Food Safety of Proteins in Agricultural Biotechnology (Food Science and Technology)

297 Pages·2007·7.4 MB·English

by  Bruce G. Hammond

Food Safety of Proteins
in Agricultural Biotechnology
Copyright 2008 by Taylor and Francis Group, LLC
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FOOD SCIENCE
AND TECHNOLOGY
Editorial Advisory Board
Gustavo V. Barbosa-Cánovas Washington State University–Pullman
P. Michael Davidson University of Tennessee–Knoxville
Mark Dreher McNeil Nutritionals, New Brunswick, NJ
Richard W. Hartel University of Wisconsin–Madison
Lekh R. Juneja Taiyo Kagaku Company, Japan
Marcus Karel Massachusetts Institute of Technology
Ronald G. Labbe University of Massachusetts–Amherst
Daryl B. Lund University of Wisconsin–Madison
David B. Min The Ohio State University
Leo M. L. Nollet Hogeschool Gent, Belgium
Seppo Salminen University of Turku, Finland
John H. Thorngate III Allied Domecq Technical Services, Napa, CA
Pieter Walstra Wageningen University, The Netherlands
John R. Whitaker University of California–Davis
Rickey Y. Yada University of Guelph, Canada
Copyright 2008 by Taylor and Francis Group, LLC
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Food Safety of Proteins
in Agricultural Biotechnology
Edited by Bruce G. Hammond
Boca Raton London New York
CRC Press is an imprint of the
Taylor & Francis Group, an informa business
Copyright 2008 by Taylor and Francis Group, LLC
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CRC Press
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© 2008 by Taylor & Francis Group, LLC
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Library of Congress Cataloging-in-Publication Data
Food safety of proteins in agricultural biotechnology / editor, Bruce G.
Hammond. -- 1st ed.
p. cm. -- (Food science and technology ; 172)
Includes bibliographical references and index.
ISBN 978-0-8493-3967-7 (alk. paper)
1. Agricultural biotechnology--Risk assessment. 2. Bacterial proteins. 3.
Food--Safety measures. I. Hammond, Bruce G. (Bruce George), 1947- II. Series:
Food science and technology (Taylor & Francis) ; 172.
S494.5.B563S24 2008
363.19’2--dc22 2007021159
Visit the Taylor & Francis Web site at
http://www.taylorandfrancis.com
and the CRC Press Web site at
http://www.crcpress.com
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Copyright 2008 by Taylor and Francis Group, LLC
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Dedication
This book is dedicated to my family who are most dear to
me. I am grateful to my wife who was always understanding
of the extra hours it took to complete the book. I am
thankful for my parents who had the vision and sacrificed
to enable their children to get an education. Lastly, I
speak to my posterity — those who are here and others yet
to come. Remember, all things are possible to those who
believe and work to make their dreams come true. This
grandpa wondered at times whether he would ever complete
this book but he never gave up, and now it’s done.
Copyright 2008 by Taylor and Francis Group, LLC
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Contents
Chapter 1 Protein Structure and Function in Plants and Animals .......................1
Peter J. Garlick
Chapter 2 The Mode of Action of Bacterial Protein Toxins:
The Role of Conformational Changes in the Life Cycle
of a Protein Toxin ...............................................................................31
Jeffrey W. Seale and Leigh English
Chapter 3 Safety Assessment of Bacillus thuringiensis and Bt Crops
Used in Insect Control ........................................................................45
Brian A. Federici and Joel P. Siegel
Chapter 4 Ecological Safety Assessment of Insecticidal Proteins
Introduced into Biotech Crops .........................................................103
Jeffrey D. Wolt, Jarrad R. Prasifka, and Richard L. Hellmich
Chapter 5 The Safety of Microbial Enzymes Used in Food Processing ..........127
Michael W. Pariza
Chapter 6 Safety Assessment of Biotechnology-Derived
Therapeutic Drugs ............................................................................133
Barbara J. Mounho, Jeanine L. Bussiere,
and Andrea B. Weir
Chapter 7 The Food Safety Assessment of Bovine Somatotropin (bST) .........167
Bruce Hammond
Chapter 8 Assessment of Food Proteins for Allergenic Potential ....................209
Scott McClain, Stefan Vieths, and Gary A. Bannon
Chapter 9 Methods for Estimating the Intake of Proteins in Food ...................223
Barbara J. Petersen
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Chapter 10 Safety Assessment of Proteins Used in Crops Developed
through Agricultural Biotechnology: Industry Perspective .............237
Elena A. Rice, Thomas C. Lee, Glen Rogan,
and Gary A. Bannon
Chapter 11 The Safety Assessment of Proteins Introduced into Crops
Developed through Agricultural Biotechnology: A Consolidated
Approach to Meet Current and Future Needs ..................................259
Bruce Hammond and Andrew Cockburn
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Preface
The editor has been involved with the safety assessment of proteins used in food pro-
