Biosafety & risk assessment in agricultural biotechnology

A WORKBOOK FOR TECHNICAL TRAINING

Biosafety and
Risk Assessment
in Agricultural
Biotechnology

Patricia L. Traynor
Robert Frederick
Muffy Koch
The Agricultural Biotechnology Support Project
Institute of International Agriculture
Michigan State University, USA


Copyright © 2002 by the Board of Trustees, Michigan State
University, East Lansing, MI
All rights reserved.
Printed in the United States of America.
ISBN 1-56525-016-8
This publication was made possible through support provided by the U.S. Agency for International Development,
Bureau for Economic Growth, Agriculture and Trade, Office
of Environment and Science Policy, under the terms of
Cooperative Agreement No. DAN-A-00-91-00126-00 and
support of the U.S. Agency for International Development,
Cairo, Egypt, under the terms of Grant No. 263-G-00-9600014-00. The opinions expressed herein are those of the
author(s) and do not necessarily reflect the views of the
U.S. Agency for International Development, Michigan State
University, Virginia Polytechnic Institute and State University, or the U.S. Environmental Protection Agency.
PHOTO CREDITS: pages vi, 18, 30, and 106: Scott Bauer, cour-

tesy of the Agricultural Research Service, U.S. Department
of Agriculture; page 46: Francisco Santos Gonzales; page 66:
Kelly Zarka; page 124: Jack Dykinga.
ADDITIONAL COPIES OF THIS WORKBOOK ARE AVAILABLE FROM:

MSU Bulletin Office, 10-B Agriculture Hall, Michigan State
University, East Lansing, MI 48824-1039, USA; tel (517)
355-0240; fax (517) 353-7168.
MANAGING EDITOR: Andrea Johanson, Assistant Director, Agri-

cultural Biology Support Project, Michigan State University
EDITOR: Kathleen McKevitt, IDIOM

LAYOUT AND DESIGN: Sharp Des!gns, Inc., Lansing, MI

PRINTING AND BINDING: BRD Printing, Inc., Lansing, MI


CONTENTS

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
About the Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii

PART ONE: Biosafety in Principle and in Practice
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Rationale and Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Context for Biosafety Review and Decision Making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Factors Affecting Decision Making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Terms of Reference for Biosafety Committees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Resource Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Methodology for Biotechnology Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Organizing the Scientific Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Practical Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Scientific Issues for Environmental Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Human Health and Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Risk Management in the Laboratory and Greenhouse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Risk Management in the Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Other Standard Risk-Management Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Risk-Management Realities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Contents

iii


Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Biosafety Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Scales of Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Practical Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Communicating about Risk and Biosafety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Objectives of Risk Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Principles of Risk Communication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
Risk Communication in Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

PART TWO: Case Study Exercises
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
1: Application for Greenhouse Trials with Ralstonia Genetically Modified for Biocontrol
of Bacterial Wilt in Potatoes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
2: Application for Greenhouse Trials with Sunflower Genetically Modified for Fungal Tolerance . . . . . . . . . . 79
3: Application for Field Trials with Genetically Modified Bananas Containing
a Vaccine Against Hepatitis B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
4: Application for Field Trials with Cotton Genetically Modified for Increased Resistance
to Insect Attack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
5: Application for Commercial Release of Genetically Modified Herbicide-Tolerant Soya . . . . . . . . . . . . . 107
6: Application for Commodity Imports of Genetically Modified Maize . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Supplemental Crop Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Sunflower as a Crop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
Cotton as a Crop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Soybean as a Crop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118
Maize as a Crop . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120

PART THREE: Appendixes
Appendix 1: Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Appendix 2: Annotated List of Internet Sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
Appendix 3: Sources and Suggested Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

iv

Contents


ACKNOWLEDGMENTS

his workbook is a product of the Agricultural

T

the workbook through numerous drafts, external

Biotechnology Support Project (ABSP), an

review, and final production. Her dedication and

international program funded by the U.S.

perseverance kept the project moving forward and

Agency for International Development and based in

on track despite our many distractions. All the

the Institute for International Agriculture at

while, her patience and good humor made it a

Michigan State University. The workbook is a natural

pleasure to work with her.

outgrowth of the many biosafety training activities

We were extremely fortunate to have as

ABSP has conducted over the past ten years in part-

reviewers a group of leading experts in the fields of

ner countries in Africa, Asia, and Latin America,

biosafety and capacity building. We wish to express

and in regional programs reaching wider audiences.

our sincere appreciation and thanks to Julian

We are grateful to Dr. Catherine Ives, former direc-

Kinderlerer, Martha Kandawa-Schulz, Javier Veras-

tor of ABSP, whose enthusiasm and support

tegui, David Heron, Piet van der Meer, and Andrew

launched the workbook project, and to Dr. Johan

Matabiri. Their insightful comments and sugges-

Brink, current ABSP director, whose continuing sup-

tions were extremely useful and led to numerous

port has made it possible to see the workbook

improvements in the text.

