Genetically modified crops: assessing safety

267 Pages·2002·1.68 MB·English

by  Keith T. Atherton

Genetically Modified Crops:
Assessing Safety

Genetically Modified Crops:
Assessing Safety
Edited by
Keith T. Atherton
London and New York
First published 2002 by Taylor & Francis
11 New Fetter Lane, London EC4P 4EE
Simultaneously published in the USA and Canada
by Taylor & Francis Inc,
29 West 35th Street, New York, NY 10001
Taylor & Francis is an imprint of the Taylor & Francis Group
This edition published in the Taylor & Francis e-Library, 2003.
© 2002 Keith T. Atherton
All rights reserved. No part of this book may be reprinted
or reproduced or utilised in any form or by any electronic,
mechanical, or other means, now known or hereafter invented,
including photocopying and recording, or in any information
storage or retrieval system, without permission in writing
from the publishers.
Every effort has been made to ensure that the advice and information
in this book is true and accurate at the time of going to press.
However, neither the publisher nor the authors can accept any legal
responsibility or liability for any errors or omissions that may be
made. In the case of drug administration, any medical procedure or
the use of technical equipment mentioned within this book, you are
strongly advised to consult the manufacturer’s guidelines.
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
Atherton, Keith T., 1949–
Genetically modified crops : assessing safety / Keith T. Atherton.
p. cm.
Includes bibliographical references (p. ).
ISBN 0-7484-0913-0 (hb : alk. paper)
1. Transgenic plants. 2. Crops—Genetic engineering. I. Title.
SB123.57 .A84 2002
631.5 ′233—dc21 2002071958
ISBN 0-203-21235-5 Master e-book ISBN
ISBN 0-203-26974-8 (Adobe eReader Format)
ISBN 0-748-40913-0(Print Edition)
Contents
Contributors vii
Preface ix
1 The regulatory and science-based safety evaluation of genetically
modified food crops – a USA perspective 1
EARLE NESTMANN, TODD COPELAND AND JASON HLYWKA
2 The regulatory requirements for novel foods – a European perspective 45
NICK TOMLINSON
3 The concept of substantial equivalence: an overview 63
PAUL R. MAYERS, PETER KEARNS, KAREN E. MCINTYRE AND
JENNIFER A. EASTWOOD
4 Strategies for analysing unintended effects in transgenic food crops 74
H.P.J.M. NOTEBORN, A.A.C.M. PEIJNENBURG AND R. ZELENY
5 Allergenicity of foods produced by genetic modification 94
DEAN D. METCALFE
6 Biosafety of marker genes – the possibility of DNA transfer from
genetically modified organisms to the human gut microflora 110
KIERAN TUOHY, IAN R. ROWLAND AND PAUL C. RUMSBY
7 Case study: canola tolerant to Roundup® herbicide: an assessment
of its substantial equivalence compared to non-modified canola 138
THOMAS E. NICKSON AND BRUCE G. HAMMOND
8 Case study: Bt crops – a novel mode of insect control 164
BRIAN A. FEDERICI
9 Case study: recombinant baculoviruses as microbial pesticidal agents 201
IVAN E. GARD, MICHAEL F. TREACY AND JOHN J. WRUBEL
vi Contents
10 Case study: virus-resistant crops 219
HECTOR QUEMADA
Index 241
Contributors
Keith Atherton Paul Mayers
Central Toxicology Laboratory, Alderley Office of Food Biotechnology, Health
Park, Macclesfield, Cheshire SK10 4TJ, UK Canada, Postal Locator 2204A1, Tunney’s
Pasture, Ottawa, Ontario, K1A 0L2 Canada
Todd Copeland
Regulatory Sciences Manager, Cantox Karen E. McIntyre
Health Sciences International, 2233 Argentia Bureau of Food Policy Integration, Food
Road, Suite 308, Mississauga, ON L5N 2X7 Directorate, Health Protection Branch,
Canada Health Canada, Ottawa, Ontario K1A 0L2
Canada
Jennifer A. Eastwood
Bureau of Food Policy Integration, Food Dean Metcalfe
Directorate, Health Protection Branch, Chief, Laboratory of Allergic Diseases,
Health Canada, Ottawa, Ontario K1A 0L2, National Institute of Allergy and
Canada Infectious Diseases, National Institute
of Health, Building 10, Room 11C205,
Professor Brian Federici
10 CENTER DR MSC 1881, Bethesda,
Department of Entomology &
MD 20892-1881, USA
Graduate Programs in Genetics &
Microbiology, University of California, Earle Nestmann, Cantox Health Sciences
Riverside, Riverside, CA, USA International
Suite 308, 2233 Argentia Road,
Ivan Gard
Mississauga, Ontario,
Entomological Associates of Northampton,
L5N 2X7 Canada
7 Ponderosa Drive, Holland, PA 19866,
USA Thomas E. Nickson
Bruce Hammond Monsanto Company, 700 Chesterfield