duction for more than 20 years. During that time, I have answered many questions
regarding the safety of proteins developed by Monsanto. Some of the questions were
asked by those who were familiar with the safety assessment of small-molecular-
weight chemicals (pesticides and food additives). They would sometimes ask why
we had not carried out classical toxicology studies with proteins as is done for pesti-
cides. At the time, I wished there had been a general text available that I could refer
questioners to that discussed how toxicology testing of proteins should be accom-
plished. Although many of the safety questions have since been resolved, there is
still a need today for a comprehensive reference text that addresses how to carry
out protein safety assessments. Therefore, several internationally recognized experts
on protein safety assessment accepted the invitation to contribute to the creation of
this book, which should serve as a needed reference text. The book may also be of
general interest to those who want to learn more about the safety assessment of bio-
technology-derived products.
The first chapter provides a background on protein biology and addresses
some of the fundamental differences between proteins and small-molecular-weight
chemicals that impact their safety assessment. The second chapter discusses the life
cycle of protein toxins and explains why some protein toxins exert toxic effects when
ingested whereas others do not. The third and fourth chapters provide a comprehen-
sive background on the safety assessment and environmental impact of insect-pro-
tected Bt crops and answers many of the safety questions that have been raised. These
crops are now widely grown in the United States and increasingly in other countries.
Chapter 5 reviews the safety assessment process developed for enzymes, which is
one of the earliest applications of proteins used in food processing and production.
Chapters 6 and 7 address the safety assessment of protein pharmaceuticals. Chapter
6 discusses the unique challenges of testing protein therapeutics in humans. Chapter
7 reviews the safety assessment of bST used in dairy cows to increase milk produc-
tion and summarizes some of the controversies that arose and how safety questions
were answered. Chapter 8 discusses how to confirm that an introduced protein does
not fit the profile of known protein food allergens. Chapter 9 provides direction on
how to carry out dietary exposure assessments for proteins introduced into food
crops, and sources of food consumption databases that are available internationally.
Chapter 10 provides four case studies on the safety assessment of proteins of differ-
ent structure and function to be introduced into biotechnology-derived agricultural
crops. The final chapter distills the conclusions about protein safety assessment from
the preceding 10 chapters that have been used to develop a comprehensive safety
assessment strategy that is applicable to existing and next-generation biotechnology-
derived crops.
Copyright 2008 by Taylor and Francis Group, LLC
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Acknowledgments
The editor gratefully acknowledges the contributions of the many authors who have
contributed so much of their time to make this book possible. Appreciation is also
expressed to my colleagues at Monsanto who have provided helpful comments on
the book and have contributed over the years to the development of a comprehensive
protein safety assessment strategy that is discussed in this book.
Copyright 2008 by Taylor and Francis Group, LLC
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Editor
Dr. Bruce Hammond was born in Canada and received a B.S. in chemistry at
Brigham Young University and a Ph.D. in pharmacology at the University of Illinois
Medical Center, Chicago. He completed postdoctoral training with Robert Metcalfe at
the Institute of Environmental Studies, University of Illinois, Urbana-Champaign.
He is the father of seven children and, at last count, has seven grandchildren.
Dr. Hammond joined Monsanto in 1978 and has worked in various divisions during
those years, including industrial chemicals, pharmaceuticals, nutritional chemicals,
and agricultural chemicals. He first became involved with biotechnology in the
1980s, as he managed the food safety assessment program for sometribove (rbST).
As the plant biotechnology program progressed, he had the opportunity to help
design and manage the human food safety studies on improved crop varieties devel-
oped through biotechnology. He has published a number of papers on biotech food
safety assessments and presented results at several conferences and symposia. Dr.
Hammond was also appointed to the Monsanto Science Fellow Program and cur-
rently serves as manager of food toxicology in the Monsanto Product Safety Center.
He is also serving a one-year term as president of the Food Safety Specialty Section
of the Society of Toxicology. His current research interests also include evaluating
the reduction of mycotoxin contamination of grain from insect-protected (Bt) corn
varieties grown around the world.
Copyright 2008 by Taylor and Francis Group, LLC
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