through to completion.
We would like to give special recognition and

Any errors or omissions in the text are the sole
responsibility of the authors.

our heartfelt thanks to Dr. Andrea Johanson, assistant director of ABSP. She managed the project

PAT TRAYNOR, BOB FREDERICK, MUFFY KOCH

throughout its development, successfully guiding

July 2002

Acknowledgments

v



ABOUT THE AUTHORS

Patricia (Pat) Traynor, Ph.D., is a research fac-

Service for National Agricultural Research (ISNAR)

ulty member in the Fralin Biotechnology Center at

Biotechnology Service. She was a member of the

Virginia Tech (University). Since 1994, she has been

core faculty for four biotechnology research man-

a biosafety consultant to the Agricultural

agement courses, conducted during 1997–2000 for

Biotechnology Support Project (ABSP), a ten-year

eight Southeast Asian countries. She has published

program of the U.S. Agency for International

research and analysis studies of biosafety systems

Development. She organized and conducted a two-

in Argentina and Egypt; Kenya and Uganda studies

week biosafety internship program at Michigan

will be conducted in 2002.

State University and has taught in national and
regional training programs throughout Africa and in

Robert (Bob) Frederick, Ph.D., is currently a

Southeast Asia and Latin America. During 1996–97,

senior scientist in the Environmental Protection

she served as an advisor to panels drafting national

Agency’s Office of Research and Development at

biosafety regulations in Egypt and Indonesia.

the National Center for Environmental Assessment

From 1995 to 2001, Dr. Traynor served as the

(NCEA). With the agency since 1984, his responsibil-

director of Information Systems for Biotechnology, a

ities have included coordination of the

project funded by the U.S. Department of Agriculture

Biotechnology Risk Assessment Research Program

(USDA) providing information resources in biotech-

and the risk assessment of genetically modified

nology and biosafety. She organized and conducted

products. He has served as an Environmental

four regional training workshops for U.S. scientists

Protection Agency representative to a number of

and regulators and a multidisciplinary scientific

entities including the National Institutes of Health

workshop in risk assessment. Dr. Traynor was editor

Recombinant DNA Advisory Committee; a Federal

of the ISB News Report and co-author of “A Practical

Coordinating Biotechnology Research

Guide to Containment: Greenhouse Research with

Subcommittee; the United States–European Com-

Transgenic Plants and Microbes” (2001).

munity Task Force on Biotechnology Research; and

Since 1997, Dr. Traynor has also been working
as a biosafety specialist for the International

About the Authors

the Office of Science and Technology Policy’s
Biotechnology Research Crosscut working group.

vii


In 1993–96, Dr. Frederick was executive secre-

ganisms and the genetic engineering of plants for

tary of the Biotechnology Advisory Commission

crop improvement. She worked with the team first

(BAC) at the Stockholm Environment Institute,

to genetically modify plants in South Africa and set

Stockholm, Sweden. While with BAC, he organized

up the first cereal transformation group in the

and taught in six international workshops on

country.

biosafety and biodiversity in Nigeria, Argentina,

Ms. Koch’s current work is centered on issues

Zimbabwe, Kenya, and Sweden. He has lectured and

concerning the safety of genetically modified

instructed on biosafety issues in many countries

organisms. During the 1990s she worked with gov-

including Argentina, Chile, China, Cameroon,

ernment task teams on the development of South

Colombia, Denmark, Germany, Hungary, India,

Africa’s GMO Act and the attendant regulations,

Kenya, Malawi, Mexico, Namibia, South Africa,

and South African position papers for the Inter-

Sweden, Syria, Zambia, and Zimbabwe. His publica-

national Biosafety Protocol negotiations and for

tions include more than fifteen on biotechnology

the Codex Alimentarius Commission relating to food

regulatory development and implementation.

labeling. She is the chairperson of the AfricaBio
working group on Biotechnology Education and

Muffy Koch is head of Innovation Biotech-

Training and editor of the monthly electronic

nology, a biotechnology and biosafety consulting

newsletter BioLines. Ms. Koch has organized nine

firm she started in 1994 in Johannesburg, South

regional biosafety training workshops in Africa and

Africa. Before that, she earned a degree in botany

been an invited speaker at numerous international

and microbiology from the University of the

biosafety training workshops. Her publications

Witwatersrand and an MSc. in microbial ecology

include papers, book chapters, biosafety work-

from the University of Stellenbosch. Her earlier

books, and biotechnology directories; to date, she

research career took her to the CSIR, a leading

has been commissioned to prepare four situation

technology and research organization in Africa,

analyses of biotechnology in South Africa and three

where she investigated the genetics of soil microor-

analyses of biosafety in developing countries.

viii

About the Authors


P A R T

O N E

Biosafety in
Principle and
in Practice

“It is a maxim universally agreed upon in
agriculture, that nothing must be done too
late; and again, that everything must be

done at its proper season; while there is a
third precept which reminds us that opportunities lost can never be regained.”
• Pliny the Elder (A.D. c. 23–A.D. 79), Natural History •



