2 GENERAL
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Statutory Documents - IMO Publications and Documents - Circulars - Ballast Water Management - BWM.2/Circular.13/Rev.4 – International Convention for the Control and Management of Ships' Ballast Water and Sediments, 2004 – (20 July 2017) - Annex – Revised Methodology for Information Gathering and Conduct of Work of the GESAMP-BWWG. Approved by MEPC 71 on 7 July 2017 - 2 GENERAL

2 GENERAL

 2.1 Legal provision

Regulation D-3.2 of the International Convention for the Control and Management of Ships' Ballast Water and Sediments, 2004, stipulates that ballast water management systems (BWMS) that make use of Active Substances to comply with the Convention shall be approved by the Organization. During its fifty-third session, the Marine Environment Protection Committee (MEPC) adopted the Procedure for approval of ballast water managemen systems that make use of Active Substances (G9) (resolution MEPC.126(53)). Resolution MEPC.169(57) revoked the initial Procedure and provided a revised version of it.

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

This section describes the principles of acceptability of BWMS that make use of Active Substances, required in section 3 of Procedure (G9).

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

2.2.2 Any system that makes use of, or generates, Active Substances, Relevant Chemicals or free radicals during the treatment process to eliminate harmful organisms and pathogens in order to comply with the Convention should be subject to Procedure (G9) (G9: 3.3).

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

2.2.4 The Administration should determine if a BWMS that uses UV irradiation produces Active Substances and decide whether it needs to make a proposal for approval to the Committee or not (MEPC 59/24, paragraph 2.17).

2.3 Submission of an application for approval

This section describes the procedure to submit an application for approval specified in sections 8.1 and 8.2 of Procedure (G9).

2.3.1 The manufacturer should evaluate the system, the Active Substances or Preparations and the potential discharge in accordance with the approval criteria specified in the Procedure for approval of ballast water management systems that make use of Active Substances G9).

2.3.2 Upon completion of the evaluation the manufacturer should prepare an application on the system that makes use of Active Substances or Preparations and submit it to the Member of the Organization concerned. An application should only be made when the ballast water management system using Active Substance or Preparations has been sufficiently designed, developed and tested to provide the full data necessary for Basic or Final Approval as appropriate (G9: 8.1.2.2).

2.3.3 For systems that have previously received Basic Approval, the provisions of the Framework for determining when a Basic Approval granted to one BWMS may be applied to another system that uses the same Active Substance or Preparation should apply (BWM.2/Circ.27).

2.3.4 Upon receipt of an application, the concerned Administration should conduct a careful completeness check to ensure that the application satisfies all the provisions contained in Procedure (G9) and that it is presented in the format recommended in this Methodology. Administrations should check the quality and completeness of any application against the latest version of the Methodology for information gathering and conduct of work of the GESAMP-BWWG, agreed by the Organization, prior to its submission to the MEPC. For Final Approval applications, the Administration should ensure that all the recommendations given by the GESAMP-BWWG during the Basic Approval process have been addressed to its complete satisfaction.

2.3.5 When the Administration is satisfied with the application received in accordance with paragraph 3.6 of Procedure (G9), it should submit a proposal for approval to the rganization consisting of the following:

  • .1 a description of the ballast water management system containing the non-confidential data in the usual format for dissemination as an MEPC document (preferably less than 50 pages). Administrations should aim at submitting the non-confidential descriptions of their ballast water management systems at the MEPC session, which precedes the MEPC session expected to decide on the approval of the systems. If this is not possible, the non-confidential description should be submitted at the earliest opportunity to the MEPC session expected to decide on the approval of the systems, but not later than the 28-week deadline established as indicated in paragraph 2.3.7 below. Documents containing non-confidential descriptions of BWMS, which contain more than 20 pages, will not be translated into all working languages in their entirety. They should include, for translation purposes, a summary of the document not longer than four pages, with the technical content submitted as an annex in the language (e.g. English) that may be needed, for example, by working groups. Proponents seeking approval of BWMS that use Active Substances should thoroughly observe the provisions of paragraph 8.1.1 of Procedure (G9), bearing in mind that failure to provide the non-confidential information could result in Member States having insufficient data to approve the proposals when requested by the Committee. INF documents could be used in conjunction with proposals for approval to ensure that all safety and environmental protection data are made available;

  • .2 a Letter of Agreement concerning the arrangements between IMO and the submitting Administrations for the evaluation of the respective system. A template of such a letter is provided in appendix 1;

  • .3 the complete application dossier in accordance with Procedure (G9) consisting of the full description of the system, tests results, study reports, references and copies of the literature referenced and any other information relevant to that system. A summary of the key data should be provided in a tabular format. The complete application dossier should contain a list of contents indicating the location of the information in the application. Pursuant to paragraphs 4.2.2, 8.1.1 and 8.1.2.7 of Procedure (G9), the information mentioned above will be treated as confidential. It should be noted, however, that all information related to safety and environmental protection, including physical/chemical properties, environmental fate and toxicity, will be treated as non-confidential; and .4 the assessment report in accordance with paragraph 4.3 of Procedure (G9).

