MEPC 57/21

I:\MEPC\57\21.doc ANNEX 1

RESOLUTION MEPC.169(57)

Adopted on 4 April 2008

PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES (G9)

THE MARINE ENVIRONMENT PROTECTION COMMITTEE,

RECALLING Article 38(a) of the Convention on the International Maritime Organization concerning the functions of the Marine Envi ronment Protection Committee conferred upon it by

the international conventions for the prevention and c ontrol of marine pollution,

NOTING that regulation D-3.2 of the Intern ational Convention for the Control and Management of Ships’ Ballast Water and Sediments, 2004 provides that ballast water management systems that make use of Active Subs tances or Preparations containing one or more Active Substances used to comply with this Convention, shall be approved by the Organization based on a Procedure developed by the Organization,

NOTING ALSO resolution MEPC.126(53) by which the Committee adopted the Procedure for Approval of ballast water mana gement systems that make use of Active Substances (G9),

NOTING FURTHER that by resolution MEPC.126( 53), the Committee resolved to keep the Procedure (G9) under review in the light of experience gained,

HAVING CONSIDERED, at its fifty-sevent h session, the recommendation made by the Ballast Water Review Group,

1. ADOPTS the revised Procedure for approval of ballast water management systems that make use of Active Substances (G9), as se t out in the Annex to this resolution;

2. INVITES Member Governments to give due c onsideration to the re vised Procedure (G9) when evaluating ballast water management system s that make use of Active Substances before the submission of proposals for approval to the Committee;

3. AGREES to keep the revised Procedure (G9) under review in the light of experience gained;

4. URGES Member Governments to bring the af orementioned Procedure to the attention of manufacturers of ballast water management system s and other parties concerned with a view to encouraging its use;

5. REVOKES the Procedure adopt ed by resolution MEPC.126(53).MEPC 57/21

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I:\MEPC\57\21.doc ANNEX

PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES (G9)

Contents



### 1 INTRODUCTION

2 DEFINITIONS

3 PRINCIPLES

4 GENERAL REQUIREMENTS

Identification Data-set for Active Substances and Preparations Assessment report

5 RISK CHARACTERIZATION

Screening for persistency, bioaccumulation and toxicity Toxicity testing of the treated ballast water Risk characterization and analysis

6 EVALUATION CRITERIA

Ship and personnel safety Environmental protection

7 REGULATION OF THE USE OF ACT IVE SUBSTANCES AND PREPARATIONS

Handling of Active Substances and Preparations Hazard documentation and labelling

Procedures and use

8 APPROVAL

Basic Approval Final Approval Notification of approval

Modification Withdrawal of approval

Appendix Approval Scheme for Active Substances or Preparations and ballast water management systems that make use of Active SubstancesMEPC 57/21

ANNEX 1 Page 3

I:\MEPC\57\21.doc PROCEDURE FOR APPROVAL OF BALLAST WATER MANAGEMENT

SYSTEMS THAT MAKE USE OF ACTIVE SUBSTANCES (G9)

1 INTRODUCTION

1.1 This procedure describes the approval and withdrawal of approval of ballast water management systems that make use of Active Substances to comply with the Convention and their manner of application as set out in regula tion D-3 of the “International Convention for the Control and Management of Ships’ Ballast Wate r and Sediments”. The Convention requires that at withdrawal of approval, the use of the rele vant Active Substance or Substances shall be prohibited within 1 year after the date of such withdrawal.

1.2 To comply with the Convention, ballast wa ter management systems that make use of Active Substances or Preparati ons containing one or more Activ e Substances shall be approved by the Organization, based on a proce dure developed by the Organization.

1.3 The objective of this procedure is to dete rmine the acceptability of Active Substances and Preparations containing one or more Active Subs tances and their application in ballast water management systems concerning ship safety, hu man health and the aquatic environment. This procedure is provided as a safeguard for the sustainable use of Active Substances and Preparations.

1.4 This procedure is no t intended for the evaluation of the efficacy of Active Substances. The efficacy of ballast water management systems that make use of Active Substances should be

evaluated in accordance with the Guidelines for a pproval of ballast water management systems (G8).