1
Rationale and Objectives

Introduction

tion, if not destruction, label GMOs and the products made from them as the seeds of inequity and

Biotechnology is a complex topic that embod-

ruin. Our view is that biotechnology is a powerful

ies difficult technical, social, and economic issues

and valuable tool that provides both new strategies

played out against a backdrop of human hunger,

to address long-standing problems and new consid-

economic marginalization, and environmental

erations regarding its safe and appropriate use.

degradation. Adoption of crops and agricultural

This workbook is written with the basic assumption

products improved through modern biotechnology

that when and where biotechnology is embraced,

has proceeded slowly in developing countries, where

knowledge and education will allow it to be used

the context for their use tends to be an uncertain

safely.

mixture of welcome and resistance. From the start,

Considerable international, regional, and

the development and deployment of genetically

national effort has been expended to pave the way

modified organisms (GMOs) and genetically

for this new technology’s benefits to reach farmers

modified (GM) products has been cast as a proposi-

and consumers. Assistance programs use a variety

tion with high stakes. Proponents promise solutions

of approaches to support developing countries to

to intractable problems in agricultural production

draft national biosafety regulations and build

and human dietary needs, and opponents warn of

capacity to establish and operate national

unsafe food and environmental disaster.

biosafety systems. Seminars and consultations are

Where inadequate and irregular supplies of

held to highlight the need for appropriate govern-

food limit standards of living, those who see

ment policies. Educational conferences and work-

genetic engineering technology as holding great

shops raise government leaders’ awareness of the

promise for improving lives anxiously await the

potential benefits as well as environmental and

arrival of GM seeds for local farmers. At the same

food safety concerns associated with biotechnol-

time, those who see modern biotechnology as an

ogy. Technical training for conducting biosafety

icon for corporate exploitation of the defenseless

reviews builds capacity in this critical area of

and the possible cause of environmental degrada-

biosafety implementation. All of these efforts are

Introduction

3


directed towards a common goal: to support devel-

will strengthen the quality of biosafety committee

oping countries in taking responsible decisions

recommendations and decisions. Specific objectives

regarding the introduction of GMOs into the envi-

of this workbook are to:

ronment and the marketplace.
The lack of biosafety capacity in developing

1. Provide a structured framework for a technical

countries is a major constraint to the transfer of

training program aimed at biosafety reviewers

this technology, as public and private sector

2. Build the competence and confidence necessary

research organizations await a clear regulatory

for reviewers to conduct science-based reviews

environment through which to bring their products

leading to appropriate decisions

to the grower and consumer.
Successful regulatory implementation requires

3. Provide instructional materials to support ongoing training conducted by local organizations

the capacity to conduct safety assessments to
ascertain whether a proposed use of a particular

The focus of this workbook is on genetically

GMO presents an unacceptable risk to the environ-

engineered agricultural crop plants. However, most

ment or human health. Such biosafety reviews are

of the material is relevant to GM ornamental and

conducted to provide a scientific basis for decisions

tree species, with some applicability to GM micro-

regarding:

organisms.

• Requests from companies seeking to import and
sell GM seed or planting material

Audience

• Applications to field test transgenic materials
developed locally or by donor-funded programs

and/or multinational companies
• Approval for importation of GMOs as commodities
or for research and testing purposes
• Requests for authorization to produce or grow
GMOs on a large scale or for commercial purposes

This workbook is designed to complement
technical biosafety-assessment training courses in
developing countries. We provide a background for
the practical application of biosafety review procedures using a case study approach.
Our intended audience for such training
includes members of national biosafety commit-

In some countries the development of GMOs in

tees, biotechnology regulatory officials, and scien-

contained facilities (laboratories) and the move-

tists working in the public and private sectors.

ment of GMOs between facilities are also regulated.

Independent of a training course, the workbook

The task necessitates training for members of

itself may be a useful resource for national deci-

national and institutional biosafety review commit-

sion-making bodies, government regulators in

tees, who typically have little or no experience with

related areas, and those charged with monitoring

biosafety issues or evaluations. In this workbook we

approved field-test releases. In addition, the work-

address the technical aspects of biosafety review.

book can serve as a resource for university and

We provide extensive background information as

postgraduate students who have an interest in the

well as guided, hands-on practice in applying risk-

responsible use of biotechnology for developing

assessment and risk-management procedures using

improved agricultural crops, trees, ornamental

a case study approach. In practice, such training

plants, and products derived from them.

