ISO/TR TECHNICAL REPORT 13121 First edition 2011-05-15 Nanotechnologies Nanomaterial risk evaluation Nanotechnologies - l -Evaluation des risques associées aux nanomateriaux Reference number ISO/TR 13121:2011(E) @ ISO 2011 vided by IHS under lic ise with IS itted without license from IHS Not for Resale ISO/TR 13121:2011(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO2011 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, Iso's member body in the country of the requester. ISO copyright office Case postale 56. CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2011 - All rights reserved py IHS unde itted without license from IHS Not for Resale ISO/TR 13121:2011(E) Contents Page Foreword Introduction .vi 1 Scope 2 Symbols and abbreviated terms ... 3 Summary of the process described in this Technical Report 4 Describe materials and applications 4.1 General 4.2 Materials descriptions. 4.3 Materials sourcing.. 4.4 Manufacturing .. 4.5 Distribution .. 4.6 4.7 End of life/recycle/waste management .... 4.8 Questions to ask regarding the nanomaterial. 4.8.1 Questions to ask regarding the description of nanomaterials. 4.8.2 Questions to ask regarding the description of applications .... 5 Profiles of the nanomaterials' properties, hazards and exposures 5.1 General 5.1.1 Introduction. 5.1.2 The use of data sets..... 5.1.3 Use of default values and assumptions. 5.1.4 Evaluating data quality .... 10 5.2 Develop physical/chemical properties profile 10 5.3 Develop hazard profile .. 11 5.3.1 Introduction.. 5.3.2 Testing issues.. 5.3.3 Use of “bridging information" 12 5.3.4 5.4 Develop exposure profile.... 14 5.4.1 Introduction... 14 5.4.2 15 6 Evaluate risks . .20 6.1 6.2 The risk evaluation process. 21 7 Assess risk management options . .22 8 Decide, document and act.. .24 8.1 General. 24 8.2 Assemble a cross-functional decision-making review team .. 8.3 Review information .... 25 8.4 Consider business, legal, and stakeholder issues .... 26 8.5 Determine who is responsible for implementing recommended actions.... 26 8.6 Based on these inputs, decide whether and how to proceed..... 8.7 Determine additional data needs and initiate data collection, as necessary. ..26 8.8 Establish and implement appropriate risk management, monitoring, compliance, and communicationprocesses. .26 9 Reviewandadapt .28 9.1 General. Copyrght International Organization for Standardizalon ghts reserved ili ed without license from IHS Not for Resale ISO/TR 13121:2011(E) 9.2 As needed reviews.. 9.3 Regularreviews .. ..28 9.4 Adapting risk management and collecting additional information, as appropriate ..29 9.5 Documenting and communicating any new decisions and actions.... Annex A (informative) Data set of physical and chemical properties.... Annex B (informative) Tiered testing approach to health hazard data .. Annex C (informative) Health hazard data set (alternative approach) ... AnnexD(informative)Environmentalhazarddataset Annex E (informative) Environmental fate data set.. Annex F (informative) Output worksheet.. Annex G (informative) Sources and references for data sets .. .57 Bibliography. .58 Copyright International Organization for Standardization @ ISO 2011 - All rights reserved py IHS under nse from IHS Not for Resale ISO/TR 13121:2011(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies (IsO member bodies). The work of preparing International Standards is normally carried out through IsO technicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeer International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/lEC Directives, Part 2. The main task of technical committees is to prepare Inte