《微生物危害分析》（英文版）Microbiological Risk Assessment in Food Processing

hted Material Woodhead Publishing in Food Science and Technology Microbiological y∠ ssessment in ood processing Edited by Martyn Brown and Mike Stringer C WOODHEAD PUBLISHING LIMITED

Microbiological risk assessment in food processing Edited by Martyn Brown and Mike Stringer CRC Press Boca Raton Boston New York Washington, DC WOODHEAD PUBLISHING LIMITED Cambridge England

Microbiological risk assessment in food processing Edited by Martyn Brown and Mike Stringer

Published by Woodhead Publishing Limited Abington Hall, Abington Cambridge CBl 6AH England Published in North America by CRC Press LLC 000 Corporate Blvd, Nw Boca Raton Fl 33431 USA First published 2002, Woodhead Publishing Limited and CRC Press LLC C 2002, Woodhead Publishing Limited The authors have asserted their moral rights This book contains information obtained from authentic and highly regarded sources Reprinted material is quoted with permission, and sources are indicated Reasonable efforts have been made to publish reliable data and information, but the authors and publishers cannot assume responsibility for the validity of all materials. Neither the authors nor the publishers, nor anyone else associated with this publication, shall be liable for any loss, damage or liability directly or indirectly caused or alleged to be caused by this bool Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming and recording, or by any information storage or retrieval system, without permission in writing from the publishers. The consent of woodhead Publishing limited and CRc Press llc does not extend copying for general distribution, for promotion, for creating new works, or for sale. Specific permission must be obtained in writing from Woodhead Publishing Limited or CRC Press LLC for such copying Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to ish Library Cataloguing in Publication Data atalogue record for this book is available from the British Library Library of Congress Cataloging-in-Publication Data oodhead Publishing Limited IsBn 1 85573 585 7(book); 1 85573 6683(e-book) CRC Press IsBN 0-8493-1537-9 CRC Press order number: WP1537 Cover design by Martin Tacchi Project managed by Macfarlane Production Services, Markyate, Hertfordshire (e-mail:macfarl@aol.com) Typeset by MHL Typesetting Limited, Coventry, Warwickshir Printed by TJ International, Padstow, Cornwall, England

Published by Woodhead Publishing Limited Abington Hall, Abington Cambridge CB1 6AH England www.woodhead-publishing.com Published in North America by CRC Press LLC 2000 Corporate Blvd, NW Boca Raton FL 33431 USA First published 2002, Woodhead Publishing Limited and CRC Press LLC ß 2002, Woodhead Publishing Limited The authors have asserted their moral rights. This book contains information obtained from authentic and highly regarded sources. Reprinted material is quoted with permission, and sources are indicated. Reasonable efforts have been made to publish reliable data and information, but the authors and the publishers cannot assume responsibility for the validity of all materials. Neither the authors nor the publishers, nor anyone else associated with this publication, shall be liable for any loss, damage or liability directly or indirectly caused or alleged to be caused by this book. Neither this book nor any part may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming and recording, or by any information storage or retrieval system, without permission in writing from the publishers. The consent of Woodhead Publishing Limited and CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale. Specific permission must be obtained in writing from Woodhead Publishing Limited or CRC Press LLC for such copying. Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe. British Library Cataloguing in Publication Data A catalogue record for this book is available from the British Library. Library of Congress Cataloging-in-Publication Data A catalog record for this book is available from the Library of Congress. Woodhead Publishing Limited ISBN 1 85573 585 7 (book); 1 85573 668 3 (e-book) CRC Press ISBN 0-8493-1537-9 CRC Press order number: WP1537 Cover design by Martin Tacchi Project managed by Macfarlane Production Services, Markyate, Hertfordshire (e-mail: macfarl@aol.com) Typeset by MHL Typesetting Limited, Coventry, Warwickshire Printed by TJ International, Padstow, Cornwall, England

Contents List of contributors Preface 1 Introduction M. Brown, Unilever Research, Sharnbrook and M. Stringer, Campden and Chorleywood Food Research Association, Chipping 11 References 2 The evolution of microbiological risk assessment S Notermans and a. w Barends- TNO Nutrition and Food research Institute, Zeist and F. Rombouts, Wageningen Universiteit ntroduction Historical aspects of safe food production 2.3 The evolution of food safety systems 2.4 International food safety standards 2.5 Present and future uses of microbiological risk assessment 2.6 List of abbreviations 38 2.7 Reference Part I The methodology of microbiological risk assessment 3 Microbiological risk assessment (MRA): an introduction L. Jowve. ecole nationale veterinaire de nantes 3.1 Introduction