4

Biosafety in Principle and in Practice


Organization

submitted to national biosafety review committees;
we have modified them to be suitable as classroom

This workbook is organized in three parts. Part

exercises. This edition contains two applications for

One: Biosafety in Principle and Practice comprises

greenhouse research, two for field testing, one for

background and instructional material organized in

commercial release (placing on the market), and

six sections. Following the purpose and rationale for

one for GM commodity import. During a training

creating the book, the intended audience, and the

course, students will gain practical experience by

organization of the book, section two presents the

evaluating applications under the guidance of

context for biosafety assessments, the resources

experienced instructors.
Part Three contains supplemental information

necessary for conducting them, and the process that
supports regulatory decision making. Section three

relevant to the text and case studies. Appendix I is

covers risk assessment and the environmental and

a Glossary of Terms. Appendix 2 is an Annotated List

health issues associated with products of agricul-

of Internet Sites providing additional information.

tural biotechnology. Section four presents risk-

Appendix 3 is a list of Sources and Suggested

management principles and applications. Monitoring

Reading.

is discussed in section five and risk communication,

We are preparing a separate instructor’s man-

the art and skill of sharing information among inter-

ual to facilitate subsequent training sessions con-

ested parties, is covered in section six.

ducted by local instructors. The instructor’s version

Part Two is the “working” part of the workbook

will include supplemental information, materials on

— a collection of case study exercises that entail

additional topics that may be of interest, notes,

use of risk-assessment, risk-management, and

supplements and guidance questions for case stud-

risk-communication procedures by training course

ies, pages to be made into transparencies, and the

participants. The cases are based on applications

like.

Introduction

5



2

Context for Biosafety Review
and Decision Making

iosafety review — the scientific evaluation

B

based, in part, on a determination that they do not

of a GMO’s potential effects on the environ-

pose an unacceptable risk to the environment or to

ment and human and animal health — is

human health.

often seen as the single factor that determines

With the pending entry into force of the

whether or not a GMO or product is approved for

Cartagena Protocol on Biosafety to the Convention

testing or use. However, safety assessments are

on Biological Diversity (the Cartagena Protocol)1 —

conducted within a larger context for decision mak-

a legally binding international protocol for the safe

ing that includes national policies for agriculture,

transfer, handling, and use of living modified

biotechnology, and biosafety (or lack thereof),

organisms — such biosafety assessments soon will

international agreements, stakeholder interests,

become part of international trade agreements.

and public attitudes (see Figure 1).

Other factors not related to environmental or
health safety are typically considered in national

decisions regarding the use of GM crops, organisms,

Factors Affecting Decision Making

and the products derived from them. Among these
are social and economic considerations, require-

Countries individually decide whether to

ments under national law and international agree-

develop, deploy, or use genetically modified organ-

ments, stakeholder input, ethical issues, and

isms and the products made from them. Such deci-

impacts on trade. These nonsafety factors, signi-

sions take into account national policies for

ficant in terms of public acceptance, are rightfully

agricultural research and development and the

considered in decision making by competent

potential role of biotechnology in meeting national

authorities. However, this workbook is focused

goals and objectives in food production, food secu-

more on the technical aspects of scientific

rity, trade, and related areas. Decisions regarding

biosafety review; we do not attempt to address

the use of this technology and its products are

nonsafety factors fully here.

Context for Biosafety Review and Decision Making

7


Figure 1. Factors governing decisions about
the release and use of GMOs. Factors in

Safety assessment*

National policies

decisions about the release of a GMO are
based in part on safety assessment and necessarily include other considerations as well.

Stakeholder input

Public opinion

Nonsafety issues such as effects on society,
economic consequences, and effects on
trade are also keys in decision making.

International
agreements

Nonsafety issues

Typically, decision making incorporates,
whether formally or informally, stakeholder
input, public concerns and opinions, existing
policies in agriculture, the environment, and
food safety and responsibilities under inter-

National
decision making
* The focus of this training workbook

national agreements.

National Policy
A strong national policy environment for agri-

ronment and human health against uncertain or
unidentified risks, allowing use of the technology

culture, new technologies, resource conservation,

only to the extent that its impacts are known or can

and related areas will foster the adoption of appro-

reliably be predicted. Others frame policy to

priate GM technologies. Coherent policies promote

encourage the introduction of technologies that will

development of an implementable regulatory sys-

benefit the country and its people, striving to iden-

tem for biosafety and guide its coordination with

tify and manage actual or potential risks, to the

related regulatory mechanisms (e.g., phytosanitary

extent possible given current knowledge, and to

requirements, seed registration, etc.). They provide

balance these against the status quo.

a basis for accommodating the differing interests

Policy decisions regarding the relative roles

of ministries of agriculture, health, science and

played by the various ministries involved shape

technology, environment, or others involved. Weak

biosafety implementation. The statutory nature of

or absent national policy, in contrast, may serve as

biosafety regulations, whether issued as law, by

an impediment to technology transfer and adop-

ministerial decree, or as advisory guidelines, will

tion.

dictate the nature and extent of enforcement
Around the world, national policies on genetic

measures and the means for addressing noncompli-

modification differ significantly in their objectives.

ance. Existing regulatory agencies, such as those

Some countries design policy to protect the envi-

for plant quarantine and seed registration, may

8

Biosafety in Principle and in Practice


have statutory authorities that apply to GMOs and
that need, therefore, to be coordinated with

