A theory of transnational regulatory contagion and its application to agricultural biotechnology in Europe and the United States, 1970--2000

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A THEORY OF TRANSNATIONAL REGULATORY CONTAGION
AND ITS APPLICATION TO AGRICULTURAL BIOTECHNOLOGY
IN EUROPE AND THE UNITED STATES, 1970-2000
Copyright 2000
by
Evan Karl Schulz
A dissertation presented to the
FACULTY OF THE GRADUATE SCHOOL
UNIVERSITY OF SOUTHERN CALIFORNIA
in Partial Fulfillment of the
Requirements for the Degree
DOCTOR OF PHILOSOPHY
(INTERNATIONAL RELATIONS)
May 2000
Evan Karl Schulz
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UNIVERSITY OF SOUTHERN CALIFORNIA
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This dissertation, written by
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under the direction of Dissertation
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Evan K. Schulz
Jonathan Aronson
A Theory of Transnational Regulatory Contagion and its Application to Agricultural
Biotechnology in Europe and the United States, 1970-2000.
This study presents a theory of regulatory contagion to describe the conditions under
which authorities might adopt or adapt foreign regulations, rather than invent entirely
new ones. In doing so, it departs from traditional explanations of regulation formation,
which rely largely on domestic actors competing within domestic settings to explain
outcomes. Regulatory contagion is applied to the development of agricultural
biotechnology regulations in the United States and Europe during the last quarter of the
20th century. It is shown to apply to three distinct stages of agricultural biotechnology’s
commercial development. The first stage is the regulation of the 1970s associated with
the Asilomar Conference and the resulting ban on deliberate release. The second stage is
the deregulation of deliberate release and subsequent field tests of the 1980s. The third
stage is the reregulation effort of the 1990s, with opponents seeking stricter control of
biotechnology crops and food. More broadly, the study documents how domestic
regulations can have foreign sources. Consequently, it is makes an important
contribution to the study of, and argues for an expansion of the phenomena considered by
those with an interest in “globalization.”
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Dedication
To my parents, Dr. Max and Dr. Muriel Schulz, and my wife, Dr. Nisha Mody.
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Acknowledgements
There stands behind the author of any study a number of individuals who
contribute to its completion.
Jonathan Aronson, my dissertation Chair, encouraged my interest in
technology, especially through his course on economic security. At a critical juncture,
he encouraged this topic over another alternative, which was very sound advice. He
responsibly cracked the whip when necessary, but at the same time gave me space,
and tolerated my disappearances into the desert. One could hardly ask for better
management skills from a Chair.
Hayward Alker, who served on my committee, nearly drove me from graduate
school when I took his advanced theory course. The cause (his daunting intellect)
soon, however, became a source of inspiration, not intimidation. His course on
complexity theory was invaluable for my grappling with biotechnology policy. He
encouraged me, and does others, to think longer and harder about things: the mark of a
superb educator and scholar.
Jeff Knopf allowed me as his student to pursue the topic of biotechnology not
once, but twice. In his domestic sources of international politics course, he took a
chance, and allowed me to write on biotechnology regulation, a subject about which I
knew very little at the time. Later, in his arms control course, he allowed me to write
about biological weapons, which provided me the background for chapter 1. In doing
so, he epitomized intellectual curiosity and exploration.
The Center for International Studies and the School of International Relations
both provided me dissertation fellowships with which I was able to focus on this topic
iii
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without interruption for 18 months. It is hard to imagine having completed this study
without their generous support.
Dr. Daniel Emerling spent hours on the phone with me discussing technical
aspects of biotechnology.
My wife, Nisha Mody read multiple drafts, always with a smile and a critical
eye. My father, Max Schulz, read the completed draft on short notice, and was
authentically proud.
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Table of Contents
Page
Dedication ii
Acknowledgments iii
List of Figures and Tables vi
List of Acronyms vii
Glossary ix
Introduction: DNA, Molecular Genetics and Political Controversy 1
Chapter 1: Single Case Study from the Early Recombinant Era 11
Chapter 2: Literature Review and Regulatory Model 38
Chapter 3: Introduction to Agricultural Biotechnology 79
Chapter 4: The American Case Study 121
Chapter 5: The German Case Study 159
Chapter 6: The British Case Study 195
Chapter 7: Transgenic Agriculture Comes of Age 226
Chapter 8: Conclusions: Regulations and the Study of Globalization 273
References 298
v
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List of Figures and Tables
Figures Page
Figure 1.1 The Anglo Sources of Early Recombinant Regulations 20
Figure 2.1 The Elements of Risk 43
Figure 2.2 Risk Space 45
Figure 2.3 Competing Conceptions of Risk and Uncertainty from Economics 52
Figure 2.4 Risk-Uncertainty Space 53
Figure 2.5 Rayner’s Typology of Scientific Regulation 59
Figure 2.6 Informational Networks Among Four Countries 73
Figure 2.7 Domestic-Transnational Sources and its Regulatory Dynamic 75
Figure 7.1 Total Number of Field Tests within the OECD, 1986-96. 228
Figure 7.2 Annual Field Tests in the United States, 1986-96 229
Figure 7.3 Annual Field Tests in Germany, 1986-96 230
Figure 7.4 Annual Field Tests in Britain, 1986-96 230
Figure 7.5 Traits Tested as Percentage of Total American Tests, 1987-99 231
Figure 7.6 American Field Tests by Phenotype, 1987-99 232
Figure 7.7 Contribution of Seven Crops to Total American Field Tests, 233
1986-1999
Figure 7.8 Terminator Technology 257
Tables
Table 1.1 The Anglo Sources of Early Recombinant Regulations 36
Table 2.1 Risk Results 44
Table 7.1 Percent of Acreage Planted with GM Crops in Three Countries 245
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List of Acronyms
ACRE Advisory Committee on Releases to the Environment (Britain)
ACGM Advisory Committee on Genetic Manipulation (Britain)
AGS Advanced Genetics Sciences AGS (United States)
APHIS Animal and Plant Health Inspection Service (United States)
ATCC American Type Culture Collection (United States)
BGA Federal Health Ministry (Germany)
BMFT Federal Ministry of Research and Technology (Germany)
Bt Bacillus thuringiensis
BWC Biological Weapons Convention
DECHMA German Chemical Society (Germany)
DNA Deoxyribonucleic acid
DoE Department of Environment (Britain)
EPA Environmental Protection Agency (United States)
EUP Experimental Use Permit (United States)
FDA Food and Drug Administration (United States)
FIFRA Federal Insecticide, Fungicide and Rodenticide Act (United States)
GMAG Genetic Manipulation Advisory Group (Britain)
GMO Genetically Modified Organism
HSC Health and Safety Commission (Britain)
HSE Health and Safety Executive (Britain)
I AC I Interim Advisory Committee on Introductions (Britain)
IBC Institutional Biosafety Committee (United States)
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MAFF Ministry of Agriculture, Fisheries and Food (Britain)
NEPA National Environmental Protection Act (United States)
NIH National Institutes of Health (United States)
OECD Organization for Economic Cooperation and Development
PWG Plasmid Working Group
RDNA Recombinant DNA techniques
RCEP Royal Commission on Environmental Pollution (Britain)
ToSCA Toxic Substance Control Act (United States)
UNSCOM United Nations Special Commission
USDA United States Department of Agriculture
WMD Weapons of Mass Destruction
ZKBS Central Commission for Biological Security (Germany)
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Glossary
Agrobacterium tumefaciens - A soil bacteria that infects dicots, one of the two major
subclasses of plants, during which it transfers some of its own DNA to the plant
genome.
Allele - One of two or more variants of a gene which give rise to alternative
hereditary characteristics.
Amino Acid - The chemical units which assemble together to create proteins.
Apical Meristem - The mass of the cells at the growing tip of shoots.
Asexual Propagation - The use of techniques not relying on traditional sexual
hybridization to produce further organisms (e.g., cloning).
Bacillus thuringiensis (Bt) - A bacterial strain that produces toxins lethal to insects.
Bacteriophage - A virus capable of infecting bacteria.
Baculovirus - A virus that infects the cells of insects.
Biolistics - A process for creating transgenic cells, by which microscopic particles
(gold or tungsten) are coated with DNA and then accelerated to a velocity sufficient to
penetrate the exterior cell wall and lodge in the nucleus.
Callus - Undifferentiated plant cells.
Chloroplast - The organelle in green plants cells where photosynthesis converts
sunlight to energy.
Chromosome - A macromolecule of DNA along which are arranged the genes.
Clones - Organism with identical genotypes.
Codon - A specific triplet of DNA that codes for a characteristic amino acid.
Commercial hybrids - A crop variety, usually with superior traits, produced by the
crossing of two homozygous recessive parent varieties.
Conjugation - A process by which bacteria pass plasmids from one to another, and
thereby can share genetic material.
Crown - The point on a plant where the root merges with the stem.
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Crown Gall - A bulbous site of plant tissue at its crown that accompanies infection by
agrobacteria.
Cytoplasm - the volume within the cell of an organism.
DNA (deoxyribonucleic acid) - The double-helical, gene-bearing macromolecule
which forms the molecular basis of both development and heredity.
Daughter Cell - A cell resulting from precursor cells, usually as a result of cell
division.
Deliberate Release - The introduction into a non-laboratory setting of a GMO (a.k.a.,
intentional release or field test).
Dicotylendonous plants (dicots) - One of the two major classes of plants whose seeds
have only two seed-leaves
Dominant - The description assigned to an allele that manifests in the phenotype when
paired with a recessive allele.
Enzyme - A chemical that catalyzes a specific reaction.
Eukaryote - Any organism possessing a cell nucleus.
Gene - A segment of DNA with which is associated the production of a protein, and
the basic molecular unit of heredity.
Gene Therapy - The transfer of novel genes into humans for therapeutic purposes.
Genetic Engineering - The deletion, addition, movement or substitution of genes for
the purpose of changing an organism’s phenotype.
Genome - the full compliment of an organism’s genes.
Genotype - An organism's underlying genetic characteristics.
Germplasm - The sum of a species’ genetic diversity.
Heterozygous - Possessing two different alleles of a gene.
Homozygous - Possessing two identical alleles of a gene.
Hybrids - The offspring resulting from a cross of two dissimilar parental strains.
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In vitro - The occurrence of a reaction or experiment in a test tube.
In vivo - The occurrence of a reaction or experiment in an organism or cell.
Land Races - Individual crop varieties that result from the selection pressure of
farmers choosing seed from one harvest for the next.
Ligase - A biochemical that can rejoin specific strands of DNA.
Lysis - The bursting of a cell.
Messenger RNA - A molecular strand derived from a segment of DNA that can be
translated into a protein.
Microinjection - A process for creating transgenic cells, by using micropipettes (fine
glass needles) to inject DNA directly into a cell nucleus or protoplast.
Micropropogation - The use of small samples of plant tissue to generate large
numbers of fully mature plants.
Mitochondria - The organelles responsible for creating a cell's energy.
Monogenic - Controlled by a single gene.
Mother Cell - A cell that is the source of subsequent cells.
Mutagen - A substance or process that increases the likelihood of an organism to
generate mutations.
Mutation - A random change in an organism’s inheritable genetic makeup.
Monocotyledonous plants (monocots) - One of the two major classes of plants,
including the world’s grasses (e.g., rice, wheat, com), whose seeds have only a single
seed-leaf.
Natural Selection - The evolutionary process by which organisms tend to see their
genes inherited according to their degree of adaptation to an environment.
Nucleus - The site in eukaryotes where the chromosomes are housed.
Oncogenic - Capable of causing host cells to subdivide and reproduce.
Opine - A biochemical produced by plants infected by agrobacteria.
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Organelle - A structure within cells with which specialized functions are associated
(e.g., chloroplasts and mitochondria).
Pathogen - An organism that causes disease.
Phenotype - An organism's observable characteristics.
Plasmid - A small segment of ring-DNA found in bacteria that can be cut open, and
into which new genes can be added. When such a plasmid is reintroduced into
bacteria, they will produce the protein associated with the new gene.
Polygenic - Relying on the interaction of two or more genes.
Prokaryote - Any organism that does not possess a cell nucleus.
Proteins - Large molecules produced by genes and composed of amino acids.
Protoplasts - Plant cells lacking their hard, cellulose exterior wall.
Recessive - The description of an allele that only manifests in the phenotype when
paired with another recessive allele (e.g., albinism).
Restriction Enzyme - A biochemical that subdivides the DNA double-helix at a
characteristic sites.
Rhizobium - A bacterium which when used in conjunction with legumes replenishes
soil with nitrogen.
Selective Advantage - The description used to describe the ability or inability of a
gene to enjoy continued expression in subsequent generations.
Somaclonal Variation - The spontaneous genetic variation exhibited by some plant
cells that are maintained in culture.
T-DNA (transfer DNA) - The segment of plasmid from agrobacteria that is transferred
to a plant genome.
Tissue Culture - A process whereby individual plant or animal cells are sustained or
grown in vitro.
Transcription - The process of generating messenger RNA from DNA.
Transformation - A process for creating transgenic cells by placing protoplasts in
solution with copies of a gene sequence of interest, and exposing it to either an
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electrical or chemical stimulus, causing some of the protoplasts to absorb the free-
DNA.
Transgenic - Any organism containing novel DNA.
Translation - The process of producing proteins from messenger RNA.
Transposons - Segments of DNA that move readily about the genome, sometimes to a
new position along the same or a different chromosome (a.k.a., “transposable
elements” or “jumping genes”).
Vector - A system for transferring genes from one organism into another.
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INTRODUCTION
I. DNA. Molecular Genetics and Political Controversy
Postwar molecular genetics represents a major scientific triumph. Since the
1940s researchers have recognized that deoxyribonucleic acid (DNA), not protein,
provides the molecular basis of heredity. Watson and Crick’s 1953 elucidation of
DNA’s double helical structure suggested a method for its replication through
successive generations. Further research by Crick, Brenner and Gamow revealed by
the early 1960s that DNA is organized into three-letter units, called codons.
Associated with these codons are characteristic amino acids, which can link together
in long chains to form the vast variety of proteins found in cells. Codons are organized
into genes, which in turn direct this assembly of proteins. DNA thereby became the
molecular basis of both heredity and development. In 1972 Cohen and Boyer first
showed that one could isolate a gene from one species and transfer it to another
species. In its new host, the novel gene would dutifully produce the familiar protein.
Cohen and Boyer thereby initiated the recombinant era.
They also initiated an international debate over the hazards such organisms
might pose to humans and the environment. In response to early concerns, regulators
in the 1970s confined genetically modified organisms (GMOs)1 to the laboratory.
Around the world, regulators adopted strict rules to govern the creation, containment
and research of GMOs. By the late 1970s, however, researchers grew increasingly
1A brief note on terminology is required. The current vogue is to refer to these organisms as
genetically modified. In the scientific literature, one is more likely to encounter the term transgenic. In
the 1980s, the familiar phrase was genetically engineered, while in the 1970s, the common phrase was
recombinant organisms. In this study, the term that prevailed during the decade under consideration is
the one that is used (e.g., genetically modified for discussion of events from the 1990s). This approach
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comfortable with their creatures, and increasingly impatient with bureaucratic
roadblocks to their creation and investigation. Despite initial fears, no ill-begotten
transgenic organism had threatened humanity. Slowly but deliberately, regulatory
authorities - many of whom themselves were active researchers - gradually relaxed
laboratory rules. During the same period, recombinant research yielded an initial
wave of biomedical products. As these first products progressed through the
regulatory system, research scientists and venture capitalists increasingly teamed in
the pursuit of recombinant profits.
By the early 1980s recombinant research promised a second wave of products.
Among these were the products of biotechnology’s application to agriculture. As
such, these products required field-testing to demonstrate their safety and efficacy to
both investors and consumers. Agricultural biotechnology proponents promised a
wide range of benefits. Biotechnology would further rationalize agricultural
production. It would provide greater nutrition at reduced cost. It would diminish
reliance on chemical pesticides and herbicides. It would open up previously
unproductive land through development of drought, cold or salt resistant crop
varieties. In short, it promised a second green revolution.
Despite this promise, critics voiced grave concern about deliberately releasing
into the environment organisms that until that time had been confined to special
laboratories. They feared unknown and uncertain hazards might accompany such
release. The initial biotechnology regulations of the 1970s reflected this fear, having
explicitly prohibited the deliberate release of genetically modified organisms into the
helps to provide consistency with the documentation provided in the footnotes. These terms,
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environment Before a single transgenic bacterium, plant or animal could be released
regulatory authorities would have to abandon this earlier prohibition. The stage was
set for a political confrontation. How was that confrontation resolved, and what rules
emerged? The following study explores this ongoing and at times uneasy relationship
between humans and their genetically modified organisms.
To do so, it presents an examination of biotechnology regulations with the aim
of focusing attention on their transnational development. What this history teaches is
that regulations do not develop in domestic isolation. When facing a regulatory
challenge, authorities may look beyond the boundaries of their own jurisdiction to see
how colleagues abroad are addressing the common challenge. Informational networks
can emerge to channel experience between regulatory jurisdictions, and thereby shape
the regulatory outcome. This study, therefore, offers a variation on the more familiar
regulatory story involving domestic actors fighting domestic battles within domestic
contexts.
II. Overview of the Study
The study begins with an investigation of biological weapons in the early
recombinant period. The purpose of this single case study is to demonstrate the
impact that domestic regulatory decisions in one country can have on domestic
regulatory decisions throughout the world. The argument is that biohazard debates of
the 1970s should have included the threat recombinant techniques posed for the
enhancement and proliferation of biological weapons. Such a consideration was
largely and purposefully excluded from the biohazard agenda in the United States and
nonetheless, are interchangeable.
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Britain; subsequent regulations discounted this hazard. Countries around the world
adopted and adapted the Anglo recombinant regulations for their own jurisdictions.
The value of zero assigned to biological weapons hazards in the United States and
Britain was consequently amplified through the international system. This provides an
example of the dynamic of interest: the foreign sources of domestic regulation.
In light of this finding, the second chapter reviews the literature on risk,
uncertainty and technology regulation. Political scientists, policy analysts and
economists use the terms risk and uncertainty when generating theories of technology
regulation. Their usage of these terms presents some analytic problems. In addition,
comparativists study regulation of technological risks to investigate the effects of
culture and institutions. They conclude that cultural and institutional variation tends to
preclude regulatory convergence under conditions of scientific uncertainty. Chapter 2
concludes with a new hypothesis of transnational regulatory contagion that helps
account for the history documented in chapter 1.
Students are frequently reminded that one must not “test” a hypothesis against
the evidence from which it is derived. Chapter 3 introduces the deliberate release
controversy, the primary empirical domain of this study. By the early 1980s academic
and commercial researchers showed increasing success in applying recombinant
techniques to a variety of products. These products were commercially promising;
however, they were organisms, governed by regulations developed primarily for
biomedical applications. The philosophical pivot for early recombinant regulations
w as limiting the accidental release of genetically modified organisms from research
laboratories.
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Because of the critical role that Anglo rules played in the 1970s, a global
regulatory provision (or norm) prohibited the deliberate release of genetically
modified organisms into the environment. This prohibition worked to the detriment of
the nascent agricultural biotechnology industry, whose products logically require
release. Establishing a viable agricultural biotechnology industry would require
revisiting this earlier prohibition.
Assessing the risks of deliberate release presented national authorities with a
regulatory puzzle. Should genetically modified organisms be released into the
environment? If so, what should be the conditions of such release? Scientific
uncertainty envelops the analysis of organisms and their environment. How do
regulatory authorities reach decisions under such uncertainty? The proposed
hypothesis foresees national regulatory authorities anchoring their own perspectives in
part on the regulatory decisions reached by foreign colleagues. A prerequisite for this
dynamic is the establishment of transnational information networks to transmit
regulatory experience from one jurisdiction to another.
Chapters 4,5, and 6 present evidence of such transnational networks between
the United States, Germany and Britain. The case studies document the complicated
yet fascinating regulatory story with the purpose of assessing the impact such
transnational networks had on the development of domestic field test regulations.
Following the three case studies, chapter 7 provides an overview of developments in
agricultural biotechnology during the 1990s. Since the field test debates of the 1980s
several companies have made substantial efforts to commercialize agricultural
biotechnology. These efforts have generated swift and substantial change in
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agricultural production in the developed world. They also portend substantial
agricultural change in the developing world. For the first half of the decade, this
change generated limited public controversy. In the second half of the decade
controversy erupted in Europe, and then spread to Asia and North America. Chapter 7
illustrates that sensitivity to the transnational context remains necessary to understand
recent developments regarding agricultural biotechnology.
The final chapter reviews and summarizes the study’s findings. The
transnational contagion dynamic is placed in the broader context of domestic
regulations and globalization. It attempts to answer the question: What implications
does this study have for our understanding of theories and concepts from International
Relations?
III. Unifying Themes: Pathogens. Regulations and Globalization
Some may find discomfort in a study that begins with a discussion of
biological weapons and ends with a discussion of global agricultural biotechnology.
Some may consider this to represent an empirical disjoint: that the transition from
issues of international security to those of international political economy lacks
thematic unity. There are several defenses to the charge. First, this study is united by
an empirical concern with biotechnology regulations. The Asilomar Conference of
February 1975 dominates chapter 1. The recommendations resulting from this
conference conceptually and functionally inhibited the commercial application of
molecular genetics to agriculture. Furthermore, even a generation later, Asilomar
remains a persistent frame of regulatory reference. This legacy cannot be ignored, and
it thereby provides an essential prologue to the deliberate release debate.
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Further, this study is united by a persistent fear that that genetically modified
organisms could be pathogens. Thus, biological weapons concern the purposeful
creation and malevolent exploitation of pathogens. Asilomar participants discounted
the intentional use of biotechnology to create pathogens, and instead focused on
containing in laboratories any pathogens researchers might unintentionally create. The
deliberate release controversy centers on fears that genetically modified organisms
might potentially prove pathogenic to humans and other forms of life. Similar public
concern now complicates efforts to introduce genetically modified crops and food:
what assurances are there that such products will not cause disease? While this study
covers varying terrain over a 30-year period, this recurrent fear reappears in differing
form.
Biotechnology is unique among high technology industries in that a social
regulatory milieu shapes its commercialization. The thesis of this study is that a
concern for transnational processes is necessary to understand and explain the
development of national agricultural biotechnology regulations; and consequently the
development of the industry itself. It is hoped that documenting these processes will
encourage a broadening of the phenomena considered under globalization.
The term globalization is used by analysts to explain a variety of economic,
political, cultural and sociological phenomena. Some see it rooted in Modernity, and
thus the continuation of a centuries-old progression, while others reserve it for more
recent developments (i.e., those that postdate World War II, or the oil shocks of the
1970s, or the Cold War). Some view it as “Westernization,” while others suggest it is
at work predominately within the developed world, and therefore represents
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“Triadization.” Despite this diversity, globalization is usually associated with
economic activity, and generally measured with reference to transnational financial
flows, international trade and the activities of multinational firms.2
While these are important measures, the argument here is that other measures
exist in the language, substance and construction of national regulatory decisions.
Domestic regulations provide further fertile ground for scholars with an interest in
globalization. On first glance, such a claim may appear obvious. Regulations,
however, have attracted surprisingly little attention from scholars interested in
globalization. In a recent review of globalization and international political economy,
Tooze (1997) frequently avoids the term regulation. Thus, he refers to
“policies.. .which are supposed to be controlled by the government of that country,”
(215) “‘domestic’ policies,” (215) “limitations on market-based economic activity,”
(216) and “protection” (216).
Where Tooze uses the term, he does so in a negative sense. Thus, he quotes the
late Susan Strange: “The new reality is that the system of states is overlaid by a highly
integrated, incompletely regulated, rapidly growing world economy” (220). This usage
2 For an early critical survey, see Hirst and Thompson (1992). Clark provides a more recent review of
globalization, in which he observes, “The vast majority of globalization theorists present it as a
characteristic of economic activity.... [T]he economic arguments concentrate upon the system of
manufacture and production (and the extent to which it remains territorially based), on levels of
international trade (and how these compare to levels of production), on the extent of international
capital flows (and their geographical spread), and on the role of multinational companies.” (1997:21).
For a broad discussion of the history, forms and issues subsumed under globalization, see Baylis and
Smith (1997). Strange (1996: xii-xiii) condemns this tendency to subsume too much under
globalization: “...change in the international political economy has so far been inadequately described
and diagnosed for what it is by most of my colleagues in the academic community of social scientists.
The evidence for that statement is to be found in a string of vague and wooly words, freely bandied
about in the literature, but whose precise meaning is seldom if ever clearly defined. The worst of them
all is ‘globalisation’ - a term which can refer to anything from the Internet to a hamburger.” It is not
this study’s goal to establish a definitive definition of the term. Rather, it is to “describe and diagnose”
(to use Strange’s terms) the effect of a transnational dynamic on the emergence of domestic regulations.
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associates globalization with minimal, or the absence of regulation. Elsewhere Tooze
echoes this sentiment: “the dominant view of neo-liberalism seeks to construct the
international economy on the same basis as the ‘free market’ domestic economy with a
minimum of political regulation” (217). The “free market” characterization of
domestic economies tends to suggest that domestic regulations are relatively
invaluable for the study of globalization.
It is Tooze himself who encourages such syntactic probe: “Part of the problem
of thinking about and understanding politics and particularly the phenomena of
globalization is that words matter [his emphasis].... The words we use both reflect and
construct our reality in general and politics in particular” (217). In agreeing with
Tooze, what explains his avoidance of the term regulation? One element undoubtedly
is that, “the dominant world view of the moment throughout the industrialized world is
that of ‘neo-liberalism’ which asserts the values and preferences of the market above
other ways of organizing society” (216). International political economists largely
construct globalization such that regulations are little more than hurdles to the
“proper” study of efficient free markets and their effects. Further evidence of this
tendency is the frequent association of globalization with deregulation and eroding
sovereignty.3
3 Thomson (1995:216) suggests that scholars have foiled to indicate clearly the direction of causality
here: “Liberal interdependence writers are not clear about the relationship between sovereignty and
interdependence. Is increasing interdependence the cause of declining sovereignty or vice versa?” With
this in mind, Held (1995:133) argues that, “the internationalization of production, finance and other
economic resources is unquestionably ending the capacity of an individual state to control its own
economic future.... [A]t the very least, it can be said that there appears to be a diminution of state
autonomy in the sphere of economic policy, and a gap between the idea of a political community
determining its own future and the dynamics of the contemporary world economy.” Casteils (1997:
261and 287-9) also emphasizes trade and financial data, and the activity of MNCs to argue that,
“globalization, in its different dimensions, undermines the autonomy and decision-making power of the
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As will soon become clear I share deeply Tooze’s belief both that words matter
and that they privilege perspectives. I learned this first hand during the course of my
research. When someone would ask what topic it was that kept me in libraries for
long hours, I had two answers. If I wished to engage the questioner, I would answer,
“biotechnology.” This term serves as a conversational stimulant, guaranteed to
provoke follow-up questions. If, on the other hand, I wished to terminate the query
(and get back to work), I would answer, “regulation.” This term serves as a
conversational opiate. Indeed, regulations enjoy little conversational currency in this
neo-liberal era. This should not lull scholars, however, into assuming their
unimportance. If successful, this study will convince the reader that domestic
regulations are both stimulating and a critical component for the study of
globalization.
nation-state.” He later identifies President Clinton’s proclamation that “the era of big government is
over” as symptomatic of the growing assault on national sovereignty. My point is not that these
observations are incorrect; but rather that they redirect analysis away from the study of domestic
regulations.
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Chapter 1 - Single Case Study from the Early Recombinant Era
I. Introduction - The Growing Prominence of Biological Weapons
On 18 December 1998 Harvey Craig Spelkin was scheduled to testify on perjury
and embezzlement charges at a federal bankruptcy court in Woodland Hills, California.
According to his FBI confession, Spelkin stopped off at a pay phone. He called the
court’s telephone operator and anonymously suggested, “You should check the air
conditioning for possible anthrax.” Police and emergency crews were summoned and
nearly 100 people were evacuated from the building. Spelkin’s hoax brought to 20 the
number of anthrax-scares during the previous 2 months in Southern California.
Authorities had dispatched up to ISO police, fire and specially-trained hazardous material
specialists to each suspected site at an approximate cost of $500,000/episode. The FBI
was busy investigating dozens of similar hoaxes across the country.1
During the same two-month period, the United Nations Special Commission
(UNSCOM) weapons-inspection regime established after the 1991 Gulf War was
collapsing, Iraq was once again blocking UN inspection of its weapons of mass
destruction (WMD) programs as required by the UN Security Council. Eventually, the
inspectors were pulled out and an American-British bombing campaign began. In its last
report of October 1998, UNSCOM expressed confidence that Iraq could soon be found in
compliance with Security Council mandates concerning dismantling of its ballistic
missile and chemical weapons programs. What UNSCOM had been unable to assure, and
‘ See Fox and Glover (1998: Bl) and Glover (1999: Bl).
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what Iraq was apparently most anxious to prevent was the dismantling of its biological
weapons program.2
A month later President Clinton requested a doubling - to $2.8 billion - of the
budget allocation to defend against a domestic terrorist attack. This request was just the
latest in a series of efforts to address a perceived vulnerability to domestic WMD use.
Biological weapons use dominates these concerns. Defense Secretary William Cohen
and others discuss the eventuality of a domestic biological weapons attack increasingly in
terms of “when,” not “if.”3
Biological weapons have quickly risen to the top of the international and domestic
security agenda. What is the source of this concern? After all, the history of biological
weapons use extends back to antiquity. Part of the explanation undoubtedly lies in
revelations of Iraq’s bioweapons program. Recent revelations of an extensive Soviet
bio warfare program, and fears of increasing international bioweapon proliferation also
fuels concern. Further, the sarin-attack on a Tokyo subway station dramatized the
vulnerability of urban centers to domestic WMD use.
The growth of biotechnology provides another element. The creation of “Dolly,”
the first successful mammalian clone developed from a somatic cell, has popularized the
power of biotechnology, a group of techniques that permit the isolation, identification and
2 “It is suggested that three central facts emerge from the present report on the Commission’s work with
Iraq during the last six months: the disarmament phase of the Security Council’s requirements is possibly
near its end in the missile and chemical weapons areas but not in the biological weapons area.... For half of
the eight-year period of the relationship between Iraq and the Special Commission, Iraq declared that it had
no biological weapons programme. When that claim was no longer tenable, Iraq provided a series of
disclosure statements all of which have been found by international experts, on multiple occasions, to be
neither credible nor verifiable” UNSCOM (1998: Sec. VI. Paras. 67 & 70). For further discussion of Iraq’s
program, see Broad (1998: S) and Tucker (1998: B9).
Not all analysts believe bioterrorism is inevitable; for example, see Sprinzak (1998) and Greenberg (1999:
A21). For discussion of the administration’s budget request, see Miller and Broad (1999: Al).
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movement of gene sequences. Connections between biotechnology and biological
weapons may run at a level deeper than popular culture. When the original recombinant
DNA (rDNA) techniques were being developed in the late 1960s and early 1970s, a
number of scientists wondered what biohazards the techniques might pose. Concern
centered on the hazards that a modified microorganism might escape the laboratory and
unleash a human pandemic. Some observers voiced fears that the new techniques would
have military application. They focused on the intentional misuse of the new techniques,
rather than conjectural effects of accidental release.
The purpose of this chapter is to revisit and to chronicle the treatment of
biological weapons during the early biohazard debates. In doing so, a link is forged
between present security concerns and these earlier debates. To accomplish this, the
discussion begins with an overview of biological weapons. What distinguishes them and
why are they important? The next section returns to the late 1960s, the eve of the gene-
splicing era. The goal is to show that observers were already aware of and voicing
concerns about links between the promised techniques and biological weapons. The final
section turns to the biohazard discussions of the early 1970s to document the exclusion of
biological weapon considerations from American and British discussions. Who was
involved and how was this accomplished? The chapter concludes with a discussion of
regulations and globalization, by asking what this episode suggests about the analytic
barriers separating private agendas, domestic rules and international norms.
II. Biological Weapons and Post-Cold War Security
Biological warfare is the use of organisms to spread death and disease among
humans, animals and plants. Historical use of biological weapons reaches back to
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antiquity when rotting human corpses were thrown into wells to poison an adversary’s
water supply; it extends into the 1930s when Imperial Japanese forces employed them
during their occupation of Manchuria. As one of the three weapons of mass destruction,
they are highly lethal. Under certain conditions their effect exceeds that of atomic
devices.4
With the exception of Imperial Japan’s offensive program, 20th century great
powers have pursued biological weapons programs for the purpose of deterrence,
although dispute persists concerning their strategic utility.5 The 1991 Gulf War initiated
debate about their use for regional deterrence, though the “lessons” from this conflict
remain ambiguous.6 At the tactical level, biological weapons exhibit several limitations.
Prevailing meteorological conditions can greatly effect their impact. They can exhibit
“boomerang effects” like those of gas during World War I. Finally they can result in
long-term contamination, complicating their use on the battlefield or against other targets.
These limitations have long been recognized, and contributed to a growing belief
among American officials in the late 1960s that biological weapons were relatively
4 For historical surveys see Poupard and Miller (1992) and Harris (1992). For comparisons with other
weapons of mass destruction, see Office of Technology Assessment (1993).
5 Steinbruner (1997-98:92) insists that “biological weapons are not plausible - let alone - legitimate
weapons of choice for any capable military establishment.” Hdden (1992:2) on the other hand warns, “it is
important that we not be misled by the widely held belief that chemical or biological weapons are of
limited value in wars between military [sic] well-equipped adversaries.” Chevrier (1996:209) concludes
that, “biological weapons are strategic weapons.”
6 Just who deterred whom from doing what remains unclear. The Pentagon’s Conduct of the War Report
concludes, “It is not known why Iraq did not use chemical or biological weapons. It is known what logistic
preparations were made to enable such use should it have been ordered by Saddam.” Navias (1991)
suggests that Saddam’s unwillingness to launch a WMD attack against Israel is evidence of the opaque
Israeli deterrent Carus (1993) claims that Saddam was deterred from launching a WMD attack on either
Israel or the Allied Coalition because of the American capacity for escalation dominance. Kahan (1997)
asks rhetorically, “In the Gulf War, we suspected that Iraq had programs in various stages of maturity, but
we did not believe that U.S. forces would face an operational NBC threat. Would we have intervened if
Iraq had been known to have operational nuclear as well as chemical and biological weapons deployed on
SCUD mobile missiles?” Finally, persistent questions about the source of “Gulf War Syndrome” suggest
that these weapons may, in fact, have been used.
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useless. In November 1969 President Nixon renounced American use of, and offensive
research on, biological weapons. This ended a substantial American program that had
weaponized and stockpiled a variety of agents, including anthrax, botulinum toxin,
brucella, tularemia and Venezuelan Equine Encephalitis. President Nixon’s decision
resulted in an arms control breakthrough and the conclusion of the Biological Weapons
Convention of 1972 (BWC).
The BWC forbids signatories from producing, developing or stockpiling
biological and toxin7 weapons. It thereby seeks to deprive states of the means to use
biological weapons. The BWC suffers from two widely recognized flaws. First, the
verification regime is weak. During the Cold War, for example, Americans were unable
to inspect Soviet centers that were later confirmed as bioweapon labs. Second, Article I
permits the production and research of biological weapon agents “for prophylactic,
protective or other peaceful means.” This creates a significant loophole, since defensive
biological weapons research often provides the familiarity necessary to exploit these
weapons offensively.8 The periodic Review Conferences mandated by the BWC have
attempted to address these shortcomings, but with limited success. Despite being
signatories to the BWC, a number of countries are currently believed either to possess or
to be pursuing offensive biological weapons programs. International proliferation
concerns have resulted in the recent American decision to inoculate the armed forces
against anthrax.9
7 A toxin is a chemical compound produced by an organism (e.g., scorpion or cobra venom). The CIA
explored and developed toxins as assassination tools before Nixon’s February 1970 executive order
instructing destruction of the American toxin stockpiles.
8 King and Strauss (1990).
9 Cimons (1997: Al).
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The biological weapons threat posed by non-state actors is also generating
concern. The February 1998 arrest of Larry Harris in Las Vegas for alleged possession of
anthrax focused American attention on the threat of “bioterrorism.” Recent efforts have
sought to develop a domestic biological (and chemical) defense program.1 0 Proposals
include mass-vaccination, the stockpiling of antibiotics and stiffened penalties. No
program can provide 100% protection against terrorist threat, and urban targets will
remain vulnerable. The capacity to spread terror with biological agents - as an invisible
organism silently attacks a population - is perhaps unsurpassed, especially if the agent
chosen is contagious.1 1 The delay between initiation of an attack and the on-set of
symptoms is frequently measured in days, rather than the seconds for a comparable
chemical or nuclear attack. This element permits the bioterrorist time to flee the target
area, though it also provides officials with some opportunity to respond to an attack.
III. Biotechnology and Biological Weapons
Why is it that biological weapons have come recently to capture the attention of
security analysts? It would be facile to “blame” these developments on biotechnology.
The recombinant revolution, however, has arguably contributed to the current policy
predicament in three ways: the capacity to enhance warfare agents, the diffusion of
technical expertise and the erosion of monopsony. Each of these factors is briefly
discussed below.
1 0 Betts (1998); Kaufinann et al. (1997). For a critical view of these efforts, see Broad and Miller (1998:
Al).
1 1 Holloway et al. (1997).
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A. Agent-Enhancement - Recombinant Hybrids
The ability to modify weapon agents is the most obvious link between rDNA
techniques and biological weapons. Zilinskas (1995:17) provides a useful inventory for
consideration:
A hypothetical weaponized agent will differ from its natural relative in several
important respects. It will have improved ability to survive storage in a munition
package; its resistance to desiccation, extreme fluctuations in temperature and
ultraviolet radiation will be increased; and it will be engineered to become
inactive or die off within a short time after release. Simultaneously, it will be
more virulent (have a greater capability of infecting its target host with a
debilitating or fatal illness) than the natural form.
Recombinant techniques permit the identification, isolation and movement of genes
responsible for such characteristics. One bacterium’s resistance to degradation, for
example, can theoretically be moved to a weapon-agent genome. Alternatively, agents
can be, and reportedly have been developed that resist available antibiotics and
vaccines.1 2 Finally, rDNA facilitates the possible enhancement of toxin weapons, whose
earlier use was inhibited by the scarce supply of toxins in nature.1 3
Despite having been a signatory to the BWC, the Soviet Union is now known to
have pursued a substantial biological weapons program throughout the 1970s and 80s. In
1989 and 1992 two key Soviet defectors provided information about this program known
as Biopreparat. Included in their revelations were accounts of genetically engineered
hybrids, indicating the application of rDNA techniques to weapon-agents. Smallpox,
1 2 “In December [1997], Andrey Pomerantsev of the State Scientific Centre of Applied Microbiology at
Obelensk near Moscow published details of an anthrax strain that he had genetically engineered to produce
bacterial toxins called cereolysins... Arthur Friedlander, head of bacteriology at the U.S. Army Medical
Research Institute for Infectious Diseases in Maryland, says: ‘We are now trying to get hold of this strain to
test it against our vaccine.’ Moreover, Pomerantsev has developed a strain of anthrax that resists six
different antibiotics, and experts fear that Iraq may have acquired it.” Mackenzie (1998). This journal
offers several useful articles on biological weapons at www.newscientist.com/nsplus/insight/bioterrorism.
1 3 For a discussion of these possibilities, see Novick and Shulman (1990:112 & 113).
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previously a symbol of international cooperation in disease-eradication, is said to have
been central to the Soviet effort. The Smallpox virus is an attractive candidate, because it
is both highly virulent and contagious. Its relatively large genome also serves usefully as
a host for the stable expression of novel genes. Smallpox has been reputedly combined
with Ebola and Marburg.1 4 In 1991 the Gorbachev government permitted British and
American weapon inspectors to tour some of Biopreparat's reputed sites. The inspectors
discovered large fermentation tanks designed for the highest levels of biocontainment,
tell-tale signs of a substantial biowarfare effort. Following these revelations and the
collapse of the Soviet Union, President Boris Yeltsin issued a formal decree in April
1992 committing the Russian Federation to dismantling its inherited biological weapons
program.1 5
The result has been a reduction in budgetary support for the institutes previously
engaged in biological weapons research and development. Despite this avowed cutback,
many analysts worry that the situation in Russia may make it impossible to shut down
entirely the previously covert program. Alternatively, analysts worry that affected
scientists will sell their skills to the highest bidders. Reports have surfaced of on-going
Russian-Iraqi cooperation on the latter’s biological weapons program. Other countries
have also been working to recruit former Soviet scientists, some of whom have gone
1 4 The issue of genetically engineered hybrids is disputed. For instance, the White House recently ran a
scenario involving a terrorist attack with a Smallpox-Marburg hybrid. “Dr. William A. Heseltine, a leading
expert on genetic engineering whom the White House asked to review the scenario, said in an interview
that [the hybrid] was realistic. ‘You could make such a virus today,’ he said. ‘Any trained molecular
virologist with a really good lab can do it’ But Dr. John W. Huggins, head of viral therapies at the United
States Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md, disagreed. ‘Most of us
think it’s many years away...’” Miller and Broad (1998: Al).
1 5 For a discussion of the Soviet/Russian program, see Lacey (1994:60-4); Preston (1998); Orent (1998).
One of the Soviet program’s defectors, Ken Alibek (a former Bioreparat deputy) has spoken in public
frequently about its clandestine achievements. See, for example, Alibek and Guernsey (1998: A19),
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unpaid for months. The ease of moving novel weapon-agents out of labs and across
borders has strengthened support for programs to finance Russian scientists and dissuade
them from international consulting.1 6
Recombinant techniques are not the only means for enhancing possible agents.
Familiarity with deadly agents would have continued to open new avenues for biological
warfare even in the absence of rDNA techniques. The familiarity necessary to develop a
vaccine against a deadly infectious agent also contributes to the agent’s offensive
exploitation. This double-edged characteristic has led to calls for the internationalization
of vaccine research.1 7 Furthermore, although recombinant techniques have opened the
door to development of exotic toxic strains, the fact is that standard biological agents are
already extremely lethal. Those who suggest that “biotechnology has unleashed new
possibilities for developing biological weapons with potentially massive destructive
capabilities” overlook the danger the standard agents already pose.1 8
B. The Coefficients of Technical and Equipment Dispersion
The claim is frequently advanced that a biology undergraduate student possesses
the requisite expertise to establish a bioweapons lab. Such a claim finesses some of the
complications of employing biological weapons. As an abstraction, Figure 1.1 represents
Langton (1998:3). Alibek (1999) recently published a book purportedly documenting the development of
the Soviet program.
1 6 For allegations of Russian-Iraqi cooperation, see Payton (1998: A2). For a discussion of Iran’s successful
efforts to entice former Soviet scientists, see Miller with Broad (1998c: Al). For a discussion of the
American financial support arrangements for former Soviet biological warfare scientists, see Miller and
Broad (1998a: A12).
1 7 Geissler and Woodall (1994).
1 8 MacLean (1992:102). Some believe genetic engineering holds the potential for development of ethnic
weapons that can exploit genetic differences among human sub-populations. There are some reports, for
example, that Iraq was researching camelpox as an agent to which local populations might already enjoy
resistance. An alternative explanation is that they used it as a simulant for smallpox, which they reportedly
possess. The potential of gender weapons that exploit metabolic and chromosomal differences between
men and women may be interesting to international relations theorists.
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the stages in developing and deploying a biological weapon. Each of these stages presents
technical challenges and exposes the would-be bio weaponeer to hazards of detection and
self-infection.
Figure 1.1. The Four Stages of Biological Weapons Exploitation
Delivery Production Agent
Acquisition
Weaponization/
Storage______
Depending on the agent, acquisition requires varying effort. Anthrax and plague are
endemic in some locations presenting opportunities for sample-collection. But a wide
variety of strains exist in nature, with varying virulence. Members of the Aum Shinrikyo
cult traveled to Zaire in 1992 in an effort to acquire Ebola samples during an outbreak.1 9
Collecting samples of such an agent obviously presents hazards to the bioweaponeer.
Theft presents another alternative, and has been used in the past.2 0 In the 1980s Iraqi
scientists simply placed a mail-order request to the American Type Culture Collection
(ATCC) to initiate its program, an approach that Larry Harris used in an effort to acquire
a plague sample in 1995. Legislation now requires the Center for Disease Control to
monitor and regulate requests to the ATCC and university research labs.2 1
Assuming one acquires the requisite stock, one must reproduce sufficient
quantities to do harm. This quantity will vary depending on the preferred target.
Production requires familiarity with culture and fermentation techniques. Weaponizing
1 9 WuDunn, Miller and Broad (1997: Al) and Miller (1998: 10). Aum attempted several attacks using
anthrax and botulinum toxin against Tokyo. These all foiled, pointing to the difficulties of employing
biological weapons.
2 0 See Kolavic et al. (1997:398).
2 1 Ferguson (1997). On the Iraqi acquisition, see Cole (1997:84-7). Larry Harris falsified stationary in his
effort, but drew attention to himself when he complained to ATCC about the slow response to his request
for Yersinia pestis.
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the agent poses another set of technological hurdles. If the goal is to generate limited
contamination, this might require little more than introducing samples at public salad
bars, as members of an Oregon cult did with salmonella.2 2 Spraying an urban target with
the aerosol form of an agent — as worst-case scenarios envision - introduces a new set of
technical hurdles. For an effective pulmonary form of anthrax, for example, one must
generate particles between one and five microns in diameter, or about 1775th the diameter
of a human hair. Familiarity with the equipment for drying and grinding an agent is
necessary to create its pulmonary form. These processes themselves, however, can
degrade an agent. Effective delivery also varies according to a number of meteorological
variables, with prevailing wind, temperature, humidity and ultraviolet levels establishing
parameters on an agent’s performance. Finally, dispersal requires aerosol equipment, the
use of which can further neutralize an agent.
Each stage in figure 1 therefore presents a set of technical and equipment hurdles.
One can imagine that a coefficient characterizes the availability of the expertise and
equipment at each stage. These coefficients will vary with the choice of an agent (e.g.,
anthrax, plague, salmonella) and the intended target (e.g., an individual, building, city). In
addition, each stage exposes the bio weaponeer to the hazards of detection and self-
infection. These will further impact the coefficient at each stage. Thus, each agent/target
generates a unique portfolio describing the difficulty of its use. With this in mind, one
might consider how these coefficients are changing.
Biotechnology continues to grow into an ever-larger commercial endeavor. It is
attracting students to the life sciences much the way the computer revolution attracted an
2 2 TO rO k et al. (1997).
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earlier generation to programming. As increasing numbers of students are trained in the
techniques of applied biology, the availability of requisite expertise grows. By 1985
Zilinskas observed that “sophisticated R&D to produce a ‘perfect’ BW agent could be
theoretically done at any of about a thousand research laboratories in industrialized
countries and about 50 in the Third World.” A decade later, he estimated that Iraq’s
civilian biotechnology infrastructure alone comprises 80 such sites.2 3 As biotechnology
spreads so too does the supply of the requisite expertise for its nefarious application.
