1、BS ISO 13073-3:2016Ships and marine technology Risk assessment on anti-fouling systems on shipsPart 3: Human health risk assessment method of biocidally active substances used in anti-fouling paints on ships during the application and removal processesBSI Standards PublicationWB11885_BSI_StandardCov
2、s_2013_AW.indd 1 15/05/2013 15:06BS ISO 13073-3:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 13073-3:2016.The UK participation in its preparation was entrusted to Technical Committee SME/32, Ships and marine technology - Steering committee.A list of org
3、anizations 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 2016. Published by BSI Standards Limited
4、2016ISBN 978 0 580 87306 5 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 June 2016.Amendments issued since publicationDate T e x t
5、a f f e c t e dBS ISO 13073-3:2016 ISO 2016Ships and marine technology Risk assessment on anti-fouling systems on ships Part 3: Human health risk assessment method of biocidally active substances used in anti-fouling paints on ships during the application and removal processesNavires et technologie
6、maritime valuation des risques pour les systmes antisalissure sur les navires Partie 3: Mthode dvaluation du risque pour la sant humaine des substances bioacidement actives dans les peintures antisalissure sur les navires durant les processus dapplication et dliminationINTERNATIONAL STANDARDISO13073
7、-3First edition2016-06-01Reference numberISO 13073-3:2016(E)BS ISO 13073-3:2016ISO 13073-3:2016(E)ii ISO 2016 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2016, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized o
8、therwise in any form or by any means, electronic or mechanical, including photocopying, or posting on 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 offi
9、ceCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 13073-3:2016ISO 13073-3:2016(E)Foreword ivIntroduction v1 Scope . 12 Terms and definitions . 13 General principles . 53.1 Application . 53.2 Application consider
10、ation . 53.3 Structure and procedure of human health risk assessment 54 Exposure assessment . 64.1 Selection of a representative product . 64.2 Defining the exposure scenario 64.2.1 General 64.2.2 Types of exposure to consider . 64.2.3 Determination of a representative exposure . 74.3 Determination
11、of dose 75 Hazard assessment. 85.1 Data and information 85.1.1 Collection and acquisition of data and information 85.1.2 Information acquisition through testing . 85.1.3 Reliability assessment of the collected data 95.1.4 Consideration of animal welfare 95.2 Defining the NOAEL 96 Risk characterizati
12、on . 96.1 General . 96.2 Tiered system 106.3 Consideration of uncertainty factor . 106.4 Characterization of risk 107 Assessment results 107.1 Decision at each tier 107.1.1 Tier 1 decision: Preliminary acceptability107.1.2 Tier 2 decision: Continuing acceptability 107.1.3 Tier 3 decision: Full accep
13、tability 117.2 Expert judgement 117.3 Additional information obtained after last risk assessment 118 Risk assessment report 11Annex A (normative) Risk characterization process for human health risk assessment of biocidally active substances used in anti-fouling paints on ships .12Annex B (informativ
14、e) Examples of operator exposure models .22Annex C (informative) Predicting operator exposure values 24Annex D (informative) Examples of setting of uncertainty factor (UF) .27Annex E (informative) Examples of testing methods 31Annex F (informative) Examples of guidance for determining data quality 3
15、3Annex G (normative) Minimum required information for a risk assessment report 34Bibliography .36 ISO 2016 All rights reserved iiiContents PageBS ISO 13073-3:2016ISO 13073-3:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
16、 (ISO member 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,
17、governmental 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 mai
18、ntenance 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 (see www.iso.org/directives).Att
19、ention is drawn 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 Introducti
20、on and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conform
21、ity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 8, Ships and marine technology, Subcommitte
22、e SC 2, Marine environment protection.ISO 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
23、ships Part 2: Marine environmental risk assessment method for anti-fouling systems on ships using biocidally active substances Part 3: Human health risk assessment method of biocidally active substances used in anti-fouling paints on ships during the application and removal processesiv ISO 2016 All
24、rights reservedBS ISO 13073-3:2016ISO 13073-3:2016(E)IntroductionThe 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. In addition, this may also r
25、esult in accidental introduction of non-indigenous species to a foreign marine environment, which may possibly cause significant and harmful impact on the local environment. In order to prevent such circumstances, an anti-fouling system that employs biocidally active substances (e.g. anti-fouling pa
26、int) to prevent attachment of fouling organisms can be applied onto the hull of the ship. The harmful effects of organotin compounds used in the maritime industry as biocides against marine organisms have been of global concern on human health. To prevent the continued use of these compounds, the In
27、ternational Convention on the Control of Harmful Anti-fouling Systems on Ships (the AFS Convention) was adopted at the International Maritime Organization (IMO) diplomatic conference held in London in October 2001 and entered into force in September 2008.The Convention envisages handling various har
28、mful 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 environment and should be restricted from u
29、se on ships; however, a marine environmental risk assessment method for making this decision is not provided. There is a global need for an international assessment method for scientific environmental risk assessment for biocidally active ingredients being substituted for organotin biocides in anti-