Cartagena Protocol on Biosafety
The Cartagena Protocol on Biosafety (CPB) is a

biosafety regulation.

legally binding international agreement negotiated
under the auspices of the 1992 Convention on
Biological Diversity. Its primary aim is to protect

International Agreements

biodiversity by ensuring the safe and responsible

At least three international agreements — the

“development, handling, use, transfer and release

Cartegena Protocol on Biosafety, Codex Alimen-

of any Living Modified Organism.” The protocol

tarius, and the International Plant Protection

addresses transboundary movement of living GMOs;

Convention — pertain to biotechnology development

it also applies to the use or trade of products

and trade. This fact indicates that a wide and com-

derived from GMOs, such as grain processed into

plex scope of regulatory issues are associated with

meal or flour, cotton fiber or seedcake, vegetable

the use of the technology.

oils, or any processed food. Under the terms of the

The Precautionary Principle as Stated in International Documents
“Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for
postponing cost-effective measures to prevent environmental degradation.”
— Rio Declaration on Environment and Development (“Earth Summit”), 1992, Principle 15

“Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of potential
adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of
import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate,
with regard to the import of the living modified organism . . . in order to avoid or minimize such potential adverse effects.”

— Cartagena Protocol on Biosafety, 2000, Articles 10.6 and 11.8

“In cases where relevant scientific evidence is insufficient, a Member may provisionally adopt . . . measures on the basis of
available pertinent information . . . (I)n such circumstances, Members will seek to obtain the additional information necessary
for a more objective assessment of risk and review . . . the measure accordingly within a reasonable period of time.”
— World Trade Organization 1993 Agreement on Application of Sanitary and Phytosanitary Measures, Article 5.7

Context for Biosafety Review and Decision Making

9


CPB, exporting member countries must obtain an

ing legislation into line with the new Codex labeling

advance informed agreement for GMO importation

guidelines when these enter into force.

before shipment. Such agreement is conditioned on
the recipient country’s performance of both an
environmental risk assessment and food-safety
assessment. The CPB includes guidelines for assess-

International Plant Protection Convention
The International Plant Protection Convention

ing environmental impact and provides for a central

(IPPC) is a multilateral treaty deposited with the

clearinghouse of information on GMO production,

director-general of the FAO and administered

export, and biosafety data.

through the IPPC Secretariat located in FAO’s Plant

Countries that sign the protocol assume cer-

Protection Service. The purpose of the IPPC is to

tain responsibilities with respect to the use of living

secure common and effective action to prevent the

GMOs. They are obliged to designate a focal point

spread and introduction of pests of plants and

for liaison with the CPB secretariat and one or more

plant products and to promote measures for their

competent authorities to carry out the assessment

control. The convention provides a framework and

provisions of the protocol. These include develop-

forum for international cooperation, harmoniza-

ment and implementation of regulations to manage

tion, and technical exchange in collaboration with

the safe use of living GMOs. In practical terms, this

regional and national plant protection organiza-

entails a review and modification of existing legis-

tions. The IPPC plays a role in trade because it is

lation or drafting of new legislation, infrastructure

recognized by the World Trade Organization in the

development, and strengthening of biosafety review

Agreement on the Application of Sanitary and

capacity within the government and scientific com-

Phytosanitary Measures (the WTO-SPS Agreement)

munities.

as the source for international standards for the
phytosanitary measures affecting trade. It therefore will affect the export and import of biotech-

Codex Alimentarius

nology products.

The Codex Alimentarius Commission is an international working group that sets standards for food
safety, quality, and labeling. It functions under the
Food and Agricultural Organization (FAO) in Rome.

Stakeholder Involvement
Stakeholders in biosafety decision making are

The Codex Ad Hoc Intergovernmental Task Force on

those interested in or affected by decisions regard-

Foods Derived from Biotechnology was formed to

ing the use of GMOs. In addition to scientists and

develop standards, guidelines, or recommenda-

research directors, the term encompasses farmers

tions, as appropriate, for foods derived from

and farm organizations, environmental groups,

biotechnology or traits introduced into foods by

local landowners, consumer organizations, industry

biotechnology. The final report is due at the

and trade organizations, seed suppliers, national

twenty-fifth session of the commission in 2003.

and local authorities, and the like. Stakeholders

In the interim, work on international guidelines

and decision makers share the common goal of

for the labeling of GM foods is progressing; a draft

using biotechnology and GM products in such a way

was made available in 2002. Signatories to the

as to derive benefits that sufficiently outweigh

Codex will be required to bring their national label-

potential detriments. The same can be said for the

10

Biosafety in Principle and in Practice


use of any technology, whether it is automobiles,

mechanisms to solicit public comment on proposed

vaccines, or electricity.

activities and pending decisions on GMO market

Stakeholder input is critical in drafting

releases and deliver it to decision makers. National

biosafety regulations and laws that are realistic and

biosafety officials may use normal government

implementable and that take into account the most

communications channels to announce such events

current credible information. Stakeholders can pro-

and call for public comment. In a few cases, even

vide critical input into setting research priorities

proposed field tests are open for public comment.

that focus on primary constraints in agriculture and

Regulatory officials may place notifications and

food supply for which biotechnology is the most

contact information in local newspapers and on

appropriate approach. They are also in a position to

radio programs or conduct local informational

promote compliance with regulatory requirements

meetings. Public meetings are especially useful in

and implementation of management plans (e.g.,

that they allow diverse points of view to be heard.

farmers charged with field surveillance).

