ISO INTERNATIONAL STANDARD 13073-3 First edition 2016-06-01 Ships 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 processes Navires et technologiemaritime-Evaluation des risques pour les systemes antisalissure surles navires Partie 3: Methode d'évaluation du risque pour la sante humaine des substances bioacidement actives dans les peintures antisalissure sur lesnaviresdurantlesprocessusd'applicationetd'elimination Reference number IS0 13073-3:2016(E) ISO @ ISO 2016 IS013073-3:2016(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2016, Published in Switzerland All 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 the internet or an intranet,without prior written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org ISO 2016-All rights reserved IS013073-3:2016(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Terms and definitions 3 General principles ..5 3.1 Application. .5 3.2 Application consideration 3.3 Structure and procedure of human health risk assessment. .5 Exposure assessment. 4 .6 4.1 Selection of a representative product .6 4.2 Defining the exposure scenario 6 4.2.1 General. .6 .6 4.2.2 Types ofexposureto consider 4.2.3 Determinationofarepresentativeexposure. .7 4.3 Determination ofdose .7 5 Hazard assessment. .8 5.1 Data and information .8 5.1.1 Collection and acquisition of data and information .8 5.1.2 Information acquisition through testing .8 5.1.3 Reliabilityassessmentofthecollecteddata .9 5.1.4 Consideration of animal welfare 9 5.2 Defining theNOAEL .9 6 Risk characterization. .9 6.1 General. .9 6.2 ..10 Tiered system. 6.3 Consideration ofuncertaintyfactor .10 6.4 Characterization of risk .10 7 Assessment results. .10 7.1 Decision at each tier .10 7.1.1 Tier 1 decision: Preliminary acceptability .10 7.1.2 Tier 2 decision: Continuing acceptability ..10 7.1.3 Tier 3decision: Full acceptability .11 7.2 Expert judgement. .11 7.3 Additional information obtained afterlast risk assessment .11 8 Riskassessmentreport .11 AnnexA (normative)Risk characterization processforhumanhealthrisk assessment of ..12 biocidallyactivesubstancesusedinanti-foulingpaintsonships AnnexB (informative)Examples ofoperatorexposuremodels .22 AnnexC (informative)Predictingoperatorexposurevalues .24 AnnexD (informative)Examplesofsettingofuncertaintyfactor (UF) ..27 AnnexE (informative)Examplesoftestingmethods. .31 Annex F (informative) Examples ofguidance for determining data quality .33 AnnexG (normative) Minimum required information fora riskassessment report ..34 Bibliography ..36 ili