BS ISO 13073-1-2012 Ships and marine technology Risk assessment on anti-fouling systems on ships Marine environmental risk assessment method of biocidally active substances used fo.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 13073-1:2012Ships and marine technology Risk assessment on anti-fouling systems on shipsPart 1: Marine environmental risk assessment method of biocidally active substances

2、 used for anti-fouling systems on shipsBS ISO 13073-1:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 13073-1:2012. The UK participation in its preparation was entrusted to TechnicalCommittee SME/32/-/2, Ships and marine technology Maritime environment pro

3、tection.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by B

4、SI Standards Limited 2012ISBN 978 0 580 69828 6 ICS 13.020.99; 47.020.99 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2012.Amendments issued since

5、 publicationDate Text affectedBS ISO 13073-1:2012 ISO 2012Ships and marine technology 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 shipsNavires et technologie maritime valuation d

6、es risques pour les systmes antisalissure sur les navires Partie 1: Mthode dvaluation des risques environnementaux maritimes des substances actives biocides utilises pour les systmes antisalissure sur les naviresINTERNATIONAL STANDARDISO 13073-1First edition 2012-08-01Reference number ISO 13073-1:20

7、12(E)BS ISO 13073-1:2012ISO 13073-1:2012(E)ii ISO 2012 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2012All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and

8、microfilm, without permission in writing 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.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 13073

9、-1:2012ISO 13073-1:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope 12 Terms and definitions . 13 Application 43.1 General . 43.2 Application considerations . 44 Structure and procedure of environmental risk assessment 55 Exposure assessment 55.1 Selection of rep

10、resentative product . 55.2 Quantification of release rate . 65.3 Preparing the emission scenario 65.4 Determination of PEC . 86 Hazard assessment . 86.1 Setting of PNEC . 86.2 Consideration of assessment factors 106.3 Determination of PNEC used for risk characterization .107 Risk characterization 11

11、7.1 General . 117.2 Data and information 117.3 Assessment results 127.4 Additional information obtained after last risk characterization 138 Risk assessment report .13Annex A (informative) Systems for estimation of release rates of biocidally active substances from anti-fouling paints 14Annex B (nor

12、mative) Details of risk characterization process of an environmental risk assessment for organic biocidally active substances used in anti-fouling systems on ships 17Annex C (normative) Issues to be considered for risk characterization for inorganic biocidally active substances used in anti-fouling

13、systems on ships .24Annex D (informative) Examples of guidance for determining data quality .28Annex E (informative) Examples of testing methods29Annex F (informative) Setting of assessment factors (AF) .34Annex G (normative) Minimum information required for the risk assessment report 40Annex H (inf

14、ormative) Previously validated models for predicting environmental concentrations 44Bibliography .46BS ISO 13073-1:2012ISO 13073-1:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing

15、 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, governmental and non-governmental, in liais

16、on with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of tech

17、nical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn

18、 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.ISO 13073-1 was prepared by Technical Committee ISO/TC 8, Ships and marine technology, Subcommittee SC 2, Marine environ

19、ment protectionISO 13073 consists of the following parts, under the general title Ships and marine technology 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

20、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 2012 All rights reservedBS ISO 13073-1:2012ISO 13073-1:2012(E)IntroductionThe

21、 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

22、possibly cause 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 organo

23、tin compounds 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 substanc

24、es was enacted 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 20

25、08.The Convention 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

26、 the environment 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 intern

27、ational fora 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 of bioc

28、idally active substances for use in anti-fouling systems. This part of ISO 13073 provides 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 help such countries improve p

29、rotection of the aquatic environment.This part of ISO 13073 is intended to be used for the positive evaluation of biocidally active substances for use in anti-fouling systems. For an evaluation of a biocidally active substances entry onto Annex 1 of the AFS Convention, which is a negative listing, t

30、he methodology can be used but the evaluation should include an extensive assessment supported by the full data requirements established in the AFS Convention. ISO 2012 All rights reserved vBS ISO 13073-1:2012BS ISO 13073-1:2012Ships and marine technology Risk assessment on anti-fouling systems on s

31、hips Part 1: Marine environmental risk assessment method of biocidally active substances used for anti-fouling systems on ships1 ScopeThis part of ISO 13073 specifies a risk assessment method that protects the marine environment from the potential negative impacts of biocidally active substances tha

