the information now received from the Applicant on this 

refined system, the Group was satisfied with the completeness of the dossier received from 

the Applicant. 

4.4.3 Having reviewed all the information provided by the Applicant, the Group agreed to 

recommend to the MEPC that Final Approval be given to the Greenship Sedinox BWMS, subject 

to the Administration verifying that these two recommendations have been fully addressed prior 

to issuance of a Type Approval Certificate: 

 .1 maximum allowable dosage of Active Substance at FAC of 1.0 mg/L as Cl2 is 

monitored by FAC sensor adequately calibrated and maintained. FAC should be 

recorded during uptake; and 

 .2 maximum allowable discharge concentration of Active Substance 

The concentration of FAC at discharge should be kept to a level not exceeding the 

range of 0.01-0.20 mg/L as Cl2 even after a short leg. During the Type Approval 

procedure by the Administration, the Applicant should decide on the maximum 

allowable discharge concentration of TRO in the range of 0.01-0.20 mg/L as Cl2 

and this value should be approved by the Administration. This parameter should 

be monitored by FAC sensor adequately calibrated and maintained. 

4.5 Specific comments related to the AquaTriCombTM Ballast Water Management 

System

4.5.1 The Group noted that the AquaTriComb system is a Ballast Water Management System 

consisting of filtration and disinfection by low-pressure ultraviolet-light and low-frequency 

ultrasound. The Group noted that the low-pressure UV technology in the system makes use of 

electromagnetic radiation (photons) and the low-frequency ultrasound technology makes use of 

ultrasonic oscillation and cavitation effects to treat the ballast water and for cleaning purposes. 

5 ANY OTHER BUSINESS 

No action was taken under this agenda item. 
GESAMP-BWWG 9/6 - 8 - 

 

I:\MEPC\59\2-19.doc 

6 CONSIDERATION AND ADOPTION OF THE REPORT 

6.1 A draft report of the ninth meeting of the GESAMP-BWWG was produced 

on 27 March 2009 and, after a paragraph-by-paragraph review, the Group agreed on the final text 

and requested the Secretariat to make the necessary editorial changes to ensure consistency 

with IMO documents’ format and style. 

6.2 The Chairman expressed his appreciation for the long hours and substantial efforts made 

by the members of the Group throughout the week and closed the meeting at 17 h 30. 

*** 
GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

ANNEX 1 

LIST OF MEMBERS WHO ATTENDED THE NINTH MEETING 

OF THE GESAMP-BWWG 

Mr. Jan Linders (Chairman) 

Senior Risk Assessor 

National Institute for Public Health and 

 Environment Expert Centre on Substances 

Anthonie van Leeuwenhoeklaan 9 

RIVM-SEC 

P.O. Box 1 

NL-3720 BA Bilthoven 

The Netherlands 

E-mail: 

Tel: 

Fax: 

jan.linders@rivm.nl 

+31 30 274 3164 

+31 30 274 4401 

Ms Teresa Borges 

Senior Technical Officer 

Avenida Rio de Janeiro, no 58, 3o dto 

1700-338 Lisbon 

Portugal 

E-mail: 

Tel: 

Mobile: 

tborges@dgs.pt

+351 2 1843 0599 

+351 9 1779 8048 

Dr. Stephan Gollasch 

GoConsult 

Grosse Brunnenstr. 61 

22763 

Hamburg 

Germany 

E-mail: 

Tel: 

Mobile : 

sgollasch@aol.com 

+49 40 390 54 60 

+49 177 590 54 60 

Mr. Shinichi Hanayama 

Senior Research Fellow 

Maritime Technology Department 

Ocean Policy Research Foundation 

1-15-16 Toranomon 

Minato-ku 

Tokyo 105-0001 

Japan 

E-mail: 

Tel: 

Fax: 

s-hanayama@sof.or.jp 

+81 3 3502 1886 

+81 3 3502 2033 

Ms Annette Kronborg 

Director 

Adalia Toxicology Consultants 

Runslingan 3E 

SE-187 72 TÄBY 

Sweden 

E-mail: 

Tel: 

Fax: 

Mobile: 

annette.kronborg@adalia.se

+46 8 510 149 36 

+46 8 510 126 02 

+46 70 483 11 23 
GESAMP-BWWG 9/6 

ANNEX 1 

Page 2 

I:\MEPC\59\2-19.doc 

Dr. Kitae RHIE 

Professor of Biology Department 

Kyung Hee University 

#1 Hoe-ki Dong 

Dong-dae-moon Ku 

Seoul 130-701 

Republic of Korea 

E-mails: 

Tels: 

Fax: 

Mobile: 

rhiekt@khu.ac.kr 

alga0720@hotmail.com 

+82 (2) 961-0720 (Univ.) 

 (2) 961-0603 (Lab.) 

+82 (2) 961 0244 (Univ.) 

+82 16 9343 3860 

Dr. Frank Stuer-Lauridsen 

LITEHAUZ ApS 

Diplomvej 381 

DK 2800 Lyngby 

Denmark 

E-mail: 

Tel: 

Mobile: 

fsl@litehauz.dk 

+45 8870 8675 

+45 2023 0202 

Mr. David Tongue 

Marine Manager 

International Chamber of Shipping 

12 Carthusian Street 

London EC1M 6EZ 

United Kingdom 

E-mail: 

Tel: 

Fax: 

Mobile: 

david.tongue@marisec.org

+44 20 7417 2860 

+44 20 7417 8877 

+44 78 5539 1258 

IMO-GESAMP CONSULTANT 

 

Dr. Andrew Craven 

23 Wenlock Drive 

Escrick 

York YO19 6JB 

United Kingdom 

E-mail: 

Tel: 

Fax: 

andrew.craven7@btinternet.com 

+44 (0) 7849 070 668 (Mobile) 

+44 (0) 1904 728 428 (H) 

GESAMP 

 

Mr. Martin Soderberg 

GESAMP Officer 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment, London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax 

Mobile: 

msoderbe@imo.org 

+44 (0)20 7463 4139 (Direct) 

+44 (0)20 7587 3210 

0755 269 9604 

 
GESAMP-BWWG 9/6 

ANNEX 1 

Page 3 

I:\MEPC\59\2-19.doc 

MED DP TH jw 

IMO SECRETARIAT

Mr. Miguel Palomares 

Director 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

mpalomares@imo.org 

+44 (0)20 7587 3218 

+44 (0)20 7587 3210 

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 3261 

Mr. Dandu Pughiuc 

IMO Technical Secretary to GESAMP-BWWG 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

dpughiuc@imo.org 

+44 (0)20 7587 3247 (Direct) 

+44 (0)20 7587 3261 

Mr. Huang Tianbing 

Technical Officer, Marine Biosafety Section 

Marine Environment Division 

International Maritime Organization 

4 Albert Embankment 

London SE1 7SR 

United Kingdom 

E-mail: 

Tel: 

Fax: 

thuang@imo.org

+44 (0)20 7463 4198 (Direct) 

+44 (0)20 7587 3261 

*** 

GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

ANNEX 2 

AGENDA FOR THE NINTH MEETING OF THE GESAMP-BWWG 

1 Introduction 

2 Issues of confidentiality 

3 Terms of reference and time frame 

4 Review of proposals for the approval of Active Substances 

– Hitachi Ballast Water Purification System (ClearBallast)) for Final Approval 

 – Greenship Sedinox Ballast Water Management System for Final Approval 

 – AquaTriCombTM Ballast Water Treatment System for Basic Approval 

5 Any other business 

6 Consideration and adoption of the report

*** 

GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

ANNEX 3 

TERMS OF REFERENCE FOR THE TECHNICAL GROUP 

1 Consideration of development of necessary methodologies and information requirements 

in accordance with the “Procedure for approval of ballast water management systems that make 

use of Active Substances (G9)” (adopted by resolution MEPC.169(57)) for consideration 

by MEPC 59. 

2 For Basic Approval, the Group should review the comprehensive proposal submitted by 

the Member of the Organization along with any additional data submitted as well as other 

relevant information available to the 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 Procedure (G9)); 

.2 scientific evaluation of the assessment report contained in the proposal for 

approval (see paragraph 4.3.1 of Procedure (G9)); 

.3 scientific evaluation of the risks to the ship and personnel to include consideration 

of the storage, handling and application of the Active Substance (see 

paragraph 6.3 of Procedure (G9)); 

.4 scientific evaluation of any further information submitted (see paragraph 8.1.2.6 

of Procedure (G9)); 

.5 scientific review of the risk characterization and analysis contained in the proposal 

for approval (see paragraph 5.3 of Procedure (G9)); 

.6 scientific recommendations on whether the proposal has demonstrated a potential 

for unreasonable risk to the environment, human health, property or resources 

(see paragraph 8.1.2.8 of Procedure (G9)); and 

.7 preparation of a report addressing the above-mentioned aspects for consideration 

by MEPC (see paragraph 8.1.2.10 of Procedure (G9)). 

3 For Final Approval, the Group should review the discharge testing (field) data and 

confirm that the residual toxicity of the discharge conforms to the evaluation undertaken 

for Basic Approval and that the previous evaluation of the risks to the ship and personnel 

including consideration of the storage, handling and application of the Active Substance remains 

valid. The evaluation will be reported to the MEPC (see paragraph 8.2 of Procedure (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.

*** 

GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

ANNEX 4 

REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER MANAGEMENT 

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

Hitachi Ballast Water Purification System (ClearBallast) 

Submitted for Final Approval by Japan

0 SUMMARY 

0.1 Having reviewed all the data and information submitted by Japan with the application 

for Final Approval and the information received from the applicant during the GESAMP-BWWG 

meeting, the Group recommended to MEPC that Final Approval be given to the Hitachi BWMS 

(ClearBallast) provided that the concerns and issues raised in this review are addressed by the 

applicant to the satisfaction of the Administration. To avoid unreasonable risk to the 

environment, human health, property or resources the system should be operated with the 

following restrictions: 

 .1 Maximum allowable dosages of Active Substances – The maximum dose for 

these Active Substances should be set as follows: 

5 mg/L of PAC (as Al) 

30 mg/L of triiron tetraoxide (Fe3O4) 

1 mg/L of PASA; and 

 .2 Maximum allowable discharge concentrations of Active Substances – The 

system should ensure a maximum discharge concentration of all the Active 

Substances and Relevant Chemicals, if the separation and filtering process are 

functionally operated. To ensure these processes, the water level in these 

components should be recorded during ballast water intake. 

 .3 PASA needs to be strictly controlled by adequate selection of the suppliers in 

order to keep the concentration of acrylamide monomers as its impurity 

below 0.2%. Procedures should be included in the Quality Assurance Program to 

ensure that only PASA with an acrylamide monomer content of less than 0.2% is 

supplied for the operation of this BWMS 

0.2 The Group recalled that Basic Approval of the Hitachi BWMS (ClearBallast) was 

given by MEPC and the report was available as document MEPC 57/2 (BWWG 4, annex 5, 

Report of Application for Basic Approval). 

0.3 The Group wished to stress that the evaluation of the ClearBallast system in this report 

did not take account of the potential risk mitigation effect of the addition of a heat treatment step 

as suggested by the applicant during the exchange of information (Questions and Answers) at the 

meeting of GESAMP-BWWG 9. Therefore, heat treatment which has not yet been developed by 

the applicant was explicitly not considered is this report. 

0.4 The Group limited itself to the system as presented, and regarded this as generally 

complete but identified a number of points which in its opinion need further attention. Some 

operational procedures appear still to be developed, such as definitive safety and maintenance 

procedures and manuals. 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 2 

I:\MEPC\59\2-19.doc 

0.5 The Group noted that the ClearBallast Ballast Water Management System (BWMS) uses 

a combination of Coagulation and then Magnetic Separation to treat the ballast water, and as such 

there is no biocidal activity involved in the treatment process, which produces significant 

quantities of separated floc material (sentence deemed to be confidential and removed at the 

request of the submitting Administration). Therefore the Group concluded that adequate 

management of the flocculated material is one of the key issues needed to prevent risks to human 

health or the environment according to the principles of the BWM Convention. The Group 

recalled that the flocculated material consists of a condensed mixture of organic matter and 

organisms including bacteria and potentially pathogens that is not disinfected by any chemicals. 

Therefore, particularly careful management will be needed for this flocculated material. 

The Group was of the opinion that such material may pose a risk if discharged at sea. 

0.6 The Group recognized that the system relies on various Active Substances (triiron tetraoxide, 

PAC and PASA) with potential safety and environmental concerns and the Group has reviewed the 

hazards and risks associated with each of the Active Substances, together with one relevant chemical 

(acrylamide monomers which occur as an impurity in PASA). 

0.7 The Group highlighted that the acrylamide impurity in PASA has toxicological 

properties of high concern towards human health as this chemical has carcinogenic 

(IARC classification 2A, probable carcinogenic to humans (IARC, 1994)) and neurotoxic 

properties. Therefore it was stressed that the quality of the polyacrylamide (PASA) needs to be 

strictly controlled by adequate selection of the suppliers in order to keep the concentration of 

acrylamide monomers as its impurity below 0.2%. Procedures should be included in 

the Quality Assurance Program to ensure that only PASA with an acrylamide content of 

less than 0.2% is supplied for the operation of this BWMS. 

0.8 In addition, the Group noted the provision by the applicant of detailed analytical results for 

the Active Substances, relevant chemical and other chemicals in treated ballast water. However, 

the Group noted that no quantitative analysis of the potential biological content of the flocculated 

material (e.g., analysis of viable pathogens) was provided as had been requested at Basic Approval. 

0.9 The Group noted that the human health assessment provided by the applicant addressed 

the risks related to occupational exposure which included a description of the different working 

operations in the system according to the recommendations made by BWWG 4, annex 5, Report 

of Application for Basic Approval. 

0.10 The Group also noted that according to the applicant, additional safety measures 

concerning occupational exposure are planned to be implemented in order to minimize the risk of 

human exposure to chemicals used in this system. The Group considered that the procedures and 

measures to be put in place related to handling and disposal of the collected flocs will necessarily 

have to take into account strict engineering control measures and detailed instructions. 

Furthermore, adequate PPE/RPE, should be included in the Operation Manual to provide the 

necessary QA standards. Alternatively a fully automated system for the treatment and handling of 

the flocculated material should be incorporated in the BWMS. 

0.11 The Group, not wanting to delay system approval unnecessarily and taking the unusual, 

biocide-free design of the system into account, considered that the applicant had provided 

sufficient information for BWWG to recommend to MEPC that it be granted Final Approval and 

that any outstanding aspects could be dealt with by the Administration prior to Type Approval. 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 3 

I:\MEPC\59\2-19.doc 

0.12 The Group noted that the total weight of an operational system appears high compared to 

other proposed ballast water management systems, and recommended that the Administration 

approving a ship installation ensures that this factor is fully taken into account when determining 

a suitable location, the additional effect on ship stability of a gravity fed “buffer tank” may also 

be found a relevant consideration in this respect. 

0.13 The Group recognized that the applicant has provided detailed information on ecotoxicity 

testing of treated ballast water, environmental risk assessment for aquatic organisms and 

proposals for maximum allowable discharge concentrations for the Active Substances and 

relevant chemical. The Group accepted the view of the applicant that there should be no 

unacceptable risks to the environment posed by the use of this BWMS, based on individual 

calculations for the different substances as well as estimations using the MAMPEC-model. 

0.14 The Group, having reviewed the dossier and additional responses requested of the 

applicant, was of the opinion that the system should be considered generally safe for the 

environment, the crew and human health, when this BWMS is correctly operated. To this end, 

the Group strongly recommended that the MEPC invites the Administration undertaking 

the Type Approval testing under Guidelines (G8) to ensure that all issues and concerns have been 

addressed prior to issuing a Type Approval Certificate for this system. 

 .1 The procedure for handling the flocculated material that contains a condensed 

mixture of organic matter and organisms including bacteria and potentially 

pathogens is unclear. In the flocs all material is concentrated and the instructions 

on how to handle this potentially bio-hazardous material should be clear and 

unambiguous to all crew concerned. Therefore, prior to operating the system, the 

applicant will have to provide an Operation/Technical Manual where all safety 

procedures should be explicitly described including the different risk mitigation 

measures and PPE/RPE prescribed in all handling, storage and treatment steps of 

the flocculated material generated by the system. 

 .2 The Group noted that a gravity “buffer tank” is a requirement of the system. 

Additional water level error detection devices will require to be incorporated into 

the BWT equipment control system to counter the potential for high 

level/overflow and low level in the “buffer tank”. The Group noted that the 

system evaluated does not utilize a discharge pump connected directly to the 

outflow of the filter separator. 

 .3 The questions relating to the provision of a drain from residue tank and its 

cleaning requirement were not answered to the Groups satisfaction and need to be 

dealt with appropriately by describing the safety procedures extensively in the 

Technical/Operations Manual. 

 .4 The Group considered that the maintenance requirements provided were very 

general and that these should be supplemented in the final Technical Manual with 

sufficient detail to enable full assessment of both the work actually required and 

the potential for operator exposure. 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 4 

I:\MEPC\59\2-19.doc 

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by Japan in 

document MEPC 59/2/5, which was supplemented by additional information provided by the 

applicant after a request for further information by the Group during its meeting. 

2 COMPLETENESS OF DOSSIER AND APPLICANT RESPONSES TO DATA 

REQUESTS FROM GROUP

2.1 The Group recalled that it had already provided the following questions and concerns 

during its evaluation of the application for Basic Approval of the system 

(see MEPC 57/2 – BWWG 4, annex 5, Report of Application for Basic Approval), section 0.4 

of Summary (.1 to .13) and section 9.4 of Conclusions (.1 to .15) which it considered should be 

addressed by the applicant prior to application for Final Approval. The applicant’s responses 

received, and the Group’s reaction to these responses is shown below, as a summary table: 
I:\MEPC\59\2-19.doc 

Table 1: Applicant’s Responses to Data Requests from the Group at evaluation for Basic Approval

Section No. 

Refs. from BA Report (Summary, 0.4 and Conclusions, 9.4) 

Group’s Question Applicant’s Response and Sectio

this Report 

2.1.1 .1 and .1 An adequate quality assurance programme needs to 

be developed for the entire system including the quality of PASA at industrial production. 

Hitachi Plant Technologies, Ltd. will assuand responsibility for the quality of the en(design, construction and maintenance of main unit, and supply of consumable chemSee Section 5.2.1 for information on amonomers in PASA 

2.1.2 .2 and .2 For final approval, the human health risks of the 

system will be evaluated by the GESAMP BWWG on the basis of its individual unit operations, i.e. each component of the system requiring operator attention. The manufacturer is therefore requested to describe separately the potential human health risks associated with each major component of the system and to describe the measures necessary to prevent human exposure for each such component. In particular, the methods employed for the collection, treatment and disposal of floc and their potential for occupational exposure need to be described. Additionally, the recommended risk reduction measures need clear explanation and documentation, e.g., for each procedure such as floc collection, dewatering, drying, incineration, sterilization, storage and disposal in whatever form.

In the assessment of crew exposure, the ricomponent of the system associated wioperations have been identified and clearlTo eliminate the material risks, the settings have been reviewed from the vcrew safety, and statements regarding suitable protective gear and safety gear added. On the basis of this review, associated with operations for the collectand disposal of flocs have been idenmeasures to reduce these risks are consdescribed. See Sections 3.1 and 3.2 for descriptsystem controls and safety consideration
GESAMP-BWWG 9/6 

ANNEX 4 Page 6 I:\MEPC\59\2-19.doc 

Section No. 

Refs. from BA Report (Summary, 0.4 and Conclusions, 9.4) 

Group’s Question Applicant’s Response and Sectio

this Report 

2.1.3 .3 and .5 The storage and handling of the three Active 

Substances on board needs to be carefully controlled and the proposed safety measures adequately documented, particularly bearing in mind the corrosive properties of poly aluminum chloride.

The physical and chemical states of the tSubstances are specified, the risks they ship’s hull are characterized and assessethe guidelines for their storage and haproposed. In particular, with regard to PAslightly corrosive to metals, measures are the prevention and avoidance of hull cousing resin coatings at surfaces in contamaterial. See Section 3.2 for safety consideraSection 5.1 for risks to ships sphysico-chemical data in Appendix)

2.1.4 .4 and .6 One major human health issue regarding the Active 

Substances relates to the residual acrylamide monomer contained in the polyacrylamide, which has a range of associated human health hazards and which, in parallel to best practices in drinking water purification, needs to be maintained at appropriately low concentrations. The quality of the polyacrylamide active substance needs to be strictly controlled and included in the QA program to ensure acceptably low concentrations of acrylamide monomer.

The maximum allowable discharge co(MADC) is based on the collected dhazards to human health and aquatic orresidual acrylamide monomers in polyPolyacrylamide of sufficient quality to sdesign concentrations is supplied by HiTechnologies, Ltd.See Section 5.2.1 for information on amonomers in PASA. MADCs are deSection 6.4 
I:\MEPC\59\2-19.doc 

Section No. 

Refs. from BA Report (Summary, 0.4 and Conclusions, 9.4) 

Group’s Question Applicant’s Response and Section 

this Report 

2.1.5 .5 and .7 The BWMS appears from the technical description to 

be partly open, allowing for possible occupational exposure to the crew to system processes and waste. This is a potential weakness of the system that remains to be adequately addressed.

The constituent equipment of this system closed structure in order to prevent the escape of liquid or dust particles. With repossibility of exposure to crewmembcarrying out their work, the assessment anare included in a response to the pointSummary 0.4.2 / Conclusions 9.4.2. See Sections 3.1 and 3.2 for descriptsystem controls and safety consideration

2.1.6 .6 and .8 Human health issues related to the potential 

concentration of pathogens in the flocs need to be examined and assessed in detail. The flocs could under heavily polluted intake conditions, have the potential to form a biohazard.

Considering the possibility of pathogencontained in the intake water, safety mhuman health have been established potential risks of pathogenic bacteria expto ship crew. To promote careful hcollected flocs in preparation of bacteria floc, labels are affixed to the collected fltanks and carrying containers recommendof protective gear and promoting care witpathogenic bacteria in the floc storage aprocesses, and stating that the storage transportation containers are to be kept cloSee Section 4.2 for assessment of exposucrew (see Section 3.2 for safety considera
GESAMP-BWWG 9/6 

ANNEX 4 Page 8 I:\MEPC\59\2-19.doc 

Section No. 

Refs. from BA Report (Summary, 0.4 and Conclusions, 9.4) 

Group’s Question Applicant’s Response and Section 

this Report 

2.1.7 .7 and .9 Adequate separation of the flocs from the treated 

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

When the equipment is scaled up, its performance does not change and there is scaling up this system. In addition, the environmental risks via treated ballast operations relating to the system remain with appropriate measures. This is not oup by theory, but has also been clearly defrom the results of comparative verificatprototype test setup and land-based test setSee Section 4.2 for assessment of exships’ crew and Section 6.2 for ecotoxiof treated ballast water

2.1.8 .8 and .10 The positioning and operation of the proposed prefiltration, as well as post filtration and its residue 

feedback system must be better described and documented. The procedures and processes for routine system maintenance, emergency procedures, filter and sludge conveyor cleaning, and the treatment and handling of the sludge must be defined and detailed.

The flow paths of water and flocs incinstallation point of the filter separator unof treated water, and the flow of filttrapped in the filter separator unit explicitly indicated. Daily and periodic mrecovery procedures for error and situations, cleaning of the filter uniseparator, and cleaning of floc collection of magnetic separator have been expressethe corresponding descriptions. The trehandling of collected flocs have been within the concerns raised in SummConclusions 9.4.2. See Sections 3.1 and 3.2 for descriptsystem controls and safety consideration
I:\MEPC\59\2-19.doc 

Section No. 

Refs. from BA Report (Summary, 0.4 and Conclusions, 9.4) 

Group’s Question Applicant’s Response and Section 

this Report 

2.1.9 .9 and .11 The risk to the marine environment from the residual 

Active Substances must be assessed. Concentrations of heavy metals, aluminum, iron, acrylamide monomer, VOCs, and faecal coliforms must be measured in the intake water, collected sludge and the discharged ballast water from the representative ballast waters associated with testing under G8. The environmental risks of discharging polyacrylamide, a non-biodegradable polymer to shore and any subsequent disposal restrictions must be assessed.

The results of analysing the content of tmetals, aluminum, iron, acrylamide VOCs and faecal coliforms in treated band flocs have been presented. The potenthazards have been assessed on the basresults. The method of measuring polyacthe treated water and influent has been and the results of this chemical analysis reported. See Section 3.4 for analysis of Active Srelevant chemical and other chemiresultant human health assessment in Se

2.1.10 .10 and .12 Disposal of the collected sludge to shore-based waste 

reception facilities should be according to the relevant IMO regulations. The availability of suitable harbour reception facilities needs to be considered.

Concerns regarding the disposal and hcollected flocs have been addressed in thraised in Summary 0.4.2/Conclusions process of unloading and disposing flocs performed in accordance with the domesthe MARPOL Convention.See Sections 3.1 and 3.2 for descriptsystem controls and safety considerarespect to storage, handling and dispomaterial 
GESAMP-BWWG 9/6 

ANNEX 4 Page 10 I:\MEPC\59\2-19.doc 

Section No. 

Refs. from BA Report (Summary, 0.4 and Conclusions, 9.4) 

Group’s Question Applicant’s Response and Section 

this Report 

2.1.11 .11 and .14 

and section 8.1.2 

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

To address this question, experiments carried out and the results have been preupper limit of the concentration of added for toxicity tests have been determined on tests in which the chemicals were added athree times the standard quantities in ordthe flocculating performance. Consequentlimit of chemicals concentration for coagulation performance has been dapproximately twice the standard amountsresult, the maximum amount of chemadded under the condition of higher concchemicals was taken to be twice the standThe results of toxicity tests performed effluent are shown. In addition, to evaluatof seawater with a higher concentratresidual Active Substances on marine ecotoxicity tests were carried out usincontaining flocs generated by this systemresults indicate that flocs in such water condition of chemicals had no effect organisms such as zooplankton and fexperiments were conducted by a GLP laboratory.See Section 6.2 for ecotoxicity testing ballast water
I:\MEPC\59\2-19.doc 

Section No. 

Refs. from BA Report (Summary, 0.4 and Conclusions, 9.4) 

Group’s Question Applicant’s Response and Section 

this Report 

2.1.12 .12 and .13 The risk assessment carried out by the applicant in 

the submission cannot be accepted, as it is unclear how the risk assessment was performed and how both the PEC and PNEC for Aluminum-ions and other relevant chemicals have been established.

In addition to the hazard data at the tapplication for Basic Approval, other research and academic reports have beesubsequently risk assessment has been with reference to typical risk assessments rSee Section 6.3 for risk assessment of for aquatic organisms 

2.1.13 .13 and .15 The maximum allowable discharge concentration 

should be set against the parameters that can be measured at such low levels. According to the applicant, it is difficult to measure the amount of PASA directly, if its concentration in water is low. This situation is considered to be unsatisfactory by the Group and an acceptable analytical method should be developed for confirming the maximum allowable discharge concentration for relevant parameters.

The PASA analysis method and measuremhave been developed according to the poinSummary 0.4.9 / Conclusions 9.4.11. On the analytical results and other studies, thallowable discharge concentration (MADCestablished by considering the risk assaccordance with the points raised in SummConclusions 9.4.13. See Section 6.3 for risk assessment of for aquatic organisms, while MAdescribed in Section 6.4 

2.1.14 Summary 0.5 As there may be a risk to the ship of flooding through 

the sludge discharge arrangements should equipment malfunction occur, this possibility should receive additional consideration and assessment of the actual risk involved prior to shipboard installation.

Concerns regarding the disposal and hcollected flocs have been addressed in thraised in Summary 0.4.2/Conclusions process of unloading and disposing flocs performed in accordance with the domesthe MARPOL Convention.See Sections 3.1 and 3.2 for descriptsystem controls and safety considerarespect to storage, handling and dispomaterial 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 12 

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2.2 During the GESAMP-BWWG meeting, the Group posed to the applicant several 

questions (a total of 20) on issues it felt needed further clarification in order to complete the 

evaluation for Basic Approval. The Group’s questions (in bold text), the applicant’s responses 

(in plain text) and the Group’s conclusions on the responses provided (in italic text) are noted as 

follows: 

Question 1: 

1 The most significant problem identified is that this BWMS produces large amounts 

of effluent stream (flocculated material for disposal). The Group needs much more 

precise clarification how to ensure the adequate management for this disposal 

procedure. How is it ensured that all the flocs are safe enough to handle with the 

usual procedure? 

Response 1: 

.1 The prevention of leakage of collected flocs from the equipment of this system is 

ensured via a closed structure of transfer pathways within the system (covering all 

pathways from the magnetic separator via the collected flocs storage tank to the 

discharge of the collected flocs from the same) (refer to 3.7.5 in the dossier). 

.2 Moreover, where the flocs are retained in mid-flow of the pathway, such abnormal 

retention is detected as an abnormal increase in water surface level via the level 

meter. When any such increase is detected, the system operation is controlled to stop 

automatically (3.12.3). 

.3 In addition, considering the maintenance procedure, safety measures, which include 

safety signage, the use of protective gears and airtight containers, must also be clearly 

ensured or stated (3.13 (2) in the dossier)). 

.4 With the above mentioned terms, the safety of ship crews and the ship body from the 

collected flocs is ensured. 

The Group did not consider that this response fully answers the question. Specific detail of 

potential for the hazards that may be present in the floc material is required, together with 

associated risk assessment. The PPE required to be used in each case where potential contact is 

identified needs specifying. The Group did not consider the generic statements regarding the use 

of PPE to provide sufficient risk mitigation.

Question 2: 

2 How is it ensured the flocs are not dumped to sea? How is this ensured formally? 

For example according to MARPOL Annex V or BWM convention itself? 

Response 2: 

.1 The collected flocs shall be processed based on the BWM Convention and its 

Guidelines (G1, G4 and G12), MARPOL Annex V, and the relevant regulations 

based on those conventions in the country of the reception facility on-land. 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 13 

I:\MEPC\59\2-19.doc 

.2 One of the methods used to manage the collected flocs in this system is installing a 

meter such as a level gauge to know the collected floc volume in the storage tank. In 

addition, the stored volume and that landed from the ship will be recorded in order to 

monitor the storage volume.