2.3.6 Proposals for approval of ballast water management systems that make use of Active Substances that need to be evaluated by the GESAMP-BWWG should be addressed to:

  • Marine Environment Division
  • International Maritime Organization
  • 4 Albert Embankment
  • London SE1 7SR
  • United Kingdom

2.3.7 A non-refundable registration fee to cover the costs related to the services provided by the GESAMP-BWWG should be paid upon receipt of the invoice issued by the Organization in this respect. It should be noted that the evaluation of a proposal for approval cannot be initiated before the payment of the fee mentioned above.

2.3.8 The GESAMP-BWWG aims to hold its meetings 20 weeks before the MEPC session expected to decide on the approval of the proposals made by the Member Governments. Consequently, a 28-week deadline has been established for the submission of the proposal for approval (including the complete application dossier). This allows eight weeks for the preparation of the meeting and enables interested parties to provide information that is relevant to the evaluation in accordance with the provisions of paragraph 8.1.2.6 of Procedure (G9). A timetable used for planning the activities related to the GESAMP-BWWG meetings is shown in appendix 2.

2.3.9 When due to the time constraints the GESAMP-BWWG is not able to evaluate all the proposals for approval submitted before the deadline established as indicated in paragraph 2.3.8 above, an extraordinary meeting of the GESAMP-BWWG may be convened, subject to the availability of the Group and with the authorization of the Secretary-General of the Organization.

2.3.10 The GESAMP-BWWG will endeavour to evaluate as many proposals for approval as possible received before the deadline described in paragraph 2.3.8 above. When due to the time limitations between two consecutive sessions of the MEPC, the GESAMP-BWWG is not able to evaluate all the proposals for approval received before the above deadline, the remaining proposals will be evaluated on a "priority basis", in accordance with the order of submission during the subsequent meetings of the GESAMP-BWWG. Proposals for approval received after the established deadline will be referred to the MEPC session following the session used to establish the deadline and will be considered after any priority proposals not considered at previous meetings.

2.3.11 Upon receipt of a complete proposal for approval, the Organization will issue a confirmation letter indicating the date and the time the proposal has been received. In order to ensure complete transparency and a fair and impartial treatment of all the submissions, the proposals for approval are evaluated in the chronological order of their receipt.

2.3.12 Face-to-face meetings between the GESAMP-BWWG and applicants/Administrations should be conducted at the request of the Administrations prior to the meeting and solely during Final Approval evaluations. Face-to-face meeting should be limited to one hour per Final Approval application.

2.3.13 Clarification of certain aspects identified during the preparation for, or in the process of, an evaluation of a proposal for approval may be requested by the GESAMP-BWWG, if it becomes evident that clarification is found to be necessary in order to finalize the evaluation. The clarifications should be received in a timely manner so that the GESAMP-BWWG is able to take the information into account during its evaluation of the system. A time limit for response to any request for clarifications should not exceed 24 hours unless otherwise agreed with the GESAMP-BWWG. Applicants may wish to designate a technical representative to provide clarifications on request during the Group's meeting.

2.3.14 After completion of the GESAMP-BWWG report, relevant annexes containing the results of the evaluation will be forwarded to the respective Administrations for confirmation that no confidential data are being disclosed. Unless the Administration advises otherwise before the deadline indicated in the request for confirmation (normally one week), the Secretariat will assume that the respective evaluation does not contain confidential data and will process the report according to the timetable shown in appendix 2.

2.3.15 If after the revision of the draft report of the GESAMP-BWWG the GESAMP provides comments on the findings of the Group, the Chair of the GESAMP-BWWG, in consultation with the members of the Group, as appropriate, will address the respective comments. The GESAMP provides confirmation of peer review and approval to the Organization for the information of the MEPC.

2.3.16 In case an Administration that has submitted a proposal for approval disagrees with the recommendations of the GESAMP-BWWG, such an Administration should be given the option to submit a document indicating the reasons for disagreement to the session of the MEPC expected to decide on the respective proposal. The explanatory document should be considered by the Committee in conjunction with the GESAMP-BWWG report.

2.3.17 Any supplementary data regarding a proposal not recommended for approval that was provided to the GESAMP-BWWG after the completion of its meeting will be considered as a new proposal, subject to a new deadline for evaluation according to the procedure described in this Methodology and subject to a new registration fee.

2.3.18 The Secretariat will endeavour to forward all the requests for clarification regarding the published reports of the GESAMP-BWWG received from the Administrations concerned to the Chairman of the GESAMP-BWWG and to the IMO consultant responsible for the respective meeting for response as appropriate.