1.5 The goal of the procedure is to ensure prope r application of the provisions contained in the Convention and the safeguards re quired by it. As such the procedure is to be updated as the state of knowledge and technol ogy may require. New versi ons of the procedure will be circulated by the Organization following their approval.

2 DEFINITIONS

2.1 For the purposes of this procedure, the definitions in the Convention apply and:

.1 “Active Substance” means a substance or organism, including a virus or a fungus that has a general or specific action on or against harmful aquatic organisms and pathogens.

.2 “Ballast Water Discharge” means the ba llast water as woul d be discharged

overboard.

.3 “Preparation” means any commercial formulation containing one or more Active Substances including any additives. This term also includes any Active Substances generated onboard for purposes of ballast water management and any

relevant chemicals formed in the ballast water management system that make use

of Active Substances to comply with the Convention.MEPC 57/21

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I:\MEPC\57\21.doc .4 “Relevant Chemicals” means transfor mation or reaction products that are produced during and after employment of th e ballast water management system in the ballast water or in the receiving envir onment and that may be of concern to the ship’s safety, aquatic environment and/or human health.

3 PRINCIPLES

3.1 Active Substances and Prepara tions may be added to the ba llast water or be generated on board ships by technology within the ballast water management system using an Active Substance to comply with the Convention.

3.2 Active Substances and Preparations accomp lish their intended purpose through action on harmful aquatic organisms and pathogens in ships’ ballast water and sediments. However, if the

ballast water is still toxic at th e time of discharge into the environment, the organisms in the receiving water may suffer unacceptable harm. Both the Active Substance or Preparation as well as the ballast water discharge should be subjected to toxicity testing in order to protect the receiving environment or human health from toxic effects due to the discha rges. Toxicity testing

is needed to determine if an Active Substanc e or Preparation can be used and under which conditions the potential of harmi ng the receiving environment or hum an health is acceptably low.

3.3 Any system which makes use of, or generate s, Active Substances, Relevant Chemicals or free radicals during the treatment process to eliminate organisms in order to comply with the Convention should be subject to this Procedure.

3.4 Ballast water management systems that make use of Active Substan ces and Preparations must be safe in terms of the ship, its equipment and the personnel to comply with

the Convention.

3.5 The approval of Active Substances and Prep arations using viruses or fungi for use in ballast water management systems is not addressed in this procedure. The approval of such substances for ballast water management should require an additional consideration by the Organization in compliance with regulation D-3 of the Convention if the use of such substances is proposed.

3.6 Administrations should check the quality and completeness of any Basic Approval or Final Approval submission, against the latest version of the Metho dology for information gathering and the conduct work of the Technical Group agreed by the Orga nization, prior to its

submission to the MEPC.

4 GENERAL REQUIREMENTS

4.1 Identification

4.1.1 The proposal for approval of an Active S ubstance or a Preparation should include a

chemical identification a nd description of the chemical compone nts even if generated on board. A chemical identification should be pr ovided for any Relevant Chemicals.MEPC 57/21

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I:\MEPC\57\21.doc 4.2 Data-set for Active Substances and Preparations

4.2.1 A proposal for approval should include inform ation on the properties or actions of the Preparation including any of its components as follows:

.1 Data on effects on aquatic plants, inverteb rates, fish, and othe r biota, including sensitive and representative organisms:

• acute aquatic toxicity;

• chronic aquatic toxicity;

• endocrine disruption;

• sediment toxicity;

• bioavailability/biomagnifica tion/bioconcentration; and

• food web/population effects.

.2 Data on mammalian toxicity:

• acute toxicity;

• effects on skin and eye;

• chronic and long-term toxicity;

• developmental and repr oductive toxicity;

• carcinogenicity; and

• mutagenicity.

.3 Data on environmental fate and effect under aerobic and anaerobic conditions:

• modes of degradation (biotic; abiotic);

• bioaccumulation, partition coefficient, octanol/water coefficient;

• persistence and identification of the main metabolites in the relevant media (ballast water, marine and fresh waters);

• reaction with organic matter;

• potential physical effects on wildlife & benthic habitats;

• potential residues in seafood; and

• any known interactive effects.

.4 Physical and chemical properties for th e Active Substances and Preparations and the treated ballast water, if applicable:

• melting point;

• boiling point;

• flammability;

• density (relative density);

• vapour pressure, vapour density;

• water solubility / dissociation constant (pKa);

• oxidation/reduction potential;

• corrosivity to the materials or equipment of normal ship construction;

• autoignition temperature; and

• other known relevant physical or chemical hazards.

