1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 13073-2:2013Ships and marine technology Risk assessment on anti-fouling systems on shipsPart 2: Marine environmental riskassessment method for anti-fouling systemson ships
2、 using biocidally active substancesBS ISO 13073-2:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 13073-2:2013.The UK participation in its preparation was entrusted to TechnicalCommittee SME/32/-/2, Ships and marine technology - Maritimeenvironment protect
3、ion.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI Stan
4、dardsLimited 2013ISBN 978 0 580 73989 7ICS 13.020.99; 47.020.99Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2013.Amendments issued since publicationDate
5、 Text affectedBS ISO 13073-2:2013 ISO 2013Ships and marine technology Risk assessment on anti-fouling systems on ships Part 2: Marine environmental risk assessment method for anti-fouling systems on ships using biocidally active substancesNavires et technologie maritime valuation des risques pour le
6、s systmes antisalissure sur les navires Partie 2: Mthode dvaluation des risques environnementaux maritimes pour les systmes antisalissure sur les navires utilisant des substances actives biocidesINTERNATIONAL STANDARDISO13073-2First edition2013-06-01Reference numberISO 13073-2:2013(E)BS ISO 13073-2:
7、2013ISO 13073-2:2013(E)ii ISO 2013 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2013All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
8、 the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.org
9、Web www.iso.orgPublished in SwitzerlandBS ISO 13073-2:2013ISO 13073-2:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Application . 24.1 General . 24.2 Application considerations. 24.3 Structure and procedu
10、re of environmental risk assessment 35 Review of the risk of a biocidally active substance when used in the anti-fouling system . 35.1 General . 35.2 Assessment when a biocidally active substance is tentatively deemed to have “relatively low risk” 45.3 Assessment when a certain type of marine enviro
11、nment is considered to be a recipient of biocidally active substances 46 Exposure assessment . 46.1 Preparing the emission scenario . 46.2 Determination of the PEC 67 Selection of the appropriate PNEC . 78 Risk characterization . 79 Risk assessment of similar anti-fouling systems 710 Substances of c
12、oncern . 711 Risk assessment report . 7Annex A (normative) Minimum information required for a risk assessment report . 8Bibliography .10BS ISO 13073-2:2013ISO 13073-2:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO m
13、ember bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governm
14、ental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenanc
15、e are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention is dra
16、wn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on
17、the ISO list of patent declarations received. www.iso.org/patentsAny trade name used in this document is information given for the convenience of users and does not constitute an endorsement.The committee responsible for this document is ISO/TC 8, Ships and marine technology, SC 2, Marine environmen
18、t protection.ISO 13073 consists of the following parts, under the general title Marine environment protection Risk assessment on anti-fouling systems on ships: Part 1: Marine environmental risk assessment method of biocidally active substances used for anti-fouling systems on ships Part 2: Marine en
19、vironmental risk assessment method for anti-fouling systems on ships using biocidally active substances Part 3: Human health risk assessment for the application and removal of anti-fouling systems (under development)iv ISO 2013 All rights reservedBS ISO 13073-2:2013ISO 13073-2:2013(E)IntroductionThe
20、 attachment of fouling organisms such as barnacles and algae on the submerged parts of a ships hull increases the propulsive resistance of the hull against water, leading to increased fuel consumption and accidental introduction of non-indigenous species to a foreign marine environment, which may ca
21、use significant and harmful changes. As a means of preventing such circumstances, an anti-fouling system that relies on biocidally active substances (e.g. anti-fouling paint) to prevent attachment of fouling organisms can be applied onto the hull of the ship. The harmful effects of organotin compoun
22、ds used as biocides (historically used in anti-fouling paint) on marine organisms and human health have been of global concern. To prevent the continued use of these compounds, a legally-binding international framework regulating the use of anti-fouling systems containing harmful substances was enac
23、ted by the International Maritime Organization (IMO). Consequently, the International Convention on the Control of Harmful Anti-fouling Systems on Ships (the AFS Convention) was adopted at the IMO diplomatic conference held in London in October 2001, and entered into force in September 2008.The Conv
24、ention envisages handling various harmful anti-fouling systems within its framework and lays out a process by which anti-fouling systems can be risk assessed. Annexes 2 and 3 of the Convention include the list of information needed to determine whether an anti-fouling system is harmful to the enviro
25、nment and should be restricted from use on ships, but a marine environmental risk assessment method for making this decision is not provided. Furthermore, Resolution 3, adopted by IMO along with the AFS Convention recommends that contracting Parties continue to work in appropriate international fora
26、 for harmonization of test methods and assessment methodologies, and performance standards for anti-fouling systems containing biocidally active substance(s).Based on this, there is a global need for an international method for conducting scientific environmental risk assessments for anti-fouling sy
27、stems substituting organotin-based anti-fouling systems. This part of 13073 allows a pragmatic approach to introducing systems (i.e., self-regulation or approval systems) in countries where either no system exists, or a less developed system is in place and would allow such countries to improve prot
28、ection of the aquatic environment. ISO 2013 All rights reserved vBS ISO 13073-2:2013BS ISO 13073-2:2013Ships and marine technology Risk assessment on anti-fouling systems on ships Part 2: Marine environmental risk assessment method for anti-fouling systems on ships using biocidally active substances