Logic requires that the more broadly available the requisite expertise, the greater the
possibility for its misuse.
C. Eroding Monopsony - The “Spin-On” Effects of Biotechnology
The final element to consider is the changing market in dual use equipment.
Originally, domestic recombinant markets were largely monopsonistic (i.e., dominated by
a single consumer). Individual national governments constituted the consumer in each
case. In the United States, for example, the National Institutes of Health reviewed
research proposals, set regulatory guidelines and allocated funding for early recombinant
research. Monposony is peculiar in that a single consumer dictates demand and,
consequently, supply, as was initially the case with recombinant research.
In the United States the year 1980 marks a turning point in the recombinant
market. In that year, recombinant research was substantially deregulated, patent
protection was extended to novel organisms, and the initial public offerings from
biotechnology firms set new Wall Street records. Monopsony gave way to a competitive
2 3 Zilinskas (1985: 17) and Zilinskas (1997:422). Foreign governments frequently support students’
technical training in the West; it should come as little surprise that the chief of Saddam Hussein’s
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market, and since then biotechnology has grown to a $30 billion a year enterprise. This
expansion created new opportunities for, and increased competitive pressures on,
biological equipment suppliers. The commercialization of recombinant activity has
resulted in better, faster, cheaper and more readily available equipment.
Zysman (1991) documents similar trends in the electronic industry. In the 1950s
and 60s government procurement of military hardware provided the main impetus for
innovation of certain electronic components. Occasionally military innovations would
“spin-off’ a commercial application. By the 1970s and 80s, accelerating development in
consumer electronics was outpacing military development as the main source of technical
innovation. This reversed the situation, with commercial innovations finding military
application (e.g., flat-panel displays). Zysman terms this a spin-on effect.2 4
Biotechnology has experienced a similar dynamic. Growth and competition have
resulted in accelerated innovation cycles and cost-pressure. Biotechnology equipment
today is cheaper and better. Further, the industry’s penchant for financial feasts, famines,
consolidations and shakeouts has resulted in a substantial secondary market in equipment.
Occasional fire sales of dual-use equipment work to the advantage of the bioweaponeer
on a budget.
What do these dynamics mean in the real world? Kathleen Bailey, Senior Fellow
at Lawrence Livermore’s Center for Security and Technology Studies, is “absolutely
convinced” that $10,000 can currently finance a biological weapons lab. How does this
compare to earlier costs? In 1977 Wade estimated the cost at between $50,000 and
biological weapons program received her training in Western universities (Brodie, Bone and Charter 1997:
12).
2 4 Zysman (1991).
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$200,000. In 1998 terms, this represents $200,000 - $850,000 even before taking into
account the substantial improvement in lab equipment made over the past 2 decades.2 5
Compare this with the fears that “loose nukes” from the former Soviet Union
might fall into the hands of terrorists or foreign states. General Lebed testified before the
US Congress that a number of backpack nuclear devices remain unaccounted for. While
such devices present an obvious security concern, the fact is they represent a temporary
hazard: the packs will either be recovered, exploited or fail. The shift in favor of
biological weapons would appear more fundamental.2 6
rDNA techniques have contributed to changes in the economics of weapons of
mass destruction. They facilitate the enhancement of biological weapon agents. Their
commercialization has increased substantially the number of people possessing the
technical familiarity necessary to exploit these weapons. Finally, commercialization has
provided cheaper, better dual-use equipment. These facts suggest the possibility that
biological weapons will organize post cold war security the way nuclear weapons
organized cold war security.2 7
2 5 Kathleen Bailey is quoted in Cole (1996:61). Wade (1977: 149). GDP deflators are found at
www.bea.doc.gov. Compare this with the following congressional testimony from Mathew Meselson of
1969:
“Sen. Symington: Doctor, if this is true...if some country got angry, all they would have to do is take a
room and walk out and the next thing you know everybody starts dying; correct?
Dr. Meselson: Not really.
Sen. Symington: Why not?
Dr. Meselson: That is a widely held impression. But making a biological weapon which would have a
predictable effect requires a sophisticated effort.
Sen. Symington: You mean Switzerland or Israel wouldn’t know how to do it?
Dr. Meselson: They would not know how to prepare a biological weapon that would have any reliability, in
my opinion...not unless they committed themselves to a large research and testing effort” (U. S. Congress
1969:10)
2 6 Kilian (1998: 8). “Terrorists worldwide have better access to anthrax, ricin or sarin than to nuclear
materials” Nye, Jr. and Woolsey (1997: 8).
2 7 This claim is meant to be as provocative as it is speculative. In considering the possibility, one might ask
what the proliferation of an anthrax-capacity - one that beats current vaccines and antibiotics - to smaller
states may mean for the ability of great powers to project force and intervene in regional conflicts?
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IV. Biological Weapons Concerns and the Recombinant Controversy
If one accepts the links between biotechnology and biological weapons, one might
ask, “Did early molecular biologists appreciate and anticipate these links?” This section
explores that question. On the eve of the recombinant era many observers anticipated
spectacular advances in fields as diverse as biomedicine and agriculture. Some also
foresaw the problems discussed thus far, and consequently viewed rDNA techniques as a
double-edged sword.
A. The Immediate Pre-Recombinant Era
What was understood of the connection between rDNA and biological weapons?
Gordon Taylor provides some indication in The Biological Time Bomb, a book of the
month selection from 1968. Taylor combines an overview of advances in biology with a
discussion of their broader social implications. He bears witness to the new era, when
“terms such as ‘gene surgery,’ ‘gene copying,’ ‘gene insertion’ and ‘gene deletion’ are
beginning to appear in scientific statements” (159).
While Taylor focuses more on the social dilemmas posed by advances in
molecular genetics, he does briefly address biological weapons. In the following passage
Taylor’s interchangeable use of the terms “genetic engineering” and “gene surgery” is an
interesting linguistic artifact from a time when these now-familiar techniques were under
development. More to the point, Taylor suggests that biological weapons were not far
from the minds of some experts in the field:
[WJhile most biologists have been fundamentally optimistic about the possible
uses of genetic engineering, Professor Luria of MIT has declared that his reaction
has ‘not been a feeling of optimism but one of tremendous fear of the potential
dangers that genetic surgery, once it becomes feasible, can create if
misapplied... .If viruses can be used to carry new genetic material into cells,
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perhaps one could tamper with the genes of another nation without their ever
realizing the fact. History would simply record, as it has so often done in the past,
that such-and-such a nation rose to power while certain other countries entered a
decline.2 8
While Taylor’s specific application of biological weapons is perhaps clumsy, it does
indicate that both scientists and authors were familiar with and concerned by possible
misuses of their research.
Seymour Hersh provides further evidence of the link between advances in
molecular genetics and biological weapons. He observes in his 1969 book Chemical and
Biological Warfare: America’ s Hidden Arsenal:
Progress in the ability to spread germ agents is being matched by progress in
finding new and virulent strains of germs. Utilizing recent dramatic strides in
genetics, scientists are working on techniques that will enable them to breed a
variety of resistance factors into a particular bacterial or viral agent - “biological
engineering,” one scientist called it. With such techniques, a special breed of
pneumonic plague, or other diseases could theoretically be developed that no
longer would be sensitive to penicillin, streptomycin, and other antibiotics. 75
While the language to describe rDNA techniques was still in question, their consequence
for biological weapons apparently was not.2 9
The observation of two authors combined with Luria’s expressed concern do not
necessarily mean others in the field were equally sensitive to the possible link to
2 8 Taylor (1968: 183 & 4). The earlier quote concerning “gene surgery” is found on page 159. S.E. Luria -
along with Max Delbrdck and Alfred Hershey - constituted the Phage Group of the 1940s which conducted
pioneering work in, and helped to found the field of molecular genetics. Presumably, his views would have
carried some weight, especially following his receipt of the Nobel Prize in 1969. For his own views, see
Luria (1969).
2 9 Another book from the era makes passing reference: “Many [scientists], unless they are bereft of
imagination, must know that their fundamental work, their ‘pure’ Science, is being corrupted... They knew
the implications of DNA, molecular biology, gene manipulation...and they must know also that intensive
work on the practical applications of such work is going on in ‘defence’ establishments. Even if they are
not participating, they are accessories before the fact, and they must be frank about this.” Lord Ritchie-
Calder (1969: 15-6). Another book on chemical and biological weapons from the era published by an
American Congressman (McCarthy 1970) does not reveal familiarity with the advances taking place in
molecular genetics. This is somewhat surprising, since his purpose is to condemn these weapons. A
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biological weapons.3 0 It is hard, however, to sustain this claim after winter 1969. It is
then that the scientific community was treated to a revolutionary first: the isolation of a
single natural gene. Dr. Jonathan Beckwith of Harvard University, who led the research
team, called a press conference to announce the scientific first. Rather than celebrate the
feat, he and others on the team worried publicly whether their achievement would
ultimately prove more costly than beneficial to humanity. Beckwith explicitly linked the
first isolation of a gene with concerns about biological weapons.3 1
Other scientists are also known to have pursued discussions with colleagues about
the social implications of their promising research. One informal discussion occurred in
the fall of 1970 between Leon Kass and Paul Berg. Kass was a bioethicist and executive
secretary of the National Academy of Sciences’ Committee on Life Sciences and Public
Policy. Berg was a molecular biologist at Stanford University. He was perfecting the use
of a simian virus to shuttle novel genes into E.coli bacteria. The two were the dinner
guests of the Singers. Maxine Singer would soon spearhead an effort to publicize the
biohazards of recombinant techniques (discussed below). Over dinner, the group pursued
a discussion of the “ethical basis of science.”
British survey from the era (Cookson and Nottingham 1969: ch.6) discusses natural gene transfer among
microbes, but does not directly address rDNA techniques.
3 0 Luria (1969:408) wrote in The Nation about possible military applications: “we may witness efforts to
invent viruses that can spread in an enemy population genes that produce sensitivity to poisons. Or
susceptibility to tumors, or even transmissible genetic defects - in other words, genetic genocide.”
3 1 “The more we think about it, the more we realize that [our technique] could be used to purify genes in
higher organisms. The steps do not exist now, but it becomes more and more frightening - especially
when we see work in biology used by our government in Vietnam and in devising chemical and biological
weapons.” Quoted in Lear (1978:20). “Let us simply point out to those who feel we have ample time to
deal with these problems that less than S O years elapsed between Becquerel’s discovery of radioactivity in
1896 and the use of an atomic weapon against human beings in 194S. As to the specific issue of genetic
engineering, we cannot predict the future. But who in 1896 could have foreseen the weapons of mass
destruction which now threaten us all?” Shapiro, Eron and Beckwith (1969:1337).
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Following their dinner, Kass sent Berg an extended letter summarizing his
understanding of the discussion. Judging from the document of 30 October 1970, their
discussion was wide-ranging. The document offers valuable insight into the concerns of
informed participants involved with the emerging techniques. In the letter, Kass
identifies a distinct category of hazard associated with the misuse of recombinant
technology. He suggests that the potential for misuse demands public control over
recombinant research and includes in his discussion reference to biological weapons:
The ethical questions about genetic manipulation will depend in part upon the
purpose served. Obviously, once a technique is introduced for one purpose, it can
then be used for any purpose. Therapeutic is one thing, eugenic, scientific,
frivolous or even military are quite another...
The more I think about this question, and the more I contemplate the possible
widespread consequences of genetic manipulation, the more I believe that all
decisions to employ new technologies and even to develop them for employment
in human beings should be public decisions. How to do this is not obvious,
although the question of who should decide and who should control, the problem
of whether control is possible remains. There much depends upon the demand for
the new technology, its expense, the scale on which it will be used, and the know
how needed to use it. The smaller the demand and scale or the greater the cost of
know-how, the better possibility for control.3 2
Kass’ correspondence to Berg echoes Luria and Beckwith’s concern. Kass’ identification
of “demand,” “control” and “expense,” “scale” and “know-how” evoke the dynamics of
spin-on and technical diffusion discussed above. In this regard, Kass would appear rather
prescient, anticipating some of the policy problems that currently absorb security
analysts.
B. The Singer-S6U Letter - Initiating the Controversy
3 2 Krimsky (1982:33) reproduces all but the letter’s final two paragraphs.
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The June 1973 Gordon Conference on Nucleic Acids is often identified as the
birthplace of the recombinant controversy. Among the conference participants was
Herbert Boyer from the University of San Francisco. Boyer was collaborating at the time
with Stanley Cohen of Stanford University. The two were perfecting a technique that
employed plasmids to shutde novel DNA into bacteria. Boyer’s presentation revealed
sufficient information to indicate to his audience that plasmid-mediated gene transfer was
feasible. This news alarmed conference co-chair Edward Ziff. He approached his co
chair to request the allotment of time for a discussion of Boyer’s presentation. His co
chair was Maxine Singer, who had hosted Berg and Kass several years earlier. Singer
agreed with Ziff, and the implications of Boyer’s presentation dominated the
conference’s closing session.
Following a lively discussion, the conference participants voted to communicate
its concerns by letter to the National Academy of Sciences. Further, participants
recommended sending a copy of the letter to Science. This leading journal published
what eventually became known as the “Singer-Soll Letter” in October 1973. At the time
of its publication, Ziff published an article in the British publication New Scientist
summarizing his own view of the benefits and hazards of rDNA techniques. Although
neither the Singer-Soll Letter nor Ziffs article raises the issue of biological weapons, in
the magazine’s introductory editorial, Bernard Dixon sought to broaden the conception of
hazard by noting:
DNA hybridization must also look an attractive proposition for biological warfare
researchers.. .the new technique offers the prospects of fabricating even nastier
BW agents, facilitating the combination of “desirable characteristics” that cannot
be brought together by conventional microbial genetics.3 3
3 3 See Dixon (1973:236), and Ziff (1973:274-5).
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The Singer-Soll Letter alerted the scientific community to the conjectural hazards of
rDNA research, and initiated a growing discussion of them. While the discussion of
biohazard mainly focused on the possibility for accidental escape of a novel organism,
both British and American observers at the time were expressing concerns about the
technique’s implications for biological weapons.
C. The Berg Letter and the International Moratorium
The recombinant DNA controversy came to a head in July 1974 with the
publication of the so-called “Berg Letter.” Berg, who had earlier supped with Kass and
the Singers, had perfected his virus-mediated gene transfer technique. His colleagues at
Stanford had expressed concerns about his experiments, and those concerns had
percolated through the scientific community. While Berg initially dismissed his
colleagues’ concern, he finally proved unable to convince himself that no hazard attended
his experiments. Consequently, in April 1974 Berg and a group of researchers met to
discuss rDNA research, to initiate plans for an international biohazard conference and to
draft a moratorium letter. Ten members of the National Academy of Sciences eventually
signed the letter, which was published in both Science and Nature.
The Berg Letter - much as the earlier Singer-Soll Letter - is a technical document
outlining the possibility for recombining genes from different species. The letter called
for “an international meeting of involved scientists from all over the world.. .to further
discuss appropriate ways to deal with the potential biohazards of recombinant DNA
molecules.” Until that meeting, the letter called for a moratorium on further recombinant
experiments. Despite Berg’s earlier contact and correspondence with Kass, the Berg
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letter advances a narrow conception of hazard and makes no reference to biological
weapons. At least one participant in the April 1974 letter-drafting meeting - Richard
Roblin — raised concerns about biological weapons at the time. Further, the issue of
biological weapons did appear in an earlier draft of the Berg letter but was excised before
the letter was submitted to the scientific journals for publication (Susan Wright 1994:
137).
Much as Dixon brought attention to the biological weapons issue when the Soll-
Singer letter was published, Nicholas Wade did so in the issue of Science wherein the
Berg letter appears. In his commentary, Wade worries that those wishing to research the
techniques’ potential for biological weapons might ignore the moratorium:
[It] is uncertain whether the ban will be observed by countries interested in the
new technique’s considerable potential for biological warfare. Many millions of
dollars were invested at the U.S. Army’s biological warfare laboratories at Fort
Detrick, Maryland, in trying - without much success - to improve on the lethality
of viruses and bacteria harmful to man. The new technique offers a theoretically
possible way of accomplishing precisely that. The motivation of the Berg group’s
proposals springs not from any long range misgivings about biological warfare or
the social impact of genetic engineering, but rather from direct concern about the
health hazards presented by the genetically engineered bacteria that are created
with the new technique.
In his final comment, Wade reveals his lack of knowledge that biological weapons had
been discussed at the April 1974 meeting, and had been included in earlier drafts of the
Berg letter.3 4
D. The Asilomar Meeting
In response to the call for an international conference, scientists gathered in
February 1975 to discuss the biohazards of recombinant DNA. The co-chairs Paul Berg
3 4 Wade (1974:332). In this same article, Wade makes reference to Beckwith’s earlier press conference
about the dangers of recombinant research.
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and David Baltimore organized the meeting at the Asilomar Conference Center in Pacific
Grove, California. While Americans dominated the conference, researchers from around
the world — including the Soviet Union — participated at Asilomar. The conference was
equally noteworthy for those who were not invited. Richard Roblin suggested at the April
1974 organizing meeting that Leon Kass be invited to Asilomar. He was not, however,
extended an invitation. Nor did Beckwith - whose research team first isolated a gene -
initially receive an invitation, though Roblin did secure him a belated invitation shortly
before Asilomar. Beckwith, convinced that Asilomar would in effect whitewash issues,
declined what he felt was an effort at tokenism. Another politically active molecular
biologist - Jonathan King - was extended an invitation 5 days before the meeting, but
was unable to attend because of a previous commitment.3 5
At Asilomar’s opening meeting, co-chair David Baltimore delivered an address to
the assembled participants. He explained that the reason for the meeting was to ask
questions unusual for scientists; for example, “when do procedures in molecular biology
become more of a hazard than a benefit?” Despite framing the purpose broadly,
Baltimore informed participants that two questions were to be excluded from discussion.
The first of these
.. .is the utilization of this technology in gene therapy or genetic engineering -
which leads one into complicated questions of what’s right and what’s wrong -
complicated questions of political motivations - and which I do not think is the
right time [for our consideration]. Second, an issue which I think is very serious
and which many of us have cared about for a long time, which is the potentiality
to utilize this technology for biological warfare. And again, although I think it is
obvious that this technology is possibly the most potent technology fo r biological
warfare, this meeting is not designed to deal with that question (my emphasis).3 6
3 3 Lear (1978:124-5). King has since written extensively on biological weapon issues.
3 6 Quoted in Susan Wright (1994: 148 & 9).
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Thereby Baltimore struck biological weapons from the biohazard agenda. In a later
interview, Baltimore claimed that the decision to bracket out biological weapons was
made at the April 1974 meeting when the moratorium letter was being drafted.
Despite Baltimore’s instruction, biological weapons did not entirely disappear.
Asilomar was organized around three working groups - the Plasmid Working Group, the
Eukaryote Working Group and the Virus Working Group. Berg and Baltimore appointed
each group’s chairman, who in turn were permitted some latitude to organize their
individual panels. Richard Novick, a microbiologist from the New York City Public
Research Institute, headed the Plasmid Working Group (PWG). In the pre-Asilomar
organizing period, the PWG met the most times and generated the most comprehensive
report.
Despite Baltimore’s admonishment, PWG members observe toward the end of
their summary report:
We believe that perhaps the greatest potential for biohazards involving alteration
of microorganisms relates to possible military applications. We believe strongly
that construction of genetically altered microorganisms for any military purpose
should be expressly prohibited by international treaty, and we urge that such
prohibition be agreed upon as expeditiously as possible.3 7
The passage echoes Baltimore’s expressed concern about the link between rDNA
techniques and biological weapons. In fact, the PWG identifies misuse as the most
important element of biohazard. Despite the PWG’s observation, biological weapons
were never broadly discussed at the Asilomar conference. Because Baltimore originally
excluded biological weapons from the agenda, the PWG’s recommendation was excluded
from the Asilomar’s final recommendations. Wright regards this omission as evidence of
3 7 Quoted in Krimsky (1982:131).
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a consensus in favor of the limits Baltimore established.3 8 It remains speculation,
however, whether the PWG’s passage would have been included had it been put to a
separate vote.
V. Asilomar’s Legacy - The Globalization of Domestic Regulatory Decisions
Many hail the social responsibility of scientists willing to impose and respect a
moratorium to consider the hazards of their research before proceeding with it. Some
critics argued that the Asilomar recommendations were inadequate, while others believe
the conference served mainly to alarm the public and generate unnecessary regulations.3 9
Stanley Cohen, a signatory to the Berg letter and a co-inventor of plasmid-mediated
transfer, later reflected:
In retrospect, it seems to me that while the [Berg] letter was perceived as
responsible, it was not really responsible at all. The most incriminating thing that
any of us could have said at the time about recombinant DNA research was, not
that there was any indication of hazard, not that there was any valid scientific
basis for anticipating a hazard, but simply that we could not say with certainty
that there was not a hazard.4 0
This is probably not a fair representation. The “most incriminating thing” one may have
said about recombinant research at the time - what Kass, Beckwith, science editorialists
and journalists were suggesting at the time, and what the PWG made explicit in its
Asilomar recommendation - was its potential for deliberate misuse. From the earliest
days, some sought to include consideration of biological weapons. From the start, others
moved to exclude them from the agenda. In restricting the definition of hazard to
3 8 See Dixon (1973:236), and Ziff (1973: 274-5).
3 9 See Wade (1974:332-34), and (1975:931-35). For a favorable view on Berg’s pivotal role for
Asilomar’s outcome, see Chedd (1975:546). Alternatively, Allan Campbell (1991:39) holds the Asilomar
Conference responsible for “the monstrous network of restrictive regulations that confronted biologists in
the 1970s.”
4 0 This quote appears in Campbell (1991:44, fii. 14).
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accident-scenarios, one wonders whether the actual social costs of recombinant
techniques were ever provided a fair airing.
The recommendations that emerged from Asilomar served as the basis for
American regulation of recombinant research. Thus, while Asilomar was one of several
meetings, it remains the critical event. Asilomar’s impact, however, extended beyond
American shores. To understand how this was the case, it is necessary to review the
relationship between Paul Berg and Eric Ashby.
In July 1974, as the biohazard controversy was gaining public profile, the British
Government asked Lord Eric Ashby to lead a study of “the potential benefits and
potential hazards” of recombinant DNA. In September 1974 Berg traveled to Britain
where, among other things, he debated recombinant issues on BBC television. He also
took the opportunity to meet Lord Ashby, after which the two remained in regular
contact. Despite having been instructed to consider the “potential hazards,” the Ashby
Committee placed biological weapons beyond the scope of its review. The Ashby
Committee limited its concept of biohazard to technical considerations of accidental
release while emphasizing the potential benefits of recombinant techniques. The Ashby
Report was released in January 1975, one month prior to Asilomar.4 1
Thus, within the Anglo world the biohazards of recombinant research were
conceived and limited in a similar fashion. Unsurprisingly, the regulatory systems
designed to govern recombinant research were similar.4 2 They both responded to
4 1 Again, Dixon (1975: 186) is critical of the Ashby Report at the time. For a discussion of the Berg-Ashby
connection, see Susan Wright (1994:143).
4 2 According to Susan Wright (1994: 158), “Given the basic similarities in the institutional position of
policymakers in the United Kingdom and the United States and evidence of frequent exchanges of
information about policy issues among scientists generally and among those with special responsibilities
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concerns about limiting the accidental escape of recombinant organisms from research
labs. When authorities in other countries moved to regulate recombinant research, they
drew heavily on the regulatory models developed in the United States and Britain. Table
1.1 summarizes the breadth of influence that the Anglo-regulatory model enjoyed:
Table 1.1. The Anglo Sources of Early Recombinant Regulations4 3
Country Model
Australia Combination American/British
Canada American
France Abridged American
West Germany American
Israel American
Holland British with American elements
Sweden British
Switzerland American
U. S. S. R. Combination American/British
Through formal and informal networks, a definition of hazard was forged that focused on
the accidental release of recombinant organisms. While some sought to include
consideration of intentional misuse, those controlling the biohazard agenda repeatedly
excluded such consideration. The Asilomar conference provided the basis for American
regulations, and the Ashby report provided the basis for British recombinant regulations.
Together, the Anglo model served as the basis for recombinant regulations throughout the
world - even on both sides of the Iron Curtain. In large measure, a global regulatory
system - an international recombinant norm - emerged to govern recombinant research.
This case suggests that, in some instances, the analytic barriers separating private
agendas, national regulations and international norms are rather thin.
for forming policy, such as Paul Berg, Sydney Brenner and Eric Ashby, it is hardly surprising that strong
conceptual similarities characterized the arguments behind decisions taken in each country.”
4 3 This table is adapted from Zilinskas (1981:246).
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VI. Conclusion
From the perspective of the individual recombinant researchers, exclusion was
entirely rational. Ending the moratorium and resuming recombinant research dominated
their preferences. The fears of accidental release generated sufficient concern to raise the
specter of a formal governmental ban on their research. Defining biohazard in terms of
accidental release served both to limit the battlefronts, and to play to the researchers’
strength. After all, who was better positioned to evaluate laboratory hazards than the
scientists developing the techniques?
Was an appropriate account made of the hazards linking recombinant research
and biological weapons? After all, the security-extemalities generated by the
commercialization of these techniques currently consume policy makers. The discussion
here suggests that biological weapons deserved a place on the agenda. The claim here is
not that their inclusion would have necessarily resulted in a different set of regulations. It
is possible that Asilomar participants may have issued identical recommendations even
after openly addressing biological weapons. Nor is the claim here that biotechnology has
generated - or will generate - more costs than benefits. The claim here is simply that
exclusion assigned a de facto value of zero to the hazards of intentional misuse. This
value was amplified through the international system by the foreign adoption of Anglo
rules. Given the efforts being made at the time to include them, and current security
concerns, the decision to exclude biological weapons was probably mistaken.
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Chapter 2 - Literature Review and Regulatory Model
I. Introduction: Risk. Regulation and I Jncertaintv
The following chapter constitutes an exercise in literature review and theory
building. The two best proceed in tandem, to ensure one’s ideas are novel, and to provide
explicit reference for their further pursuit A key question guides the inquiry: How have
scholars and practitioners defined the terms risk and uncertainty, and how have they
applied them to the regulation of technology? A substantial body of literature - from
economics, the policy sciences and the social sciences - addresses these terms. Despite
this, scholars often disagree on the meaning of these terms, use them imprecisely,
interchangeably, or sometimes without benefit of definition. The alternative framework
presented here provides systematic and explicit definition of these common terms.
In the first section, expected utility theory is used to show how scientific risk
assessment can generate pareto-optimal regulations, while risk management can generate
regulations that advance social goals. Many criticize expected utility theory for lacking
descriptive power, and question the empirical validity of its assumptions (e.g., complete
information and rank-ordered preferences). Expected utility theory, however, serves
usefully to describe how regulations might ideally be generated under conditions of risk,
thus fulfilling an important normative function.
In addition to its normative function, expected utility theory serves a prescriptive
function for current “risk orthodoxy.” Disciples of risk orthodoxy believe that Science is
available and essential for the rational regulation of technology. Quantitative and
probabilistic risk analysis represent the pinnacle of this effort. When quantitative
methods are unavailable, adherents of risk orthodoxy believe that the expected utility
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approach should guide one’s efforts. Thus, the solution to scientific uncertainty has been
a call for experts to offer “best-estimates.”
Following this discussion, the question of scientific uncertainty is tackled. What
are its sources? What are its implications for the study of risk and decision making?
Among the conclusions, uncertainty limits attempts to assess the risks associated with an
innovation. This led scholars to investigate risk from a social scientific perspective. Two
analytic approaches - culture and institutions - have dominated the social scientific study
of risk. Culturalists explain why group members identify the hazards they do.
Institutionalists explain why some groups enjoy access to decision making while others
do not, and offer prescriptions for improved risk management.
Analysis of risk within the social sciences has relied mainly on case studies of
domestic actors within domestic contexts. Recently scholars have called for comparative
approaches to technological risk analysis. The methods and findings of the comparative
approach are presented. In particular, scholars conclude that scientific uncertainty does
not generally contribute to policy convergence across national jurisdictions. There are
two reasons to reject this conclusion. First, the methods employed cannot answer
questions about regulatory convergence. Second, such a conclusion is at odds with
evidence that they themselves present.
In response to this criticism, a model is advanced illustrating how information
shared across borders may effect regulatory development. This model supports the
hypothesis that scientific uncertainty can contribute to regulatory convergence across
national jurisdictions where information networks emerge. Later chapters explore this
hypothesis with reference to the regulation of agricultural biotechnology.
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II. Three Distinctions
In this first section, essential terms come under scrutiny. Three sets of pairs
organize the discussion: risk v. hazard, assessment v. management, and risk v.
uncertainty. Such a discussion serves two functions. First, it demonstrates that these
terms have been used in ways that have frequently confused or prejudiced analysis.
Second, it suggests the need for clear reconsideration of these terms.
A. Distinction #1 - Risk v. Hazard
Historically the term risk has been linked to the probability of events and the
probable magnitude of their outcome. Probability has roots in early Enlightenment
efforts to understand games of chance, played an important role in Imperial British
shipping and insurance, and dominates notions of modernity and reason.1
In its contemporary use, however, risk has come increasingly to refer only to the
costs associated with a decision or outcome. Among both practitioners and observers,
risk has become synonymous with hazard. As Douglas (1990: 3) observes,
the word has changed its meaning. It has weakened its old connection with
technical calculations of probability.... The risk that is a central concept for our
policy debates has not got much to do with probability calculations. The original
connection is only indicated by arm waving in the direction of possible science:
the word risk now means danger; high risk means a lot of danger.... The word has
been preempted to mean bad risks. The promise of good things in contemporary
discourse is couched in other terms (her emphasis).2
Popular uses bear this observation out. The phrase “at risk” usually describes someone
particularly vulnerable to danger (e.g., an inner-city child’s increased exposure to random
1 For a history of probability, see Bernstein (1996) and David (1962). For a specific look at biostatistics, see
Kevles (1985).
2 She also writes, “Whereas originally a high risk meant a game in which a throw of the die had a strong
probability of bringing great pain or great loss, now risk refers only to negative outcomes” (1990:3). In
light of her thesis, this sentence makes greater sense if one replaces pain with gain. Otherwise, it retains
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gunfire); a “no-risk” decision is one without costs (e.g., a money-back guarantee). Wall
Street gurus advise assessing the “risks and rewards” when considering an investment.
The equivalence of risk and hazard is widespread.3
Some fail to define or distinguish the term risk. Lave’s (1980) widely-cited
discussion of social regulation is instructive. He argues that eight different “frameworks”
organize a regulator’s alternatives. Three of these contain the term risk (“no-risk,” “risk-
risk” and “risk-benefit”), yet nowhere in his discussion does he define the term itself.
Usually, the term substitutes for hazard.4 Twice, he implores regulators to include
estimates of the “costs, risks and benefits.”5 While this suggests that a risk is neither a
cost nor a benefit, it does not clarify what it is, or how to measure it. Lave assigns
obvious importance to risk but ultimately leaves it undefined.
the contemporary link between risk and negative outcomes which she criticizes. I believe this to be a
critical typo.
3 Douglas’ discussion (1986?: 20) of the phrase “risk-benefit” echoes the equivalence of risk and hazard.
“The idea that risk means only probabilities of harm is very widespread, even where ‘risk-benefit’ is a
method deliberately compared with cost-benefit analysis.” One can trace this equivalence back to Starr’s
seminal piece (1969) on technology regulation. The title of his piece, “Social Benefit versus Technological
Risk,” implies that the opposite of a “social benefif ’ is a “technological risk,” rather than a “social cost.”
His measure of risk is a simple mortality rate, thus establishing a conceptual link between risk and death.
Derby and Keeney (1981:220) add morbidity for their own definition of risk: “the possibility of
consequences involving mortality, morbidity, or injury to members of the public.” Others suggest
equivalence between risk and “net cost”: “With a clear set of concepts, it is possible to begin making the
hard tradeoffs between risks and net benefits” (Fischhoff et al. 1984: 133). Both Perrow (1984:310) and
Wildavsky (1988:60) suggest that cost-benefit is distinguished from risk-benefit by the latter’s refusal to
assign monetary values to human life, a contentious exercise. The term risk-benefit enjoys broad use at the
federal level. See for example U.S. Congress (1980). Lave (1980:17-8) includes “risk-benefit” among his
eight frameworks for regulation.
4 This usage is most clear from his discussion of the “no-risk” framework: “This approach is typified by the
Delaney Clause, which bans a substance from being used as a food additive if there is any evidence of
carcinogenicity” (Lave 1980: 11-3). Carcinogenicity represents a hazard. The frame-work can be renamed
“no-hazard” without any loss of meaning.
5 “Costs, risks, and benefits” and “risks, costs, and benefits” (Lave 1980: vii & 18). Brooks (1988:167) uses
a similar phrase in his title, but does not clarify the relation between the terms. His clearest statement
equates risk and “social cost”: “Until very recently, the exemption of innovators from the risk of having to
bear the social costs of their innovations was almost absolute - to a degree, in fact, that seems almost
unimaginable today.”
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Among Lave’s eight frameworks are “risk-benefit” and “benefit-cost” He
suggests that these two frameworks share consideration of “non-health effects” (e.g.,
impacts on ecosystems, endangered species, individual freedom). What distinguishes
these two approaches from one another, however, is unclear. Lave initially writes that
“risk-benefit analysis requires as much information as benefit-cost analysis, although it is
less formal” (9, footnote 3). He elsewhere claims that one is more mathematically
rigorous than the other: “benefit-cost analysis is the most general and quantitative of the
frameworks, and thus elicits the most information and requires the most analysis “ (24).
But he contradicts this when he claims that “risk-benefit” includes “consideration of all
risks, costs and benefits” (18). If risk-benefit can include consideration of “all risks,
costs, and benefits,” then what information is additionally considered by “benefit-cost”?
Lave’s analytic categories raise a number of unanswered questions.
This conceptual link between risk and hazard is pervasive. The Harvard Center
for Risk Analysis recently defined risk “as the chance of an adverse outcome to human
health, the quality of life, or the quality of the environment” (Graham and Wiener 1995:
22). Such a usage illustrates the shortcomings of equating risk and hazard. First, such a
definition prejudices analysis: if a problem is defined as “the chance of an adverse
outcome,” solutions must seek to minimize that chance. Such a strategy appeals to the
common notion that “an ounce of prevention provides a pound of cure.” Analytically,
however, it fails to recognize that diminishing returns dominate the level of protection
provided by subsequent ounces. Taken to its logical end, the Harvard conception of risk
advocates reducing one’s hazard-exposure despite the inevitable increasing costs
associated with further attempts to do so. Furthermore, one occasionally embraces “the
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chance for an adverse outcome” for a potential payoff (e.g., when purchasing a stock or
playing the lottery). The possibility of an adverse-outcome - losing one’s initial stake -
is dominated in these cases by the possibility for a handsome return.6
A judicious definition of risk must include both the probable costs and the
probable benefits of a decision. While some scholars have urged this for over a decade,
the council continues to go ignored.7 Throughout this study, risk will refer to the
probable costs and the probable benefits associated with available options. It thus
adheres to the term’s historical usage. Instead of the cumbersome phrases “probable
costs” and “probable benefits,” the terms hazard and opportunity will substitute,
respectively. The definitions can be represented schematically:
Figure 2.1: The Elements of Risk.
Risk
Hazard Opportunity
This distinction circumscribes the frequent synonymous use of risk and hazard}
6 Compare the Harvard study with Wiidavsky’s extensive discussion of opportunity costs and other
definitional issues (1988: chs. 1-3).
7 It is stunning how often “risk assessment” ignores benefits. Even Ramo (1981: 837-42), who
characterizes trade-offs between benefits and harms as “key” fails to sustain this comparison through his
discussion of regulatory reform. Derby and Keeney (1981:219) assume “benefits of all alternatives are
identical,” and then proceed to compare the different disadvantages posed by alternatives. This is a useful,
though unrealistic assumption. Others, however, simply compare the hazards related to different options,
characterizing them as “more or less risky,” while ignoring the probable - and differing - benefits
generated by these options. Wilson (1979:44), for example, produces a list of activities that he says
increases one’s chance of death by one in a million, including travelling 10 minutes by bicycle and 1000
miles by je t He argues “it would be a better policy to try to measure out risks quantitatively, and to give an
upper limit on a risk.” See also Tewksbury et al. (1980).
8 Endless examples are available. Perrow (1984: 3) writes, “if we can understand the nature of risky
enterprises better, we may be able to reduce or even remove these dangers.” Perrow’s focus of concern is
“catastrophic accidents,” though he assumes agreement on (and therefore fails to define) the term
“catastrophic” (1984: chs. 3 and 9).
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Such a definition has implications for decision making. Any decision can have
one of three results with regard to both opportunity and hazard. It can increase one’s
exposure, it can decrease one’s exposure, or it can leave one’s exposure unchanged with
respect to both. These three possibilities combine to yield a matrix of nine mutually
exclusive categories for comparing risk-options (table 2.1).
Table 2.1: Risk Results.
Increase
Opportunity
Neutral
Decrease
A decision that increases exposure to opportunity while decreasing exposure to hazard is
categorized as optimal. Alternatively, a decision that increases exposure to hazard while
decreasing exposure to opportunity is categorized as worst. A decision is neutral if it
does not affect exposure to either hazard or opportunity. A decision can be neutral with
regard to one of the variables, thus yielding an inferior or superior outcome in relation to
the second. Finally, two mixed outcomes generate either increased opportunity and
hazard, or decreased opportunity and hazard.
These alternatives can be graphed along twin axes, as in figure 3.2. A decision
can be understood as generating a vector radiating from the origin, which itself represents
the status quo. A pareto-optimal frontier circumscribes the capacity to provide limitless
opportunity and diminishing hazard. An upward bound exists for hazard: this represents a
situation where the probability of a worst possible outcome approaches 1. Similarly, a
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Hazard
Mixed Superior Optimal
Inferior Neutral Superior
Worst Inferior Mixed
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lower bound exists for opportunity. Solitary confinement may serve to represent
conceptually this boundary.
Figure 3.2: Risk-Space.
Mixed
Optimal;
Mixed Worst
Catastrophe
Hazard
The dashed lines intersect at a status-quo position. A decision would be represented
schematically as a vector originating from this intersection (e.g., the arrow). The four
quadrants describe the consequence of a decision in terms of hazard and opportunity.
Decisions effect exposure to hazards and opportunities (via probabilities and
magnitudes), thereby shifting the status quo position, though their impact may never in
fact be realized.
Solid lines circumscribe the consequence of decision making. Thus, the upper left
quadrant is circumscribed by the familiar pareto-optimal curve. The frontier’s extension
into the “mixed” quadrants circumscribes the rate at which hazards and opportunities are
swapped. The bold vertical line to the right of the status quo circumscribes the degree of
hazard to which an individual can be exposed. The “worst ” quadrant represents
decisions resulting in increased exposure to hazard and diminished exposure to
opportunity. Within the suboptimal quadrant lies a region of “catastrophe,” a lower
bound on the consequence of a decision.
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B. Distinction #2 — Risk Assessment v. Risk Management
In the 1980s risk discussions increasingly distinguish between assessment and
management. The National Research Council (NRC) defines risk assessment as “the
characterization of the potential adverse health effects of human exposure to
environmental hazards” (1983:18).9 Such a definition thus retains the problematic
equivalence of risk and hazard discussed above. Furthermore, the definition is too
narrow, having been derived from an empirical concern with environmental hazards.
Taken literally, the NRC definition implies that FDA drug-testing is beyond the scope of
risk assessment, since drugs are not typically considered “environmental hazards.”
Finally, such a definition assigns the process of assessment no allowance for estimating
probable benefits. Without that estimate, one is hard-pressed to evaluate the wisdom of
employing a technique or using a novel compound.
For these reasons, a general definition of risk assessment must be broadened.
With reference to the definition of risk developed above, risk assessment will refer here
to the process of estimating the hazards and opportunities of competing choices.
Scientific experts typically perform this task linking the probability of outcomes with the
magnitude of their consequence. These generate the decision trees and von Neumann-
Morgenstem utilities familiar to policy analysts.
The NRC defines risk management as “the process of evaluating alternative
regulatory action and selecting among them” (1983: 19). Such a definition also exhibits
limitations. The emphasis on regulatory action suggests that risk is a topic of unique
concern for public authorities. The discussion developed here, in contrast, is more
9 Jayner (1996: p. S) denounces this document as offering a “naive-realist view of science.”
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general and assumes that individuals continually confront decisions of risk. Again, a
broader definition is required. The term risk management will refer to the process of
selecting among available risk-options. The two terms therefore describe the process of
decision making under risk.
1. Expected Utility Theory and Regulation
Expected utility theory (EUT) dominates economic descriptions of rational
decision making. While its empirical application is frequently contested, EUT identifies
pareto-optimal decisions, thereby describing where it is one ultimately seeks to be.1 0 To
develop a model, assume a given technological innovation. Associated with any
innovation are a variety of possible activity-sets, each with an attendant set of hazards
and opportunities (a.k.a., risks). These hazards and opportunities are both publicly and
privately distributed. Public authorities seek to privilege some activities in order to
generate and distribute a preferred set of public and private risks. The instrument they
employ is a regulation, a prescription on private activity by a public authority for a public
purpose.1 1
Because expected utility theory assumes complete information, scientific issues
are largely technical. A mythical panel of best-informed “experts” assesses scientifically
the risks associated with all relevant activity sets. They generate estimates of magnitude
and probability for relevant options. These estimates serve as different regulatory options
1 0 A more formal account of the ideas used here is found in Hey (1979: chs. 2 “Utility Theory” and 7
“Information”).
1 1 Mitnick (1980: ch. 1) provides a valuable discussion of the term refla tio n . He defines regulation as “the
public administrative policing of a private activity with respect to a rule prescribed in the public interest”
(1980:7). Francis (1993: 5) defines regulation as “State intervention in private spheres of activity to
realize public purposes.” Thus, regulations are distinguished by three characteristics. First, they attempt to
advance social utility. Second, they prescribe private action. Prescriptions can be both positive and
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for public authorities.1 2 Much as “experts” possess complete information in the scientific
domain, “authorities” possess complete information of social preferences within their
regulatory domain.1 3 Authorities choose regulations that maximize an expected social
utility.1 4
Expected utility theory thus generates a two-stage model of
technology-regulation. In the first stage, experts insure pareto-optimality among
regulatory options. In the second, authorities choose the regulation that maximizes a
preferred set of public and private benefits. Risk assessment ensures pareto-optimality,
while risk management identifies the point along the pareto-optimal frontier that a
jurisdiction will occupy. Note that EUT says relatively little about the distribution of
opportunities and hazards.1 5
This model of innovation-regulation possesses two sources of feedback. First, as
scientific knowledge advances, so too does the definition of complete information. Thus,
regulations can remain pareto-optimal only if they incorporate best-available science.
One must assume either that information is static, or that regulations are continuously
negative, either requiring or forbidding an activity. Third, they emerge from a public administrative source
with recognized jurisdiction.
1 2 It is not unreasonable to suggest that, in the ideal, scientists themselves would also be the regulatory
authorities. The two are kept separate here to retain the distinction between assessment and management.
1 3 This claim largely ignores the complications posed by preference cycling (Hey 1979:28). For the
purposes of this discussion, social utility is simply exogenous. This assumption is similar to the simplifying
function of the Walrasian auctioneer, who stands outside markets and sets equilibrium prices (Hey 1979:
221). One can agree with Fischoff et al. (1987:17) that “of course, there is no all-purpose public any more
than there are all-purpose experts,” but still use the model as a point of comparison.
1 4 Hatziandreu, Williams and Graham (199S: 42) offer a similar ideal model to describe physician-patient
decisions: “If die physician-patient relationship is functioning well, the physician gives the patient an
objective assessment of the risks of going without treatment and the risks that may be induced by each
potential therapy. The final decision about therapy is a balancing of risks made by the patient in
consultation with her physician.” Note that the use here implies a conception of risk that includes both
probable benefits and costs.
Proponents recognize the problem of distribution. See for example Okrent (1980) and Starr and Whipple
(1980).
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updated. Second, to the extent that social values evolve, regulations must shift along the
pareto-optimal frontier. Thus, an ideal model of innovation-regulation is dynamic and
adaptive.
2. Sources o f Variation among Regulatory Jurisdictions
These two sources of feedback — information and preferences - provide the source
of regulatory variation among different jurisdictions. For example, two countries
confronting the same innovation may, for linguistic reasons, possess different sets of
“complete” information. This possibility makes information disparity a potential source
of regulatory variation.1 6
Even if one assumes complete and common information across regulatory
jurisdictions, variation may yet result. This is because risk assessment alone does not,
nor cannot, generate regulation.1 7 Risk management requires weighing the scientific
assessment against expected social utility functions. There is no a priori reason to
assume similar preferences across regulatory jurisdictions.
C. Distinction #3 - Risk v. Uncertainty
A final distinction is required between the terms risk and uncertainty. This
discussion has been pursued mainly in Economics, where two approaches are found.
Frank Knight is credited with the approach that sets risk and uncertainty in contrast to
each other. Mainstream economics, in contrast, generally subsumes uncertainty within
risk. The key difference is the role for probability analysis. Each of these approaches
1 6 Information-disparities would have been greater in the pre-industrial age, where the costs of relaying
information were greater. Relatively little research on early technological risk is available. Ferguson (1987:
308-9) provides an interesting discussion of evolving 19th century boiler standards.
1 7 As a former Director of the Hastings Center observed before a congressional forum, “Facts do not simply
present themselves to the naked eye; interpretation is always necessary” Callahan (1980:6).
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will be discussed in turn.
Frank Knight is credited with distinguishing between risk and uncertainty. In his
1921 work Risk, Uncertainty and Profit (1964), Knight identifies three ideal-types of
decision making. In the first (a priori probability), general principles are used to
calculate distributions. Knight’s example is the distributions associated with fair dice. In
the second type (statistical probability), distributions are generated empirically.
Statistical methods can then be applied to such data, as might an actuary. According to
Knight probabilities can be assigned to both of these types of decision making.
Situations of risk are those to which one can apply the tools of probability analysis.1 8
In contrast to the two risk-categories, a third type of decision making requires
estimates be made without benefit of either a priori or statistical probabilities. These
decisions are “more or less based on experience and observation...it is doubtless
principally after all simply an intuitive judgment or ‘unconscious induction,’ as one
prefers” (1964: 229). Humans are continuously called upon to exercise such judgment
without recourse to probability. Uncertainty describes those situations to which one
cannot assign probabilities. Knight’s typology therefore places risk and uncertainty at
opposing ends of a spectrum.1 9 Wubben argues that Knight’s concept of uncertainty was
initially engaged, but gradually ignored by subsequent generations of economists.2 0
1 8 See Knight (1964: chs. vii and viii). For a useful discussion of Knight, see Wubben (1993: chs. 1 & 2).