The discussions sensitize scientists and regulators
to public concerns and at the same time provide an
opportunity for the public to obtain accurate infor-

Public Input
The general public cannot have confidence in

mation. (See section six, “Communicating about
Risk and Biosafety.”) A few countries (e.g., the

official statements that assert “this GM crop is safe

Philippines and the United Kingdom) have insti-

to grow and safe to eat” if they feel deliberately

tuted direct public involvement in biosafety assess-

excluded from the decision making. Needless to

ment of GMOs by including representatives of the

say, opponents of biotechnology are aware of this,

general public on their national biosafety commit-

too, and easily raise suspicion and fears by claim-

tees. These committee members may or may not

ing that the public has no voice in decisions regard-

have a technical background.

ing the use of GM technology. Furthermore,
perceptions that biosafety reviews are inadequate,
that deliberations are conducted behind closed

Terms of Reference

doors, and that private sector interests are strongly

for Biosafety Committees

influential seriously undermine the credibility of
biosafety reviewers and competent authorities.
With few exceptions, technical biosafety reviews

Groups best work together when members have
a common understanding of the group’s purpose,

are primarily scientific evaluations conducted by a

scope of subject matter, and mode of operation.

small group of specialists and, usually, government

Ideally, such information for national biosafety

officials. Final decisions about consumers’ use of

committees is specified in formal or informal terms

GMOs, however, must necessarily consider both

of reference. Although few committees in develop-

safety and nonsafety (e.g., socioeconomic, trade,

ing countries have written terms of reference (and

equity) issues. It is at this point that public input

many in developed countries lack them as well),

should become a factor in decision making.

they can be instrumental in setting up a functional

Public participation in biosafety decision mak-

and effective biosafety committee and serve to

ing, specifically addressed in Article 23 of the

coordinate its operations within the larger national

Cartagena Protocol, typically is achieved through

regulatory framework.

Context for Biosafety Review and Decision Making

11


Terms of reference (principles of operation)

tations for its deliberations and output. The choice

are often the first level of guidance for a biosafety

of topics to include and the language used to

committee. They may be articulated within national

describe them will reflect the regulatory framework

regulations, guidelines, rules for implementation,

and the perspectives of those drafting the terms. In

or as a separate document. They may address a

practice, the list would be longer, perhaps including

range of topics, several of which are listed in the

such additional topics as document management

box below. Usually, terms of reference establish

and record keeping, committee procedures, han-

how the committee is to function, the boundaries of

dling of confidential business information, review

activity in which it may be involved, and the expec-

procedures, member confidentiality, use of external

Terms of Reference for Biosafety Committees: Topics and Samples
The terms provided for each topic are examples of how each

Agriculture as assigned in the Agricultural Products Use Act

topic could be addressed; many other approaches are possible.

of 1999.
B. In accordance with Environmental Protection Directive

PURPOSE

86-041, as amended on 3 June 1991, the Council for the

A. The National Biosafety Committee (NBC) is constituted to

Environment will establish, maintain, and provide support

conduct scientific reviews of applications to import, field

to an NBC.

test, produce, and/or place on the market genetically
modified organisms (GMOs).
B. The NBC is the competent authority for determining the

APPOINTMENT

A. Members of the NBC will be appointed by the Deputy

acceptability of a GMO intended for local consumption as

Minister of the Environment upon recommendation by the

food, feed or fiber, export or trade, production of indus-

Secretary of the National Council of Environmental Affairs.

trial or pharmaceutical products, or any other applica-

B. The Director of Agricultural Development and Trade will

tions, on the basis of a scientific evaluation of risks,

receive nominations for membership annually. After formal

benefits, and comparison of these with those of their con-

screening, selected individuals will be invited to sit on the

ventional counterparts.

committee for a term of 5 years.