29、1 ScopeThis part of ISO 13073 specifies a risk assessment method that protects the marine environment from the potential negative impacts of anti-fouling systems intentionally using biocidally active substances applied to a ship during its service life. This method can also be modified for use in fr
30、eshwater environments.This part of ISO 13073 does not provide specific test methods for evaluating the hazards nor recommends usage restrictions for certain anti-fouling systems. It also does not provide an efficacy-evaluation method of the anti-fouling system using a specific substance.The followin
31、g uses of anti-fouling systems are also not covered by this part of ISO 13073: use at the application and removal stages, during new building, vessel maintenance and repair or ship recycling; use of systems intended to control harmful aquatic organisms and pathogens in ships ballast water and sedime
32、nts according to the International Convention for The Control and Management of Ships Ballast Water and Sediments, 2004; use of anti-fouling systems applied to fishing gear, buoys and floats used for the purpose of fishing, and to equipment used in fisheries and aquaculture (nets/cages, etc.); and t
33、est patches of anti-fouling systems on ships and small panels for the purposes of research and development of anti-fouling systems.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated refe
34、rences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 13073-1:2012, Ships and marine technology Risk assessment on anti-fouling systems on ships Part 1: Marine environmental risk assessment method of bioci
35、dally active substances used for anti-fouling systems on ships3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 13073-1 and the following apply.INTERNATIONAL STANDARD ISO 13073-2:2013(E) ISO 2013 All rights reserved 1BS ISO 13073-2:2013ISO 13073-2:2013(
36、E)3.1substance of concernan intentionally added non-biocidal substance which is classified as acute or long-term hazard category 1 or 2 for “hazardous to aquatic environment” under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) (United Nations, 2009) and is release
37、d to the marine environment based on emission scenario(s)4 Application4.1 GeneralRisk assessment, as defined in this part of ISO 13073 and ISO 13073-1, is conducted for the protection of the marine environment. In order to confirm the risk of a biocidally active substance in an anti-fouling system,
38、a risk assessment according to this part of ISO 13073 shall be conducted. In this part, the risk assessment is conducted for anti-fouling systems using biocidally active substances which have undergone the risk assessment given in ISO 13073-1. This assessment will identify the risk categorization of
39、 the anti-fouling system to allow decisions to be made on the use of this anti-fouling system in a certain environment.This part of ISO 13073 provides a minimum guideline for the following uses: regulation of anti-fouling systems by government organizations; self-regulation or approval systems carri
40、ed out for industry by industrial organizations or other third parties; and evaluations conducted for product development by the industry.This part of ISO 13073 will enable the quantitative characterization of the environmental risk posed by an anti-fouling system on the marine environment and deter
41、mine whether the environmental risk of the system is acceptable.This part of ISO 13073 could be modified for assessing risk to freshwater environments such as rivers and lakes. Special attention should be given to defining the emission scenarios required for freshwater areas, and particular care sho
42、uld be taken to consider the effects on the species found in those environments.4.2 Application considerationsThis part of ISO 13073 provides a method for quantifying the marine (and freshwater, where necessary) environmental risk posed by an anti-fouling system, but does not directly regulate or ap
43、prove the use or commercialization of the anti-fouling system. As a result of risk characterization of an anti-fouling system designated in Clause 8, a categorization into “possible high risk to the marine environment” does not necessarily mean a prohibition of its use. It may be accepted for use un
44、der certain conditions which demonstrates a reduction in the environmental exposure such as by use of additional mitigation measures, by refinement of the exposure assessment or by continuous monitoring of the relevant environment.The risk assessment of the biocidally active substances that are in a
45、n anti-fouling system shall be conducted in accordance with ISO 13073-1 prior to making the assessment using this part of ISO 13073. Substances categorized as “low risk” or “relatively low risk” to the marine environment through the ISO 13073-1 risk assessment should generally be used in this risk a
46、ssessment. In exceptional cases, special care shall be taken with the description designated in 5.1 when substances categorized as “risk of high concern” to the marine environment through the ISO 13073-1 risk assessment are used.All data submitted by an applicant are, and shall remain, the property
47、of the applicant under this part of ISO 13073. These data shall not be made available to other applicants without prior written approval from the owner of the data.2 ISO 2013 All rights reservedBS ISO 13073-2:2013ISO 13073-2:2013(E)4.3 Structure and procedure of environmental risk assessmentThe envi
48、ronmental risk assessment procedure consists of four components: review of the risk of biocidally active substance under ISO 13073-1, exposure assessment, representation of result of the hazard assessment, and risk characterization. The ratio of the predicted environment concentration (PEC) to the p
49、redicted no-effect concentration (PNEC) (PEC/PNEC) is used as a quantitative index for the risk assessment. The procedure is summarized in Figure 1.Figure 1 Composition and schematic procedure of environmental risk assessment for anti-fouling systems on ships using biocidally active substances5 Review of the risk of a biocidally active substance when used in the anti-fouling system5.1 GeneralIt shall be confirmed in accordance with the procedures in ISO 13073-1 that biocidally active substances intentionally added to an anti-fou
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