1 9 “The practical differences between the two categories, risk and uncertainty, is that in the former the
distribution of the outcome in a group of instances is known (either through calculation of a priori or from
statistics of past experience), while in the case of uncertainty this is not true, the reason being in general that it
is impossible to form a group of instances, because the situation dealt with is in a high degree unique” Knight
(1964:233).
2 0 According to Wubben (1993: SS), “By the end of the interwar period, uncertainty had undergone a
metamorphosis in its meaning.... The emphasis shifted from immeasurable outcomes, which Knight
stressed, and came to lie with unknown chances.”
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The other approach - represented here by Hey (1979) — is to subsume uncertainty
within risk. Hey reveals familiarity with Knight’s approach, observing “many authors -
myself included - have come to use the term ‘uncertainty’ rather loosely as a blanket
term meaning ‘the lack of certainty’...few authors have used the term ‘uncertainty’ in the
sense given by Knight” (41). For Hey, uncertainty acquires various meanings. It refers to
“a world of doubt, haziness, hesitation and ignorance. It is about disequilibrium” (7);
alternatively, it refers to “increased realism” (71). Hey offers a formal definition, “For y
> 0, increasing y implies a stretching of the distribution about a constant mean. Thus,
increases in y can be thought of as increases in uncertainty” (73). Ultimately, Hey falls
back on a working definition of uncertainty that equates it to risk. His discussion and
analysis reveal the two are indistinguishable and linked by information inadequacies: “in
very general terms, risk and uncertainty can be described as lack of information: with
complete information, appropriately defined, one would have complete certainty. Thus
the process of acquiring information can be considered as a means of reducing the
amount of uncertainty present in a given decision problem.”2 1 Hey’s discussion leaves
uncertainty largely indistinguishable from risk.2 2
2 1 According to Hey’s introduction, “We assume that the individual whose decision-making we are
studying perceives the lack of certainty as a situation of risk. By this, we mean a situation in which the
individual can list all the possible states of the world (that he perceives may occur) and can attach
probabilities (necessarily subjective, though they may coincide with so-called objective probabilities) to
these various states of the world. This assumption enables us to proceed...using von
Neumann-Morgenstem utility theory; this theory provides a way of encapsulating the individual’s attitude
to risk (expressed via the effect of risk on the individual’s behavior) in terms of a utility function” (1979:
11). According to the conclusion, “we began by assuming that the perception of the uncertainty by the
individual could simply be described in conventional probabilistic terms. That is, we assumed that the
individual simply attached probabilities to all uncertain events, and that he manipulated, where necessary,
such probabilities according to the conventional probability rules” (1979:214). I am not claiming that this
is not a useful means of proceeding with choice-analysis. I am asking a different question, “what
independent effects — if any — does uncertainty generate?”
2 2 Schlaifer (1969) similarly treats uncertainty as equivalent to risk. Raiffa (1968: 17) does the same: “The
methodology of these lectures requires that preferences for consequences be numerically scaled in terms of
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Thus, economics provides two competing conceptions of risk and uncertainty.
Mainstream economists represent uncertainty as simply a special case of risk. For
Knight’s adherents, “to conflate uncertainty with risk and represent them by means of
probabilities is evidence of a fundamental misunderstanding of uncertainty tantamount to
an illusion of knowledge, resulting in false self-confidence among the economists
concerned” (Wubben 1993: 5). These two approaches can be represented schematically.
For Knight, a spectrum describes the relationship between the two; for the mainstream, a
Venn diagram serves the purpose:
Figure 2 3 : Competing Conceptions of Risk and Uncertainty from Economics
A. Knight: Risk<--------------------- > Uncertainty
B. Mainstream:
Risk
Uncertainty
How does uncertainty relate to the model of risk developed earlier? A Z-axis can be
added to the x and y axes generated by hazard and opportunity. In this case, the z axis
represents uncertainty. One can limit values of Z between 0 and 1. A value of 0 (e.g., the
origin) represents, in Knight’s terms, decisions of probability analysis. For all decisions
where Z > 0, choices become increasingly dominated by uncertainty, and therefore less
subject to probability analysis (see figure 2.4).
utility values and that judgments about uncertainties be numerically scaled in terms of probabilities" (his
emphasis). See also Raiffa (1968: ch. 5). Knight’s distinction may be on the return. Perlman and McCann,
Jr. (1996) provide a valuable review of uncertainty and its relation to risk in economic thought This recent
review - unlike earlier ones - provides Knightian uncertainty a central place.
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Figure 2.4: Risk-Uncertainty Space
Opportunity
Uncertainty
Hazard
A z-axis can be added to a risk-space graph to represent the level of uncertainty. Values
for Z can vary between 0 and 1. When Z = 0, there is no uncertainty associated with a
decision. In these cases, decisions are dominated by risk.
Where Z > 0, the status quo point lifts off the risk-plane. As Z 1, decisions become
increasingly dominated by uncertainty. Risk decisions are circumscribed by curves
representing possible consequences. Uncertain decisions are circumscribed by curves
linking the elevated status quo point to the risk plane.
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III. Science. Uncertainty, and Technology Regulation
Many identify the 1962 publication of Rachel Carson’s Silent Spring as marking
the advent of the era of environmental concern.2 3 Concurrent with growing concern was
a growing call for protection of public health through social regulation.2 4 Authorities
have often relied on experts to provide a scientific basis for action, very similar to the
recommendations of expected utility theory. Unfortunately, the application of science to
regulation has rarely been as simple as theory implies. Uncertainty often dominates
attempts to regulate technology scientifically.
A. The Policy Sciences - Orthodoxy and Its Opponents
Much as in economics, the policy sciences have struggled over the relationship
between, and the meanings of, risk and uncertainty. Weinberg (1987) provides an
appropriate point of departure with his oft-cited distinction between science and
“trans-science,” and their role in regulation. He observes that, “The domain of science
covers phenomena that are deterministic, or the probability of whose occurrence can
itself be stated precisely; trans-science [describes] the domain of events whose
probability of occurrence is itself highly uncertain” (29). Weinberg’s distinction between
science and trans-science echoes Knight’s distinction between risk and uncertainty.
According to Weinberg, authorities are too often called upon to regulate issues in the
domain of trans-science, though by definition science cannot help here. Even though
authorities may assign a probability to an event, the probability itself remains uncertain.
2 3 “The birth of Modem environmental movement is often traced to the publication of Rachel Carson’s
Silent Spring 1962, which highlighted the injurious impacts of chemicals such as DDT on birds and fish.”
(Gray and Graham 1995: 173). See also Levenson( 1995).
2 4 “Between 1969 and 1974, the United States Congress went on a regulation binge...” (Lowi 1990:33).
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While Weinberg refers to the “domains” of science and “trans-science,” his
discussion suggests that these constitute opposing ends of a spectrum. According to him,
moving along the spectrum from “science” toward “trans-science” increases the role of
values: “No one would dispute that judgments of scientific truth are thus affected by the
scientists’ value system when the issues are at or close to the boundary between science
and trans-science. On the other hand, as the matter under dispute moves away from the
border into the domain of science, most would claim that the scientists’ extra-scientific
values intrude less and less” (34). Weinberg’s approach links certainty with science, and
uncertainty with “trans-science.”
Weinberg offers an orthodox view that assigns science a central role in regulation.
The orthodoxy assigns primacy to mathematical methods whenever possible.2 5 Lave
(1982: 2) claims that “despite its limitations, quantitative risk assessment has no logical
alternative.” He goes further than Weinberg, however, by arguing that even in the realm
of trans-science, one must use orthodoxy to organize analysis:
risk assessment is of little use unless attention is given to the sources of
uncertainty and the effects each have on the resulting estimates. Each source of
uncertainty must be specified and related to the final estimates...reasonable high
and low estimates must be calculated in addition to a best-guess estimate and this
range of estimates must be carried through the analysis. Often the resulting range
will be so large that uncertainty dominates and risk assessment is of no direct
help, even though it is of immense help in sorting out the issues and structuring
analysis. (1982: 11-12)
Lave does not specify how to identify “each source of uncertainty,” what constitutes
“reasonable estimates” in the face of uncertainty, let alone a “best-guess estimate.” After
all, honest experts can disagree (or all be wrong). Lave’s prescription of a “best-guess
2 5 Orthodox methods are applied in Rasmussen (1990) and Keeney, Kulkami and Nair (1990).
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estimate” in the face of uncertainty is common in the risk literature.2 6 Such a view,
however, overlooks the possibility that uncertainty itself may impose a dynamic on
decision-making itself.
Orthodoxy has its detractors. Two schools — “skeptics” and “rejectionists” — both
question the applicability of Science to technology-regulation. Poliak (1996: 28-9) argues
that “regulatory science in general and risk assessment in particular, despite their
scientific pretensions, are not real Science.... The leap from the objective, quantitative
data obtained from bioassays and epidemiological studies to conclusions about the effects
on humans of relatively low levels of exposure is a leap of faith.” This criticism focuses
on the methods used for making estimates: bioassays and epidemiological studies. The
skeptics’ inability to offer alternative methods for risk-analysis substantially weakens the
criticism.2 7
Rejectionists go even further, focusing ontological attack on the concepts of
“science” and “progress.” For the rejectionist, risk assessment increases moral hazard:
by “preventing” disaster today, the risk assessor assures even greater disaster tomorrow.2 8
2 6 For example, Douglas and Wildavsky (1983: 80) observe that professional risk assessors “try to separate
the problem from everything except the pure calculation of probabilities. Risk assessors offer an objective
analysis. We know that it is not objective so long as they are dealing with uncertainties and operating on
big guesses.... Risk assessors are not the only ones who fill the gaps in knowledge with educated guesses.”
According to Graham and Rhomberg (1996:21), “Even when absolute estimates of risk are highly
uncertain, confident risk comparisons may still be made if the hazards to be compared share common
uncertainties.” This would seem as much to compound the problem of uncertainty, rather than account for
it.
2 7 According to Cranor (1993:7), “Epidemiological studies are both frequently insensitive and plagued by
numerous practical problems; either may prevent the detection of risks of concern. And in many cases, but
not necessarily all, such studies must sacrifice either scientific accuracy or evidentiary sensitivity - one
cannot have it both ways.” He devotes chapter 1 to a discussion of bioassays and epidemiological
limitations. See also Sapolsky (1990: 88-90).
2 8 Beck (1992) is most closely associated with this view: “My thesis is that the origin of the critique of
science and technology lies not in the ‘irrationality’ of the critics, but in the failure of techno-scientific
rationality in the face of growing risks and threats from civilization.... [It is not] the failure of individual
scientists or disciplines; instead it is systematically grounded in the institutional and methodological
approach of the sciences to risks. As they are constituted - with their overspecialized division of labor,
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The rejectionist critique relies on an eventual “civilizational crash” to assign greater long
term costs than benefits to technological innovation. The only solution is a fundamental
transformation of society itself, to divert humanity from its disastrous path. One can
question whether their review of technology is judicious. Alternatively, to the extent that
“worst-cases” fail to materialize, rejectionist condemnations of technology appear
superficial.2 9
1. The Sources o f Uncertainty
Even if one embraces orthodoxy, one is still confronted by the complication of
uncertainty and its necessity for “best-estimates.” To understand better the issue of
uncertainty, one might look to its sources. Freudenberg (1990) identifies three sources of
uncertainty in the regulatory process: questions about facts, questions about values and
questions about blind spots. Questions about facts enter the process at the assessment
phase. Incomplete data and contested analysis complicate the search for causal claims
and probability analysis. Contending claims concerning global warming provides a
possible example.3 0 Two strategies are available in such situations - the gathering of
more facts, and the better analysis of available facts. Each of these strategies has its
their concentration on methodology and theory, their externally determined abstinence from practice the
sciences are entirely incapable of reacting adequately to civilizational risks, since they are prominently
involved in the origin and growth of those very risks”(59). Related to Beck are ethnographic laboratory
studies such as those reviewed by Cetina (1995) and Edge (199S).
2 9 Schrader-Frechette (1991: 31) uses the term “cultural relativists” to refer to another potential group of
rejectionists. According to her “cultural relativists...say that any judgement or risk evaluation is merely a
social construct.” She further claims Douglas and Wildavsky’s Risk and Culture exemplifies this approach,
though I believe that to be a misrepresentation of their work.
3 0 For critical surveys of the science of global warming, see Wiener (1995) and Wildavsky (1995). For a
discussion of the precautionary principle and global warming, see Houghton (1997: ch. 9).
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partisans, though they need not be mutually exclusive.3 1 Furthermore, facts can never be
used to prove a negative.3 2
Values are another source of uncertainty, confounding attempts to regulate
innovation “rationally.” Perhaps the most contentious example is the “proper” value to
assign a human life in any cost/benefit analysis. Attempts at valuing human life generate
a spectrum of response, from moral repugnance, to simple estimates of net present
value.3 3 Other value-questions (The value of an endangered species? The value of an old
growth forest?) generate similar debate and disagreement.
A third source of uncertainty - blindspots - is particularly relevant for regulating
technological innovation. Coping with the impact of “unknown unknowns” is especially
vexing, because “not only do we often fail to see something, but we fail to see that we fail
to see” (Freudenberg 1990:49). Under certain conditions an unexpected problem can
overwhelm an estimated prior-probability, rendering ineffective efforts at quantitative
3 1 In their editorial preface, Wiener and Graham (199S: ix) write, “The authors urge that the risk problem be
treated holistically, with efforts to contain risks made not in isolation but in the context of the entire picture.
To this end, they emphasize the need to compile much more information about risk levels and to act on the
basis of that information rather than relying on guesswork, sensationalism, or interest-group pressures.”
Roberts and Weale (1991: xiii) make the alternate appeal: “improvements in the quality of [risk]
understanding may emerge from a better analysis of known facts than from new facts themselves.” Their
call is accompanied by encouragement to “think imaginatively” about the issue at hand, or to develop
analytic trees which encourage the asking of questions which are not otherwise asked. Ultimately, the
question pivots on the locus of uncertainty: is it with the data, or the analyst?
Thus Lave (1980:9) observes, “A substance cannot be proved to be safe; testing can only indicate
whether exposure to a substance significantly increases the incidence of some condition.” Our capacity to
detect the presence of substances at ever-minute levels (parts per billion) combined with the difficulties in
isolating epidemiological effects from statistical noise make proof of safety at all levels impossible to
prove. See also Wildavsky (1995:430). Issadore (1987: 196) echoes this theme: “Scientists performing
risk assessment must by nature of the scientific method deal with uncertainty, and they are unable to give
an exact answer to the question of micro risk-assessmenL One of the limits of science is that a negative
cannot be proved.”
3 3 For discussions, see Keeney (1996) and Gregory, Brown and Knetsch (1996). For a discussion of the life
controversy, see Lewis (1990:82-91), Teuber (1990:241-3), Wildavsky (1986:59-60), and Horowitz and
Carson (1990).
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risk assessment.3 4 Cooke (1991: ch 2, especially table 2.5) shows that experts concerned
with estimating the failure of the space shuttle and nuclear power plants have generated a
broad range of subjective prior probabilities, which differ by magnitudes
Others have explored the relationship between uncertainty and regulation. Rayner
(1987:9) uses “system uncertainty” and “decision stakes” as axes to generate a three-fold
typology of scientific regulation (Figure 2.5). Issues characterized by little uncertainty
and minor stakes fall under the category “consensual science.” Consensual science is
marked by large, reliable data sets and agreed upon methods of investigation among a
reliable technical community. The stakes are low, meaning that outcomes are of limited
magnitude.
Figure 2.5: Rayner’s Typology of Scientific Regulation
Uncertainty ▲
Total Environmental
Assessment
Clinical
N.
\ Consultancy
\
\
\
\
\
Consensual \ '
Science \ \
Decision Stakes
3 4 Freudenberg (1990: SO ) provides the following example: assume experts agree that a given system has a
1:1 million probability of catastrophic failure. If in reality, however, the real risk of catastrophic failure is
1:1000 10% of the time, while for another 10% of the time the real risk is 1 :1 billion, then the overall true
risk associated with the system is slightly more than 1:10,000. Thus, “the unexpected problem dominates
the ultimate probability.”
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Clinical consultancy describes issues of moderate uncertainty and stakes. Rayner (1987)
suggests that investigation in this area employs “quantitative tools supplemented
explicitly by experienced qualitative judgment.” The term evokes the modem practice of
medicine: various quantitative measures are made (e.g., temperature, heart rate, blood
pressure), but these alone do not indicate the exact nature of an illness. Instead, a
physician supplements such measures with a variety of other subtle indicators learned
through experience to arrive at a diagnosis.3 5 Finally, total environmental assessment
describes the domain of issues characterized by high stakes and uncertainty. These are
“permeated by qualitative judgments and value commitments. Inquiry, even into
technical questions, takes the form largely of a dialogue, which may be in an advocacy or
even an adversary mode” (10). Rayner’s categories are useful to the extent that
generalizations provide predictive or explanatory power. For instance, do phenomena
from each of the three categories exhibit similar dynamics? Do issues pass from one
category to another in similar fashion?3 6
He suggests that in this last domain, cultural analysis will prove most fruitful:
“although the proportion of risk assessments that fall into [total environmental
assessment] is only a tiny proportion of the whole, they are often those of greatest
3 5 Smithson (1989) provides the example of structural engineers confronting two different classes of design.
For one class - mass-produced items - destructive testing of prototypes (“proving”) is used to reduce
uncertainties involved in actual performance. In the other - one-off designs - the proving of a prototype is
not an option, because the design is genuinely unique: “In a one-off job, no theory or prior information
about similar structures is strictly applicable, and while the mass production designer can resolve
considerable uncertainty during the prototype testing phase, the structural engineer cannot” (21). According
to Smithson, structural engineers rely more on “old style rules of thumb.” Judges similarly must work
under conditions of uncertainty, deciding cases based on unreliable testimony and potentially dishonest
witnesses. Smithson notes also that “in fingerprinting, for example, experts in various Western countries
require from 8 to more than 16 matching characteristics and no unexplained points of difference to risk the
claim that two prints could have come from the same person” (24).
3 6 Issues, after all, need not remain in one domain indefinitely. As information is gained, and familiarity
acquired, an issue should pass from the domain of uncertainty into that of certainty.
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political significance...total environmental assessment provides the most plausible
opportunity for the application of a cultural-relativist perspective, for here the social
constraints on the knowledge process are clearly dominant over natural feedback” (10).
There are reasons to challenge his specific claim. To suggest as he does that knowledge
processes, to work, must be devoid of social constraints is troubling.3 7 Second, it suggests
the unimportance of culture from areas of “consensual science.” While the harmful
effects from smoking are generally accepted, and thereby qualify as “consensual
science,” it is questionable whether one can understand smoking patterns and regulations
without some reference to “culture.”3 8
IV. Risk Analysis and the Social Sciences
In suggesting culture as an analytic lens, Rayner presents one of the two main
risk-related research programmes in the social sciences. In the first, culturalists use risks
- actual and perceived - to develop theories of group behavior. In the second,
institutionalists focus on the role of institutions in contributing to outcomes. A review of
these approaches reveals not only differences, but important similarities.3 9
3 7 Kuhn’s discussion of paradigms is rife with both social constraints and knowledge processes. For a
review of the “sociology of scientific knowledge” literature, see Edge (1995).
3 8 “The cigarette provides a means of tracing an important watershed in medical ‘ways of knowing.’ But
the issues raised go beyond the realm of biomedicine; the debate about smoking was shaped by the
meaning of the cigarette in American culture, the nature of the tobacco industry, public health, and
government In short, the process by which risk is assessed and perceived reveals deep social, cultural, and
political values” (Brandt 1990: 157).
Both the cultural and the institutional approaches predominately use a definition of risk that is equivalent
to hazard.
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A. Cultural Approaches
Douglas and Wildavsky’s publication of Risk and Culture (1983) marks the
ascent of cultural approaches to risk. They ask, “why do groups select certain dangers for
attention, while ignoring others.” Their definition of group relies on two parameters:
links within groups and links between groups. Their typology generates three distinct
group-types (hierarchies, markets and sects), each with its particular “cultural bias.” This
bias guides group-identification of hazards, and influences the form of response.
Decisions serve to confirm a group’s cultural bias as much as to address an objectively
identified hazard. They explore the theory in relation to a variety of non-randomly
selected case studies, and do not seek to test a set of falsifiable propositions.4 0
The Douglas-Wildavsky thesis is a theory of how technological risks acquire
different meanings for different groups.4 1 In the wake of its publications, a number of
case studies sought to extend their approach. Among the findings: professional training
generates culturally rooted perspectives, which impact risk analysis.4 2 Experts and
laypersons differ in their perception of risks.4 3 Competing risk perceptions create
opportunities for affecting negotiations among groups.4 4 Risk serves to allocate blame
4 0 Douglas and Wildavsky (1983:186) conclude that “the selection of dangers and the choice of social
organization run hand in hand.” Wildavsky (1995:335) later summarized the thesis somewhat tautologically in
the following fashion, “In Risk and Culture I argue that people choose what to fear to support their way of life.”
4 1 This is my perspective, and their thesis has stimulated discussion and controversy. For a critical review
of their woric, see Johnson (1987).
4 2 Thus Tarr and Jacobson (1987:335) argue, “Different types of professional training have involved
alternative value systems and these values have resulted in different estimates of risk.” They suggest
elsewhere that the same group of experts can adjust their perceptions in response to shifts in opportunity:
“The New York health department...adjusted their definition of the hazards posed by Love Canal according
to the availability of [Federal] government resources.”
4 3 Slovic, Fischhoff and Lichtenstein (1979) aims to provide the risk perceptions of the “lay person.”
4 4 Bronstein (1987:202) argues, “Whether negotiations proceed on the basis of shared understandings or
shared misunderstandings over meanings and values, the skillful use of symbols affects the outcome, helping to
determine which parties goals are best satisfied.”
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and responsibility within and among groups.4 5 Finally, national groups exhibit cultural
propensities with regard to technological risks.4 6
B. Institutional Approaches
The second research programme has focused on institutions and risk.4 7 As with
the cultural approach, the institutional approach has yielded a similar litany of findings.
Institutions limit discussion.4 8 “Decision rules” shape institutional responses to a
risk-issue (Reiss 1992). Standards of access, and of the qualifications necessary to offer
expert scientific testimony, contribute to outcomes.4 9 The proper degree and form of
public participation in decision-making is also contested.5 0
4 5 According to Douglas (1990:1), “A culture needs a common forensic vocabulary with which to hold
persons accountable and...risk is a word that admirably serves the forensic needs of the new global culture.”
Surprisingly, American culture has long been characterized as more risk-averse than most Douglas and
Wildavsky (1983: 10) ask, “How can we explain the sudden, widespread, across-the-board concern about
environmental pollution and personal contamination that has arisen in the Western world in general and with
particular force in the United States?” A decade later, Sapolsky (1990:93) would ground the observation in a
cultural propensity to distrust authority: “No other country has anything near the national tumult over risk
issues that America has. Elsewhere governmental authority is more secure, policy-making proceedings more
secretive, and official expertise more respected.” Miller (1997:4) recently confirms this as the prevailing
sentiment: the “American public [is] known for a high degree of risk aversion.”
4 7 Douglas (198S: 83) asks, “if it is conceded that institutions play any role, then it would follow that much of
the inquiry about risk perception has been applied to the wrong units, to individuals instead of to institutions.”
Short (1992:3) argues “Increasingly, organizations - oflen very large organizations such as national and
international business firms - and institutions such as governments and regulatory bodies - set the parameters
and terms of debate of risk decisions...institutions and the organizations that comprise them provide the
primary contexts for the assessment and the management of risk.”
According to Walsh (1987:85), “Prior to the Three Mile Island accident, the handful of local opponents
at the licensing hearings...in the early 1970s were not permitted to raise questions about citizen evacuation
in the event of a serious accident because such an event was defined by the mainstream assessors and
hearing officials as virtually impossible.”
4 9 For example, Huber (1990: 103) argues that, whereas admission of expert testimony in U.S. courts
previously relied on the standard of “general acceptance” among experts in the field (the so called Frye
rule), Federal Rules of Evidence since 1975 allow admission of any expert testimony “relevant” to the case.
According to Huber, this institutional change now permits “ junk-science” into court, resulting in
sub-optimal regulatory outcomes. “Authority has thus been taken away from scientific and professional
communities, and given instead to individual scientists and professionals.”
3 0 Kunreuther and Slovic (1996:123 & 5) argue the limitations of risk science demand, “introducing more
public participation into both risk assessment and risk decision making in order to make the risk-decision
process more democratic, improve the relevance and quality of technical analysis, and increase the
legitimacy and public acceptance of the resulting decisions.... Participation and process issues may, in the
long run, lead to more satisfying and successful ways to manage the risks posed by modem technologies.”
JasanofF(1996:69) supports broader enfranchisement, “The task ahead then is to design institutions that
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Institutional approaches unsurprisingly yield competing “solutions” of
institutional reform. Based on his experience as EPA’s first administrator, Ruckelhaus
argues that agencies empowered to protect public health require sufficient “flexibility” to
be effective. Breyer, viewing American regulation of public health risks, advocates the
creation of an elite, centralized administrative group with interagency authority to
rationalize the efforts of various agencies involved with risk. Both these approaches
identify institutional design as the source of sub-optimal regulation. They yield,
however, competing prescriptions: the need to re-invent existing institutions, versus the
need for new institutions.51
There is a third institutional prescription: deregulation. Here, the problem is
identified as an institutional proclivity to regulate. Wildavsky identifies the
“precautionary principle” as the problematic source: authorities must act when there is a
possibility of harm, lest they be accused of neglecting public health.5 2 The 1958 Delaney
Clause - which requires that “no [food] additive shall be deemed safe if it is found to
induce cancer when ingested by man or animal” - symbolizes the precautionary
principle. Wildavsky argues the precautionary principle assigns only health benefits -
will promote trust as well as knowledge, community as well as participation - institutions in short that can
repair uncertainty when it is impossible to resolve it”
5 1 Each also includes a significant role for uncertainty. Ruckelshaus (198S) writes, “Environmentalists
believed, and Congress agreed, that if quality-based standards were adopted, industry would use the
uncertainties of the science to delay indefinitely any investments in controls” (23). Scientific uncertainty is
associated with delay. Elsewhere, uncertainty generates responsibilities: “The uncertainties involved in
risk assessment must be explained, and people must be brought to understand that ‘safety’ is a social
construct, the definition of which is, or ought to be, a part of each citizen’s duty in our society” (35).
Breyer’s survey (1993) of health risk regulation in America identifies scientific uncertainty as one of three
variables that contribute to a “vicious circle” of inadequate regulation. The other two are public
misperceptions and congressional overreaction.
5 2 Jamieson, in advocating the precautionary principle, suggests that “if an action or policy potentially has
catastrophic effects, then we should refiain from undertaking it even if the probabilities are uncertain”
(1996:40). The key problem here is that he leaves the critical term catastrophic undefined. The collision
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and no health costs — to regulation. His prescription is to regulate only in the face of
probable harm. Thus, one should not invent new - nor re-invent existing - institutions,
but rid oneself of an institutional propensity to regulate.5 3
Cultural and institutional approaches represent analytic lenses, and are not
mutually exclusive. Walsh’s discussion of Three Mile Island (1987) reflects the tension
between these two. Culturalists might focus on two group’s competing perceptions of the
hazards posed by the Three Mile Island facility. Institutionalists, on the other hand,
might focus on the rules that excluded the voice of local opponents.
Cultural and institutional approaches overlap in other respects. Douglas and
Wildavsky identify three “cultures” - sectarians, individualists and hierarchs - each with
a theory of how society should be organized (1983: 9). According to their theory cultural
bias manifests as an institutional bias. This is hardly surprising. Different cultures are
defined by the four quadrants generated from their group/grid axes. Douglas (1982:9)
writes that where grid is highly positive “an explicit set of institutionalized classifications
keeps [individuals] apart and regulates their interactions, restricting their options.” She
thereby reveals the analytic barrier between culture and institution to be thin.5 4
of two jumbo jets may be “catastrophic,” but few would suggest foregoing the benefits provided by modem
jet transportation.
5 3 Wiladavsy (1993) is concerned with “a network of regulation more extensive and intensive than any
previously experienced by Americans” (446). He is unabashed and unambiguous, “It is one thing to say
what virtually everyone agrees on: Superfund is too slow and too expensive and lawyers take far too much
of the insurance fund. It is another to claim, as I do, that Superfund, for all the billions spent on it, provides
no health benefits. Indeed, I would go further and argue the likelihood that Superfund (except for its
valuable emergency actions) damages health” (1993:436).
5 4 Gerlach (1987) writes, “Superficially, at least technical controversy takes the same form across the
Western industrial democracies. The constituents and their interactions appear similar....Cross-cultural
research is called for to investigate these deeper similarities and differences” (141). He uses the term
culture as a catch-all for national variation. Jasanoff (1986) observes “technical decision-making has
received undeservedly little scholarly attention in the past;” and that “the creation and diffusion of
knowledge in policy-relevant science thus merit study in their own right” (vi & 83). Rose (1993)
investigates lesson-drawing across borders, though not with specific regard to technological risks.
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Institutionalists are also guilty of retaining a thin definitional barrier between
institutions and cultures. Wubben (1993:16) offers the consensus of economists that “an
institution can be identified by three characteristics: 1) a group of persons, 2) common
behaviour patterns, 3) explanations or justifications of activities or rules.” The problem
here is that these same characteristics frequently serve as the basis for the definition of a
culture.
V. International Comparative Research on Technology Regulation
Scholars have recently directed their attention to the comparative study of
technological risks across national regulatory jurisdictions.5 5 Jasanoff, one of those most
active in this approach, suggests that “by looking at risk decisions across national
boundaries, we can begin to sort out how different institutional and procedural traditions
bear on the production and use of knowledge” (1990:62). Her goal is to provide insights
concerning “national styles.” As the preceding passage suggests, she analytically blends
institutional (i.e., “institutional traditions”), cultural (i.e., “procedural traditions”) and
constructivist (i.e., “the production of knowledge”) approaches. To this extent, “national
styles” threatens to become a “catch-all” for any and all variation across national
boundaries.
Close review of her research raises questions about her methods and doubts about
her conclusions. It is very difficult to categorize her approach as cultural or institutional.
In her study of “American exceptionalism,” for instance, she observes that
5 5 Gerlach (1987) writes, “Superficially, at least technical controversy takes the same form across the
Western industrial democracies. The constituents and their interactions appear similar....Cross-cultural
research is called for to investigate these deeper similarities and differences” (141). He uses the term
culture as a catch-all for national variation. Jasanoff (1986) observes “technical decision-making has
received undeservedly little scholarly attention in the past;” and that “the creation and diffusion of
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in the U.S. political setting, no single institution enjoys an exclusive right to speak
for science, and when Americans seek scientific support for their risk perceptions,
they seem prepared under appropriate circumstances to believe the [Natural
Resources Defense Council] as much as the [Environmental Protection Agency],
Nader as much as the National Academy of Sciences. (1990: 70)
The American national style is either (culturally) tolerant of competing truth-claims,
(institutionally) structured to facilitate their representation, or both. It is in this sense that
one is hard-pressed to categorize Jasanoff.
Having identified this attribute of American “exceptionalism,” she admits that
actors outside the United States use these competing truth-claims for their own debates:
the risk constructs that the United States generates in such generous profusion are
available to interested actors in other societies, and the literature on risk
controversies already provides numerous examples of the successful exploitation
of American public interest science by groups outside the United States....Does
this mean that policy differences on particular risks and hazards [!] will tend to
disappear? I think not. The uncertainty of our predictive sciences is such that
citizens will always have scientific leeway to choose among alternate
characterizations of risk. (1990: 75; 77-78)
Elsewhere she reaches similar conclusions: scientific uncertainty does not contribute to
policy convergence. Institutional and cultural variation tends to preclude such
convergence.5 6
A subtle, yet substantial criticism can be leveled at her conclusions. First, a
research programme investigating cultural and institutional variation should rely on cases
knowledge in policy-relevant science thus merit study in their own right” (vi & 83). Rose (1993)
investigates lesson-drawing across borders, though not with specific regard to technological risks.
S 6 Jasanoff concludes more recently (1996:79) that “an examination of existing political and administrative
frameworks indicates why science foils to exert a greater harmonizing influence on risk management. In
dealing with uncertainty and expert conflicts, national regulatory systems take into account a host of
interests besides the scientific community’s views about risk. Cultural factors influence goals and priorities
in risk management.... Different societies also respond differently to questions of political process and
institutional design: Who should participate, how much should they know, how should disputes be
resolved, and by what ultimate authority? The answers to these questions shape the assessment of
uncertainty, overshadowing science and leading in the end to widely divergence policies for managing the
same technological hazards.”
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that are informationally isolated from one another. Otherwise the informational networks
between nations may contribute to outcomes. In empirical terms, if public interest
science generated in one country is “successfully exploited” in other countries, as she
observes, then the informational network linking the two countries must be considered in
any explanation of the outcome. These networks, however, may diminish the impact of
cultural and institutional variation, and contribute to regulatory convergence.
As the following passage shows, Jasonoff herself has found evidence of
regulatory convergence. In a later account of her earlier research (1992: 62), Jasanoff
acknowledges apparent convergence of chemical regulations in the US and Europe:
Though official bodies in the United States and Europe frequently differed in their
assessments of scientific information, the decisions they took against particular
hazards often seemed to converge.... In seeking to understand this pattern of
divergences and convergences, the scholarly literature focused on key differences
in the political, legal, and scientific traditions of decision making in Europe and
the United States (my emphasis).5 7
The problem here is that she seeks to explain the discovered “patterns of convergence”
with reference to “key differences.” Her analytic focus on variation makes this
understandable; however, methodologically, one cannot use differences to explain
similarity o f outcome. Instead, “key similarities” are required. She herself identifies a
potential source of similarity - shared information - but does not pursue it.
A theory of differing national styles cannot be used to explain regulatory
convergence. A research programme relying on differing national styles is limited to
those cases where similar phenomena are confronted by authorities in isolation from one
3 7 I use her recollection of the earlier work to emphasize the fact that her thinking has not changed
substantially on this subject. Earlier, she and her collaborators write, “Our conclusions emphasize the
difficulty of transplanting regulatory approaches from one national setting to another, since each country's
policies are rooted in unique political traditions and practices” (Brickman, Jasanoff and Ilgen 1985:27).
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another. As was earlier suggested, such an approach would be useful for studies of risk
regulation in the early and pre-industrial era. In the post-industrial era of global
telecommunication, jet transportation, email and the Internet, to ignore the impact of
transnational information networks on domestic regulations is to chance analytic peril.
Having argued that this parameter must be taken into account, one may ask, “to what is
this parameter sensitive?” The experimental research of cognitive psychologists suggests
a role for uncertainty. In the next section, the insights of decision-making under
uncertainty are used to develop a model of regulatory convergence across national
borders.
VI. Scientific Uncertainty and Regulatory Harmonization
Experimental research by cognitive psychologists over the last two decades
suggests that decision making under uncertainty is prone to systematic biases.
Researchers have generated a catalogue of heuristics mainly through laboratory
experiments on voluntary subjects. Among the heuristics are anchors, status quo biases,
framing, availability, overconfidence, and ignorance of the law of small numbers. Each
e a
of these is briefly presented.
A. Anchors and Availability
An anchor serves as an orientation point for estimating probabilities or outcomes.
In ambiguous situations, people have been observed to adjust their estimates from an
anchor, while remaining close to it. The availability of limited information serves to
establish subsequent estimates. Tversky and Kahneman (1974) have even shown that
S 8 This discussion draws upon Tversky and Kahneman (1974); Kahneman and Tversky (1981); Tversky and
Kahneman (1982). For a convenient summary of their work, see Neale and Bazerman (1991), especially, ch. 3
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anchors can be entirely arbitrary. In a widely cited experiment, a roulette wheel was spun
before different groups of college students. Unbeknownst to the students, the wheel was
“rigged” so as to generate one of two numbers: 10 or 65. Students were asked whether
the percentage of countries in the United Nations that were African was above or below
the revealed number, and then to estimate that percentage. The average group-estimate
after displaying a 10 was 24%; the average group estimate after displaying a 65 was 45%.
Tversky and Kahneman conclude that even a random number generator can anchor
perceptions and estimates.
In the same study, Kahnemann and Tversky argue that under uncertainty,
decisions are sensitive to availability. One experiment involved reading names from a
list. The lists differed in two ways: according to the relative frequency of men and
women’s names, and according to the inclusion of famous men or women on a list. Lists
were read containing relatively more men than women, but with famous women.
Subjects were then asked whether more men or women’s names appeared on the list, to
which they responded more women. They reversed the situation (e.g., more
women/famous men) and found that, again, respondents answered that more men were on
the list. Kahnemann and Tvesky argue that particularly vivid, or available, information
(e.g., famous names and faces) can impact a decision-maker’s estimate, despite being at
odds with facts.
B. Status Quo Bias
Samuelson and Zeckhauser (1998) conducted experiments that suggest
individuals exhibit a significant status quo bias across a range of decisions. The degree
and Bell, Raiffa and Tversky (1988). For an application of some of these ideas in political science and
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of bias varies with the strength of the individual’s discernible preference and with the
number of available alternatives. Their findings concur with those of Thaler who
associates loss-aversion with a preference for the status quo. Thaler’s so-called
endowment effect is at odds with expected utility theory.
C. Framing and Prospect Theory
Tversky and Kahneman (1981) asked subjects to choose between one of two
policies (A & B) in response to a novel flu that is expected to kill 600 people. Policy A
will save the lives of 200 people. Policy B, on the other hand, is expected to result in a
1/3 probability that all 600 will be saved, and a 2/3 probability that none of the 600 will
be saved. According to expected utility theory, policies A and B are equivalent (200
lives saved v. 600/3 + 0/6), however, respondents preferred policy A 76% of the time. In
another variation, two groups were told that Policy A would result in 400 people dying,
while policy B remained the same. Again, the expected utilities for A and B are
identical; however, respondents preferred policy B 87% of the time. The implications are
that the presentation of options - whether in terms of gain or loss - effects individual
preference. Their conclusion is that individuals are risk-averse when faced with potential
gain, and risk-seeking when faced with potential loss.
D. The Law of Small Numbers
Individuals tend to believe a sample of events is more representative of a
population than simple statistics otherwise suggests. Tversky and Kahneman (1981)
posed the following question. Assume a town has two hospitals (A and B). Hospital A
averages 45 births/day, while Hospital B averages 15/day. The probability that any given
international relations, see Jervis (1976) and Famham (1992).
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birth will result in a boy is 50-50, as it is for having a girl. For one year, each hospital
was asked to record the number of days when more than 60% of births resulted in boys.
Respondents were then asked which hospital was more likely to have had more of these
days. Sampling theory predicts that the large hospital is less likely than the small hospital
to stray from the known mean of 50%. They found that 21% of respondents identified
the large hospital, 21% the small hospital, and 51% claimed that they should be about the
same. Further research suggests that even professional statisticians and actuaries are
prone to making such errors.
VII. A Theory of Global Policy Contagion
These insights from cognitive psychology may provide the basis for a theory of
transnational regulatory formation under conditions of uncertainty. A hypothetical
example can serve to illustrate its ramifications. Assume a technological innovation
generates public hazard concerns, and a demand for regulation. Assume further that four
countries - A, B, C and D - are at different stages of technological development. Country
A must immediately respond to the innovation, Country B will need to respond in two
years, while countries C and D will do so two years after B. Finally, assume that D is
informationally isolated from the other three countries, whereas A, B and C enjoy
substantial contact with one another (figure 2.6).
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Figure 2.6: Informational Networks Among Four Countries.
Shared Experience versus Isolation
A
B< >c
0
In such a situation, regulators in country A generate the first set of rules governing the
technology. Country A’s regulatory experience - debates, decisions and outcomes - can
have a potential impact on subsequent regulatory decisions in other countries. Even if
A’s experience is limited, and thus statistically insignificant, the law of small numbers
suggests that it will be viewed as more representative of the technology’s “class” than
statistics permits. The anchoring and availability heuristics suggest that country A’s
experience will impact those countries that are exposed to such information. According
to the scenario, Country B begins regulation two years after A. To the extent that
information from A is available to B, one might expect it to anchor Country B’s
regulations.
When countries C and D confront the regulatory requirement, four years of
Country A’s experience and two years of B’s experience is available. In the case of
Country C, one would expect the experience of A, or B, or a combination of the two, to
contribute to an explanation of C’s regulations, ceteris paribus. In contrast, Country D’s
isolation diminishes the impact of A and B’s experience. Domestic political theories
should govern the formation of regulations in Country D. According to this model,
understanding regulatory outcomes requires consideration not only of domestic cultural
and institutional factors, but also of the transnational informational networks between
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jurisdictions. This theoretical perspective offers some explanation for the amplification
dynamic documented in chapter 1.
One can of course add countries to this model indefinitely. As the number of
countries increases, the number of available anchors increases as well. What drives this
dynamic of transnational regulatory contagion5 9 is the availability of information. Where
3 9 This model strongly echoes extensive research on diffusion presented in Rogers (1995), especially
chapter 8 “Diffusion Networks.” This suggests two obvious questions. First, why use the term contagion
instead of diffusion? Second, how does this model differ?
As regards the first question, linguistically, contagion is a term with biological connotations.
Diffusion as a term generally evokes chemical and physical connotations. At that level, the former is more
thematic of biotechnology. More significantly, the term contagion is better suited for the dynamic of
decision making under uncertainty imported from cognitive psychology. Rogers writes, “At the persuasion
stage, and especially at the decision stage, an individual is motivated to seek imovation-evaluation
information, the reduction in uncertainty about an innovation’s expected consequences. Here an individual
usually wants to know the answers to such questions as ‘What are the innovation’s consequences?’ and
‘What will its advantages and disadvantages be in my situation?’ This type of information, while often
easily available from scientific evaluations o f an innovation, is usually sought by most individuals from
their near-peers” [my emphasis] (168). The next chapter argues that scientific evaluation was incapable of
providing clear evaluation of deliberate releasing genetically modified organisms into the environment.
Further, later chapters suggest that non-generalizable information had an impact on decision making. In
this sense, diffusion is purposeful, while contagion is to some degree unintended.
This distinction contributes to an answer for the second question. Rogers largely relies on things
for his case studies of diffusion (e.g., hybrid corm, clothing fashions, hair styles, harvesters, personal
computers, cell phones, fax machines, the internet, etc...). If this study concerned the diffusion of
agricultural biotechnology perse, it would more closely follow in the tradition established by the diffusion
literature. This study, in contrast, focuses on the transnational context in which regulations emerge. In this
sense, it more approximates an application at the global level the of approach pioneered by Jack Walker in
his study of regulatory diffusion among American states. Discussion of his work is reserved for the final
chapter.
I am not alone in offering a distinction between diffusion and contagion. Midlarsky (1978)
provides a distinction in his study of American urban violence: “Diffusion can be defined as the spread of a
particular type of behavior through time and space as the result of the cumulative impact of a set of
statistically independent events. The modal response to the independent precipitating events may be the
same (a disorder), but the individual initiations are mutually independent. Contagion...on the other hand,
can be defined as the spread of a particular type of behavior through time and space as the result of a
prototype or model performing the behavior and either facilitating that behavior in the observer or reducing
the observer’s inhibitions against performing that same behavior” (1006). While I am somewhat interested
in Midlarsky’s reduction of inhibitions, I am more interested in linking contagion to the research of
cognitive psychologists investigating decision-making under uncertainty.
Finally, while Rogers could take issue with my substitution of contagion for diffusion, he would
arguably laude my effort to offer a broad study of regulation. He complains that, “Past diffusion
investigations overlooked the fact that relevant activities and decisions usually occurred long before the
diffusion process began... the entire prediffiision series of activities and decisions is certainly an important
part of the innovation-development process, of which the diffusion phase is one component. Past diffusion
researchers usually began with the first adopters of an innovation, that is, with the left-hand tail of the S-
shaped diffusion curve. Events and decisions occurring previous to this point have a considerable influence
upon the diffusion process. We urge that the scope of future diffusion research should be broadened to
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countries enjoy no exchange of information concerning technological regulation,
regulatory decisions under uncertainty should follow traditional models of domestic
political interaction. Where countries exchange information about the regulation of a
technology, regulatory decisions under uncertainty may result from a combination of
domestic politics and foreign sources of regulatory experience. Under uncertainty,
decision-makers are likely to adapt available regulations, rather than invent new
regulations. Alternatively, authorities may simply import regulations in toto from abroad.
Predilections to adapt and adopt should contribute to regulatory convergence.6 0
These three possibilities define a spectrum of regulatory origin implied by Figure 2.7.
Figure 2.7: Domestic-Transnational Sources and its Regulatory Dynamic.
Domestic <-------------------------------------------------------------- ►Transnational
Invent <----------------------------► Adapt <----------------------------► Adopt
A final element should reinforce the dynamic thus far postulated. The essential
finding of prospect theory is that individuals are risk averse when facing potential gains,
include study of the entire process of how an innovation is generated” (131-2 & 159). Elsewhere he urges
that, “researchers should investigate the broader context in which an innovation diffuses, such as...how
public policies affect the rate of diffusion” (109). Chapters 1 and 7 respond to both recommendations.
Rogers (1995:174) uses the term re-invention where I use the term adaption. Brooks (1988) is the only
person to share my expectations about convergence. He bases his expectations on the harmonizing effects
of regulatory norms, whereas I am looking at the harmonizing effects of uncertainty. “What, then, can we
Ieam from the comparative study of European and American approaches to the use of science for policy in
the governance of technology and the management of risk? In the first place, it seems that actual outcomes
of the regulatory process in other countries are, on average, little different from those in the United States,
despite the much greater political turbulence and energy in the U.S. system.... As for the future, I think we
may expect to see increasing convergence between the U.S. and European styles in using science for
regulation and policymaking. One reason for this belief is the observation that twenty years ago the U.S.
approach to the role of science in regulation was very similar to what the European approach is now.... In
other countries, we will see a trend toward opening up the decision process to public participation much as
has happened in the United States in the past twenty years.... Convergence seems to be taking place among
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and risk seeking when facing potential losses. In the case of a novel innovation, the
decision of one country to authorize an activity may spur others to do so as well. This is
because that decision arguably shifts the equation facing regulators. Where no country
has proceeded, each must face the expected gains and losses of an activity. Even where
uncertain gains are expected to surpass uncertain losses, prospect theory suggests
regulators may prove risk averse. One country’s decision to authorize an activity,
however, provides firms conducting the activity within that jurisdiction with a distinct
advantage not enjoyed by competitors in foreign jurisdictions. Foreign regulators now
face a new problem: the increasingly probable loss of competitive advantage to foreign
industry. With the issue thus re-framed, prospect theory predicts regulators to switch to
risk-seeking behavior. One country’s decision to proceed provides both incentive and
direction for subsequent countries. As other countries deregulate the activity, prospect
theory suggests that a snowball effect should ensue, as the probability of losses mount for
those who have yet to deregulate.6 1
VIII. Summary
This chapter offers an exercise in theory building, relying on insights from
economics, political science, risk analysis and cognitive psychology. Technology
regulation is its broad domain. Innovation generates both hazards and opportunities.