The Group was of the opinion that the framework indicated by the applicant how to prevent 

dumping the flocs was not appropriate, because the Guidelines for sediment reception facilities 

(G1) and Guidelines on design and construction to facilitate sediment control on ships (G12) 

should be addressed as the issue for management of sediment, not for the flocculated material 

from this BWMS. Also the reception facility for sediment under Guidelines (G1) does not exist 

everywhere around the world at this moment, so that the applicant cannot ensure an adequate 

management of flocculated material related to sediment management. Also, MARPOL Annex V 

prohibits the dumping waste to sea in general, however, the Group believed that this flocculated 

material could have the potential risks of biohazard, same as “Medical Waste”. Therefore, the 

management of such pathogenic material would be out of scope of “garbage and waste under 

usual operation” associated to MARPOL Annex V. 

The Group noted that this response gives the first indication of a need for record keeping to 

provide documented control of system’s flocculated material. It is not clear as to the specific 

function of the “meter”, as this may be to provide automatic recording or simple manual 

reading. The Group considered that such procedures should be adequately described in the 

operation manual, when this becomes available. Specific manufacturer’s instructions will be 

required to permit correct compilation of the Ballast Water Management Plan described in the 

Guidelines for ballast water management and development of ballast water management plans 

(G4) and it is not considered relevant to reference Guidelines (G1) and (G12) that relate only to 

the handling of sediments removed from ballast water tanks. Specific procedures are required 

that detail permissible means of disposal of the system’s flocculated material. 

The Group noted that this response gives the first indication of a need for record keeping. It is 

not clear as to the specific function of the “meter”, this may be to supply automatic recording or 

simple manual reading. The Group considered that such procedures would be adequately 

described in an operation manual, if such was available. 

Question 3: 

3 How is it ensured the flocs are adequately managed at reception facilities on-land? Is it 

possible to guarantee an adequate reception facility around the world? If not, how is it 

ensured that the flocculated material is unloaded only at a port with adequate reception 

facilities? The Group notes that the applicant has made detailed proposals about floc 

disposal in Japan but has provided no information for other ports. If they cannot ensure 

adequate management of disposal under the open cycle including reception facilities, the 

system should be completed with a closed-cycle in which all the disposal and treatment 

processes could be done by components onboard ship, for example, incineration on 

board. 

Response 3: 

.1 As stated in section 3.15 of the dossier, we are investigating the availability of the 

reception facilities on-land in countries other than Japan. 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 14 

I:\MEPC\59\2-19.doc 

.2 If there is the potential for the collected flocs to be processed at reception facilities 

on-land under the open cycle, consideration will be made as to whether it is possible 

to receive the collected flocs at those facilities or not. The use of protective gears, as 

described in section of 3.13(3) in the dossier, is also required for those facilities. 

.3 When selling this system to customers, a list of recommended facilities shall be 

provided, with consideration of the customers shipping route information. Where 

there is no adequate reception facility available, the system, including the 

heat-treatment process of collected flocs on board, is proposed to customers upon the 

inquiry. 

.4 It is desirable that the collected flocs be treated at the G1 reception facilities for 

sediments. 

The Group was not satisfied with the response of the Administration on this matter. As has been 

stated in the evaluation of the system at Basic Approval the need was expressed to receive an 

operation manual, albeit an example. The Group understood that it is not feasible to provide a 

manual for all possible situations onboard ships. Up to now such a manual was not received by 

the Group. Therefore, too many open ends are still present in the operation of the system and the 

related potential risk for crew can not be judged sufficiently. 

The Group did not consider the possibility or availability of managing flocs, rather the Group 

considered the practical manual or facilities which is already set to evaluate the safety for 

managing flocs to crew and environment. The evidence of well-operated facilities supposed to be 

submitted to evaluate the safety. 

Question 4 

4 In the case of the proposals for heating or incineration of flocs, is it possible to make up a 

closed re-use cycle using heating of flocs? For example, are there any chemical properties 

changed after heating, such as decomposition of polymer (PAC) by heat? If there are 

possibilities for such changes, the cycle should be once-through. Even in this case, the 

disinfection before disposal should be considered. So floc disinfection by heater or 

incineration should be needed for all the BWMS in this particular case. 

Response 4: 

.1 Among the Active Substances used in this system, PAC and PASA can function only 

once due to their coagulation mechanism. Therefore, PAC and PASA, as new 

material, must be injected and used under rated conditions. However, tri-iron tetraoxide is reusable provided its magnetization remains unchanged. The magnetic 

characteristics of tri-iron tetra-oxide remain unchanged below 200°C even after they 

are heated above 200°C. The collected flocs containing the tri-iron tetra-oxide thus 

can be re-used for the magnetic separation operation as replacement material. 

The Group noted that only tri-iron tetra-oxide can be reused using heater under flocculated 

material management. However, the completion of decomposition of PAC and PASA should be 

confirmed in the actual heating process, in which heating duration and temperature should have 

been defined and ensured. 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 15 

I:\MEPC\59\2-19.doc 

The Group did not consider that this response fully answers the question. Specific detail of 

potential for hazard arising from the polymers in floc material after changes with heat is 

required, together with associated risk assessment. 

Question 5: 

5 The applicant’s concept for storage of the floc material is that 0.1% volume of 

treated ballast water is kept in the storage tank without any disinfection during the 

whole leg to another port with reception facilities? In that case how can the system 

prevent the bacterial growth in the tank and production of some waste gases 

(i.e. H2S, CH4 and CO2)? Could you kindly provide any results for the measurement 

of viable bacteria and other organisms in flocs in the storage tank after 5 days 

(after long leg)? 

Response 5: 

.1 As days pass, a declining tendency is apparent in the number of plankton and bacteria 

present in seawater and sediments. Similarly, the number of organisms in collected 

flocs is reasonably assumed to remain constant or less in spite of large growth in the 

collected flocs storage tank. However, the collected flocs may still potentially contain 

organisms. 

.2 Since the system does not employ disinfection treatment, all transfer pathways of 

collected flocs in the system are completely closed to prevent human exposure to the 

collected flocs (as stated in section 3.12.3 of the dossier). Moreover, workers must 

wear protective gear when engaging in maintenance of the system. 

.3 As for the generation of waste gases from the stored collected flocs in the storage 

tank we have no experimental data. This is however virtually negligible, since the 

ratio of organic matter contained within the collected flocs is extremely low, namely 

less than one % relative to that contained in sludge produced during sewage 

treatment. 

The Group noted that the applicant does not provide any information of tank holding time of 

flocs, which was clearly requested by the Group in above question. 

Also the Group concurred with this views of the applicant that there are no re-growth or 

pathogenic bacteria or production of gasses in the flocs tanks. The Group recalled that the 

applicant does not provide any actual measurement of either bacteria or organic contents in 

flocs tank. Also the Group recalled that if all the POC and DOC in Guidelines (G8) test soup are 

condensed to flocs, the concentration should be both 5 g/l. Also if the E. coli, which was detected 

in untreated water described in table 5-5 of non-confidential version, is condensed to same flocs , 

then we can easily expect more than 10^7 cfu/ ml, which would be same level as Human waste 

(Faeces and urine). 

The Group was the position that more precise and quantitative assessment for the fate of bacteria 

in flocs tank, which is based on actual measurement of density changes, should be needed for 

evaluation for the risk of bio-hazard. 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 16 

I:\MEPC\59\2-19.doc 

Question 6: 

6 In the confidential material there is indicated a possibility to employ a flocs 

treatment step by using a flocculate heater. There is no detail of such additional 

equipment, its positioning or operational requirements. Is such a step to be 

considered? If yes, these details are required for a new assessment of all risks that 

may be associated. 

Response 6: 

.1 Since the system does not employ disinfection treatment, all transfer pathways of 

collected flocs in the system are completely closed to prevent human exposure to the 

collected flocs (as stated in section 3.12.3 of the dossier). Moreover, workers must 

wear protective gear when engaging in maintenance of the system. 

.2 However, as stated in section 3.15 of the dossier, where sufficient steam is available 

on board, this can be harnessed to eliminate organisms contained in the collected 

flocs via heat-treatment processing of the latter. 

.3 An example of a device for the heat-treatment processing of flocs is shown and stated 

in Figure 3.31 in sections of 3.15. This device will be assessed by the relevant agency 

as an optional piece of equipment for the system. 

.4 All the transfer pathways of collected flocs in the system, from the collected flocs 

storage tank to the heat-treatment processing device, are enclosed with a closed 

structure, virtually eliminating the possibility of human exposure to the collected 

flocs. However, handling the flocs treated by heat-treatment processing is safer and 

easier, since the organisms contained in the flocs have been annihilated. 

.5 It is desirable that the heat-treatment processing device be installed in the engine 

room, since the device includes heating parts. Moreover, part of the piping within the 

device should be covered or shielded by a heat insulator to prevent human burn 

injuries. 

The Group did not consider the possible methods for handling the flocs but well-designed 

manual or equipment to evaluate the safety. 

The Group noted that a possibility to employ a flocs treatment step by using a flocculate heater is 

mentioned in the confidential material. The applicant was requested to submit detailed 

information on such additional equipment, its positioning and operational requirements. The 

answer received did not fulfil these criteria and the Group was not in a position to assess the 

safety and environmental issues of such an optional step. 
GESAMP-BWWG 9/6 

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Question 7: 

7 The LOD unit in Table 4-12 p 23 of the non-confidential submission for heavy metal 

in eluted floc is given as mg/L. Can you recalculate or estimate to mg/kg as 

in Table 4-2 and 4-3 also p 23? 

Response 7: 

.1 The data shown in Tables 4-12 of the non-confidential submission for heavy metal in 

collected flocs was measured by elution analysis. Therefore it is difficult to 

recalculate the density to mg/kg. 

.2 The Group noted lack of mass based concentrations of heavy metals in floc since an 

elution based method was used. The answer from the applicant on this issue does not 

include concentrations in mg/kg nor does it allow for such calculation by providing 

the mass of floc. The Group concludes that an assessment of the risk associated with 

heavy metals in the floc is therefore not possible at the present level of information 

and this should be further evaluated. 

Question 8: 

8 The results of ecotoxicity testing from the confidential dossier show significant 

differences between control and treated groups in mortality and weight (Figure 2 to 

Figure 5) in pp. 33-35 of IDEA (2007c) and the results from the equivalent 2008 test. 

The same toxicity test in 2008 showed no significant difference between control and 

treated group. How do you explain this anomaly? 

Response 8: 

.1 As for mortality, statistical significant differences emerged between the control and 

certain treatment groups in the Early life stage toxicity test (IDEA 2007c), whereas 

no significant difference was observed in the Acute toxicity tests (IDEA 2008f and 

IDEA 2008g), as pointed out by the GESAMP. However, the mortalities in the 

treatment groups were smaller than those of the control group, hence the indication of 

the statistical significant difference in IDEA (2007c). The result of the Early Life 

Stage toxicity test indicated no mortality in the treatment group exposed to 100% 

treated-water (i.e. at the 1/1 group). This result was consistent with the results from 

the IDEA (2008f) and IDEA (2008g). 

.2 Regarding the Early life stage toxicity test (IDEA 2007c); the cumulative mortality in 

the control group from embryo to 28 days post-hatching was 23.5% (i.e. 1.7% 

and 21.8% during the embryonic and post-hatch phases respectively). This mortality 

is within the 9-32% range in the control group of the Early Life Stage toxicity test 

for Java medaka, as conducted by the testing facility. We believe the test results of 

the IDEA (2007c) test to be reliable. 
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.3 As indicated by the GESAMP, in the Early life stage toxicity test (IDEA 2007c), 

a statistical significant difference emerged between the control and treatment groups 

regarding the endpoint for embryonic and larval growth, i.e. the time to hatching 

(Figure 2 on p. 33), and the length and weight at 28 days post-hatching (Figures 4 

and 5 in pp. 34-35). However, as discussed in paragraph 6 on p. 25, the results show 

that the treated water had no adverse effects on the Early Life Stage of Java medaka. 

.4 To conclude, the results of IDEA (2007c), IDEA (2008f), and IDEA (2008g), are 

consistent in showing that the treated water had no adverse (lethal and sub-lethal) 

effects on Java medaka. It should be noted, however, that the results cannot be 

simply compared, because the life stage of the test organism and the duration of 

exposure varied among the three tests. 

The Group was satisfied with this response from the applicant. 

Question 9: 

9 Acrylamide monomer in PASA – there are 3 references to this impurity: 

– p. 38 on confidential dossier less than 0.2%, 

– Appendix 2 of confidential dossier technical report showing less than 0.05%, 

– Report of BWWG 4 (Basic Approval) 0.05%. 

Please confirm the value used for QA. 

Response 9: 

.1 As stated in section 7.5.1.4 (p. 105) of the confidential dossier, considering the 

evaluation data on toxicity for acryl-amide monomers and its dosage concentration of 

the system, it has been confirmed that no effect on ecosystem is caused, even in cases 

when 100% of the treated water (non-diluted water treated with seawater) is 

discharged, even when using PASA in which 2% or less of acryl-amide monomer is 

contained. 

.2 Studies and investigation by our group have determined the existence of two types of 

PASA on the market. It is ensured that the acryl-amide monomer content in PASA 

is 0.2% or less in one of those two and 0.05% or less in the other. These figures are 

guaranteed by the manufacturers. 

.3 When acryl-amide monomer is contained in PASA as an impurity at a ratio of 0.2% 

or less, safety is ensured based on the studies mentioned above. The value of 0.2% is 

thus stated in the dossier. 

The Group was satisfied with this response from the applicant. 
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Question 10: 

10 At Basic Approval it was raised that a QA programme needed to be developed for 

the entire system. Detail of QA received in 3.11 is for the manufacturing process but 

not for system operational process which was asked for. It is noted that Hitachi 

states it will assume responsibility for maintenance, how is this to happen? Please 

note section 4.1.2 of the GESAMP BWWG Methodology informs what the dossier 

should contain; is a definitive technical manual available? 

Response 10: 

.1 A technical manual for the system operational process is employed for operation of 

onboard test and land-based test. The manual is being assessed by the relevant agency 

at the present for G8 application procedures. Operation procedure is stated in section 

of 3.8 and work operation is stated in section of 7.3.3.1 in the dossier. Details of 

maintenance and its essential contents are stated in section of 3.13. 

The Group suggested that as it would appear a Technical Manual exists, then this should 

have been supplied as a part of the submitted dossier as recommended under the 

approved GESAMP-BWWG Methodology. If this had been made available possibly many of the 

questions raised by the Group could have been clarified as the procedural information provided 

in sections 3.8, 7.3.3.1 and 3.13 is noted to mainly provide a general and limited overview and is 

lacking the specific detail normally expected that provides the basis for sound evaluation and 

certainty in the safety assessment being undertaken. 

Question 11: 

11 It is noted that the required retention time for flocculation is stated as two minutes. 

This must require a comparatively large volume of ballast water retention in the 

treatment plant to attain the stated throughputs. For information please advise the 

total operational weight of the five proposed systems, including full floc storage 

tanks. 

Response 11: 

.1 Please refer the following table showing the wet weight including full floc storage 

tanks. 

Type [m3/h] 200 400 800 1200 1600 

Weight (wet) t 27 54 100 148 198 

The Group noted that the operational weight of this ballast water treatment system may also be a 

significant consideration in Administration approval for any individual ship installation as 

careful choice of a suitable location with regard to scantling strength and effect to stability will 

be necessary. 
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Question 12: 

12 In section 3.3 of confidential dossier it is stated that the suspended solid uptake is 

low – how can this be guaranteed in normal operation, especially now that there is 

no pre-filter with the system? Please give details of the effect on the system process if 

the uptake water continuously contains high SS. 

Response 12: 

.1 The Coagulation technique can treat and purify influent with high SS concentration 

such as IMO soup using electrical neutralization on particle surface charge by PAC 

and bridge functions by PASA to form flocs. Indeed, the method of coagulation of 

sedimentation is employed in the field of waster water processing with high SS 

concentration. 

.2 The flocs are removed efficiently by the magnetic separator and this method of 

coagulation magnetic separation is not easily affected by SS concentration of 

influent. Pre-filter is thus unnecessary to remove SS in advance before coagulation 

technique. 

The Group was satisfied with this response. 

Question 13: 

13 In section 3.4 of the confidential dossier it is stated discharge from the filter 

separator is by either gravity or pump. Does use of a pump affect carry over from 

this filter unit? What tests have been carried out to confirm continued correct 

operation with use of a discharge pump? 

Response 13: 

.1 Part of the equipment is omitted in the schematic diagram shown in Figure 3-3. 

Therefore, the explanation is given using Figure 4-2. In this system, the effluent from 

the filter separator, and the treated water, are discharged into ballast tank and buffer 

tank by gravity as shown in Figure 4-2. Pumps are used to send the treated water to 

the respective ballast tanks. 

The Group noted that this response is the first indication that a gravity “buffer tank” is a 

requirement of the system. Notwithstanding the operational limitations this will impose, 

additional water level error detection devices will require to be incorporated to the BWT 

equipment control system to counter the potential for high level/overflow and low level in the 

newly identified “buffer tank”. The Group noted that the system evaluated does not utilize a 

discharge pump connected directly to the outflow of the filter separator. 
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Question 14: 

14 On page 14 of confidential dossier is a reply to GESAMP BWWG Basic Approval 

comment on proposed pre-filtration and residue feed back system. It is noted that 

the system does not now have a pre-filter component and there is detail provided on 

the filter separator. There is no detail information on “residue tank” from filter 

washing. Is there a drain from this tank? What is the cleaning requirement? Please 

supply full detail of this residue feedback loop. 

Response 14: 

.1 As stated in section of 3.7.4, the filter separator consists of a sealed filter separator 

casing, a rotating filter, filter-washing sprays, and filter residue collecting trough and 

these machines are installed within the sealed casing (closed structure). The water 

after magnetic separation flows inside the filter separator drum and then the filtered 

water flows out of the filter separator drum. And the treated water is sent to the 

ballast tank (refer to previous answer 4). 

.2 The trapped flocs on the filter surface are collected with filter washing (the flow rate 

of the washing water with washed off flocs is around 1% of the treatment rated 

capacity for ballast water purification operation) and sent into filter washing residue 

tank. The water containing the residue is returned to the ballast water feed pipe before 

the first chemical injection points to form new floc in the next untreated ballast water 

cycle (see Figures 3-2, 3-3 and 3-12). 

The Group was not satisfied with this response. The questions relating to the provision of a 

drain from residue tank and its cleaning requirement were not answered. 

Question 15: 

15 In 3.5.1 the environmental considerations detail slant required being less 

than 22.5 degrees. Is this in both directions? Is there any limitation on operation of 

equipment when ship is rolling or pitching? 

Response 15: 

.1 The environmental setting of the system on slant is within 22.5 degrees all-around. 

The recommended operation condition of slant is within 5 degrees all-around. 

However, the operation itself can be conducted in the condition where slant is higher 

than 5 degrees. 

The Group was satisfied with this response. The operational recommendations identified will 

require to be clearly identified in the Technical Manual. 
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Question 16: 

16 Detailed procedures for handling and storage of chemicals are not provided 

in 3.14.2. Detail of PPE required to be used is necessary for each case. General 

reference to need for PPE is not considered sufficient for safety. 

Response: 

.1 PPE must be used when handling chemicals. Detail of PPE when handling the 

chemicals is stated in section of 3.13. (3) A. 

The Group was not satisfied with this response. Specific detail of the PPE recommended to be 

used in any given situation is not provided as requested, only general examples of PPE and 

signage is made available.

Question 17: 

17 In 3.15 it is stated “proper method for treatment of floc” is required. It is considered 

that this waste stream must be viewed as bio-hazard material and all appropriate 

safety measures are required. What is proper method? There is no detail of correct 

procedure for loading of sealed containers for discharge of floc. This operation is 

considered safety critical for operating personnel and full details of how such 

decanting of floc into the containers is requested. There is also reference to this 

operation in 7.3.3.1, again detailed procedures with risk mitigation measures is 

required. What is asked for is detailed minimum requirements for handling that will 

be applicable and required of all ballast water treatment installations irrespective of 

ship type. 

Response 17: 

.1 In the original application dossier, the procedure of landing and disposing collected 

flocs is based on the understanding it is most hazardous to hull and humans. The 

concept is based on unloading with sealed containers after temporary storage in the 

onboard tank to carry it to on-land facility for disposal. However, there are some 

processes remaining that require manual handling depending on user’s discretionary 

operation. Therefore it is found to be difficult to ensure complete safety throughout 

the entire process. 

.2 Therefore, we are now considering employing the concept of installing heat-treatment 

system for the collected flocs such as stated in 3.15 of non-confidential in order to 

ensure the complete safety through the floc treatment process. Heating system can 

eliminate the bacteria in the flocs, and then biohazard risks can be eliminated. In this 

case, onboard incinerator or steam is assumed as the source of heat and the choice 

depends on the situation of the individual ship. The device employing steam will be 

assessed by the Administration as an optional piece of equipment for the system. 
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The Group was not satisfied with this response. It would appear that the applicant is now to 

incorporate a heat treatment component for the treatment of the flocculated material as a 

definitive risk control measure. The Group recognized that heat treatment could be an effective 

means of mitigating the risks identified, but as no detail of what the treatment will be is provided, 

and then no assessment of the adequacy of such treatment can be made. The Group also 

considered that effective and adequate risk mitigation procedures could be specified to be put in 

place for the safe handling of untreated flocculated material by personnel, but such measures 

have not been identified or specified in either the dossier or the replies to the request for 

additional information. 

Question 18: 

18 There would be potential risk that the flocs will adhere at the magnetic disk array, 

especially around the centre of array, where scraper and washing water could not 

reach easily. Are there any potential risks that after long term use, the efficient 

surface of the array would be blocked with adhered flocs, and therefore the removal 

efficacy of flocs will be decreased? To monitor such potential decrease of removal 

efficacy, the Group feels SS sensor will be needed after separator. 

Response 18: 

.1 It is important to remove all of the flocs on the magnetic disk for operation because 

the removal step is essential for purification efficacy. The scraper blade mechanism is 

flexible and fit the surface of the disk, and therefore the scraper can wipe the sticking 

flocs on the whole attractive surface efficiently. Moreover, the scraper blade and 

surface of the disk is to be washed by the spray shooting water alongside the edge of 

the scraper blade during the shut down mode. The shooting water reaches the centre 

of the disk and removes easily the remaining floc that has high fluidity because the 

spray washes immediately after submersion. 

.2 If the removal performance of flocs by magnetic separator decreases 

SS concentration of effluent from magnetic separator increases. The load for filter 

separator thus increases. Consequently, the water level in the filter separator may rise 

and level switch in the filter separator will detect the unusual rise in water level and 

stop intake automatically as stated in section of 3.12.2. 

.3 As was pointed out, sensors to measure SS concentration of magnetic separation 

effluent were tested. However, the abovementioned detection method, which is the 

one using water level in filter separator, was found to be more effective and practical 

especially from the view point of sensitivity. 

The Group received efficient answer and satisfied with that. 
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Question 19: 

19 In the confidential dossier at section 6.2.1, you say that capacity of 50 m3/hr was 

used. The group feels this should be 200, not 50. Have you any comment? 

Response 19: 

.1 The chronic toxicity test described in section 6.2.1 of the confidential dossier utilized 

the treated water samples generated by the prototype setup (treatment rated capacity 

of 50 m3/hr). Floc removal performance was improved on the land based test setup 

(present system, treatment rated capacity of 200m3/hr) compared with the prototype 

test setup (refer to sections 5.1 and 5.3 of the confidential dossier), although both 

setups have the same system diagrams (sections 3.3 and 3.4 in the confidential 

dossier). This meant the chronic toxicity test used less purified treated water. 

.2 Chronic toxicity tests require treated water samples (water samples) on a daily basis for an 

extended period (longer than 40 days) (IDEA 2007a, 2007b, 2007c). Processing of 

seawater by the prototype test setup, which is practically capable of providing treated water 

samples, was carried out and supplied to the test facility daily. The treated water samples, 

which are supplied for the chronic tests from the prototype test setup, were: (1) produced 

under conditions where the final chemical dosage concentrations were two times higher 

than those of the rated processing conditions for this system (section 6.2.2 of the 

confidential dossier), and (2) may have a higher concentration of aluminum remaining in 

the treated water (Table 4-4 in Appendix 4) than in the present system (such as the 

land-based test setup with TRC of 200m3/h) (Table 5-7 in the confidential dossier). 

Taken together with the results of chronic toxicity tests in algae, invertebrate and fish, 

the present system, which has been improved compared to the prototype test setup, is 

expected to be much safer and have virtually no toxic impact on aquatic organisms 

(Table 6-8 in the confidential dossier). 

The Group was satisfied with this response from the applicant. 

Question 20: 

20 On page 62 (section 6.2.2), you say “... samples of treated water were carried into the 

test facility the next day ...” What does this mean? How long were the samples 

stored – is overnight 12 hours, or more, or less? Please specify how long? 

Response 20: 

.1 The laboratory where the toxicity tests were conducted is about 150 km from the site 

where the prototype test setup is installed. This chronic toxicity test required treated 

water samples on a daily basis for an extended period (longer than 40 days). It took an 

average of about 16 hours to transport the treated water samples from the test setup to 

the laboratory for the toxicity tests. They were transported to the test laboratory in cool 

(4°C), shaded conditions. Immediately after being delivered to the laboratory, the 

treated water was applied to the chronic tests and kept for 24 hours until the next batch 

of treated water was delivered the following day (IDEA, 2007a, b, c). 

.2 The relevant physical chemical properties of the Active Substances expected to 

remain in the treated water by this system are stable and virtually non-reactive 

(sections 7.1.2, 3.2 and 3.3 in the confidential dossier). The transportation duration of 

treated water, which is stated above, thus has no effect on the chronic toxicity test 

results. 
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The Group was satisfied with this response from the applicant.

2.3 In view of the above responses from the applicant to questions posed by the Group during 

evaluation for Basic Approval (see at section 2.1 above), together with responses from the 

applicant to questions posed by the Group during the GESAMP-BWWG meeting (see at 

section 2.2 above), and considering all the data and information submitted by the 

applicant in the dossier, the Group is not satisfied with the completeness of the dossier 

received from the applicant. The Group draws to particular attention the following points 

to be included in those addressed by the applicant for evaluation at Final Approval: 

• The procedure for personnel handling the flocculated material is unclear. In the flocs 

all material is concentrated and the instructions on how to handle this potentially 

hazardous material should be clear and without any doubt to all crew concerned. 

• The Group notes that a gravity “buffer tank” is a requirement of the system. 

Additional water level error detection devices will require to be incorporated to the 

BWT equipment control system to counter the potential for high level/overflow and 

low level in the “buffer tank”. The Group notes that the system evaluated does not 

utilize a discharge pump connected directly to the outflow of the filter separator. 

• The questions relating to the provision of a drain from residue tank and its cleaning 

requirement were not answered to the Groups satisfaction. 

• Specific detail of the PPE recommended to be used in any given situation has not 

been provided. 

• The applicant informs of the intention to incorporate a heat treatment component for 

the treatment of the flocculated material as a definitive risk control measure. Heat 

treatment could possibly be an effective means of mitigating the risks identified, but 

as no detail of what the treatment is to be has been provided, no assessment of the 

adequacy of such treatment has been made. The Group considered that effective and 

adequate risk mitigation procedures could be specified and put in place for the safe 

handling of untreated flocculated material by personnel, but such measures have not 

been identified or specified in either the dossier or the replies to the request for 

additional information. The handling, storage and treatment of the flocculated 

material require to be satisfactorily addressed. 

• The Group considered that the maintenance requirements provided were very general 

and require to be supplemented in the final Technical Manual with sufficient detail to 

enable full assessment of both the work actually required and the potential for 

operator exposure. 

3 DESCRIPTION OF THE SYSTEM

3.1 Overview 

3.1.1 The Group recalled that this Ballast Water Management System (BWMS) had already 

been described and reviewed in the report for Basic Approval. The Group noted that after 

the Basic Approval was granted, from April to October 2008 shipboard testing of this system 

with a treatment rated capacity of 50 m3/h mounted on board an LPG carrier belonging 

to Yuyo Steamship Co., Ltd. and built by Mitsubishi Heavy Industries Ltd, was performed. 
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From April 2008, land-based tests were also performed in Tokyo Bay, using a land-based test 

set-up (treatment rated capacity of 200 m3

/h). 

3.1.2 The Group recalled that Figure 1 schematically shows the BWMS. First, triiron tetraoxide 

and PAC are added to intake water containing marine organisms. Next, PASA is added to form 

flocs of about 1 mm in diameter. These flocs are then separated from the ballast water using 

permanent magnets. Finally, any flocs that were not removed by the magnetic separation are 

removed by filtering to produce treated water. 

The Group noted that the maximum dose for these Active Substances was set as follows: 

5 mg/L of PAC (as Al) 

30 mg/L of triiron tetraoxide (Fe3O4) 

1 mg/L of PASA 

The Group also noted that these dose are not changed according with any water conditions so that 

the BWMS dose note include any control scheme to change the dose. 

3.1.3 The Group noted that the residue from filter washing is returned to the ballast feed pipes 

before the first chemical (triiron tetraoxide) injection point through a filter washing residue tank 

and treated together with untreated water to maintain clear water processing. 

3.1.4 The Group noted that, with this system, the ballast water can be purified either during 

storage in the ballast tank, during intake, or during discharge. Purification during intake is the 

most effective way to ensure that a minimal amount of organisms and SS enter the ballast tanks 

and thus reduces sediment build-up in the tanks. Therefore, this application for Final Approval 

focuses on the system components and operations for purification during intake. 

Hitachi ballast water purification system 

Magnetic 

seprator

Coagulator

Filter 

separator

Filter residue from filter 

 washing 

(to be treated with seawater)

Collected flocs 

storage tank 

Treated water 

(to ballast tank)

Ballast 

pump 

Ballast water 

PASA 

Landing and waste 

treatment, etc.

Flash 

mixer 

Flocculator

Triiron tetraoxide 

PAC 

Residue tank

from filter 

washing 

Chemical injectors

Figure 1 – Schematic process diagram of BWMS 

This figure was supplied by the applicant. It is to be noted that the system proposed discharges 

treated ballast water to a gravity fed buffer tank prior to pumping to the ballast tanks (see 3.1.7 

and Figure 3). 
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3.1.5 The Group noted that according to the applicant, it is necessary to install the system in a 

closed casing with thermal insulation, ventilation, etc to achieve the environment settings shown 

below: 

Environmental settings: Temperature: 0 to 50 degrees Celsius 

Humidity: less than 90% 

 Slope: less than 22.5 degrees 

3.1.6 The Group noted that according to the applicant, the BWMS (ClearBallast) is 

automatically operated by the controller, and no operator is required onsite. An operator operates 

the control panel in the centre console room to issue a remote command for starting the 

equipment and monitors the operational status indicated on the control panel’s display during 

operation. If no problems occur, the operator is only required to issue a remote command for 

stopping the equipment. 