.5 Analytical methods at environm entally relevant concentrations.MEPC 57/21

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I:\MEPC\57\21.doc 4.2.2 A proposal for approval should include the above data set either for the Preparation or for each component separately, and a list of the name and relative quantities (in volumetric percentages) of the components should be also attached. As described in section 8.1, all proprietary data should be treated as confidential.

4.2.3 The tests for Active Substances and Prepara tions should be carried out in accordance with internationally recognized guidelines 1

.

4.2.4 The testing process should contain a rigo rous quality control/quality assurance programme consisting of:

.1 Both a Quality Management Plan (QMP ) and a Quality Assurance Project Plan (QAPP). Guidance on preparation of th ese plans, along with other guidance documents and other general quality control information are available for download from the International Orga nization for Standardization (ISO) ( www.iso.org ).

.2 The QMP addresses the quality control ma nagement structure and policies of the Test Organization (inclu ding subcontractors and outside laboratories).

.3 The QAPP is a project specific technical document reflecting the specifics of the system to be tested, the test facility, and other conditions a ffecting the actual design and implementation of the required experiments.

4.2.5 Dossiers already used for registration of ch emicals can be submitted by the applicant to satisfy the required data needed for the eval uation of Active Substances and Preparations according to this procedure.

4.2.6 The proposal should describe the manner of application of the Pr eparation for ballast water management, including requir ed dosage and retention time.

4.2.7 A proposal for approval should include (Mat erial) Safety Data Sheets ((M)SDS).

4.3 Assessment report

4.3.1 A proposal for approval should include an assessment report. The assessment report should address the quality of the test reports, the risk characterization and a consideration of the uncertainty associated with the assessment.

5 RISK CHARACTERIZATION

5.1 Screening for persistency, bioaccumulation and toxicity

5.1.1 An assessment on the intrinsic properties of the Active Substa nce and/or Preparation such as persistency, bioaccumulation and toxicity shou ld be conducted (see Table 1 in section 6).

1 Preferably Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals (1993) or other equivalent tests.MEPC 57/21

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I:\MEPC\57\21.doc .1 Persistence tests: Persistence should preferably be assessed in simulation test systems that

determine the half-life under relevant c onditions. Biodegradation screening tests may be used to show that the subs tances are readily biodegradable.

The determination of the half-life should include assessment of relevant

chemicals.

.2 Bioaccumulation tests: The assessment of the (potential for) bioaccumulation should use measured bioconcentration factors in marine (or fr eshwater) organisms. Where these tests are not applicable, or if logPow <3, Bio Concentrati on Factor (BCF) values may be estimated using (Quantitative) Stru cture-Activity Rela tionship ((Q)SAR)

models.

.3 Toxicity tests: Acute and/or chronic ecotoxicity data, id eally covering the sensitive life stages, should in principle be used for the assessment of the to xicity criterion.

5.2 Toxicity testing of th e treated ballast water

5.2.1 Toxicity testing is necessary for the Active Substance, or Preparations (see sections 4.2.1 and 5.3) and the treated ballast wa ter discharge as covered in this section. The advantage of conducting toxicity testing on the ba llast water discharge is that it integrat es and addresses the potential for interactions of the Active Subs tances and Preparations with the possible by-products:

.1 For the Basic Approval process, the disc harge testing should be performed in a laboratory using techniques and equipmen t to simulate ballast water discharge following treatment by the Preparation.

.2 For Final Approval, the discharge testi ng should be performed as part of the land-based type approval process using the treated ballast water discharge.

5.2.2 The applicant should provide both acute and chr onic toxicity test data using standardized test procedures to determine the toxicity of th e Preparation and Relevant Chemicals as used in conjunction with the ballast wa ter management system. This testing approach should be performed on the treated ballast water discharge, as the ballast water management system could either mitigate or enhance the adverse effects of the Preparation or Relevant Chemicals.

5.2.3 The discharge toxicity test s should be conducted on samples drawn from the land-based test set-up, which would be representative of the disc harge from the ballast water

management system.