Risks constitute competing sets of hazards and opportunities associated with different
choices. An expected utility model suggests how science can contribute to rational
differing national norms, so that the universality of science is likely to extend gradually to the use of
Science, both social and natural, in the process of controlling technology” (181-3).
6 1 Rogers (1993) supports this idea, though without explicit reference to competitiveness. His review of
diffusion posits, among other generalizations, that “an individual is more likely to adopt an innovation if
more of the other individuals in his or her personal network have adopted previously’ 1 (322).
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regulation. For prescriptive purposes, an expected utility models serves admirably.
Descriptively, however, it suffers; in practice, “scientific knowledge” is often ambiguous
and contested.
Both practitioners and scholars recognize these problems in regulating
technological risk, and a broad literature exists on the topic. Most acknowledge that
uncertainty constrains attempts to develop science-based regulations. They divide,
however, on its implications. Risk orthodoxy advocates suggest that the same methods
used for risk are useful under uncertainty. Skeptics question the sense of applying
otherwise useful methods to these circumstances. Rejectionists challenge the sentiment
of “progress” generally assigned to technology. In addition, social scientists have viewed
risk through two prevailing analytic lenses - culture and institutions. On closer
inspection, these two approaches somewhat overlap.
In recent years, scholars have used comparative methods in an effort to reveal
national differences with regard to risk. In particular, Jasanoff has traced the regulation
of a common innovation across different countries. Among her useful observations is that
groups occasionally import public interest science developed abroad to argue and
advance regulatory preferences in their home country. Despite these links between
regulatory jurisdictions, she contends that cultural and institutional variation generally
dilutes the occurrence of regulatory convergence under conditions of scientific
uncertainty.
It has been suggested here that transmission of information across regulatory
jurisdictions complicates such an approach. Cognitive psychologists suggest why one
might expect authorities to take their cues from abroad when attempting to regulate under
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conditions of scientific uncertainty. Their research suggests that under uncertainty, one is
prone to make decisions based on tangentially related or even irrelevant information. This
dynamic suggests an alternative regulatory model in which transnational information
contributes to the development and outcome of domestic regulatory decision-making.
Such contagion suggests a spectrum. At one end, regulations result from
traditional domestic political battles. At the other extreme, domestic authorities simply
adopt foreign regulatory approaches. Between these extremes, a process of adaption
results from the interplay of both domestic and transnational variables. The previous
chapter provided examples of all three possibilities: invention, adaption and adoption.
The case study and the model suggest a research program to investigate the transnational
sources of domestic regulations. The following chapters document changing agricultural
biotechnology regulations in three countries with a focus on this transnational dynamic.
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Chapter 3 — Introduction to Agricultural Biotechnology
I. Introduction
In the previous chapter, a model provided expectations for transnational
regulatory contagion under conditions of scientific uncertainty. This model stands in
contrast to the expectations associated with existing theoretical work on uncertainty and
technology regulation. The purpose in this chapter is to initiate specific analysis of
agricultural biotechnology. Specifically, the goal here is to show that the deliberate
release of genetically engineered organisms into the environment was an activity
enveloped in scientific uncertainty. Doing so provides an appropriate empirical domain
for investigating the transnational effects of uncertainty on the formation of domestic
regulations.
The logic followed here is to select an empirical domain that maximizes scientific
uncertainty. This will present the necessary conditions for the contagion-hypothesis. In
addition to scientific uncertainty, informational networks are a necessary condition, to
transmit the regulatory experience from one jurisdiction to another. Therefore, this
chapter sets forth the first precondition - scientific uncertainty - while later chapters
document the second precondition - the presence of informational networks among
different countries.
II. Industrial Pillars of Biotechnology: Regulations. Intellectual Property and Capital
Three developments preceded the evolution of biotechnology from an academic
laboratory activity to a substantial industrial enterprise. First, the early recombinant
regulations had to be relaxed to permit industrial scales. Second, the legal standing of
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novel organisms needed clarification. Until 1980 organisms did not enjoy intellectual
property protection. Third, financing had to be secured. Recombinant therapies, drugs
and products require substantial research and development investment. Each of these
pillars was a prerequisite for establishing a biotechnology industry. Without new
regulations, industrial scales could not be established. Without intellectual property
protection, recombinant products would not attract investment. Without capital,
recombinant research and development could not be financed.
Recombinant research during the 1970s quickly yielded an increasing number of
commercially promising products. Early breakthroughs confirmed initial expectations
that biotechnology would revolutionize biomedical research (Panem 1984). This promise,
and a growing comfort with recombinant activities, led researchers to complain evermore
loudly about the regulatory burdens they faced. They complained of the strict 10-liter
limit on fermentation containers that prevented industrial scales. They complained of
elaborate and costly laboratory standards that guarded the public from conjectural
hazards. They complained of the endless paperwork and required notification procedures
to pursue experiments increasingly considered routine. Members of the American federal
agency overseeing recombinant research - the NIH’s Recombinant Advisory Committee
(RAC) - were sympathetic to these complaints. This was unsurprising, in that many
RAC members were themselves trained microbiologists. The RAC responded to this
growing chorus of complaints, by gradually deregulating recombinant research
throughout during the late 1970s.1
1A thorough account of this period is provided in Susan Wright (1994).
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Consequently, a nascent industrial biotechnology effort continued to grow. In
1980 a second pillar was erected. In that year, biotechnology products gained formal
intellectual property protection. Ananda Chakrabarty, a Bell Labs researcher, modified a
bacterium to degrade oil more efficiently. The bacteria, he reasoned, could be used to
clean up oil spills. He applied for a patent in June 1972 but was immediately challenged
in court.2 After 8 years in the judicial system the US Supreme Court agreed to hear the
case. In 1980 the Supreme Court ruled 5-4 in Chakrabarty v . Diamond that a “patent can
be granted on anything under the sun which can be made by man.” Recombinant
organisms were thereby afforded the protection of other forms of intellectual property.3
The Court’s decision initiated a tumultuous affair between Wall Street and
biotechnology firms. Until 1980 private venture capitalists provided the bulk of funding
for commercial biotechnology research. This changed on 14 October 1980, when
Genentech became the first major company to go public. Genentech’s initial public
offering set records on Wall Street, signaling investors’ deep interest in biotech-related
issues (Wade 1980d: 506). Five months later in March 1981 Cetus established another
record with the largest single stock offering by a new corporation. The early 1980s saw a
flurry of biotechnology IPOs, reaching a peak in 1983, a year when more biotechnology
2 Chakrabarty’s microbe was not a recombinant organism, despite many false claims to the contrary; the
date of its creation alone supports that Instead, he isolated several different plasmids, with differing
capacities to act upon and breakdown hydrocarbon rings. He introduced these plasmids into a single
otganism. See Wade (1980f: 31) and Wade (1980c: 1445).
3 D. E. (1990: 88). Specifically, Chakrabarty’s organism met the patent-criteria of being unique, useful and
non-obvious to those skilled in the art. Raines (1988:65-6). According to Amgen’s CEO, “Tlie
Chakrabarty decision set the stage for Genentech’s public offering and was directly linked to our ability to
start this company” E.C. (1988: 128). In a preview of what was to come, the Environmental Protection
Agency hesitated to permit General Electric to release the organism. Among the questions: What, they
asked, would clean up the organisms? Would they persist? What impact might they have on other
organisms? On the environment? On humans? Carmen (1985: 6-8).
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IPO’s were floated than in the previous three years.4 Since then biotechnology has
experienced alternating periods of financial feast and famine — of growth, shakeout and
consolidation.3
in. Deliberate Release: Terms. Distinctions. Disagreements
Among high-tech industries, biotechnology distinguishes itself with the ability to
generate controversy. The very selection of terms to discuss an issue often identifies one
as a partisan for one or another position.6 Among the terms used to describe basic
biotechnology processes are gene-splicing, genetic engineering, genetic manipulation and
genetic modification. Such techniques yield a recombinant, hybrid, chimera, a
bioengineered-, genetically engineered-, genetically manipulated-, or genetically
modified organism. Purposefully allowing the product to pass beyond laboratory
biocontainment is a deliberate release, an intentional release or a field test.
* For a discussion of these early heady days, see Kenney (1986: ch. 7).
3 “Stock prices of publicly traded biotech firms have come down anywhere from IS percent to as much as
40 percent from their highs last June.... Although most analysts believe that the stocks could go down
another 25-30%, they do not expect the drop to be as severe as the one following the highs in 1983”
Klausner (1986b: 759). The early 1990s bore witness to another surge in biotech. “The industry is still
peddling dreams, and it did raise $4.7 billion in public and private capital in the 12 months ended last June.
But investors are getting leery, and the money flow is drying up...The Amex Biotech Index is off more
than 50% from its zenith in 1992” (O’C Hamilton 1994: 84). Business Week followed up this pessimistic
cover-page article with an optimistic report three short years later entitled “The Biotech Century”
Freundlich (1997). For other useful economic surveys, see Wyke (1988) and Morton (1995).
6 The following two excerpts reflect the emotion of these issues. “The greatest present controversy is over
the intentional introduction of engineered bacteria into the environment. (This procedure is often called
deliberate release in this country, though not in England; but since that term seems to imply that the
material should have been held back, most contributors to this book have accepted the more neutral term
planned introduction.)” Davis (1991a: 4). Davis’ claim is not supported by the facts. The British Royal
Commission that reviewed the issue uses the terms “deliberate release” and “genetic manipulation.” Lapp£
and Bailey (1998) also commit this error when they suggest, “While the United States government confiises
the identity of genetically altered food crops by calling them ‘transgenic plants,’ Europeans call them
‘genetically modified organisms’ (10). Polemic trumps research here: the term transgenic appears in
British, German and French publications. “The original term was ‘genetically engineered organism’
(GEO), but the key adjective became ‘modified’ (hence GMO) when the EC took initial steps toward
statutory regulation in 1986, and when the UK government did likewise for GMO releases in 1989. Indeed,
the name change sought the [technique’s] normalization” Levidow (1994:274).
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This chapter explores some of these definitional issues. It is divided into two
parts. The first half addresses the term genetically engineered. It introduces agricultural
biotechnology by presenting traditional crossbreeding, culture techniques, and more
recent recombinant techniques. The second addresses the term organism within the
deliberate release context. It reviews the different possible organisms for release, and
presents two widely-cited episodes of unauthorized release. These discussions offer a
scientific primer to the topic and underscore the uncertain nature of deliberate release
analysis.
A. “Genetic Engineering”: From Land Races to rDNA.
The term genetic engineering is often ill-defined. It is frequently used as a
substitute for biotechnology. This latter term, however, is generally reserved for
commercial applications of the techniques in question.7 Some emphasize the movement
of genes from one species to another, though this omits the use of recombinant
techniques to delete genes from an organism.8 Others use it to refer to all gene-splicing,
though this formulation arguably omits protoplast fusion (discussed below). Another
pitfall is conflating processes and their products.9 With these previous omissions in
7 The first use of the term biotechnology is attributed to the Hungarian agricultural economist Karl Ereky.
He defined the term in 1919 as the interaction of biology and technology, connoting all production by
means of biological transformation. It first appeared in a Nature title (but not the article itself!) in 1933. In
1962 the Journal of Microbiology Technology and Engineering changed title to Biotechnology and
Bioengineering. Biotechnology was used broadly here to refer to all aspects of the exploitation and control
of biological systems. In 1979, E. F. Hutton obtained trademark protection for the word biotechnology to
cover its magazine of genetic engineering, cementing that association. For a discussion of this etiology, see
Kennedy (1991).
8 For example, Smith (1996:34) defines genetic engineering as, “the formation of new combinations of
heritable material by the insertion of nucleic acid molecules, produced by whatever means outside the cell,
into any virus, bacterial, plasmid or any other vector system so as to allow their incorporation into a host
organism in which they do not naturally occur but in which they are capable of continued propagation.”
9 For example, Miller (1989:144) suggests, ‘ “Genetically engineered' may describe fusion products, new
enzyme capabilities, new fermentations, or as is most often meant, new recombinant DNA products. The
processes may be applied to microorganisms, plants, or animals.”
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mind, the most general definition of genetic engineering would be the deletion, addition,
movement or substitution of genes for the purpose of changing an organism’s
phenotype.1 0 Genetic engineering at its most basic level encompasses a broad range of
techniques and activities.1 1 The most recent of these - recombinant DNA techniques -
have contributed to a biological revolution that facilitates the creation of organisms
previously difficult or impossible to attain. They have opened an era of rapid change and
promise in fields as diverse as agriculture, medicine, mining and environmental clean up.
The following section concentrates on genetic engineering in agriculture. Traditional
crossbreeding is presented first to provide a baseline for comparing more recent
advances. Thereafter, the advances in modem agricultural biotechnology are discussed
and distinguished from one another.1 2
1. Traditional Breeding, Land Races and Scientific Hybrids
For millennia farmers have selected seeds and offspring exhibiting desirable
characteristics to plant a subsequent harvest or to renew their store of livestock. Preferred
characteristics (e.g., larger fruit, insect resistance, and drought tolerance) result from a
mutation, a random change in an organism’s inheritable genetic makeup, or genome. By
choosing seeds from such preferred strains, farmers have exerted selection pressure
resulting in differentiation. Centuries of differentiation resulted in land races, crops and
1 0 This definition echoes that adopted by a congressional staff report (U.S. Congress 1984a: 2).
1 1 Miller and Young (1987: 184) plead “for more precise communication in science and technology
generally, and specifically for cleaning up the ‘biotechnology’ and ‘genetic engineering’ jargon. Reference
to the appropriate constituents or subsets of these catch-alls would be more informative, clear and useful.”
1 2 This strategy will raise some hackles, since it suggests that rDNA is an extension of traditional practices.
My purpose is not to assume that position, but rather to present otherwise unfamiliar scientific information
in an approachable manner. Indeed, “the very definition of biotechnology is a matter of controversy,
because definitions emphasizing its similarity to techniques that have existed since time immemorial, like
breeding and cross-breeding animals and plants, suggest that nothing very new (and therefore very
worrisome) is going on” Wildavsky (1991:78).
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seeds well adapted to a specific locale. Thus, differentiated land races result from the
interplay of mutation, farmer-selection and local ecology.1 3
Understanding of inheritance was significantly advanced by the work of Gregor
Mendel, a monk working in a monastery in Bmo. Trained in biology, mathematics and
physics, Mendel dedicated some of his scientific attention to growing peas in his garden.
By meticulously crossbreeding different peas, he observed that distinct characteristics
were inherited in mathematically regular fashion. These patterns led him to infer laws of
inheritance and the existence of discrete factors of patrimony - what we refer today as
genes. Two examples drawn from his work - the shape of seeds and the color of seeds -
illustrate his scientific contribution.
Among the eight characteristics of interest, Mendel chose the “roundness” or
“wrinkledness” of a garden pea seed. He found that when he pollinated a round-seed
garden pea stigma with the pollen from a wrinkled-seed garden pea, the offspring had
rounded seeds. Similarly, rounded-seed offspring result from the cross of pollen from a
round-seed garden pea with the stigma of a wrinkled seed. He wondered, “what had
happened to the wrinkledness?”
Next, he let this generation of hybrids self-pollinate. The results were not
uniform: the majority of offspring had round seeds, but some of the offspring had
1 3 Darwin (1979:114) suggests this when he observes that, “variability is not actually caused by man; he
only unintentionally exposes organic beings to new conditions of life, and then nature acts on the
organisation and causes it to vary. But man can and does select the variations given to him by Nature, and
thus accumulates them in any desired manner. He thus adapts animals and plants for his own benefit or
pleasure. He may do this methodically, or he may do it unconsciously by preserving the individuals most
useful or pleasing to him without any intention of altering the breed. It is certain that he can largely
influence the character of a breed by selecting, in each successive generation, individual differences so
slight as to be inappreciable except by an educated eye. This unconscious process of selection has been the
great agency in the formation of the most distinct and useful domestic breeds.” For a discussion of Darwin
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wrinkled seeds. The wrinkled characteristic had somehow “disappeared” for a
generation, only to “reappear” in the next. When Mendel counted the number of round-
seeded and wrinkled-seeded offspring, he found they occurred in a ratio of approximately
3:1.
Mendel drew several conclusions from these observations. First, the ratio
suggested that mathematical rules govern inheritance. Second, traits do not blend, but
rather disappear and reappear. From this, Mendel inferred that any individual garden pea
contains two copies of a factor inherited from its parents. Any individual garden pea
passes on only one of the two copies to its progeny. To explain the disappearance and
reappearance of any given characteristic, Mendel concluded that for any characteristic,
one factor is dominant over the other: when these two are shared in a single garden pea,
only the dominant factor is expressed. Factor dominance explained the 3:1 ratio among
self-pollinating hybrids.
Discovery of the mathematical principles of inheritance might have been
sufficient to assure Mendel’s scientific standing, but he pursued the experiments further.
Mendel found that the color of seeds behave similarly to their shape: he found that yellow
is dominant over green. This led him to consider the relationship between seed-shape
and seed-color. He therefore set out to observe how these two characteristics (shape and
color) are inherited together.
He first crossed a pure round-yellow with a wrinkled-green. This yielded a
generation of hybrid garden peas whose seeds are round and yellow, given the dominance
of the two traits. Next, he allowed this hybrid generation to self-pollinate. When a
and evolution, see Dawkins (1996) and Dawkins (1989). For a discussion of evolutionary psychology, see
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sufficiently large number of offspring were produced, he discovered that all four
combinations are possible (round/yellow, round/green, wrinkled/yellow, wrinkled/green).
These four possibilities do not occur with the same frequency. In much the same way
that dominance generated the patterned frequency among hybrids of 3:1, the combination
of two characteristics generated the patterned frequency of 9:3:3:1. This is Mendel’s
other famous ratio. Mendel concluded from these observations that characteristics are
inherited independently, one of the basic laws of genetics. Mendel published his findings
in the Society’s journal Transactions in 1866 where they lingered in obscurity until their
“rediscovery” at the turn of the century.1 4
The rediscovery of Mendel’s work on genetics placed breeding programs on a
scientific footing in the early 20th century. The result was a move away from small farms
and land races toward larger farms and commercial hybrids. To create a commercial
hybrid, two sexually compatible strains are required. One strain is an established
agricultural variant; the other is a related variant expressing a preferred trait (e.g., insect
resistance). In the first stage, large numbers of the two strains are crossed. The purpose is
to identify a hybrid of the established variant that possesses the preferred trait. During
this initial cross, however, a number of other genes are introduced into the established
variant. Thus, a second stage of “back-crossing” with the established variant is pursued
to “dilute” the hybrid of the unwanted genes introduced by the initial cross. The goal is
to introduce the preferred trait - and only the preferred trait - into the established variant.
Scientific breeding programs greatly accelerated the selection process that had
Robert Wright (1994).
1 4 Mendel’s contributions are discussed in Tudge (1993: ch. 3).
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been pursued by fanners for centuries. Despite this advantage, two limitations remain.
First, the method remains slow and uncertain, requiring large numbers at each stage to
optimize the probability of generating a preferred hybrid. Second, breeding is restricted to
variants that sexually hybridize. Despite these limitations a number of commercial
hybrids were developed that spread quickly through agriculture in the developed world.
The resulting strains were superior to their predecessors in many ways, and served as a
cornerstone for the Green Revolution.1 5
Scientific breeding programs led researchers to comb the planet for wild variants
expressing beneficial traits (e.g., resistance to a specific pest). In addition, seed banks
were established to store the seeds of wild variants for later research and use. The
impetus for seed banks relied on the growing concern for the loss to development of
germplasm, or the sum of a species’ genetic diversity. Furthermore, throughout the 20th
century commercial agriculture came to rely increasingly on monogenic strains. Such
diminished genetic diversity in the field increases a harvest’s vulnerability to a novel
pathogen. Occasionally, a novel pest will arise - either through invasion or mutation -
and devastate an entire harvest. Famous examples of this are the Irish potato famine and
the American com blight of 1970.1 6 In the case of such a new vulnerability, scientists
1 5 The use of the term superior in this context should be understood to refer to a variety of characteristics.
Some of these are strictly industrial, such as ease of harvest “Scientists had developed new varieties of
high-yielding wheat and rice that were introduced - along with fertilizers, pesticides, and modem farm
equipment - into many Third World countries. This effort, now known as the green revolution,
dramatically increased global food production over the next two decades. According to one recent
estimate, the improved wheat and rice varieties are directly responsible for providing S O million tons of
grain annually, or enough to feed 500 million” Tangley (1987: 176). For a review of pre-20th century crop
improvement, and 20th century plant breeding, see Fowler (1994: ch. 1 and ch. 2).
1 6 For example, in 1970, an epidemic of Southern lead blight fungus devastated the American com harvest:
“Beginning in Florida, the outbreak of Southern leaf blight was a wave of infections in com crops caused
by a species of pathogenic mold....the outbreak spread like wildfire, traveling at speeds of up to 80
kilometers per day.. ..By the end of the 1970 growing season, Southern leaf blight had devastated more
than 12 percent of the annual U.S. harvest and more than the anticipated losses from all other com diseases
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must return to the seed banks in search of a wild cousin resistant to the pest.1 7
2. Culture Techniques1 8
Early 20th century breeding programs were limited to variants that sexually
hybridize. Technical advances since World War II have permitted crosses between
variants that do not sexually hybridize. The foundation for these techniques relies on the
ability to sustain and grow plant cells in vitro, or in a familiar petri dish. In the 1950s,
Folke Skoog of the University of Wisconsin at Madison discovered a class of hormones -
the cytokinins - that stimulates cell division. Concurrently, a team of researchers at the
Curie University in Paris identified another class - the auxins - which stimulate division
of callus, undifferentiated plant cells. These discoveries permit researchers to grow plant
cells, rather than simply sustain them in culture. Further, researchers discovered that by
varying the nutrient base, they could encourage differentiation of root, stem and leaf
cells. These findings permit the regeneration of entire plants from isolated cells.1 9 Tissue
culture techniques since the early 1990s permit researchers to maintain certain types of
plant cells in nutrient-rich solution.
combined....Later studies showed that an estimated 80 percent of the 1970 U.S. com crop possessed a
heritable trait known as male sterility factor, which plant geneticists had intentionally bred into hybrid com
crops. The reason the male sterility trait was introduced into hybrid com populations was to genetically
emasculate plants so that they would not accidentally fertilize their own flowers. But unbeknownst to well-
meaning plant geneticists, another, temporarily hidden trait turned out to be closely associated with the
male sterility factor - an inherited susceptibility to the poisons secreted by the fungus that causes Southern
leaf blight” Suzuki and Knudtson (1990:296 & 7). “The U.S. com blight epidemic in 1970 underlined the
importance to the developed nations of Third World genetic diversity” ICIoppenburg, Jr. and Kleinman
(1987: 191).
1 7 For an alarmist account of collapsing seed banks and spreading monocultures, see Raeburn (1985). For a
discussion of the global implications of “genetic interdependence,” see Kloppenburg, Jr. and Kleinman
(1987).
1 8 This discussion draws upon Cocking (1989).
1 9 The ability to generate an entire organism from a single cell is termed totiponcy. Totiponcy was a
characteristic initially believed to be limited to plants and lower organisms. However, Ian Willut’s team in
Scotland stimulated totiponcy in a mammalian somatic ceil, thereby creating the lamb famously known as
“Dolly.” Totiponcy would appear to be a universal characteristic of DNA, rather than organism-specific.
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Culture techniques opened the door to asexual propagation o f clonal variants,
conceptually akin to growing new plants from clippings.2 0 Asexual clonal propagation
provides an advantage, since preferred traits are often lost through sexual propagation. It
thereby facilitated basic research on uniform populations of plant cells, much as earlier
colonies of E.coli grown from a single bacterium had permitted. This has substantially
advanced the study of plant molecular biology. Cell culture methods can also be used to
develop pathogen-free plant strains. Pathogens frequently infect cells throughout a plant.
Cells from an infected plant can be isolated and sterilized, removing the pathogens.
These pathogen-free cells can then be regenerated to yield pathogen-free varities.
A surprising but persistent discovery of asexual reproduction is that daughter cells
occasionally vary genetically from the mother cell. Surprisingly, the process of culture
propagation seemed to elicit spontaneous genetic variation, termed somaclonal variation.
Since the early 1980s, however, researchers have relied on Barbara McClintock’s
research on transposons to explain this variation. Transposons - sometimes referred to as
“transposable elements” or “jumping genes” - are segments of DNA that move readily
about the genome, sometimes to a new position along a chromosome, sometimes from
one chromosome to another. Associated with these movements are subtle, sometimes
preferred changes in an organism’s phenotype, its observable characteristics. If the
2 0 “Micropropogadon is a form of clonal propogadon in which the apical meristem - the mass of the cells
at the growing tip of shoots - is removed and induced to develop many additional shoots. When these are
separated and rooted, each becomes a clonal copy. Organogeneisis involves culturing explants from root,
leaves or stems to form undifferentiated callus tissues; after the ceils form shoots, they are separated and
rooted.” Van Brunt (1985: 978). “Of all the technologies and techniques that have influenced horticulture
in the last 25 years, mircropropagation has had the most significant impact in shaping and developing
commercial horticulture... [it] has shaped not only the practice of horticulture, but also to some degree the
aspirations of the horticulture industry....The precise requirements for nutrients, growth regulators, and
cultural and environmental conditions must be determined for each and every species and variety, as
significant differences often exist” Giles and Friesen (1994:111 & 2).
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variation pre-exists in a selected cell, all daughter cells will exhibit the same variation.
Thus, cell and tissue culture techniques serve the twin, and somewhat contradictory
purposes of providing clonal propagation and a source of variation.2 1 Somaclonal
variation is observed in many commercial crops, and has been used to select for preferred
traits for modem food processing.2 2 Somaclonal variation offers a powerful tool for
selecting preferred traits.2 3
Some useful traits resulting from somaclonal variation can be screened in vitro,
but not others. Only those traits expressed at the cellular level - for instance, pathogen
resistance - can be so screened. In contrast, shortened flowering periods cannot be
screened in vitro; nor the ability of roots to resist salt uptake. These traits can only be
observed after regeneration of the entire organism. In addition, frequently the traits of
interest are polygenic, relying on the interaction of two or more genes. Screening for
these more complicated traits requires regenerating an entire plant from tissue culture and
permitting its development in a greenhouse. Current research, therefore, combines in
vitro and traditional breeding methods.
2 1 Transposons are associated with antibody diversity exhibited by human immune response. The presence
of transposons in eukaryotes demands a rejection of concept that the genome is static: “It would appear
that the mobility and mutation of certain elements within the genome of vertebrate animals is normal and
essential for the success of their immunological defenses against invasion by foreign agents, and
transposable genetic elements are now believed to be a major feature of all DNA” Wheale and McNally
(1988: 89).
2 2 “Somaclonal variation has been observed in over 30 species, including alfalfa, barley, wheat, maize, rice,
oats, potato, celery, tomato, banana, oil palm, lettuce, sugarcane, carrot, and tobacco” Van Brunt (1985:
976).
2 3 Transposons, like most mutations, usually result in an inferior phenotype. Sometimes, however, they
lead to the expression of a new or previously repressed useful trait This is because, in the course of
moving, a gene may reposition itself in the proper direction along the chromosome to be read in traditional
5’ to 3’ transcription. These techniques thereby permit more rapid screening of preferred traits than that
permitted by traditional breeding techniques.
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3. Protoplast Fusion2 4
The techniques described represent variations on traditional breeding. There are
several paths available to generate transgenic plants, those containing novel DNA. The
most basic of these relies on protoplasts, plant cells lacking their exterior wall. In 1971
Takabe first showed that a morphologically normal tobacco plant could be raised from a
single protoplast.2 5 In the mid-1970s, protoplast fusion techniques opened the door to
hybrids previously beyond the scope of traditional sexual breeding programs. Protoplast
fusion is a multi-stage process. First, plant cells from separate, sexually-incompatible
strains are isolated. Next, enzymes are used to dissolve the semi-permeable exterior plant
cell walls. This process exposes the interior protoplast, the site of a plant’s
chromosomes. The two protoplasts are placed together and are either electrically or
chemically stimulated. This causes the two to fuse, permitting their nuclear and
cytoplasmic genes to mix.2 6 The novel protoplast is nourished and encouraged to sub
divide. If successful, the process will yield a novel variant available for planting. Such
intergeneric hybrids are generally sterile, and therefore not suitable for traditional cross
breeding programs.2 7
4. Recombinant Techniques
Recombinant techniques rely on a panopoly of restriction enzymes that subdivide
the DNA double-helix at characteristic sites. Restriction enzymes “cut” DNA, leaving
2 4 This discussion relies on Evans (1983a) and Watson et al. (1992: ch. 15).
2 5 See Shepard, Bidney and Shahin (1980:18).
2 6 “The ability to transfer mitochondria and chloroplasts is especially promising, since traits such as disease
resistance, herbicide resistance, and male sterility are all encoded in these organelles. Cytoplasmic male
sterility is especially desirable in high-volume low-cost commercial hybrid seed production...the problem
of self-fertilization is eliminated” Van Brunt (1985:976).
2 7 See Evans (1983b: 856).
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sticky and complimentary ends which other enzymes can “paste” together. The sticky
ends can be reattached to one another, or to other segments of similarly rendered DNA.
These two enzymatic classes establish the basis for assembling together DNA from
varying sources.
The rapid development of recombinant techniques relied not only on advances in
enzymology, but also on the characteristics of plasmids, small segments of ring-DNA
found in bacterial cytoplasm. Plasmids complement a bacterium’s own genes. In the
1940s Joshua Lederberg showed that bacteria occasionally replicate these segments of
ring-DNA and pass them to other bacterium in a process termed conjugation. Further
research showed that plasmids conferred antibiotic resistance, and that conjugation was
the path through which resistance was spread among bacteria,
a. Agrobacterium tumefaciens-Mediated Transfer2 8
As was discussed in chapter 1, plasmid- and virus-mediated gene transfer struck
many observers as unnatural in the early 1970s. Shuttling genetic material between
different species was feared and challenged by opponents who found it “unnatural.” The
unique capacity of the soil bacterium Agrobacterium tumefaciens (Agrobacterium) draws
into some question these earlier claims of “unnaturalness.”2 9
Agrobacteria are soil bacteria that infect dicots, one of the two major subclasses
of plants.3 0 Agrobacteria strike at a plant’s crown, the point where the root merges with
the stem. Normally this region is hermetically sealed against invasion by tough coatings
2 8 This discussion draws upon Suzuki and Knudtson (1990: ch 11) and Chilton (1983).
2 9 Marx (1979) turns this phrase in his article, “Nature as Genetic Engineer.”
3 0 Monocotyledonous plants (monocots) have seeds with a only a single seed-leaf; dicotylendonous plants
have two. Monocots include the world’s grasses (e.g., rice, wheat, com).
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of cellulose and wax. Animals, wind or other elements can injure the crown’s epidermal
cells, exposing it to infection. Wounded plants secrete low molecular weight phenolic
compounds that activate virulence genes in the agrobacterium, and initiate an infection
cycle. Plant tissue so infected is identifiable by a crown gall, a bulbous site of cancerous
growth.
Crown galls are the evidence of a rather amazing genetic event. Agrobacteria are
host to a tumor-inducing (Ti) plasmid. During infection, Agrobacteria transfer the Ti
plasmid to the plant’s cells. There, the Ti plasmid integrates a specific segment of its own
DNA into the plant’s genome. This segment is called the T-DNA (for transferred
DNA).3 1
Once integrated into the plant genome, the T-DNA directs two changes. First, the
T-DNA sequence is oncogenic, causing host cells to subdivide and reproduce. It is this
rapid growth which generates the characteristic galls. Second, the T-DNA in each of
these gall cells directs the synthesis of a class of novel chemical compounds called
opines, a metabolite not found inside normal plant cells. Through both tumor induction
and opine synthesis, the T-DNA generates significant amounts of the metabolite. The
opines leach from the crown galls into the soil where they provide nutrients - carbon and
nitrogen - to the agrobacteria. The type of opine synthesized varies according to the
strain of bacterium causing the infection: only the infecting strain possesses the enzymes
necessary to catabolize the released opine.
3 1 T-DNA should not be confused with tDNA. The latter - transfer DNA - are the clover-shaped segments
that recognize specific codons of mRNA and thereby link together strings of amino acids in the cytoplasm
to generate proteins.
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Agrobacteria are interesting on several levels. It is the only documented case of
routine genetic exchange between prokaryotes and eukaryotes, thereby crossing the most
fundamental taxonomic divide in the biological world.3 2 This “natural example of
genetic engineering”3 3 also confers exclusive benefits to Agrobacteria. But most exciting
for agricultural research was that it offered an obvious vector for transforming plants.
Sequences of interest can be spliced into the Ti plasmid, after which the infection cycle
can be initiated. Next infected cells can be isolated, screened and placed through the
culture cycle previously described.
b. Virus-mediated Transfer
As previously discussed, bacteria can be genetically modified using both plasmids
and retrorviruses. Plant-infecting viruses can be used to in similar fashion to introduce
novel DNA into target cells. Plant viruses have generally not received the same level of
attention that bacterial phages have, and these vectors are still under development. Virus-
mediated-transfer, however is seen as a promising avenue for genetic modification.
Some initial success has been recorded using cauliflower mosaic virus and Brome mosaic
virus to modify turnip and barley, respectively.
c. Physical Transfer Techniques
There are three other approaches used to modify the genome of a target organism.
Each of these physically transgresses a target cell to introduce DNA directly into the
3 2 Eukaryotes possess a nucleus, an organelle housing the cell’s chromosomes. In prokaryotes, in contrast,
the chromosomes are housed in the cytoplasm. “...By joining a plant chromosome, the microbe’s genes are
in effect bridging a gap of more than three billion years - the span of time since the ancient lineage of
contemporary higher plants diverged from that of modem bacteria” Suzuki and Knudtson (1990: 2S4).
3 3 Chilton (1983: 51), one of the scientists responsible for describing the process, writes, “it has become
clear that the infective process is a natural form of genetic engineering.” Such phrasing suggests that other
methods of recombinant DNA are “unnatural.”
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protoplast or nucleus. One approach — transformation - places protoplasts in solution
with copies of a gene sequence of interest. When the solution is exposed to either an
electrical or chemical stimulus, some of the protoplasts take up the free-DNA in solution.
These protoplasts can then be screened to identify which have taken up the DNA of
interest. Microinjection uses micropipettes - fine glass needles - to inject DNA directly
into a cell nucleus or protoplast. While this process is more labor-intensive than
transformation, it achieves higher success rates of incorporation. Biolistics works by
coating microscopic particles (gold or tungsten) with DNA. Researchers then literally
use a small shell to accelerate the particles to a velocity that permits them to transverse
the exterior cell wall and lodge in the nucleus.3 4 These techniques have the advantage
that they can be used on all types of plant cells.3 s
This brief technical review suggests a continuum that proceeds from organism
through cell to genome.3 6 Pre-twentieth century farmers selected exceptional strains for
subsequent generations of crops and livestock. With the rediscovery of Mendel’s laws,
crossbreeding techniques were placed on stronger scientific footing. The early 20th
century saw expanded and accelerated breeding programs. Land races gave way to
commercial hybrids. These selection techniques impose genetic variation at the level of
3 4 See “Shotgun Marriage” (1987:23).
3 5 “The main advantage of particle bombardment-mediated DNA delivery to obtain transgenic plants is that
it is genotype independent.... This has been a major limitation of other techniques for DNA delivery into
plant cells. The only limitation in producing transgenic plants using this technology is the availability of
suitable regeneration protocols that are also amenable to selection of transformed cells using a selective
agent.... Another important use of particle bombardment is its ability to deliver DNA in all three genomes
(nucleus, chloroplasts, and mitochondria) in the plant cell” Chibbar and Kartha (1994:49 & 50).
3 6 It should be observed that this “continuum” is frequently used to argue that recombinant techniques
represent a change in kind: “Hardy and Glass have carefully distinguished three modes of genetic
engineering that constitute a continuum of scientific sophistication and precision: whole organism, cellular
and molecular genetic engineering. They point out that in all three, DNA is modified or combined to
increase genetic variation, thereby enlarging the pool of potentially useful traits. The three modes differ
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the organism. Ceil and tissue culture techniques combined with protoplast fusion
permitted selection techniques to impose variation at the cellular level. Finally,
recombinant techniques — Agrobacterium-mediated transfer, virus-mediated transfer,
transformation, microinjection and biolistics — permit directed genetic variation at the
molecular level. What all these genetic engineering processes share is the goal of
directing an organism’s evolution in order to encourage the expression of preferred
characteristics. Breeding is now understood and defined at the genetic level.3 7
B. Organisms
Modifying crops and livestock formed the initial hope for agricultural
biotechnology. Animals were not an early focus of regulatory interest, because of the
technical complications involved in their modification and their costs of maintenance.3 8
According to the OECD, the great majority of field tests have been conducted on familiar
crops. Despite this, the initial controversy regarding field tests, however, centered on
planned releases of microorganisms. Since recombinant techniques were perfected on
microbial - as opposed to plant - models, early petitions for release included transgenic
microorganisms. The proposed release of genetically modified microorganisms generated
particular regulatory controversy. In contrast to animals and plants, microorganisms are
not in the end product but in the process used to generate the genetic variability” Young and Miller (1988:
17).
3 According to the FDA, “Breeding techniques include hybridizations between plants of the same species,
between plants of different species, and between plants of different genera; chemical and physical
mutagenesis interspecies and intergeneric protoplast fusions; somaclonal variation resulting from
regeneration of plants from tissue culture; and in vitro gene transfer techniques” Kessler et al. (1992: 1747).
3 8 Making predictions of biotechnology’s limits may be folly. In 1991, Bernard Davis, Adelman Chair in
Microbiology at Harvard University, and a vocal proponent of deliberate release wrote: “there is suggestive
evidence that in mammals, unlike plants or lower animals, the process of cell differentiation not only
selectively turns various genes on or off in different kinds of cells, but also destroys their ability to code for
a new individual - presumably as a result of irreversible duplications or losses in the content of the
genome. Cloning from adult mammals may therefore remain science fiction” (1991b: 251 & 2). Six short
years later Dr. Ian Wilmut of the Roslin Institute introduced ‘Dolly,’ making science fact of science fiction.
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difficult to observe and track. Their reproductive rates are prodigious, with colonies
capable of doubling as frequently as every 20 minutes. As a practical matter, it is
virtually impossible to assure that released microorganisms have not spread beyond the
site of application.
Viruses are a special case. Viruses consist of nucleic acid - either RNA or DNA -
packaged within a protective protein coat. Though possessing genetic material, viruses
are incapable of reproducing outside a host-cell. In this way, they are more similar to
plasmids than bacteria. When a virus comes in contact with the appropriate host cell, it
attaches to the surface. Once affixed, it injects its nucleic acid into the host-cell. It
thereafter moves to the nucleus, where it commandeers the cellular machinery for its own
purposes. Viruses have been used to control agricultural pests. Attenuated viruses can
also be used as vaccines to protect livestock from disease, and several early episodes
involved recombinant rabies vaccines.3 9 Genetically engineered viruses raised similar
concerns as release of other microorganisms. They differ in three respects. First, a virus’
reproductive cycle necessarily involves infection of a host. Second, they are often
pathogenic. Third, small mutations have been occasionally observed to produce
significant changes in virulence.4 0
Two further nuances should be briefly mentioned. First is the question of whether
a genetically engineered organism that has then been killed should be released into the
environment. What sets the deliberate release debate apart is the reproductive potential
of engineered organisms. Modified organisms that were killed before release did not
3 9 The British bacculovirus and the pseudorabies episodes are discussed at length later in this study.
4 0 See Kamely (1986:152).
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generate the same concerns as those that remained alive, since the former were no longer
capable of reproduction.4 1 Second, in the 1980s biotechnology was opening new
biomedical frontiers. One of these was gene therapy - the transmission of novel genes
into humans for therapeutic purposes. The first authorized gene therapy was performed
in September 1988 by W. French Anderson.4 2 Depending on one’s definition, a gene
therapy patient released from the hospital could conceivably constitute a deliberate
release. Indeed, German gene legislation governing deliberate release was originally
sufficiently broad that a gene therapy patient would have been in violation had he or she
moved across national borders.4 3
C. Unauthorized Deliberate Releases
As a study of regulation, the central issue here is the authorization of deliberate
releases by the competent national authorities. Just as laboratory microsplashes result in
the release of recombinant organisms, so too were there several celebrated examples of
4 1 Before the first authorized American release of a live genetically engineered organisms in the US,
Mycogen field tested a dead recombinant strain Pseudomonas fluorescens engineered to contain the insect
toxin, B.t. “The bugs are killed by chemical washing...because the [EPA] has ruled that the dead microbes
can be treated as a chemical, not as recombinant organisms, the tests can be carried out - on cabbage
loopers infesting lettuce - without special precautions” “Chronicle” (198S: 1062).
4 2 This is not the first instance of gene therapy. In 1980, Dr. Martin Cline of UCLA used recombinant
techniques to treat patients in Israel and Italy suffering from Thessalamia. The Institutional Biosafety
Committee at UCLA was reluctant to grant Cline permission to perform his experimental therapy at the
university medical center. Cline received permission abroad to conduct a similar - though not strictly -
recombinant therapy. It eventually emerged that he had misrepresented his actions to foreign regulators,
and had switched back to the recombinant therapy at the last moment. This was seen as both an attempt to
circumvent his home IBC and an unethical rush to claim a medical and scientific first. Cline was severely
rebuked and stripped of his chairmanship at the UCLA Oncology Department. His actions set back gene
therapy by several years. For a discussion, see Lyon and Comer (1995:68-77).
4 3 MacKenzie (1993:6). The OECD maintains a summary of deliberate release activity at
http://www.oecd.org/ehs/summary.htm. Remarkably, the fourth figure on this site is called “Data Entries
by Common Name.” It summarizes all the field tests of genetically modified organisms. In the fifth
column, you can find: “Sunflower, Apple, Walnut, Currant, Eggplant, Human.” The sixth figure on this site
is called “Data Entries by Scientific Name.” Homo Sapiens does not appear, suggesting that someone has
played games with their site.
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unauthorized deliberate release. Two are mentioned here because of their relevance in
later discussions of national regulations.
1. Unauthorized Release I: AGS in Oakland
In June 1984 the National Institutes of Health’s Recombinant DNA Advisory
Committee authorized Advanced Genetics Sciences, Inc. (AGS) to spray within the
confines of a greenhouse a plot of fruit trees with 100 billion recombinant bacteria,
altered to inhibit frost formation. In February 1986 EPA received information from an
anonymous whistle-blower within the company that AGS had instead injected the
recombinant bacteria into the bark of trees located on the company’s roof. At the time,
AGS headquarters were located in densely populated Oakland, California. While AGS
did not deny the episode, they did question whether the activity constituted a deliberate
release.4 4 AGS officials argued before a congressional hearing that because the modified
bacteria were injected into tree tissue, it was not a deliberate release.4 5 The episode
resulted in a fine for AGS and postponement of further field tests. These events are
discussed in further detail in the next chapter.
4 4 McCormick (1986b: 253).
4 5 “[AGS] believed the inoculation methods to be used in the rooftop tests would minimize any potential for
release, and [we] were confident that the test organisms were not pathogens and therefore would not
multiply in the fruit tree tissues. Moreover, they were confident that the tests involving the injection of
bacteria into branches of trees located on the roof would not constitute any greater risk of an environmental
release than a greenhouse experiment because the injected bacteria would be contained within the plant
tissues and the tissues would be sterilized and properly disposed of at the conclusion of the experiment. In
short the experiment was done outdoors on the roof top without prior notice to EPA because the researchers
felt that the experiment did not constitute a ‘field test,’ that the methodology and physical environment
provided adequate ‘containment’ and did not involve a ‘direct release’ of altered bacteria to the
environment” Robert Colwell, an evolutionary biologist from U.C. Berkeley, observed, “assuming that
[ice-minus] aren’t pathogenic and then saying it is OK to do it on the rooftop because we know they aren’t
pathogenic when you are testing pathogenicity just doesn’t fly in terms of logic” U.S. Congress (1986a: 22
& 90).
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2. Unauthorized Release II: Wistar in Argentina
In September 1986, information surfaced of an unauthorized test of an engineered
rabies vaccine in Argentina. The Wistar Institute of Pennsylvania conducted the test at a
remote field station in Azul about 250km south of Buenos Aires. The field station is
operated by the Pan American Health Organization (PAHO), a United Nations
organization dedicated to the study of animal disease. (Fox 1987)
The organism in question was a modified vaccinia virus, an innocuous relative of
smallpox frequently used for the development of vaccines. In this case, engineered into
the vaccinia virus was a gene coding for a surface antigen of the bovine rabies virus. The
experimenters sought to discover whether the live hybrid vaccine would inoculate
animals against rabies. The main attraction for this product would be in protecting
livestock, though it was also being considered in Europe as a means to eradicate rabies
from nature reserves. Wistar had received the vaccine from Transgene, a French
biotechnology company based in Strasbourg.4 6
PAHO volunteered its station for field testing the vaccine. On 1 June 1986 20
cows were injected with the vaccine and housed with 20 unvaccinated animals. Neither
the Argentine government (site of the test) nor the American government (home of the
Wistar Institute) were informed of the test, a fact that a PAHO official conceded was
“impolitic” in retrospect.4 7
4 6 “The company has supplied vaccine for tests by the Wistar Institute in Philadelphia, but use of the
vaccine in the wild is likely to take place in Europe first...” Walgate (1986:297). In an interesting aside,
the Wistar Institute was awarded the patent on hybridoma technology when their original inventors - Cesar
Milstein and Georges Koeler - failed to submit a patent See Wade (1980e: 693).
4 7 Palca (1986:202).
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When reports of the tests surfaced in September 1986, the Argentine government
promptly terminated the experiment. A group of 134 Argentine scientists sent a letter to
Nature expressing their concern. They emphasized the uncertain effects that accompanied
the tests, and the absence of warning signs near the experimental area. They noted that
the farm hands caring for the vaccinated cows had neither been vaccinated against
smallpox, nor submitted to medical surveillance. Finally, some of the farm hands and
their families consumed the milk from the inoculated cows prior to its pasteurization; the
rest was sent to the local market after pasteurization. The scientists concluded: “we feel
that out country has been illegally used as a test field for a kind of experiment that is not
yet accepted in the countries where basic research on this vaccine had originated.”4 8
IV. The Central Confrontation - Molecular Biologists v. Ecologists
At its most basic level, the deliberate release issue pits molecular geneticists and
ecologists. From their shared position within the Life Sciences both focus on the
diversity, behavior and organization of life. Yet they come to these questions from very
different perspectives. Each can lay a claim of analytic expertise with regard to
deliberate release. Molecular geneticists develop the organisms in question, while
ecologists study the environments into which the proposed organisms are to be released.