3.1.7 The Group noted that in the response to additional questions the applicant informed of 

the need for a gravity-fed “buffer tank” to receive the ballast water outlet from the filter separator 

prior to pumping to the ship’s ballast water system. The flow rate through this “buffer tank” will 

also need to be regulated and controlled in the automatic function of the BWMS. 

3.1.8 The Group noted that according to the applicant, there are three operational modes for the 

system – Setup mode, Operational mode and Shut down mode: 

− In Setup mode, chemicals required for this system are prepared automatically and the 

system automatically checks that the devices operate normally. 

− In Operation mode, the system starts and stops operation corresponding to ballast water 

pump operation. 

− In Shutdown mode, upon receiving the stop command from the centre console room, the 

machines in this system are stopped automatically, the inside of the system 

(constituents machines) is cleaned, and preparations for the next operation are performed. 

3.1.9 On the question of storage of floc material on-board ship, the Group noted that a tank is 

used to temporarily store flocs collected by the magnetic separator (the volume of collected flocs 

with water is about 0.1 % of ballast water processing throughput). The tank is equipped with a 

dedicated pump for drawing the collected flocs, which can be performed without manual 

operation. 

3.1.10 The Group noted the following information provided by the applicant. Treatment of 

collected flocs should be appropriately conducted in accordance with the MARPOL Convention. 

A proper method for treatment of the floc should be designed according to requirements of users 

because the available methods differ depending on ship types, route, ship space and utility supply 

capacity (such as electric power and steam). According to the applicant, after it is temporarily 

stored in its onboard storage tank, the collected flocs are put into sealed containers and loaded on 

a barge using the ship’s crane to carry it to land. (Sentences deemed to be confidential and 

removed at the request of the submitting Administration). However the Group noted that the risk 

assessment for flocs when managed with various methods, also, practical equipments with well 
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organized manual for managing flocs should be established from the references of risk 

assessment. 

3.1.11 The Group noted that detailed information had been supplied by the applicant, 

concerning onshore unloading and disposal of collected floc in Japan, which is in accordance 

with domestic law (Law for the Prevention of Marine Pollution and Maritime Disasters, based 

on the MARPOL Convention). The collected flocs unloaded on land are sent to the waste 

disposers, and are dehydrated or incinerated as for normal sludge or industrial wastes. However, 

the Group noted that the applicant should prepare the data of risk assessment in handling with 

flocs to land deposition for this specific chemicals produced by the applicant such as aluminum, 

poly acrylamide and organic matters in the coagulants. 

3.1.12 The Group noted that it is now intended to incorporate a heat treatment unit to the 

system to mitigate the inherent risk to personnel handling untreated flocculated material. The 

operational procedures of such a unit will need to be assessed so as to ensure the effectiveness of 

the treatment to be proposed. If the intention is also to facilitate reduction of the sludge by 

de-watering, then such procedures should also receive an official approval. The Group evaluated 

the current system explicitly without the heat treatment unit. 

3.2 Safety Considerations 

3.2.1 The Group noted that according to the applicant, operation and monitoring of this system 

is automated, so no operators or crew are required. Some manual operations are required for 

refilling the chemicals into the storage tank, unloading the collected flocs, and maintenance 

checks; the frequency of such manual operations will depend on system usage. The applicant 

informs all equipment comes in a closed-structure, pressure resistant casing to prevent leakage 

and scattering of liquid and chemicals. 

3.2.2 The Group noted that problems identified by the applicant in this system are classified 

into three categories related to flow rate, water level (water height in tanks and casings) and 

equipment. Any irregularities are detected by sensors which are controlled and monitored by the 

control system. If irregularities are detected in this system by the sensor, the equipment is 

automatically controlled corresponding to its error level by the control system while a warning 

buzzer and indication lamp start to operate. After an error is detected and the equipment shuts 

down automatically, the operator should check the control panel’s display to identify the error 

and perform inspection and recovery work. Since the equipment is not automatically reset after 

an error is solved, the operator should issue a command to re-start operation after checking that 

the operation/control panel in the centre console room does not indicate any error. 

3.2.3 Furthermore, the Group noted that if a blackout occurs while the equipment is operating, 

the equipment stops operations, and automatically controlled valves are reset to starting position. 

The intake valve automatically closes when the power supply stops, preventing ballast water 

leakage from pipes or other areas. The performance of this system is assured by keeping the 

water flow velocity in piping and constituents machines (coagulator, magnetic separator and 

filter separator) within a certain range, and so can be scaled up while keeping the rated flow 

velocity. This method of scaling up is the same as general centrifugal pumps and piping, and so 

poses no specific risks. 

3.2.4 The Group noted that according to the applicant, the system is produced in a designated 

factory (ISO9001 certified factory) of Hitachi Plant Technologies Ltd, which has a strict quality
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control programme, and meets the required quality, by the Guidelines for approval of Ballast 

Water Management Systems (G8). The factory controls quality according to the quality control 

programme in the respective stages of production. 

3.2.5 The Group recognizes that the applicant has paid particular attention to the issue of 

prevention of chemical leakage in order to protect the safety of humans and the ships. The 

following preventive measures are listed by the applicant: 

.1 Measures for preventing leakage from the chemical storage tank 

Plastics such as PE (polyethylene) are used for the wetted surface of the storage 

tank and the injection line of PAC, which is slightly corrosive to metals, to avoid 

the risk of leakage caused by corrosion. The closed structure of the respective 

chemical tanks reduces the risks of chemical leakage and scattering. Each 

chemical storage tank has level sensors to detect chemical leakage and alert crew 

and is protected by a save-all. The leaked chemicals are sent to the filter washing 

residue tank, and are treated appropriately. 

.2 Measures for preventing liquid leakage in the chemical injection line 

The causes of chemical leakage from the chemical injection line are corrosion, an 

unusual pressure rise in the piping and degradation of packing gland of flange 

junction, so special care is taken for the materials and structure of the chemical 

injection line. The injection line is equipped with a pressure safety valve to safe 

guard against unusual pressure increase and the increased pressure, and the 

chemical are returned to the chemical injection storage tank. Increased pressure is 

relieved in the chemical storage tank. Therefore, the possibility of chemical 

leakages from unusual pressure increases is eliminated. The packing gland on 

flange junction is checked and replaced periodically. 

3.2.6 In addition, the Group noted that the applicant provided the following information on 

preventing leaks of water and collected flocs: 

.1 Measures for preventing water leakage from the equipment 

The causes of water leakage are corrosion and equipment defect, so special care is 

taken for the painting and structure of the equipment and operation control at the 

time of any problems. 

.2 Measures for preventing water leakage from the piping 

The causes of water leakage from the piping are corrosion and unusual pressure 

rises in the piping, so special care is taken for surface treatment of the wetted 

surface and operation control in the event the piping becomes occluded. 

.3 Measures for preventing leakage of collected flocs 

Sufficient care is taken for the painting and structure of the equipment and 

operation control at the time of any error to prevent floc leakage. 
GESAMP-BWWG 9/6 

ANNEX 4 

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I:\MEPC\59\2-19.doc 

3.2.7 The Group noted that the applicant advised adequate electrical protection safety devices 

are provided for the local control panel and equipment have been incorporated to the BWMS. 

3.2.8 The Group noted the following information provided by the applicant on system 

maintenance - the Hitachi BWMS is operated automatically, and so no individual operation by 

ship crew is required and no dedicated operators are needed. This section describes the inspection 

work to be performed by the operator. The check results are to be recorded and managed: 

.1 Daily inspection 

Daily inspection requires only visual inspection of the following items before and 

after operation: 

- checking of error display; 

- storage quantity of chemicals; 

- leakage from the equipment and piping; 

- appearance of the equipment and instruments; and 

- loose nuts and bolts. 

.2 Periodic inspection/maintenance 

The outline is described below: 

- checking the operation of the devices (operation, vibration, abnormal sound, 

deformation, damage and oil leakage): monthly; 

- checking the storage status of chemicals (check the powder supply opening 

and liquid storage tank interior): monthly; 

- inspection and refilling of lubricant: monthly; 

- cleaning of the strainer: monthly; 

- replacement of the lubricant: yearly; 

- inspection/replacement of consumables: yearly; 

 cleaning of the chemical storage tank: yearly; 

- inspection and cleaning of the local control panel (looseness, contact status, 

damage on the insulated section, deformation and discoloration): yearly; 

- checking of insulation resistance for the cable and transformer: at docking; 

- checking of sequence: at docking; 

- checking of the painting and lining: at docking; and 

- disassembly for maintenance: every 5 years 
GESAMP-BWWG 9/6 

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3.2.9 The Group considered that the maintenance requirements provided were very general and 

require to be supplemented in the final Technical Manual with sufficient detail to enable full 

assessment of both the work actually required and the potential for operator exposure. 

3.2.10 The Group noted the following information provided by the applicant on safety 

measures for humans and the ship - safety precautions are required for inspection, recovery and 

maintenance work because chemicals, collected flocs or lubricant may leak and humans could be 

exposed to it. Basic safety precautions and actions in case of leakage or exposure are described 

below: 

1 Safety precautions 

When supplying/inspecting chemicals and performing recovery work for leakage, 

operators should wear protective gear and take measures to prevent the leaked 

chemical from spreading and reduce the associated risks, because the chemicals 

could cause injury to operators and damage to the ship. 

2 Emergency treatment for exposure and measures in case of leakage 

If any chemicals or collected flocs leak, and a person is exposed to it, MSDS 

counter measures should be taken. As eye exposure poses the highest risk, a 

portable eye washer should be equipped near the working area. The chemicals 

used in this system do not have a risk of ignitability or self-reaction, and the 

preventive measures for leakage described assure the safety of humans and the 

hull structure. Material Safety Data Sheets (MSDS) for each chemical must be 

indicated in the same or adjacent area on board the ship, in which the chemical is 

stored. 

3.2.11 The Group noted the following information provided by the applicant. While 

transporting flocs in sealed containers, there are potential risks that the contained flocs leak, 

subsequently the operator may be exposed to it. Therefore, containers that are sufficiently sturdy, 

sealed and anti-corrosive should be used for handling and transportation of flocs, to minimize the 

risk. In addition, during the operation of transferring flocs from onboard storage tanks to landing 

containers, operators are required to wear protective gear. Accordingly, risks of flocs to the 

workers are minimal, even if a small amount of flocs leaks in the equipment due to device 

malfunction. The sealed containers also minimize risk of exposure during handling and transfer 

to land-based facilities. Consequently, the Group accepted that there could be appropriate 

measures to minimize the risk of human exposure to flocs through all of the exposure scenarios 

identified; however, such measures have not been adequately detailed in the information 

provided to ensure the necessary certainty. 

3.2.12 The Group, noted that human exposure risk mitigation could be adequately addressed 

through the use of engineering control measures and the use of relevant PPE, however, the 

recommendations in this regard given in the dossier are only general indications and nor specific 

requirements assessed necessary on each individual case by case situation. 
GESAMP-BWWG 9/6 

ANNEX 4 

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3.3 Chemicals used in the system (information provided by the applicant) 

3.3.1 The Group recalled that the following chemicals are used in the BWMS: 

1 Triiron tetraoxide 

Name of substance (IUPAC): triiron tetraoxide 

Molecular formula or structural formula: Fe3O4

2 PAC 

Name of substance (IUPAC): Basic aluminum chloride 

Synonym: Polyaluminum chloride 

Molecular formula or structural formula: [Al2(OH)nCl6-n]m (1≤n≤5, m≤10) 

3 PASA 

Name of substance (IUPAC): Acrylamide sodium acrylate copolymer 

Synonym: Polymeric Acrylamide Sodium Acrylate 

Molecular formula or structural formula: 

CH2 CH n CH2 CH m

CONH2 COONa

3.3.2 The Group noted the following data provided by the applicant - in the standard operation 

of the BWMS using the coagulation and magnetic separation method, the amounts of chemicals 

added to ballast water are as given below in Table 2, and the applicant states that these are the 

concentrations used for all analyses of treated ballast water described in this section (see below). 

Table 2: Standard rated concentration of chemicals 

Agent Concentration (mg/L) 

Triiron tetraoxide 30 

PAC 5 (as Al) 

PASA 1 

3.3.3 The Group noted that the applicant states the qualities of water treated by the land-based 

and shipboard test equipments with respect to regulation D-2 of the BWM Convention all satisfy 

regulation D-2, verifying that this technology is reliable under both land-based and shipboard 

conditions. 
GESAMP-BWWG 9/6 

ANNEX 4 

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3.4 Active Substances (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.4.1 The Group noted that the applicant has provided analyses of treated ballast water 

for Active Substances, relevant chemical and other chemicals as part of this application 

for Final Approval. Samples of untreated ballast water and treated ballast water were taken from 

the appropriate sampling positions indicated in Figure 2. 

Tokyo 

Bay

Intake 

pump

Treatment 

equipment

Simulated 

Ballast Water Tank

Tokyo 

Bay

Untreated water 

is sampled. 

Treated water is sampled

at the outlet of the rotary 

filter separator, which is the 

final stage of the system.

Feed 

Tank

Treated water is s sampled

after 5 days’ storage.

Figure 2 – Schematic diagram of treated ballast water sampling positions 

3.4.2 The Group noted that according to the applicant, in this BWMS, the Active Substances 

are as follows – triiron tetraoxide, PAC and PASA, which are responsible for inactivating all 

harmful aquatic micro-organisms and pathogens present in the ballast water. The applicant has 

provided analyses of treated ballast water for Active Substances as part of this application 

for Final Approval, with the following results (using the land-based test setup on reclaimed land 

in Tokyo Bay with treatment rated capacity of 200 m3

/hr) – Tables 3-5: 

Table 3: Aluminum concentration of treated ballast water 

Sample Value Limit of Detection 

Untreated Water 0.048 

Treated Water 0.022 0.001 mg/L 

Table 4: Iron concentration of treated ballast water 

Sample Value Limit of Detection 

Untreated Water 0.05 

Treated Water Not detected 0.01 mg/L 
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Table 5: PASA concentration of treated ballast water (measured by PGC-MS) 

Sample Untreated Water Treated Water Limit of 

Detection 

1 Not detected Not detected 0.1 mg/L 

2 Not detected Not detected 0.1 mg/L 

3.4.3 The Group recalled that in this BWMS, the acrylamide monomer (which occurs as an 

impurity in PASA) should be treated as a relevant chemical. The applicant has provided analyses 

of treated ballast water for this relevant chemical as part of this application for Final Approval, 

with the following results – Table 6 

Table 6: Acrylamide monomer concentration of treated ballast water 

Sample Value Limit of Detection 

Untreated Water Not detected 

Treated Water Not detected 0.0001 mg/L 

The Group recognizes that from these results, no acrylamide monomer was detected in either 

treated or untreated ballast water. 

3.4.4 The Group noted that the applicant has identified certain other chemicals as being 

possible resultant products of the treatment system and had analysed the treated ballast water for 

them, as part of the application for Final Approval, with the following results – Tables 7 and 8: 

Table 7: Heavy Metals concentration of treated ballast water 

Metal Value Limit of 

Detection 

Cadmium (Cd) Not detected. 0.002 mg/L 

Lead (Pb) Not detected. 0.005 mg/L 

Mercury (Hg) Not detected. 0.0001 mg/L 

Chromium [VI] (Cr[VI]) Not detected. 0.02 mg/L 

Arsenic (As) Not detected. 0.001 mg/L 

Selenium (Se) Not detected. 0.001 mg/L 
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Table 8: VOCs concentrations of treated ballast water 

(measured by purge-and-trap gas chromatograph-mass spectrometry) 

VOC Value 

1,1-dichloroethylene Not detected. 

Dichloromethane Not detected. 

Trans-1,2- dichloroethylene Not detected. 

Cis-1,2- dichloroethylene Not detected. 

Chloroform Not detected. 

1,1,1-trichloroethane Not detected. 

Carbon tetrachloride Not detected. 

Benzene Not detected. 

1,2-dichloroethane Not detected. 

Trichloroethylene Not detected. 

1,2-dichloropropane Not detected. 

Bromodichloromethane Not detected. 

Cis-1,3-dichloropropene Not detected. 

Toluene Not detected. 

Trans-1,3-dichloropropene Not detected. 

1,1,2-trichloroethane Not detected. 

Tetrachloroethylene Not detected. 

Dibromochloromethane Not detected. 

m,p-xylene Not detected. 

o-xylene Not detected. 

Bromoform Not detected. 

p-dichlorobenzene Not detected. 

Limit of Detection: 0.0001 mg/L as converted into toluene 

3.4.5 The Group noted that the applicant has provided analytical results for heavy metal, VOC, 

and acrylamide monomer in the collected floc material during the land-based test associated 

with Guidelines (G8) efficacy testing. The analysis used the collected flocs produced in 

processing seawater at the land-based test setup and/or prototype test setup on reclaimed land in 

Tokyo Bay. Results obtained are presented below in Tables 9-11. 
GESAMP-BWWG 9/6 

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3.4.6 However, the applicant did not perform the actual measurement for the concentration of 

either other chemical properties (i.e. POC, DOC and DO) or density of bacteria. So that the 

chemical and biochemical changes in flocs could not be evaluated. The Group is of the opinion 

that this system has a potential risk for the bacterial growth in the tank and production of some 

waste gases (i.e. H2S, CH4 and CO2). The Group strongly request to the applicant that more 

precise and quantitative assessment for the change in flocs tank with actual measurement of 

relevant parameters should be needed for evaluation for not only for the risk of bio-hazard but 

also the ship safety. 

Table 9: Heavy metal concentrations in floc (by elution analysis) 

Metal Value Limit of 

Detection 

Mercury (Hg) Not detected. 0.0005 mg/L 

Cadmium (Cd) Not detected. 0.001 mg/L 

Lead (Pb) Not detected. 0.001 mg/L 

Chromium [VI] (CrVI]) Not detected. 0.005 mg/L 

Selenium (Se) Not detected. 0.001 mg/L 

Table 10: VOCs in floc (by purge and trap gas chromatography-mass spectrometry) 

Item Value 

Benzene Not detected. 

Tetrachloroethylene Not detected. 

Trichloroethylene Not detected. 

1,2-dichloroethane Not detected. 

Dichloromethane Not detected. 

1,1,1-trichloroethane Not detected. 

Carbon tetrachloride Not detected. 

1,1-dichloroethylene Not detected. 

Cis-1,2-dichloroethylene Not detected. 

1,1,2-trichloroethane Not detected. 

1,3-dichloropropene Not detected. 

Limit of Detection: 0.0001mg/L as conversion into Toluene 

Table 11: Acrylamide monomer in floc (chromatography-mass spectrometry) 

Substance Value Limit of 

Detection 

Acrylamide monomer Not detected. 0.02 mg/kg 
GESAMP-BWWG 9/6 

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4 HUMAN HEALTH RISK ASSESSMENT

4.1 Hazard assessment 

The Group had reviewed during its BWWG 4/9 the potential human health hazards associated 

with the Active Substances (Triiron tetraoxide, PAC and PASA) and Relevant Chemical 

(Acrylamide Monomers) used by this system. The main hazardous properties are the following: 

Triiron tetraoxide: 

Inhalation of iron oxide dust during occupational exposure can cause a benign 

pneumoconiosis. 

PAC: 

PAC is irritating to skin and eyes (according to supplier MSDS, ie self-classification). 

LOAEL was 0.25 mg/m3 or more with lung injury occurring at a PAC concentration 

of 0.25 mg/m3

 or more. 

PASA: 

The toxicological concern associated with PASA is due to the occurrence of the monomer 

(acrylamide). 

Acrylamide: 

Acrylamide is toxic if swallowed according to GHS classification (LD50 between 50 

and 300 mg/kg), irritating to skin and eyes, sensitising. Furthermore acrylamide is a 

neurotoxicant, a reprotoxicant, and it also has mutagenic and carcinogenic properties. 

Risks associated with exposure of the crew 

The Group requested that the risk to the crew would need to be assessed on the basis of the 

individual unit operations. In this sense, the applicant submitted for Final Approval the 

description of the working operations that could raise a concern in terms of occupational 

exposure and the safety measures planned to be implemented to reduce the risk associated with 

each component of the system. 
GESAMP-BWWG 9/6 

ANNEX 4 

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Figure 3 – Work operations in this system entailing the risk of worker exposure 

(Diagram elaborated by the Group for the Basic Approval report (BWWG 4/9) and further 

adapted by the Group for the Final Approval report (BWWG 9/9) 

Work operations pointed out by GESAMP-BWWG 4/9 representing potential risks to the crew 

included the operations A to G as shown in Figure 3. According to this, the Group examined the 

following exposure scenarios: 

A – Injection of flocculants (PAC and PASA) and triiron tetraoxide 

The Group identified a work operation prior to A which is addressed by the applicant as G in the 

confidential dossier namely the “Delivery of chemicals”. This operation can involve a) manual 

handling of the chemicals packages (20 kg) (triiron tetraoxide, PAC and PASA) and b) opening 

the packages and filling the containers. These situations can lead to crew exposure to 

dusts/powders/particles with hazardous properties. 

According to the applicant the risk can be properly controlled by means of installing a forced 

exhaust in the worksite in addition to the use of protective personal equipment (PPE). The Group 

agreed that if the proposed measures are to be put in place, the risk would be acceptable. 

B – Potential aerosol discharged (emitted) from the magnetic separator 

The Group agreed with the applicant that as it is a sealing casing, the risk of being exposed to the 

discharged aerosol when working in vicinity of the magnetic separator under normal operational 

conditions is minimal. 

C – Maintenance of the screw conveyer used for floc collection and process of floc 

collection 

Taking into consideration that the magnetic separator including the screw conveyor and the 

transportation path lines of collected flocs are within the sealed casings of the magnetic 

separator, the Group concluded that the risk of human exposure during this maintenance work 

seems to be acceptable. 
GESAMP-BWWG 9/6 

ANNEX 4 

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D – Transferring process of collected flocs containing water into dedicated sealed storing 

containers 

The Group had a strong concern about the manual decanting of the collected flocs (storage tank) 

into the dedicated containers because these materials represent a biohazard (viable pathogens) 

and a potential chemical hazard due to the presence Active Substances and its 

residues/impurities, namely acrylamide monomers. The Group considered that these risks could 

only be mitigated by implementation of strict engineering control measures, QA standards, 

instructions manual and specified PPE/RPE or fully automated system of collecting flocs to 

ashore treatment facilities. 

E – Debarkation of dedicated sealed containers storing collected flocs 

Please see comments above (D) 

F – Treatment of collected flocs on land 

Please see comments above (D). 

4.2 Human Exposure Scenarios related to General Public 

4.2.1 The Group concurred with the applicant that the general public target groups would be 

people subject to indirect exposure by way of sea bathing or through the environment or the food 

chain. The Group recalled that in the Methodology for information gathering and the conduct of 

work of the GESAMP-BWWG (IMO circular BWM.2/Circ.13, Appendix 2, “Human Exposure 

Assessment”) the following procedures for the assessment of exposure and risk to human health 

have been recommended: 

.1 identification of exposure routes and development of exposure scenarios for 

respective exposure routes; and 

.2 estimation of the amounts of exposure (intake) and risk assessment. 

4.2.2 The Group noted that the applicant had supplied literature data on NOAEL to be used in 

the assessment of risk to human health, (see below in Table 13). In addition, the results on 

assays of chemicals in treated ballast water have been collected together in Table 12 below. 

Table 12: Summary of results of assays of chemicals in treated 

ballast water (taken from tables above) 

Substance Concentration in 

treated ballast water Limit of Detection 

Aluminum 0.022 mg/L 0.002 mg/L 

PASA n.d. 0.1 mg/L 

Acrylamide monomer n.d. 0.0001 mg/L 

Iron n.d. 0.01 mg/L 
GESAMP-BWWG 9/6 

ANNEX 4 

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Table 13: Data on toxicity studies in mammals utilized in risk assessment 

Substance Test Route Species Duration Result References 

PASA Repeated 

toxicity 

Oral 

(feeding) Dog 2 years 

NOAEL: 

>1250 

mg/kg/day1)

Cosmetic 

Ingredient 

Review, 2005 

Acrylamide 

monomers 

Repeated 

toxicity 

Oral 

(drinking 

water) 

Rat 90days 

NOAEL: 

0.2 

mg/kg/day 

EU, 2002; 

NTP-CERHR, 

2005 

Aluminum (Guideline for drinking water treatment 

facility) 

0.2mg/L 

(small facility) 

0.1mg/L 

(large facility) 

WHO, 2003 

1) convert mixing ratio 5% of dose level into dose amount per kilogram of body weight 

(food intake data referred to Lehman, A.J. (1954) ) 

4.2.3 The Group considered that the NOAEL used to calculate the different MOS would need 

to be allocated with the appropriate assessment factor (AF). As a standard procedure and 

according to the Methodology BWWG 3/9, annex 9, the use of an AF of 100 (10 for interspecies 

variability and 10 for intraspecies variability) is recommended in order to address the 

uncertainties deriving from the extrapolation of results from animal toxicity testing to human 

exposure. 

4.3 Exposure of general population through the environment and food chain 

4.3.1 The Group recalled that possible scenarios of exposure to the general population through 

the environment and food chain are limited to the following: 

Scenario 1: Oral exposure (through water drinking) of sea bathers and workers in the 

surrounding water areas; and 

Scenario 2: Oral exposure to the general population through the food chain (by way of marine 

foods). 

4.3.2 Examining the data in Tables 12 and 13 above, the Group concurred with the applicant 

that the concentration of aluminum in treated ballast water is 0.022 mg/L and this value is 

substantially lower than the allowed concentration of aluminum in tap water specified by 

the WHO, that is, 0.1 mg/L or 0.2 mg/L (for large and small drinking water treatment plants, 

respectively). Therefore, the Group considered that the concentration of aluminum (PAC) in 

treated ballast water discharged from this BWMS would not raise a concern to human health. 

In what regards the assessment of risk to the general population of oral exposure through the food 

chain by way of marine products and taking into consideration that aluminum did not shown 

bioaccumulative properties in marine fish, the Group concluded that the risk to PAC through the 

food chain would be also acceptable. 
GESAMP-BWWG 9/6 

ANNEX 4 

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4.3.3 In the case of PASA, the Group noted the data in Tables 12 and 13 above and while the 

concentration of PASA in treated ballast water can only be a maximum of 0.1 mg/L, its 

concentration is expected to be further diluted in the discharged water area. The Group agreed 

with the applicant that MOS can be estimated in accordance with a worst-case scenario, in which 

no dilution in water is assumed to occur, under the assumption that the water concentration 

of PASA derived from treated ballast water is 0.1 mg/L. 

MOS = 1,250 mg/kg/day/(0.003 mg/kg/day) 

 = 4.2 x 106

The Group concurred with the applicant that since this MOS value is considerably higher than 

the MOSref (100), it can be judged that exposure through drinking water to PASA derived from 

discharged treated ballast water will represent an acceptable risk to sea bathers or workers in 

surrounding water areas. Moreover in the assessment of risk to the general population of oral 

exposure through the food chain by way of marine products, the Group believes that 

bioconcentration for PASA in marine organisms showed to be of low potential and therefore the 

human health risk is considered to be acceptable. 

4.3.4 In the case of acrylamide monomer, the Group noted the data above in Tables 12 and 13 

and while the concentration of acrylamide monomer in treated ballast water was found to be less 

than 0.0001 mg/L, its concentration is expected to be further diluted in the discharged water area. 

The Group agreed with the applicant that MOS can be estimated in accordance with a worst-case 

scenario, in which no dilution in water is assumed to occur and the concentration of acrylamide 

monomer derived from treated ballast water is set at 0.0001 mg/L. 

MOS = 0.2 mg/kg/day/(3.3 x 10-6 mg/kg/day) 

 = 6.7 x 104

The Group concurred with the applicant that since this MOS value is considerably higher than 

the MOSref (100) and considered conservative because it was based on a drinking water worst 

case scenario (oral intake per day of 2L/person), it can be judged that exposure through drinking 

water to acrylamide monomers derived from discharged treated ballast water will represent an 

acceptable risk to sea bathers or workers in surrounding water areas. 

Moreover in the assessment of risk to the general population of oral exposure through the food 

chain by way of marine products, the Group believes that bioconcentration for acrylamide 

monomers in marine organisms showed to be of low potential and therefore the human health 

risk is considered to be acceptable. 

4.3.5 In the case of triiron tetraoxide, the Group noted the data above in Tables 12 and 13 and 

while the concentration of iron in treated ballast water was found to be less than 0.01 mg/L, and 

its concentration is expected to be further diluted in discharged water area. On the other hand, 

the Group recalled that the concentration of iron in water has been reported to be 0.01 mg/L in 

seawater and 1 mg/L in river water (OECD, 2007). The Group agreed with the applicant that 

these findings indicate that iron concentration in treated ballast water is similar to or less than 

that in the water areas into which treated ballast water is to be discharged, and that iron in 

discharged treated ballast water will not alter the iron concentration in the environment. 

Therefore, the Group judged that the amount of iron, which is derived from discharged treated 

ballast water, ingested by sea bathers or workers in surrounding water areas through water
GESAMP-BWWG 9/6 

ANNEX 4 

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drinking is not relevant. Moreover in the assessment of risk to the general population of oral 

exposure through the food chain by way of marine products, the Group recalled the information 

in the Basic Approval application dossier that the accumulation of iron in the marine organisms 

does not need to be considered. Taken together, it would appear that there is no risk to the health 

of humans (the general population) by the oral route through the food chain. 

5 RISKS TO SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC

5.1 Safety of the ship 

5.1.1 The Group noted the specific countermeasures that can be employed in this system to deal 

with identified potential emergency and safety problems during the ballast water purification 

have been described and discussed above. A description of the various safety measures 

developed by the applicant is given above in section 3.2. 

5.1.2 In line with the mention in the Report of the Application for Basic Approval of this 

system, the Group concurred with the applicant that the treated water should have no increased 

corrosivity effect to ballast water tanks or other equipment in the ship, compared with normal 

seawater. 

5.1.3 Moreover, the Group concurred with the statement in the Report of the Application 

for Basic Approval of this system, that issues connected with the storage on board ship of the 

acidic and potentially corrosive un-diluted PAC, have been sufficiently addressed by the 

applicant by specifying the use of appropriate protective coatings to storage arrangements and 

piping subject to direct contact with undiluted PAC. 

5.2 Safety of the crew 

5.2.1 Based on the evaluation in the above section 4, the Group considered that risk to safety 

of the ships’ crew by exposure to chemicals can be mitigated to an acceptable level by the safety 

measures planned to be put in place by the applicant. However, the Group considers that 

procedures and measures to be put in place related to handling and disposal of the collected flocs 

require additional strict engineering control measures and detailed instructions for procedures, 

together with specified PPE/RPE, to be included to the required Operation Manual thus providing 

the necessary QA standards, or alternatively a fully automated system for the treatment and 

handling of the flocculated material should be incorporated to the BWMS. 