5.2.4 These toxicity tests should include chronic te st methods with multiple test species (a fish, an invertebrate and a plan t) that address the sensitive life-stage. The preference is to include bothMEPC 57/21

ANNEX 1 Page 8

I:\MEPC\57\21.doc a sub-lethal endpoint (growth) and a survival endpoi nt. Either freshwater or marine test methods

should be tested 2

.

5.2.5 The test results to be provided include : acute 24-hour, 48-hour, 72-hour, and 96-hour

Lethal Concentration at which x % of the test organisms die (LCx), No Observed Adverse Effect Concentrations (NOAECs), chronic No Observed Effect Concentration (NOEC) and/or Effect Concentration at which x % of test organisms s how effect (ECx), as appropriate based on the experimental design.

5.2.6 A dilution series including a 100% ballast wate r discharge would be tested to determine the no adverse effect level using the statistical endpoints (NOEC or ECx). An initial analysis could use a conservative appr oach where the dilution capacity would not be taken into consideration (no modelling or plumes analysis would be used). The rationale for taking a conservative approach is that th ere could be multiple discharges into one location (even though this is not necessarily the case).

5.2.7 The acute and chronic toxicity test data in conjunction with the information in

section 4.2.1 should be used to determine the hol ding time necessary to achieve the no adverse effect concentration upon discharge. Knowing the half-life (days), decay rate, dosage rate, volume of system and toxicity tests with time seri es, then a computational model can be used to

determine the amount of time needed to hold th e treated ballast water before discharge.

5.2.8 Information on Total Residual Oxidants (TRO ) and Total Residual Chlorine (TRC) should be provided as part of the application for eval uation, for both the ballast water treatment process and the ballast water discharge.

5.3 Risk characterization and analysis

5.3.1 For the Basic Approval process, fate and effect testing should be performed in the laboratory with Active Substances and Preparations. This section lists information that could be useful for a preliminar y risk characterization.

5.3.2 Both the Active Substance or Preparation as well as the tr eated ballast water discharge should be subject to toxi city testing in order to protect th e receiving environment from toxic effects due to discharges.

5.3.3 The reaction with organic matter of Active Subs tances and Preparations that produce free radicals, should be addressed qualitatively so as to identif y products of concern to the

environment.

5.3.4 The rate and route of abiotic and biotic degradation of the Active Substances and Preparations under aerobic and anaerobic cond itions should be assessed, resulting in the

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

2 Currently there is no compelling physiological or empirical proof that marine organisms are more sensitive than freshwater organisms or vice versa. Should this however be demonstrated for the substance under consideration, this shou ld be taken into account.MEPC 57/21

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I:\MEPC\57\21.doc 5.3.5 The rate of abiotic and biotic degradati on of the Active Substances and Preparations

under aerobic and anaerobic conditions should be assessed, resultin g in the characterization of the persistence of the Active Substances, Prepar ations and Relevant Ch emicals in terms of degradation rates under specified co nditions (e.g., pH, redox, temperature).

5.3.6 The partition coefficients (s olids-water partition coefficien t (Kd) and/or organic carbon

normalized distribution coefficien t (Koc)) of the Active Substances, Preparations and Relevant

Chemicals should be determined.

5.3.7 For Active Substances and Preparations, the potential for bioaccumulation should be

assessed in marine or freshwater organisms (fish or bivalves) if the logarithm octanol/water partition coefficient (logPow) is >3.

5.3.8 Based on the information on fate and behavi our of Active Substan ces and Preparations, the discharge concentrations at selected time intervals should be predicted.

5.3.9 The effect assessment of the Active Substances, Preparations and Relevant Chemicals is initially based on a dataset of acu te and/or chronic ecot oxicity data for aqua tic organisms, being primary producers (algae or sea grasses), consum ers (crustaceans), predators (fish), and should include secondary poisoning to mammalian and av ian top-predators, as well as data for sediment species.

5.3.10 An assessment of secondary poisoning is redundant if the substance of concern demonstrates a lack of bioaccumulation potenti al (e.g., BCF <500 L/kg wet weight for the whole organism at 6% fat).

5.3.11 An assessment of sediment species is redund ant if the potential of the substance of concern to partition into the sedi ment is low (e.g., Koc <500 L/kg).

