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ANNEX 4
RESOLUTION MEPC.126(53)
Adopted on 22 July 2005
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 Environment Protection Committee conferred upon it by the international conventions for the prevention and control of marine pollution,
RECALLING ALSO that the International Conference on Ballast Water Management for Ships held in February 2004 adopted the International Convention for the Control and Management of Ships' Ballast Water and Sediments, 2004 (the Ballast Water Management Convention ) together with four Conference resolutions,
NOTING that Regulation A-2 of the Ballast Water Management Convention requires that discharge of ballast water shall only be conducted through Ballast Water Management in accordance with the provisions of the Annex to the Convention,
NOTING FURTHER that Regulation D-3.2 of the Annex to the Ballast Water Management Convention provides that Ballast Water Management systems that make use of Active Substances 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 that resolution 1 adopted by the International Conference on Ballast Water Management for Ships invited the Organization to develop this Procedure as a matter of urgency,
HAVING CONSIDERED, at its fifty-third session, the draft Procedure for Approval of Ballast Water Management systems that make use of Active Substances developed by the Ballast Water Working Group,
1. ADOPTS the Procedure for approval of Ballast Water Management Systems that make use of Active Substances, as set out in the Annex to this resolution;
2. INVITES Governments to apply the Procedure as soon as possible, or when the Convention becomes applicable to them; and
3. AGREES to keep the Procedure under review.
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 Regulation D-3 of the "International Convention for the Control and Management of Ships' Ballast Water and Sediments". The Convention requires that at withdrawal of approval, the use of the relevant Active Substance or Substances shall be prohibited within 1 year after the date of such withdrawal.
1.2 To comply with the Convention, Ballast Water Management systems that make use of Active Substances or Preparations containing one or more Active Substances shall be approved by the Organization, based on a procedure developed by the Organization.
1.3 The objective of this procedure is to determine the acceptability of Active Substances and Preparations containing one or more Active Substances and their application in Ballast Water Management systems concerning ship safety, human 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 not 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 Approval of Ballast Water Management Systems".
1.5 The goal of the procedure is to ensure proper application of the provisions contained in the Convention and the safeguards required by it. As such the procedure is to be updated as the state of knowledge and technology may require. New versions of the procedure will be circulated by the Organization following their approval.
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 ballast water as would 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.
.4 "Relevant Chemicals" means transformation or reaction products that are produced during the treatment process or in the receiving environment and may be of concern to the aquatic environment and human health when discharged.
3.1 Active Substances and Preparations may be added to the ballast 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 accomplish 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 the 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 discharges. Toxicity testing is needed to determine if an Active Substance or Preparation can be used and under which conditions the potential of harming the receiving environment or human health is acceptably low.
3.3 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.
3.4 The approval of Active Substances and Preparations 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.
4.1.1 The proposal for approval of an Active Substance or a Preparation should include a chemical identification and description of the chemical components even if generated onboard. A chemical identification should be provided for any Relevant Chemicals.
4.2 Data-set for Active Substances and Preparations
4.2.1 A proposal for approval should include information on the properties or actions of the Preparation including any of its components as follows:
.1 Data on effects on aquatic plants, invertebrates, fish, and other biota, including sensitive and representative organisms:
・acute aquatic toxicity;
・chronic aquatic toxicity;
・endocrine disruption;
・sediment toxicity:
・bioavailability/biomagnification/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 reproductive 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 the 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 environmentally relevant concentrations.
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 Preparations should be carried out in accordance with internationally recognized guidelines5.
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5 Preferably Organization for Economic Cooperation and Development (OECD) Guidelines for Testing of Chemicals (1993) or other equivalent tests.
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4.2.4 The testig process should contain a rigorous 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 these plans, along with other guidance documents and other general quality control information are available for download from the International Organization for Standardization (ISO) ( www.iso.org).
.2 The QMP addresses the quality control management structure and policies of the Test Organization (including 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 affecting the actual design and implementation of the required experiments.
4.2.5 Dossiers already used for registration of chemicals can be submitted by the applicant to satisfy the required data needed for the evaluation of Active Substances and Preparations according to this procedure.
4.2.6 The proposal should describe the manner of application of the Preparation for Ballast Water Management, including required dosage and retention time.
4.2.7 A proposal for approval should include (Material) Safety Data Sheets ((M)SDS).
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.
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