5.3 Safety of the general public 

5.3.1 Based on the evaluation in the above section 4, the Group agreed that 

the Active Substances and Relevant Chemical produced by this system do not pose a significant 

risk to the general public (sea bathers and workers in the surrounding water areas) and through 

the food chain (by way of marine foods). 
GESAMP-BWWG 9/6 

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6 ENVIRONMENTAL RISK ASSESSMENT 

6.1 Assessment of Persistence (P), Bioaccumulation (B) and Toxicity (T) 

6.1.1 The Group recalled that as corroborated at the Basic Approval, none of 

the Active Substances triiron tetraoxide, PAC and PASA, nor the acrylamide monomers are 

classified as PBT substances. 

6.1.2 Based on these results, the Group concluded that these chemicals should not be classified 

as PBT-substances. 

6.2 Ecotoxicity testing of treated ballast water 

6.2.1 The Group noted that in this section, the results of acute and chronic aquatic ecotoxicity 

studies performed by the applicant with 100% treated ballast water as a test substance are 

presented in accordance with the Procedure for approval of ballast water management systems 

that make use of Active Substances (G9). 

6.2.2 Acute aquatic ecotoxicity tests 

6.2.2.1 The Group noted that the acute ecotoxicity tests for high and low salinity water were 

performed using the land-based test setup of the Hitachi BWMS, and employing 1-day-hold 

and 5-day-hold 100% treated ballast water samples on algae, invertebrates and fish. From the 

results shown in Tables 14 and 15, the Group concluded that 100% treated ballast water, which is 

a non-diluted sample of treated ballast water, has no acute toxicity impact on these aquatic 

species. 

Table 14: Acute NOEC of 100% treated ballast water for high salinity water (>32 psu) 

Test sample Classification Species End point NOEC 

Algae Skeletonema 

costatum

Growth 

inhibition 

72-h NOEC 

100% treated 

ballast water*

Invertebrate Hyale 

barbicornis

Mortality 

96-h NOEC 

100% treated 

ballast water*

1-day-hold treated 

water discharge 

sample 

Fish Oryzias 

javanicus

Mortality 

96-h NOEC 

100% treated 

ballast water*

Algae Skeletonema 

costatum

Growth 

inhibition 

72-h NOEC 

100% treated 

ballast water*

Invertebrate Hyale 

barbicornis

Mortality 

96-h NOEC 

100% treated 

ballast water*

5-day-hold treated 

water discharge 

sample 

Fish Oryzias 

javanicus

Mortality 

96-h NOEC 

100%treated 

ballast water*

* No effects were observed in 100% treated ballast water which is a non-diluted sample of treated water. 
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Table 15: Acute NOEC of 100% treated ballast water for low salinity water (<22 psu) 

Test sample Classification Species End point NOEC 

Algae Skeletonema 

costatum

Growth 

inhibition 

72-h NOEC 

100% treated 

ballast water*

Invertebrate Hyale 

barbicornis

Mortality 

96-h NOEC 

100% treated 

ballast water*

1-day-hold treated 

water discharge 

sample 

Fish Oryzias javanicus Mortality 

96-h NOEC 

100% treated 

ballast water*

Algae Skeletonema 

costatum

Growth 

inhibition 

72-h NOEC 

100% treated 

ballast water*

Invertebrate Hyale 

barbicornis

Mortality 

96-h NOEC 

100% treated 

ballast water*

5-day-hold treated 

water discharge 

sample 

Fish Oryzias javanicus Mortality 

96-h NOEC 

100% treated 

ballast water*

* No effects were observed in 100% treated ballast water which is a non-diluted sample of treated water. 

6.2.3 Chronic aquatic ecotoxicity tests 

6.2.3.1 The Group noted that the chronic ecotoxicity tests for high salinity water were 

performed using the land-based test setup of the Hitachi BWMS, and employing 100% treated 

ballast water samples on algae, invertebrates and fish. The Group noted that according to the 

applicant, the Active Substances were injected into seawater collected from Tokyo Bay to 

produce final concentrations two times higher than those of the standard rated processing 

conditions for this system and these water samples were analyzed (see Table 16 for results). 

Approximately 20 L of the treated water was sampled from the effluent in the outfall of the filter 

separator when the processing had been carried out for 16 to 32 minutes. The sample of treated 

water was put in a 20 L polyethylene bottle and transported to the test facility in cool, shaded 

conditions. All the samples of treated water were carried into the test facility the next day and 

were used in the chronic ecotoxicity tests. 

6.2.3.2 From the results shown in Table 17, the Group concluded that 100% treated ballast 

water, which is a non-diluted sample of treated ballast water, has no chronic ecotoxicity effects in 

any of the species tested. 

Table 16: Final concentrations of chemicals after injection for chronic ecotoxicity test 

Active Substance 

Concentration in untreated 

seawater for chronic 

ecotoxicity tests 

Triiron tetraoxide 60 mg/L 

PAC 10 mg/L (as Al) 

PASA 2 mg/L 
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Table 17: NOEC on chronic ecotoxicity of 100% treated ballast water for 

high salinity water (>32 psu) 

Test 

sample Classification Species End point NOEC 

Algae Skeletonema 

costatum

Growth inhibition 

72-h NOEC 

100% treated 

ballast water*

Invertebrate Hyale 

barbicornis

Mortality 

21-days NOEC 

100% treated 

ballast water*

Treated 

ballast 

water 

Fish Oryzias 

javanicus

Post-hatch mortality 

40-days NOEC 

100% treated 

ballast water*

*No effects were observed in 100% treated ballast water which is a non-diluted sample of treated water. 

6.2.4 Ecotoxicity tests of water with flocs 

6.2.4.1 The Group noted that according to the applicant, water containing flocs generated by 

this system using the standard rated concentration of Active Substances, was employed for 

ecotoxicity tests. The Group noted that the stated test results indicate that flocs in treated water 

(100% floc water) had no physical effect on aquatic organisms such as zooplankton and fish. 

6.3 Risk assessments of chemicals for aquatic organisms 

6.3.1 The Group recalled that in the Report of the Application for Basic Approval of this 

system, the PEC/PNEC ratios and risk assessments as calculated by the applicant were not 

accepted by the Group and the applicant was requested to completely revise its risk assessment 

for aquatic organisms. 

6.3.2 The Group noted that in the dossier for Final Approval, the applicant has treated the risk 

assessment of aluminum (in PAC) differently to the other chemicals in this system 

(triiron tetraoxide, PASA and acrylamide monomers). In addition, the Group referred to the 

summary of results of assays of chemicals in treated ballast water (see above in Table 12), where 

aluminum is the only one of the four chemicals that is routinely detected in the treated ballast 

water even though its concentration is reported by the applicant to be significantly lower than the 

concentration in natural seawater (see above at sections 3.4.2 and 3.4.3 for all analytical results). 

6.3.3 Based on this situation with aluminum concentration in treated ballast water being lower 

than in natural seawater, the Group agreed with the applicant that aquatic organisms are quite 

unlikely to be exposed to harmful levels of aluminum as a result of PAC being used in this 

system that produces detectable aluminum levels in the treated ballast water, particularly bearing 

in mind that the treated ballast water will be mixed with the receiving natural seawater upon 

discharge. In order to be sure, the Group performed a worst-case risk assessment for aluminum 

in the form of a PEC/PNEC ratio calculation, as follows, based on data provided by the applicant 

in the dossier for Final Approval: 

Concentration of Al in treated ballast water (from Table 12 above) = 0.022 mg/L; 

Using a default dilution rate of 10, PEC = 0.0022 mg/L; 

Worst case chronic toxicity NOEC for Al (from data provided in Appendix) = 0.4 mg/L; 

Using Assessment Factor of 100, then PNEC = 0.004 mg/L; 

Then PEC/PNEC ratio = 0.55

The Group considered that the risk assessment for aluminum is acceptable. 
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Bearing in mind the points above and also taking into account the information provided by the 

applicant concerning the background concentration of aluminum in open seas (variation is 

from 0.03 μg/L in intermediate deep ocean waters (0.15 μg/L in surface waters at sea) 

to 800 μg/L in rivers) (Table 7-6, p. 91, confidential dossier), the Group considered that the risk 

assessment for aluminum is acceptable. The concentration in discharges ballast water is likely to 

decrease the Al-concentration in the receiving waters. 

6.3.4 In addition, the Group noted that the applicant has provided results of tests using influent 

seawater to which kaolin was added to increase the SS concentration and the concentrations of 

aluminum ions in the influent water to a much higher level than in natural seawater. The test 

results are shown in Table 18 below. The Group recalled that kaolin is a natural mineral 

containing aluminum so the concentrations of total aluminum in the influent were several times 

higher than in natural seawater. The results show that the total aluminum concentrations in the 

treated ballast water were still lower than in influent seawater. 

Table 18: Results of analysis of aluminum 

(Case where kaolin was added to influent seawater) 

Influent Treated water Detection limit 

0.34 mg/L 0.044 mg/L 0.001 mg/L 

The Group concluded that even in this case of elevated aluminum levels, the treated ballast water 

has no effect on aluminum concentration in the water area discharged. 

6.3.5 Turning their attention now to triiron tetraoxide, PASA and acrylamide monomers, 

the Group noted that the applicant has performed a risk assessment of these chemicals on aquatic 

organisms based on the calculation of PEC/PNEC ratios, using literature aquatic ecotoxicity data 

(see Appendix) to provide PNEC values (see Table 19 below), with PEC values taken from the 

analytical data of treated ballast water in Table 12 above. 

Table 19: PNECs for triiron tetraoxide, PASA and acrylamide monomers 

Substance Toxicity 

(mg/L) 

Assessment 

factor 

PNEC 

(mg/L) 

Triiron 

tetraoxide 48-h LC0 (acute) > 1,000 1000 > 1 PNECshort

48-h LC50 (acute) 180 1000 0.18 PNECshort

PASA 30-day NOEC 

(chronic) 75 100 0.75 PNEClong 

96-h LC50 (acute) 59 1000 0.059 PNECshort Acrylamide 

monomers 28-day NOEC 

(chronic) 2.04 100 0.02 PNEClong 
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6.3.6 The Group concurred with the applicant that the PEC/PNEC ratios shown in Table 20 

below are all lower than 1 for all these three Active Substances. Therefore, the Group agreed 

there is no risk to aquatic organisms from these three Active Substances used in this system. 

Table 20: PEC/PNEC ratio for triiron tetraoxide, PASA and acrylamide monomers 

Substance PEC (mg/L) PNEC (mg/L) PEC/PNEC 

ratio 

Triiron tetraoxide < 0.01 > 1 < 0.01 

PASA < 0.1 0.18 < 0.56 

Acrylamide monomers < 0.0001 0.02 < 0.005 

6.4 To establish the maximum allowable discharge concentrations 

6.4.1 The Group noted that the applicant has provided proposals for maximum allowable 

discharge concentrations (MADC) of all chemicals in the ballast water, based on consideration of 

the PNEC values calculated above, assessment reports evaluated by international bodies and 

governmental bodies (see in Appendix), and system dosage concentration of each substance. 

6.4.2 In the case of aluminum, the Group noted that the applicant proposes to base the MADC 

on Canada’s 0.074 mg/L (see data in Appendix), which is the strictest criterion stated. At a 

background concentration of 0.074 mg/L, the MADC of aluminum is 0.22 mg/L according to 

the MAMPEC (Ver. 1.6) model simulation (CERI, 2008). The default commercial harbour of 

the MAMPEC model is half the size of Rotterdam Port, and other conditions were used without 

change. In addition, the Group noted the applicant states that considering this simulation, at a 

background concentration less than 0.074 mg/L, it may be clear that the calculated result 

of MAMPEC is to be less than 0.074 mg/L in the case of an emission load of 0.22 mg/L. On the 

other hand, at a background concentration larger than 0.074 mg/L, aquatic organisms living in 

the area are expected to have some tolerance to such concentrations of aluminum. In this case, 

the result calculated with MAMPEC is less than the background concentration 

(larger than 0.074 mg/L) when the emission load is 0.22 mg/L, so it is concluded that the 

discharged ballast water has little impact on the aquatic environment. Considering all of the 

above, the Group notes the MADC of aluminum proposed by the applicant is 0.22 mg/L. 

The Group agrees with this value. 

6.4.3 In the case of iron, the Group noted that the applicant proposes to base the MADC on the 

following discussion. Iron is one of the most abundant metals in the Earth’s crust and is found in 

natural fresh waters at levels ranging from 0.5 to 50 mg/L. Iron is known as an essential element 

in human and other organisms’ nutrition and there is no data on biotoxic forms of iron. 

Therefore, it is difficult to establish the MADC from an ecotoxicity point of view as specified 

in Metals Environmental Risk Assessment Guidance (UK, International Council of 

Mining & Metals). In the Hitachi BWMS, the applicant stated that triiron tetraoxide is added as 

slurry and NOT a solution, so that dissolution of iron ions into either ballast water or the 

ecosystem may not occur. Therefore, the Group noted the MADC of iron is proposed by the 

applicant as 30 mg/L. The Group agrees with this value. 
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6.4.4 In the case of PASA, the Group noted that the applicant proposes to base the MADC on 

the PNEC of PASA at 0.18 mg/L in Table 20 above. Furthermore, according to water quality 

guidelines of Canada’s CCME, the US EPA and similar bodies in other countries, dilution may be 

considered because, for the most part, the immediate concentration of substances at the discharge 

point will not be an adequate representation of the concentration of the substance in the water body as 

a whole. For instance, for the most part, aquatic life will not be exposed to the concentration of the 

substance in the pipe but rather to the receiving waters mixed with effluent. The Group notes that the 

applicant states there is no simulation model to examine dilution similar to MAMPEC, and which is 

specialized for a macromolecular organic compound such as PASA, so an alternative approach is 

considered such as the use of dilution factors. Canada’s CCME has established a framework 

of Effluents Discharge Objectives considering dilution factors. For lakes and enclosed bays, the 

default dilution factor is a maximum of 1 in 10. Following this framework as an example, the Group 

notes that the applicant proposes the MADC of PASA is 1.8 mg/L. The Group agreed with this value. 

6.4.5 In the case of acrylamide monomers, the Group notes that the applicant proposes to base 

the MADC on the PNEC of acrylamide monomers at 0.02 mg/L in Table 20 above. The Group 

noted that according to the applicant, some parameters required to simulate the discharge load 

by MAMPEC are unclear, so that a dilution factor of 10 may be applied as for PASA. 

Thus calculated, the Group noted that the MADC of acrylamide monomers proposed by the 

applicant is 0.2 mg/L. The Group agreed with this value. 

6.4.6 Based on the above discussion, the Group concurred with the applicant that each 

substance can comply with the established MADC values taking into account the properties of 

each substance and the specifications and mechanisms of the Hitachi BWMS. It was concluded 

by the Group that this system presents no risk to the aquatic environment. 

6.4.7 The applicant performed its calculation with the MAMPEC-model version 1.6. As 

the Group did not have this version available, it estimated the concentrations with version 2.0. 

The main difference is the more dynamic character of the new version. Nevertheless the initial 

concentrations concurred exactly with the ones provided by the applicant. Therefore, the Group 

considered the calculations of the applicant acceptable. 

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to safety of the ship 

7.1.1 The Group noted that specific countermeasures can be employed in this system to deal 

with envisaged emergency and safety problems during the ballast water treatment plant 

operation, and that subject to all the necessary identified risk mitigation measures being detail 

developed and implemented this BWMS should present no undue risks to the safety of the ship. 

7.2 Risks to the crew and general public 

7.2.1 The Group considered that risk to safety of the ships’ crew by exposure to chemicals can 

be mitigated by the safety measures planned to be put in place by the applicant. However, 

the Group considers that procedures and measures to be put in place related to handling and 

disposal of the collected flocs require additional strict engineering control measures and detailed 

instructions for procedures, together with specified PPE/RPE, to be included to the 

required Operation Manual thus providing the necessary QA standards, or alternatively a fully 

automated system for the treatment and handling of the flocculated material should be 

incorporated to the BWMS. 
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7.2.2 The Group also concluded that the Active Substances and Relevant Chemical produced 

by this system do not pose a significant risk to the general public (sea bathers and workers in the 

surrounding water areas) and through the food chain (by way of marine foods). 

7.3 Risks to the environment 

7.3.1 Having reviewed all of the information submitted with this application, the Group agreed 

that this system will not cause any harm to the environment. The initial estimations of 

the PEC/PNEC values for the different substances were all < 1, except the value for aluminum. 

As the background concentration of Al is generally higher than what was produced by this 

system, it was considered that the PEC for Al was not to cause any harm to the receiving water. 

In addition, the MAMPEC calculations of the applicant concurred with the results achieved by 

the Group, although another version of the model was used. 

7.3.2 However the chemicals for coagulation, such as aluminum is well known as its toxicity, 

and the complexity of mechanical operation for disinfection, the applicant should prepare the 

managing program when the BWMS is not functioned normally. 

7.4 Recommendation 

7.4.1 Having reviewed all the data and information submitted by Japan with the application 

for Final Approval and the information received from the applicant during the GESAMP-BWWG 

meeting, the Group recommended to MEPC that Final Approval be given to the Hitachi BWMS 

(ClearBallast) provided that the concerns and issues raised in this review are addressed by the 

applicant to the satisfaction of the Administration. To avoid unreasonable risk to the 

environment, to humans and to resources the system should be operated with the following 

restrictions: 

 .1 Maximum allowable dosages of Active Substances 

The maximum dose for these Active Substances should be set as follows: 

5 mg/L of PAC (as Al) 

30 mg/L of triiron tetraoxide (Fe3O4) 

1 mg/L of PASA; and 

 .2 Maximum allowable discharge concentrations of Active Substances 

 The system should ensure a maximum discharge concentration of all the Active 

Substances and relevant chemicals, if the separation and filtering process are 

functionally operated. To ensure these processes, the water level in these 

components should be recorded during ballast water intake. 

 .3 PASA 

 PASA needs to be strictly controlled by adequate selection of the suppliers in 

order to keep the concentration of acrylamide monomers as its impurity 

below 0.2%. Procedures should be included in the Quality Assurance Program to 

ensure that only PASA with an acrylamide monomer content of less than 0.2% is 

supplied for the operation of this BWMS. 
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7.4.2 The Group, not wanting to delay system approval unnecessarily and taking the unusual, 

biocide-free design of the system into account, considered that the applicant had provided 

sufficient information for BWWG to recommend to MEPC that it be granted Final Approval and 

that any outstanding aspects could be dealt with by the Administration prior to Type Approval. 

7.4.3 The Group, having reviewed the dossier and additional responses requested of the 

applicant, was of the opinion that the system should be considered generally safe for the 

environment, the crew and human health, when this BWMS is correctly operated. To this end, 

the Group strongly recommended that the MEPC invites the Administration undertaking 

the G8 Type Approval testing to ensure that all issues and concerns have been addressed prior to 

issuing a Type Approval Certificate for this system. 

 .1 The procedure for handling the flocculated material that contains a condensed 

mixture of organic matter and organisms including bacteria and potentially 

pathogens is unclear. In the flocs all material is concentrated and the instructions 

on how to handle this potentially bio-hazardous material should be clear and 

unambiguous to all crew concerned. Therefore, prior to operating the system, the 

applicant will have to provide an Operation/Technical Manual where all safety 

procedures should be explicitly described including the different risk mitigation 

measures and PPE/RPE prescribed in all handling, storage and treatment steps of 

the flocculated material generated by the system. 

 .2 The Group noted that a gravity “buffer tank” is a requirement of the system. 

Additional water level error detection devices will require to be incorporated into 

the BWT equipment control system to counter the potential for high level/overflow 

and low level in the “buffer tank”. The Group notes that the system evaluated does 

not utilize a discharge pump connected directly to the outflow of the filter separator.

 .3 The questions relating to the provision of a drain from residue tank and its 

cleaning requirement were not answered to the Groups satisfaction and need to be 

dealt with appropriately by describing the safety procedures extensively in the 

Technical/Operations Manual. 

 .4 The Group considered that the maintenance requirements provided were very 

general and that these should be supplemented in the final Technical Manual with 

sufficient detail to enable full assessment of both the work actually required and 

the potential for operator exposure. 

* * * 
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Appendix 

PHYSICOCHEMICAL AND BIOLOGICAL PROPERTIES OF ACTIVE SUBSTANCES 

(TRIIRON TETRAOXIDE, PAC AND PASA) AND RELEVANT CHEMICAL 

(ACRYLAMIDE MONOMERS) 

1 EFFECTS ON AQUATIC ORGANISMS 

1.1 Aluminum 

1.1.1 The Group notes that the applicant states aluminum is the most abundant metallic element 

on earth and constitutes 8.13% of the earth's crust. Natural sources of aluminum released to 

aquatic systems include weathering of rocks, glacial deposits and soils and their derivative 

minerals and atmospheric deposition of dust particles (WHO, 1997; EC and HC, 2000). It is not 

recognized as a toxic substance in natural marine environment due to the high concentration of it 

found in clay particles in marine waters and its relatively constant pH of approximately 8.2. 

Clay particles tend to bind rapidly with aluminum and form large colloids, thus removing 

aluminum from the water column. Therefore, the concentrations of dissolved aluminum in 

seawater remain low in accordance with the equilibrium of aluminum specifications, in spite of 

the existence of a wide variety of natural aluminum sources (WHO, 1997; CCME, 2003; EC and 

HC, 2000). 

1.1.2 Previous risk assessment of aluminum in reports of international bodies and governmental 

bodies – provided by applicant 

The following is a summary of representative evaluations of aluminum effects as previously 

reported by international bodies and governmental bodies: 

WHO, Environmental Health Criteria, 194 Aluminum, 1997 

Hazards posed to human health by aluminum have been systematically identified in a number of 

previous studies. However, no evidence has yet been produced that supports the primary 

causative role of aluminum in Alzheimer’s disease that has been suggested. Nor is there any 

indication that aluminum is carcinogenic. Taking these facts together, it has been concluded that 

there is insufficient health-related evidence to justify revising the existing WHO Drinking-Water 

Guidelines with respect to aluminum. 

WHO, Guideline for drinking water quality, 2006 

Owing to the limited amount of data relevant to the effects of aluminum on animals and the 

uncertainty surrounding available data on its effect on humans, no accurate health-based 

guideline values on it can be derived. However, practicable levels based on optimization of the 

coagulation process in drinking-water plants using aluminum-based coagulants have been 

derived as 0.1 mg/L or less in large water treatment facilities, and 0.2 mg/L or less in small 

facilities. 
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EC and HC (2000), Canadian Environmental Protection Act 1999, Priority Substances List 

Assessment Report for Aluminum Chloride, Aluminum Nitrate, Aluminum Sulfate 

This report characterized the environmental risk of aluminum posed to pelagic organisms. 

Environmental exposure to aluminum in water is assumed to be greatest in areas in proximity to 

places where process wastewater (backwash water) is directly released to aquatic environments 

from drinking water treatment plants. Table 5 of EC and HC (2000) presents estimated total 

aluminum concentrations in backwash waters for 13 drinking water treatment plants, including 

those with the highest estimated levels of concentration. The total aluminum levels present in 

effluent from drinking water treatment plant wastewater were measured (Table 5 of EC 

and HC, 2000; 0.76~115mg/L). In order to estimate the amount of bioavailable aluminum present 

in rivers, the report performed speciation with MINEQL + and WHAM models. These models 

calculated the concentration levels of dissolved inorganic monomeric forms of aluminum 

following the releases of wastewater from selected drinking water treatment plants, using the 

estimated aluminum level in effluents and assuming a 1:10 dilution. 

The possibility that modeled concentrations overestimate actual values is further supported by 

measured data. The report concluded that organisms are unlikely to be exposed to harmful levels 

of aluminum as a result of using aluminum to treat water. 

In a study done with collected flocs, it was concluded that all the collected flocs tested were 

non-toxic using a microbial test and acutely and subacutely non-toxic to rainbow trout. 

1.1.3 Risk assessment of aluminum on aquatic organisms – provided by applicant 

The following is a summary of representative evaluations of aluminum effects as previously 

reported by international bodies and governmental bodies. As a prerequisite for assessing the 

influence of aluminum contained in treated ballast water, the literature of aluminum 

concentration in natural water areas was surveyed especially where intake/discharge of ballast 

water is conducted. 

Consideration of natural background concentration in risk assessment has been recommended in 

guidance for the risk assessment of various metals, and this recommendation has been carried out 

(ICMM, 2007a, b; EA 2008, etc.). 

Risk assessment from a quantitative evaluation of aluminum risk according to EC and HC (2000) 

Key studies of the acute toxicity and chronic toxicity of aluminum selected from the hazard data 

on aluminum for aquatic organisms. Considering that the total aluminum concentration in the 

treated ballast water using this system was 1/10 to 1/10000 smaller than that in the effluent 

described in the report (0.76 to 115mg/L, EC and HC, 2000), it can be reasonably concluded that 

organisms are unlikely to be exposed to harmful levels of aluminum resulting from the use of 

aluminum for ballast water treatment. 
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 Key studies of the acute toxicity of aluminum 

Substance Biological 

classification Organism species End point Toxicity (mg/L) 

Skeletonema costatum, 

SW

Growth 

inhibition 

72-h EC50

4.65 

Algae 

Pseudokirchneriella 

subcapitata, FW

Growth 

inhibition 

96-h EC50

0.57 

Invertebrates Nitocra spinipes, SW Mortality 

96-h LC50

10 

Shellfish Physa sp., FW Mortality 

96-h LC50

30.6 

Aluminum 

ions 

Amphibia Bufo americanus, FW Mortality 

96-h LC50

0.86 

Abbreviations: SW: marine species, FW: fresh water species 

 Key studies of chronic toxicity of aluminum 

Substance Biological 

classification Organism species End point Toxicity (mg/L) 

Skeletonema costatum, SW Growth 

inhibition 

72-h NOEC 

1.04 

Algae 

Pseudokirchneriella 

subcapitata, FW 

Growth 

inhibition 

96-h NOEC 

< 0.4 

Aluminum 

ions 

Invertebrates Ceriodaphnia sp., FW Mortality 

8-day NOEC 4.9 

 Abbreviations; SW: marine species, FW: fresh water species.

Effects of aluminum accumulated in sediments in discharge water areas 

The report on aluminum assessment by EC and HC (2000) of Canada revealed that 

they conducted toxicity studies of flocs collected in the process of drinking water treatment 

and found no significant toxicity either in studies using micro-organisms or in acute or subacute 

toxicity studies using rainbow trout (fish). In a simulation using the MAMPEC model, the 

contents of aluminum in sediments after 10 years of accumulation have been calculated 

at 0.000777-0.0349 mg/g. Since this range of simulated contents is substantially smaller than the 

aluminum content in natural soil, aluminum adsorbed to sediments may not exert adverse effects 

on living organisms. 

1.1.4 Establishing the maximum allowable discharge concentration for aluminum 

It is practical to manage the total concentration of dissolved monomeric aluminum and 

particulate aluminum for risk management with respect to human species and aquatic organisms. 

In the United States and Canada, relevant water quality criteria have been established, but there 

are no criteria in Japan and the United Kingdom. 
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Criteria for aluminum in water 

Country Environmental Criteria Notes 

Canada 0.074 mg/L 

Minimum criterion for fresh water. 

Aluminum is not expected to be toxic 

in the natural marine environment. 

USA 

CMC: 0.75 mg/L 

(Criteria Maximum Concentration) 

CCC: 0.084 mg/L 

(Criteria Continuous Concentration) 

Both criteria are freshwater criteria. 

No criteria for seawater. 

UK n.a. - 

Japan n.a. - 

n.a.: no established criteria 

1.2 Triiron tetraoxide, PASA, and acrylamide monomers 

1.2.1 The Group noted that the applicant had provided key studies of acute toxicity and chronic 

toxicity respectively extracted from the hazard data that are used for calculation of PNEC values 

of substances employed for Hitachi BWMS. 

Key studies of acute toxicity of triiron tetraoxide, PASA, and acrylamide monomers 

Test 

substance 

Biological 

classificatio

n 

Organism species End point Toxicity 

(mg/L) 

Algae 1 n.a. n.a. No data 

Invertebrates n.a. n.a. No data 

Triiron 

tetraoxide 

Fish Leuciscus idus, FW Mortality 

48-h LC0

* > 1,000 

Algae n.a. n.a. No data 

Invertebrates Ceriodaphnia dubia, FW Mortality 

48-h LC50

218 

Girella punctata, SW Mortality 

48-h LC50

840 

PASA 

Fish 

Oryzias latipes, FW Mortality 

48-h LC50

180 

Algae Pseudokirchneriella 

subcapitata, FW 

Growth inhibition 

72-h EC50

33.8 

Mysidopsis bahia, SW Mortality 

96-h LC50

78 Invertebrates 

Daphnia magna, FW Swimming 

inhibition 

48-h EC50

98 

Acrylamide 

monomers 

Algae Danio rerio, FW Mortality 

96-h LC50

59 

 Abbreviations: SW: marine species, FW: fresh water species, n.a.: not available 

* This evaluation is using LC0 in which no lethality occurs, because this evaluation stands safer value than 

using LC50.
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Key studies of chronic toxicity of triiron tetraoxide, PASA, and acrylamide monomers 

Substance Biological 

classification Organism species End point Toxicity(mg/L) 

Algae n.a. n.a. No data 

Invertebrates n.a. n.a. No data 

Triiron 

tetraoxide 

Fish n.a. n.a. No data 

Algae n.a. n.a. No data 

Invertebrates n.a. n.a. No data 

PASA 

Fish Salvelinus namaycush, 

FW 

Mortality 

30-day NOEC 75 

Algae Pseudokirchneriella 

subcapitata, FW 

Growth 

inhibition 

72-h NOEC 

16 

Invertebrates Mysidopsis bahia, SW Mortality 

28-day NOEC 2.04 

Acrylamide 

monomers 

Fish n.a. n.a. No data 

Abbreviations; SW: marine species, FW: fresh water species, n.a.: not available 

1.3 Information on Endocrine Disruption 

1.3.1 The Group noted that no reports indicating that these chemicals might have any endocrine 

effects on aquatic organisms had been found. The Group agreed that, as with other similar 

applications there was no reason to suspect that the Active Substances and relevant chemical 

would have any endocrine disrupting effects. 

1.4 Sediment toxicity/bioavailability/biomagnification/bioconcentration/foodweb-population 

effects 

1.4.1 The Group agreed that the Active Substances and relevant chemical are neither expected 

to adsorb to sediment nor to accumulate in the food web. 