5.3.12 The effect assessment of the Active Substa nces, Preparations and Relevant Chemicals should include a screening on carcinogenic, muta genic and endocrine disruptive properties. If the screening results give rise to concerns, this shoul d give rise to a further effect assessment.

5.3.13 The effect assessment of the Active Substan ces, Preparations and Relevant Chemicals, taking the indicated informati on into account, should be based on internationally recognized guidance 3

.

5.3.14 The results of the eff ect assessment are compared to the results of the discharge toxicity testing. Any unpredicted re sults (e.g., lack of toxicity or unexpected toxicity in the discharge assessment) should give rise to a furthe r elaboration on the effect assessment.

5.3.15 An analytical method suitable for monitori ng Active Substances a nd Preparations in ballast water discharges should be available.

3 Such as relevant OECD guidelines or equivalent.MEPC 57/21

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I:\MEPC\57\21.doc 6 EVALUATION CRITERIA

The Organization should evaluate the applic ation for approval based on the criteria in

this section.

6.1 The information that has been provided should be complete, of sufficient quality and in

accordance with this Procedure.

6.2 That this information does not indicate possible unacceptable adverse effects to environment, human health, property or resources.

6.3 Ship and personnel safety

6.3.1 In order to protect the ship and personnel safety the Technical Group should evaluate the physical and chemical hazards (see paragrap h 4.2.1.4) to ensure that potential hazardous properties of the Active Substances, Preparations or Relevant Chemicals formed in the treated ballast water should not create any unreasonable risk to the ship and personnel. Proposed procedures for the use and technical equipment introduced needs to be taken into account.

6.3.2 For the protection of personnel involve d in the handling an d storage of the Active Substances and Preparations, the propos al should include relevant ((M)SDS). The Organization should evaluate (M)SDS, mammalian toxicity da ta and chemical properties hazards (see paragraphs 4.2.1.2 and 4.2.1.4) and ensure that potential hazardous properties of the Active Substances, Preparations or Relevant Ch emicals should not create any unreasonable risk to the ship or personnel. This evaluation shoul d take into account the different circumstances that a ship or personnel may face in its tr ade (e.g., ice, tropical, humidity, etc.).

6.3.3 A Human Exposure Scenario (H ES) should be provided by the applicant as part of the Risk Assessment procedure for ballast water management systems.

6.4 Environmental protection

6.4.1 In order to approve the application, the Organization should determine that the Active Substances, Preparations or Relevant Chemicals are not Persistent, Bioaccumulative and Toxic (PBT). Preparations that exceed all th ese criteria (Persistence, Bioaccumulation and Toxicity) in the table below are considered PBT.

Table 1 Criteria for identification of PBT substances

Criterion PBT criteria

Persistence Half-life: > 60 days in marine water, or > 40 days in freshwater * , or > 180 days in marine sediment, or > 120 days in freshwater sediment *

Bioaccumulation BCF > 2,000 or LogP octanol/water ≥ 3 Toxicity Chronic NOEC < 0.01 mg/l

* For the purpose of marine environmental risk assessment half-life data in freshwater and freshwater sediment can be overruled by data obtained under marine conditions.MEPC 57/21

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I:\MEPC\57\21.doc 6.4.2 The Organization should determine the overall acceptability of the risk the Preparation may pose in its use for ballast water management. It should do so by co mparing the information provided and the undertaken assessment of PBT a nd the discharge with scientific knowledge of the Active Substances, Preparations and Releva nt Chemicals concerned. The risk evaluation should qualitatively take into acco unt cumulative effects that may occur due to the nature of shipping and port operations.

6.4.3 The risk evaluation should consider the unc ertainties involved in the application for approval, and as appropriate, provide advice on how these uncertainties can be dealt with.

6.4.4 An Emission Scenario Document (ESD) shoul d be provided by the applicant as part of the Risk Assessment procedure for ballast water management systems. The ESD should be based on the worst-case discharge scenario and should be regarded as the first stage of a stepped approach to the development of a full ESD, when more data on potential discharges and technologies becomes available.

7 REGULATION OF THE USE OF ACTIVE SUBSTANCES AND PREPARATIONS

7.1 Handling of Active Substances and Preparations

7.1.1 The proposal for approval of Active Subs tances and Preparations should include

information on their intended us e and application. The quanti ty of Active Substances and Preparations to be added to the ballast water and the maximum allowable concentration of the

Active Substances therein should be described in the instructions provided by the manufacturer. The system should ensure that the maximu m dosage and maximum allowable discharge concentration are not exceeded at any time.