They also divide according to the questions they ask and the answers they expect.
Molecular genetics’ epistemological core is reductionist; as the French Nobel Lauriet
Jacques Monad put it, “what is true for the E.coli is true for the elephant.” Its Central
4 8 Grigera (1986:610). Wheale and McNally (1988: 187) report that the farmhands also tested positive for
the antigens, though I have not found confirmation of this claim.
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Dogma (DNA/RNA -> Information) is unidirectional.4 9 Molecular biologists emphasize
the precision of their recombinant techniques. They view genomes largely in additive
terms: the behavior of a genetically engineered organism will depend on the
characteristics of the host organism’s genotype and the novel sequence added.
Ecologists study interactions among organisms, and between organisms and their
environments. Two main approaches dominate their research - structural and functional
ecology. Structural ecology, with roots in the taxonomy studies of 19th century
naturalists, catalogues the richness of biological diversity. It is symbolized by food webs.
Functional ecologists focus on biological cycles (e.g., ultraviolet protection, waste
disposal, nutrient generation), and seek to generalize across ecosystems.5 0 Rather than
enjoy a powerful reductionist epistemology, ecologists contend with the numerous
examples of non-linear behavior. Accordingly, they look askance at general claims of
how genetically engineered organisms would behave in poorly understood ecosystems.
Rather, than accept the reductionist approach of molecular genetics, they emphasize the
boundaries on predictability.5 1 Thus, while molecular biologists were generally
4 9 “This scheme - that information flows from DNA to RNA to protein - became known as the central
dogma of molecular biology” Watson et al. (1992: 36). “The essence of the Central Dogma was that since
the transfer of genetic information depends on the formation of hydrogen bonds between complementary
purine and pyramidine bases of polynucleotide chians, there can be no reverse flow of genetic information
from proteins to nucleic acids. But the Central Dogma did not foreclose the possibility of transfer of
genetic information from RNA to DNA, via the Watson-Crick base-pairing mechanism” Stent and
Calendar (1978:604). “In the mid-fifties this information flow from DNA->RNA->protein came to be
regarded as ‘the central dogma’ of molecular biology. Then in 1970 came the discovery that tumor viruses
(and more recently the AIDS virus), which are made of RNA rather than DNA, are first transcribed into
DNA, and only later back to RNA. Thus DNA<— >RNA->protein. Once the RNA viral chromosome has
been restated in DNA language, it can insinuate into one of the host’s own chromosomes” Komberg (1989:
94). The difference between DNA and RNA is that the former is composed of the four phosphate groups
adenine thiamine, guanine and c; in RNA uracil substitutes for guanine.
5 0 Caims, Jr. and Niederlehner (1993).
5 1 Roberts (1989:1141). “Genetically engineered organisms should be evaluated and regulated according
to their biological properties (phenotypes), rather than according to the genetic techniques used to produce
them...precise genetic characterization does not ensure that all ecologically important aspects of the
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proponents of field tests, some ecologists criticized what they believed to be a potentially
hazardous endeavor.
Many of the themes developed in the previous chapter regarding risk and
uncertainty appear in the analysis of deliberate release. Almost universally, disputants
conceive of risk as hazard*2 In addition, disputants compare risks to benefits*2 Such
terminology misguides analysis, since the term risk conceptually includes probability,
while benefit generally excludes it Almost all parties acknowledge that uncertainty
enveloped deliberate release analysis, though they fail to distinguish uncertainty from
risk.5 4 Yet after acknowledging that uncertainty, they generally proceed to treat the
phenotype can be predicted for the environments into which an organism will be introduced” Tiedje et al.
(1989:220).
3 2 NATO sponsored an Advanced Research Workshop devoted to deliberate release in Rome, June 6-10,
1987. Contributors to the volume equate risk and hazard. Travis and Hattemer-Frey (1988: 74) urge that
“the development and use of biotechnology products...must be addressed so that the potential risks can be
minimized and potential benefits maximized.” One can substitute the term risk with hazard without any
loss of meaning.
3 3 Note that the samples below span a decade, emphasizing both the depth and breadth of misunderstanding
surrounding risk-analysis. “We now seem poised for another full-scale debate about the risks and benefits
of biotechnology” McGarity (1985:41). “If risk is reduced, objective observers and the general public
would be far more inclined to accept [biotechnology] with a sense of anticipation of its benefits” Alexander
(1985:68). “Long experience with the risks and benefits of organismal technology provides an appropriate
and sensible baseline for evaluating the products of molecular and cellular biotechnology, but additional
ecological questions may arise with genetic constructions not previously possible” Colwell (1988: 171).
“Evaluating the benefits and risks of biotechnology products requires expertise in many scientific
disciplines including molecular biology genetic, cell biology, evolutionary biology, physiology, population
and community ecology, and ecosystem science” Tiedje et al (1989:299). “The next generation of
environmental experiments and applications of biotechnics brought a new group of scientist-stakeholders
into the discourse of risks and benefits of new technologies” Krimsky (1991:93). “As for the
environmental applications of [biotechnology], they should not be endorsed until more is known about both
risks and benefits” Mellon (1991:73). “In spite of the unanimous conclusion of the EPA’s panel of
extramural scientific experts and other federal agencies that there was virtually no likelihood of significant
risk in the [Psuedomonas] field trial (and leaving aside the enormous potential benefit to fanners and
consumers)...” Miller (1997: 194).
3 4 A broad sampling: “Clearly, substantial uncertainty surrounds the magnitude of risk posed by genetic
engineering...some degree of uncertainty will remain even with a thorough testing program” Alexander
(1985:61 & 67). “Our scientific understanding of the possible long-term effects of releasing novel
recombinant organisms into ecosystems around the world is simply too crude to permit us to reliably
answer these and other unsettling questions. As a result, any discussion of the potential risks of agricultural
genetic engineering is necessarily speculative - as are most confident assurances that no risks exist at all. It
is also fair to argue, of course, that we will never know enough about the ecological impacts of
recombinant creatures to reduce the risk of their release to zero” Suzuki and Knudtson (1990:267).
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question as one of risk. Deliberate release, however, lacked an acknowledged empirical
record for probabilistic analysis, and suffered from a highly contentious and ambiguous
theoretical base.5 5 Many lamented the “blindspots” that dogged analysis.5 6 In response
some advocated the precautionary principle, requiring proof of a negative before taking
action while dismissing the costs of opportunity (both public and private) associated with
delay.5 7 Others urged regulatory flexibility.5 8
Knight’s subdivision of risk analysis into statistical and a priori approaches is
useful for presenting the deliberate release controversy. Each approach serves as a
strategy to estimate the wisdom of competing courses of action. The first approach
“Where disagreements over deliberate release exist, they have more to do with how we should conduct our
lives in the face of uncertainty... Uncertainty is the theme that unifies much of the criticism leveled against
biotech agriculture by scientists and environmentalists” Pollan (1998:49).
5 5 A conference dedicated to the Geld test issue was held in Philadelphia in June 1985. The keynote speaker
emphasized Knightian uncertainty when he noted that “when discussing the risks of recombinant
technology, one deals with ‘conjectural’ rather than statistical or even potential risks (which after all must
rest on data collected from experience)” McCormick (1985f: 686). Young and Miller, perhaps the strongest
proponents of deliberate release, simultaneously conflate risk, hazard and uncertainty. “The risk
assessment literature generally defines ‘risk’ as the potential for adverse consequences of an event or
activity. Risk assessment or analysis is the process of obtaining quantitative or qualitative measures of risk
levels, including estimates of possible health and other consequences. Implied, of course, are
approximations of the uncertainty of those estimates” (1988:13).
5 “‘We don’t know what the potential hazards are,’ says Richard Hill, science adviser at the EPA’s Office
of Toxic Substances and Pesticides. ‘We don’t know what it is we don’t know’” Dwyer (1983: 15).
5 7 “...we would argue that it is better to be safe than sorry” McGarity (1985:47). “The lesson from the
Challenger disaster is that safety should be the primary, overriding value in administrative or regulatory
decision making.... A safety-first approach should reign in technology development.... The history of
modem technology and the dangers inherent in deliberate release compel adoption of the deep ecology
paradigm to prevent injury to public health and the natural environment” Deatherage (1987:216,217 &
219). “For a genetically engineered organism, a plant must show no more so-called weediness than its non
engineered precursor...The most effective way to reduce harm from new nonindigenous species is to
assume that all are problematic - guilty until proven innocent. Such an approach at most delays the
introduction of crops, biological control agents, plants, and commodities that genuinely contribute to our
well being” Ruesink et al. (1995:467 & 474). “Given the current lack of sufficient information with which
to make competent assessments of the risks involved and the extreme difficulties which are likely to inhibit
attempt to gain such information in a timely fashion, we conclude that a compelling case for deliberate
release programs has not been made” Sherlock and Kawar (1989:129).
5 8 “Of particular importance to industry is the need, regardless of how the regulatory framework is
ultimately structured, for flexible requirements that can be modified and relaxed as circumstances warrant.”
Price (1985:272). “In the matter of flexibility, Agracetus urges that regulations be structured in a manner to
assure their periodic review and modification - both to cope with problems which may not be initially
recognized, and to remove restriction directed to fears which prove unfounded” U. S. Congress (1985a: 33).
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requires identifying phenomena that approximate the category of interest. Several
proxies for deliberate release were advanced, including the laboratory record, and the use
of microorganisms in agriculture. Any relevant empirical experience could serve as a
proxy for deliberate release, which itself was generally not considered directly
measurable. The second a priori approach makes a theoretical assessment. Both these
approaches are reviewed in turn below.
A. Empirical Precedents - The Laboratory and Agricultural Records
The original biohazard debate and laboratory regulations of the 1970s aimed to
limit the accidental release of recombinant organisms into the environment The fear was
that recombinant organisms might expose humanity to unspecified hazard. Subsequently,
both the American NIH and British GMAG regulations had explicitly forbid the
deliberate release of genetically engineered organisms into the environment. These two
sets of rules formed the basis for global regulation in the early recombinant period (see
chapter 1).
Before the mid-1980s, no field test was authorized within the OECD. It would be
an overstatement to claim that, prior to this, no genetically engineered organism had
escaped into the environment. The NIH/GMAG regulations, in fact, philosophically
embraced the inevitability of accidental release. That various levels of containment were
required of different experiments reflects this fact. Because some experiments were
believed to constitute a greater biohazard than others, various levels of bio- and physical
containment were established to govern recombinant research. The alternatives to such
differentiation were either to forbid all recombinant research, or to demand that all
recombinant activity be conducted within bio-level 4 containment (reserved for the so-
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called “hot” organisms such as Ebola). Both of these alternatives would have squelched
recombinant research. Thus, recombinant regulations were philosophically grounded in
an effort to limit, not prevent releases. In fact, estimates are that billions of recombinant
microorganisms escaped laboratory containment each year before a single deliberate
release was ever conducted.5 9
The recombinant experiments conducted in labs since the mid-1970s have
enjoyed an exemplary safety record. Experiments were conducted in hundreds of
laboratories, exposing thousands of workers, without a single illness attributable to
recombinant organisms.6 0 Proponents used this record to argue that field tests posed
minimal hazards. Opponents challenged such “evidence,” noting that prior to 1980
laboratory research was conducted on organisms that had been intentionally weakened to
inhibit their reproduction outside the laboratory.6 1 Others concluded that the early
5 9 “Most workers will inevitably be contaminated during the course of routine manipulations. Several
common laboratory techniques cause ‘microsplashes,’ whereby millions of microorganisms will land on a
wrist, sleeve, or shoe. Curtiss estimates that more than 10 billion recombinants escape each year, without
causing any adverse health or environmental effects...NIH [rules are designed to] merely limit, not prevent
escape” Brill (1988: 19).
6 0 “In modem genetic engineering, not a single life has been lost; not a single person has become ill, even
though thousands of laboratories carry out recombinant DNA research on the open benches” Szybalski
(1985: 112).
6 1 “Most laboratory research before 1980 was conducted with strains designed to perish outside special
conditions provided in the laboratory” (his emphasis) Colwell (1988:169). Wheale and McNally (1988:80)
suggest that American acceptance of these strains signaled to European researchers that recombinant
activities could now proceed: “It took until late 1976 to develop the first genetically enfeebled derivatives
of E. coli K-12 that would comply with the NIH-RAC biological containment category EK2, and these then
had to be certified by the NIH-RAC as approved EK2 hosts. The first enfeebled plasmid vectors, pMB9
and pBR322, were certified as biologically safe by the NIH-RAC in the late spring of 1977. The NIH-
RAC’s approval of these enfeebled hosts and vectors was interpreted by several European laboratories as a
signal to proceed with recombinant DNA research, and structural analysis of specific eukaryotic DNA
fragments using recombinant DNA techniques began in 1977.” Sharpies (1987:1329), a RAC member,
characterizes recombinant- laboratory experience as “not particularly relevant” “The fact that some of
these organisms undoubtedly did leave the laboratory, but caused no harm, is certainly reassuring.
Unfortunately, however, this experience has limited bearing on ecological risks presented by engineered
organisms designed to survive and reproduce outside the laboratory” (his emphasis) Colwell (1988: 169-
70). “A commonly cited argument for the safety of genetically engineered organisms stems from the
laboratoiy experience gained since the mid-1970s with recombinant-DNA microorganisms. Although
some of these organisms have probably escaped containment, negative effects have not been detected.
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regulations themselves contributed to the laudable safety record.6 2
Further analytic resort was made to the years of releasing microbes into the
environment for agricultural purposes. Proponents pointed to the widespread use since
the turn of the century of Rhizobium in conjunction with legumes to replenish soil with
nitrogen. Rhizobium was first licensed in the U.S. in 1896. Despite an estimated
application of 10" organisms added to the soil each year, no harmful effects have been
documented.6 3 Bacillus thuringiensis (Bt) provides another example. Bt is a bacterial
strain that produces toxins lethal to insect pests. Different strains of Bt produce toxins of
varying characteristic. Bt was licensed in 1948 and is used extensively as a biological
pest control agent.6 4 Over 20 other microorganisms were licensed in the United States at
the time of this controversy.6 5
These escapes have probably ended in local extinction because the escapees arrived in incompatible
habitats in numbers below the threshold densities for establishment, and because these organisms were
often intentionally designed to have lower fitness than their genetically unaltered counterparts” Tiedje et al.
(1989: 306).
“It could well be that these controls have been responsible for the safe record of recombinant research
and development to date” Lenski and Levin (198S: 14). The original NIH Guidelines are not universally
lauded: “The Guidelines were drawn up in an overly cautious way. They promoted what has proved to be
an idiosyncratic and largely invalid set of assumptions that overestimated the nature of risks associated with
molecular biology techniques and rDNA-modified organisms” Miller (1997:2). “It is appealing, and
popular in some quarters, to admire the lofty goals that motivated the authors of the Berg letter and to
attribute the monstrous network of restrictive regulations that confronted molecular biologists in the 1970s
to the workings of the federal bureaucracy” Campbell (1991:42). It is ironic to note that in the early
recombinant period Campbell shared the ecologists’ fears he later pooh-poohed. “Campbell maintained
that there would be an extremely minute chance of producing a catastrophic result...since such an
improbable but finite catastrophic result exists, Campbell recommended that containment procedures for
such [rDNA] experiments be established and followed. The burden of proof, according to Campbell,
should be on the investigators to show that possible ecological risks have been explored. Next to the
problem of a possible disturbance to the biochemical cycle, Campbell wrote, the worry that rDNA research
might cause a few thousand extra cancer deaths seemed less significant” Krimsky (1982: 122-3).
6 3 Hardy and Glass (1985:71).
6 4 Wheale and McNally (1988:157).
6 5 “More than a thousand naturally occurring microorganisms or microbial products have been shown to be
active against insects, but only 14 have been approved by EPA for commercial use in the US. These
include sue bacteria, four viruses, three fungi and a protozoan” Klausner( 1984:409). Krimsky (1991: 186)
provides a useful table.
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Field test proponents also pointed to the enormous release of microorganisms in
sewage and other basic human activities. Some argued that nature would have probably
combined and recombined over the eons many different sequences; the vast majority of
these had not proven evolutionarily competitive. Field test critics countered that the
distinguishing characteristic of recombinant techniques is that it permitted the exchange
of genes across the species-boundary. Thus, while it was perhaps fair to assert that
through the eons Nature had conducted many recombinant experiments, these were
limited to genetic exchange between sexually compatible organisms.
Critics proposed generating data to assess better field tests. While the pattern of
disagreement should by now be clear, nevertheless, this discussion generated a highly
acrimonious exchange. Ecologists advanced proposals for using greenhouses and
microcosms to contain novel organisms, while assessing their effects on various species.
Acknowledging that such research would require “substantial” resources, ecologists
argued that industry should share in these costs, since it stood to profit from the
commercialization of the technology.
Field test proponents attacked the idea of microcosm experiments on several
grounds. First, they challenged the notion that such tests would yield any useful
information. They pointed out that even the most sophisticated greenhouses are
incapable of reproducing natural ecosystems, and that ecology is generally a descriptive -
not a predictive - science.6 6 Second, such an approach placed proponents in the position
of proving a negative by demonstrating the “safety” of a recombinant organism. Finally,
6 6 “A result that appears promising in the laboratory and greenhouse is not necessarily reproduceable in the
field - its complex and continually changing conditions are not well simulated even in the best greenhouse”
Brill (1988:47). See also Davis (1987:1335) and Campbell (1991:40).
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there would never be any way to show that released organisms had failed to spread
beyond the protected release sites.6 7
B. Theoretical Approaches - The Organizing Power of Metaphors
While empirical evidence was suggestive, it was not conclusive. If general
agreement had existed on the risks of release, then petitions to conduct field tests would
not have generated such controversy.6 8 In addition to the empirical arguments, field tests
were justified - and condemned - on theoretical grounds. The inconclusive nature of a
priori approaches further hampered agreement as to the hazards of release.6 9
Lakoff uses the term metaphor to describe systems of understanding that organize
and simplify complicated issues.7 0 To some degree, the deliberate release debate
constitutes a confrontation between two competing metaphorical systems.7 1 Molecular
geneticists generally advanced a metaphoric system of traditional cross breeding to
substantiate their position. Ecologists, on the other hand, advanced a metaphoric system
6 7 “If the concept of harm is open-ended, it is difficult to see how a nonpathogen can be proved to be
innocent” Davis (1987: 133S). “There is no test to demonstrate that an added microorganism has not
traveled to distant sites, and no test can show that a microorganism established in low numbers could not
erupt if the environment changed” Brill (1988:48).
6 8 Ethical issues are not irrelevant. In the Fall of 1983, however, “Pope John Paul II [announced] that
genetic engineering of plants and animals, especially for food production, was perfectly in line with the
Christian tradition, and represented a collaboration between the laboratory worker and the Creator”
Powledge (1984a: 11).
6 9 “Today’s ecology seems incapable of determining, on a priori grounds, which species will and will not
become pests (itself an anthropomorphic rather than biological term)” Dixon (1986a: 481). The more
appropriate term to use here is anthropocentric.
“Metaphorical thought, in itself is neither good nor bad; it is simply commonplace and inescapable.
Abstractions and enormously complex situations are routinely understood via metaphor” Lakoff (1991: 59).
The most complete account of metaphors appears in Lakoff (1987).
7 1 Krimsky (1991: 150) uses the Kuhnian term paradigm to describe the differences. “Two centers of
disciplinary activity address the problem and this brings into sharp relief their different modes of analysis
and applications of biological theories. It is instructive to apply the concept of ‘paradigm conflicts’ to the
debate between ecologists and molecular geneticists over [genetically engineered organisms].” Segerstrale
(1990) uses the term analogy, without providing it any theoretical meaning. Representative John Dingeil
observed during a Congressional hearing: “I think that we are tending to point up here is that scientists are
being compelled to reason by analogy, regulators are being compelled to reason by analogy, and the
Congress understands the situation may be compelled to reason by analogy. That is a form of reasoning I
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of biotic invasion. Frequently the analysis of the competing metaphors served as a
substitute - or proxy - for direct analysis of deliberate release. Advocates debated the
hazards of their respective metaphors, as much as they directly debated the hazards of
deliberate release.7 2 This reflects the uncertainty attached to field tests. These metaphors
served to justify rival regulatory approaches, despite the analytic burden such an
extension need bear.7 3
1. Cross Breeding: The Molecular Biologist’ s Preferred Metaphor
Field test proponents referred to the long history of traditional crossbreeding to
defend field tests.7 4 They argued that fanners have conducted genetic engineering by
controlling and directing genetic recombination.7 5 Through their efforts, farmers have
improved crops and livestock, selecting for disease resistance, flavor, drought tolerance
or other preferred traits. A variety of strains - Holstein Dairy Cow, Burbank potato,
find useful in certain cases but I am not sure it is the best way for us to approach the problem” U.S.
Congress (1984b: 86).
7 2 “Once we realize that much of ordinary everyday thought is metaphorical, the question arises as to
whether we can have metaphorical belief. The answer is yes. Indeed they are very common, though, like
everyday metaphorical thought in general, metaphorical beliefs tend not to be noticed as such. Indeed,
most people with metaphorical beliefs will take them as being literaP' (my emphasis) Lakoff (1993: 27).
7 3 “Even the most sophisticated descriptions tend to be metaphorical and, except for unrealistically
constrained systems, are inadequate to permit long-term predictions of a complex system’s behavior”
Cowen and Pines (1994: 710). “Most molecular biologists tend to discount the hazards presented by
planned introductions, while many ecologists believe that the impact of engineered organisms on complex
natural systems is poorly understood at present and that releases may pose appreciable risks of
environmental disruption through such mechanisms as colonialization, genetic transfer, and the pathogenic
effects of pest controls on nontarget species” Stewart (1991:218).
7 4 “Thus, a more applicable model for organisms modified by the techniques of new biotechnology is the
selective breeding and testing of domesticated plant, animals and microbes, with which there is vast
experience and which boasts an admirable safety record” Young and Miller (1988:26). “Information
derived from the long history of introducing, breeding and releasing domesticated plant and animal species
and certain microbes can provide important baseline data for assessing the rDNA organisms...Information
on the recipient organism may well be useful in predicting the fate of the modified organism” OECD
(1986:39).
7 5 There are various excellent accounts of agricultural history. For an overview of the history of major food
groups, see Heiser, Jr. (1990). For a history of seed improvement in the 19th and early 20th century, see
Fowler (1994). For a critical account of modem agribusiness, see Raeburn (1995). The links between
biotechnology and agriculture are outlined in Tudge (1993). A darker view of these links is provided in
Pollan (1998).
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short-horn cattle, Fuji apple - are widely recognized and consumed. Others are selected
variants of the same species (e.g., cabbage, cauliflower, Brussell sprouts and broccoli).
Molecular biologists argued that when traditional breeders seek to improve
strains, they randomly recombine thousands of genes from wild relatives. Modem
crossbreeders were not required to predict how their hybrids might behave when released.
Why then, they asked, must field test proponents predict how a recombinant organism
will behave before a release?
This, they argued, was an unreasonable double standard. Rather than regulate the
recombinant product, field test opponents sought to regulate on the basis of the
recombinant processes. The “process versus product” debate became a focus of
regulatory disagreement. Proponents pointed out that some recombinant organisms could
be created through non-recombinant techniques (i.e., using chemical or X-ray mutagens),
especially microorganisms engineered to lack a single gene. Field testing non
recombinant organisms did not generate concern. If the products of the two processes
were genotypically identical, why should one class be afforded special attention and
concern?7 6
Instead, proponents argued in favor of regulating recombinant products. The host
organism should dominate analysis.7 7 Further, so long as the genes being deleted or
added were well characterized, proponents believed there to be little cause to fear that the
7 6 “No conceptual distinction exists between genetic modification of plants and microorganisms by
classical methods or by molecular techniques that modify DNA and transfer genes... The product of
genetic modification and selection should be the primary focus for making decisions about the
environmental introduction of a plant or microorganism and not the process by which the products were
obtained” (their emphasis) National Research Council (1989: 14).
7 7 “How novel is a com plant with a newly-inserted gene for a Bacillus thuringiensis endotoxin which
confers endogenous protection against European com borer? It is, after all, still a com planf' Miller (1997:
16).
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product would behave in remarkably unforeseen ways. In essence, phenotype follows
genotype in additive fashion. And where organisms and novel genes are well
characterized, the behavior of their novel product generates a predictable organism.
Some proponents argued further that the products of recombinant techniques are
safer than those produced by traditional crossbreeding. Crossbreeding randomly
recombines tens of thousands of genes. Recombinant techniques, in contrast, shift (add,
delete or modify) only a limited number of genes.7 8 Proponents adhered to the claim that
recombinant techniques constitute a difference in kind when compared to crossbreeding,
not a difference in type.7 9
2. Biotic Invasions: The Ecologist’ s Preferred Metaphor
Critics of the traditional crossbreeding metaphor raised several objections. Rather
than focus on the precision of recombinant techniques, they focused on the novelty of the
recombinant organism. The techniques permitted gene-combinations that modem
crossbreeding could never create, surmounting fundamental evolutionary barriers
separating species. Trans versing such fundamental boundaries raised more concern than
traditional crossbreeding.8 0 Further, the offspring of crossbreeding have occasionally
behaved in ways that were neither anticipated, nor welcomed.8 1 Ecologists challenged the
7 8 “If anything, in light of the directed nature of the changes introduced into organisms through molecular
genetic engineering, the possible adverse effects of modified organisms can be more reliably predicted than
those associated with organisms mutated by traditional breeding” Hardy and Glass (1985:80). With genetic
engineering “one knows exactly which characteristics are being added or deleted from an organism, and
therefore one can predict what ecological advantage that organism might have” Johnson (1985: 18). See
also Young and Miller (1988: 19).
7 9 Young and Miller (1988: 17).
8 0 “The new technologies can more readily introduce and spread foreign genes into new lineages whereas
selection only rearranges genes already present. Although such cases [of problematic organisms] may be
infrequent, they should be avoided” Colwell et al. (1985: 111).
8 1 Davis (1991) asserts that “the important point here is that the benefits of domestication have been
remarkably free of harmful side effects” Colwell et al. (1985: 111) disagree, “We would argue that even
traditional breeding has not been ecologically trouble-free...”
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claims of precision assigned to genetic engineering, to the choice of vectors, and the
predictive capacity they were said to confer.8 2 Plasmid-mediated transfer was accorded
special concern, since plasmids are known to reproduce and disperse widely through
microbial populations.8 3 This extends the possible range of novel DNA beyond the target-
organism and subsequently beyond the target environment.8 4 Critics emphasized the poor
state of knowledge concerning dynamic ecosystems.8 5 They rejected an additive
approach to understanding an organism’s behavior, denying that phenotype follows
clearly from genotype.8 6 Critics rejected the assumption that gene deletion, the simplest
8 2 “Yet another difference from traditional crossbreeding is that viruses and plasmids are used as vectors (in
conjunction with transposons) in gene splicing. These vectors can also rearrange genes in new ways,
leading to unanticipated results. Science is just beginning to understand the implications of their activity in
nature” Regal (1985: 15).
8 3 “The reproductive fitness of plasmid-carrying bacteria depends on the stability and partitioning of
plasmids into daughter cells as well as the ‘metabolic load’ of the plasmids on cellular growth... if plasmid-
free cells are more fit under a given set of growth conditions, the plasmid-carrying cells will be displaced
from the population rapidly” Bialy (1984:239).
8 4 “Many genes of interest.. .are carried on plasmids. Plasmid-carried genes are a serious problem for risk
assessment, because many aspects of their proliferation, transport, invasion, and establishment are
predicted not by the initial host organism that is introduced, but by the properties of organisms to which the
plasmid may be transferred. Cell-oriented models and experimental methods are of at best limited value for
detecting and modeling the activity of g a gene that is transferred to many hosts.... The array of potential
hosts in real ecosystems is far to [sic] great for explicit modeling of plasmid transfer among all possible
hosts” Bamthouse et al. (1988:94). “Plasmids have attracted considerable attention because many
engineered traits will be plasmid-borne, and because it is clear that historically there has been a great deal
of exchange of plasmids through conjugation, transduction, or transformation among distantly related
bacterial species” Levin (1991:55).
8 5 “If case-by-case review is required, then the ecology of specific release sites must be well understood
before any analysis is possible. Given the limited knowledge base already in place and the time required for
generating such knowledge, we do not believe that the ability to make any such informed assessment will
come to pass in the near term” Sherlock and Kawar (1989: 56).
8 6 “One of the major difficulties of this whole debate is that there is no way of predicting the ecological
behavior of the phenotype from a knowledge of the genoytype” Crawley (1993:46). “In 1977, two
scientists in New Zealand... attempted to enhance the nitrogen fixing capability of a certain species of pine
tree by genetically modifying a fungus that inhabited the trees. In seeking to modify this fungus, the
scientists combined two normally nonpathogenic microorganisms. This combination theoretically should
have produced a harmless fused organism capable of bringing about the desired result. In contrast,
however, one strain of the newly created recombinant [sic] fungus was in fact pathogenic and one isolate
killed tree seedlings to which it was applied” U. S. Congress (1984a: 2).
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alteration, necessarily produces small effects on an organism behavior.8 7 Ecologists
challenged the indiscriminate use by molecular biologists of the terms niche and
advantage, and their conceived relation to genotype.8 8
Ecologists viewed deliberate release through the metaphorical lens of biotic
invasions. They focused on the numerous examples of non-native species running
rampant when introduced into new environments.8 9 Some celebrated North American
examples are the kudzu vine, the Mediterranean fruit fly, the Africanized honeybee and
the Russian zebra muscle. These and other examples highlight the fact that, under certain
and unspecified conditions, non-native organisms enjoy substantial advantage in new
ecosystems. Furthermore, they can inflict significant costs - economic, aesthetic and/or
loss of diversity - on invaded ecosystems.
Field test proponents pointed out that the vast majority of domesticated crops
require active human intervention to sustain them. In addition, many agronomic traits are
anti-evolutionary. For example, comhusks have been selected to prevent natural
8 7 “Pleiotropic effects (secondaiy phenotypic effects of a single genetic alteration), however, may easily be
overlooked in focusing on intended primary effects, and some effects may be expressed only in particular
environments, even if the geneotype is fully characterized” Tiedje et al. (1989:224).
8 8 “[jhgj jdea (1 ,^ junctional niches exist, in some sense, independent of the species that ‘occupy’ them,
presents serious philosophical problems for a positivist Science, and serious philosophical ones for the
hypothetico-deductive method. Nowadays, most theoretical ecologists are careful to define ‘niche’ as a
property o f a particular population or species - essentially an extended phenotype” Colwell (1988: 165). “A
symptom of this view is a tendency to speak of a transgenic plant’s ‘competitive ability’ as if this were
some kind of genotype-specific trait. This is a mistake. Ecological performance is highly context specific,
and the same genotype will give rise to phenotypes with different fitnesses in different environments”
Crawley (1990:134).
8 9 No more an authority than Charles Darwin (1979: 52 & 55) observed, “the numerous recorded cases of
the astonishingly rapid increases of various animals in a state of Nature, when circumstances have been
favourable to them during two or three following seasons. Still more striking is the evidence from our
domestic animals of many kinds which have run wild in several parts of the world; if the statements of the
rate of increase of slow-breeding cattle and horses in South America, and latterly in Australia have not been
well authenticated, they would have been incredible. So it is with plants; cases could be given of
introduced plants which have become common throughout whole islands in a period of less than ten
years.... Slight modifications, which in any way favoured the individuals of any species, by better adapting
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dissemination of the seed. Did it really make sense to fear that transgenic com would run
wild?9 0
Ecologists concerned with deliberate release agreed that plants are more amenable
to monitoring than microorganisms. Nevertheless, they argued that such monitoring
overlooked a critical point: one must ultimately concern oneself with the movement of
the introduced genes. Many of the characteristics envisioned (e.g., drought-resistance,
herbicide-resistance, pest-resistance) would conceivably enhance a crop’s selective
advantage. While one might monitor the movement of a plant, it is more difficult to
monitor the movement of its pollen.
Those concerned with transgenic crops raised troublesome issues. A crop
engineered for pest-resistance would produce pollen possessing the pest-resistance gene.
A problem could start if that pollen sexually hybridized with a wild relative. If the
sequence in question provides a selective advantage, several consequences can follow.
First, it may expand the wild relative’s range, crowding out established species. If the
selective advantage is substantial, the gene may spread through the wild relative
population. This in turn would place selective pressure on the pest originally targeted. If
a resistant strain of the pest were to arise, it would enjoy a selective advantage in its own
them to their altered conditions, would tend to be preserved; and natural selection would have free scope
for the work of improvement”
9 0 One element of the biotic invasion discussion is frequently omitted. Field test opponents feared that
transgenic organisms would invade and alter existent natural ecosystems. They do not, however, identify
those ecosystems. There is perhaps no ecosystem less “natural” than tilled farmland. The goal there is to
reduce the ecology to one species - the crop. Herbicides, fungicides, pesticides all seek to create an
environmental tabla rasa. Thus, to argue as some did that invasions would bring change to a natural
ecosystem is to overlook the extent to which change is fundamental to Nature, and that the ecosystems of
interest are not natural. Others took ecologists to task for failing to devote research to agroecology. For a
critique of applied ecology, see Buttel (1989).
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population. If this gene were to disseminate, it would result in pests consequently
resistant to the original engineered crop.9 1
While the distance between molecular biologists and ecologists was frequently
portrayed as broad and irreconcilable,9 2 these two metaphorical systems — of biological
invasion and cross breeding - are not necessarily mutually exclusive. If the vast majority
of releases produce no negative consequences, then the traditional cross breeding system
generally holds. If a small minority of releases produces negative consequences, then the
biotic invasion metaphor system is also appropriate. In this sense, the sides frequendy
appear to argue across one another, as much as engage one another.9 3 In this way one
9 1 Several further points should be made in reference to the preceding discussion. Not all crops have
proximate wild relatives. Further, some plants are natural outbreeders, meaning that they will not hybridize
with strains of close genetic proximity. The most extreme form are self-incompatible. Inbreeders, in
contrast, can be fertilized with pollen from genetically proximate varieties. The most extreme form are
those plants that self-pollinate. An implication of this is that although outbreeders are more likely to share
a novel characteristic, that trait is less likely to become widely established. This is because the gene pool
for outbreeders is larger and more varied. Conversely, whereas it is more difficult for a novel trait to
become introduced into a population of inbreeders, in the case that it does, it is more likely to become
established: “Cabbage, scarlet runner beans, and millet are examples [of outbreeders].... Many cherries
and plums are such emphatic outbreeders that they are actually self-incompatible. Wheat, barley and
sorghum are examples [of inbreeders]. Some are such committed inbreeders that ova are fertilized by
pollen from the same flower, as in Mendel’s garden peas” Tudge (1993: 166-9).
“Those who believe in the monstrous potential of biotechnology - in disasters so bad that no good from
the same technology could possibly overcome them - should be arguing not for stronger regulation but
rather for the prohibition of biotechnological research and its application. And those who believe that
biotechnology leads to results no different from those spontaneously occurring in nature or practiced for
centuries by breeders and hybridizers, so that the wondrous good it will do is bound to exceed vastly the
damage it causes, should not even accept existing regulation but should rather argue for its abolition”
Wildavsky (1991: 77). “To an ecologist, a molecular biologist is the ultimate simplifier, the ultimate
reductionist, who not only loses the forest for the trees, but who claims there is no forest. The molecular
biologist is the ultimate manipulator who thinks one knows enough to be able to change the world in a
beneficial way and not take any significant risk. To a molecular biologist, the ecologist is the ultimate
dreamer, the romantic who imagines that systems that are as complex as biological communities could ever
be understood to a level of developing a predictive theory. To a molecular biologist, the ecologist is the
ultimate conservator who is by nature against intervention of any sort” Hartl (1985: 70-71). It is an
oversimplification to suggest, as Wildavsky and Hartl do, that debate was composed of two recalcitrant
sides. It remains useful, however, for understanding the positions of those who were advancing the most
unambiguous claims. Of course, there were more nuanced perspectives (e.g., Levin below), but these were
frequently drowned out in the rancor that accompanied debate.
9 3 In contrast, “Few issues in recent memory have caused such divisions in the scientific community as the
deliberate release of genetically engineered organisms; yet examination of the underlying arguments
reveals few differences among the scientific points put forward by ecologists, molecular biologists, and
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side may have been advancing “the rule,” and the other advancing “the exception.” Even
if this were the case, little could be said of the relative occurrence of such rules and
exceptions. As a consequence, hapless regulators the world-over were left to sift among
these competing and complicated scientific claims. Their efforts are documented in the
following chapters.
V . Summary
The goal of this chapter has been to introduce the topic of agricultural
biotechnology. While this area of scientific and commercial enterprise shares similarities
to biomedical biotechnology, its commercial development is more recent. This
development was presented as a logical extension of age-old efforts to improve
agriculture. To that end, the specialized techniques were presented in the context of
traditional crossbreeding. In one sense, agricultural genetic engineering has moved from
the organism through the cell to the genome.
This background presents a basis for proceeding to the deliberate release
controversy. The argument has been that deliberate release is an enterprise enveloped in
uncertainty. There is little doubt that deliberate release presented scientists, public policy
experts and regulatory officials with a complex puzzle. As a novel enterprise, no
unambiguous empirical basis existed with which to assess the risks of deliberate release.
Similarly, a priori approaches generated contending perspectives. Experts from
two disciplines laid claim to the deliberate release issue. Molecular geneticists developed
other scientists” Levin (1991:45). One observer suggests that only one or the other perspective dominated
international conferences devoted to deliberate release: the two sides engaged in limited intellectual
exchange. “Microbiologists and ecologists would seem to attend different conferences. At neither of these
recent international meetings [REGEM 1 and the Brussels conference] was the tacit or overt consensus
about science and risks challenged. Meanwhile, a different consensus prevailed at each conference,
corresponding to the orientation of the scientists dominating each” Segerestrale (1989: 225).
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the organisms in question. They viewed the hazards of transgenic organisms with
reference to the host-organism and the novel genes, reflecting a reductionist
epistemology. Ecologists have focused on the ecosystems into which transgenic
organisms were to be released. Since ecosystems are complex and dynamic, ecologists
must frequently confront unexpected emergent properties. Prediction is highly
circumscribed.
Few have dared to assign numbers to either the probability or the magnitude of
outcomes associated with any individual deliberate release. Nor have they attempted to
generate general rules for release, and instead have relied on evaluating individual release
proposals. Perhaps the one point on which both sides agreed was the necessity of
qualitative analysis. From a Knightian perspective, this aspect belies proponents’ claims
to be “assessing risks.” From a Knightian perspective, uncertainty dominates analysis of
deliberate release.9 4 Two metaphorical systems largely organized each discipline’s
approach to deliberate release, with each suggesting a corresponding level of hazard, and
an appropriate degree of regulatory concern.
A final observation concludes this discussion of risk, uncertainty and deliberate
release. Insurance companies serve as “bookies,” offering a variety of hedges against
unpleasant outcomes to both private and public parties. One simple distinction between
risk and uncertainty is that one can only sensibly offer insurance to cover the former.
Policy clauses limiting liability brought on by “acts of God” can be understood as an
9 4 “Predicting the specific type, magnitude, or probability of environmental effects associated with the
deliberate release of genetically engineered organisms will be extremely difficult, if not impossible at the
present time. This is principally the case because no historical and scientific data base exists concerning
the behavioral characteristics of genetically engineered organisms in the environment, and no standard
ecological methodology for predicting the outcome of an exotic introduction currently exists” U. S.
Congress (1983:20).
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effort to maintain a separation between risk and uncertainty. With this in mind, in the
mid-1980s insurance companies proved unwilling to offer the American biotechnology
industry insurance against liability from any negative effects of deliberate release.9 5 This
commercial fact offers final support to the argument that uncertainty originally
dominated deliberate release. This establishes deliberate release as an appropriate
empirical domain for comparing the expectations of two competing theories of regulation
formation under uncertainty. This study now turns to a discussion of those regulations.
9 5 “The insurance industry quietly let it be known that it would not insure the release of genetically
engineered organisms into the environment against the possibility of catastrophic environmental damage
because the industry lacks a risk assessment science - predictive ecology - with which to judge the risk of
any given introduction... the question of liability for catastrophic environmental losses remains unresolved,
despite the fact that large-scale commercial releases of genetically modified organisms are now being
approved for the first time” Rifkin (1998b: 79 & 80). Rifkin (1999: BS) reiterates this point with regard to
the commercial transgenic crops: “The insurance industry has quietly let it be known that while it will
provide coverage for negligence and short-term damage resulting from the introduction of genetically
engineered crops into the environment, it will not offer liability coverage for long-term catastrophic
environmental damage because the industiy lacks a risk assessment science - a predictive ecology - with
which to judge the risks.”
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Chapter 4 - The American Case Study
I. Introduction
The previous chapter argues that field tests were an activity enveloped by
scientific uncertainty. The lack of empirical data circumscribed probabilistic assessment
of the risks of deliberate release. The secondary effects such organisms might have on
both non-target organisms and ecosystems further complicated analysis. The limitations
of predictive ecology circumscribed a priori approaches. The field test debate largely
turned on the two metaphorical systems of biotic invasion and traditional crossbreeding.
These two competing systems were not mutually exclusive, if one assumes that the
majority of releases would fail to generate mishap, while an unknown - and unknowable
- minority would result in unforeseen, unforeseeable and undesirable consequences.
The contagion hypothesis provides expectations for regulatory adoption and
adaption across national jurisdictions under such conditions. Because of these factors,
deliberate release regulation provides an appropriate empirical domain with which to
investigate the occurrence of transnational regulatory contagion.1 This study now turns its
attention to three domestic case studies (the United States, Germany and Britain) to
document the presence of information networks between jurisdictions.
1 Other empirical areas that could serve to explore contagion effects are somatic gene therapy,
xenotransplantation and global wanning. Each of these also exhibit high levels of scientific uncertainty.
Somatic gene therapy is the use of introduction of novel DNA or RNA (as in the case of antisense
technology) into human beings for therapeutic purposes. As described in a 1985 report, “Protocols for
human gene-therapy experiments will not be approved...until experimenters can predict how their subjects
will respond; experimenters cannot make those predictions without investigating a model system - and for
many inherited human diseases, there is no model in a lower animal” McCormick (1985: 669).
Xenotransplantation is the use of non-human organs for human medical therapy. The transplant of pig and
baboon hearts has been widely publicized. The fear is that the organ-recipient will expose the entire human
population to novel viruses, though the hazard in this case remains largely conjectural. Finally, “global
warming” remains somewhat contested, with skeptics pointing to cloud cover, carbon sinks, historical data
and solar flares, among other elements that circumscribe the certainty of the phenomenon.
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This chapter initiates that investigation by documenting the development of field
test regulations in the United States. There are several reasons to start with the American
case. First, according to data from the Organization for Economic Cooperation and
Development, the United States has conducted the vast majority of all field tests (see
chapter 7). It was not a forgone conclusion in the early 1980s, however, that the US
would establish such dominance in agricultural biotechnology.2 Given this dominance,
however, a reasonable hypothesis is that American regulations may have anchored the
views of foreign regulators wrestling with the deliberate release issue. Initial anecdotal
evidence supports this proposition.3
Furthermore, chapter 1 documents howNIH rules served as a template for global
recombinant regulations in the 1970s. A reasonable working assumption is that American
field test regulations may have served a similar role in the 1980s, as some observers
hoped they might.4 Familiarity with the American case permits eventual comparison with
the regulatory approach adopted by other countries. For all these reasons, the American
case is the appropriate point of departure for investigation.
This chapter is divided into two halves. The first half provides a general
overview of the relevant regulatory actors. As will be seen, all three branches of the
2 “Indeed in Europe, where for the most part public reactions are more muted, field tests involving the
(scrupulously monitored) release of manipulated organisms are scheduled for this year.... In the end it may
be Europe’s initiative that saves the day: Americans hate to be left behind” Robertson (1986: S71).
3 The U.S. was the first to confront and permit deliberate release. “[Regulatory] moves appear to be
confined at present to the United States because environmental testing of genetically engineered organisms
is not yet being undertaken elsewhere in the world” Powledge (1984c: 11). Powledge (1983c: 328) had also
observed, that “Experts on both [Germany and Belgium] say [authorities] tend to take their cues from
activities in the U.S.” Krimsky (1991:99) observes, “Beginning in the 1980s, industry and university
proposals for field-testing genetically modified plants and organisms triggered a major policy debate in the
United States that spilled over to the European community.”
4 “If EPA’s standards work well for industry here [USA], they could also establish a model for European
countries to copy. This proved the case in regulation of recombinant DNA experimentation in European
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federal government advance claims of authority to regulate the deliberate release of
genetically engineered organisms. Sorting out these competing claims substantially
delayed field test activity. The second half of the chapter focuses on the first authorized
American release of a genetically modified bacterium. A lengthy regulatory fight - at the
federal, state and local levels — preceded its release. The chapter concludes with initial
observations of the release’s implications for the study of transnational regulatory
contagion
II. Agricultural Biotechnology Applications
Before proceeding to the specifics of the American case, some clarification of the
term agricultural biotechnology is appropriate. One might assume that regulators had to
focus initially on the field testing of genetically engineered crops (e.g., wheat, soy, com).
Such an expectation is bolstered by the degree to which crops have dominated field test
activity during the last 10 years (discussed at length in chapter 7). As will be seen,
however, the release of genetically engineered microorganisms initially dominated the
American debate. Similar controversies erupted in the two other case studies considered
in the next two chapters. Three reasons explain why microorganisms dominated the
regulatory consideration of deliberate release.
Thomas Morgan, considered the father of molecular genetics, founded the
discipline before World War II through his celebrated work on the common fruit fly,
Drosophila. Fruitflies were a useful model for the field of genetics because of their small
size, relatively cheap storage and low maintenance costs, relatively speedy reproductive
cycle, and the visibility of their limited number (8) of chromosomes. These factors
countries, which were impressed by standards set by the Recombinant DNA Advisory Committee of the
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permitted Morgan’s lab to study large numbers of offspring from particular mutants, to
follow these mutations through successive generations, and to map the characteristics to
specific sites along the chromosomes.5
In the 1930s, development of the electron microscope permitted geneticists to
experiment with microorganisms previously too small to observe. Microorganisms
exhibited Drosophila's original advantages to even greater degree. The field of genetics
therefore shifts from models employing multicellular organisms to those employing
single-celled microorganisms.6 The shift to microorganisms is symbolized by Delbruck
and Luria’s “fluctuation experiments” of 1943, by Avery’s groundbreaking experiments
with bread molds in the early 1940s, and by the contributions of the “phage group” at
Cold Spring Harbor in the 1950s.7 As was noted earlier Monad conceptually defended
the shift to single-celled models with his famous dictum that, “what was true for E.coli,
was true for the elephant.”