C. The Biosafety Advisory Group serves in an expert capacity

C. Members are appointed by the Deputy Director of Agri-

to evaluate the potential risks of GMOs to human health

cultural Research and Development. In addition, the

and the environment and make recommendations to the

President may at any time appoint an additional member

Ministry of the Environment regarding their use and distri-

or members of his/her own choosing.

bution.
MEMBERSHIP

A. The committee is composed of scientists having expertise

AUTHORITY

A. The NBC is constituted under authority of the Minister of

12

in relevant scientific disciplines, including molecular biol-

Biosafety in Principle and in Practice

or ad hoc advisors, and dealing with conflicts of

field test or commercialize GMOs. Risks are to be

interest. Each country or committee must formulate

identified, their magnitude estimated, and their

its own terms of reference according to its bio-

potential negative consequences described.” The

safety objectives, regulatory infrastructure, human

wording confines reviewers to look only at risk. No

resources, and similar contributing factors.

balancing consideration is to be given to potential

Note that some of the sample terms of refer-

benefits or positive consequences.

ence are overly restrictive. An example is “Scope of

In other cases, the terms are very broad. An

Review: The committee’s primary responsibility is to

example is “Membership: The committee is com-

conduct a safety assessment of applications to

posed of scientists having expertise in relevant sci-

ogy, plant breeding, genetics, plant pathology, agronomy,

and comparative advantages/disadvantages over non-GM

weed science, ecology, and others.

varieties.

B. Members include the Deputy Minister of Agriculture,

E. The NBC will not comment on the proposed experimental

Director of the National Council for Science and Tech-

design or choice of scientific methods except where con-

nology, the Minister’s science advisor, representatives of

cerns are raised that safety could be compromised.

the Ministries of Environment, Health, Production and
Trade, and scientists having expertise in disciplines.

F. Nonsafety concerns (e.g., socioeconomic impact) will be

referred to an auxiliary body established for that purpose
or to the decision-making authority for independent eval-

SCOPE OF REVIEW

uation.

A. Biosafety reviews will focus on scientific issues related to

environmental impacts of the proposed activity. Analyses

POSTREVIEW RESPONSIBILITIES

will be based on scientific data provided by the applicant

A. The committee will be responsible for establishing a fol-

or by outside sources.
B. The NBC evaluation will focus on the potential risks and

low-up monitoring program for compliance with regulatory
decisions and any constraints therein. This may be accom-

potential benefits of a particular GMO in light of the known

plished through submission by the applicant of annual

risks and benefits of the nonmodified conventional variety.

reports or a final report, site visits by NBC member(s) or

C. The committee’s primary responsibility is to conduct a risk

assessment of applications to field test or commercialize
GMOs. Risks are to be identified, their magnitude estimated, and their potential consequences described.
D. The Biosafety Advisory Board Review will, in the course of

its assessment, consider the necessity for developing the

their representative(s), or as otherwise deemed sufficient
by the committee.
B. After completion of each review, the committee

or an appointed spokesperson will be available to the
Deputy Minister of Agriculture to respond to follow-up
questions or additional analyses as deemed necessary.

GM variety, its relevance to national needs and priorities,

Context for Biosafety Review and Decision Making

13



entific disciplines, including molecular biology,

sity for certain crop species. Local experts will need

plant breeding, genetics, plant pathology, agron-

to evaluate the available data. They may request

omy, weed science, ecology, and others.” This term

that additional data pertaining to local conditions

leaves open who makes the appointments, by what

be provided before approval can be given or that

process, the number of members, and their length

additional safety data be collected during the

of service. Both strong and weak examples are

field-testing phase of a GM product with commer-

given as a way to stimulate discussions of the mer-

cial potential. Regional environmental similarities

its, drawbacks, and, most importantly, the implica-

and crop preferences may allow neighboring coun-

tions of each.

tries to share biosafety data and collaborate on

Additional terms of reference may address

environmental risk assessments for the region. This

topics such as committee procedures, use of exter-

approach offers advantages in sharing biosafety

nal or ad hoc advisors, record keeping, handling of

costs and expertise within the region and reduces

confidential business information, and dealing with

duplication of effort, yet leaves decision making to

conflicts of interest.

national authorities.
To facilitate access to previous biosafety
review data, the Secretariat for the Cartagena

Use of Prior Reviews
Applications for field tests or market releases

Protocol on Biosafety will provide a clearing house2
for biosafety data that can be accessed by national

in developing countries in many cases involve GMOs

scientific review and decision-making committees.

previously approved by national biosafety commit-

This database will house information that

tees elsewhere in the world. The findings of these

addresses concerns about specific GM products in

committees are a valuable resource because they

specific environments and methods to manage and

can direct subsequent reviewers to specific areas of

monitor them. Parties to the protocol will be

concern and indicate how these concerns might be

required to submit their biosafety information to

addressed. Sharing documentation from prior

the clearing house.

reviews helps build familiarity with specific GM

products, gives insight into management procedures, provides direction on additional information
that may be needed for the current review or at

Decision Documents
Biosafety decisions typically are recorded in

later stages in the development process, and raises

some form of decision document. The documents

the confidence with which decisions are made.

present key findings of the biosafety review com-

The validity of conclusions from risk assess-

mittee and of other parties providing information

ments conducted in other countries is limited, how-

and advice that collectively form the basis for a

ever, by the extent to which there are significant

final decision to use, or not, a particular GMO in a

differences in environmental, ecological, and agro-

specified way.