7.1.2 An assessment should be undertaken to ensure the safe on-board handling and storage of chemicals used to treat ballast water, using the existing IMO Conventions, Codes and guidance

as a basis.

7.2 Hazard documentation and labelling

7.2.1 The proposal should include ((M)SDS) as required. The (M)S DS should describe appropriate storage and handling to gether with the effects of degr adation and chemical reactivity during storage and should be included in the instructions provided by the manufacturer.

7.2.2 Documentation of hazards or the (M )SDS should conform to the UN Globally Harmonized System of Classification and Labe lling of Chemicals ( GHS) and the relevant IMO regulations (e.g., the IMDG Code) and guide lines (e.g., the GESAMP Hazard Evaluation Procedure). Where these regimes are not applicab le, relevant national or regional regimes should

be followed.

7.3 Procedures and use

7.3.1 Detailed procedures and information for sa fe application of Active Substances and Preparations on board should be developed and supplied, taking into cons ideration existing IMO Conventions, Codes and guidance. The procedures should comply with the approval conditions

such as maximum allowable concentration a nd maximum discharge concentration, if any.MEPC 57/21

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I:\MEPC\57\21.doc 8 APPROVAL

8.1 Basic Approval

8.1.1 All proprietary data should be treated as confidential by the Organization and its Technical Group, the Competent Authorities invol ved, and the evaluating regulatory scientists, if any. However, all information related to safety and environmental protection, including physical/chemical properties, environmental fate and toxicity, should be treated as

non-confidential.

8.1.2 Procedure to be followed:

.1 The manufacturer should evaluate the Ac tive Substances or Preparations and the potential discharge in accordance with the approval criteria specified in this procedure.

.2 Upon completion, the manufacturer should prepare an Application on the Active Substances and Preparations and submit it to the Member of the Organization concerned. An application should onl y be made once the ballast water management system, Active Substance or Preparation has been sufficiently designed, progressed and tested to pr ovide the full data necessary for a Basic Approval.

.3 The Administration having received a satis factory application should as soon as possible propose an appr oval to the Organization.

.4 Members of the Organization may propose an approval.

.5 The Organization should announce and se t the time frame for the evaluation of Active Substances and Preparations.

.6 Parties, Members of the Organization, the United Nations and its Specialized Agencies, intergovernmental organiza tions having agreements with the Organization and non-governmental organizatio ns in consultative status with the Organization may submit in formation that is rele vant to the evaluation.

.7 The Organization should esta blish a Technical Group in ac cordance with its rules of procedure ensuring that proprietary da ta should be treated as confidential.

.8 The Technical Group should review the comprehensive proposal along with any additional data submitted and report to the Organization whether the proposal has demonstrated a potential for unreasonable risk for environment, human health, property or resources in accordance with th e criteria specified in this procedure.

.9 The Technical Group’s report should be in written form and circulated to the Parties, Members of the Organization, the United Nations and its Specialized Agencies, intergovernmental organiza tions having agreements with the Organization and non-governmental organizatio ns in consultative status with the Organization, prior to its consider ation by the competent Committee.MEPC 57/21

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I:\MEPC\57\21.doc .10 The Committee of the Organization s hould decide whether to approve any proposal, introduce any modifica tions thereto, if appropr iate, taking into account the Technical Group’s report.

.11 The Member of the Organization th at submitted the application to the Organization should inform in writing the applicant about the decision made with regard to the respective Active Substan ce or Preparation and their manner of application.

.12 Active Substances or Preparations r eceiving Basic Approval by the Organization may be used for prototype or type a pproval testing based on the guidelines developed by the Organization 4 . Subject to evaluatio n against the criteria developed by the Organization, an Active Substance or Preparation may be used for Prototype or Type Approval testing for the approval of different BWMS.

.13 An applicant seeking to take advantage of an Active Substan ce or Preparation’s Basic Approval should provide in its app lication a written agreement from the applicant whose Active Substance or Prep aration has been granted the initial Basic Approval.

