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MEPC52 日本提案文書 原文
資料1: Progress on the development of a procedure for the approval of Active Substances (G9) (MEPC52/2/6)
 
 
MARINE ENVIRONMENT PROTECTION
COMMITTEE
52nd session
Agenda item 2
MEPC 52/2/6
9 July 2004
Original: ENGLISH
 
HARMFUL AQUATIC ORGANISMS IN BALLAST WATER
Progress on the Development of a Procedure for Approval of Active Substances (G9)
Submitted by Germany, Japan and the Netherlands
 
SUMMARY
Executive summary:
This document serves as a basis for the preparation of Procedure for Approval of Active Substances which are to be approved at MEPC 52. States are invited to submit comments and information which may help complete this text.
Action to be taken: Paragraph 6
Related documents: BWM/CONF/INF.5, BWM/CONF/37
 
Introduction
 
1 The Diplomatic Conference in February of this year adopted the International Convention for the Control and Management of Ships' Ballast Water and Sediments, 2004. Regulation D-3.2 of the Convention requires active substances to be approved by the Organization taking into account procedure developed by the Organization. This procedure has been given priority in its development by the Ballast Water Working Group at MEPC 51.
 
2 A programme for development of the guidelines for uniform implementation of the Ballast Water Management Convention has been adopted at MEPC 51. Germany, Japan and the Netherlands had offered to serve as informal group co-ordinators to develop a Procedure for Approval of Active Substances (G9).
 
3 Germany, Japan and the Netherlands undertook to prepare a draft Procedure for Approval of Active Substances (G9).
 
4 The document still needs a lot of work to be undertaken. Germany, Japan and the Netherlands will work on these matters in the intersessional period, but hope to be able to build on contributions from other States. Square brackets mark proposals that could not be finalized in harmony by all involved in the short time frame given.
 
5 The members of the Ballast Water Working Group are invited to consider the draft text and to provide comments and information as appropriate. Any contributions are welcome.
 
Action requested of the Committee
 
6 The Committee is invited to consider the draft Procedure for Approval of Active Substances set out at annex and decide as it deems appropriate.
 
 
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.
 
***
 
 
ANNEX
DRAFT
PROCEDURE FOR APPROVAL OF ACTIVE SUBSTANCES
1 INTRODUCTION
 
1.1 This procedure describes the approval and withdrawal of approval of Active Substances and their procedure of application as set out in Regulation D-3 of the "INTERNATIONAL CONVENTION FOR THE CONTROL AND MANAGEMENT OF SHIPS' BALLAST WATER AND SEDIMENTS, 2004".
 
1.2 To comply with the Convention, Ballast Water Management systems which make use of Active Substances or preparations containing one or more Active Substances to comply with this Convention shall be approved by the Organization, based on a procedure developed by the Organization.
 
1.3 This procedure describes the approval and withdrawal of approval of Active Substances and their proposed manner of application. The Convention requires that at withdrawal of approval, the use of the relevant Active Substance or Substances shall be prohibited within one year after the date of such withdrawal.
 
1.4 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 concerning ship safety, human health and aquatic environment. This procedure is provided as a safeguard for sustainable use of Active Substances.
 
1.5 This procedure is not intended to determine the efficacy of the active substances. The efficacy of Ballast Water Management systems, which make use of Active Substances shall be evaluated in accordance with GUIDELINES FOR APPROVAL OF BALLAST WATER MANAGEMENT SYSTEMS after the active substances or preparations containing one or more active substances have been approved by the Organization.
 
1.6 The goal of the procedure is to ensure proper application of the standards 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.
 
2 DEFINITIONS
2.1 "Administration" means the competent authority of a Party to the Convention that processes an approval for an Active Substances product under its authority and the approval procedure given under chapter [...] of this guideline.
 
2.2 "Ballast Water" means water with its suspended matter taken on board a ship to control trim, list, draught, stability or stresses of the ship.
 
2.3 "Convention" means the International Convention for the Control and Management of Ships' Ballast Water and Sediments.
 
2.4 "Harmful Aquatic Organisms and Pathogens" means aquatic organisms or pathogens which, if introduced into the sea including estuaries, or into fresh water courses, may create hazards to the environment, human health, property or resources, impair biological diversity or interfere with other legitimate uses of such areas.
 
2.5 "Organization" means the International Maritime Organization.
 
2.6 "Active Substance" under this guideline means a chemical substance that has a general or specific action on or against Harmful Aquatic Organisms and Pathogens. The organisms, including viruses or fungi, to which the Convention refers are not used in these guidelines. For the time being their use in Ballast Water Management is not foreseen and as such no approval shall be given.
 
2.7 "Preparation" means any product containing one or more Active Substances.
 
3 PRINCIPLES
 
3.1 Active Substances and preparations may be produced by chemical companies to be added to the ballast water or be generated on board ships by installed technology within the Ballast Water Management System.
 
(Further discussion with regard to the definition of "generated on board ships by installed technology within the ballast water system" is required at MEPC 52. For example, ultraviolet lighting may generate ozone, and thermal process may cause chemical reactions in seawater or biomass.)
 
3.2 Active Substances accomplish their intended purpose through toxicity against unwanted organisms in the ballast water. 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 effluent from treated ballast water require toxicity testing in order to protect the receiving environment from toxic effects due to discharges. [In evaluating possible effects, both discharges from a single ship and simultaneously from several ships in a port basin or an estuary should be considered following a few distinct generic risk assessment scenarios.] 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 is acceptably low.
 
3.3 Ballast Water Management systems which make use of Active Substances must be safe in terms of ship safety, its equipment and the crew to comply with the Convention.
 
4 GENERAL REQUIREMENTS
 
Identification
 
4.1 The proposal for approval shall include a chemical identification and description of the Active Substance or preparation to be approved. This should take into account any additives to the Active Substance or preparation. A chemical identification should be provided for any possible intermediary products, side products and end products that may arise due to the use of the Active Substance or preparation in the ballast water and subsequent discharge.
 
Data-set for active substances
 
(In analogy to annex 3 to the AFS Convention rasp. IBC Code chapter 1, paragraph 1.2).
 
4.2 A proposal for approval should include information on each of the following hazardous properties of the Active Substance or preparation, [any identified harmful intermediate products, side products or end products]:
 
.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 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 waters);
- [reaction with organic matter;]
- potential physical effects on wildlife and benthic habitats;
- potential residues in seafood; and
- any known interactive effects.
 
.3 Data on human toxicity;
- acute toxicity
- effects on skin and eye;
- chronic and long-term toxicity;
- developmental and reproductive toxicity;
- carcinogenicity; and
- mutagenicity.
 
.4 Physical and chemical properties of the Active Substances product 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 of normal ship construction (principally steel);
- autoignition temperature; and
- other known relevant physical or chemical hazards.
 
4.3 A proposal for approval should include the above data-set either for the preparation and each component or for each component separately, and a list of the name and relative quantities (in volumetric percentages) of the components should be also attached. GESAMP Hazard Profiles for the components, if available, may be submitted to provide data required under 4.2. As described in Chapter 8.1.3, all proprietary data will be treated as confidential.







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