nomic conditions. Existing biosafety data should be

Decision documents prepared by biosafety

acceptable but are not necessarily sufficient for

committees serve to communicate their science-

reviews conducted elsewhere, particularly in coun-

based findings to regulators, applicants, stake-

tries that are centers of origin or centers of diver-

holders, and interested parties. Such reports will:

Context for Biosafety Review and Decision Making

15


• Summarize the application
• Note any information missing from the original

Decision documents serve to advise regulators
and government officials and inform the public of

application and steps taken to provide it to the

how a decision was reached. As such, the language

committee’s satisfaction

should be nontechnical — key words should be

• Summarize the review process, discussions, and
findings of the committee
• Detail the committee’s recommendations in

defined and all jargon eliminated. For transparency
and accountability, documents should be signed by
the review committee or competent authority.

regard to their mandate
• Add additional comments (outside the immediate mandate of the committee and the scope of

Resource Requirements

the present application) that regulators or the
applicant may wish to consider in subsequent
applications
• Outline the conditions under which an approved

Scientifically sound safety assessments and
measures for handling GM crops, trees, and ornamental species and their products safely require

activity is to proceed, including required risk-

human, financial, and information resources as well

management measures, reporting procedures in

as an adequate infrastructure. Below we detail

case of unexpected events, and record keeping

some of the specific resource needs.

In contrast to the relatively simple safety
assessments of field-test applications, requests for
large-scale or commercial GMO production and/or

Personnel
Scientists

marketing are subject to much more extensive

Sound biosafety reviews require the expertise

review that includes factors such as long-term

of scientists knowledgeable about the organisms,

environmental effects, food-safety assessment,

the introduced traits, and the environment into

and nonsafety considerations. Accordingly, in addi-

which specific GMOs will be released. The scope of

tion to the findings and recommendations of the

disciplines relevant to biotechnology and biosafety

review committee, decision documents pertaining

is extensive. Some countries, such as the Philip-

to commercial releases may incorporate:

pines and China, have a large pool of qualified life
scientists and thus are capable of securing the nec-

• Findings and recommendations of the national
food-safety committee
• Opinions given by ad hoc scientific experts as
requested by the review committee (e.g., ecological studies)
• Findings of outside review teams charged with

essary expertise. Many others lack sufficient scientific capacity and will find it difficult, if not
impossible, to assemble a properly constituted
national biosafety committee.
Circumventions (not necessarily solutions) to
this widespread problem include:

evaluating the social, economic, and trade
impacts of the GMO
• A summary of input from the public
• Any combination of these depending on the structure of the advisory groups and their mandates

16

• Using experts drawn from neighboring countries
• Using international experts, consultants, or
advisors
• Accepting biosafety assessment conclusions

Biosafety in Principle and in Practice


reached by national review committees in other
countries
• Establishing a regional biosafety system that

Government Officials / Decision Makers
Political support, or its absence, is key to
determining whether a functional biosafety system

pools resources to evaluate proposed field-test

can be established and put into operation, or

releases having regional relevance

whether the effort falls short despite strong support
at the institutional level and among scientists. Thus

In addition to basic scientific expertise, bio-

it is vitally important that ministry officials and

safety reviewers need skills in risk-assessment and

their science advisors are well informed about the

risk-management procedures (see sections three

role of biotechnology in agricultural development

and four). Those who will serve as inspectors and

and the role of the biosafety system in bringing

monitors of field-test releases need to understand

beneficial products to all citizens.

the why, where, when, and how of field or facility
inspection and monitoring (see section five).
Training programs can help build technical

Officials who have formal responsibility for
biosafety and who make decisions on proposed
field-test releases are, in essence, the gatekeepers

capacity; however, it takes time to build the com-

who determine what biotechnology products, if any,

petence and confidence of biosafety officials.

will be allowed, and when. Those more directly

Training should be an ongoing activity; attendance

involved in biosafety operations are potential allies

at one course, such as one based on this workbook,

in helping secure necessary financial resources.

is not equivalent to being “knowledgeable and

Those having regulatory authority set the pace for

trained.” For that, accumulated practice and

actual testing and commercial use. The cooperation

hands-on experience are needed.

and support of these people may, in fact, be the
most important resource of all. Efforts to engage
them and keep them as informed as possible are

Managers

likely to be well worthwhile.

In the course of implementing biosafety, management responsibilities are commonly placed on
people who have little or no prior experience in this
area. New managers will need skills in:
• Priority setting

Scientific Expertise Used in Reviewing
South Africa’s First 150 Field-Test Applications

• Resource acquisition and allocation
• Coordination with multiple agencies

Molecular biology

Agronomy

Human health

• Meeting management

Plant pathology

Pesticide usage

Biochemistry

• Communications across many sectors

Microbiology

Nutrition

Plant genetics

• Information access and management

Plant taxonomy

Soil biology

Biocontrol

• Handling of confidential or proprietary

Fermentation

Ecology

Food safety

Pollination biology

Plant physiology

Weather

Veterinary science

Entomology

Law

information

Context for Biosafety Review and Decision Making

17