Monsanto Company, 700 Chesterfield Parkway North, St Louis, MO 63198,
Parkway North, St Louis, Missouri 63198, USA
USA
Hubert P.J.M. Noteborn
Jason Hlywka RIKILT-DLO, Department of Food
Cantox Health Sciences International, 2233 Safety & Health, Bornsesteeg 45, PO
Argentia Road, Suite 308, Mississauga, ON Box 230, NL-6700 AE Wageningen,
L5N 2X7 Canada The Netherlands
Peter Kearns A.A.C.M. Peijnenburg
Environmental Health and Safety Division, RIKILT-DLO, Department of Food
Environmental Directorate, Organisation for Safety & Health, Bornsesteeg 45, PO
Economic Cooperation and Development, 2 Box 230, NL-6700 AE Wageningen,
rue André Pascal, 75775 Paris, France The Netherlands
viii Contributors
Hector Quemada Michael F. Treacy
Crop Technology Consulting Inc., 2624 Agricultural Products Research Division,
East G. Avenue, Kalamazoo, NI 49004, American Cyanamid Company, Princeton,
USA NJ 08543, USA
Ian R. Rowland Kieran M. Tuohy
Northern Ireland Centre for Food and Food Microbial Science Unit, School of
Health, School of Biomedical Sciences, Food Biosciences, University of Reading,
University of Ulster, Coleraine BT52 1SA, Whiteknights PO Box 226, Reading RG6
UK 6AP, UK
Paul C. Rumsby John J. Wrubel
MRC Institute for Environment and Health, Agricultural Products Research Division,
University of Leicester, 94 Regent Road, American Cyanamid Company, Princeton,
Leicester, LE1 7DD, UK NJ 08543, USA
Nick Tomlinson R. Zeleny
Food Standards Agency, 73 Grove Road, Institute for Agrobiotechnology, Center for
Harpenden, Herts, AL5 1EN, UK Analytical Chemistry, A-3430 Tulin, Austria
Preface
Man has cultivated plants for thousands of years, during which time crop plants have
been continually selected for improved yield, growth, disease resistance or other
useful characteristics. Plant breeding is an exceptionally successful enterprise that has
fashioned the raw material of unimproved germplasm into the modern high-yielding
crop and pasture varieties on which we now depend. Until recently plant breeders
had to depend on empirical methods to reach their goals. However, the discovery of
plant transformation is changing the way that breeders approach the challenge of
creating new varieties to fulfil specific needs. Directed genetic changes provide an
important new tool and allow the use of genetic information from almost any life
form to be introduced into crop plants and produce desirable new characteristics.
Improvements in agronomic traits such as yield and disease resistance continue
to be driving forces behind today’s seed industry, but increasingly, attention is also
focussed on speciality traits, including high oilseed grains, low saturated fat oilseeds
and delayed ripening fruits and vegetables. Such traits command premium values in
the market place. Whilst plant breeders have used conventional breeding methods
coupled with techniques such as tissue culture and mutagenesis to produce new
commercial lines, genetic engineering now provides a real alternative. The first gen-
eration of genetically modified (GM) crop varieties, which have been altered for
agronomic traits are generally those encoded by a single gene, such as virus-,insect-,
or herbicide resistance. A comprehensive list of these can be found on the Biotechnology
Industry Organisation website (www.Bio.org).
A long history of producing new varieties of crop plants by conventional breeding
has rarely resulted in forms that have had to be withdrawn from the market because
of health concerns. Plant breeders have introduced thousands of new crop varieties
that have had little, if any, effect on food safety. The concern over GM crops stems
mainly from the fact that plant breeders now have access to a much wider range
of genetic information from any living organism or synthetic DNA sequences. The
developers of new plant varieties using genetic engineering have the responsibility
of establishing that the newly introduced varieties, and the food products derived
from them are as safe and nutritious as their traditional counterparts.
This book attempts to lead the reader through the main issues associated with the
safety evaluation of GM crops. Chapters 1 and 2 deal with the regulatory require-
ments for the registration of GM crops both in the USA and in the European Com-
munity. Since there are significant limitations in the use of conventional animal
toxicology studies for the safety assessment of whole foods, a new approach has had