2.4 Confidentiality and data protection

This section describes the confidentiality and data protection specified in paragraphs 8.1.1 and 8.1.2.7 of Procedure (G9).

The confidential information in the submitted documents should be clearly identified. All information related to safety and environmental protection, including physical/chemical properties, environmental fate and toxicity, will be treated as non-confidential with the understanding that original proprietary test reports and studies, with the exception of the summary of the results and test conditions to be prepared by the applicant and validated by the GESAMP-BWWG, are considered confidential (G9: 8.1.1). Once an approval procedure is completed and the system using the Active Substance is approved, the following data should not be regarded as confidential:

  • .1 the name and address of the Administration;

  • .2 the names and addresses of the Administrations of the Active Substance and/or the Preparation (if different);

  • .3 the names and amount of the Active Substance(s) in the Preparations and the name of the Preparation;

  • .4 the names of other components of Preparations, in particular those that are regarded as dangerous according to the UN GHS or relevant IMO regulations and contribute to the hazard documentation of the Preparation;

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

    • .1 the names of other chemicals that may be formed during or after the application of the BWMS with a technical justification as to why they should not be treated as Relevant Chemicals;

  • .6 methods of chemical analysis, including the Limit of Detection (LOD);

  • .7 physical and chemical data concerning the Active Substance, the Preparation and its components and Relevant Chemicals;

  • .8 a summary of the results of the tests conducted pursuant to section 4.2 of the Procedure (G9) to establish the effects of the substance(s) or Preparation(s) on humans and the environment;

  • .9 a summary of the results of the tests conducted on the treated ballast water pursuant to section 5.2 of Procedure (G9);

  • .10 recommended methods and precautions against dangers resulting from handling, storage, transport and fire;

  • .11 any means of rendering the Active Substance or Preparation harmless;

  • .12 methods of disposal of the product and of its packaging;

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

  • .14 first aid and medical advice to be given in the case of injury to persons;

  • .15 Safety Data Sheets, which should contain the information required of items .7 to .14;

  • .16 all results of the Persistence, Bioaccumulation and Toxicity (PBT) assessment and the risk characterization pursuant to sections 5.1 and 5.3 of Procedure (G9); and

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

2.5 Test methods

This section describes the test methods specified in paragraphs 4.2.3 to 4.2.4 of Procedure (G9).

2.5.1 Tests, which are described in 3.3.2, 3.3.3 and 6.1.3., should be carried out under internationally recognized guidelines (preferably OECD or equivalent) (G9: 4.2.3), and according to an internationally recognized quality assurance system (G9: 4.2.4) (e.g. Good Laboratory Practice (GLP)). Information may be derived from existing data where an acceptable justification is provided. Full copies of sources of data (e.g. literature papers) and relevant documents for QA/QC (i.e. QAPP) should be provided electronically and in hard copy. The relevant document should include validity criteria for all tests.

2.5.2 Care should be taken to provide full supporting references and copies of the appropriate test laboratory reports in support of each application electronically and in hard copy. If submissions are lacking relevant information, it may not be possible for the GESAMP-BWWG to conduct its risk assessment.

2.5.3 Many substances have acquired large databases for many of the hazards concerned and a weight of evidence approach has become necessary to ensure that the rating reflects the body of data rather than simply using the most conservative value. This, however, means that the submission of all available end-point data for Active Substances and Relevant Chemicals is necessary to enable a review.

2.6 Alternatives to testing and non-submission of data

2.6.1 Alternative methods to testing on live organisms, e.g. in vitro testing methods, Quantitative Structure-Activity Relationship (QSAR), extrapolation by analogy to known chemicals, or grouping of similar substances, may be used whenever justified. Sufficient documentation or references to documentation on the validity of the method should be provided, as well as documentation that the substance or Preparation lies within the applicability domain of the method.

2.6.2 Information that is not necessary, owing to the nature of the substance, need not be supplied. The same applies where it is not scientifically justified or technically feasible to supply the information. In such cases, a justification for not supplying such information should be submitted.

2.7 Additional data

2.7.1 If, in the course of the review by the GESAMP-BWWG, the Group considers that additional data are found to be necessary to finalize the evaluation, the Group may, in exceptional circumstances, request that such data are provided to facilitate the review.

2.7.2 The applicant should not submit any additional data after the dossier has been submitted to the Organization for evaluation unless such data have been requested by the Group.

2.8 Retrospective requirement

Once a ballast water management system has received Final Approval under this procedure, then the respective applicant should not have to retrospectively submit new data in accordance with this revised Methodology (paragraph 8.2.3 of Procedure (G9)).

Parent topic: Annex – Revised Methodology for Information Gathering and Conduct of Work of the GESAMP-BWWG. Approved by MEPC 71 on 7 July 2017
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