32、t are intentionally used in the anti-fouling system applied to a ship during its service life. This method can also be modified for use in freshwater environments.This part of ISO 13073 does not provide a specific test method for evaluating the hazard and toxicity or usage restrictions of certain su

33、bstances. This also does not provide an efficacy-evaluation method for an anti-fouling system using a specific substance.The following are not covered by this part of ISO 13073: the risk assessment of biocidally active substances in anti-fouling systems during their application and removal during ve

34、ssel maintenance and repair, new building or ship recycling; use of anti-fouling systems intended to control harmful aquatic organisms and pathogens in ships ballast water and sediments according to the International Convention for The Control and Management of Ships Ballast Water and Sediments, 200

35、4; 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); test patches of anti-fouling systems on ships for the purpose of research and development of anti-fouling products; the assessment o

36、f risk of biocidally active substances in cases of accidental releases, such as spillage during ocean transport or releases into the sea from rivers and/or coastal facilities.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1acute testexposure tes

37、t on an aquatic species conducted for a short period (mostly for several dozen hours, although it varies among species), in order to obtain an LC50or EC50for fish fatality, abnormal behaviour of invertebrates, or inhibition of algal growth as the end point2.2anti-fouling system(s)coating, paint, sur

38、face treatment, surface, or device that is used on a ship to control or prevent attachment of unwanted organismsINTERNATIONAL STANDARD ISO 13073-1:2012(E) ISO 2012 All rights reserved 1BS ISO 13073-1:2012ISO 13073-1:2012(E)2.3assessment factor(s)numerical factor that accounts for the uncertainty of

39、extrapolating an effect concentration based upon experimentally derived hazard end points (for example, dose-dependent measures such as NOEC) to Predicted No-Effect Concentrations for use in environmental risk assessmentNOTE The hazard end point derived using a particular data point is divided by th

40、e assessment factor to define the PNEC for that particular biocidally active substance. It is equivalent to the “uncertainty factor” used in risk assessment for human health effects.2.4biocidally active substance(s)substance having general or specific action such as mortality, growth inhibition, or

41、repellence, on unwanted fouling organisms, used in anti-fouling systems, for the prevention of attachment of sessile organisms2.5chemical substance(s)chemical element and its compounds in the natural state or obtained by any manufacturing process2.6chronic testexposure test on an aquatic species con

42、ducted through most of its lifecycle, during its sensitive period (for fish, from fertilized eggs to the early life stage such as larvae and juveniles that take food), or for several generations, in order to obtain a NOEC for mortality, growth or reproduction as the end pointNOTE OECD Guidelines for

43、 Testing of Chemicals, Test Nos. 212 and 215 are not chronic tests.2.7correction factornumerical factor that accounts for the difference between the estimated release rate using a given method and the expected release rate from an anti-fouling system in-service; the estimated release rate using a pa

44、rticular method is divided by the correction factor to allow a more accurate and representative estimate to be made of the release rate to the marine environment2.8emission scenarioset of parameters that define the sources, pathways and use patterns with the aim of quantifying the releases of a chem

45、ical or biocidally active substance into the environmentNOTE Emission scenarios are used in the risk assessment to establish the conditions on use and releases of the chemicals that are the bases for estimating the predicted concentrations of chemicals in the environment.2.9exposure assessmentproced

46、ure for evaluating the exposure of an organism, system or (sub)population to a biocidally active substance (and its degradants and/or metabolites), accounting for the exposure path, exposure amount, and concentration2.10harmful organismany organism that has an unwanted presence or a detrimental effe

47、ct on human activities, products they use or produce, animals or the environment2.11hazard assessmentprocess designed to determine the possible adverse effects of a biocidally active substance to which an organism, system or (sub)population could be exposed2 ISO 2012 All rights reservedBS ISO 13073-

48、1:2012ISO 13073-1:2012(E)2.12lowest-observed effect concentrationLOEClowest tested concentration of a test substance at which the substance is observed to have a significant effect when compared with the controlNOTE All test concentrations above the LOEC must have an effect equal to or greater than

49、those observed at the LOEC.2.13marine environmentphysical, chemical and biological features surrounding marine organisms, affecting the viability and bio-function of the organismsNOTE Seawater and estuarine regions are included.2.14no-observed-effect concentrationNOEChighest tested concentration of a test substance at which no statistically significant lethal or other effect is observed when compared with the control2.15predicted environment concentrationPECestimated concentration of a substance in a defined environment as quantif