30、fouling systems.ISO 13073-1 and ISO 13073-2 specify the risk assessment methods for biocidally active substances and anti-fouling systems containing the biocidally active substances, respectively. In addition to these risk assessments to protect the delicate marine ecosystems, there is also a need f
31、or protecting human health. Anti-fouling paints, which are the most commonly used anti-fouling systems to ships, potentially result in risk to the workers applying or removing them.This part of ISO 13073 describes a method which allows a pragmatic approach to introducing human health risk assessment
32、 particularly for the workers engaged in anti-fouling paint application and removal operations. This method provides comprehensive guidelines for a risk assessment that helps protect workers in countries without a self-regulation or approval system on anti-fouling paints or those with a less well-de
33、veloped system. ISO 2016 All rights reserved vBS ISO 13073-3:2016BS ISO 13073-3:2016Ships and marine technology Risk assessment on anti-fouling systems on ships Part 3: Human health risk assessment method of biocidally active substances used in anti-fouling paints on ships during the application and
34、 removal processes1 ScopeThis part of ISO 13073 specifies a method of human health risk assessment that enables the evaluation of anti-fouling paint application and removal in order to determine if the product can be used safely where users are at risk of being exposed to biocidally active substance
35、s contained within anti-fouling paints. This can be used for a risk assessment to determine the impact(s), if any, on professional or non-professional operators.This part of ISO 13073 does not specify a specific test method for evaluation of hazard and toxicity or recommend usage restrictions of cer
36、tain substances.NOTE 1 This part of ISO 13073 is a “minimum” method, i.e. additional regulations or assessments based on national needs can be warranted.NOTE 2 While the approach prescribed is a tiered system, studies required in higher tiers can be undertaken in lieu of equivalent lower tier studie
37、s.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.NOTE Some of the definitions for environmental risk assessment provided in ISO 13073-1 and ISO 13073-2 may be different from those of this part of ISO 13073.2.1adverse effectchange in morphology, ph
38、ysiology, growth, development or lifespan of an organism which results in impairment of its functional capacity or impairment of its capacity to compensate for additional stress or increased susceptibility to the harmful effects of other environmental influencesNote 1 to entry: This definition is gi
39、ven in reference WHO/IPCS, 1994 63.2.2anti-fouling painttype of anti-fouling system supplied as a form of paint typically consisting of a matrix polymer, pigment(s) and solvent(s)2.3anti-fouling systemcoating, paint, surface treatment, surface, or device that is used on a ship to control or prevent
40、attachment of unwanted organismsNote 1 to entry: Systems of control utilizing only physical means are not included within this International Standard.INTERNATIONAL STANDARD ISO 13073-3:2016(E) ISO 2016 All rights reserved 1BS ISO 13073-3:2016ISO 13073-3:2016(E)2.4biocidally active substancesubstance
41、 having general or specific action such as mortality, growth inhibition, or repellence, on unwanted fouling organisms, used in anti-fouling systems, for the prevention of attachment of sessile organisms2.5by-standerperson who is not a direct user of the product or application/removal equipment but w
42、ho nevertheless may be exposed to the product during its use2.6chemical substancechemical element or its compound in the natural state or obtained by any manufacturing process2.7core datainformationstudybasic data, information or study which should, in principle, be provided for all biocidally activ
43、e substances2.8expertperson with great knowledge or skill in hazard assessment of chemicals certified by academic society, organization or authorityNote 1 to entry: Those experts include Diplomat of American Board of Toxicology (USA), Fellow of the American Toxicological Society (USA), Diplomat of J
44、apanese Society of Toxicology (Japan), European Registered Toxicologist (EU), Diploma, Korean Board of Toxicology (Korea), Expert in Toxicology, DGPT: sponsored by the German Society of Experimental and Clinical Pharmacology and Toxicology (Germany), UK Register of Toxicologists: sponsored by the So
45、ciety of Biology and the British Toxicology Society (UK) and Diplomat of the Chinese Society of Toxicology (China).2.9exposure assessmentestimation of the range of possible doses (of a biocidally active substance, its degradants and/or metabolites) to individuals (operators) exposed to the biocidall
46、y active substance, taking into account the magnitude, frequency, duration, route, and extent (number of people) of exposure2.10exposure scenarioset of conditions estimating or clarifying the exposure pathways of a chemical substance to the operatorNote 1 to entry: The exposure scenario should descr
47、ibe the conditions of use, including, but not limited to, routes of exposure, application method, protective equipment used, job duration, etc.2.11hazard assessmentprocess to identify and characterize the adverse effects of a biocidally active substance to which individuals could be exposedNote 1 to
48、 entry: Effects should be assessed adverse only if they affect the viability and normal function of the organism under test.2.12lowest observed adverse effect levelLOAELlowest tested dose or exposure level at which there are statistically significant increases in frequency or severity of adverse eff
49、ects between the exposed population and an appropriate control group2 ISO 2016 All rights reservedBS ISO 13073-3:2016ISO 13073-3:2016(E)2.13lowest observed effect levelLOELlowest concentration or amount of a substance, found by experiment or observation, that causes any alteration in morphology, functional capacity, growth, development, or life span of target organisms distinguishable from normal (control) organisms of the same species and strain under the same defined conditions of exposureNote 1 to entry: This definition is given in r