8.2 Final Approval

8.2.1 In accordance with regulation D-3.2, a balla st water management system using an Active Substance or Preparation to comp ly with the Convention (which re ceived Basic Approval) must be approved by the Organization. For this purpose, the Member of the Organization submitting an application should conduct the Type Approval tests in accordance with Guidelines for approval of ballast water management systems (G8). The re sults should be conveyed to the Organization for confirmation that the residual toxicity of the disc harge conforms to the evaluation undertaken for Basic Approval. This would result in Final Appr oval of the ballast water management system in accordance with regulation D-3.2. Active Substa nces or Preparations that have received Basic Approval by the Organization may be used for evaluation of ballast water management systems using Active Substances or Preparations for Final Approval.

8.2.2 It is to be noted that from the Guidelines (G8) land-based testing on ly the results of the residual toxicity tests should be included in th e proposal for Final Approval in accordance with Procedure (G9). All other Guidelines (G8) tes ting remains for the assessment and attention of the Administration. Although Basic Approval under Procedure (G9) should not be a pre-requisite of Type Approval te sting, as an Administration can regulate discharges from its own ships in its own jurisdiction. Basic Approval would still be required, and the specific technology could not be used in vessels in a nother jurisdiction without Basic Approval.

8.2.3 It should be noted that once a system has r eceived Final Approval under this Procedure, then the respective applicant shoul d not have to retros pectively submit new data if there is a change in the Methodology ag reed by the Organization.

4 Guidelines for approval and oversight of prototype ballast water treatment technol ogies (G10) and Guidelines for approval

of Ballast Water Mana gement Systems (G8).MEPC 57/21

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I:\MEPC\57\21.doc 8.3 Notification of approval

8.3.1 The Organization will record the Basic a nd Final Approval of Active Substances and Preparations and ballast water management syst ems that make use of Active Substances and circulate the list once a year including the following information:

• Name of ballast water management system that make use of Active Substances and Preparations;

• Date of approval;

• Name of manufacturer; and

• Any other specifications, if necessary.

8.4 Modification

8.4.1 Manufacturers should report any modifications in names, including trade and technical name, composition or use of the Active Substances and Preparations in the ballast water management systems approved by the Organizat ion, to the Member of the Organization. The Member of the Organization should inform the Organization accordingly.

8.4.2 Manufacturers intending to signi ficantly change any part of a ballast water management System that has been approved by the Organizati on or the Active Substances and Preparations used in it should submit a new application.

8.5 Withdrawal of approval

8.5.1 The Organization may withdraw any appr oval in the following circumstances:

.1 If the Active Substances and Preparatio ns or ballast water management system

that make use of Active Substances no longer conforms to requirements due to

amendments of the Convention.

.2 If any data or test reco rds differ materially from data relied upon at the time of approval and are deemed not to satisfy the approval condition.

.3 If a request for withdrawal of a pproval is made by the Member of the Organization on behalf of the manufacturer.

.4 If unreasonable harm to environment, human health, property or resources is demonstrated by any Member of the Organi zation or observer to have been caused by the approved ballast water management system that make use of Active Substances or Preparations.MEPC 57/21

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I:\MEPC\57\21.doc Appendix

Approval Scheme for Active Substan ce or Preparation and Ballast Water Management systems that make use of Active Substances

*** Manufacture r Only laboratory scale data is necessary, and discharge time is predicted in simplified dilution model

The Member of the Organization

IMO Technical Group Organization

Using Active Substances that have received basic approval Evaluate as confidential

Type Approval according to relevant IMO guidelines Dossiers of existing registration may be

submitted

Organization (MEPC) Risk Characterization and Analysis Basic Approval by, and report to Organization

For approved Active Substances the Organization

circulates the list to the Parties Request for
additional
data set

2. FINAL APPROVAL The Member of the Organization

Manufacture r

Discharge test with whole

system on the test-bed Submi t

Submit application Data set
Discharge Test-data
Discharge Time

Etc.

IMO Technical Group Organization

Organization (MEPC) Request for
additional
data set

The Member of the Organization The Member of the Organization Data set
Discharge Test-data
Discharge Time

Confirm residual toxicity of discharged ballast water with the evaluation under the basic approval

Approve the Ballast Water Management system that make

use of Active Substances

Publish list of approvals 1. BASIC APPROVAL