National Institutes of Health” Edwards (1983: 725).
5 “During the first decades of the twentieth century, genetic research was dominated by Thomas Hunt
Morgan and his collaborators at Columbia University.... Morgan established that genes appear in a linear
arrangement on the chromosome. Thus, genes on the same chromosome are linked to one another to form
a so-called linkage group. This concept explained exceptions to Mendel’s second law of independent
segregation: as a rule, only genes belonging to different linkage groups can segregate independently. Of
fundamental importance to his concept of genes and chromosomes were Morgan’s studies of the exchange
of genes between homologous chromosomes during meiosis (the formation of the mature gametes). This
phenomenon he called crossing over.... The farther apart genes were, the more likely it was that a crossing
over during meiosis would lead to an exchange of such genes between homologous chromosomes”
Lagerkvist (1998: 104 & 5).
6 This is admittedly an overstatement Pioneering work in genetics was accomplished without
microorganisms. For the example of Barbara McClintock’s use of com to document transposons, see
Keller (1983).
7 “This now famous experiment furnished statistical evidence of the spontaneous nature of bacterial
mutation and was purported to be a direct confirmation of the theory of evolution by natural selection. The
fluctuation experiment indicated that bacteria have a hereditary mechanism which is consistent with the
theory of neo-Darwinism, and marked the birth of bacterial genetics. After the fluctuation experiment
bacteria were widely adopted as the research material for the study of heredity... In adopting the bacterial
genome as a model for the study of heredity, the fundamental problem of biological reproduction was
restated in terms of the maintenance and propagation of bacterial cells. Most research on the molecular
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This reliance on bacterial models continued into the 1960s. Biochemists’ research
resulted in the isolation and purification of bacterial enzymes that cleave DNA at
characteristic sites. Bacteria use these to disarm foreign DNA that may infect the cell.
Molecular geneticists first envisioned the use of these newly discovered enzymes to cut
and paste genes from different organisms in the late-1960s. Molecular biologists
achieved this feat by employing adenoviruses and plasmids as vectors to shuttle novel
sequences into target bacteria in the early 1970s. Thus, the dominant line of research for
postwar genetics relies on microbial models.
Plant research during this period also advanced,8 but the key point is that
development of recombinant techniques relied on bacterial models. When recombinant
researchers turned their attention to possible agricultural applications, they focus
unsurprisingly on agriculturally important microorganisms. Rhizobium, for example, is a
microbe used in conjunction with legumes to replenish fields with nitrogen. Enhancing
the nitrogen fixing capacity of Rhizobium was one goal of early agricultural attention.9
Another microorganism - Pseudomonas syringae - was investigated as a possible frost
retardant. The regulatory battle over release of this latter organism is discussed at length
below.
basis of genetics has been carried out on prokaryotic organisms, particularly the bacterial species £ coli
and on bacterial viruses” Wheale and McNally (1988: 79).
* Komberg (1989:133) identifies the different review processes at NIH and USD A as one reason research at
the former excelled, while that at the other languished in the postwar period. “The Department of
Agriculture retained all authority within its own bureaucracy and limited research activity to its few
established regional laboratories around the country. There were no grants to universities and private
institutes. With this old-fashioned system of management, the knowledge base for agriculture remained
stagnant Little was learned about the basic biochemistry and genetics of plants and farm animals. Only
recently, with the introduction of recombinant DNA technology, has there finally been a slight awakening
of interest and activity in basic agricultural research.”
9 Thus, the second field test approved by the EPA is of a Rhizobium strain developed by Monsanto that
increases the yield of nitrogen by 15% in greenhouse experiments.
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As chapter 3 indicates, several techniques were available by the mid-1970s for
transferring genes to plants, but these were not as advanced as those for bacteria. Plant
modification techniques were limited and imprecise. While a single plant cell can be used
to regenerate an entire plant, the techniques for doing so were available only for dicots,
not monocots (i.e., the major grasses wheat, rice and com). In contrast, a single, properly
nourished bacterium can quickly and cheaply yield an enormous colony of genotypically
similar organisms. Furthermore, understanding metabolic mechanisms — and their genetic
basis - in unicellular organisms represents a substantial challenge. Understanding similar
mechanisms in multicellular plants presents an even greater challenge. Fundamental gaps
persist in the understanding of metabolic pathways and gene systems in the plant
kingdom.1 0
Finally, the deliberate release of recombinant microorganisms generates greater
concern than the release of recombinant plants. The reasons for this are obvious. Plants
reproduce and move more slowly than microorganisms. Their spread can be more easily
monitored and checked if necessary. Microorganisms are the source of many human
diseases, some fatal. Plants, to be fatal, must be eaten; microorganisms need often only
1 0 Murray nicely summarizes state of knowledge at the beginning of the field test era. “In contrast to the
microbial sciences, which form the basis for health care biotechnology, knowledge about the chemical
pathways and specific gene systems in plants is relatively limited. Furthermore, agricultural applications of
biotechnology usually involve a large number of different plants or crops rather than the single, though
complex, human system relevant to health applications. In many cases, agricultural applications involve
direct introduction of specific genetic material into the plants, and the maintenance of transferred genes
over generations. Such systemic intervention on the target organism requires a basic far-reaching
understanding of existing systems and genetic control mechanisms.... There are three major barriers to
effective and efficient exploration of genetic modification of plants at the cellular level. First, not all plant
systems, e.g. soya beans and wheat, can be successfully cultured and propagated. Second, an effective
general method for inserting and expressing foreign DNA in plant cells has not yet been developed. Third,
plant systems that can be cultured and transformed, e.g. tobacco, lack effective genetic markers that
indicate the presence of a foreign gene. These scientific barriers have prevented the sort of rapid
exploratory process necessary to discover and exploit commercially valuable interventions in plants
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be inhaled. For ail these reasons, the hazards of deliberately releasing recombinant
microorganisms - not plants - initially dominated the regulatory debate.
HI. The Path to Release: The Proliferation of Claims
Uncertainty stands at the heart of the field test controversy. Discussion of that
uncertainty will not be needlessly repeated here. The focus here is the development of
American field test regulations. The discussion generally proceeds chronologically. A
number of federal, state and local agencies laid claim to the issue, substantially delaying
deliberate release activity.
A. The RAC and the Legacy of the 1976 NIH Guidelines
The 1976 NIH Guidelines relied on two philosophical commitments that
originally inhibited development of agricultural biotechnology. One concerned the
deliberate release of recombinant organisms. On that count, the original RAC guidelines
were unambiguous: “The deliberate release into the environment of any organism
containing a recombinant DNA molecule [is] not to be initiated at the present time.”1 1 By
1980 it was apparent that commercial and academic researchers would soon be seeking
permission to move their activities out of labs and into fields. The RAC addressed this
eventuality in its periodic review of the Guidelines, gradually relaxing its original
opposition to field tests.1 2
systems. As plant molecular biology continues to develop, many of these obstacles can overcome” Murray
(1983:249). See also Office of Technology Assessment (1981).
1 1 National Institutes of Health (1976: sec. Ill, p. 2).
1 2 “[T]he first revisions of the guidelines in 1978 still prohibited ‘deliberate release into the environment of
any organism containing recombinant DNA,’ but individual waivers were permitted after proper public
notification, RAC review, and approval by the director of the NIH. The revised guidelines of 1982
eliminated the entire list of proscribed experiments. By June 1983, the prohibition against intentional
release of rDNA organisms was replaced by a multitiered review process. Submissions for deliberate
release required review approval by the RAC, the institution’s biosafety committee and the NIH director, in
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In September 1982, the RAC received its first submission to field test a
recombinant microorganism. Steve Lindow and Nicholas Panopoulos, researchers at the
University of California at Berkeley, requested authorization to field test a strain of
Pseudomonas syringae modified to provide crops frost protection. In the face of this and
other impending petitions, the RAC empowered a Working Group on Revision of the
Guidelines to reconsider the deliberate release provisions. The Working Group proposed
empowering local institutional biosafety committees (IBC’s) to approve field tests of
genetically engineered plants. Such a change would have been consistent with the RAC’s
routine extension of local IBC authority over a broader range of recombinant laboratory
research. In the late 1970s and early 1980s the RAC had replaced the permit system with
a notification system for an increasing number of laboratory experiments. Expanding
local IBC authority to deliberate release appeared a logical extension of the earlier
precedent. At an April 1983 meeting, however, the RAC rejected the recommendation
and decided instead to share local IBC authority with its own Working Group on Plants
and Associated Organisms, which would consult outside members on an ad hoc basis.1 3
While the RAC was the federal regulatory forum for rDNA activity, it had
heretofore concerned itself mainly with biomedical and confined industrial applications
of recombinant research.1 4 Some questioned the RAC’s competence to expand its
purview into field tests. Critics frequently point out that the RAC did not have a single
addition to various subcommittees” Krimsky (1991: 106). Dr. Bernard Talbot provides a valuable summary
of RAC’s evolving view of deliberate release in testimony before Congress (U.S. Congress 1983: 111-16).
1 3 Powledge (1983b: 314).
1 4 “The first gene spliced products to reach the market are research enzymes.... Genetech has sought NIH
permission to proceed to large-scale culture with a recombinant DNA project. Last month the NIH
approved five such projects, concerning human growth hormone, somatostatin (a brain hormone), the A
and B chains of human insulin, human proinsulin, and thymosinalpha-1” Wade (1980a: 689).
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ecologist on its board.1 5 Further, the RAC enjoyed limited statutory authority,
complicating its legal ability to regulate field tests.1 6 But with nowhere else to go,
researchers submitted field test petitions to the RAC for review.
B. Jeremy Rifkin and the Courts
As these efforts mounted, Jeremy Rifkin’s organization, Foundation on Economic
Trends, emerged as the key opponent to deliberate release.1 7 In fall 1983, Rifkin brought
suit against the NIH, challenging the RAC’s efforts to accommodate the Guidelines for
field tests (NIH was the RAC’s parent agency). Rifkin’s suit claimed that the National
Environmental Protection Act (NEPA) of 1976 impelled NIH to issue an environmental
impact statement concerning deliberate release. This represented the first in a series of
legal challenges designed to impede and prevent release of recombinant organisms into
the environment. At every juncture in the field test saga, Rifkin led a legal and public-
crusade against biotechnology in general - and against deliberate release in particular.
Throughout the 1980s, Rifkin enjoyed mixed results. For example, Cetus
Madision Corporation was among the first to submit petitions to field test a disease
resistant recombinant plant. Following a Cetus request, RAC agreed to review the plan in
1 5 “Critics (and even some of its friends) point out that [the RAC] lacks expertise in dealing with non
medical areas such as microbial ecology. Many observers believe such questions ought to be the province
of the EPA, the USDA or both” Powledge (1984b: 205). “RAC itself, at the time of its first approvals of
genetically engineered organisms for environmental testing, in 1982-3, was ill-equipped to assess potential
ecological effects of these tests; not a single professional ecologist or evolutionary biologist sat on the RAC
at the time” Colwell (1987: 170).
1 6 “It would be unfortunate to allow the RAC to expand into areas beyond its scope, developing detailed
regulatory policies for manufacturing or for release of products into the environment. Seated within the
[NIH], the RAC has neither the industrial expertise nor the appropriate position in the government to form
policies affecting the spectrum of bioresearch” Edwards (1983a: 7). Industry may have enthusiastically
supported a lead role for RAC had it known the delay and conflicts it would confront over the next four
years.
“On genetics policy he has had more impact on the media than any single group or individual in the
United States” Krimsky (1991:109).
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closed-door session to protect propriety information.1 8 Rifkin unsuccessfully challenged
the closed-door session in court. He was later successful at opening a different review
session after its corporate sponsor - Advanced Genetics Sciences (AGS) - made a similar
closed-door request. AGS wished to keep the location of its test site private to protect it
from vandals, but a Federal Appeals court issued a temporary injunction against closed-
door sessions. In response, AGS pulled its submission.1 9 Thus, the RAC’s initial
attempts to authorize field tests generated controversy, lawsuits and confusion, as field
tests were submitted and then withdrawn; approved and then immediately reconsidered.2 0
Somewhat surprisingly, private companies such as Cetus and AGS did not
initially require RAC permission to field test their organisms. The original Guidelines
only applied to federally funded recombinant research; they did not apply to privately
funded research. Legislation would have been required to bring private research under the
NIH’s regulatory yoke. While Congress considered various biotechnology bills
throughout the late 1970s and early 1980s, these efforts never resulted in law.2 1 Privately
1 8 ‘ “You have here situation in which a company that has no legal obligation to take its business to the RAC
in the first place comes to Bethesda and asks permission to do something...in large part because it is good
corporate public relations to do so - and not because there is any legal necessity to take it business to the
NIH - and it then wishes to argue that proprietary information and corporate secrecy extend to the very
identity of the disease that its nifty product is going to cure...’ complains [the] news editor of Science"
Powledge (1984c: 12).
1 9 Powledge (1984b: 204).
2 0 “The RAC has backed off from giving local institutional biosafety committees (IBC’s) complete
authority to approve field experiments for genetically-engineered plants. Turning down the
recommendation of its Working Group on Revision of the Guidelines at its last meeting April 11, RAC
decided instead to share that responsibility between IBCs and its own Working Group on Plants and
Associated Organisms. Scientists who want to experiment with growing genetically engineered plants out-
of-doors will have to explain their plans not only to their local IBCs, but also to the RAC Working Group,
which will be reconstituted with a broader membership to include outside, ad hoc members, especially
those with expertise on plant and microorganisms” Powledge (1983b: 314). Thus, Cetus Madison saw
shelved its desire to test new kinds of wheat, cotton, soybeans, tomatoes, developed with recombinant
techniques. Winston Brill, vice president and director at Cetus Madison advanced their petition. At the
same time, Brill was also a RAC member whose term was to expire the same year.
2 1 See for example Wade (1980b: 745). For a useful overview of legislative activity, see the testimony of
Rep. Don Fuqua before Congress (U. S. Congress 1985a: 10-20).
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funded biotechnology researchers voluntarily adopted the NIH Guidelines. This system
of voluntary compliance helped dilute support for biotechnology legislation. Voluntary
compliance also strengthened public confidence in industry’s activities; it may have also
provided some legal cover in the event of a mishap.2 2 Finally, as a participant to the
Guidelines, industry could work within the system to relax the NIH rules.
The distinction between publicly and privately funded research complicated the
regulation of field tests. In May 1984 Judge Sirica decided on Rifkin’s NEPA challenge.
The judge issued a preliminary injunction against the NIH from its “approving or
continuing to approve experimentation involving the deliberate release of recombinant
DNA.” The decision, however, applied only to federally funded activity; private firms
were explicitly exempt from the ruling.2 3 In February 1985 a U.S. Court of Appeals
lifted the preliminary injunction, provided that the NIH conduct and issue an
environmental impact assessment.
C. The Environmental Protection Agency
Concurrent with the RAC’s review, the Environmental Protection Agency (EPA)
initiated its own review of deliberate release. The EPA was established in December
1970 in response to growing concern about chemical contamination of the environment.
The agency immediately established a highly public profile, taking the lead in a number
of public health controversies (e.g., asbestos, dioxin, and acid rain). It was not initially
clear whether EPA possessed either the expertise or the authority to regulate
biotechnology products and applications. In August 1983 EPA announced its intention to
2 2 See Geoffrey Kamey, quoted in Krimsky (1991: 101).
2 3 Korwek (1984: 728).
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oversee biotechnology, and set about developing in-house expertise on environmental
applications of biotechnology.2 4 EPA lawyers also reviewed the statutory framework to
substantiate the agency’s claim to biotechnology. They identified two relevant statutes -
FIFRAandToSCA.
The 1947 Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) originally
empowered the United States Department of Agriculture (USD A) to ban any pesticide
that presents an unreasonable hazard. Before a pesticide can be the subject of interstate
commerce, the manufacturer must show that the substance will not cause “unreasonable
adverse effects to humans or the environment.” Otherwise it will not be granted a
license. Upon its creation in 1970, EPA assumed some of USDA’s functions, including
the administration of FIFRA.2 5 While FIFRA was used primarily to control chemical
pesticides (it was the act used to ban DDT, for example), EPA had also used it to regulate
microbial pesticides - microorganisms used to control agricultural pests.2 6 FIFRA confers
authority to demand an Experimental Use Permit, through which EPA can solicit further
information before the testing of a pesticide.2 7
The 1976 Toxic Substance Control Act (ToSCA) impels EPA to review and
2 4 “The agency has conducted dozens of seminars over the past year to educate its staff... ” Dwyer (1983:
15).
2 5 Gray (1991). “FIFRA provides EPA authority over pesticidal products, including the authority to review
and register new pesticides...according to the EPA, FIFRA establishes authority over both conventional
pesticides and nonindigenous and genetically engineered microbial pesticide products. Under this statute,
EPA requires the submission of data and information concerning each pesticide product in order to make
regulatory judgements on its safety. If the product poses no human health hazard or environmental hazard,
it is then registered to be sold...a pesticide is defined as ‘any substance or mixture of substances intended
for preventing, destroying, repelling, or mitigating any pest...[or] intended for use as a plant regulatory,
defoliant or desicant’” Jaffe (1987:512).
2 6 “EPA...has evaluated and registered more than a dozen microbial agents in the past decade. None has
been the product of genetic manipulation” Powledge (1983a: 638).
2 7 McCormick (1985d: 1067).
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register new chemical substances before their manufacture. Manufacturers must provide
EPA with relevant information about a proposed substance as part of the screening
process. Based on this data, EPA can reject new chemicals if they present an
“unreasonable risk,” or postpone their production if EPA decides it lacks sufficient
information to render judgment.2 8 EPA had used ToSCA in the past to regulate
chlorofluorocarbons, asbestos and dioxin.2 9
Congress enacted ToSCA and FIFRA to diminish the harmful impact of
chemicals on the environment. Biotechnology products, however, are not chemicals but
organisms. EPA justified its regulatory claim with two arguments. First, because
deoxyribonucleic acid (DNA) is a chemical, recombinant DNA is a new chemical.
Second, EPA officials argued that Congress originally intended ToSCA to plug gaps left
by other environmental legislation; ToSCA is consequently quite broad.3 0 By virtue of its
obligation to protect the environment, and through the extensive provisions of FIFRA and
TOSCA, EPA claimed jurisdiction over environmental applications of biotechnology. In
December 1984 EPA released an interim policy requiring manufacturers to notify EPA
2 8 “Although an “unreasonable risk” is not defined, the legislative history makes it clear that the
determination of risk involves an analysis that considers the probability of harm based upon exposure and
severity and balances the risks and benefits to society” Korwek (1984: 7S8).
2 9 “Unlike the pesticides program, which regulated substances that are supposed to kill other organisms, the
toxic substances program regulates substances which may harm humans and other living organisms. But
TSCA’s mandate is not as broad as that of FIFRA in controlling pesticides, TSCA does not allow EPA to
request extensive data, nor can it halt commercial production unless there is a finding based on what
limited data the manufacturer submits, of unreasonable risk not outweighed by the products benefit” Dwyer
(1983: 16). “TSCA requires the EPA to review new substances before manufacture, and thus makes it
possible to act against risks before harm occurs rather than after. It is often used as the gap filling
environmental law, because its purpose is to regulate chemical substances in any application not
specifically covered by other regulatory authorities” Jaffe (1987:512).
Powledge (1983a: 638). “TSCA covers the manufacture, processing, distribution, labeling, use, and
disposal of any ‘chemical substance’ or ‘mixture,’ giving EPA authority over virtually every substance in
the universe” (Korwek 1983:758). Drugs are specifically excluded from TSCA’s definition of “chemical
substance.”
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prior to a field test.3 1 The EPA would then initiate a 90-day review of the proposal. If
the EPA decided that the proposed test raised concerns, then it would require that an
Experimental Use Permit (EUP) be issued, through which a firm could be impelled to
provide further information.3 2 EPA’s action ended the regulatory distinction between
publicly and privately funded recombinant activities.
Industry responded to EPA’s regulatory claim with suspicious cooperation. Some
within industry doubted whether ToSCA conferred sufficient authority, and disputed
EPA’s definitional interpretation of chemicals and pesticides.3 3 At the same time,
however, representatives from the Industrial Biotechnology Association had worked with
EPA officials to develop the interim policy.3 4 Such cooperation was deemed superior to
the alternative of stricter prohibitions against field tests.3 5 The December 1984 interim
3 1 The term environmental application o f biotechnology is used here purposefully. The primary focus of
the deliberate release debate related to products intended for agricultural purposes. But these are not the
only possible forms of deliberate release. Bioremediation and mineral extraction are two other activities
believed available to benefit from the release of novel organisms.
3 2 Krimsky (1991:125). “Under FIFRA, section 5 authorizes EPA to grant experimental use permits for
limited use to enable prospective registrants to gather information about unregistered pesticides, to develop
that kind of information so that a decision may be made about registration” U. S. Congress (1986a: 54).
3 3 ‘ “It’s a pretty farfetched extension of what a pesticide is,”’ says Danial Adams, chairman and chief
executive officer of AGS. General Counsel at EPA ruled ‘wild type bacterium is a pest, and that ice minus
is therefore a pesticide’...[FIFRA] requires that all pesticides, including microbial agents, be tested for
safety before they can be marketed” Powledge (1984a: 12).
3 4 Powledge (1983a: 638-9). Included in this article are industry doubts about the relevance of ToSCA.
For industry doubts about FIFRA, see Powledge (1984a: 12).
3 5 “A stricter policy would, in addition to causing unnecessary costs for industry, give the public an
impression that products of genetic engineering are unusually dangerous.... EPA’s risk assessments, if
properly conducted, could help curb unnecessary corporate R&D costs using genetic engineering. By
discovering and publicizing any high-risk products and processes, the EPA saves companies from investing
money in products that are risky from the marketing point of view simply because they may pose
identifiable harm to the environment.... Before companies react too harshly to the extra burden of cost and
paperwork that will accompany regulation, they should keep its benefits in mind” Edwards (1983c: 725).
The author bases this view on an estimate that pre-manufacture notices to EPA would require $10,000 and
90 days. Chevron provided one of the earliest petitions to test a genetically engineered organism. They
cooperated extensively with EPA before abandoning their proposed test Carl Crisp, Chevron’s chief
scientist for the project indicated that such cooperation may have provided some legal cover: “‘We’ll
probably overreact and go far beyond the testing requirements to make sure we don’t do anything
embarrassing to the company or anything that will get us into a lawsuit’” Dwyer (1983: 16). One can
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policy resulted in industry’s redirection of field test petitions away from the RAC and
toward the EPA.3 6
The biotechnology industry’s goal was not to be free of federal regulation.3 7 This
largely reflected the inevitable: few expected that biotechnology companies would be left
to release recombinant organisms of their own choosing into ecosystems of their own
choosing. But more significantly, industry recognized that its success or failure depended
on consumer-confidence in genetically engineered products.3 8 Regulations provided
biotech products and activities a governmental imprimatur. Further, federal regulations
would trump state and local regulatory initiatives, and prevent the emergence of a crazy-
patch work of rules across the country. Despite this initial cautious engagement, the
relationship between industry and the EPA progressively worsens over the period as
delays mount.3 9
D. The United States Department of Agriculture
The United States Department of Agriculture (USDA) was the other federal
agency with a regulatory claim to deliberate release. USDA could rely on a battery of acts
to assert such a claim. The Plant Quarantine Act empowers the Secretary of Agriculture
to limit import of any plants or nursery stocks whose movement “may result in the
entry.. .of injurious plant diseases or insect pests.” It can also be used to regulate
question the logic of asserting the safety of an activity on one hand, while actively insuring against
something unpleasant. This pattern is repeated in the case study of ice-minus below.
3 6 Monsanto submitted an 800-page report to EPA outlining its intention to release a P.Fluorescens strain
engineered with the Bt toxin. Monsanto did not notify the NIH (“Chronicle” 1985:1062).
3 7 In this vein, Robert Cape, co-founder of Cetus, testified before Congress that, “Agracetus recognizes the
need for regulation of the products of biotechnology, and supports the proposal of the Office of Science and
technology Policy for a coordinated multi-agency approach to regulation under existing legislation” U. S.
(1985a: 33).
3 8 Edwards (1983b: 137).
3 9 Price (1985:272).
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interstate commerce of plants that are “capable of carrying any dangerous plant disease or
insect infestation” that is “new to or not heretofore widely prevalent or distributed within
and throughout the United States.”4 0 The 1957 Federal Plant Pest Act regulates the
movement of any organism that might constitute a plant pest The 1974 Noxious Weed
Act regulates movement of any novel plant that might injure crops, plants, livestock or
hamper irrigation, navigation or fishing. The Federal Seed Act controls traffic of seeds.4 1
With its mission to advance American agriculture, USDA actively financed a substantial
array of agricultural biotechnology research that would ultimately result in field tests.4 2
Thus, USDA lacked not the authority, but an institutional interest in stringent field test
regulations. For two reasons, however, it plays a secondary role. First, USDA’s principle
purpose is to promote agriculture; its regulatory approach is best characterized as
reactive, rather than proactive. Second, the early controversy centered on
microorganisms. In contrast to the EPA, USDA officials were slow to develop interest in
biotechnology regulation and the requisite expertise.
E. The Reagan Administration - Coordinating Agencies
New regulatory legislation was anathema to both industry and the Reagan
administration. The biotechnology industry had always argued that agricultural products
and activities were conceptually similar to those developed by traditional crossbreeding.
4 0 U. S. Congress (February 1984a: 36).
4 1 McCormick (1985d: 1067).
4 2 According to Congressional testimony (U. S. Congress 1985a: 1), “the USDA is funding 87 projects
across the country which will soon result in the intentional release of genetically altered organisms into the
environment.” According to a Congressional Staff Report (U. S. Congress 1984a: 35) “The role of the
USDA in overseeing biotechnology can best be described as unclear. USDA has been involved in
recombinant DNA activities to some extent, but unlike the NIH and EPA, the agency has not made an
effort to regulate in this area. USDA potentially has authority to regulate the deliberate release of
genetically engineered organisms. That authority may be limited, however, by USDA’s focus on matters
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To the extent that their activities were to be regulated, industry sought extension of
existing statutes, rather than development of new, biotechnology-specific legislation. In
essence, they preferred extension of the devil they knew.
The Reagan administration opposed new regulations on ideological grounds. It
believed new regulations represented an unnecessary burden on a promising technology
in which American industry enjoyed preeminence. In the mid-1980s, amid talk of losing
the competitive race in biotechnology to Japan and Europe, and in response to threatened
congressional action, the Reagan administration increasingly worked to clarify and
coordinate the regulatory roles of the responsible agencies.
Beginning in April 1984, the White House Office of Science and Technology
Policy and a Cabinet Council Working Group on Biotechnology developed the
administration’s biotechnology policy.4 3 Their effort produced a December 1984 draft
document, Proposal fo r a Coordinated Frameworkfor Regulation o f Biotechnology,
published in the federal registry. The Proposal consists of three sections.4 4 The first
presents a “matrix” of existing laws and regulation appropriate for biotechnology. This
was the administration’s effort to head off calls among critics for new biotechnology-
specific legislation. The second section presents policy statements from the EPA, USDA
and the Food and Drug Administration (FDA). These served as the agencies’ interim
policies until the fiamework was finalized. Finally, a third section proposed creation of
the Biotechnology Science Board, an intra-agency scientific panel that would offer
affecting agriculture and by the requirement in most pertinent legislation that an activity be involved in
interstate commerce before it comes within the agency’s jurisdiction.”
4 3 “The working group was formed in 1984 to serve as an interagency forum in which the executive branch
of government could develop a federal biotechnology policy” Panem (1985:6).
4 4 Bulkey (1985: 73-9).
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further scientific guidance on issues. While industiy found points of contention with the
Proposal, they generally offered it their support4 5
The Proposal generated hundreds of written public comments, and initiated an
18-month process of further federal regulatory overhaul.4 6 During this period, federal
agencies reviewed field test proposals under existing statutes, while polishing their
regulatory approach to biotechnology. On June 20,1986, the Reagan administration
released a revised version, the Coordinated Framework fo r Regulation o f Biotechnology.
The Framework clarified agency jurisdiction with regard to various biotechnology
activities. The Framework distinguishes between standard organisms, and intergeneric
organisms, “those deliberately formed to contain a... combination of genetic material.”
This implied gene deletions, as well as those that manipulated an organism’s regulatory
regions, merited less concern. The Framework also treated known pathogens and
sequences from pathogens with greater regulatory scrutiny. Surprisingly, the Framework
provided no clear definition of deliberate release.*1
The Framework designates EPA as the lead agency for genetically engineered
pesticides; USDA’s Animal and Plant Health Inspection Service (APHIS) enjoyed a
4 5 The main contention was with the proposed creation of the Biotechnology Science Board, composed of
high ranking members from FDA, EPA, NIH, NSF and USDA. The BSB provided a second tier of
scientific review in addition to the most appropriate agency. This was considered to add another
unnecessary bureaucratic layer, which contributed to the perception that biotechnology was dangerous
(Johnson 1985b: 496). In the final version the BSB was replaced by the Biotechnology Science
Coordinating Committee (BSCC). The BSCC’s main objectives included “resolving jurisdictional disputes
between agencies, coordinating international biotechnology mattes, identifying any deficiencies in the
regulation of biotechnology, and developing standard definitions” Gibbs (1986:690). This alleviated the
two-tier system of review.
4 6 Kingsbury (1990: 162).
4 7 “The agency would abbreviate its evaluation for organisms that are non-pathogenic and have been
altered, for example, by the deletion of genes, the addition of genes from the same genus, or the addition of
a ‘well-characterized, non-coding sequence’ from a pathogenic microbe. But an organism from a species
that includes strains that are pathogenic in themselves would undergo more extensive review. EPA also
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secondary role. EPA retained the lead role for release of non-pesticide intergeneric
microorganisms, though APHIS enjoyed oversight of intergeneric combinations
involving pathogens. USDA was responsible for commercially developed animal
biologies. In addition, EPA announced authority to review all intergeneric organisms
before release, including small scale and R&D testing. This was quite different from the
treatment afforded non-recombinant pesticides and chemicals. EPA also expanded
information requirements on such products. The USDA’s statement represents a
tightening of the rules. The agency’s oversight had come under fire for being too lax,
resulting in several embarrassing episodes. In response, USDA announced plans for a
permit system to regulate the movement and importation of plant pests and
biotechnology-derived products.4 8 Industry, facing the alternative threat of congressional
action, publicly endorsed the Framework.
The stated goal of the Framework was to limit potential product hazards while
encouraging industrial innovation and development. The rules formalized EPA and
USDA’s regulatory authority over the environmental applications and products of
biotechnology. In exchange, the Framework made two philosophical commitments.
First, the focus of regulatory attention should be the product, not the process by which a
product is derived. This approach assumes that biotechnology is not inherently
hazardous. Second, while the proposals advanced certain agency reorganizations to
accommodate biotechnology, they argued against the need for new legislation.
says that microbes will be scrutinized more closely if genetic material from a different genus has been
added to an organism” Sun (1986b: 1189).
4 8 Gibbs (1986:690).
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F. The Congress - Failed Attempts at Legislation
Throughout the 1980s, Congress held hearings about, and considered legislation
for biotechnology. Representative Albert Gore brought early congressional attention to
biotechnology. Gore originally limited his subcommittee’s concern to the human
applications of biotechnology, but he soon expanded his subcommittee’s inquiry into the
field test issue.4 9 This resulted in a February 1984 subcommittee advisory report. The
report advocated formation o f an interagency task force to review the risks of deliberate
release, until EPA developed sufficient competence to take control of the issue. It also
advised clarification of USDA’s role. Most significantly, it echoed Judge Sirica’s ruling
by demanding that the NIH “cease its practice of evaluating and approving proposals for
deliberate releases from commercial biotechnology companies.”5 0 After his election to
the Senate in 1984, Gore continued to address the deliberate release issue.s >
Other subcommittees also held hearings on deliberate release. These hearings can
be divided into two different sets. One set provided a forum for consideration of
deliberate release. At these hearings, molecular biologists and ecologists presented
competing viewpoints and scientific opinions of field test hazards. Officials from EPA,
USDA, FDA and the White House presented their respective institutional perspectives
4 9 “Although Gore has introduced legislation to provide continuing oversight of human applications of
genetically engineering, his staff says he presently has no similar plans for biotechnology, but instead is
waiting to see what EPA does” Powledge (1983a: 640). “Gore [who chairs the Subcommittee on
Investigations and Oversight of the Committee on Science and Technology] is moving ahead with
explorations of environmental issues...and his staff is drafting a report that may recommend setting up an
interagency task force to over see deliberate release of genetically engineered organisms. Among those
working on the report is Morris Levin, director of EPA’s Office of Exploratory Research” (Powledge
1984c: 12).
5 0 Powledge (1984b: 205).
3 1 At his request, a special conference on field tests was held in June 1985. The conference was
interdisciplinary, bringing together members from seven different biological societies, including ecologists,
microbiologists and molecular biologists. Officials from the USDA, EPA and FDA also participated
(McCormick 1985f: 686).
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and regulatory intentions. Industry representatives and environmentalists also provided
testimony concerning the commercialization of recombinant techniques.
A second set of hearings was investigative in nature. These hearings responded to
two controversial episodes of unauthorized deliberate release. One involved the firm
AGS, which injected a modified organism into trees located on the roof of its corporate
headquarters in Oakland California. The other involved USDA’s testing and licensing of
a recombinant pseudorabies vaccine. These two hearings held in March and April 1986,
respectively, mark the high water mark Congressional concern with oversight of
agricultural biotechnology.
If Congress were ever to have passed biotechnology-specific legislation, it would
have occurred during these controversies. Several Representatives sought unsuccessfully
to galvanize support for biotechnology legislation in the mid-1980s. Congressmen James
Florio (D-NJ) had made a name for himself as one of the architects of the EPA
“Superfund” legislation. Convinced of deliberate release’ potential for catastrophe,
Florio described the December 1984 Proposal as “a sham, and a dangerous sham at
that.”5 2 Congressman John Dingell (D-MI) also expressed fears about biotechnology.5 3
Both Dingell and Florio served on the House Committee on Energy and Commerce,
which would take the lead in writing any proposed legislation. Dingell was its
Chairman.5 4
5 2 McCormick (1985a: 183).
5 3 Dingell claimed at a Brookings Institution forum that, “I am certain that society faces real dangers from
the use of biotechnology” Panem (1985:27).
5 4 McCormick (1985b: 205).
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In June 1986 when the Framework'was released, Congress was considering
several different forms of legislation to tighten biotechnology regulation.5 5 Dingell still
pursued legislation, though his views were somewhat tempered. He argued that American
regulations must “harmonize” with foreign regulations “so that national regulatory
programs do not become an obstacle to the US biotechnology industry, and so that
Americans are not exposed to unacceptable dangers from misuse of biotechnology
abroad.” Thus, his legislation was designed to advance both competitiveness and public
safety. Sen. Durenberger (R-MN) introduced a bill amending TSCA, providing it - and
therefore, the EPA - clear authority on all field tests. The bill’s language was so general,
however, so as to include all industrial microorganisms. His bill also required industry to
“prove” the safety of their product before marketing.5 6 Representative Don Fuqua (D-
FL) also introduced a bill that would compel the regulation of three different types of
release: contained sites, broader scale tests, and commercial distribution. His bill
employed a “reasonable risk” standard, thereby avoiding the pitfalls of Durenberger’s
bill. Fuqua’s announced plan to retire, however, weakened support for his bill.5 7
Since release of the original NIH Guidelines in 1977, Congress had flirted with
seizing control of biotechnology regulation. Congressional committees had convened a
number of hearings addressing all facets of biotechnology activity. During the same
period, a variety of bills were introduced. Despite these efforts, Congress never produced
a bill regulating biotechnology. This does not mean that their impact was negligible.
5 5 Gibbs (1986).
5 6 According to the language of the bill, industry would “at all times have the burden of demonstrating that
the activity in question will not cause an adverse effect on human health or the environment” McCormick
(1986a: 479). This is an impossible standard to fulfill.
5 7 McCormick (1986e: 274); Crawford (1986a: 1501).
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Quite to the contrary - much of the regulatory dynamic (i.e., the early industry-agency
cooperation, and the Reagan administration’s activism) was motivated by an interest to
pre-empt Congressional action.
IV. Discussion - The Absence of Cnntapinn
The deliberate release issue elicited regulatory concern and a litany of
bureaucratic claims. All three branches of the federal government were drawn into the
deliberate release controversy. Initially, the RAC and the NIH attempt to establish field
test rules. These efforts came under attack from several directions. Rifkin challenged the
NIH and the RAC in court. Congress also intervened by conducting hearings on the issue,
and by demanding the NIH Director to terminate RAC’s review of field tests. Finally,
EPA staked a large claim on biotechnology activities with environmental implications.
The biotechnology industry responded to these currents with “active resignation.”
Industry resigned itself to the inevitability of regulation, and actively sought to shape that
regulation.
The review thus far has viewed American biotechnology regulation formation
through the traditional lens of domestic politics. Review of the major American hearings
and documents from the early 1980s yields little evidence of transnational regulatory
contagion. One is hard-pressed to find among participants much discussion of foreign
regulatory approaches to the field test issue. This logically follows from the observation
made at this chapter’s outset that the United States was the first to address the issue.
This section provides the background for consideration of the first authorized
release of a genetically engineered microorganism in the United States. As will be shortly
revealed, this specific controversy provides significant evidence for the role of
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transnational networks on regulation formation. Of equal importance, later chapters
reveal how American decisions played a role in the deliberations among regulatory
participants outside the United States.
V. The First Authorized Release of a Microorganism - Science v. Symbolism
A. Introduction - The Critical Role of Ice-Minus
The previous section documents how different American political actors wrestled
with the field test issue in general. This section focuses on the specific regulatory path
traveled by the first deliberately released recombinant organism. The story of that
organism - ice-minus - has been variously recounted. The discussion of ice-minus
provided here differs by focusing on the relationship between transnational networks and
regulation formation. Because the ice-minus episode represents the first authorized
deliberate release of a recombinant microorganism, it enjoyed worldwide attention. Some
evidence is presented concerning the impact of transnational networks on American
regulation formation. Later chapters trace the impact of this American episode on foreign
regulatory debates and decisions.
1. Background - Crops, Frost and Pseudomonas
In the early 1980s, the RAC began to receive petitions to release genetically
engineered organisms - both plants and microorganisms - into the environment. Steve
Lindow and his colleagues at the University of California were the first to submit an
application to release a recombinant microorganism. In September 1982 Lindow
requested permission to field test a modified strain of the bacterium Pseudomonas
syringae, a common leaf colonizing bacterium found on most North American plant
species. His recombinant strain was designed to protect crops from frost damage.
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Frost damage is a significant source of agricultural loss, although estimates of its
costs from the time vary substantially.5 8 Tropical fruits (e.g. citrus) are especially prone
to frost, and a cold snap can result in the sudden loss of an entire year’s crop.5 9 Freezing
temperatures result in the formation of ice crystals among fruit cells. Intracellular ice
pierces the cell walls and releases the cytoplasm, resulting in mushy inferior fruit.
Moisture cooled to the freezing point, however, does not necessarily form ice crystals. In
fact, water can cool substantially below the freezing point without forming ice crystals.
Moisture in such a state is said to be super-cooled. While it can remain in its liquid state,
super-cooled moisture will quickly turn to solid ice if crystallization is facilitated.
There is among Pseudomonas strains one that possesses a specific surface-protein
that facilitates the phase-change of super-cooled water to ice at approximately -1 .5°C.
Because of this characteristic, it is referred to as an ice nucleating strain. If the
temperature drops below freezing in the presence of moisture and ice-nucleating
Pseudomonas, damaging ice will form. In the absence of Pseudomonas, ice is less likely
to form.
Another Pseudomonas strain lacks the ice-nucleating surface protein. This
characteristic earns the strain the label ice-minus. Lindow’s idea was simple: crops might
be protected against frost by spraying them with the ice-minus strain. The hope was that
5 8 One of the central tenants of this study is that risk-analysis requires comparing probable costs against
probable benefits. Given this, one might ask the probable benefits that might derive from using frostban.
Estimates from the period of frost damage costs are all over the map: Krimsky (1991: 1 IS) provides a
lower bound of SI billion. Stein (1987:A1) reports that frost damage costs American farmers S1.6 billion
per year. The OECD (1986:19) uses the figure of $3 Billion for the United States in its study of deliberate
release. McCormick (1985e) claims that “$14 billion worth of crops are lost to ice every year.”
5 9 Californian fanners were recently reminded of this. “The cold early Tuesday morning destroyed the
entire lemon crop in the San Joaquin Valley, which produces about 15% of the state’s lemons. The loss was
estimated at about $90 million. The freeze also damaged strawberry, avocado and other crops elsewhere in
the state” Davan (1998: Al).
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the ice-minus strain would compete with the wild, ice-nucleating strain. Sufficient
numbers of the ice-minus strain would crowd out its ice-nucleating cousin, inhibiting the
formation of ice-crystals and protecting crops against frost damage. Lindow had
identified the gene that coded for the surface protein responsible for ice-nucleation. He
had then used recombinant techniques to excise the gene from the ice-nucleating strain,
creating in its stead the ice-minus strain. Lindow’s initial laboratory and greenhouse
experiments were encouraging.6 0
2. Federal Challenges - The Cycle o f Approvals and Lawsuits
Among possible microbial candidates for field test, ice-minus was a relatively
innocuous choice. Since a single gene codes for the ice-nucleating surface protein,
spontaneous mutation (i.e., “deletion”) of the responsible sequence results in naturally
occurring ice-minus strains. Lindow’s recombinant version was phenotypically similar to
these wild-strains in that they both lacked the ice-nucleating surface protein.6 1 Neither
strain was known to cause damage to the health of humans or other organisms.
Recombinant techniques were not the only means of generating ice-minus strains
from ice-nucleating strains. Chemical and x-ray mutagens could also be used to generate
ice-minus strains. In fact, had Lindow used these alternative methods, he would not have
required authorization, since they do not involve recombinant techniques. In June 1983,
the RAC approved Lindow’s petition to test ice-minus, but his scheduled October 1983
"H iram K ^S : 1074).
6 1 They are not necessarily genotypically identical. A single point mutation at the appropriate site along the
gene can result in a malformed protein stripped of its ice-nucieating property. The mutation can revert, and
therefore restore this property. Lindow removed the entire ice-nucleating sequence, thus making the ice-
minus property much more stable.
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test was postponed for 4 years, by Jeremy Rifkin’s legal efforts, the need to satisfy EPA,
and regulatory impediments at the state and local level.6 2
Lindow was not the only researcher pursuing ice-minus strains of Pseudomonas.
Advanced Genetics Sciences, inc. (AGS) in Oakland California was also working with
the microorganism. Lindow had collaborated with AGS over the years.6 3 AGS hoped
eventually to commercialize and sell the ice-minus strain under its trademark Frostban.
AGS voluntarily submitted its proposal to the RAC and in June 1984 the RAC granted
authorization to spray a plot of fruit trees with 100 billion Frostban bacteria.6 4
Rifkin immediately petitioned the court asking it to extend the NIH-ban to all
field tests. In June 198S, a Federal court ruled that private companies do not require NIH
permission to conduct field tests. By then, however, the EPA had already released its
interim policy of December 1984 and was reviewing the AGS proposal. After requests
for further information, which AGS supplied, EPA approved the field test in November
1985. This immediately initiated another Rifkin lawsuit, and further delay.6 5
3. Local Challenges and the European Green Connection
As both Lindow and AGS pursued petitions through a federal regulatory maze,
another battle erupted at the local level. AGS had informed EPA of its intention to
6 2 A chronology of the legal challenges and decisions appears in McCormick (1985c: 1066). Baskin (1988:
338) provides some scope of the regulatory challenge: “The permit to field test would take five years, two
federal court suits, and at least 1300 pages of formal paperwork as [Lindow] pioneered the route through an
ever-shifting regulatory frontier. This included his original 98-page proposal to the NIH RAC; an 80-page
revision; a 67-page federal Environmental Assessment and Finding of No Significant Impact; a 312-page
Experimental Use Permit application to the EPA; and a three-volume, 725-page California Environmental
Impact Report.”
6 3 Fox (1992: 56-7).
6 4 Wines (1984: A3).
6 5 “Rifkin...asked the court to block the release because the EPA has not completed studies that would
allow it to evaluate the environmental impact of the experiment” May (1985: A3).
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conduct the Frostban field test in Monterey, California. As word of the proposed site
spread, local opposition erupted.6 6 The Monterey County Board of Supervisors scheduled
a series of public hearings to review the tests and permit locals to express their concern,
presenting AGS officials with yet another barrier.
At a lively 27 January 1986 meeting, locals heard from a variety of experts from
both sides. Two main points of contention emerged. One was that the test was to be
conducted in a densely populated area. This came despite EPA’s request - and AGS’
assurance - that the test would proceed in an isolated area. Second, local citizens
objected to the fact that they had enjoyed no voice in the selection of Monterey County.6 7
In response to the sudden concern, AGS agreed to postpone its test 30 days. Despite this
concession, the Monterey County supervisors voted unanimously in mid-February for a
45-day moratorium on deliberate releases.6 8
A notable aspect of the Monterey confrontation was the presence of a
transnational link. The Chairman of the Monterey County Board, Sam Karas, emerged as
the spokesman for field test opponents. Early on in the Monterey debate, European
Greens from both the European and the German parliaments contacted Karas, urging him
6 6 Stein (1986b: A3).
6 7 “AGS officials blame themselves for what they describe as a complete failure to inform local citizen
about the nature of the test.” EPA requested that AGS conduct the field test at a remote location.
According to Sam Karas of the Monterey Board of Supervisors, “...it came as a rude shock to leam from
Fred Betz of the EPA that no on-site inspection of the testing area was ever done. The agency was not
aware that the site was not located in a rural area, but within 'A mile of a residential area of ten thousand
people” (U. S. Congress 1986a: 110). “The board indicated it would use its zoning authority to place a
moratorium on the experiment and hinted strongly that the experiment will have to be relocated.... Local
sensitivity to the experiment is acute because Salinas Valley is one of the most productive vegetable-
growing areas in the country. It is called the, artichoke capital, and also grows cauliflower, strawberries,
lettuce, celery, and broccoli” Sun (1986a: 667 & 8).
6 8 “By forbidding the application of such bacteria in their county of such bacteria in their county, even for a
brief period, and by proposing permanent county regulation, the Monterey County board has set the stage
for a legal showdown over state and perhaps federal laws defining pesticides” Stein (1986a: A24).
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to block the field test.6 9 In addition, Bay Area environmental activists were also in
contact with their European colleagues.7 0 A transnational network therefore served to
channel information concerning American tests to European Greens, and to channel the
protests of European Greens to American authorities.