2 MAMMALIAN TOXICITY

2.1 Risk to human health 

2.1.1 Data on NOAELs to be used in the assessment of risk to human health 

Key studies utilized in the assessment of risk to human health 

Substance Test Species Route Duration Result References 

Iron oxide 

(Reference) Occupation Human Inhalation - TLV-TWA: 5 mg/m3 1) ACGIH, 2005 

Triiron 

tetraoxide 

Repeated 

toxicity - 

Oral 

(drinking 

water) 

- - - 

PAC Repeated 

toxicity Rat Inhalation 6 months LOAEL: 0.25 mg/m3 Steinhagen et al., 1978 

PAC Repeated 

toxicity - 

Oral 

(drinking 

water) - - - 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 56 

I:\MEPC\59\2-19.doc 

Substance Test Species Route Duration Result References 

Aluminum 

(Reference) 

Repeated 

toxicity Human 

Oral 

(drinking 

water) 

0.1 mg/L or 

less2)

0.2 mg/L or 

less 

WHO, 

2003b 

PASA Repeated 

toxicity - Inhalation - - - 

PASA Repeated 

toxicity - 

Oral 

(drinking 

water) 

- - - 

PASA Repeated 

toxicity 

Rat, 

dog 

Oral 

(feeding) 2 years NOAEL: >5% 

Cosmetic 

Ingredient 

Review, 

2005 

Acrylamide 

monomers Occupation Human Inhalation - TLV-TWA: 0.03 mg/m3 3) ACGIH, 2005 

Acrylamide 

monomers 

Repeated 

toxicity Rat 

Oral 

(drinking 

water) 

90 days 

NOAEL: 

0.2 

mg/kg/day 

EU, 2002; 

NTPCERHR, 

2005 

1) Measured as respirable fraction of the aerosol. 2) Owing to the uncertainty surrounding the human data and the limitations of the animal data as a model for 

humans, a health-based guideline value for aluminum cannot be derived at this time (WHO, 2003b). 

Therefore, the practicable level is derived based on optimization of the coagulation process in 

drinking-water plants using aluminum-based coagulants, to minimize aluminum levels in finished water. 

Concentrations of aluminum of 0.1 mg/L or less are achievable in large water treatment facilities. For 

small facilities (e.g., those serving fewer than 10,000 people), 0.2 mg/L or less is a practicable level for 

aluminum in finished water (WHO, 2003b). 

3) Measured as inhalable fraction and vapour.
GESAMP-BWWG 9/6 

ANNEX 4 

Page 57 

I:\MEPC\59\2-19.doc 

3 PHYSICAL AND CHEMICAL PROPERTIES 

3.1 Physical chemical properties of Active Substances, relevant chemical and treated 

ballast water (G9:4.2.1.4) 

3.1.1 The Group noted that the relevant physical chemical properties below provided by the 

applicant show that all the substances listed are well known and that the chemicals employed are 

relatively harmless except for undiluted PAC solution, which is acidic and slightly corrosive, as 

stated in the application for Basic Approval. In water, the chemical characteristics of the listed 

materials other than PAC are relatively simple. However, dissolved aluminum compounds, 

including PAC, show complicated chemical characteristics. 

Physical chemical properties 

Property Triiron 

tetraoxide PAC PASA Acrylamide monomers 

Treated 

ballast 

water 

CAS No. 1317-61-9 1327-41-9 25085-02-3 79-06-1 None 

Melting point 

(°C) 

1,538 1) About -12 2) Not Applicable 84.5 1) NR9)

Boiling point (°C) Not 

Applicable 

About 103 2) Not Applicable 125 at 3kPa 1) NR 

Flammability 

(Flash point for 

liquids; °C) 

Not 

Applicable 

Noncombustible5) None#1, 4) 138 (closed 

method) 3)

NR 

Density (20°C; 

kg/m3

) 

5,200 

(5.2g/cm3) 1)

1,340 

(1.34g/cm3) 2)

Bulk specific 

gravity; 

0.55-0.65 4)

1,130(1.13g/cm3) 

3)

NR 

Vapour pressure 

(20°C; Pa) 

Not 

Applicable 

Non-evaporable 

5)

Nonevaporable #21 3) NR 

Vapor density (air 

= 1) 

Not 

Applicable 

Not Applicable Not Applicable 2.46 (calculated 

value) 

NR 

Water solubility 

g/L 

Insoluble 6) Soluble1) Mixing with 

water forms 

highly viscous 

gel-like material 

4)

2,040 (25°C) NR 

Oxidationreduction 

potential 

Not 

Applicable 

None 5) None 4) None 7) None 

Corrosivity to 

material 

equipment 

None Corrosive to 

metals 

None None None 

Autoignition 

temperature (°C) 

Not 

Applicable 

Noncombustible5) None 4) 424 3) NR 

Explosive 

properties 

Not 

Applicable 

None None None 7) NR 

Oxidizing 

properties 

Not 

Applicable 

None 5) None 4) None 7) NR 
GESAMP-BWWG 9/6 

ANNEX 4 

Page 58 

I:\MEPC\59\2-19.doc 

Property Triiron 

tetraoxide PAC PASA Acrylamide monomers 

Treated 

ballast 

water 

Surface tension None Equal to water 

because of 

aqueous solution 

None None NR 

Viscosity 

(mPa.s) 

None 28mPa·s (25°C) 

2)

Mixing with 

water forms 

highly viscous 

gel-like 

material 4)

2.71 mPa·s (25°C) 

(50% aqueous 

solution) 8)

1.55cP 

(16°C) 

Thermal stability Transformed 

into iron 

oxide 

(Fe2O3) by 

heating in 

air1)

Non flammable Combustible by 

heating at high 

temperature 

Violently 

polymerizes when 

heated to over 

85°C or when 

exposed to of light 

or oxidizing 

agents. 

When heated to 

decomposition, 

fumes and 

nitrogen oxide are 

generated. 3), 8)

NR 

Reactivity to 

storage tank 

material 

None None None None NR 

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

Salinity N.D. 

Conductivity 4.5 S/m 

TOC 1.3 

mg/L 

DOC N.D. 

Other physicochemical 

properties 

None None None Because acrylamide 

readily polymerizes, common 

products contain 

polymerization 

inhibitors1)

None 

Dissociation 

constant (pKa) 

Not 

Applicable 

No dissociable 

group 

No dissociable 

group 

No dissociable 

group 

NR 

 1) Merck, 2006, 2) EU, 2000b, 3) IPCS, 2000, 4) Dia-Nitrix, 2004, 5) Asada Chemical Industry, 

 2003, 6) Dean,1999, 7) EU, 2002, 8) HSDB, 2007, 9) NR: not required for G9 

1.1 #1 Non-combustible under conditions of normal use (normal pressure, 0-50°C). 

 #2 Non-evaporable under normal pressure and normal temperature because of high molecular 

weight polymers (several million or more).
GESAMP-BWWG 9/6 

ANNEX 4 

Page 59 

I:\MEPC\59\2-19.doc 

4 OTHER INFORMATION 

4.1 pH and SS 

4.1.1 The Group noted that the applicant has provided analytical results for pH and SS 

concentration in treated ballast water. The table below shows the average pH values of treated 

ballast water and untreated water. These analyses were carried out with both the prototype 

in 2007 and the land-based setup in 2008. The pH of treated water is lower than that of untreated 

water, but differs only slightly. The pH reduction is limited in the ambient water environment 

due to the mechanism of equilibrium, as described in the Basic Approval Application. Therefore 

no pH-reducing effect is expected in the aqueous environment, considering that the treated water 

is discharged immediately after treatment. 

Average pH value of treated ballast water 

Treatment system Sample pH 

Untreated water 8.5 Land-based setup Treated water 7.1 

Untreated water 8.3 Prototype Treated water 7.0 

(n=10) 

The table below shows the average SS concentration in treated water and untreated water. The 

results show that the SS concentration in the treated water of the loaded test was lower 

than 1 mg/L, as it also was in the control test. 

SS concentration of treated ballast water 

(Unit: mg/L) 

SS concentration Treatment 

system Test Before 

treatment 

After 

Treatment LOD 

Control 1) Land-Based 5 or < 5 < 1 

Test Equipment Loaded test 2) 50 ~ 60 < 1 1 

Control 1) Prototype 5 or < 5 < 1 

Equipment Loaded test 2) 50 ~ 60 < 1 1 

1) Actual seawater taken from Tokyo Bay, LOD: Limit of Detection; (n=10) 

2) Kaolin was added to the actual seawater before the treatment 

4.1.2 The Group noted the applicant states the above test results show that this system is 

appropriate for use in large-scale treatment in terms of its pH and SS removing performance. 

*** 

GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

ANNEX 5 

REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

Greenship Sedinox Ballast Water Management System 

Submitted for Final Approval by the Netherlands

0 SUMMARY 

0.1 Having reviewed all the data and information submitted by the Netherlands with the 

application for Final Approval and the information received from the Applicant during 

the GESAMP-BWWG meeting, the Group recommended to MEPC that Final Approval be given 

to the Greenship Sedinox BWMS. 

0.2 The Group recalled that Basic Approval of the Greenship Sedinox BWMS was 

given by MEPC 58 (under the name of Greenship’s BWMS) and the report is 

available at document MEPC 58/2/7 (GESAMP-BWWG (6), annex 6, Report of Application for 

Basic Approval). 

0.3 The Group noted that in response to the comment of the GESAMP-BWWG that the 

system needed refinement (MEPC 58/2/7, annex 6, paragraph 2.1.9), the Applicant has 

significantly refined the system without changing the principles of the treatment. The refinement 

consists of three main adjustments: (1) lowering the maximum dose concentration 

of Active Substance at uptake, (2) removal of the disinfection at ballast water discharge 

and (3) installing online continuous monitoring of Active Substance during uptake with 

continuous feedback to the electrolytic cells to maintain an optimum dose concentration 

of Active Substance. The Group reviewed these modifications in detail and noted that significant 

improvements to the BWMS have resulted. 

0.4 In view of the responses from the Applicant to questions posed by the Group and listed in 

the Basic Approval Report, together with the information received from the Applicant during 

the GESAMP-BWWG meeting, the Group was satisfied with the completeness of the dossier 

received from the Applicant. 

0.5 The Group noted that the Greenship Sedinox Ballast Water Management System (BWMS) 

uses a combination of sedimentation and in situ electrolysis using seawater to produce 

the Active Substance to treat the ballast water. 

0.6 As the BWMS does not require the storage of chemicals on board ship, the Group 

recognized that there will not be any associated storage safety problems. 

0.7 The Group recognized that the system utilises an Active Substance with potential safety 

and environmental concerns and the Group reviewed the hazards and risks associated with 

the Active Substance. 

0.8 The Group recognized that the Applicant had provided detailed information on system 

controls and safety considerations for installation of the BWMS on board ship, together with 

provisions for maintenance and emergency operations of the system. As such the Group 

considered that the Greenship Sedinox BWMS should present no unacceptable risks to the safety 

of the ship. 
GESAMP-BWWG 9/6 

ANNEX 5 

Page 2 

I:\MEPC\59\2-19.doc 

0.9 In addition, the Group noted the provision by the Applicant of detailed analytical results and 

assessments for the Active Substance and other chemicals in treated ballast water. The Group accepted 

the view of the Applicant that there are no unacceptable risks in the chemical composition of ballast 

water, presented to marine ecosystems or human health (even in the worst case), by the use of 

this BWMS. 

0.10 However, the Group was of the opinion that the system could have some uncertainties 

regarding how to ensure the maximum dose of Active Substance, particularly for the reliability of 

controlling this dose under varied chemical parameters in natural seawater and for the long-term 

durability of all sensors. The Group recalled to the Committee that these issues are significantly 

important for this system, because the concept of the treatment proposed by the applicant is that 

ballast water treated with a low level of Active Substance does not need any mitigation or post 

treatment, such as neutralisation or aeration. The Group considered that if the maximum dose 

of Active Substance of FAC is 1 mg/kg, which is clearly less than that of other systems, was 

ensured under all conditions, the need for the mitigation to ensure the maximum allowable 

discharge concentration is less. In conclusion, the Group requested to the Committee to invite 

the Administration conducting Type Approval to verify that all recommendations concerning the 

reliability and durability for the system (including those at 0.14) have been fully addressed prior 

to issuance of the Type Approval Certificate. Furthermore, the Group strongly recommended to 

the applicant that the FAC should be automatically monitored and recorded not only at the 

treatment stage, but also at the discharge stage to ensure that the discharge concentration 

stipulated below is always met. 

0.11 The Group noted the detailed human health assessment provided by the Applicant that 

includes occupational exposure to ships’ crew, BWMS operators and the exposure of the general 

public via the environment and the food chain. The Group accepted the view of the Applicant 

that there should be no unacceptable risks to human health posed by the use of this BWMS. 

0.12 Moreover, the Group recognized that the Applicant had provided detailed information on 

ecotoxicity testing of treated ballast water, environmental risk assessment for aquatic organisms 

and a proposal for maximum discharge concentration for the Active Substance. The Group 

accepted the view of the Applicant that there should be no unacceptable risks to the environment 

posed by the use of this BWMS, based on the maximum allowable discharge concentration 

presented under 0.14. 

0.13 The Group noted that a quality assurance project plan (QAPP) was in place from the start 

of the tests performed for this application for Final Approval. 

0.14 In conclusion, having reviewed all the information provided by the Applicant, the Group 

agreed to recommend to the MEPC that Final Approval be given to the Greenship Sedinox 

BWMS, subject to the Administration verifying that these four recommendations have been fully 

addressed prior to issuance of a Type Approval Certificate: 

.1 evaluate that the maximum allowable Active Substance (FAC) dose of 1 mg/kg 

could be ensured with FAC sensors adequately calibrated during test-bed 

treatment operation against seawater (>32 PSU) and low salinity brackish water. 

For this evaluation, FAC dose should be adequately measured both by DPD 

method and FAC sensor; 
GESAMP-BWWG 9/6 

ANNEX 5 

Page 3 

I:\MEPC\59\2-19.doc 

.2 evaluate that the maximum allowable Active Substance (FAC) dose of 1 mg/kg 

could be ensured with FAC sensors adequately calibrated during on board 

operation against seawater (>32 PSU) and low salinity brackish water; 

.3 evaluate that the maximum allowable discharge concentration of Active 

Substance (FAC) at discharge should be kept to a level not exceeding the range 

of 0.01-0.20 mg/kg even after a short leg. During the Type Approval procedure 

by the Administration, the Applicant should decide on the maximum allowable 

discharge concentration of TRO in the range of 0.01-0.20 mg/kg and this value 

should be approved by the Administration. This parameter should be monitored 

and automatically recorded by FAC sensor adequately calibrated and maintained; 

and 

.4 evaluate the operation and installation manuals, which include the adequate 

timings for the various maintenance procedures. Particularly, the maximum 

duration for the calibration of FAC sensor should be provided by the Applicant to 

ensure the long term durability of the BWMS. 

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by 

the Netherlands in document MEPC 59/2/6, which was supplemented by additional information 

provided by the Applicant after a request for further information by the Group during its meeting. 

2 COMPLETENESS OF DOSSIER AND APPLICANT RESPONSES TO DATA 

REQUESTS FROM THE GROUP

2.1 The Group recalled that it had already posed certain questions during its evaluation of the 

application for Basic Approval of the system (see MEPC 58/2/7, GESAMP-BWWG (6), annex 6, 

Report of Application for Basic Approval), sections 0.5/0.6.2, 0.6.3 and 0.6.4 of Summary 

and sections 2.1.1.1 to 2.1.1.6, 2.1.2 to 2.1.7 and 2.1.9 of chapter 2 which it considered 

should be addressed by the Applicant for Final Approval. In addition, during the 

GESAMP-BWWG meeting, the Group posed a total of 15 further questions to the Applicant. The 

Applicant has responded to all these questions and the Group’s questions, the Applicant’s 

responses and the reactions of the Group to the Applicant’s responses are shown in Table 1 below: 
GESAMP-BWWG 9/6 

ANNEX 5 Page 4 I:\MEPC\59\2-19.doc Table 1 Applicant Responses to Data Requests set by the Group 

Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.1 0.5/0.6.2 1.2 The Applicant did not provide information concerning 

the Human Exposure Scenario (MEPC 56/2/2, annex 9) and therefore the risk characterization for human health could not 

be adequately performed. Also request from Group for MSDS. 

This application contains a quantcharacterization for human health using E(see section 4.4 and appendix IX). MSDS are provided for FAC and all relevanby-products (see appendix V). 

2.1.2 0.6.3 The organic content of the test water with treated natural 

seawater should be provided. 

The organic content of the water of tests for Approval is reported in section 3.3.5 and app

2.1.3 0.6.4 The Level of Quantification (LOQ) for the haloacetic acids 

was too high. This may lead to understatement of the potential levels in the treated ballast water. This uncertainty should be clarified in additional analyses during the full scale testing on land and/or onboard ships by the Applicant. 

The level of quantification (LOQ) for haloduring the tests for Final Approval was natural surface water. In the Netherlands no could be found with better performance (s3.3.8 and 3.3.9 and appendix III).

2.1.4 2.1.1.1 A more detailed description of system layout should be 

provided. 

The Applicant has provided the complete out in appendix I. 

2.1.5 2.1.1.2 Details of the protection devices and failsafe controls 

incorporated should be provided. 

Protection devices and failsafe controls: see and appendix I.

2.1.6 2.1.1.3 1.3 Specific details of the treatment should be provided 

(e.g., is treatment upon intake and/or treatment upon discharge). 

Details of the treatment: see sections 3.1 aappendix I.

2.1.7 2.1.1.4 Maximum dose concentration – the Group noted that this was 

stated as 2 mg/L but not consistently reported throughout the documentation. 

Maximum dose concentration: the proposed dose concentration is 1 mg/kg (see sections 3.1 to 3.3 and appendices I and III). 
I:\MEPC\59\2-19.doc 

Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.8 2.1.1.5 Maximum allowable discharge concentration (MADC) – the 

Group wanted to know the MADC that the system would produce NOT what is allowable. 

The proposed MADC is < 0.01 mg/kg (see section 6.4 and appendix III). 

2.1.9 2.1.1.6 Information on means of determining and controlling dosage 

rates (including differing salinity of uptake water) should be provided. Means of determining and control

rates: see sections 3.1 to 3.3 and appe

2.1.10 2.1.2 2 It was noted that the tests referred to in the submission 

had been carried out with a single dose of 10 mg/L sodium hypochlorite and this resulted in table 2.4 where different disinfection by-products had been determined. It was not clear what would happen if the system had been applied at both ballasting and deballasting – the Group wanted to know the concentration of by-products at the point of discharge. 

The concentrations of Active Substance products at the point of discharge are section 3.3. 

2.1.11 2.1.3 The quantification of THM and HAA for salted fresh water 

may be completely different from those obtained from natural seawater or brackish water – the Applicant indicated that tests had been carried out in natural seawater. 

See for the quantification of THM and HAA surface water section 3.3. 

2.1.12 2.1.4 The Group needed clarification of whether the doses are for 

both ballast intake and discharge and how it is ensured that the maximum concentration of FAC is environmentally acceptable at the time of discharge – the Group agreed that a complete description of monitoring and control systems would be needed.

See for a complete description of moncontrol systems section 3.2 and appendix I. 
GESAMP-BWWG 9/6 

ANNEX 5 Page 6 I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.13 2.1.5 The Group noted the application indicated that the generation 

of free hydrogen gas does not pose risk to the ship or crew but requested further verification of this statement – the Group recognized that the theoretical calculations indicated 

little risk, however, as hydrogen will be entrained in solution and the treated ballast water in the tank will have little free volume then this risk will require further evaluation during full scale testing to verify the calculated no risk indicated. 

See for hydrogen measurements section appendix III. 

2.1.14 2.1.6 Results of the corrosion monitoring need to be presented. See for a complete description of the corro

section 5.1.2 and appendix VII.

2.1.15 2.1.7 The risks associated with the additional known by-products 

may need to be quantified e.g. dibromochloromethane and bromochloroacetic acid. 

Risks associated with by-products are rsection 6.3 and appendices IV, V, VIII and I

2.1.16 2.1.9 The Group requested the input parameters used to run the 

MAMPEC model for all Substances – the calculated PEC had been made using a degradation rate for FAC but if this was not applied the resultant PEC produces a PEC/PNEC ratio of 70 and 110. Whilst recognizing that the PEC is a long term steady state value, some concern was still expressed that the short term exposure had not been taken properly into account. It was also agreed that this treatment system required further development and refinement as system discharging this level of FAC would probably not be recommended, by the Group, for Final Approval. 

The BWMS has been significantly refimaximum dose concentration of FAC has beand the treatment at discharge abolished. A online dose control and failsafe controls installed (See section 3.2 and appendix I). on PEC/PNEC ratio calculations are rsection 6.3 and appendix VIII; measuremenin the plume of the discharge of treated baimmediately after uptake and treatment, are section 6.4 and appendix III to illustrate the the risk of short-term exposure. Undoperating conditions, ballast water widischarged immediately after uptake and trea
I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.17 Question 1 The FAC concentration is stated by the Applicant to be 

regulated by the level of actual concentration whenever the water quality is changed on a case by case basis. Therefore the monitoring of FAC level is very important in order to not produce excessive disinfectant by-products. A detailed design of regulating FAC in both hardware and software (to include the probe) should be explained. Is it possible to present the data for the actual experiment that proves the system works precisely? 

a) The FAC measuring device has an eledriven pressure proof flow armature for recisample water. The sample water is kept in mkeeping the FAC potentiostatic sensor fre(Keeping it clean). b) For experiment see Appe(Attached Calibration report from Om10 September 2008). All measuring instruments are calibrated beftests/analyses are done by accredited bodies/lc) The instrument is fixed on a maximum FAC level of 1 mg/kg. 
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ANNEX 5 Page 8 I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 
I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.18 Question 2 Is there any proposed method in cases where the maximum 

concentration of FAC proposed is exceeded, for example, when the ballast water should be discharged at the port because of the short voyage etc? 

Normal controlling that is done by the ckeeps the FAC amount lower than 1 arranging an appropriate amount of power to unit of the Termanox. When the FAC is in mg/kg due to any mishap of the unit there is followed by an alarm 30 seconds later and shut down of the operation. The failure is regshown on the display. After which, fault-fhave to follow. See further the answer to que

2.1.19 Question 3 Is there any reason that the application does not include the 

ecotoxicity and chemical analysis data for seawater, and the data of storage intervals in de-ballasting from the ballast water tank? 

The question is not fully clear. The applicatiecotoxicity and chemical analyses of treateincl. controls (= untreated seawater). ecotoxicity were done in treated balimmediately after treatment (T=0) and afte(T=48) storage according the G9 guidelineanalyses were done additionally after differtime intervals: see tables 3 to 8 in the document. 

2.1.20 Question 4 The dilution factor of treated ballast water in WET 

ecotoxicity test should be 1/2. Is there any reason why you do not follow that, or the reference can be submitted to defend the dilution you made? 

We are not aware of any guidance that pdilution factor of 2. The procedure (see Mannex 1, art. 5.2.6, page 8) prescribes, thaseries should be tested. This was done and in the Imares report (Appendix VI Tox. tetable 2, page 9). This series included of 56.2%. 

2.1.21 Question 5 Is it accepted to define the fresh water as 0.5% of salinity? Is 

there a reference to define that? 

The generally accepted definition for freswater with a salt content of less than 1 % (sewater FAQ pages http://www.lenntech.FAQ.htm ). 
GESAMP-BWWG 9/6 

ANNEX 5 Page 10 I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.22 Question 6 The lack of a fish WET test is not mentioned in 

MEPC 59/2/5. In the report from IMARES C82/08 appearing in the confidential material appendix VI, it is stated that fish tests are waived since previous tests indicated that fish larvae 

were not affected. A reference is made to Kaag & Sneekes 2007 (IMARES report C091/07), included as text in MEPC 58/2/7, annex 6. In annex 6 there appears to be only a short two line paragraph on the results noting a “good (87.5% to 100%)” survival throughout tests. For the Group to agree to waive acute and chronic fish ecotoxicity tests (which is specifically required in the Methodology) on this basis, the original data must be submitted. 

The Imares report C091/07 is attached; see data the data tables in the appendix. 

2.1.23 Question 7 The ecotoxicity test data suggest residual toxicity in both 

freshwater and marine algae species (up to x20 dilution required for the freshwater species to reach NOEC) and 

therefore even more to reach PNEC. Do these results, and the fact that a 48h holding time was able to reduce toxicity considerably, lead to any suggestions from the Applicant for limitations in the applicability of the BWMS in relation to discharge in freshwater or holding time needed. 

For the calculation of environmental Applicant has assumed a worst case scenarballasting immediately after treatment with concentration of 1 mg/kg FAC. The resultthe environmental risks at all times stay welsafety ratio (PEC/PNEC < 1) for FAC and rproducts (see table 12 of the application). the Applicant does not see any limitatapplicability of the BWMS, either in fresh or 
I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.24 Question 8 The Applicant set the maximum dose for FAC as 1 mg/kg. 

However, could the Applicant kindly provide some clarification for this criterion? For all treatment of seawater, 

is the FAC fixed to 1 mg/kg? Because certain paragraphs, such as 2.3, have indicated a possibility that 0.1 mg/kg FAC has enough efficacy for Guidelines (G8). Does the Applicant have any intention to reduce the dose for FAC at sea? Also, para 3.3.1 of dossier stated that maximum FAC monitored for brackish water was only 0.38 mg/kg. Was the system operated with serial Termanox? In that case, is this the theoretical limitation for brackish water? And finally, are there any actual FAC measurements for fresh water using 3 

serial Termanox in operation? 

The Applicant has refined the BWMS after had expressed concern on high FAC concede-ballasting in the review for Basic ApprGreenship BWMS (see MEPC 58/2/7, point 2.1.9). It was decided to lower concentrations to a level which would not environmental concern and at the same time compliance to efficacy criteria under G8. for 1 mg/kg as a maximum for treatment and as a minimum was based on tests which environmental risks are negligible with 1 discharge and efficacy criteria are still treatment with 0.1 mg/kg FAC. Thus the sysdesigned that a maximum of 1 mg/kg and of 0.1 mg/kg is allowed. The system gives astops intake in case FAC concentrations get limits (see also answers to your questionDuring the tests reported the system wawith 3 serial Termanox devices. So, the vamg/kg in fresh water (not in brackish) wawith 3 Termanox in serial operation. 
GESAMP-BWWG 9/6 

ANNEX 5 Page 12 I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.25 Question 9 The appendix 3 (Technical Manual) provides that the 

Potentiostatic sensor will be used for monitoring and controlling the FAC. Could you provide the relationship between FAC, which was measured manually by DPD method, and the sensor’s output of FAC, which was estimated only from Potentiostatic value, pH and temperature? Also the Group has some concern that this one single relationship or formula cannot be applied to wide ranges of salinity and alkalinity. The Group has the position that additional salinity monitoring should be needed for compensation, which is not described in the appendix. The Group feels that more direct 

and sophisticated monitoring sensors (such as monitoring the difference of each parameter before and after Termanox) for FAC should be needed particularly in use for low salinity water. 

Various FAC measuring instruments are bover the past 8 years of R&D. These needed to be calibrated explicitly. Our equipment has been calibrated with the DPD Omegam Water (Accreditation number L41answer to Question 1, b. Additional salinity monitoring is done as yon the scheme (attached). It is measured juspump. The amount of NaCl converted to additional graphs and info attached) is scontrol unit, which in turn activates the poTermanox units During all the tests done in the past years were there mishaps or deviations. All tests done after a DPD calibration check. The saon the NaCl sensor. In most cases we wredundant measuring equipment. We do have failure indications of all sencontrol unit (f.e. P; FAC; NaCl; Power; Presulting in a common alarm in the engine roThe Aldos/Grundfos company is bringing tequipment on the market since 1975. Our equipment is on the market since 2000 anvery solid. We have used this equipment for and it never failed. 
I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.26 Question 10 The diagram in the Operational Manual indicated that the 

FAC and relevant parameters would be monitored and recorded. However, there are no descriptions how to control the Termanox by FAC values or other parameters such as electrical current through electrodes. Could you provide more 

information how to ensure the maximum FAC dose as 1 mg/kg from the Termanox, using these parameters? 

By measuring NaCl value before the wthrough the system, the control unit has pre-and is able to control the power unit on the in such a way that the FAC value will end the 0.01 and 1 mg/kg. The voltage has a fixethe control is done by varying the components are Marine Equipment Directapproved at Lloyds Register. Failure is indpre alarm, an alarm and then shut down. 

2.1.27 Question 11 The Applicant claimed in their Operational Manual that “If 

the amount of NaCl is <3PSU, the water is stipulated as fresh (IMO regulations). Then a third Termanox will have to be installed.” So the Group has the position that the system with only two Termanox components, which is the usual case, cannot be operated in fresh water. That means a limitation of application. Please clarify? 

Since only 4 % of the world ship movemwater with less than 3 PSU we decided flexible possibility on the Termanox unittesting was done with the possibility of Termanox units. We only needed two when operating in b

salt water but three when operating in watethan 3 PSU in order to get sufficient FAC. In so doing we managed to have a lconsumption in all cases, which helps in SOX equation in the end as well. 

2.1.28 Question 12 Also even with two Termanox components, how could the 

operation mode be switched to serial Termanox operational mode automatically? The Applicant only stated that “Depending on FAC level, seawater temperature and amount of NaCl the start-up of the installation will include the first 

and/or the second Termanox.” There is no description how the system monitor will calculate the conductivity level (NaCl) in the Operational Manual. What is the actual criterion for switching? 

Because NaCl is measured by start calculation table is in the appendix) and prthe control unit. The control unit switchand/or 3 Termanox units. By measuring thputting that back to the control unit, the pTermanox units is continuously readjusted way that we have sufficient FAC with possible power consumption. 
GESAMP-BWWG 9/6 

ANNEX 5 Page 14 I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.29 Question 13 The Applicant set maximum allowable discharge 

concentration for FAC as “<0.01 mg/kg”. However, this criterion was based only on 2 typical degradation rates described in appendix III. How is it ensured that the maximum discharge concentration at very short voyage (less than 1 day) will be achieved, and with another (lower) degradation rate for FAC? Or does the Applicant intend to set the minimum holding time for treated ballast water, such as “the treated ballast water should be discharged after more than 2 days tank holding time”? Please clarify. 