List of contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xi Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv 1 Introduction ...................................................... 1 M. Brown, Unilever Research, Sharnbrook and M. Stringer, Campden and Chorleywood Food Research Association, Chipping Campden 1.1 References . . . ................................................ 4 2 The evolution of microbiological risk assessment ............... 5 S. Notermans and A. W. Barendsz, TNO Nutrition and Food Research Institute, Zeist and F. Rombouts, Wageningen Universiteit 2.1 Introduction . . ................................................ 5 2.2 Historical aspects of safe food production . . ................. 6 2.3 The evolution of food safety systems ........................ 7 2.4 International food safety standards . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 2.5 Present and future uses of microbiological risk assessment . . 29 2.6 List of abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 2.7 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Part I The methodology of microbiological risk assessment . . . . . . . 45 3 Microbiological risk assessment (MRA): an introduction . . . . . . 47 J. L. Jouve, Ecole Nationale Ve´te´rinaire de Nantes 3.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Contents

vi Contents 3.2 Key steps in MRA 3.3 Hazard identification .4 Hazard characterisation/dose-response assessment 3.5 Exposure assessment 3470 3.6 Risk characterisation 3.7 References 4 Hazard identification M Brown. Unilever Research. Sharnbrook 4.1 Introduction: the importance of correct hazard identification 4.2 What is hazard identification? 4.3 What hazard identification should cover and produce as an output 4.4 What to do in hazard identification 4.5 Key information in hazard identification 4.6 Tools in hazard identification 4.7 Microbial hazards 4.8 Identifying the origin and distribution of microbial hazards hanges in microbial hazards 4.10 Other biological hazards 4.11 References 6676023557 5 Hazard characterization/dose-response assessment S. B. Dennis.M d. Milotis andr.. Buchanan US FDA, College Park 5.1 Introduction: key issues in hazard characterization 5.2 Types of dose-response data 5.3 Modeling dose-response relationships 7369 5.4 Problems in hazard characterization 5.5 Future trends 94 5.6 Sources of further information and advice 5.7 References 6 Exposure assessment M. Brown. Unilever Research. Sharnbrook 6.1 6.2 The role of exposure assessments in microbiological risk assessment 10l 6.3 What's in an exposure assessment? 6.4 Who should do an exposure assessment and when? 6.5 Building up supply chain data for an exposure assessment 6.6 Sources of information 6.7 Types of data used in an exposure assessment

3.2 Key steps in MRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 3.3 Hazard identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 3.4 Hazard characterisation/dose–response assessment . . . . . . . . . . . 54 3.5 Exposure assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 3.6 Risk characterisation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 3.7 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 4 Hazard identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 M. Brown, Unilever Research, Sharnbrook 4.1 Introduction: the importance of correct hazard identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 4.2 What is hazard identification? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 4.3 What hazard identification should cover and produce as an output . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 4.4 What to do in hazard identification . . . . . . . . . . . . . . . . . . . . . . . . . . 66 4.5 Key information in hazard identification . . . . . . . . . . . . . . . . . . . . . 67 4.6 Tools in hazard identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 4.7 Microbial hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70 4.8 Identifying the origin and distribution of microbial hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 4.9 Changes in microbial hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 4.10 Other biological hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 4.11 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 5 Hazard characterization/dose–response assessment . . . . . . . . . . . . . 77 S. B. Dennis, M. D. Milotis and R. L. Buchanan, US FDA, College Park 5.1 Introduction: key issues in hazard characterization . . . . . . . . . . . 77 5.2 Types of dose–response data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 5.3 Modeling dose–response relationships . . . . . . . . . . . . . . . . . . . . . . . 86 5.4 Problems in hazard characterization . . . . . . . . . . . . . . . . . . . . . . . . . . 90 5.5 Future trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 5.6 Sources of further information and advice . . . . . . . . . . . . . . . . . . . 96 5.7 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 6 Exposure assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 M. Brown, Unilever Research, Sharnbrook 6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 6.2 The role of exposure assessments in microbiological risk assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 6.3 What’s in an exposure assessment? . . . . . . . . . . . . . . . . . . . . . . . . . . 105 6.4 Who should do an exposure assessment and when? . . . . . . . . . . 109 6.5 Building up supply chain data for an exposure assessment . . 109 6.6 Sources of information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 6.7 Types of data used in an exposure assessment . . . . . . . . . . . . . . . 114 vi Contents