4. Further D elay-A G S’ Unauthorized Deliberate Release
The Monterey confrontation was quickly overtaken by news of an unauthorized
field test. In February 1986 newspaper reports surfaced of AGS’s unauthorized deliberate
release on the roof of its headquarters.7 1 EPA received its information from an
anonymous whistle-blower within the company. EPA claimed that AGS had injected a
recombinant strain of Pseudomonas into the bark of trees located on the company’s roof.
The allegation had several consequences. First, EPA immediately suspended
AGS’s Experimental Use Permit pending an investigation. Second, Rifkin had been
pursuing a lawsuit against EPA, arguing that its issuance of the EUP was “capricious.”
In March 1986 a Federal Judge rejected Rifkin’s suit, but withheld summary judgment
pending EPA’s investigation.7 2 Finally, Congress summoned officials from EPA, AGS,
the Monterey County Board and the Foundation on Economic Trends to discuss the
unauthorized release, and the more general issue of regulating field tests.
6 9 “Karas reports that members of the board of supervisors have received telegrams from members of the
Green Party in the West German Parliament as well as from members of the European Parliament urging
them to oppose the tests” Palca (1986a: 254). Karas repeats this claim in later congressional testimony.
7 0 A Berkeley professor of biophysics recounts an exchange he had with students protesting deliberate
release in front of his university building. He notes, “the demonstrators then started to chant slogans and
wave placards for the benefit of television cameras and news reporters... .A leader of the group read a
telegram from 27 German Bundestag members alleging that ‘our health and environment must not be
sacrificed,n Jukes (1986:617).
7 1 “At the time of the tests, the EPA was under the impression that the testing was indoors.... Officials now
know that [the tests] took place on a roof’ May (1986: A3).
7 2 "Chronicle: The EUPs...” (1986:258)
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While AGS did not deny the episode, they did question whether their rooftop
experiment constituted a deliberate release.7 3 AGS officials argued at congressional
hearings that because ice-minus was injected into the tree tissue, it was not deliberately
released.7 4 Some thought their arguments weak, noting that the bacteria could ooze in sap
from the injection sites, where they could be dispersed, or be consumed by birds and
insects. EPA originally charged AGS with falsifying data and levied a $20,000 fine. It
later reduced the charge to one of providing inadequate data, and reduced the fine to
$13,000.7 5 EPA also required AGS to repeat the rooftop experiments within the confines
of a greenhouse. Until completion of such tests, EPA refused to grant AGS the necessary
license to conduct the release.7 6
This was not the only incident from the spring of 1986. The USDA became
embroiled in its own deliberate release controversy. In January 1986 USDA authorized
Biologies Corporation of Omaha, Nebraska to market Omnivac, a genetically engineered
vaccine against porcine pseudorabies. USDA had been seeking to eradicate the disease,
which kills young animals, and which can also pass to cows and sheep. Like ice-minus,
7 3 McCormick (1986b: 253).
7 4 “[AGS] believed the inoculation methods to be used in the rooftop tests would minimize any potential for
release, and [we] were confident that the test organisms were not pathogens and therefore would not
multiply in the fruit tree tissues. Moreover, they were confident that the tests involving the injection of
bacteria into branches of trees located on the roof would not constitute any greater risk of an environmental
release than a greenhouse experiment because the injected bacteria would be contained within the plant
tissues and the tissues would be sterilized and properly disposed of at the conclusion of the experiment. In
short the experiment was done outdoors on the roof top without prior notice to EPA because the researchers
felt that the experiment did not constitute a ‘field test’ [and] that the methodology and physical
environment provided adequate ‘containment’ and did not involve a ‘direct release’ of altered bacteria to
the environment” (U. S. Congress 1986a: 22). Robert Colwell, an evolutionary biologist from U.C.
Berkeley, observed, “assuming that [ice-minus] aren’t pathogenic and then saying it is OK to do it on the
rooftop because we know they aren’t pathogenic when you are testing pathogenicity just doesn’t fly in
terms of logic” (U. S. Congress 1986a: 90).
7 5 “Chronicle: Field Testing” (1986:612).
7 6 Maugh II (1986: A29).
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Omnivac constituted a single gene deletion.7 7 In reviewing Omnivac tests, USDA treated
the product as a routine vaccine, permitting field tests in 198S. In reviewing the product,
the Biologies Licensing Division failed to consult the USDA’s own DNA Research
Committee. Relying on logic similar to that advanced by AGS officials, USDA officials
asserted that because the product was injected into animals, it did not constitute a
deliberate release. When Rifkin learned of the product, he brought suit against Biologies
Corporation, because no environmental impact statement had been filed. Field test
proponents found little of comfort in the embarrassing episode, and sales of the product
were halted. The incident also resulted in a joint congressional hearing, featuring
officials from the USDA, Biologies Corp. and Jeremy Rifkin.7 9 These hearings from the
middle of 1986 mark the high-water mark of congressional concern with deliberate
release.
After AGS repeated the rooftops tests within the confines of a greenhouse, EPA
re-instated AGS’ experimental use permit permission in September 1986.8 0 In response
to the outcry in Monterey, AGS moved their test site to Contra Costa County, where local
officials proved more receptive. On April 2 4 ,1987 at 6:30am AGS conducted the first
authorized field test of a genetically engineered microorganism. The test took place less
than 24 hours after both a Superior Court and a California Appeals Court rejected final
7 7 “The engineered virus lacks the thymadine kinase gene apparently responsible for the wild-type virus and
which allows the curs to ‘hide’ in latent form in the central nervous system” Beardsley (1986:473).
7 8 McCormick (1986d: 373) and Klausner (1986a: 380).
7 9 See U. S. Congress (1986b). One of the vaccine’s developers - Dr. Saul Kit - was later reprimanded for
his outdoor tests of the vaccine. Because his research was NIH-supported, he was at the time to receive
permission from his local Institutional Biosafety Committee and the RAC to conduct the experiment
(Crawford 1986b: 667).
8 0 Dolan (1986: A3).
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calls for further laboratory testing.8 1 While environmentalists had lost the battle, their
challenges had helped delay by five years the first American field test of a genetically
altered microbe.
B. Assessing the First Deliberate Release
In the five years leading up to the test, many claims had been made about the risks
of deliberate release. What is striking about the Pseudomonas episode is the paucity of
scientific evidence the experiment yielded. This should not be criticized so long as it
does not result from poor experimental design. In this section the details of the
Pseudomonas case are discussed with reference to regulatory contagion.
Several variables intrude upon the field test and limit the extent to which one can
generalize from the episode. To test its modified Pseudomonas strain, AGS planted 2400
strawberry plants on a 0.2 acre patch. Sometime in the night before the release, vandals
broke into the fenced plot and uprooted 2000 of the plants. AGS scientists replanted
these in the early hours before the test. The shock of uprooting limited the number of
blossoms available for study. Blossoms were essential, since that is what Frostban was
designed to protect.8 2
The weather proved a second variable. Court delays had pushed the eventual
experiment late into the growing season. This diminished the purpose of a field test: to
evaluate the performance of a product under expected conditions of use. Frost is
arguably a necessary condition for any purposeful field test. During the late-April field
test, however, there was no frost. The test site had enjoyed two weeks of unusually warm
8 1 Crawford (1987: SI 1). Steve Lindow conducted a second and similar test two weeks later.
8 2 These articles have corporate headlines. See Stein (1987: Al). Maugh II (1987: A3).
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weather. This warm weather reduced the growth rate of both Frostban and the naturally
occurring, ice-nucleating Pseudomonas strains. Consequently, Frostban did not
proliferate as well as expected during the test After spraying the strawberries with
Frostban, AGS moved the plants from the test plot to a freezer at the company’s Oakland
headquarters.8 3 Ironically, three years earlier, a Rifkin court challenge had delayed the
original AGS field test. At the time its CEO had observed that “even if fall tests had been
conducted, they would have been of questionable value, since the company believes the
organism’s chief utility to be in protecting tender seedlings from spring frost.” Three
years of delay had apparently been sufficient time for him to reconsider his opinion.
These facts raise questions about the episode’s scientific value, and the limits of its
generalizability.
Other facts from the episode are curious. Dr. Julie Lindemann was responsible for
spraying the field with Frostban the morning of the test. State and federal regulations
required that she wear a “moonsuit.” These white, polylaminated Tyvex anti
contamination suits were required equipment during the field application of any non
registered pesticide. Dr. Lindemann was required to breathe through a respirator and to
apply the bacteria in droplets so as to minimize their aerosolized dispersal. Photographers
captured the first authorized test of a genetically engineered organism. These photos
show Dr. Lindemann in her moonsuit, which she had whimsically decorated with a
“Frostbusters” logo.8 4
In addition to reporters, a handful of protestors had gathered for the event.
8 3 Powledge (1984a: 12).
8 4 A photograph appears in the July-August 1988 issue of American Scientist, the 27 May 1989 issue of
New Scientist and the 30 April 1987 edition of Nature.
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Observers stood unprotected at a distance of only 60 feet Neither they nor anyone else
present were required to wear moonsuits. Trevor Suslow, an AGS spokesman, explained
the moonsuit as “an attempt by regulatory agencies to exercise extreme and extraordinary
caution this first time out We don't wear anything even approximating this when we
work with this material in the lab.” His observation reflects the curious risk space that
the regulators had constructed. If indeed Frostban did present a hazard, the attending
public would have been exposed, whereas the scientist conducting the experiment would
have been the only one protected! To complete the irony, if Frostban’ s promise bore out,
AGS stood to enjoy the disproportionate share of any benefits.
The construction of this peculiar risk space was not lost on authorities. Consider
the congressional testimony between an AGS official and Representative Volkmer a year
prior to the test:
Mr. Volkmer: You are going to have the neighbors out there seeing these people
spraying stuff around the strawberry patches and they are not going to have those
kind of suits. Can you see some possibility of concern by those people?
Dr. Bedrock: I can certainly see a perception that would indicate that this was
something dangerous that must be going on here.
Mr. Volkmer: Yes
Dr. Bedrock: But I can assure you, sir, that the reason for wearing these suits and
so on was at the advice of the regulatory people as an indication o f our caution
rather than an indication o f the risk involved. But I can certainly understand the
potential for the perception, yes sir.8 5 (My emphasis)
To confuse matters further regulatory authorities were probably purchasing too much
insurance. AGS official Tuslow claimed that, “we consume these bacteria all the time
when we eat fresh fruits and vegetables.” Despite this, EPA required positioning of
nearly 300 detectors around the site in a 0.8 acre buffer zone to track Frostban's
8 3 U. S. Congress (1986a: 34).
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movement. In addition, the plot would be disinfected upon completion of the test, and
any remaining strawberry plants would be burned on site.8 6
The first field test of a genetically engineered organism was steeped in
controversy. Proponents and AGS insisted that the tests were safe, because the host
organism Pseudomonas is benign. Furthermore, they argued that gene deletions are the
most innocuous form of alteration. Finally, the recombinant strain mimicked wild
strains. Opponents portrayed Frostban as potentially hazardous to both human health and
the environment. They advanced the possibility that it could harm the health of the
young, the old and the sick. They expressed fear that its release could potentially impact
cloud formation and change local weather patterns.
Given these competing perspectives, the compromises and contradictions were
simultaneously understandable and farcical. Thus the moonsuit and detectors were used
but the public was permitted to observe events in close proximity. Although
Pseudomonas is naturally occurring, and the genetically engineered strain mimicked its
wild cousin, authorities required disinfecting the test site. While these compromises
make some political sense, they are hard to defend scientifically.
Much as the regulatory actions are contradictory, the test itself yielded little in the
way of useful “science.” Under ideal circumstances, experiments involve the control of
all but one variable. It is difficult achieve that ideal outside the laboratory. Biologists
have long questioned whether the term experimental field test constitutes an oxymoron.8 7
8 6 Lest this go unmentioned, detecting bacteria is a difficult task (McCormick 1986c: 419). And of course,
one can never prove that an altered bacteria has not left a test site.
8 7 “By the 1870s, few doubted the need for scientific agriculture or the value of creating what became
known as experiment stations. But as soon as anyone attempted to put this generally accepted idea into
practice furious debate began. Scientists themselves divided on the value of field experiments. Some
insisted that true scientific research required laboratory conditions where variables could be controlled and
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With regard to Frostban, one can ask whether the test was designed to produce any
scientific information. The shock of uprooting, the absence of buds, the absence of frost
and unseasonably warm weather were hardly the conditions of Frostban's expected
application.
Of course, the Frostban field test served as much a political as a scientific
purpose. This explains the urgency with which both sides pursued the release. American
regulators advocated “case-by-case” review for deliberate release. Thus opponents to
hazardous tests would be provided the opportunity to challenge future tests. But
subsequent tests were incapable of generating the same level of concern and activism that
Frostban did. European Greens no longer sent telegrams and Rifkin tilted his lance at
other windmills. Regulators also understood that the symbolic game was over: they
quickly rescinded the moonsuit requirement for further ice-minus field tests.8 8
VI. The Implications of Frostban for a Study of Regulatory Contagion
The Frostban episode is central to the American history of deliberate release
regulation. While of little scientific consequence, it was of enormous symbolic
consequence, marking a fundamental change in the regulation of recombinant activities.
While true that no apparent hazards resulted from the test, it is equally true that the
conditions of the experiment hardly approximated the conditions of its expected use.
More generally, any single field test can yield only very limited scientific
information. Even if the field test had not suffered the faults discussed, generalizing from
research replicated. Others argued that scientific research in agriculture could have little meaning unless it
was conducted under real field conditions” Woodman (1986:1200).
8 8 “Six weeks later, it became evident that the EPA did not believe in the precautions on which they had
insisted. Miraculously, ice-minus bacteria had become harmless. Clad in blue jeans and a short-sleeved
sports shirt and unprotected, Dr. Lindemann was photographed on 4 June when she dug up the sprayed
plants to take them back to the laboratory” Jukes (1992:142).
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it would represent an analytic leap of faith. Doing so would assume that 1) deliberate
release constitutes a clear analytic category, 2) some releases are more representative of
the category than others, and 3) the Pseudomonas release was one of those more
representative examples.8 9 Foreign authorities would have to embrace these assumptions
before using the Frostban episode to generate and justify their own regulatory approach.
Cognitive psychologists suggest that even non-relevant events can anchor
decision making under conditions of uncertainty: recall the impact a random number
generator had on estimates of the world’s nations that are in Africa. Similarly, the
contagion hypothesis assigns possible explanatory value to an event beyond the limits of
its generalizability. Thus, while scientifically flawed, Frostban’ s standing as the first
authorized deliberate release of a recombinant microorganism may trump a rational
consideration of its implications by foreign regulatory authorities.
How might this occur? American Scientist published an extended article on field
tests. Accompanying the article is a photo of Lindemann in her moonsuit with the
caption, “No matter what scientists say, news photos tell their own story.”9 0 Field test
proponents complain that the moonsuit photographs communicated a false message of
hazard.9 1 This is not the only possible interpretation. One might equally complain that the
8 9 “Some categories, like tall man or red, are graded; that is, they have inherent degrees of membership,
fuzzy boundaries, and central members whose degree of membership (on a scale from zero to one) is one.
Other categories, like bird, have clear boundaries; but within those boundaries there are graded prototype
effects - some category members are better examples of the category than others” Lakoff (1987: 56).
9 0 Baskin (1988:337).
9 1 It serves Jukes’ rhetorical purpose to emphasize the photo’s hazardous impression, though he provides no
direct evidence of this effect “The picture, which went around the world, was sufficient to convince
practically everybody who saw it that ice-minus bacteria must be quite deadly, or why should the person
dispensing them be enveloped in a moon suit and wear goggles and a mask?” Jukes (1992: 141). My goal
is to show that the Frostban episode had a transnational regulatory impact beyond its scientific value. In
fairness to Jukes, the British Biotechnology Association criticized the later use of the photo, and the
possibility that it communicates hazard. See the caption to the photograph accompanying Watts (1989b:
32).
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photographs communicate a false notion of scientific grounding: moonsuits are, after all,
the garb of scientists. Alternatively, knowledge of the field test but ignorance of the
photographs might communicate the idea that field tests are not hazardous; or that their
hazards are acceptable. It is in these multiple ways that information of the release may
have effected the views of foreign regulatory authorities. The next two chapters address
the regulation of field tests in Germany and Britain. Both provide occasion to revisit the
ice-minus episode, despite the argument here that foreign regulators would have been
equally justified to ignore the episode as scientifically and empirically irrelevant.
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Chapter 5 - The German Case Study
I. Introduction
Germany provides the second case study of deliberate release regulations.
Economic and political considerations justify its inclusion. In April 1987, the same month
as the ice-minus test, the United States Commerce Department published Biotechnology
in Western Europe. According to this report:
Intrinsically, West Germany is in a most favorable position for the industrial
development of biotechnology. Its basic research establishment is the best funded in
Europe, facilities are first-class, and research covers a broad spectrum of biological
subjects. In addition, West Germany has always had a consensus within its government-
industrial establishment to support basic research. In industry, almost all biotechnology
activities are concentrated in a number of large, highly profitable, technologically
advanced chemical and pharmaceutical companies. (Yuan 1987: B-24)
In the early and mid-1980s many observers believed Germany stood to benefit as much
as any country from biotechnology. Since the early 1970s government and industry had
worked together to finance biotechnology.1 The resultant research centers were among
the most highly admired in Europe.2 With specific regard to agricultural biotechnology,
1 “West Germany could certainly claim to be the first European nation to recognize the potential of
biotechnology research. The German Chemical Apparatus Association set up a biotechnology research
program in 1972 and support has been maintained ever since, with most money channeled through the
Federal Ministry for Research and Technology.... The Gessellschaft [sic] filr Biotechnologische Forschung
is the only research institute in Europe devoted solely to biotechnology” Gumsey (1983:564). “During
[the 1970s] German funding for biotechnology far outstripped British or French public expenditures in this
field, at one time by a factor of ten to one” Jasanoff (1985:29).
2 “The most notable government research center is the Society for Biotechnology (GBF), which has a
research staff to perform basic studies and provide services to the public and private German community.
A major focus of the GBF is to foster technology transfer to industry. The goals of the GBF include
bioprocess and scale-up technologies, joint projects with industry, and interdisciplinary training. The GBF
is now considered one of the best biotechnology research facilities in Europe” Dibner (1986:1369).
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Germany was recognized for research strengths in the area of plant tissue culture.3 At-
mediated transfer was developed in the lab of Dr. Josef Schell at the Max-Planck Institute
for Breeding Research in Cologne in the early 1980s.4 Soon thereafter, COGENE chose
the institute as the site for its conference on rDNA and plant breeding.5
Despite these advantages, West German biotechnology in the mid-1980s suffered
one critical handicap: a rising Green political movement. In 1984 for the first time, the
environmentally minded Green party entered West German federal politics. From a
position within the Bundestag, Greens immediately raised an anti-biotechnology banner.
Throughout the second half of the 1980s West German biotechnology politics were
strident, divisive and highly public.
The politics of West German deliberate release regulation differ significantly
from those of the United States. These differences are best revealed by a set of
concomitant decisions made in each country. In April 1987 AGS finally conducted its
ice-minus field test. Four months before that test, the West German Bundestag received a
report from a special parliamentary Commission of Inquiry. The Bundestag had
empowered this commission two years earlier to evaluate “the opportunities and risks” of
biotechnology. In January 1987 the commission presented approximately 170
recommendations for biotechnology legislation. Among these was a proposed five-year
3 “The large European pharmaceutical and biotechnology firms are reportedly interested in ptc [plant tissue
culture], but only Boehringer Mannheim and the Gesellschaft filr Biologische Forschung mbH (GBF) have
made their interests public. GBF presented preliminary results on secondary metabolite production in
culture at the 1982 International Congress of Plant Tissue and Cell Culture in Tokyo. Said one impressed
U.S. attendee at that Congress, ‘we always knew the Japanese were doing well in this area - fermentation is
one of their traditional strong points - but the Germans are definitely giving them a run for their money’”
Curtin (1983:654).
4 Schell and Van Montagu (1983).
5 Dixon (1983:309).
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moratorium on deliberate release. Thus, at the same time that American authorities were
tentatively approving field tests, West German authorities were tightening regulatory
control over field tests. This juncture in 1987 - with the United States cautiously
embracing field tests and West Germany embracing a moratorium — would appear on the
surface to preclude the presence of transnational regulatory contagion from the United
States.
To further complicate the case, one can argue that within the OECD, Germany
stands out as a cultural outlier. What distinguishes Germany is the legacy of the Nazi
past. Hitler divided the world into iiber- and untermensch. The Third Reich, so it was
claimed, would enjoy 1000 years of Arian supremacy over enslaved, non-Arian races.
The Final Solution for some of these races was annihilation. This darkest episode in
German and European history can be understood at one level as a political program
grounded in a facile understanding of genetics.
The Nazis were not the first eugenicists, only the most ruthless, organized and
motivated. With the rediscovery of Mendel’s work, the early 20th century witnessed a
number of eugenic programs. In Britain, groups of prominent men increasingly worried
about the dilution of the human gene pool, and the enfeeblement of the British nation.
These fears produced proposals to regulate human breeding. Of course, the privileged
class possessed superior genes; and to complete the circle, superior genes generated and
justified privilege. The resultant positive eugenic proposals were as self-serving as they
were unscientific. Negative eugenic proposals designed to check the spread of
“defective” genes resulted in odious sterilization programs. It bears remembering that by
the mid-1930s, over 20,000 forced sterilizations had been performed in the United States,
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disproportionately on those considered of “lesser races.”6 Similar programs persisted in
Sweden until the mid-1970s, where over 60,000 were performed.7
The Nazi legacy sets apart the cultural context for German biotechnology.
Confrontations over biotechnology regulation recalled the horrors of the Nazi past.8
Biotechnology opponents could invoke this link rhetorically to powerful effect.9 No
other OECD member state brings a similar cultural burden to considerations of
biotechnology. Thus, in addition to this study of contagion, Germany presents an
interesting case for those with an interest in culture and regulation.
On the other hand, Germany and the United States exhibit institutional similarity.
Each is a federal system, with the United States divided into S O states and Germany
currently divided into 20 Lander. For students of comparative politics, Germany and the
United States are frequently grouped together as “weak states,” whereas France and
Britain are grouped together as “strong states” with central administration.1 0 Thus, for
one interested in studying institutional variation and regulation formation, the United
6 “State sterilization laws applied only to the inmates of public mental institutions, whose residents were
disproportionately from lower-income and minority groups. In Virginia, the overwhelming majority of
those sterilized were poor; perhaps as many as half of them were black.. .the foreign-born were more likely
to be admitted to state mental institutions and to be sterilized once there” Kevles (1985: 168). The 20,000
figure is quoted on p. 112.
7 According to French television news, the Swedish program ran from 1935-76. Florence Bouquillat, FR2,
September 25, 1997.
8 As a Nature editorial notes amid the regulatoiy debate, “The particular issue of genetic engineering,
semantically linked as it is in West Germany with still recent horrors at places such as Auschwitz, is bound
to be difficult” “Greens Against Genes” (1988:667). “One explanation for the differences between Anglo-
American scientists and their German colleagues in defending embryo research is the history of German
medicine and genetics during the Third Reich, which permitted eugenics and experiments on humans.
Eugenics in German is a loaded term. Many people know it better as the Nazi’s Rassenhygiene (‘racial
hygiene’)” Zell (1989a: 28).
9 For example, “Der hier ablaufende gentechnische Holocaust dokumentiert, dafl die Vielfalt der Allen
ethischrectliche ungeschOtzt ist” Altner (1989:7).
1 0 For a discussion of this typology, see Katzenstein (1978:324).
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States and Germany would appear more appropriate to group together across form these
others.
These elements should be kept in mind as one proceeds through the German case
study, since they suggest alternative means to explain the history. This chapter is
organized into three sections. First, brief review is made of the pre-Enquete Commission
period in German biotechnology. Second, the Enquete Commission is discussed at
length, since it is the critical report of the German political process. Third, the
consequences and political battles that followed its publication are addressed. This
review will provide a basis for assessing the impact of transnational effects on German
biotechnology regulation.
II. The Pre-Enquete Commission Period
On the eve of the field test controversy, Germany held both hope for and promise
in biotechnology. By one measure, German researchers boasted the second most
commercially creative minds in international biotechnology competition. In the early
1980s, Germans were an international leader in biotechnology patents - holding 20%
worldwide, compared to 30% in the United States.1 1 Their industrial strengths included
advanced fermentation techniques, and a world-class chemical industry, with such
notable firms as Bayer, Hoechst and BASF.
Since the 1960s successive German governments of both the left and right had
expanded public support for the life sciences. In 1973 the German Chemical Society
(DECHMA) issued an early report on the promise of biotechnology. Somewhat
surprisingly, this report did not emphasize the concomitant revolution in genetic
1 1 Edington (1995: 752).
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engineering. German scientists participated at Asilomar and they returned to advise the
government on regulating recombinant research. German authorities relied heavily on
NIH rules for their own recombinant regulations, which they adopted in 1978.
By the early 1980s, American and British authorities were moving to deregulate
activities and to facilitate the emergence of industrial scales for genetic engineering. In
contrast, West Germany’s 1978 biotechnology regulations remained essentially
unchanged. German industry increasingly complained of threats to its international
competitiveness in this “key technology” (Schlusseltechnologie). The German regulations
were modeled after NIH rules, which resulted in two consequences. First, the NIH had
previously placed a limit of 10 liters on fermentation tanks. Consequently, German firms
required special permission to scale up their biotechnology efforts. This inhibited the
emergence of industrial scales. The American and British governments abandoned these
limitations in 1980. Second, the Germans had adopted the rule that made regulations
apply only to those scientists receiving public funds for their research; private firms,
however, had adopted a system of voluntary compliance, similar to that practiced in the
United States.1 2
1 2 “An ad hoc group of experts appointed by BMFT recommended guidelines closely patterned on those
developed by the National Institutes of Health in the US.... Guidelines based on the advisory committee
report were officially approved by the federal cabinet in February, 1978. They were binding only for
projects carried out with federal funds, hence not for privately supported research in or outside industry. Or
for university research funded by Lander governments.... To review applications concerning rDNA
research, the guidelines established a Central Commission for Biological Safety (Zentrale Kommission filr
die Biologische Sicherheit, ZKBS).... The rDNA guidelines prescribe that four of the twelve ZKBS
members much have experience in biosafety issues, and four must be drawn from affected interest groups,
such as labor, industry, occupational health professionals or research-supporting institutions. The
unorganized lay public has no role in ZKBS’s review process” Jasanoff (198S: 32). “Auch wenn sich
mittlerweile andere Anwender der Gentechnik, etwa aus der chemischen und pharmazeutischen Industrie,
der Richtlinie im Wege der ‘freiwilligen Selbstbindung’ unterworfen haben sollten, Sndert dies nichts an
dem unzureichenden Inhalt und den mangelnden Kontroll- und SanktionsmOglichkeiten. Zudem zeigen
verschiedene VorfiUle - nicht nur in den USA - dafl mit Verstfiflen gegen
‘Selbstverpflichtungserklarungen’ immer gerechnet werden mufl” Fdhr (1989:224).
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A. The Greens, the Bundestag and the Enquete Commission
At the same time that industry lobbied for deregulation, West German politics
entered a new era. Through the 1970s environmental movements enjoyed increasing
political support throughout Europe. In 1983 the Greens broke into federal politics when
they received 5.6% of the national vote, just greater than the necessary 5% electoral
support necessary to enter the German Bundestag.
From their position within the Bundestag the Greens had an immediate impact on
West German biotechnology politics. In autumn 1984 the Greens called for a special
parliamentary commission of inquiry on biotechnology. They secured the support of the
SPD, the other opposition party within the West German parliament. These requests
resulted in the establishment of a 17-member Enquete-Kommission, or “Commission of
Inquiry” (hereafter “Commission”). Dr. Wolf-Michael Catenhusen, a member of the
SPD, chaired the commission, which included eight experts from industry, science and
religion and nine members from parliament (4 Christian Democrats, 3 Social Democrats,
1 FDP and 1 Green member).1 3
The Commission’s broad mandate was to review the “opportunities and risks” of
biotechnology.1 4 Much as elsewhere, it defines risk as the product of a harmful outcome
1 3 “In 1969 a new instrument of parliamentary politics was established: the Enquete-Kommission (Inquiry
Commission)... it was decided that an Enquete-Kommission would be instituted if one-fourth of the
members of the Bundestag demanded one. The function of an Enquete-Kommission as to prepare
decisions about complicated and highly contested issues” Gottweis (1999: 267-8).
1 4 The commission’s report is entitled Chancen und Risiken der Gentechnologie. American and English
reporters of the time variously translate the term Chancen as chances, prospects and opportunities. The
report’s context makes quickly apparent that the latter is the more appropriate term. The Commission’s
definition of the term Risiken is equivalent to hazard. If one accepts this equivalence, then the report
would appear to evaluate and compare opportunities and hazards - the strategy of risk analysis advocated
in chapter two.
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and the probability of its occurrence, thereby equating risk with hazard.1 5 German
biotechnology opponents also apply this definition.1 6 The commission’s purpose was to
provide recommendations for an overhaul of West German biotechnology regulation.
This required it to address the entire gamut of ethical and safety issues raised by
biotechnology, not just the limited question of deliberate release. The Commission
scheduled two years of hearings to complete its review.
B. Governmental Efforts to Support Industry
As the Bundestag initiated its review of biotechnology, Helmut Kohl’s
CDU/CSU/FDP coalition government made moves to support the German biotechnology
effort. The instrument for this support was the government’s Ministry for Research and
Technology, which initiated two efforts to advance German commercial biotechnology.1 7
The first of these involved public funds. In July 1985, the Minister for Research and
Technology Heinz Riesenhuber announced plans to spend DM 1 billion to support
biotechnology research. While the majority of this money was allocated to basic
research, DM120 million was specifically earmarked to offset industrial R&D.1 8
The second was a proposal for deregulation. In October 1985 Riesenhuber
proposed revamping and relaxing West German biotechnology regulation.1 9 German
1 5 “Technisch wird Risiko definiert als das Produkt von SchadensausmaB und Eintrittswahrscheinlichkeit.”
(Enquete 1987:234).
1 6 A widely-cited opponent writes, “Zum Risikobegriff in der Gentechnologie is anzumerken, daB
quantitative Risikoerhebungen gentechnischer Experimente und Verfahren heite praktisch noch nicht
vorliegen, daB Risiken nicht als Produkt von Eintrittswahrscheinlichkeit mal SchadenshOhe dargestellt
werden kOnnen” Kollek(1989: 189).
1 7 “A powerful new agency, the Federal Ministry for Research and Technology (Bundesministerium filr
Forschung und Technologie, BMFT) was created in 1972 to promote industrial competitiveness through
directed use of R & D funds. BMFT’s central mission was to develop effective research programs aimed at
the high-technology industries.. .biotechnology was designated a ‘key technology’” Jasanoff (1985:23).
“ Neffe(1985:287).
1 9 Dickson (1986:13-14).
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industry welcomed Riesenhuber’s proposal, arguing that German regulations were
antiquated and placed it at a competitive disadvantage. The proposal drew fire from the
SPD/Green opposition. Enquete Commission Chair Catenhusen criticized Riesenhuber’s
initiative, arguing that new regulations should follow - not precede - publication of the
Enquete Commission’s findings. The Commission’s position was strengthened by news
that a Heidelberg-based firm, Gen-Bio-Tec, was experimenting with microorganisms
genetically engineered to produce a human blood-clotting factor.2 0 The legal standing of
such commercial recombinant enterprises was ambiguous at the time.
These initial episodes highlight the differences that distinguish the West German
regulatory debate. There is, however, some evidence of transnational regulatory
contagion. The Kohl government’s deregulatory effort was cast in terms of bringing West
German regulation up to date with rules around the world. This in itself suggests that
West German authorities were aware of, and responding to foreign regulatory approaches
to biotechnology.
To make its case, the Kohl government argued publicly that the proposed changes
would simply bring German biotechnology regulations into harmony with international
approaches. The government claimed to model its proposals after OECD
recommendations. Importantly, the OECD’s proposals were based largely on previous
American regulatory decisions. While the government attempted an end-run with regard
2 0 Much as NIH rules had applied only to research supported with NIH funds, German rules only covered
research supported by the BKZB. German industry - much like their American counterparts - had
accepted these regulations voluntarily. This voluntary system threatened to unravel under the strain of
foreign deregulation.
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to scaled-up fermentation and recombinant production, the government specifically
pledged not to short-circuit the Enquete Commission’s review of deliberate release.2 1
in. The Enquete Commission Report
A. The Substance of the Report
In January 1987 following 55 meetings and 18 hearings the Enquete Commission
released its report.2 2 The Commission’s Report (hereafter “Report”) offers a 400-page
comprehensive review of biotechnology, with 176 specific recommendations for
legislation. Whereas American reports generally treat the field test issue in isolation,
field tests only constitute one subsection to the larger West German effort. Because of
this, much space is devoted to non-environmental discussions. Among these are
discussions of human genetics, somatic v. germ-line research and therapy, genetic
discrimination, the dangers of renewed eugenics, biotechnology and the Third World, and
the military applications of biotechnology. In this regard it is perhaps the most
comprehensive single report ever published on the social implications of biotechnology.
Deliberate release (die Freisetzungproblematik) enjoys an individual chapter
within the Report, marking the perceived relevance of this issue for any analysis of
biotechnology’s risks. The Report reiterates many of the ambiguities then current as to
the possible and probable effects of deliberate release, as well as the fundamental
2 1 “The government has promised that in some areas, such as the release of genetically engineered
microorganisms into the environment, no decisions will be taken until the [commission’s] report
appears....The new guidelines are expected to be modeled closely on those currently under discussion
within the Organization for Economic Cooperation and Development, which drawn [sic] heavily on current
practices in the United States. The [Kohl] government clearly hopes that referring to the OECD’s
recommendations will help to legitimate its actions” Dickson (1986: 14).
2 2 According to later debate in the Bundestag, only four of these meetings were held publicly. “Die
Mehrheit der Kommission hat eine breite Offentliche Debatte liber die durch die Gentechnologie
aufgeworfenden Grundfragen eher berhindert als unterstUtzt...von mehr also 50 Sitzungen waren ganze
vier Sitzungen Offentlich.” Testimony of Frau Schmidt-Bott (Green),
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limitations to such analysis. Consequently, the Report notes the necessity of reasoning
with “analogies,”2 3 as English language reports do as well. The Report also advocates
development of international standards for the deliberate release of microorganisms.2 4
The field test discussion is organized into four subsections, each devoted to a
different kingdom: 1) viruses, 2) bacteria/fungi, 3). plants, and 4) animals. This
subdivision is echoed in the entirety of the Report, with other chapters devoted to
discussing more specifically the techniques for and opportunities of applying genetic
engineering to 1) animals, 2) plants, and 3) microorganisms. The conclusions for each of
these groups are summarized below.
1. Viruses
The Report singles out the deliberate release of viruses as posing exceptional
hazards. The Report voices concern about their survivability,2 5 communicability,2 6 their
2 3 “Innerhalb der wissenschatlichen Diskussion existiert eine Reihe von unterschiedlichen Positionen
bezQglich der mit der Freisetzung solcher Organismen verbundenen Risiken....Bisher liegen keine
Erfahrungen Qber die Auswirkungen des Eindringens von gentechnisch verandertem biologischem Material
in die Umwelt vor. Ansatzpunkte filr die EinschOtzung des Verhaltens solchen Materials und der aus seiner
Freisetzung potentiell sich entwickelnden Konsequenzen mOssen deshalb in Bereichen gesucht werden, die
Analogien zur Freisetzung gentechnisch verOnderter Organismen in die Umwlet aufweisen” (Enquete 1987:
215-6).
2 4 “Die Bundesregeienmgwird aufgefordert, sich dafilr einsusetzen, daB alle MaBnahmen filr die gezielte
Freisetzung von Mikroorganismen und Viren grenzOberschreitend (mOglichst weltweit) harmonisiert und
koordiniert werden” (Enquete 1987:235).
2 5 “Die Oberlebensdauer ist fO r jede Virusart unterschiedlich. Sie wird sowhol durch die
Zusammensetzung der das Virus umgebenden Halle bestimmt, als auch durch die physikkalischen und
chemischen Einflate (z.B. ultraviolettes Licht, Temperatur, Feuchtigkeit), die auf das Virus wirken”
(Enquete 1987:217).
2 6 “Verbreitet werden Virenen in der Regel dadurch, daB sie von dem bereits infizierten Organismus an
einen anderen weitergegebenen werden.... Je longer die Latentzzeit, also die Zeit zwischen Infektion und
Ausbruch der Krankenheit, wird, desto grOBer wird die Zahl der Individuan, die potentiell angesteckt sind
und das Virus weiter verbreiten kOnnen, bevor die Krankenheit erkennbar sind” (Enquete 1987:216).
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capacity for latency2 7 and reactivation,2 8 their chromosomal mobility and subsequent
inheritability,2 9 the potential for intracellular recombination among differing viral
strains,3 0 and the anticipated enormous number that would accompany their release.3 1
Because of these concerns, the Enquete Commission recommends banning the
deliberate release of genetically engineered viruses, with two exceptions. First, the ban
does not extend to human and veterinarian viral vaccines. A second exception is proposed
for baculoviruses, viruses that attack insects. Because of these organisms’ promise for
biological pest control, the commission encourages further research and development of
genetically modified baculoviruses. The commission recommends initial testing within
contained and simulated ecosystems (e.g., greenhouses). After evaluation of such
simulations, the Federal Health Ministry (BGA) should take under advisement from its
Central Commission for Biological Security (ZKBS) and in agreement with its Biological
Department the possibility of excluding baculoviruses from the ban on viral releases.
This exception does not apply to baculoviruses modified to expand their host range.3 2
2 7 “Anderseits ktfnnen Viren aber auch in das Erbmaterial der Wirtsorganismen integrieren und dessen
Funktionszusammenhange langfristig stfiren” (Enquete 1987:218).
2 8 “Eine zweite MOglichkeit ist...dafi das virale Erbmaterial sich als extrachromosomales Element etabliert
und, ohne daB seine Information zundchst abgerufen wird, bei den Zellteilungen auf die Tochterzellen
weitergegeben wird” (Enquete 1987:216).
2 9 “Eine zweite MOglichkeit ist dadurch gegeben, daB das virale Erbmaterial sich als extrachromosomales
Element etabliert und, ohne daB seine Information zundchst abgerufen wird, bei den Zellteilungen auf die
Tochterzellen weitergegeben wird” (Enquete 1987:216).
3 0 “Bei den Rekombinationen handelt es sich einerseits urn den Austausch von genetischem Material
zwischen zwei Viren. Das Erbmaterial der Nachkommenschaft enthdlt dann Nukleinsduresequenzen beider
Eltem” (Enquete 1987:218).
3 1 “Im Falle einer Freisetszung warden viele Millionen bis Milliarden genetisch verdnderter Viruspartikel
gleichzeitig in die Umwelt gelangen” (Enquete 1987:219).
“Die (Commissionempfiehltdem Deutschen Bundestag, die Bundesregierungauszufordem, I. die
Freisetzung von genetisch verdnderten Viren in den Sicherheits-Rlchtlinien grundsdtzlich zu untersagen. 2.
Die Mdgichkeit des Einsatzes von Baculo-Viren zur Schddlingsbekdmpfung und im Pflanzenschutz
verstdrkt untersuchen zu lassen. Dazu sollen mflglichst bald Experimente mit gentechnisch verdnderten
Viren unter Bedingungen des physikalischen Containment untemommen werden (z.B. im Gewdchshaus).
Nach Auswertung dieser Experimente kann das Bundesgesundheitsamt nach AnhOrung der ZKBS und im
Einverhmen mit der Biologischen Bundesanstalt fO r die Freisetzung gentechnisch verdnderter Baculo-Viren
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2. Microorganisms
According to the Report, the deliberate release of microorganisms presents similar
concerns as those associated with viruses. The Report observes that while thousands of
microbial strains are known, only a small minority of these is genetically characterized.
Further, little is known of their microbial ecology.3 3 The Report voices concern about
their survivability (with anthrax spores used as the example),3 4 mobility,3 5
pathogenicity;3 6 the exchange of genetic information through transduction3 7 and
conjugation,3 8 limited predictability,3 9 potential direct ecological effects,4 0 possible
Ausnahmen vom grundsatzlichen Freisetzungsverbot filr Viren zulassen. Dies gilt nicht filr Baculo-Viren
mit gezielt veranderter Wirtsspezifitat. Entsprechend ist mit pflanzlichen Viren vom Typ des CMV zu
verfahren. Enie VerSnderung des Verbots der Freisetzung von genetisch verSnderten Viren in den
Sicherheits-Richtlinien soli nach dem gleichen Verahren erfolgen, wie dies filr die OberprQfung des von der
(Commission vorgeschlagenen Moratoriums fO r die Freisetzung gentechnisch verdnderter Mikroorganismen
vorgesehen ist” (Enquete 1987:221).
3 3 “Mikroorganismen kommen in der Umwelt in groBer Vielfalt vor, allein im Boden wird die Zahl der
Arten auf ca. 3000 geschatzt. Diese sind, von einigen Ausnahmen abgesehen, genetisch kaum
charakterisiert, von ihren Interaktionen untereinander sowie mit Flora und Fauna gar nicht zu reden”
(Enquete 1987:219). Selbst gut charakterisierte Mikroorganismen geben gelegentlich zu Oberaschungen
AnlaB, indem sie plfltzlich ganz neue, aber an sich schon vorhandene Soffwechselswege zu ihrer Emdrung
aktivieren kflnnen” (Enquete 1987:233).
3 4 “Ein Beispeil fO r die Oberlebensf&higkeit von Bakterien, die Dauerformen (Sporen) bilden kflnne, ist der
Miizbrand-Erreger Bacillus anthracis” (Enquete 1987:220).
3 5 “Mikroorganismen kOnnen durch Wind- und Luftbewegungen Ober groBe Distanzen transportiert
werden” (Enquete 1987:220).
3 6 “Dennoch bleibt die Frage offen, ob nicht doch einmal durch das EinfQgen eines unbekannten Gens ein
nicht-pathogener zu einem pathogenen Organismus werden kOnnte. Alle Erfahrungen, beispielweise aus
S O Jahren wissenschaftlicher Versuche mit Exoli sprechen gegen diese MOglichkeit” (Enquete 1987:234).
3 7 “...darOber hinaus kOnnen Teile ihres Erbmaterials mit Hilfe von Bakterienviren in einem Transduktion
genannten Vorgang auf andere Bakterien abertragen wereden” (Enquete 1987:222).
“Bei diesem Vorgang [(Conjugation] werden Plasmide, Chromosomenbereiche oder auch ganze
Chromosomen von einem Bakterium auf ein anderes abertragen” (Enquete 1987:222).
3 9 “Eine exakte Einschatzung des Verlaufes von Freisetzungen fremder Arten im voraus ist jedoch nicht
mOglich” (Enquete 1987:224).
4 0 “Freigesetzte Mikroorganismen kOnnen die unterschiedlichen Organisationensstufen eines Okosystems
beeinflussen, d.h. einzelne Individuen, Gruppen, Arten, bestimmte LebensrSume oder ganze Okosysteme”
(Enquete 1987:222-3).
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secondary effects,4 1 limitations in monitoring,4 2 and the vast number expected to
accompany release.4 3
The Report also distinguishes among types of microbial alterations. It argues that
gene deletions should generate less concern than the introduction o f novel sequences into
an organism. In making its case, the Report invokes ice-minus, the example then
confronting American regulatory authorities. The Commission argues that ice-minus’
genetic similarity to wild-strains makes assessment of its release analogous to the release
of a naturally occurring strain.4 4 The Report thereby echoes the decisions being reached
by American regulators.
The Report proposes a 5-year moratorium on the release of microorganisms
possessing novel genes. After 5 years, the ban should be reviewed according to the best
available evidence.4 5 Meanwhile, the Report recommends that the Federal Ministry of
Research and Technology (BMFT) pursue a public and interdisciplinary effort to develop
criteria with which to assess proposed deliberate releases, despite the Report’s
4 1 “Auch sekundflre Auswirkungen mdfien berOcksichtigt werden” (Enquete 1987: 224).
4 2 “Es mufi also davon ausgegangen werden, dafi trotz sezifischer und empfindlicher Tests ein vollstflndiges
‘Monitoring’ von freigesetzten Mikroorganismen bzw. Direr Erbinfromation prinzipiell nicht mOglich ist”
(Enquete 1987:229).
4 3 “Grundsatzlich kkann es also bei der Freisetzung groQer Mengen gleichartiger Mikroorganismen zu
Okologischen und toxikologischen Problemen kommen” (Enquete 1987:232).
4 4 “Ein wichtiger Parameter wird die Art der genetischen VerSnderung sein. In diesem Zusammenhang
sind die Deletion eines Gens oder die erhote Expression eines bereits vorhandenen Gens anders zu
berwerten als die EinfOrung von Genen, die die Organismen zu Leistungen befilhigung, zu denen sie
normal weise iemals gekommen w8ren...Ein Beispeil dafQr wSren durch genetische Eingriffe hergestellte
“Eis-Minus”-Bakterien, wenn sie sich von den als Wildtyp betrachteten “Eis-Plus”-Bakterien durch eine
blofie Deletion des Gens filr das an der Eiskrystallbildung beteiligte Protein unterschieden und dartlber
hinaus als solche auch in der Natur vorkHmen. Deren Freisetzung m O fite analog zur Freisetzung
konventionell veribiderter Mikroorganismen bewertet werden” (Enquete 1987:234).
4 5 “Die gezielte Freisetzung von Mikroorganismen, in die genetisch fremde Gene eingefDgt worden sind, ist
in den Sicherheits-Richtlinien weitherhin zu untersagen. Nach einem Zeitraum von S Jahren mufi unter
Beteiligung des Bundestages entschieden werden, ob neue Erkentnifie eine angemessene Abschatzung
mOglicher Folgen solcher Experimente ermOglichen und die aufhebung dieses Verbots rechtfertigen”
(Enquete 1987:235).
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observation that such efforts are greatly constrained.4 6 Furthermore, the Report
recommends that the release of any large number of identical microorganisms - whether
genetically engineered or not - should require approval from the BGA with assistance
from the ZKBS and input from the Environmental Ministry (Umweltbundesamt). Risk
assessment in all events is to proceed on a “case-by-case” (Fall zu Fall) basis 4 7
3. Plants
The Report distinguishes between two categories of plants - wild plants and
crops. These differ according to their dependence on humans for propagation. With
regard to plants, the Report voices concern about possible genetic exchange between
plants and microorganisms,4 8 lateral genetic transfer to wild varieties4 9 or different plant
varieties,5 0 gaps in understanding with regard to “weediness,”5 1 the possibility for toxicity
4 6 “Inzwischen mufi durch das BMFT ein mittelfristig angelegtes Programm der Sicherheitsforschung
durchgefilhrt werden, um systematisch die Grundlagen und Kriterien zu erarbeiten, die eine Einschatung
des Risikopotentials gentechnisch veranderter Mikroorganismen und ihrer Wechselwirkungen mit einem
Okosystem erlauben. Die Erarbeitung eines solchen interdisziplinSren Forschungsprogrammes mufi
transparent erfolgen” (Enquete 1987:235).