The maximum discharge concentration oFAC occurs only when, e.g., for security treated intake water will be discharged imactually during intake. We consider this a situation. Nevertheless the Applicant has environmental risks with a woFAC concentration of 1 mg/kg (see also question 7). FAC breaks down very rapidly: on page 13 of the applicatiwithin 30 minutes and 90% within 2 hours. Scan be found in literature (see reference hypochlorite). Based on these data, the Appnot see a need to set minimum holding timeballast water. The proposed maximum discharge concentration of 0.01 mg/kg within 4 hours, which is a very short timintake and actual arrival in another haApplicant has no objection if the GESAMallows a maximum allowable discharge coof 0.1-0.2 mg/kg (see also GESAMP-BWannex 4, review of application by Norway). 
I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 
GESAMP-BWWG 9/6 

ANNEX 5 Page 16 I:\MEPC\59\2-19.doc Section No. 

Refs. from BA Report (Summary and chapter 2) or Question No. from meeting 

Group’s Question Applicant’s Response and Section No. in t

(Appendix Nos. refer to the Applicant’s cdossier) 

2.1.30 Question 14 Does your system always have three Termanox units 

installed, or not? 

Termanox units in operation: Salinity range > 32 – one Termanox moperation; Salinity range >3 - <32 – two Termanox operation; Salinity range < 3 – three Termanox moperation. If a ship has a worldwide certificate (so, 

salinity range of < 3 PSU); then the ship mTermanox units. In that case the answer is: be installed three Termanox units. 

2.1.31 Question 15 Please can you confirm that the measurement units of TRC 

and FAC are expressed in mg Cl2 per litre. 

Yes, TRC and FAC are calculated equivalents of Cl2 and expressed as mg disinfection is caused by hypochlorite in wavailable free chlorine includes in principle chlorine: gaseous chlorine, hypochlorous hypochlorite (the dissociated form of hyacid). The distribution among these 3 specipH dependent in aqueous solutions. At pH gaseous chlorine is practically absent in pH above 8, practically only the hypochlorpresent. In regular seawater (pH ahypochlorite and hypochlorous acid are abSee for further details: the EU RAR for hypar. 2.4, 2.5 and 2.6 (reference 62). 
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ANNEX 5 

Page 17 

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2.2 In view of the above responses from the Applicant to questions posed by the Group, and 

considering all the data and information submitted by the Applicant in this dossier, the Group 

was satisfied with the completeness of the dossier received from the Applicant. 

3 DESCRIPTION OF THE SYSTEM

3.1 Overview 

3.1.1 The Group recalled that this Ballast Water Management System (BWMS) had already 

been described and reviewed in the report for Basic Approval. The Group noted that after 

the Basic Approval was granted, Greenship had abolished the second disinfection step at 

discharge, since treatment at uptake results in full compliance to the efficacy criteria and 

discharge standard of regulation D-2 of the Convention. Bearing in mind the changes to the 

system since the granting of Basic Approval, the Group noted that Figure 1 schematically shows 

the BWMS being reviewed for Final Approval. 

3.1.2 The Group recalled that the Applicant proposes a BWMS that combines destruction and 

removal of biota and removal of sediment at uptake of ballast water using a patented multi 

hydrocyclone technology followed by a mild disinfection step, using chloride ions in seawater in 

an electrolytic process to produce Active Substance in situ for the killing of remaining 

micro-organisms. 

3.1.3 The Group noted that the electrolytic process produces Free Active Chlorine (FAC) 

as Active Substance from chloride ions present in natural seawater on board. Furthermore, 

the Group noted that according to the Applicant, a major advantage of this type of electrolytic 

cell is the long lasting coating. The electrolytic cells can disinfect with a minimum 

of maintenance (once a year cleaning is all that is required) for the duration of 

approximately 5 years. Furthermore, the Group noted that the FAC calculations by the Applicant 

were equivalent to the TRO unit values (mg Cl2/L) more normally provided by other Applicants. 

Ballasting 

Î Î Î 

 De-ballasting Í

Figure 1 – Schematic process diagram of BWMS 

3.1.4 As the BWMS does not require the storage of chemicals on board ship, the Group 

recognized that there will not be any associated storage safety problems. 

3.1.5 Therefore, the Group recognized that this application for Final Approval focuses on the 

system components and operations for ballast water treatment during intake. 

Sedimentation Electrolysis 

Ballast 

Water 

Tanks 
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ANNEX 5 

Page 18 

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3.2 Safety and Control 

3.2.1 The Group noted the information provided by the Applicant, stating that the BWMS is 

equipped with a number of measuring points to measure a variety of parameters like pressure, 

flow, NaCl, FAC, temperature, etc, and the data coming from these measuring points are entered 

into the monitoring and control unit of the system that manages and controls the power unit and 

the valves in order to have a safe and correct operation of the system. And if needed, in case of 

malfunction, to close the system or parts thereof down. 

3.2.2 The Group also noted that the system incorporates control equipment, which 

automatically and continuously monitors and adjusts necessary amperages of the electrolytic 

units during operation. One visual alarm is for the operation of the electrolytic cells. The 

maximum allowable dose concentration of the BWMS is regulated through continuous 

monitoring of the FAC concentration in the system itself during uptake of ballast water. 

The FAC monitoring unit is registering FAC concentration, pH and water temperature. The 

sensor is able to measure FAC concentration in the range of 0.01-2.0 mg/kg. In practice a 

minimum of 0.1 mg/kg and a maximum value of 1.0 mg/kg for FAC concentration will be preset 

in the control unit for alarm purposes. According to the Applicant, the control equipment stores 

data for at least 24 months and can display or print records for official inspection and the 

equipment is Marine Equipment Directive (MED) approved. 

3.2.3 In addition, the Group noted the detailed information presented by the Applicant on safety 

and control of the BWMS, in appendix I of the Applicant’s confidential dossier. This appendix 

presents details of the system layout and its operation, as required in the review 

for Basic Approval by the GESAMP-BWWG. The protection devices and failsafe controls are 

described in appendix I, technical manual at pages 49 to 54. The two components of the BWMS 

have no moving parts. Safety controls are incorporated for a number of parameters: pressure, 

flow and maximum-minimum allowable dose concentration of FAC (see technical manual in 

appendix I). 

3.3 Active Substances (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.3.1 The Group recalled the chemical reactions involved in the electrolysis of natural 

seawater, as reviewed and described in detail for the evaluation of Basic Approval of the BWMS. 

In summary, electrolysis of aqueous NaCl solution gives a mixture of hydrogen gas and chlorine 

gas and an aqueous sodium hydroxide solution. The chlorine gas then reacts with the aqueous 

mixture to form sodium hypochlorite and Free Active Chlorine (FAC) is produced which acts as 

the disinfectant Active Substance. In addition, the Group noted that various halogenated 

by-products and bromide analogues can also be produced by electrolysis of natural seawater due 

to the reaction with organic compounds and other components in seawater such as ammonia. 

These are variously referred to as relevant chemicals or other chemicals, but for the purpose of 

this review, the Group referred to all these by-products and analogues as “Other Chemicals”. 

3.3.2 The Group recalled information provided by the Applicant explaining that FAC production 

inside an electrolysis cell depends on chloride concentrations in the natural water and the settings 

of the cell. In practice in this BWMS, brackish and salt water is pumped via two cells at uptake; in 

fresh water a third cell needs to be added in order to produce the needed dose for disinfection (see 

for details in appendix 1 of Applicant’s confidential dossier). The range of values that can be 

measured with the online sensor in treated natural water, situated at a distance of 10 x D (pipe 

diameter) after the cells, is 0.01-2.0 mg/kg. The Group noted that this online sensor adjusts 

FAC production at a continuous constant level of maximum 1.0 mg/kg. 
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ANNEX 5 

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3.3.3 The Group noted that the Applicant has provided analyses of treated ballast water 

for Active Substances and other chemicals as part of this application for Final Approval. 

Samples of untreated ballast water and treated ballast water were taken during tests of a full-scale 

BWMS with natural surface waters, according to the requirements of sections 4 and 5 

of Procedure (G9). The Group noted that according to the Applicant, a BWMS with a capacity 

of 100 m3/h was installed on board of a moored ship. This equipment had been tested already 

for two years on board of M.V. Elizabeth (see also Appendices II and VII of confidential 

dossier). It was the same equipment as used in 2007 for G8 land-based efficacy tests and the 

tests for the Basic Approval application (see MEPC 57/2/7). 

3.3.4 The Group noted the following information provided by the Applicant. The BWMS 

treated two types of surface water and the treated ballast water was stored in a storage tank 

during 2 days. In August 2008 brackish water from the harbour of Harlingen, the Netherlands, at 

the border of the Waddensea (test location 1), was treated and stored. In September 2008 

fresh water from the “van Harinxma Channel”, just after the sea-locks of Harlingen harbour (test 

location 2), was treated and stored. Samples for chemical analysis and ecotoxicity evaluation for 

this Final Approval application, were taken at different time intervals after treatment and 

distributed to different specialized laboratories with full accreditation. Control samples consisted 

of untreated natural surface water. 

3.3.5 The Group noted the following results in Tables 2 and 3 presenting the characteristics of 

the brackish and fresh waters used in this testing by the Applicant. 

Table 2: Characteristics of brackish water 

Oxygen 

% 

Temperature 

oC 

Salinity 

‰ 

pH TSS, 

mg/L 

DOC, 

mg/L 

POC, 

mg/L 

TOC, 

mg/L 

91.7 19.3 18.8 7.93 15 8.5 - 7.5 

Note from Applicant – TOC is lower than DOC. Theoretically this is not possible, because DOC 

is part of TOC. Explanation of the minor difference is a measurement inaccuracy. 

Table 3: Characteristics of fresh water 

Oxygen 

% 

Temperature, 

oC 

Salinity 

‰ 

pH TSS, 

mg/L 

DOC, 

mg/L 

POC, 

mg/L 

TOC, 

mg/L 

94.3 16.2 2.8 7.84 9.9 14 1.0 15 

Details of the analytical methodology and results are contained in appendix III of confidential 

dossier. 
GESAMP-BWWG 9/6 

ANNEX 5 

Page 20 

I:\MEPC\59\2-19.doc 

3.3.6 The Group noted that Active Substance (FAC) was analyzed by Omegam-Water, Wognum, 

the Netherlands. The analyses were performed with the same sensor as used for the online 

measurements during treatment of ballast water. The sensor was calibrated by Omegam-Water 

using the method according to NEN/EN/ISO 7393-2. Results are reported for control samples 

(source water) and samples taken from the stored treated ballast water at different time intervals: 

immediately after treatment (T=0), after 30 min (T=0.5), 1 h (T=1), 2 h (T=2), 4 h (T=4), 12 h 

(T=12) and 48 h (T=48). Tables 4 and 5 present the results for the two types of water. The dose 

rates of FAC, measured on line immediately after the cells, were 1.0 mg/kg for brackish water 

and 0.38 mg/kg for fresh water. 

Table 4: Concentrations of FAC in mg/L in treated brackish water 

Control T=0 T=0.5 T=2 T=4 T=12 T=48 

 <0.01 1.0 0.4 0.1 <0.01 < 0.01 < 0.01 

Table 5: Concentrations of FAC in mg/L in treated fresh water 

Control T=0 T=0.5 T=2 T=4 T=12 T=48 

 <0.01 0.38 0.2 < 0.01 <0.01 < 0.01 < 0.01 

See for details of the analytical methodology and results: appendix III and for the FAC data set: 

appendix IV. 

3.3.7 The Group noted that halogenated other chemicals were analysed 

by Omegam-Laboratoria, Amsterdam, the Netherlands. The analyses were performed according 

to NEN/EN/ISO 15680. Results are reported for control samples (source water) and samples 

taken from the stored treated ballast water at different time intervals: immediately after treatment 

(T=0), after 30 min (T=0.5), 2 h (T=2), 4 h (T=4), 12 h (T=12) and 48 h (T=48). Tables 6 and 7 

present the results for the two types of water. 
GESAMP-BWWG 9/6 

ANNEX 5 

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Table 6: Concentrations in μg/L of halogenated other chemicals in treated brackish water 

 Control T=0 T=0.5 T=2 T=4 T=12 T=48 

dichloromethane <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 

1,1-dichloroethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

1,2-dichloroethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

trans-1,2-dichloroethene <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

cis-1,2-dichloroethene <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

1,2-dichloropropane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

trichloromethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

tetrachloromethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

1,1,1-trichloroethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

1,1,2-trichloroethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

trichloroethene <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

tetrachloroethene <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

tribromomethane <0.5 47 70 80 73 82 84 

sum C/T dichloroethene 0.7 0.7 0.7 0.7 0.7 0.7 0.7 

sum chloroaliphatics 2.9 2.9 2.9 2.9 2.9 2.9 2.9 

Volatile chlorinated aliphatics – remainder: 

dibromomethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

bromodichloromethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

dibromochloromethane <0.5 3.8 5.2 5.9 5.4 6 6.3 
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Table 7: Concentrations in μg/L of halogenated other chemicals in treated fresh water 

 Control T=0 T=0.5 T=2 T=4 T=12 T=48 

dichloromethane <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 <1.0 

1,1-dichloroethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

1,2-dichloroethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

trans-1,2-dichloroethene <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

cis-1,2-dichloroethene <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

1,2-dichloropropane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

trichloromethane <0.1 0.3 0.4 0.5 0.6 0.8 0.9 

tetrachloromethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

1,1,1-trichloroethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

1,1,2-trichloroethane <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

trichloroethene <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

tetrachloroethene <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

tribromomethane <0.5 11 14 15 15 16 16 

sum C/T dichloroethene 0.7 0.7 0.7 0.7 0.7 0.7 0.7 

sum chloroaliphatics 2.9 3.1 3.2 3.3 3.4 3.6 3.7 

Volatile chlorinated aliphatics – remainder: 

dibromomethane <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 

bromodichloromethane <0.5 2.6 3.6 4.0 4.3 4.7 4.9 

dibromochloromethane <0.5 9.9 13 13 14 15 16 

See for details of the analytical methodology and results in appendix III of the confidential 

dossier. For the data sets of tribromomethane (bromoform), dibromochloromethane and 

dichlorobromomethane in appendix IV of the confidential dossier. 

3.3.8 The Group noted that the other chemicals (haloacetic acids and chloramines) were analyzed 

by RPS Analyse BV, Breda, the Netherlands. The analyses of haloacetic acids were performed by 

GC-MS. Results are reported for control samples (source water) and samples taken from the stored 

treated ballast water at different time intervals: immediately after treatment (T=0), after 30 min 

(T=0.5), 2 h (T=2), 4 h (T=4), 12 h (T=12) and 48 h (T=48). Tables 8 and 9 present the results for 

the two types of water. The analyses for chloramines were performed by titration. Chloramines 

were not detected in both types of treated surface water (detection limit: 0.1 mg/L). 
GESAMP-BWWG 9/6 

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Table 8: Concentrations in mg/L of chloramines and in μg/L of halogenated acetic acids 

in treated brackish water 

 Control T=0 T=0.5 T=2 T=4 T=12 T=48 

monochloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

dichloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

trichloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

chloroacetic acid <1 <1 <1 <1 <1 <1 <1 

dichloroacetic acid <1 <1 <1 <1 <1 <1 <1 

bromoacetic acid <1 24 72 77 59 86 5.8 

trichloroacetic acid <1 <1 <1 <1 <1 <1 <1 

dibromoacetic acid <1 40 76 64 47 69 3.6 

bromochloroacetic acid <1 4.1 6.7 5.8 4.5 6.2 <1 

bromodichloroacetic acid <1 2.2 3,2 2.3 2.4 3.1 2.8 

dibromochloroacetic acid <1 <1 <1 <1 <1 <1 <1 

tribromoacetic acid <1 9.9 14 12 12 13 12 

Table 9: Concentrations in mg/L of chloramines and in μg/L of halogenated acetic acids 

in treated fresh water 

 Control T=0 T=0.5 T=2 T=4 T=12 T=48 

monochloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

dichloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

trichloramine <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 

chloroacetic acid <1 7 5.3 7.1 4.5 4.1 1.3 

dichloroacetic acid <1 5.1 5.5 5.4 3.8 3.6 6.4 

trichloroacetic acid <1 <1 <1 <1 <1 <1 <1 

bromoacetic acid <1 17 16 15 12 9.9 12 

dibromoacetic acid <1 39 40 40 31 32 30 

tribromoacetic acid <1 <1 <1 <1 <1 <1 <1 

bromochloroacetic acid <1 24 23 22 18 17 17 

dibromochloroacetic acid <1 <1 <1 <1 <1 <1 <1 

bromodichloroacetic acid <1 <1 <1 <1 <1 <1 <1 

See for details of the analytical methodology and results: appendix III. For the data sets of 

chloroacetic acid, bromoacetic acid, dichloroacetic acid, dibromoacetic acid, bromochloroacetic 

acid, bromodichloroacetic acid and tribromoacetic acid: appendix IV. 

3.3.9 The Group recognized the comprehensive nature of the data sets provided by the 

Applicant on the analysis of Active Substance and other chemicals in treated ballast water. 

However, the Group notes that in the review of the Basic Approval application of this Applicant, 

the GESAMP-BWWG expressed concern about the level of detection of the haloacetic acids: 

(MEPC 58/2/7, annex 6, paragraph 0.6.4). In a statement from the Applicant, the Group was 

informed that the Applicant “could not find a laboratory with a better performance than 1 μg/L. 
GESAMP-BWWG 9/6 

ANNEX 5 

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Given the MRR, the Applicant considers that the application of Best Available Technique (BAT) 

in the Netherlands is satisfactory”. Although the Group was not satisfied with this response since 

the choice of BAT should not be limited to only one country and other Applicants have been able 

to find laboratories capable of analysing haloacetic acids down to 0.1 μg/L, it is accepted because 

the haloacetic acids with PEC/PNEC ratio closest to one (Table 13; bromoacetic acid and 

dibromoacetic acid) are both found in concentrations above the limit of detection. 

4 HUMAN HEALTH ASSESSMENT

4.1 Identification of routes of human exposure and risk assessment parameters 

4.1.1 The Group concurred with the Applicant that the target groups are ships’ crew 

and BWMS operators, who may be at risk of occupational exposure as well as the general public 

who may be subjected to indirect exposure by way of sea bathing or through the environment or 

the food chain. The Group recalled that in the Methodology for information gathering and the 

conduct of work of the GESAMP-BWWG (IMO circular BWM.2/Circ.13, Appendix 2, 

“Human Exposure Assessment”) the following procedures for the assessment of exposure and 

risk to human health have been recommended: 

 

.1 identification of exposure routes and development of exposure scenarios for 

respective exposure routes; and 

.2 estimation of the amounts of exposure (intake) and risk assessment. 

4.1.2 Moreover the Group recalled that risk assessment is to be conducted by comparing the 

margin of safety (MOS), which can be calculated by dividing the NOAEL (no observed adverse 

effect level) allocated with the appropriate AF* by the estimated amount of exposure, 

with MOSref (100) in compliance with the “Human Exposure Assessment” mentioned above, as 

follows – 

MOS = NOAEL/estimated exposure amount 

* As a standard procedure and according to the Methodology BWWG 3/9, annex 9, the use of an AF of 100 (10 

for interspecies variability and 10 for intraspecies variability) is recommended in order to address the 

uncertainties deriving from the extrapolation of results from animal toxicity testing to human exposure.

4.2 Assessment of exposure to ships’ crew 

4.2.1 The Group recalled the recommendations of the GESAMP-BWWG “Human Exposure 

Assessment”, in that work operations to be performed in the BWMS that may entail risk of 

occupational exposure should be identified. Moreover the Group concurred with the statement 

from the Applicant that measures adopted in this BWMS make it possible to minimize the risk of 

human exposure to Active Substance or other chemicals in this system, through the exposure 

routes of concern assessed (dermal and inhalation). A summary of all the various safety measures 

developed by the Applicant is given above in section 3.2. 

4.2.2 Therefore the Group considered that exposure and risk to human health of the ships’ crew 

and BWMS operators by exposure to Active Substance and other chemicals is judged to be 

acceptable due to the measures developed by the Applicant for installation on board ship 

for Final Approval. 
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4.2.3 In addition, the Group recommended that precautionary measures, e.g., by using personal 

protective equipment (PPE) should be followed when any operator enters the ballast tanks for 

inspection or for sampling operational procedures. 

4.3 Exposure of general public through the environment and food chain 

4.3.1 The Group recalled that possible scenarios of exposure to the general public through the 

environment and food chain are limited to the following: 

Scenario 1: Oral exposure (through water drinking) of sea bathers and workers in the 

surrounding water areas; and 

Scenario 2: Oral exposure to the general public through the food chain (by way of marine 

foods). 

4.4 Risk assessment calculations with EUSES model (provided by Applicant) 

4.4.1 The Group noted that the Applicant has provided detailed data on human health risk 

assessment using the EUSES model (version 2.1), and appendix IX of the confidential dossier 

presents the summary report on calculations. 

4.4.2 The EUSES model calculated MOS values for the system and MOS/MOSref (MRR) 

values for the occupational scenarios (dermal and inhalation routes). These were based on the 

assumptions of the number of events of 2/year, exposure duration of 8-10 h, dealing only with 

acute risks and taking into consideration the unit operation which represents the worst case 

exposure scenario at the working site, the Termanox part of the BWMS. These MRR values are 

presented below in Table 10. 

4.4.3 The Group noted that for the general public the main routes evaluated by EUSES were 

inhalation, oral intake by drinking water and eating fish. Only the chronic risk was calculated. If the 

MRR value was ≥ 1 a safety margin of at least 100 was obtained and the risk was considered 

acceptable. 

Table 10: MRR (MOS/MOSref) values from EUSES model 

Substance MRR (MOS/MOSref) lowest value 

Ships’ crew a General public b

FAC 502 6.31E+4 

Tribromomethane 36.1 4.71E+3 

Dibromochloromethane 6.49E+3 3.07E+5 

Bromodichloromethane 1.39E+4 2.94E+4 

Bromoacetic acid 3.22E+3 1.54E+5 

Chloroacetic acid 2.76E+5 4.70E+6 

Dibromoacetic acid 2.45E+6 6.49E+6 

Dichloroacetic acid 1.30E+5 2.92E+6 

Bromochloroacetic acid 2.57E+4 2.86E+6 

Bromodichloroacetic acid 3.58E+4 4.74E+5 

Tribromoacetic acid 1.06E+2 7.66E+4 

a

 Based on acute toxicity data 

b

 Based on repetitive dose and/or development toxicity data 
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4.4.4 The Group concurred with the Applicant that, from the EUSES calculations in Table 10 it 

is clear that MRR values for ships’ crew (BWMS operators included) and the general public for 

all substances produced by the BWMS are much larger than 1. The highest risk (under 

unrealistic worst-case assumptions) is observed for tribromomethane, which still has a margin of 

safety of 3610 for ships’ crew and a margin of safety of 4.71 x 105 for the general public. 

Therefore, the Group was satisfied that these results show that the BWMS does not pose an 

unacceptable risk to ships’ crew (BWMS operators included) and to the general public. 

5 RISKS TO SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC

5.1 Safety of the ship 

5.1.1 The Group noted that specific countermeasures that can be employed in this system to 

deal with envisaged emergency and safety problems during the ballast water treatment have been 

summarised above. In particular a summary of the various safety measures developed by 

the Applicant is given above in section 3.2. 

5.1.2 The Group concurred with the Applicant that the treated ballast water should have no 

increased corrosivity effect to ballast water tanks or other equipment in the ship, compared with 

normal seawater as the treatment levels of FAC are stipulated as a maximum 1 mg/kg which is 

recognized as the lower limit for any corrosive effect from chlorine. The Applicant states that 

the sedimentation unit is made of a synthetic material, resulting in a lightweight construction and 

preventing corrosion within the system. The electrolytic cell itself, including connecting pipes, is 

fully protected by special coatings against corrosion. The ballast water tanks in principle are 

subject to corrosion, especially immediately after treatment, so therefore these tanks are normally 

coated against corrosion. This regular practice is expected to be sufficient for treated ballast 

water. The FAC produced by the BWMS will be present in low concentrations and disappears 

quickly (see above at section 3.3.6). The Group noted the Applicant states that the BWMS has 

been used for two years on MV “Elizabeth” and corrosion of ballast water tanks was monitored 

and inspected by Germanischer Lloyd. According to the shipowner no sign of any corrosion 

could be observed after two years (see for details appendix VII of confidential dossier). 

5.1.3 The Group recalled that as mentioned above at section 3.3.1, during electrolysis 

hydrogen gas (H2) is produced. According to the Applicant, theoretically the cell produces 0.0186 

mol H2 gas per ampere (A) per hour, which equals 7.5 g H2 per hour under standard operation 

with 200 A. With a flow in the cell of 100 m3

/hour, this results in a H2 gas concentration of less 

than 0.1 mg/kg. The Group agreed with the Applicant that this is far below any dangerous 

concentration. This was confirmed by the Applicant using H2 measurements in the head space of 

the ballast water storage tank immediately after treatment. All results (brackish and fresh water 

treatment) were below detection (< 0.05 %v/v). For details: see appendix III of Applicant’s 

confidential dossier. 

5.2 Safety of the crew 

5.2.1 The Group considered that risk to safety of the ships’ crew (BWMS operators included) 

by exposure to chemicals and treated ballast water is judged to be acceptable based on the 

measures developed by the Applicant for installation on board ship, this being confirmed 

by EUSES calculations. A summary of the various safety measures developed by the Applicant is 

given above in section 3.2. The Group considered that in this system, the risk to ships’ crew is 

judged to be appropriately managed based on the facts that the Active Substance (FAC) is 
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produced in situ as well as that system components are adopted that are expected to minimize the 

exposure risk of ships’ crew to chemicals and ballast water before and after treatment. 

5.3 Safety of the general public 

5.3.1 It is reasonably considered by the Group that the system has an acceptable risk to the 

health of the general public in light of the outcome of results of human risk assessment developed 

by EUSES. 

6 ENVIRONMENTAL RISK ASSESSMENT 

6.1 Assessment of Persistence (P), Bioaccumulation (B) and Toxicity (T) 

6.1.1 The Group recalled that as corroborated at the Basic Approval, neither 

the Active Substance nor the other chemicals are classified as PBT substances. The Group noted 

that in order to re-confirm the situation the Applicant has made a further comprehensive listing 

of P, B and T criteria for the Active Substance and other chemicals found in the treated ballast 

water, with results being presented in Table 11. 

Table 11: PBT evaluation of Active Substance and other chemicals 

(as provided by the Applicant) 

Chemical Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Hypochlorous acid No 

1⁄2-Life: 0.058 days in water 

(Taylor, 1993) 

No 

Log Pow=-3.42 

No 

7d NOEC for unknown species, 

0.0027 mg/l (MEPC 58/2/7, annex 6) 

Bromodichloromethane No 

1⁄2-Life: 0.08 days in water 

(EU-RAR Hypochlorite, 

par. 3.1.2) 

No 

LogPow= 1.88 

No 

Oryzias latipes NOEC= 

0.78 mg/l/21days 

(MEPC 58/2/7, annex 7) 

Dibromochloromethane No 

1⁄2-Life: 0.11 days in water 

(EU-RAR Hypochlorite, 

par. 3.1.2) 

No 

Log Pow = 2.08 

No 

Daphnia magna NOEC = 

0.063 mg/l/21days (GLP) 

(MEPC 58/2/7, annex 7)

Tribromomethane No 

1⁄2-Life: 0.30 days in water 

(EU-RAR Hypochlorite, 

par. 3.1.2) 

No 

Log Pow = 0.38 

No 

Cyprinodon variegates NOEC= 

4.8 mg/l/28 days 

(MEPC 58/2/7, annex 6)

Dichloroacetic acid No 

1⁄2-Life: 5.4 days in water 

(Hashimoto et al., 1998) 

No 

Log Pow = 0.92 

No 

Nitocra spinipes LC50= 23 mg/l/96 h 

(MEPC 58/2/7, annex 7, 

original reference unknown) 

Bromochloroacetic acid No 

1⁄2-Life: 2.7 days in water 

(Hashimoto et al., 1998) 

No 

Log Pow = 0.61 

No 

Pimephales promelas LC50= 

6.9 mg/l/96 h (Dibromoacetic acid) 

Dibromoacetic acid No 

1⁄2-Life: 3.1 days in water 

(Hashimoto et al., 1998) 

No 

Log Pow = 1.22 

No 

Pimephales promelas LC50= 

6.9 mg/l/96 h (Mayes et al, 1985) 

Tribromoacetic acid No 

1⁄2-Life: 0.04 days in water 

(Yuefeng Xie, 2004)

Spontaneous decomposition 

in water (EU-RAR 

Hypochlorite, par. 3.1.2) 

No 

Log Pow = 1.71 

No 

Pimephales promelas LC50= 

6.9 (mg/l/96 h) (Dibromoacetic acid)
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Chemical Persistent 

(y/n) 

Bioaccumulative 

(y/n) 

Toxic 

(y/n) 

Chloroacetic acid No 

1⁄2-Life: 3.9 days in water 

(Hanson et al., 2002) 

No 

Log Pow = 0.22 

No 

Daphnia magna, 48 h EC50= 77 mg/l

(US-EPA Ecotoxicology database, 

2008)

Bromoacetic acid No 

1⁄2-Life:3.2 days in water 

(Hashimoto et al., 1998) 

No 

Log Pow = 0.295 

No 

Daphnia magna NOEC= 

1.6 mg/l/21days

(Kuhn, R. et al., 1989) 

Bromodichloroacetic 

acid 

No 

1⁄2-Life: 3.6 days in water 

(Hashimoto et al., 1998) 

No 

Log Pow =1.71 

(tribromoacetic acid)

No 

Pimephales promelas LC50= 

6.9 (mg/l/96 h) (Dibromoacetic acid)

6.1.2 Based on these results, the Group concluded that these chemicals should not be classified 

as PBT-substances. 

6.2 Ecotoxicity testing of treated ballast water 

6.2.1 The Group noted that in this section, the results of aquatic ecotoxicity studies performed 

by the Applicant with 100% treated ballast water as a test substance are presented in accordance 

with the Procedure for approval of ballast water management systems that make use 

of Active Substances (G9). According to the Applicant, samples for the ecotoxicity tests were 

taken during full scale land-based tests in the summer of 2008 with the same equipment as used 

on board a ship for 2 years (see appendix VII of Applicant’s dossier) and as used for Guideline (G8) 

test cycles performed in the summer of 2007 (see appendix II). The Applicant considers this 

procedure in compliance with the Methodology and in compliance with Procedure (G9), and 

the Group agreed with this view. 

6.2.2 The Group noted that the Applicant has commissioned the Institute for Marine Resources 

and Ecosystem Studies of Wageningen IMARES, Den Helder, the Netherlands, to perform the 

prescribed toxicity tests on the treated ballast water. Samples of two types of treated ballast 

water (brackish with salinity <20‰ and fresh with salinity <5‰) were taken under the same 

technical conditions as samples taken for chemical analysis (see chapter 3, section 3.3.4 of this 

document). Ballast water treatment was performed as normal using both sedimentation and 

electrolysis steps. The full report is presented in appendix VI of the Applicant’s dossier. 

6.2.3 The Group noted that the ecotoxicity tests were performed using three aquatic organisms: 

two algae (Phaeodactylum tricornutum and Pseudokirchneriella subcapitata) and a crustacean 

(the brine shimp Artemia franciscana). The test species were adapted to the desired salinity 

regime prior to testing. According to the Applicant, tests were performed directly after treatment 

and 48 hours after treatment and storage in a container. For each test, dilutions 

of 10% 18%, 33%, 56% and 100% treated ballast water were made, using untreated ballast water 

(only hydrocyclone treated) as dilution medium and blank. The Group noted that tests with fish 

were not conducted, since according to appendix VI of the Applicant’s dossier, previous tests 

(in Basic Approval application) indicated that fish larvae were not affected. In this test 

on Solea solea egg yolk larvae, survival is monitored and 87.5-100% fish larvae were shown to 

survive in treated ballast water. 

6.2.4 The Group noted the following results. Treated ballast water showed no negative effects 

in the tests with the brine shrimp, but it caused a significant effect on both algal species. The 

freshwater species P. subcapitata appeared to be the most sensitive. Table 12 below gives an 
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overview of results for the algae tests (see for explanation of sample codes and sample 

characteristics: page 29, appendix A of appendix VI of Applicant’s dossier). In July, tests in 

duplicate were done with treated ballast water immediately after uptake (sample codes 200807). 

In August and September, tests were done immediately after uptake and after 48 hours storage 

(sample codes 200808 and 200809). 

Table 12: Summary results of the algae ecotoxicity tests with treated ballast water 

Phaeodactylum tricornutum

Sample code NOEC 

(m/m%) 

LOEC 

(m/m%) 

EC50

(m/m%)

2008070853b 

2008070853b 

2008082553 

2008082700 

Intake 

intake (duplo) 

intake 

discharge 

17.0 

17.0 

17.2 

30.2 

30.2 

30.2 

30.2 

53.7 

48.7 (47.6 – 49.7) 

44.0 (42.5 – 45.6) 

32.8 (30.3 – 35.4) 

>95.6 

Pseudokirchneriella subcapitata 

Sample code NOEC 

(m/m%) 

LOEC 

(m/m%) 

EC50

(m/m%) 

2008070853f 

2008070853f 

2008091553 

2008091700

Intake 

Intake (duplo) 

Intake 

discharge

<9.3 

<9.3 

9.4 

29.6

9.3 

9.3 

16.6 

52.7 

16.9 (16.3 – 17.1) 

15.3 (13.3 – 17.5) 

20.3 (19.1 – 21.7) 

58.7 (51.0 – 67.6)

6.2.5 The Group concluded from these results that on average a 6–fold (P. tricornutum) 

to 20-fold dilution (P. subcapitata) is needed to reach NOEC in the testing of treated ballast 

water. According to the Applicant, in some ballast water tests, a clear effect of volatile 

substances was observed in the blank wells that were added as control for volatile substances. 

This effect was observed in all tests with the freshwater algae P. subcapitata and in the 

August 26 test with the marine algae P. tricornutum. The effect was limited and did not affect 

the performance of the test. 

6.3 Risk assessments of chemicals for aquatic organisms 

6.3.1 The Group recalled that in the Report of the Application for Basic Approval of this 

system, the PEC/PNEC ratios as calculated by the Applicant, were not accepted by the Group 

and the Applicant was requested to revise its risk assessment for aquatic organisms. 

6.3.2 In responding to this request, the Group noted that in the dossier for Final Approval, 

the Applicant has used the model MAMPEC (version 2.0) to obtain values for Predicted 

Environmental Concentration (PEC). In this application, a standard commercial harbour has been 

used with an exchange volume of 259,000,000 m3

 per tidal period of 12.4 hours. The daily volume 

of discharged treated ballast water and the concentration of the Active Substance and other 

chemicals are critical input data. According to an investigation by Haskoning, commissioned 

in 2008 by the authorities of the Port of Rotterdam, a realistic average value of ballast water 

discharge is 50,000 m3 per day, and this is the value used in this application. According to the 

Applicant, for all MAMPEC calculations the highest chemical concentration from the time series 

of measurements, with either brackish or fresh water, was used. (See Tables 4 to 9 in chapter 3 of 

this document). The Group accepted that this implies the worst case scenario, e.g., for Active 

Substance (FAC) the maximum allowable dose concentration of 1 mg/kg was used, instead of the 

discharge concentration (< 0.01 mg/kg). All input data and results of the MAMPEC calculations 

and the Haskoning report are presented in appendix VIII of the Applicant’s dossier. 
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6.3.3 In the case of the Active Substance (FAC), the Group noted the following data provided 

by the Applicant: 

Predicted Environmental Concentration (PEC) from MAMPEC model – 

Main input data for FAC is: 

Load: 50 kg/day (based on 50,000 m3/day and maximum of 1.0 mg/L); 

Half life: 0.058 days in water. 

The MAM-PEC model calculates for FAC a steady state situation (= PEC) in the harbour 

of 0.013 μg/L and of 0.002 μg/L in the surroundings. 

Effects on aquatic organisms: Predicted No Effect Concentrations (PNEC) – 

In various documents, predicted no effect concentrations of FAC (PNEC) have been calculated 

with different outcomes. Annex 7 to document MEPC 56/2/2 (review by the GESAMP-BWWG 

of the application by Japan, MEPC 56/2), reports a value of 0.07 μg/L. Document MEPC 57/2/1 

(application by Korea) reports 8 μg/L. The GESAMP-BWWG used 0.27μg/L in document 

MEPC 58/2/7, annex 6. 

6.3.4 The Group noted that similar data from the Applicant on PEC and PNEC for all the other 

chemicals, is presented in the Appendix (section 1.1) to this document. 

6.3.5 The Group was satisfied that in order to assess the risk to the aquatic environment, 

the Applicant has calculated the PEC/PNEC ratio for the Active Substance (FAC or 

hypochlorite) and the other chemicals, and the results are presented below in Table 13. 

Table 13: PEC/PNEC ratios for Active Substance and other chemicals 

Chemical PEC (Max) 

(mg/L) 

Toxicity 

(mg/L)

Factor Applied PNEC 

(mg/L) 

PEC/PNEC 

(Max) 

Hypochlorite 1.33E-05 2.7E-03 10 2.7E-04 4.9E-02 

Bromodichloromethane 8.47E-07 0.78 500 1.56E-03 5.4E-04 

Dibromochloromethane 3.62E-07 0.063 500 1.26E-04 2.9E-03 

Tribromomethane 4.04E-06 4.8 100 4.8E-02 0.8E-04 

Chloroacetic acid 2.03E-06 77 10,000 77E-04 2.6E-04 

Bromoacetic acid 2.30E-05 1.6 500 3.2E-03 0.7E-02

Dichloroacetic acid 2.33E-06 23 1,000 23E-03 0.1E-03 

Bromochloroacetic acid 5.71E-06 6.9 1000 6.9E-03 0.8E-03 

Dibromoacetic acid 2.00E-05 6.9 1,000 6.9E-03 0.3E-02 

Tribromoacetic acid 1.32E-07 6.9 1,000 6.9E-03 0.2E-04

Bromodichloroacetic acid 6.53E-07 6.9 1,000 6.9E-03 0.9E-04 

6.3.6 The Group concurred with the calculations of the Applicant concerning the results of the 

MAMPEC model. The Group was able to recalculate the results with the same assumptions as 

the Applicant. Therefore, the Group was satisfied with the establishment of the PEC values in the 

receiving waters. 

6.3.7 The Group concluded from these results that the PEC/PNEC ratios for Active Substance 

and all other chemicals are far below 1, even though a worst case scenario has been used: 

maximum dose (FAC) and maximum concentration of other chemicals found in treated ballast 

water. The Group was satisfied that this indicates there is no unacceptable risk to the aquatic 

environment from any of these chemicals. The highest PEC/PNEC ratio was found for 
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FAC: 4.9E-02. The Group considered that even this value will not occur during normal operation 

of the BWMS since no FAC could be detected in the treated, stored ballast water 4 hours after 

treatment (see Tables 4 and 5, chapter 3). Moreover, the Group recalled that FAC concentrations 

are regulated on line and the maximum dose concentration will be kept at a constant level, 

regardless of TSS or TOC/DOC/POC content. In addition, the margin of safety of the PEC/PNEC 

ratio for FAC and other chemicals is such that no adverse effects will occur if higher concentrations 

will be produced as a result of higher concentrations of organic carbon content in the intake water. 

6.3.8 The Group obtained further information on the consequences of the 6-20 fold dilution 

required for algae mentioned earlier (see section 6.2.5 in this report) in relation to the discharge 

into the environment of treated ballast water. The calculation of PEC values with the 

model MAMPEC and comparison to toxicity testing NOEC data for brackish and fresh water 

were carried out by the Group. It shows that the dilution effect of the MAMPEC model is about 

a factor 350. With this figure in mind it was not expected by the Group that there will be 

unacceptable risks for algae in the receiving waters. 

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to safety of the ship 

7.1.1 The Group noted that specific countermeasures that can be employed in this system to 

deal with envisaged emergency and safety problems during the ballast water treatment have been 

well described and discussed above, and as such the Group considered that the Greenship Sedinox 

BWMS should present no risks to the safety of the ship. 

7.2 Risks to the crew and general public 

7.2.1 The Group considered that the Greenship Sedinox BWMS has no unacceptable risk to the 

health of the crew and the general public regarding the exposure to chemicals and treated ballast 

water, based on the facts that the Active Substance (FAC) is produced in situ and on the 

measures developed by the Applicant for installation on board ship. This was confirmed by the 

outcome of the human health risk assessment performed by the EUSES model (v. 2.1). 

7.3 Risks to the environment 

7.3.1 Having reviewed all of the information submitted with this application, the Group agreed 

that this system will not cause any harm to the environment. Although the whole effluent tests 

(WET) showed some residual toxicity for algae the Group did not consider this a risk for the 

environment as on a daily basis there would be a dilution in the receiving harbour of a factor of 

about 350. With this figure in mind, the Group felt satisfied that there will be no unacceptable 

risks for the environment. 
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7.4 Recommendation 

7.4.1 In conclusion, having reviewed all the information provided by the Applicant, the Group 

agreed to recommend to the MEPC that Final Approval be given to the Greenship Sedinox 

BWMS, subject to the Administration verifying that these four recommendations have been fully 

addressed prior to issuance of a Type Approval Certificate: 

.1 evaluate that the maximum allowable Active Substance (FAC) dose of 1 mg/kg 

could be ensured with FAC sensors adequately calibrated during test-bed 

treatment operation against seawater (>32 PSU) and low salinity brackish water. 

For this evaluation, FAC dose should be adequately measured both by 

DPD method and FAC sensor; 

.2 evaluate that the maximum allowable Active Substance (FAC) dose of 1 mg/kg 

could be ensured with FAC sensors adequately calibrated during onboard 

operation against seawater (>32 PSU) and low salinity brackish water; 

.3 evaluate that the maximum allowable discharge concentration of Active 

Substance (FAC) at discharge should be kept to a level not exceeding the range 

of 0.01-0.20 mg/kg even after a short leg. During the Type Approval procedure 

by the Administration, the Applicant should decide on the maximum allowable 

discharge concentration of TRO in the range of 0.01-0.20 mg/kg and this value 

should be approved by the Administration. This parameter should be monitored 

and automatically recorded by FAC sensor adequately calibrated and maintained; 

and 

.4 evaluate the operation and installation manuals, which include the adequate 

timings for the various maintenance procedures. Particularly, the maximum 

duration for the calibration of FAC sensor should be provided by the Applicant to 

ensure the long term durability of the BWMS. 

* * * 
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Appendix 

PROPERTIES OF ACTIVE SUBSTANCE AND OTHER CHEMICALS 

1 EFFECTS ON AQUATIC ORGANISMS 

1.1 Input data for calculation of PEC/PNEC ratio for other chemicals 

1.1.1 Tribromomethane (bromoform) 

Predicted environmental concentration (PEC) 

Main input data for tribromomethane is: 

Load: 4.2 kg/day (based on 50,000 m3

/day and maximum of 84 μg/l); 

Half life: 0.30 days in water. 

The MAM-PEC model calculates for tribromomethane a steady state situation (= PEC) in the 

harbour of 0.004 μg/l and of 0.0009 μg/l in the surroundings. 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

In various documents, predicted no effect concentrations of tribromomethane (PNEC) have been 

calculated with different outcomes. Annex 7 to document MEPC 56/2/2 (review by 

the GESAMP-BWWG of the application by Japan, MEPC 56/2), reports a value of 7.1 μg/l. 

RIVM (2005) reports a value of 1.5 μg/l. The GESAMP-BWWG used 48μg/l in document 

MEPC 58/2/7, annex 6. 

1.1.2 Dibromochloromethane 

Predicted environmental concentration (PEC)

Main input data for dibromochloromethane is: 

Load: 0.8 kg/day (based on 50, 000 m3

/day and maximum of 16 μg/l); 

Half life: 0.11 days in water. 

The MAM-PEC model calculates for dibromochloromethane a steady state situation (= PEC) in 

the harbour of 0.00036 μg/l and of 0.00008 μg/l in the surroundings. 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

In various documents, predicted no effect concentrations of dibromochloromethane (PNEC) have 

been calculated with different outcomes. Annex 7 to document MEPC 56/2/2 (review by 

the GESAMP-BWWG of the application by Japan, MEPC 56/2) reports a value of 27 μg/l. 

Document MEPC 57/2/6 presents 5.2 μg/l and document MEPC 58/2 presents 3 μg/l. 
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1.1.3 Tribromoacetic acid 

Predicted environmental concentration (PEC)

Main input data for tribromoacetic acid is: 

Load: 0.7 kg/day (based on 50, 000 m3/day and maximum of 14 μg/l); 

Half life: 0.04 days in water. 

The MAM-PEC model calculates for tribromoacetic acid a steady state situation (= PEC) in the 

harbour of 0.0001 μg/l and of 0.00002 μg/l in the surroundings. 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

Document MEPC 58/2 reports a value of 10 μg/l. Document MEPC 58/2/7, annex 7 

reports 6.9 μg/l. 

1.1.4 Dibromoacetic acid 

Predicted environmental concentration (PEC) 

Main input data for 2, 2 dibromoacetic acid is: 

Load: 3.8 kg/day (based on 50,000 m3/day and maximum of 76 μg/l); 

Half life: 3.1 days in water (calculated). 

The MAM-PEC model calculates for 2,2 dibromoacetic acid a steady state situation (= PEC) in 

the harbour of 0.020 μg/l and of 0.0016 μg/l in the surroundings. 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

In various documents, the predicted no effect concentrations of 2,2 dibromoacetic acid (PNEC) 

have been derived with different outcomes. Annex 7 to document MEPC 56/2/2 (review by 

the GESAMP-BWWG of the application by Japan, MEPC56/2), reports a value of 6.9 μg/l. 

Document MEPC 58/2/7, annex 7, reports 6.9 μg/l and document MEC 58/2 6.5 μg/l. 

1.1.5 Bromodichloromethane 

Predicted environmental concentration (PEC) 

Main input data for bromodichloromethane is: 

Load: 0.245 kg/day (based on 50,000 m3

/day and maximum of 4.9 μg/l); 

Half life: 0.08 days in water. 

The MAM-PEC model calculates for bromodichloromethane a steady state situation (= PEC) in 

the harbour of 0.0008 μg/l and of 0.00017 μg/l in the surroundings. 
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I:\MEPC\59\2-19.doc 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

The predicted no effect concentration of bromodichloromethane (PNEC) is 1.58 μg/l 

(MEPC 58/2/7, annex 7). 

1.1.6 Bromoacetic acid 

Predicted environmental concentration (PEC) 

Main input data for bromoacetic acid is: 

Load: 4.3 kg/day (based on 50,000 m3

/day and maximum of 86 μg/l); 

Half life: 3.2 days in water (calculated). 

The MAM-PEC model calculates for bromoacetic acid a steady state situation (= PEC) in the 

harbour of 0.023 μg/l and of 0.0018 μg/l in the surroundings. 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

In various documents, predicted no effect concentrations of bromoacetic acid (PNEC) have been 

derived with different outcomes. Document MEPC 58/2 reports a value of 3.4 μg/l and document 

MEPC 57/2/6 reports even 2 different values: 1.6 μg/l and 0.12 μg/l. Document MEPC 58/2/7, 

annex 7, reports 2.8 μg/l. 

1.1.7 Chloroacetic acid 

Predicted environmental concentration (PEC) 

Main input data for chloroacetic acid is: 

Load: 0.355 kg/day (based on 50,000 m3

/day and maximum of 7.1 μg/l). 

Half life: 3.9 days in water. 

The MAM-PEC model calculates for chloroacetic acid a steady state situation (= PEC) in the 

harbour of 0.002 μg/l and of 0.00015 in the surroundings. 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

Document MEPC 58/2 reports a PNEC of 7.7 μg/l and 0.066 in MEPC 58/2/7, annex 7. 

1.18 Dichloroacetic acid 

Predicted environmental concentration (PEC) 

Main input data for dichloroacetic acid is: 

Load: 0.320 kg/day (based on 50,000 m3

/day and maximum of 6.4 μg/l) 

Half life: 5.4 days in water (calculated) 

The MAM-PEC model calculates for chloroacetic acid a steady state situation (= PEC) in the 

harbour of 0.0023 μg/l and of 0.0001 μg/l in the surroundings. 
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I:\MEPC\59\2-19.doc 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

Document MEPC 58/2 reports a PNEC of 8.2 μg/l and the review of this application 

reports 23 μg/l (MEPC 58/2/7, annex 7). 

1.1.9 Bromodichloroacetic acid 

Predicted environmental concentration (PEC) 

Main input data for bromodichloroacetic acid is: 

Load: 0.160 kg/day (based on 50,000 m3

/day and maximum of 3.2 μg/l); 

Half life: 3.6 days in water (calculated). 

The MAM-PEC model calculates for bromodichloroacetic acid a steady state situation (= PEC) 

in the harbour of 0.0006 μg/l and of 0.00006 μg/l in the surroundings. 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

No PNEC values were found for bromodichloroacetic acid or could be derived from 

toxicological data. Therefore, the PNEC values for tribromoacetic acid will be used. Document 

MEPC 58/2 reports a value of 10 μg/l. Document MEPC 58/2/7, annex 7 reports 6.9 μg/l. 

1.1.10 Bromochloroacetic acid 

Predicted environmental concentration (PEC) 

Main input data for bromochloroacetic acid is: 

Load: 1.2 kg/day (based on 50,000 m3/day and maximum of 24 μg/l); 

Half life: 2.7 days in water (calculated). 

The MAM-PEC model calculates for bromochloroacetic acid a steady state situation (= PEC) in 

the harbour of 0.005 μg/l and of 0.0005 μg/l in the surroundings. 

Effects on aquatic organisms: predicted no effect concentrations (PNEC) 

Document MEPC 58/2 reports a PNEC of 7.7 μg/l. Document MEPC 58/2/7, annex 7, reports a 

value of 0.07 μg/l. 

1.2 Information on Endocrine Disruption 

1.2.1 The Group noted that no reports indicating that these chemicals might have any endocrine 

effects on aquatic organisms had been found. The Group agreed that, as with other similar 

applications there was no reason to suspect that the Active Substance and other chemicals would 

have any endocrine disrupting effects. 
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1.3 Sediment toxicity / bioavailability / biomagnification / bioconcentration / foodweb–

population effects

1.3.1 The Group agreed that the Active Substance and other chemicals are neither expected to 

adsorb to sediment nor to accumulate in the food web. 

*** 

GESAMP-BWWG 9/6 

I:\MEPC\59\2-19.doc 

ANNEX 6 

REVIEW OF PROPOSALS FOR APPROVAL OF BALLAST WATER 

MANAGEMENT SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES 

AquaTriCombTM Ballast Water Treatment System 

Submitted for Basic Approval by Germany 

0 SUMMARY 

0.1 Having reviewed all the information received from the Applicant and the information 

received during the GESAMP-BWWG (9) meeting, the Group agreed to recommend 

that Basic Approval be given to the ballast water management system proposed by Germany. 

0.2 The Group noted that the Aquaworx ATC GmbH AquaTriComb Ballast Water 

Management System uses a combination of filtration, low-pressure UV disinfection, together 

with low-frequency ultrasound cleaning and disinfection to treat the ballast water. 

0.3 The Group was satisfied that, as the system does not involve the storage or generation 

of Active Substances or chemicals to treat ballast water, there were no associated storage safety 

problems on board ship. 

0.4 The Group noted that the Low-Pressure UV technology in the ballast water management 

system (BWMS) makes use of electromagnetic radiation (photons) and the Low-Frequency 

Ultrasound technology makes use of ultrasonic oscillation to treat the ballast water and for 

cleaning purposes. As such, the Group considered that it was neither necessary nor practical to 

provide the physical characteristics or toxicological profiles of the photons. 

0.5 However, it was recognized by the Group that the photons might react with naturally 

occurring organic molecules in seawater to form by-products with safety and environmental 

concerns. Half lives of the photons in water are expected to be in the order of micro- to 

milli-seconds. 

0.6 Based on results from the chemical analyses of treated ballast water, the Group concurred 

with the views of the Applicant that it was not necessary to provide toxicological and 

ecotoxicological data on these individual by-products and that the evaluation of the possible 

effects of treated ballast water provided in the submitted dossier was sufficient to 

recommend Basic Approval. 

0.7 The Group noted that the UV radiation level for the ballast water tests during the chemical 

analysis is set to 400 mJ/cm2

. Therefore the Group concluded that the maximum dose for this 

system is stated by the Applicant as 400 mJ/cm2

 during this evaluation under Procedure (G9). 

0.8 Currently the Applicant applies low-frequency ultrasound cleaning mechanism of both 

the UV tubes and filters. If the Applicant considers it necessary to change this mechanism, then 

the Group recommends submission of quantified data. 

0.9 The Group noted that the submitted dossier did not contain any results of ecotoxicity 

testing of treated ballast water. In accordance with the requirements of Procedure (G9), 

the Group recommended that acute and chronic aquatic ecotoxicity testing of treated ballast 

water should be performed by the Applicant, if the BWMS is to be reviewed for Final Approval 
GESAMP-BWWG 9/6 

ANNEX 6 

Page 2 

I:\MEPC\59\2-19.doc 

in the future. The Group recalled that this requirement of ecotoxicity testing is part 

of Basic Approval, so that the Applicant can make use of ballast water from the laboratory-scale 

BWMS. The Group considered that the possibility for an Applicant to provide chemical analysis 

and/or acute toxicity testing, in lieu of whole effluent ecotoxicity testing for Final Approval 

should not be permitted in this particular case as ecotoxicity testing was not supplied for 

the Basic Approval evaluation, and this is a necessary step to provide certainty of environmental 

acceptability. 

0.10 The Group noted that the potential hazards for human health, related to overheating 

of UV lamps and exposure to UV irradiation and ultrasonic oscillation resulting from operating 

this system, were sufficiently addressed by the Applicant by engineering control measures put in 

place and training of operators. Therefore, the Group concluded that the risks to the crew from 

exposure were sufficiently mitigated by the measures identified and put in place. 

0.11 The Group recommended that an application for Final Approval of this system includes 

confirmation by testing, that the effluent from the filter backflush during application of treatment 

at ballast water discharge, is effectively treated by UV radiation, as indicated by the Applicant in 

their replies to additional questions posed by the Group during this evaluation. 

0.12 In addition, the Group noted that all the disinfection by-products measured in the 

discharged ballast water were under LOD (limit of detection). The Group considered that these 

chemicals are short-lived and would not pose a toxicological concern towards the general public 

swimming and eating fish from the area. 

0.13 Having reviewed all the data and information submitted by Germany for Basic Approval 

and the information supplied by the Applicant in response to questions posed by the Group 

during this GESAMP-BWWG meeting, the Group had the following requests for information, if 

this system is to be reviewed for Final Approval in the future – see requests at points 0.8, 0.9 

and 0.11 in this summary. 

1 INTRODUCTION

1.1 The data used to evaluate this system were extracted from that supplied by Germany in 

document MEPC 59/2/8, supplemented by additional confidential information provided by 

the Applicant. 

2 COMPLETENESS OF DOSSIER

2.1 During the GESAMP-BWWG meeting, the Group posed to the Applicant a total of 6 

questions on issues it felt needed further clarification in order to complete the evaluation 

for Basic Approval. The Group’s questions, the Applicant’s responses and the Group’s 

conclusions on the responses provided are listed below, as follows: 
I:\MEPC\59\2-19.doc 

Section No. 

Question No. from meeting 

Group’s Question Applicant’s Response 

2.1.1 Question 1 The description of the operation of the system appears 

unclear as to whether the treatment is applied only at ballast water uptake or at both uptake and discharge. In the nonconfidential submission, section 1.3 “Technology overview” it would appear that the treatment is applied only at ballast water intake, however in the dossier, section 1.4 “Conclusion: technology overview”, it is stated in bullet point 3 “during de-ballast operations”. Please confirm the intended process. 

The AquaTriComb BW System is designed ballast water during the uptake as well adischarge. The water will be treated passinprocess of filtration and UV treatment both dand before discharge. 

2.1.2 Question 2 What happens to the filter backwash effluent? Is it 

discharged directly overboard? The system description is unclear on this point. It would also be helpful to be provided with an indication of the percentage flow rate that will be used to provide the filter back-flush function. 

During ballast operations the filter backfunobjectionable discharged overboard, becaplace of origin of the water. The rate of backballast operation will be 0.7 % of the whole effluent. During de-ballast operations the ballast watanks is pipelined through the complete ptreatment plant before discharge. We dsystem in this way especially with respect tballast water treatment - to avoid dispeorganism via ballast water. Organisms, e.g., bacteria and phytoplankton, which in spite of effective trgrow again during long ship voyages particles, if present in ballast tanks (before process), will be with this method effectivede-ballast water treatment the "Reactor In Rehas been developed. During de-ballast opfiltrated ballast water firstly will be stored in the transfer container. After this the pipelined permanent through the UV reactor tubes very close along the UV tubes (20 mwhich results in an very effective treatmenhigh energetic impact of the UV radiationbackflush during de-ballast operation will the whole ballast water effluent.
GESAMP-BWWG 9/6 

ANNEX 6 Page 4 I:\MEPC\59\2-19.doc 

Section No. 

Question No. from meeting 

Group’s Question Applicant’s Response 

2.1.3 Question 3 If the system is used also at discharge as would appear to 

have been indicated; has any evaluation of constituents of the filter backwash water, when used during ballast water discharge, been performed? If so, please provide the results and any assessment of the risk of discharge of active regrowth of organisms or pathogens through this source. 

a) Constituents - In the RIR (reactor in reactor) the backflush through separate tubes very close along the Umm distance), what results in very effective Because the “normal” filtered water passing reactor is also passing the UV emitters in thclose distance as the water in the RIR, we asno difference between the normal filtered wbackflush water regarding the constituents of both waters. For this reason we did not backflush water separately from the norwater. b) Risk of re-growth - The risk of re growth of organisms or patfilter backflush is much lower (because treat

reactor RIR) then the tanks ballast watedischarged overboard without any treatment one step of treatment (filtration or disinfectio

designed system the discharge of any backflush water and treated water through thsystem, the risk of re-growth is much mordischarge of water overboard without or onltreatment. 
I:\MEPC\59\2-19.doc 

Section No. 

Question No. from meeting 

Group’s Question Applicant’s Response 

2.1.4 Question 4 Applying ultrasound into water can generate very high 

temperatures in short periods of time by cavitation according to the references submitted. The chemical composition of seawater may be altered under such conditions, depending on water quality. The Group needs some assurance (with specific evidence) that there is no adverse chemical reaction in that case, recognizing there are lots of references about the degradation of chemicals, or production of H2O2 etc by 

ultrasound. 

The following expertise (* see text below) Technical University of Hamburg Harburg (We were interested in this expertise becausto optimise our BWTS especially in this wmuch as possible the generation of any by-presult of this expertise by the TUHH we dec20 kHz ultrasound for the whole system (freactor) and during very short times. The reof ultrasound for the normal filtration proces1 second (high flow rate), during the cleaninthe filter less than 10 seconds and durtreatment process again less than 1 seconhigh flow rate). For this reason the generation of by-prodH2O2 by ultrasound we can exclude to a very 

with our system.
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ANNEX 6 Page 6 I:\MEPC\59\2-19.doc 

Section No. 

Question No. from meeting 

Group’s Question Applicant’s Response 

2.1.5 Question 5 There is a description for use of ultrasound for self-cleaning 

as follows; “The application of low pressure radiation and very low frequency ultrasound (20 Hz) with extremely shortterm ultrasound impact (< 1 s) generated, based on analysis of treated water, no Other Chemicals during the treatment process.” Is this level of ultrasound to be applied both to the filter and the UV tube? The main purpose for cleaning the surface of UV tube, we are informed is the removal of biofilm. However, the Group believes that low frequency ultrasound could have less cleaning effect on such biofilm, please comment. The positioning of the ultrasound probe is unclear, is one probe intended for both Filter and UV tube, or are separate sources to be provided for each function? 

Yes, the level of ultrasound is applied in thfor both filter modules and UV emitters: 20 operating times less than 1 second. The results of our test during the last monththe removal of biofilm from filter moduemitters works very effective. More thgeneration of inorganic accumulations (ewhich appears in seawater very effective very hard to remove by normal cleaning wipers, can also be avoided by ultrasound also in the range of 20 Hz. This is documentof Phytoplankton (done by NIOZ), Zooplankus) and bacteria analysis of samples. The very promising. Another evidence of effectiveness of the cleaning impact from gave us the inspection of filter modules and after months of running time. We could nbiofilm or inorganic accumulations. Positioning of ultrasound emitters: For every filter module as well as for the single Ultrasound emitters are allocated. 
I:\MEPC\59\2-19.doc 

Section No. 

Question No. from meeting 

Group’s Question Applicant’s Response 

2.1.6 Question 6 In the non-confidential material acute ecotoxicity of nitrite is 

given in Table 1 (referred to as Table 2 in Table 5) with LC50

and EC50 values as low as 11.2 and 27.1 mg/L. It is stated that 

reliable chronic toxicity data are not available. Nevertheless, based on three chronic NOECs a PNEC of 0.01 mg/L has been suggested from EU member states’ competent authorities. A reference is made in 5.3.5.1 to acute and chronic toxicity data in 2.3.2, however, this section does not exist in the nonconfidential material. Where is this chronic ecotoxicity data? How do you explain the nitrite concentrations you have measured in discharges? 

We apologize very much for this wrong phraThe same sentence both in the confidential in the non confidential submission in chapter Acute and chronic toxicity data have been chapter 2.3.2. The appropriate phrasing of the sentence is: Acute toxicity data have been dchapter 2.3.1.6. Unfortunately our external expert (TUHH) after a deep literature search, any data toxicity. The nitrite concentrations in the freshwawater and saltwater pre and post sampleAnnex A of the Basic Approval Application material) are highly variable, but the freshwnot assessed and not shown in the nonmaterial, because the statistical method choallow for their test. Nevertheless, in TablPRE data are close to the detection limit andata are from detection limit to 0.148 mgwell above the PNEC. Fresh water data are not assessed because mtreatment data are below the limit of detectstatistical testing is not possible. For freshwater data on post treatment, the indeed very high. But there are two groups with low values and one with higher values. it is not possible, to calculate even a mean because the data are not normally distributedNevertheless there are more low values median of 0.009. Again this value is slightlimit of detection. We assume that the increased values arcarryover from salt water tests which hadirectly before the fresh water tests.
GESAMP-BWWG 9/6 

ANNEX 6 Page 8 I:\MEPC\59\2-19.doc * TUHH Expertise statement from Applicant (see Question 4 above) - 

The ultrasound frequency spectrum ranges from 20 kHz and 500 mHz (in liquids and solids). Usually the application options of this larfrequency ultrasound covers 2 to 10 mHz, and low frequency ultrasound covers 20 to 100 kHz (Mason & Lorimer 2002). The latter, alsterilization and waste water treatment since years. In German water treatment plants large ultrasound modules are applied at a frequencplankton (e.g., copepods and rotifers) (Mason & Peters 2002). The basic process is the induction of cavitation (lat.: cavus = hollow) by the ultrasound treatment. Cavitation, also named hollow suctionsubsequent collapse of micro bubbles (hollow areas, gaseous bubbles), which cause tissue damage. The bubbles are emerge and collapamounts of energy into the direct environment. Cavitation concentrates the diffuse energy of ultrasound onto the bubbles. The generation of radicals heavily depends on the frequency and the sounding period. High frequencies enlarge the number of free r

Doraiswamy 1999, Abu-Hassan et al. 2006). 

In a study into sono degradation (degradation by ultrasound) of persistent tensides (LAS) Abu-Hassan et al. (2006) could demonstrate an in

the first 60 minutes with ultrasound of 20 kHz. The concentration was determined by H2O2 which is generated by the re-combi

After 60 minutes the H2O2 concentration equalled 1400 μg/L. only a very small amount was generated within the first 5 minutes (< 100 μ

and low frequency (20 kHz) will generate none radicals or if then in extremely low amounts. 
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ANNEX 6 

Page 9 

I:\MEPC\59\2-19.doc 

2.2 Having reviewed all the data and information submitted by Germany for Basic Approval 

and the information supplied by the Applicant in response to questions posed by the Group 

during this GESAMP-BWWG meeting, the Group had the following requests for information, if 

this system is to be reviewed for Final Approval in the future: 

.1 Currently the Applicant applies low-frequency ultrasound cleaning mechanism of 

both the UV tubes and filters. If the Applicant considers it necessary to change 

this mechanism, then the Group recommended submission of quantified data. 

.2 The Group recommended that an application for Final Approval of this system 

includes confirmation by testing, that the effluent from the filter backflush during 

application of treatment at ballast water discharge, is effectively treated by 

UV radiation, as indicated by the Applicant in their replies to additional questions 

posed by the Group during this evaluation. 

.3 The Group noted that the submitted dossier did not contain any results of 

ecotoxicity testing of treated ballast water. In accordance with the requirements 

of Procedure (G9), the Group recommended that acute and chronic aquatic 

ecotoxicity testing of treated ballast water should be performed by the Applicant, 

if the BWMS is to be reviewed for Final Approval in the future. The Group 

recalled that this requirement of ecotoxicity testing is part of Basic Approval, so 

that the Applicant can make use of ballast water from the laboratory-scale 

BWMS. The Group considered that the possibility for an Applicant to provide 

chemical analysis and/or acute toxicity testing, in lieu of whole effluent 

ecotoxicity testing for Final Approval should not be permitted in this particular 

case as ecotoxicity testing was not supplied for the Basic Approval evaluation, 

and this is a necessary step to provide certainty of environmental acceptability. 

3 DESCRIPTION OF THE SYSTEM

3.1 Working principles of the AquaTriComb Ballast Water Management System 

3.1.1 The Group noted that the Applicant had supplied the following information on the basic 

operation of the system. The ballast water is treated at intake (ballasting) and again at discharge 

(de-ballasting). The treatment during intake ensures that a minimal amount of viable organisms 

enters into the ballast water tanks and reduces sediment build-up in the tanks, which is a potential 

area for survival and growth of organisms. The water is treated again during discharge to ensure 

that any potential re-growth of organisms in the ballast water tanks is prevented. The working 

principle is disinfection or destruction of organisms through UV radiation and ultrasonic 

oscillation, without addition of chemical compounds. 

3.1.2 The Group noted that the Aquaworx ATC GmbH AquaTriComb BWMS uses 

a combination of Filtration, Low-Pressure UV disinfection, together with Low-Frequency 

Ultrasound cleaning and disinfection to treat the ballast water. 
GESAMP-BWWG 9/6 

ANNEX 6 

Page 10 

I:\MEPC\59\2-19.doc 

3.1.3 The Group noted that the Low-Pressure UV technology in the BWMS makes use of 

electromagnetic radiation (photons) and the Low-Frequency Ultrasound technology makes use of 

ultrasonic oscillation and cavitation to treat the ballast water and for cleaning purposes. 

The UV-light employed is monochromatic, obtained from mercury vapour lamps, at a wavelength 

of 254 nm. 

3.1.4 The Group noted that the UV radiation level for the ballast water tests during the chemical 

analysis is set to 400 mJ/cm2

. Therefore the Group concludes that the maximum dose for 

this BWMS is stated by the Applicant as 400 mJ/cm2 during this evaluation under Procedure (G9). 

3.1.5 The Group noted the following information provided by the Applicant. The BWMS will 

be installed in line after the ballast water pumps with a bypass pathway. Both the ballast water 

intake flow, as well as de-ballasting flow, will be directed via the whole treatment system. The 

first treatment module consists of mechanical filtration in combination with ultrasonic oscillation 

for filter self-cleaning, followed by the second module of UV radiation also in combination with 

ultrasound for self-cleaning of UV lamps. The intake water then passes to the ballast water tanks 

and the whole treatment process is repeated at discharge. 

3.2 Overview 

3.2.1 The AquaTriComb BWMS 

3.2.1.1 The Group noted that this BWMS consists of: filtration, disinfection of marine 

organisms through UV radiation and ultrasonic oscillation, cleaning through ultrasonic oscillation 

together with controls and auxiliary functions, all arranged into two separate modules as follows: 

 .1 a filtration with ultrasonic oscillation module; and 

 .2 a UV reactor with ultrasonic oscillation module. 

Then, at ballast water discharge, the whole process is repeated, so the overall treatment scheme is 

indicated in Figure 1 below. 

Ballasting 

 

 

Î Î Î

 

 

Í Í Í 

De-Ballasting 

Figure 1: Schematic Process Diagram of AquaTriComb BWMS 

Filtration with 

Ultrasound

UV Reactor 

with 

Ultrasound 

Ballast 

Water 

Tank Filtration with

Ultrasound

UV Reactor 

with 

Ultrasound 
GESAMP-BWWG 9/6 

ANNEX 6 

Page 11 

I:\MEPC\59\2-19.doc 

3.2.1.2 The Group accepted that this system represents a chemical-free disinfection procedure as 

no chemical compounds are added to the process. 

3.2.1.3 The Group decided this application for Basic Approval should focus on the disinfection 

of marine organisms through UV radiation and ultrasonic oscillation, as this is the only area 

involving the use of Active Substance. 

3.2.2 Description of pilot scale test system used for Basic Approval 

3.2.2.1 The Group noted that, in order to confirm and justify this system, the Applicant had 

developed a pilot scale system and experiments were performed in accordance with the 

IMO requirements. The treated ballast water was used for the chemical water analysis (see below 

for results). 

3.2.2.2 The Group noted that according to the Applicant, the BWMS test plant volume flow rate 

is designed at 250 m3/h and the capacity can be up-scaled as needed. The ballast water intake is 

filtered through three identical MicroSintFilter (MSF) modules to remove particles and 

organisms. The MSF Aquaworx filter pore size is 35 μm and filter material consists of a sintered 

high grade steel alloy. The automatic self-cleaning process of the filter modules is realized via 

permanent ultrasonic oscillation inside the filter tube. By means of reversed flow, the effluent 

from the filter backflush is disposed of via separate piping, during application of treatment at 

ballast water discharge. 

3.2.2.3 According to the Applicant, the most important impact of the ultrasound is the highly 

effective and permanent cleaning of the UV-emitter through the ultrasonic transmission along the 

full length of the UV-reactor, avoiding accumulations of bio films or inorganic salts on the 

quartz-crystal tubes. Inside the UV-reactor the aquatic organisms are lethally affected by UVlight and ultrasound. The Group noted that the Applicant provides this information for use of 

ultrasound for self-cleaning - the same level of ultrasound is applied in the same way for both 

filter modules and UV emitters; very low frequency sound (20 Hz) with extremely short-term 

ultrasound impact (< 1 s). 

3.2.2.4 Abiotic parameters such as pH, conductivity, temperature, turbidity, oxygen content, 

flow rate volume and pressure are recorded during tests online via automatic sensors. 

3.2.2.5 The Group noted that, according to the Applicant the performance test was done 

according to Guidelines (G8). Test results showed that the AquaTriComb system meets the 

Ballast Water Performance Standard contained in regulation D-2 of the Ballast Water 

Management Convention. 

3.3 Safety considerations 

3.3.1 The Group noted that the treatment plant is designed to need minimum input from the 

crew. The crew member performs ballasting and de-ballasting procedures as normal and 

the AquaTriComb starts operations after activation of a switch-on device. Further, Aquaworx is 

offering a training unit to the key shipboard personnel to get familiar with the system. 

3.3.2 According to the Applicant, the AquaTriComb treatment plant is fully automated and 

completely self-contained with electronic control, switchboard, and control panel including
GESAMP-BWWG 9/6 

ANNEX 6 

Page 12 

I:\MEPC\59\2-19.doc 

emergency shut-off device. The plant can be readily pre-mounted for connection to the shipboard 

power supply system. During the treatment process no liquid or solid waste appears. 

3.3.3 The Group noted that the ultrasonic tube oscillators need to be exchanged at the earliest 

after approximately 16,000 to 20,000 operating hours, the low-pressure UV mercury lamps after 

about 12,000 operating hours. All other system components do not need any extra maintenance 

and will be integrated into the routinely applied shipboard plant maintenance schedule. 

3.3.4 In view of the above considerations, the Group was satisfied that the Applicant had 

reviewed relevant safety measures concerning location and handling of the plant and training of 

crew. In connection with a risk assessment, these measures are considered to be adequate to 

avoid uncontrolled or emergency situations and to operate the ballast water treatment plant in a 

safe manner, while performing the necessary tasks to generate the data needed to apply 

for Final Approval in the future. 

3.4 Chemical processes involved (provided by the Applicant) 

3.4.1 The Group recognized that the AquaTriComb BWMS produces photons emitted by the 

low-pressure UV (LPUV) system, and cavitation generated by the low-frequency ultra-sound 

(LFUS) system. The photons and cavitation effects are entirely responsible for the inactivation of 

harmful aquatic micro-organisms and pathogens present in ballast water. Half lives of the 

photons in water are expected to be in the order of micro- to milli-seconds. The photons and 

cavitation are not resident in the water and consequently cause no harm upon release of treated 

ballast water. For the purpose of this review, the Group regarded the photons 

as Active Substance. 

3.4.2 For the system, the Group noted that ballast water discharge is the treated ballast water 

that has passed the LPUV system and LFUS system twice each, during ballasting and 

deballasting, respectively. 

3.4.3 The Group recognized that the BWMS does not intentionally add any preparation or 

chemicals. 

3.4.4 The Group noted that according to the Applicant, the BWMS can produce a 

Relevant Chemical. The LPUV and LFUS can be absorbed by certain molecules, such as nitrate 

and dissolved organic matter (DOM) in the seawater and cause photo-chemical and/or 

sono-chemical reactions to produce reactive oxygen species such as hydroxyl radical (OH•). 

Therefore hydroxyl radical (OH•) is defined by the Applicant as a Relevant Chemical. However, 

the Group accepted that the amount of OH• potentially produced in the system is extremely small. 

The OH• radical reacts with any organic compound and exists for about 10-9 seconds. 

3.4.5 It was recognized by the Group that the photons might react with naturally occurring 

organic molecules in seawater to form disinfection by-products (with safety and environmental 

concerns). The Group referred to these by-products as Other Chemicals. 

3.4.6 As a result of the above points, the Group accepted that chemicals are neither required to 

be stored on board nor generated on demand. 
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3.5 Active Substance (AS), Relevant Chemicals (RC) and Other Chemicals (OC)

3.5.1 Active Substance 

3.5.1.1 In this LPUV- and LFUS-based system, the Group accepted that photons are the 

only Active Substance available to kill and inactivate micro-organisms. Accordingly, as the 

photons and cavitation effects are only available upon turning on the system controls, there must 

be no residual photons or cavitation in both the ballast water and ballast water discharge. 

Half-lives of the photons are expected to be in the order of micro- to milliseconds. 

3.5.1.2 Therefore the Group accepted that the photons and cavitation effects have no chance of 

being exposed to aquatic plants, invertebrates, fish, and other biota, including sensitive and 

representative micro-organisms. Therefore, all tests for effects on such biota, are “not applicable” 

due to the non-residual characteristics of the photon and cavitation effects. 

3.5.1.3 Likewise, since the photons and cavitation effects are generated in the BWMS, they are 

never exposing mammals therefore there is no need to provide any data with regards to 

mammalian toxicity. 

3.5.2 Relevant Chemical 

3.5.2.1 The Group noted that the hydroxyl radical (OH•) is defined by the Applicant as 

a Relevant Chemical in this BWMS. The Group concurred with the Applicant that the extreme 

reactivity and high oxidizing potential of the hydroxyl radical (OH•) is indicated by its short 

half-life, typically nanoseconds. Under these circumstances where the hydroxyl radical (OH•) 

can react non-selectively with organic compounds to give possible reaction products, the Group 

proposed that it was neither necessary nor practical to provide the physical characteristics or 

toxicological profiles of the hydroxyl radical. 

3.5.3 Other Chemicals

3.5.3.1 It was recognized by the Group that the LPUV- and LFUS-based system may react with 

naturally occurring organic molecules in ballast water to form by-products with safety and 

environmental concerns. It was agreed by the Group that it was neither necessary nor practical to 

individually provide their physical characteristics or toxicological profiles. The Group referred to 

these by-products as Other Chemicals. 

3.5.3.2 It was noted by the Group that the Applicant had identified certain possible resultant byproducts of the treatment system and had analyzed the ballast water for these other chemicals, as 

part of the application for Basic Approval. To evaluate the impact of ballast water treatment on 

the production of other chemicals, water samples were analysed chemically before and after the 

treatment process. All THM, halohydrocarbons, HAA, bromophenols, acetonitriles, AOX, EOX 

and TRO (in all 32 substances or substance groups) were measured before and after treatment, 

the complete list being shown in Table 1 below. 
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Table 1: Possible Other Chemicals, including Levels of Quantification and standardized 

methods, analysed by three certified laboratories (as provided by Applicant) 

Parameter Level of 

Quantification (LOQ) Methods Used 

Nitrite (NO2

-

) 0.007 mg/L DIN EN 26 777 1993-04 

AOX 0.02 mg/L DIN EN 1485: 1996-11 

EOX 0.002 mg/L DIN 38141-S17 1989-11 

THM: 

Chloroform 

Bromoform 

Dibromochloromethane 

Dichlorobromomethane 

0.02 μg/L EN ISO 10301 1997-04 

Halohydrocarbon: 

1,2- dibromoethane 

1,2,3-trichloropropane 

2-chlorotoluene 

4-chlorotoluene 

1,2-dibromo-3-chloropropane 

1,2,3-tribromobenzene 

1,1,1-Trichlorethane 

Carbon tetrachloride 

Tetrachlorethene 

0.02 μg/L EN ISO 10301 1997-04 

HAA: 

Monochloracetic acid 

Dichloroacetic acid 

Trichloroacetic acid 

Monobromoacetic acid 

Dibromoacetic acid 

Tribromoacetic acid 

Bromochloroacetic acid 

Dibromochloroacetic acid 

Bromodichloroacetic acid 

1.0 μg/L DIN 38407 F25 

Bromophenols: 

2,4-Dibromophenol 

2,6-Dibromophenol 

0.01 μg/L GC-MS after derivatization and 

extraction 
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Parameter Level of 

Quantification (LOQ) Methods Used 

2,4,6-Tribromophenol 0.04 μg/L GC-MS after derivatization and 

extraction 

Acetonitriles: 

Monobromoacetonitrile 

Dibromoacetonitrile 

Bromchloroacetonitrile 

1.0 μg/L US EPA Method 551.1 

TRO: Cl2, H2O2, O3, BrO All substances: 

0.05 mg/L EN ISO 7393-1 2000-04 (G4-2) 

3.5.3.3 The Group recognized that analysis of treated ballast water was carried out by the 

Applicant using three different salinities (see Table 2 below) and with two to three duplicate 

samples in several runs (two to four), both before and after treatment of the ballast water. 

Table 2: Range of salinities during analytical investigation of Other Chemicals (with 

temperature ranges from 16.1 to 17.8°C) 

Test medium Salinity (PSU) 

Freshwater 0 

Brackish Water 18.9 – 19.5 

Saltwater 31.6 – 33.1 

3.5.3.4 The Group noted the following information on Levels of Quantification provided by 

the Applicant. According to the report of GESAMP-BWWG 7 in annex 5 (MEPC 58/2/8) 

Levels of Quantification (LOQ) for THM and HAA for surface waters are recommended 

as 0.01-0.05 μg/L. The laboratories involved in the analysis were able to reach LOQ for THM, 

halohydrocarbons and bromophenols of 0.02 μg/L, which meets the recommended range. In the 

case of the HAA, experts of the laboratories spent considerable effort to find methods or 

laboratories, which are able to meet the recommended LOQ. The effort to find a solution also 

included the attempt, to establish and optimize a standardized analytical method regarding this 

special demand. As the best result, a laboratory was able to reach a LOQ for HAA of 1 μg/L. 

The Group recognized the work performed by the Applicant and accepted the analytical data 

provided for Basic Approval. 

3.5.3.5 The Group noted the results of analysis reported by the Applicant, as follows – all TRO, 

HAA, THM, halohydrocarbons, acetonitriles and bromophenols measured in samples before and 

after treatment were below their respective Levels of Quantification. 

3.5.3.6 In the case of nitrite ions, the Group noted that analytical values are above the LOQ both 

for measurements before and after the ballast water treatment process. Nitrite concentrations 

especially for brackish and salt water are above the LOQ and show a high variability in samples, 

both before and after the ballast water treatment. The Applicant performed a detailed statistical 

investigation (Mann-Whitney U Test) of nitrite concentrations before and after treatment, which 
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were statistically proven to be not significantly different, so the Group accepted that this means 

the nitrite ion is not generated by the treatment process. In addition, the Group noted that all 

nitrite values before and after treatment are within the German, EU, EPA and WHO drinking 

water regulations. 

3.5.3.7 In the case of chloroform, the Group noted that some results for samples before and after 

treatment were at or slightly above the LOQ (0.02 μg/L), but these values simply indicate that 

chloroform background concentrations within the test water in the Bremerhaven harbour are 

around 0.02 μg/L. From these results the Group concluded that the treatment process did not 

cause higher levels of chloroform. 

3.5.3.8 In the case of AOX, the Group noted that this parameter could be measured in some 

samples at very low concentrations around the LOQ (0.02 mg/L) in samples before and after 

treatment, and here again the Group accepted that the same conclusion can be applied as above 

for chloroform. 

3.6 Conclusions

3.6.1 Based on these results, the Group concurred with the views of the Applicant that it was 

not necessary to provide toxicological and ecotoxicological data on these individual by-products 

(other chemicals) and that the information provided should suffice to provide a recommendation 

regarding Basic Approval of the BWMS. 

3.6.2 The Group agreed that it was not necessary to evaluate the properties of any Active 

Substance or Relevant Chemical associated with this system. 

3.6.3 The Group agreed with the Applicant that potential increases in concentration of all 

measured other chemicals in different salinities during ballast water treatment by the AquaTriComb 

BWMS are shown by water analysis to be below their Levels of Quantification. 

4 HUMAN HEALTH ASSESSMENT

4.1 The Group noted that the potential hazards for human health, related to overheating 

of UV lamps and exposure to UV irradiation and ultrasonic oscillation resulting from operating 

this LPUV- and LFUS-based system, were sufficiently addressed by the Applicant by 

engineering control measures put in place and training of operators. The Group considered that 

normal operation and maintenance procedures of the BWMS do not pose any risks to human 

health. The Group accepted that in the case of an emergency on board ship, it is assumed that the 

power supply to the BWMS is cut-off anyway, resulting in cessation of UV-radiation and/or 

US-oscillation, and associated processes. Therefore the Group concluded that the risk of crew 

exposure was sufficiently mitigated by the measures put in place. 

4.2 In addition the Group noted that all the disinfection by-products (other chemicals) 

measured by the Applicant in the discharged ballast water were under their respective 

LOQ values. The Group considered that these chemicals are short-lived and would not pose 

a toxicological concern towards the general public swimming and eating fish from the area. 
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5 RISKS TO SAFETY OF THE SHIP, ITS CREW AND THE GENERAL PUBLIC 

5.1 Risk to safety of ship 

5.1.1 The Group was satisfied that, as the system does not involve the storage or generation of 

chemicals to treat ballast water, there were no associated storage safety problems or risks on 

board ship. 

5.1.2 The Group noted the Applicant stated that all the internal components of 

the AquaTriComb BWMS are designed and constructed to match the effects of acoustic 

cavitation, where appropriate. 

5.1.3 The Group noted the Applicant stated that the AquaTriComb BWMS is characterized by 

the absence of any preparations or aggressive additives or generated substances. Therefore, 

the Group recognized that the risk of additional corrosion effect was so low that no corrosion 

supporting, or corrosion stimulating effects are necessary to this technology. 

5.2 Risk to safety of crew 

5.2.1 The Group noted that the submission identified the only potential risk to the crew present 

in the BWMS was related to UV irradiation, ultrasonic oscillation and overheating in the 

treatment unit from the UV lamps. The submission confirmed that these identified risks had been 

addressed by system safety measures that ensure that there is no risk of personnel exposure 

to UV irradiation and ultrasonic oscillation, and that automatic shut down occurs, in a no-flow 

situation, in order to prevent overheating.

5.2.2 The Group accepted the following information provided by the Applicant on low 

frequency ultrasonic oscillation, as providing sufficient reassurance of safety on this issue. 

By the application of US-oscillation at a low frequency for a very limited time period of less than 

one (1) second only, the size of the cavitation bubbles is as small as possible, and the effect 

of hydroxyl radical generating physical sonoluminescence is reduced to the most practicable 

minimum. In addition, the effects of acoustic cavitation, which are generated by the ultrasonic 

oscillation, are restricted to the interior of the filtration and UV reactor modules, respectively. 

5.3 Risk to safety of general public 

5.3.1 The Group noted that all the disinfection by-products (other chemicals) measured by 

the Applicant in the discharged ballast water were under their respective LOQ values. 

The Group considered that these chemicals are short-lived and would not pose a toxicological 

concern towards the general public swimming and eating fish from the area. 

6 ENVIRONMENTAL RISK ASSESSMENT 

6.1 Assessment of Persistence (P), Bioaccumulation (B) and Toxicity (T) 

6.1.1 The Group recognized that it was not possible to evaluate the persistence, 

bioaccumulation and toxicity of any chemicals within or produced by the system, as it does not 

use a chemical Active Substance or produce any relevant chemical for assessment. Assessment 

of the PBT-criteria is therefore considered not applicable. 
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6.2 Derivation of the Predicted No Effect Concentration (PNEC) 

6.2.1 The Group noted that the submitted dossier did not contain any results of ecotoxicity 

testing of treated ballast water. In accordance with the requirements of Procedure (G9), 

the Group recommended that acute and chronic aquatic ecotoxicity testing of treated ballast 

water should be performed by the Applicant, if the BWMS is to be reviewed for Final Approval 

in the future. 

6.2.2 The Group agreed that the derivation of a PNEC is not possible as the nature of the 

system does not involve the use of chemicals that make the derivation of a PNEC either possible 

or necessary. 

6.3 Calculation of the Predicted Environmental Concentration (PEC) 

6.3.1 The Group agreed that there would be no point in calculating the PEC of the treated 

ballast water, in view of the absence of any PNEC values. 

6.4 Calculation of the PEC/PNEC ratios 

6.4.1 The Group noted that neither the PEC nor the PNEC had been derived. The Group 

agreed that it was not necessary to do so in the present assessment. 

7 CONCLUSIONS AND RECOMMENDATIONS

7.1 Risks to the safety of the ship

7.1.1 Based on the points expressed above in this Annex, the Group agreed that the information 

provided is sufficient to make a recommendation regarding Basic Approval of the BWMS. 

7.2 Risk to the crew and the general public

7.2.1 The Group agreed that the potential hazards for human health related to overheating 

of UV lamps and exposure to UV irradiation and ultrasonic oscillation resulting from operating 

this system were sufficiently addressed by the Applicant by engineering control measures put in 

place and training of operators. Therefore the Group concluded that the risk of crew exposure 

was sufficiently mitigated by the measures put in place. 

7.2.2 In addition the Group noted that all the disinfection by-products measured in the 

discharged ballast water were under their respective LOQ values. The Group considered that 

these chemicals are short-lived and would not pose a toxicological concern towards the general 

public swimming and eating fish from the area. 

7.3 Risks to the environment 

7.3.1 The Group agreed that the system would not pose a risk to the environment if operated 

under the description in the dossier received. 

7.3.2 Based on the points expressed above, the Group agreed that the information provided 

should suffice to make a recommendation regarding Basic Approval of the BWMS. 
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7.3.3 In accordance with the requirements of Procedure (G9), the Group recommended that 

acute and chronic aquatic ecotoxicity testing of treated ballast water should be performed by 

the Applicant, if the BWMS is to be reviewed for Final Approval in the future. 

7.4 Recommendations

7.4.1 Having considered all of the data submitted for Basic Approval, and the information 

supplied by the Applicant in response to questions posed by the Group during 

this GESAMP-BWWG meeting, the Group agreed to recommend that Basic Approval be given 

to this system. 

7.4.2 The Group considered that the following points should be addressed by the Applicant if 

the system is to be evaluated for Final Approval in the future: 

.1 Currently the Applicant applies low-frequency ultrasound cleaning mechanism of 

both the UV tubes and filters. If the Applicant considers it necessary to change 

this mechanism, then the Group recommended submission of quantified data. 

.2 The Group recommended that an application for Final Approval of this system 

includes confirmation by testing, that the effluent from the filter backflush during 

application of treatment at ballast water discharge, is effectively treated by 

UV radiation, as indicated by the Applicant in their replies to additional questions 

posed by the Group during this evaluation. 

.3 The Group noted that the submitted dossier did not contain any results of 

ecotoxicity testing of treated ballast water. In accordance with the requirements 

of Procedure (G9), the Group recommended that acute and chronic aquatic 

ecotoxicity testing of treated ballast water should be performed by the Applicant, 

if the BWMS is to be reviewed for Final Approval in the future. The Group 

recalled that this requirement of ecotoxicity testing is part of Basic Approval, so 

that the Applicant can make use of ballast water from the laboratory-scale 

BWMS. The Group considered that the possibility for an Applicant to provide 

chemical analysis and/or acute toxicity testing, in lieu of whole effluent 

ecotoxicity testing for Final Approval should not be permitted in this particular 

case as ecotoxicity testing was not supplied for the Basic Approval evaluation, 

and this is a necessary step to provide certainty of environmental acceptability. 

* * * 
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Appendix 

PROPERTIES OF TREATED BALLAST WATER 

1 PHYSICOCHEMICAL PROPERTIES

1.1 The Group recognized that it was both unnecessary and irrelevant to report the physical 

properties of treated ballast water. 

2 MAMMALIAN TOXICITY

2.1 The Group noted that the Applicant had indicated that, as there were no measurable 

chemical by-products, there was no need to provide any data with regards to mammalian toxicity. 

The Group agrees with this view. 

3 ENVIRONMENTAL EFFECTS 

3.1 Ecotoxicological testing of treated ballast water 

3.1.1 In accordance with the requirements of Procedure (G9), the Group recommends that acute 

and chronic aquatic ecotoxicity testing of treated ballast water should be performed by 

the Applicant, if the BWMS is to be reviewed for Final Approval in the future. 

3.2 Information on endocrine disruption 

3.2.1 The Group noted that the endocrine disruption potential of treated ballast water had not 

been tested for specifically but the Applicant reported that no potential endocrine disrupting 

chemicals had been identified in the treated water. 

3.2.2 Based on this information, the Group agreed that the treated ballast water was unlikely to 

have any endocrine disrupting effects. 

3.3 Sediment Toxicity 

3.3.1 The Group noted that the Applicant had indicated that, based on the chemical analysis of 

the treated ballast water, there would not be any sediment toxicity associated with the treated 

ballast water. The Group agrees with this view. 

3.4 Bioavailability/Biomagnification/Bioconcentration 

3.4.1 The Group noted that the Applicant had indicated that, based on the chemical analysis of 

the treated ballast water, there was no indication of any chemical by-products that might be 

bioaccumulative. The Group agrees with this view. 
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3.5 Food Web/Population Effects 

3.5.1 The Group noted that the Applicant had indicated that, taking into account the results of 

chemical analysis of 100% treated ballast water, it would be unlikely for the diluted ballast water 

to have any significant negative effects on ecological communities at environmentally relevant 

concentrations. The Group agrees with this view. 

3.6 Environmental Fate and Behaviour

3.6.1 The Group recognized that there is no chemical Active Substance or any assessable 

relevant chemical produced by the system and so there was no need to consider their 

environmental fate any further. 

_______________