4 7 “Die gezielte Freisetszung grofier Mengen identischer, gezielt gezOchteter Mikroorganismen mufi einem
Anmeldungs- und Genehmigungsverfahren unterliegen, das in den Sicherheits-Richtlinien festzulegen ist.
Die Anmeldungs- und Genenhmigungspflicht gilt filr Experimente mit Mikroorganismen, die Qberhaupt
nicht oder nur durch klassische Techniken verandert wurden, ebenso wie filr genetisch veranderte
Mikroorganismen, bei denen einselne Gene beseitigt wurden....Der Antragsteller mufi eine
Risikoabschatzung und eiune Risksobewertung vorlegen. Der Kriteerienkatalog mufi umfassen und der
jeweiligen Situation angepafit sein. Die Gewichtung der oben angegebenen Kriterien wird dabei von Fall
zu Fall verschieden sein” (Enquete 1987:235).
4 8 “In den letzten Jahren mehren sich aber die Hinweise dafUr, dafi der Gentransfer von Bakterien auf
Pflanzen und umgekehrt mOglich ist” (Enquete 1987:224).
4 9 “Eine grose Zahl von Wildkrautem ist sehr nhe mit Nutzpflanzen verwandt und hybridisiert leicht mit
ihnen” (Enquete 1987:225).
5 0 “Auf diesem Wege [Hybridisierung] kOnnen im Prinzip auch neue oder veranderte Gene ihren Weg aus
gentecnisch veranderten Pflanzen in andere Pflanze finden” (Enquete 1987:225).
“Welche Eigenschaften allerdings filr einen wildkrautartigen Wuchs verantwortlich sind, und ob sie -
gezielt oder zufailig - durch gentechnische Eingriffe verandert werden kOnnen, ist ungewifi” (Enquete
1987:225).
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in humans and other organisms,5 2 the hazards of possible increased herbicide use,5 3 and
the varying longevity of different variants.5 4
With regard to plants, the commission recommends that the ZKBS should be
notified of the intention to release a genetically modified plant, whether in a greenhouse
or in the field. Conducting a field release should require an applicant to provide the BGA
risk analysis of the possible environmental effects. The BGA should rely on advisement
from the ZKBS and the Biology Bundesanstalt, when reviewing such requests.5 5
4. Animals
The Report’s treatment of genetically engineered animals is brief. The Report
argues that deliberately released animals also pose hazards. The least hazardous release
involves large animals. The assessment of their hazard relies more on the potential that
animals may have on ecosystems, than on the hazard of the gene transfer itself.5 6
Because of these hazards, permission to release should vary according to the organism’s
“recallability” (Ruckholbarkeit). This results in three animal subcategories: 1. small
5 2 “Wesntlicher ist vielmehr die Frage - unabh&ngig von der ursprOngiichen Herkunft des Gens ob durch
das gentechnisch veranderte Genprodukt eine mbgliche toxische Wirkung filr Mensch oder Nutztier zu
erwarten ist” (Enquete 1987:236).
5 3 “Bei herbzidresistenten [sic] Pflanzen wird man selbstversandlich die Abbauprodukte des Herbizids
kennenlemed und auf ihre Toxizitat prOfen mOssen” (Enquete 1987:236).
5 4 “Bei der PrOfung zur Freisetzung gentechnisch veranderter Pflanzen wird zu beachten sein, ob es sich um
einjahrige oder mehijahrige Pflanzen handelt, da tnehijahrige generell bessere Verbreitungs- und
Oberlebenschancen besitzen” (Enquete 1987:236).
5 5 “Alle Experimente zur Erzeugung und zur Freisetzung gentechnisch veranderter Pflanzen mdssen der
ZKBS gemeldet werden. Experimente in Gewachshaus sowie experimentelle Anwendungen im Freiland
(small and large scale field tests) beddrfen der SicherheitsdberprQfung und Zustimmung der
ZKBS...Anwendungen im Freiland setzen eine Genehmigung des Bundesgesundheitsamtes nach AnhOrung
der ZKBS und im Einvemehmen mit der zustandigen Biologischen Bundesanstalt voraus...Der
Genehmigung filr die Anwendung im Freiland mufi eine Risksobewertung des Anwenders (z.B. des
Zdchters) insbesondere hinsichtlich Umweltvertraglichkeit und Toxizitat zugrundeliegen” (Enquete 1987:
237).
5 6 “Fremde Gene, die in tierische Organismen eingefQrt werden, bleiben grundsatzlich an diese gebunden.
Man kann davon ausgehen, dafi sie nicht auf andere Organismen abertragen werden... .Die gefahren der
Freisetzung genetischen veranderter Tiere liegen in erster Linie in den mfiglichen Okologischen
Auswirkungen” (Enquete 1987:236).
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animals (e.g., insects, worms, etc.), 2. Large animals that are independent of humans
(e.g., wild animals, fish.), and 3. Human-dependent livestock (e.g., cows).
The Report recommends that small animals be treated with caution commensurate
with that for microorganisms. The Report recognizes that genetic engineering of these
animals may not be devoted only to the enhancement of agriculture, but also holds
promise for eventual medical application. Because of this promise, the Report
recommends that release of large animals should require the approval of the ZKBS.
Further, this approval must follow an independent and interdisciplinary “risk/benefit” 5 7
analysis.
The chapter on deliberate release reaches several conclusions. First, because
earlier chapters lay out the potential benefits that may accrue from agricultural
biotechnology, deliberate release is seen as an important - and welcome - eventuality.
The Report simultaneously acknowledges the complications of assessing the behavior of
modified organisms in new environments. The goal becomes exploiting the benefits
while avoiding the costs of field testing genetically modified organisms. Toward this
end, the Commission establishes a precautionary position.
B. Elements of Contagion
Although the product of West German politics, the Enquete Report provides
powerful evidence of transnational regulatory contagion. This section presents that
evidence, and thereby provides further description of German biotechnology politics.
5 7 “...die Freisetzung genetischen veranderter grOBerer Wildtiere, die vom Menschen unabhdngig leben,
von einer Zustimmung durch die ZKBS abhdngig zu machen. Der Entscheidung der ZKBS hat eine
Risiko-Nutzen-Abwagung durch ein von der ZKBS unabhangiges interdisziplinar besetztes Gremium, dem
Okologen, Toxikologen, medizinische Hygieniker und Evolutionsbiologen angehdren soilen,
vorauszugehen” (Enquete 1987:232).
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/. The Impact o f American Perspectives
Part of the Enquete Commission’s organizational structure included a Secretariat,
analogous to the staff support provided to American congressional reports. Rainer
Hohlfeld was a member of this Sekretariat. Three years after release of the final Report,
Hohlfeld contributed an essay for a German publication exploring science and
responsibility. Within that article Hohlfeld notes that with regard to deliberate release,
Commission members confronted two competing positions: “On one side, the demand for
a total moratorium; while on the other, consideration of exclusionary cases when the
petitioner previously presented a risk analysis (the proposed American rules).”5 8 If he is
to be believed, Commission members saw their regulatory alternatives as framed on one
side by the American approach to field tests.
Each chapter from the Report provides a list of works cited. Presumably, these
texts helped shape the Report’s conclusions. The chapter on deliberate release includes
62 citations. O f these 62, a remarkably small number (4) are German-language
publications; the remaining 58 (or more than 93%) are English language publications.5 9
Of these, the large majority (44) are scientific journal publications (e.g., Nature, Science,
Proceedings o f the National Academy o f Sciences). While it is not surprising that
English-language science publications should be cited, their disproportionate
5 8 “Hier standen sich in der (Commission am Anfang zwei kontrire Positionen gegenQber: Die Forderung
nach einem totalen Moratorium einerseits sowie die Freigabe filr den Einzellfal! (‘case to case’), wenn
vorher der Betreiber eine RisikoabwSgung vorgelegt hat (der amerikanische Regeiungsvorschlag)”
Hohlfeld (1990:210).
3 9 Two of the four German citations might be described as tangential to deliberate release. One is a general
review of Botany (Lehrbuch der Botanik) and the other addresses weapons issues (Chemische und
Biologische Wqfferi). The other two citations are specifically related to the deliberate release issue, and are
chapters from a book, Die Ungekldrten Gefahrenpotentiale der Gentechnologie (The Uncertain Threats o f
Gene Technology).
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representation is somewhat surprising. It suggests the transnational effect English-
language scientific literature can have on framing regulatory perspectives.
The Report also cites a number of American governmental publications
concerning deliberate release.6 0 In particular, the US congressional testimony of two field
test critics - Martin Alexander and Francis Sharpies - appears in the Report’s citations.
Appearing in these same hearings were several witnesses who downplayed the hazards of
release; the Report does not reference these witnesses.6 1 In contrast, American
government publications generally omit reference to regulatory trends or events in
foreign countries.6 2
6 0 Citations include two separate hearings of the U.S. House Committee on Energy and Commerce and the
Office of Science and Technology Policy’s The Suitability and Applicability o f Risk Assessment Methods
for Environmental Applications o f Biotechnology, 1985.
6 1 For instance, in the publication horn which Sharpies and Alexander’s testimony is derived, Anada
Chakrabarty offers the following answer in response to a question from Rep. Al Gore: ‘ “What do you see
as the potential environmental damage, if any, that could result from the release of new organisms such as
the ones you are developing?’
‘I do not really see any potential damage to the environment because of the use of laboratory-
developed microorganisms. This is because these microorganisms are derived from Nature, and have been
changed in such a way that they can now ‘eat’ some toxic chemicals at an enhanced rate. No other genetic
changes have been conferred on them. Thus the newly developed bacteria are no different from their
natural parents in all other respects, and pose little additional danger to the environment.’” Ralph Hardy,
Director of Life Sciences at DuPont, offered a similar view that the Enquete Report ignores. In response to
the same question, Hardy offers, “The potential for environmental damage in the field of agriculture is
believed to be small or negligible, particularly if a controlled, stepwise, progressive program of releasing
new organisms into the environment is begun in the laboratory, moved with deliberate caution through the
greenhouse, and then followed by closely supervised limited field evaluations.” E. L Kendrick, Acting
Deputy Assistant Secretary for Science and Education at the USDA, responds to the same question, “No
unique potential dangers are envisioned by the introduction of new genetically engineered organisms into
the environment of the nation by private and/or public interests in the United States, as long as existing
oversight procedures are fully utilized” United States 1984a: (226 & 230 & 257, respectively).
6 2 An exception to that rule is International Biotechnology Competitiveness. The Office of Technology
Assessment produced a report entitled, Field-Testing Engineered Organisms: Genetic and Ecological
Issues. Released in May 1988, the report usefully synthesizes much of the scientific and regulatory debates
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2. The Green Dissent and Further Transnational Effects
The Enquete Commission enjoyed broad support across the German political
spectrum. Members of the CDU/CSU, FDP and SDP all endorsed its findings.6 3
Support, however, was not unanimous: on the eve of publication, the Greens demanded
the right to issue a minority report. The Greens’ 50-page dissenting opinion (hereafter
“Minority Report”) appears as an annex to the original Enquete Commission Report.
The Greens express uncompromising hostility to recombinant technology and
concerns for “genetic imperialism.” With specific regard to deliberate release, the
Green’s Minority Report advances a three-fold recommendation: 1) An unconditional
German ban, 2) Negotiation of a global ban, and 3) Formation of an international
commission to enforce a global ban.6 4 To arrive at their recommendations, the Greens
argue that 1) Engineered organisms possess genomes that would otherwise not emerge
through natural genetic exchange, 2) Their impact on ecosystems cannot be pre
ascertained, and 3) Their impact can be negative.6 5
The Minority Report specifically condemns the majority conclusions concerning
gene deletions. It argues that organisms engineered with a gene deletion pose hazards
similar to those engineered to possess novel genes. In making their argument, the Greens
of field-testing. The 150-page report devotes the space of one-page to foreign approaches to field test
regulation.
6 3 The goal of compromise among Enquete Commission members was alluded to later in Bundestag
discussion of the report.
6 4 “Deshalb empfiehlt die Fraktion DIE GRONEN dem Deutschen Bundestag, die Bundesregierung
aufzufordem, die Freisetzung gentechnisch veranderter Organismen ohne Ausnahme zu verbieten; jede nur
mOgliche Anstrengung zu untemehmen, um ein solches Verbot auch international durchzusetzen; die
Grdndung einer intemationalen DberprOfungskommission zu initieren, die die Einhaltung des Verbotes
Q berprU ft und bei Zuwiderhandlung Sanktionen in die Wege leiten kann (emphasis in original)” (Enquete
1987:328).
6 5 The Green position was supported by the Arbeitsgemeinschaft Okologischer Forschunginstitute. Its
director, Beatrix Tappeser (1990:17), rejects field tests altogether “Die Arbeitsgemeinschaft Okologischer
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reference the ice-minus debates then current in the United States. Specifically they cite
American studies linking ice-positive strains to atmospheric condensation. Since ice-
minus strains were designed to compete with - and crowd out - their ice-positive cousins,
critics feared that in addition to protecting crops, ice-minus could adversely affect local
condensation patterns.
The presumed hazardous link between ice-minus and precipitation patterns served
as Rifkin’s principal argument against its release.6 6 Rifkin was familiar to both
biotechnology proponents and opponents in West Germany.6 7 It should also be recalled
that European Greens were in contact with the Monterey Board of Supervisors (chapter
4). Given the Green dissent, this network apparently served a dual function. It first
served as a conduit for European intrusion into the American regulatory debate. It also
communicated the American regulatory experience back to the German regulatory
debate.
3. Fallout and Fears o f Contagion
At the time of its publication, the Enquete Report received coverage in the major
science journals.6 8 A month after this coverage, a letter appeared in the journal Nature by
Frank Young and Henry Miller. At the time Young and Miller were both officials at the
Forschungsinstitute sieht in der gezielten und durch die Produktion stattfindenden Freisetzung gentechnisch
veranderter Organismen groBe Gefahren filr Mench und Umwelt.”
6 6 “The benefits of introducing [ice-minus]...appear impressive. It’s only when one looks at the long-term
ecological costs that problems begin to surface. To begin with, the first question a good environmental
scientist would ask is what role does the naturally occurring P-syringae play in nature? The experts that
have studied this particular organism say that its ice-making capacity helps shape worldwide precipitation
patterns and is a key determinant in establishing climatic conditions on the planet” Rifkin (1985:49).
As one member of the ZKBS notes, “in the United States there is only one Jeremy Rifkin, but [in
Germany] there are lots of them and they are better organized” Dickman (1988:672). “One of the staff
advisers to the European Green Group [within the European Parliament] is Linda Bullard, formerly an
associate of Jeremy Rifkin and a member of the Genethisches Netzwerk” Dixon (1993:48).
6 8 See Nefife (1987:474).
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U.S. Food and Drug Administration, which enjoyed a secondary role in the regulation of
American field tests. Both were strong proponents of biotechnology in general and field
tests in particular, and both had represented the United States in preparing the OECD’s
1986 report on biotechnology.6 9
Despite Young and Miller’s position within the FDA, their letter does not respond
to any German proposals concerning food or drugs. Rather, their letter focuses
exclusively on the proposed West German field test moratorium. Young and Miller argue
that the German report failed to include analysis of numerous examples of deliberate
release, including EPA-licensed microbial pesticides, insects used for biological pest
management, the importance of non-indigenous crops for food and fiber, and microbial
applications for ore-concentration in mining operations. To accomplish these tasks, they
argue, the organisms in question required “genetic engineering.” They thereby assume
rhetorically that “genetic engineering” represents a change in degree not kind, an
assumption which the Enquete Commission rejects in its Report.7 0
Of particular interest is the manner in which Young and Miller frame their
concern. They argue that the proposed West German moratorium
6 9 The key OECD report (1986:64) lists Young as FDA Commissioner and Miller as an FDA Medical
Officer.
7 0 They claim as much in the letter “U.S. government agencies and the scientific community generally
view the techniques of new biotechnology as extensions or refinements of older techniques for genetic
manipulation” Young and Miller (1987a: 326). Ample evidence to refute this claim has already been
presented. One might suspect that Young and Miller misrepresent this view with their audience in mind:
after all, Nature is a British journal. Since they worry about the transnational effects of a German
moratorium, they may in turn be seeking to create their own transnational effects through the British
publication. Judging from their letter, and the report to which they respond, it would appear likely that they
did not actually read the German report This is because neither the report nor the letter makes reference to
the system of exclusions established by the Commission. Neffe (1987:474) reports that, “The release of
genetically transformed microorganisms must be stopped for five years and this moratorium should be used
for risk analysis and further research into possible ecological dangers.” He thereby failed to report the
system of exemptions from this moratorium recommended by the Enquete Commission.
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is illogical and regressive, and, if adopted, would debilitate important areas of
basic and applied research in West Germany. Moreover, adoption would send an
ominous, misleading message to regulators and others throughout the world that
all genetically manipulated microorganisms are hazardous. (My emphasis)
Young and Miller express concern not so much for the effect the moratorium might have
on German biotechnology, as for its possible effect on biotechnology regulation outside
West Germany. They are explicit in identifying the potential transnational effects the
German moratorium could have. In doing so, they articulate a simple formulation of the
contagion-hypothesis in the field test domain. According to Young and Miller, the
proposed German moratorium had implications for the global regulation of agricultural
biotechnology.
IV. Post-Enquete Commission Politics
The publication of the Enquete Report was the first step in developing German
biotechnology law. While the Report advanced some 170 recommendations, it remained
for the Bundestag to translate those recommendations into specific legislation. With the
Greens already dissenting from the Commission’s Report, the stage was set for a
substantial political confrontation.
A. The Tutzinger Forum
Because the Enquete Commission wrestled with a broad range of issues, an
equally broad range of interest groups participated in discussion of biotechnology. One
of these discussions took place in Tutzing between December 14-17,1987. The Tutzinger
forum assembled a variety of participants from scientific, political, medical, legal and
theological branches. Perhaps most prominently, Wolf-Michael Catenhusen, former
chairman of the Enquete Commission, participated in the forum.
7 1 Young and Miller (1987a: 326). (g l
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Conveniently, the forum's participants published their perspectives in an edited
volume. Unfortunately, several participants failed to provide their contributions in time
for publication. Most notable is the absence of the Green’s contribution to the forum.
Two elements stand out that are relevant for this study. First, both proponents and
opponents of field tests invoke developments in the United States to buttress their own
perspectives. Thus, Hubert Weinzierl, spokesman for the German Alliance for Protection
of Nature and the Environment (Bundfur Umwelt und Naturschutz Deutschland) invokes
passages from a book by Jeremy Rifkin during his condemnation of biotechnology.7 2
Alternatively, Peter Starlinger, spokesman for the German Research Society {Deutsche
Forschungsgemeinschaft), twice invokes the American National Academy of Science:
first, to defend a product-based approach to deliberate release, and second to defend field
tests of recombinant plants.7 3 Somewhat surprisingly, while West German activists
appear familiar with regulatory perspectives in the United States, they do not show
evidence of comparable familiarity with perspectives in neighboring European countries.
B. Debate within the German Parliament
With the results of the Enquete Commission before them, between June 1987 and
October 1989 the West German Bundestag wrestled with the recommendations. These
Bundestag proceedings are organized conveniently in a February 1990 publication from
the German government (Bundestag 1990). The parliamentary debate is dominated by
two trends. First, members from the CDU, CSU, FDP and SDP endorse the Report, and
congratulate one another on their difficult work and artful compromise. Second, Green
7 2 Weinzierl (1990:18).
7 3 Starlinger (1990:21 & 75).
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members continue to snipe at both the Enquete process and its product, adhering to the
position that genetic engineering poses such an important threat that all recombinant
activities should be suspended.7 4
Amid the many pages of testimony, several Bundestag members make explicit
reference to American regulatory decisions. During testimony only two months after the
April 1987 American ice-minus test, Chairman Catenhusen refers explicitly to these
events, noting that they mark the transition from concern for hypothetical releases to
concern for actual releases.7 5 Despite this familiarity, Catenhusen appears not to change
his mind with regard to the proposed moratorium. In his parliamentary testimony of 6
October 1989, Catenhusen speaks in support of the proposed five-year moratorium.7 6
C. Unauthorized Release - The European Community and Rhizobium Research
Much as the US experienced controversial releases before regulations were in
place to govern them, Europe experienced a similar eruption shortly after publication of
the Enquete Report. These controversies centered on a series of Rhizobium field tests in
Britain, France and West Germany in the summer of 1987. These tests intensified the
confrontation between the opposing sides to the German biotechnology debate.
7 4 “Wir wollen keinen Umgang mit Gentechnologie” Bundestag (1990: 17)
7 3 “Und gait, meine Damen und erren, die ErOrterung mflglicher Risisken bei einer gezielten Freisetzung
gentechnisch manipulierter Lebewesen fU r unser kosystem 1984 noch als hypothetische Erfirtung weiit in
der Zukunft liegender AnwendungsmOglichkeiten, so ist dieser Weg in den letzten Monaten in den USA
bereits eingeschiagen worden.” Catenhusen also refers to an Office of Technology Assessment study of
American attitudes toward genetic engineering. See Bundestag (1990:12 & 92). Reference is also made to
American gene therapy rules (100) and to Asilomar (107).
7 6 “Aber, meine Damen und Herren, es gibt auch Bereiche, in denen denkbare Nutanswendungen heute sehr
schwer zu bejahen sind, weil die mit ihnen verbundenenen flkologischen Risiken heute zum teil nicht
abschatzbar und deshalb nach unserer Berzeugung auch nicht verantwortbar sind. Das heifit, ob wir
irgendwann einmal gentechnisch manipulierte Mikroorganismen zu Zwecken der Umweltsanierung
einsetzen kfinnen, hangt doch davon ab, ob wir wirklich in der nahen Zukunft die Grundlagen schaffen
kOnnen, die es uns ermOglichen, eine qualifizierte Abschatzung des Risikos solcher Eingriffe in
Okosysteme vorzunehmen. Es ist die AufFasung der SPD-Bundestagsfraktione, daO die nicht rQckhoibare
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Rhizobium is a prokaryotic bacterium that has been used extensively in agriculture
for over 100 years.7 7 It provides an effective means of addressing the problem of
nitrogen-depletion in soil. Nitrogen is a key molecular component of proteins and nucleic
acid, and thus is an essential element of life. Although nitrogen is abundant in the form of
atmospheric gas, agriculture readily depletes soil of it. The depletion of soil-nitrogen
places limits on agricultural production. One way to address this limitation is to add
nitrogen directly to fields in the form of fertilizer.7 8 Another is to combine legumes and
Rhizobia in a crop rotation system. Rhizobia are able to “fix” - or add hydrogen - to
atmospheric nitrogen to form ammonia. Nitrogen fixation is an energy-intensive process.
To offset this catabolic requirement, Rhizobia enjoy a symbiotic relationship with
legumes.7 9 As the legumes grow, Rhizobia establish nodules on the roots of the legumes.
There, they provide a source of nitrogen in exchange for the legumes’ carbon-fixing
ability.
Because of nitrogen’s limiting role on agricultural production, the development of
superior Rhizobia strains was an early focus of agricultural biotechnology research. The
European Community (EC) was among those supporting such research. Beginning in the
Freistezung gentechnisch veranderter Mikroorganismen zur Zeit nicht vertantwortbar ist” Bundestag (1990:
93).
7 7 “The first pure cultures of Rhizobium isolated from root nodules and produced commercially were called
‘ Nitragin,’ patented by Nobbe and Hiltner in 189S, and manufactured by Meister, Lucius and BrOning at
Hfichst am Main in Germany in the late nineteenth century. Today throughout the world, 20 million
hectares of legumes are inoculated with Rhizobium each year and many scientists are working towards
improving the symbiotic performance of rhizobid' Hirsch and Spokes (1988: 11).
7 8 “Around 40 million tons of nitrogen fertilizer are manufactured each year, nearly all by the Haber-Bosch
process in which gaseous nitrogen and hydrogen are passed over a catalyst at high temperature and pressure
to form ammonia” Johnston (1989:103).
7 9 “The reason for this symbiosis comes back to the question of energy. The triple bond that joins the two
nitrogen atoms in a molecule of gaseous nitrogen is a tough one to crack. Just as there is a high energy cost
for the chemical production of ammonia, there is a high energy burden for the nitrogen-fixing bacteria.
Then the bacteria associate with carbon-fixing green plants, the result is a nice nutritional trade-off. The
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early 1980s the EC financed both basic and applied research through a series of multi
year “Biotechnology Action Programs.”8 0 European scientists working in France, Britain
and Germany, and financed by the EC, developed a strain of Rhizobium possessing the
antibiotic marker kanamycin. This marker could be used to track the persistence and
spread of Rhizobia after release. In March 1987 a small-scale release was quietly
conducted in a wheat and alfalfa field outside Dijon, France. In May 1987 a similar
release was conducted in a pea field in Bavaria, West German. Similar tests were
pursued in Britain.
News of these tests surfaced in the summer of 1987, igniting a firestorm of
controversy.8 1 The Dijon test was legal under French law, since permission was only
required of products intended for commercial sale. This test, in contrast, was designed to
generate scientific data on the fate of the bacteria and its plasmid-vector. French scientists
insisted that the release was entirely safe, while at the same time assured protestors that
the field in question would be sterilized after the test. When Green members from the
European Parliament became aware of the test, they demanded its immediate halt. While
not possessing the authority to demand unilaterally changes in a member state’s
plant gets its fixed nitrogen and the bacterium acquires the fixed carbon it needs for energy” Johnston
(1989: 105).
8 0 “The [EC] Directorate General for Science, Research and Development drafted proposals for the support
of biotechnology in Europe as long ago as 1977-78, but not until December 1981 was the Biomolecular
Engineering Program finally accepted. Actually launched in April 1982, the program is far less ambitious
than originally conceived” Stone (1983: 825). “The Council of Ministers of the member states of the
European Economic Community has agreed on a four-year research program in biotechnology, for 1985-
89. The price tag, S35 million, is a bit more than half what the EEC committee asked for in its six-point,
April 1984 program” van Kasteren (1985: 512).
8 1 Panesar and Knorr (1989:216-7).
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regulation, the MPs unsuccessfully claimed jurisdiction over the experiments because
they were financed by the EC’s research funds.8 2
The Bavarian test - led by Walter Klingmuller of the University of Bayreuth -
appeared to violate German restrictions against deliberate release, which at the very least
required authorization from the ZKBS. Klingmiiller disagreed, arguing that the German
definition of “genetically manipulated organism” included only those strains modified
using recombinant techniques in vitro] the rhizobium strain in question had been modified
in vivo, and therefore did not require authorization.8 3 West German Greens were incensed
by what they considered technical hair-splitting. They were further outraged to discover
that a September 1986 report to parliament from the BMFT asserted that no German
projects were under consideration “in which a proposed goal is to develop genetically
manipulated organisms for later release into the environment.”8 4 French authorities did
not review the test, but British authorities did, because their definition of genetic
manipulation included organisms derived through conjugation.8 5
8 2 Dickson (1987a: 357).
8 3 The in vitro/in vivo distinction is a technical difference. The in vivo technique involved three stages.
First, researchers selected a rhizobium strain from the test site. Next, they selected an E.coli strain
possessing a transposon-bearing plasmid. This transposon confers resistance to the antibiotics neomycin
and kanamycin, and therefore serves as a useful genetic marker. This E.coli strain can confer its plasmid-
bom transposon to the selected rhizobium strain via conjugation. After conjugation, the transposon
integrates itself in the rhizobium genome, thereby conferring resistance. This strain could then be released
and tracked. As this description points out, the released rhizobium strain was not the product of in vitro
recombinant techniques (e.g., the use of restriction enzymes to create a novel plasmid-vector for
introducing novel sequences into a bacterium). A technical account of the rhizobium experiment is
provided in Hirsch and Spokes (1988). Recombinant viruses have been similarly created in vivo: “[A team
at l/C Davis] crammed cells from a silkworm full with the two viruses and created recombinant strains of
AcNPV that could also infect silkworms” Coghlan (1994c: 15).
8 4 Dickman (1987:568).
8 3 Beringer (1988:169). In October 1986 Klingmdller organized and hosted the first meeting of all BAP-
contractors to discuss the risk assessment of genetically engineered microorganisms. According to his
introduction to the subsequent publication, “the important problem of regulating the release of genetically
manipulated organisms was covered at the meeting, with special attention to the experience in the USA, the
United Kingdom and the Federal Republic of Germany” (Klingmdller 1986 vi). Elizabeth Milewski of the
EPA represented the views of the United States. For the purposes of later study, it is worth noting now that
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D. Industry’s Increasing Frustration
These tests did little to diminish the already poisoned dialogue between West
German biotechnology proponents and opponents. In this same summer, the Bundestag
began considering the panoply of biotechnology recommendations the Enquete
Commission presented. This left the West German biotechnology industry in several
years of regulatory limbo. This was the case not only for field test research, but also
contained production facilities. Characteristic was the situation of a proposed facility in
Hesse to produce recombinant human insulin.
Recombinant insulin was one of the early biomedical successes of biotechnology.
Authorities in both the United States and Britain had permitted recombinant insulin
production since the early 1980s.8 6 In 1985, the German firm Hoechst initiated
construction of a similar plant in the West German Land of Hesse. Hoechst invested over
DM60 million on its Hesse recombinant insulin plant, which was ready to begin
production in fall 1987.8 7 In August 1987 Hoechst finally received permission to begin
production, but was challenged by a series of lawsuits. In September 1988, the
Bundestag revised the West German Federal Emission Protection Act so as to encompass
recombinant facilities. All proposals for recombinant facilities were consequently to be
the subject of public hearings prior to licensing.8 8 The September 1988 rule-change froze
biotechnology investment in West Germany. The problem with the revised emission
her paper explains that “For the immediate future, EPA will review submissions received under FIFRA and
TSCA on a case-by-case basis” (Milewski 1986: 186).
8 6 “Erst 1983 brachte der US-Konzem Eli Lilly das Produkt auf den US-Markt” Barth (1989:247).
8 7 The figure $60 million also appears. Here, I rely on FOhr (1989:227).
8 8 “Zum 1.9.1988 wurde die ‘Verordnung aber genehmigungsbedOrftige Anlagen’ 4.
Bundesimmissionschutzgesetz gedndert. Seitdem sind auch gentechnische Produktionsanlagen
genhemigungspflichtig. Vor dem Bau einer solchen Anlage muB daher ein Offentliches
Genehemigungsverfahren durchgefllhrt werden” FOhr (1989:227).
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regulations was that they did not provide clear guidance for the conduct of public
hearings. The lack of regulatory procedures worked to the advantage of biotechnology
opponents, who used the hearings both to stage public demonstrations and to force
recurrent delays in industrial investment.8 9
As the decade drew to a close, German biotechnology appeared on the ropes. The
regulatory fight had dragged on for five years. Domestic investment was at a stand still.
German firms were unable to find foreign investment partners. Young West German
molecular biologists sought employment opportunities abroad. Operating in this
environment became increasingly difficult even for the large West German chemical
firms interested in establishing themselves in the emerging biotechnology market.
In the face of this situation, West Germany’s large chemical firms began to shift
their biotechnology efforts abroad. BASF announced plans to open a biotechnology lab
in Cambridge, Massachusetts. Bayer announced plans to open its production facility for
recombinant Factor VIII in Berkeley, California. Hoechst announced publicly that it too
was considering its investment options outside Germany. These high-profile decisions
clearly communicated the chemical industry’s dissatisfaction with West German
regulation. The message was loud and clear, especially to Chancellor Kohl, whose
Q A
Bundestag district in Ludwigshafen is home to BASF headquarters.
The Kohl government found itself buffeted by environmental Greens whose
electoral strength they feared, and by industry, whose investment decisions were quickly
8 9 “There are few administrative guidelines on how the law should be put into practice, and this has resulted
in a kind of regulatory limbo. No new production facilities have been approved in the 8 months since the
amendment was passed.... One consequence of all this is that many companies have put on ice any
development plants that include the use of recombinant DNA techniques.” Dickson (1989: 1251).
9 0 Dickson (1989:1251-2).
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diminishing German participation in the global biotechnology race.9 1 In July 1989, the
Kohl government presented a draft gene law to the Parliament for consideration. The
proposed draft mirrors these competing political interests. Consequently, it retained
some of the more intrusive regulatory elements (e.g., public hearings for deliberate
release proposals), while relaxing others (e.g., strengthening the authority of the ZKBS at
the expense of individual Lander).
E. The German Courts
In November 1989 West German biotechnology was struck a critical blow.
Biotechnology proponents had petitioned the Land Administrative Supreme Court of
Hesse to review the legal standing of Hoechst’s proposed recombinant insulin plant. The
Hesse Court ruled that recombinant production lacked legal standing; consequently,
recombinant facilities could not be built and operated in the Federal Republic. The
Court’s decision was binding on all other West German Lander. The court decision
effectively suspended commercial biotechnology activity in West Germany.9 2
F. The Bundestag and the 1990 M Gene Law”
Within this environment, the cabinet’s draft law began its path through the
Bundestag. The institutional structure of the parliament and the cycle of German politics
9 1 The strength of the Greens appeared confirmed at the time by a strong showing in the June 1989
elections to the European Parliament. See “Greens Capture Europe’s Imagination” (1989:56S).
9 2 “A spokesman for Hoechst said the verdict was ‘frightening,’ adding that the company was ‘greatly
worried’ about the future of industrial genetic engineering in Germany.. ..‘The verdict is so shocking,’
[BASF spokesman Erdwig] Meyer said, ‘no one is going to invest in West Germany any more’” Bachtler
(1989:881). “Hoechst has invested an estimated $60 million in the plant” Dickman (1989b: 218). “The
pharmaceuticals company Grunenthal in Aachen wants to build a plant to engineer an anti-blood-clotting
substance called saruplase; Bayer in Leverkusen seeks approval for production of blood factor VIII, a
protein essential to haemophiliacs; and Hoechst’s subsidiary Behringwerke, in Marburg, is in the middle of
an approval process for its production of erythropoitin, a protein used as a growth factor for red blood
cells.... ‘Only legislation can decide whether or not gene technology can be used on an industrial scale,’ the
judges said in their verdict... because of the different dimensions and the quality of the risks connected to
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demanded action by May 13,1990, the date elections were scheduled in the West
German Land of Lower Saxony. A Green/SPD victory would erase the CDU/CSU/FDP
majority in the Bundesrat, the upper house of the Bundestag, complicating passage of any
biotechnology law.
Through Spring 1990 hearings reviewed the proposed “gene law.” Industry and
university researchers offered the law their tepid support, since they continued to face the
legal freeze imposed by the Hesse Administrative Court. Not surprisingly, Greens
emphasized biotechnology’s hazards and its ethical repugnance. Much as American
authorities had found it difficult to develop clear definitions of deliberate release, so too
did Bundestag representatives.9 3 The parliamentary hearing-process served to water-
down aspects of the gene law. Rather than have the Lander license deliberate release as
originally proposed, the proposed law centralized licensing in Bonn.9 4 Further, the
Bundestag scaled back the public-participation in licensing decisions, though it remained
in place for deliberate release licenses.9 5
gene technology.’ The new verdict redoubles pressure on the West German parliament to pass a new law
that regulates research and industrial use of gene technology” Zell (1989b: 19).
9 3 “Although he was glad that the release of genetically engineered organisms into the environment will be
allowed under the new law, [Vice President of the Deutsche Forschnggemeinschaft Emst-Ludwig]
Winnacker warned that the law does not distinguish between different types of release” Dickman (1990b:
298).
9 4 “Most decisions will remain with the states, but in a change to the bill that has now passed the committee
state, the federal government in Bonn will approve the licensing of any release of genetically modified
organisms and the marketing of products containing them” MacKenzie (1990a: 28).
9 5 “[The bill] cuts out many provisions for public debate that appeared in earlier drafts. Greens and
opposition socialists disapprove strongly of the bill, saying that it has been changed completely by the
government since public hearings in January...public debate is also required for the deliberate release of
GMO’s for commercial but not research purposes. These public deliberations carry no clout The law
enlarges the ZKBS, which has supervised genetic manipulations in West German so far, and gives it legal
status” MacKenzie (1990b: 17).
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On May 11,1990 the Bundesrat approved the gene law providing West Germany
with legal regulations governing recombinant activities.9 6 The vote was cast along party
lines, with unanimous support from the CDU/CSU/FDP coalition, and rejection by the
SPD and Greens. Two days later, Greens and the SPD captured sufficient votes to seize
control of the weaker Bundesrat. Passage of the gene law appeared to clarify the status
of recombinant activities in Germany, and to open the door both to deliberate release and
to the enclosed production of recombinant products.9 7
If industry and academia thought their problems were behind them, they were
mistaken. The gene law created enormous headaches for both. Molecular biologists
pursuing recombinant research found the regulatory system to be essentially unworkable
in practice. Scientists with decades of experience found themselves required to attend
courses on lab safety. The notifications required to conduct experiments which the
regulations treated as “safest” (SI) ran hundreds of pages. The exodus of young German
molecular biologists - and investment capital - resumed.9 8
By 1993 the mood in Germany had shifted. Industry, scientists and the majority
CDU/CSU became increasingly alarmed by the vanishing advantage once claimed for
9 6 Among the provisions: “Deliberate release of micro-organisms or genetically altered plants will be
subject to approval by ZKBS without a public hearing. Companies or institutions releasing gene-spliced
materials will be held responsible for damage to the environment beyond normal liability under civil law,
up to a ceiling of DM 160m, and for damage to health up to DM 200” Williams (1990:34).
Last week, the local government in Cologne approved the construction of a production plant at the
company GrOnenthal AG in Aachen that will use genetically-engineered bacteria to produce the anti
clotting drug Saruplase. And in Frankfurt, the passage of the so-called ‘gene law’ led to a swift retreat of
local activists who had appealed to the courts to prevent operation of a nearly completed pilot plant at
Hoechst AG that will produce human insulin from Escherichia coli bacteria” Dickman (1990a: 60).
9 8 “Just like the familiar guidelines of the National Institutes of Health, [German law] divides experiments
into four categories, from S1 to S4, based on the known or predicted pathogenicity of the organisms in the
experiment.... Scientists registering SI labs must provide the same detailed information about lab
installations - for example, positive air pressure - as those working in S3.... Some researchers protest that
regional differences in enforcement constitute another serious problem, and that the differences are not
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German biotechnology. To make its own case, DECHMA released a report touting the
benefits of biotechnology using rhetoric that played on the popular Single European
00
Act. Concomitantly, German Greens suffered political setbacks. Kohl’s government
spoke increasingly publicly about the need to revisit both German and European
deliberate release rules.1 0 0
In December 1993, the Bundestag relaxed important aspects of the gene law
governing deliberate release. Greens remained the only party opposed to the change, the
SPD having dropped its support for stringent biotechnology regulation. SPD support for
the changes was critical because of the country’s majority in the weaker Bundesrat.
When last minute changes were made to the rules governing deliberate release, SPD
threatened to scuttle the entirety of the changes, reflecting continued sensitivity on the
subject of deliberate release.1 0 1 Despite this threat, they backed off when the bill was
voted upon.1 0 2 The revised regulations reduced the paperwork required to pursue
recombinant experiments and eliminated the requirements for public hearings that had
thwarted deliberate release petitions. Industry and academia greeted the new measures
scientifically based but represent officials’ own interpretations of the law, fearing of making mistakes, or,
worst of all, local political attitudes” Kahn (1992: S23 & 4).
9 9 “Pro Gentechnik countered the ‘risks of biotechnology’ with ‘the risks of no biotechnology,’ and
highlighted the economic consequences for ordinary German people. It also argued that more political and
fiscal incentives were needed to slow the continuing German biotechnology diaspora” Ward (1995b: 1049).
The Single European Act was bolstered by a report entitled, The Costs o f Non-Europe.
1 0 0 “Josef Rembser, head of biotechnology at the Ministry of Research and Technology, says the
government wants to relax both the German law and the Community directive. At a meeting in Brussels
last month, Rembser said: ‘The R&D emigration issue is alarming’” MacKenzie (1993:5). The title refers
to a confidential report to the Bundesrat suggesting that the fear of German industrial exodus was
overblown. Given the imminent change in German gene laws, it would appear to have had little effect.
1 0 1 “Only a few days before the bill appeared in Parliament, the Christian Democrats added a further clause,
which had not been discussed with the opposition parties, allowing the release into the environment of
genetically modified plants without a public hearing. This move...caused most Social Democrats to
abstain from the final vote in the Bundestag” Abbot (1993:684).
1 0 2 “Field experiments with genetically modified organisms which may now proceed without a public
hearing...” Abbot (1994:210).
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enthusiastically, and field test activity accelerated significantly after 1993. Prior to the
regulatory change, only 3 releases had been authorized in Germany.1 0 3
After abandoning its stringent regulations, reports of German biotechnology
turned 180 degrees. Whereas before, accounts questioned whether the German
biotechnology industry could survive, reports began to hail Germany’s renewed strength
in biotechnology.1 0 4 Even German Greens moderated their total opposition to
biotechnology, seeing in it the promise of new drugs to combat AIDS and cancer,
although they retained their hostility to its agriculture applications.1 0 5
V. Conclusion
Although the history of American regulation demonstrated that field tests were an
activity shrouded in controversy, the controversy generated in the United States cannot
compare to that set loose in the Federal Republic of Germany. German recombinant
politics included proposals for a moratorium, bombs threats, protests and pressure.
Several factors distinguish German field test regulation. First, it represented a legislative
approach to the issue. That is, the Bundestag established a review commission to design
recommendations specifically for biotechnology legislation. It formulated law based on
those recommendations with input from a number of domestic actors, including the
religious leaders, academics, industry and environmentalists. The Reagan administration
had studiously avoided this approach; viewing developments in Germany would provide
some satisfaction in having done so.
1 0 3 Simm (1994:23).
1 0 4 The government allocated $840 million in annual funding for biotech research despite the economic
pressures of reunification. Miller and O’C. Hamilton (1995). Edington (1996: 13).
Williams (1997).
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Furthermore, the German case is marked by the participation of strong
biotechnology opponents. The presence of Greens added a political dimension to the
German fight absent from the other two cases presented in this study. This is obviously
an important domestic variable. To complicate matters, the field test issue was only one
part of a broader Bundestag effort to address biotechnology in toto.
Despite these unique characteristics, several instances of transnational regulatory
contagion are clear. Kohl’s government sought to legitimize its own deregulation efforts
with reference to OECD recommendations, which themselves largely reflected the
American approach. Members of the Enquete Commission viewed their alternatives in
terms of the American case-by-case approach versus a moratorium. Their Report is most
marked by the presence of abundant foreign - and especially American - citations to
support its conclusions. At various stages, both opponents and proponents used
developments in the United States to bolster their position. These political battles set
back the German biotechnology industry by several years.
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Chapter 6 - The British Case Study
I. Introduction
Britain provides the final case for qualitative consideration. There are reasons to
assume that Britain and the United States might exhibit regulatory contagion. Linguistic
affinity is one obvious reason. Another is the cultural and historical affinities the two
countries share. Watson and Crick’s 1953 elucidation of DNA’s helical structure
symbolizes the academic and research ties in molecular biology binding the two
countries. And with specific regard to the early recombinant era, chapter 1 documents
interactions between American and British scientists dating back to the 1970s.
Another factor makes this a potentially easy case study for investigating the
contagion hypothesis. As previously noted, Germany and the United States both enjoy a
federal institutional system. This helps to “control” somewhat for institutional variation
when studying the two countries. In contrast, the British system is characterized as
institutionally centralized, setting it apart from both Germany and the United States. At
the same time, however, the cultural differences between the United States and Britain
are relatively minimal, especially when compared with other possible dyads among
OECD members. This political cultural sympathy was especially strong through the
1980s, when Reagan and Thatcher dominated their respective countries.1 Given these
factors, the effort to document transnational regulatory contagion would sensibly direct
inclusion of the British case study.
1 “Like the Reagan administration, the Thatcher government aimed at providing a social environment that
placed minimal restraints on the activities of private industry” Susan Wright (1994:63). Wright provides a
thorough account of the early recombinant era in Britain.
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II. The British Institutions Governing Recombinant DNA Research
As Chapter 1 documents, the British were at the forefront of efforts in the early
1970s to regulate the new recombinant techniques. The Ashby Report of 1975 led to
establishment of the Genetic Manipulation Advisory Group (GMAG) in 1976 and
publication of the Health and Safety Regulations Governing Genetic Manipulation
published in 1978. The British recombinant regulation served as one of two models for
national regulations around the world. Similarly to the American rules, British rules
forbid the deliberate release of genetically engineered organisms.
Susan Wright (1994) argues that when compared with the American rules, British
biotechnology regulation has always expressed an elevated concern for worker health.
Thus, since the early days, workers groups have been represented on the British boards
overseeing recombinant DNA research. The British Health and Safety at Work Act of
1974 empowers the Health and Safety Executive (HSE) to serve a laboratory notice if
activities there threaten human health or safety. This act was available as a means to
prohibit release in some cases (RCEP 1989 ch. 7, paras. 4-5). One limitation of this act,
however, is that it cannot be applied to threats against the environment.
The British approach to regulating rDNA research served to maintain the country
on the leading edge of commercial development through the late 1970s and early 1980s.
Much as laboratory research in the United States enjoyed a period of gradual
deregulation, so too did British recombinant regulations gradually loosen. In addition to
changing research regulation, authorities overturned previous limitations so as to
facilitate the emergence of industrial scales. By the mid-1980s, the British biotechnology
industry was considered second only to the American industrial effort.
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By the mid-1980s, British authorities confronted a growing expectation that
biotechnology would expand into the agricultural realm. To prepare for this eventuality,
in 1984 the Health and Safety Commission (HSC) reorganized the GMAG, and
established in its stead the Advisory Committee on Genetic Manipulation (ACGM). In
addition to 8 scientific members, the committee included 5 employer representatives and
5 employee representatives.
From the outset, the ACGM confronted the deliberate release issue. It
immediately directed a working group to prepare deliberate release guidelines. Upon
their completion, both the ACGM and HSC approved the guidelines, and released them
in April 1986. The initial guidelines required that parties interested in conducting a field
test notify the HSE before doing so. As part of the notification process, the guidelines
required petitioners to submit a pre-release “risk assessment.” This would initiate the
HSE’s case-by-case review of the proposal. The HSE formalized the working group that
had developed the April 1986 rules, and renamed it the Planned Release Sub-Committee
of the ACGM (hereafter, Sub-Committee).
The Sub-Committee’s functions were to review individual field test proposals and
to advise HSE about deliberate release guidelines in general. When making its review,
the Sub-Committee was to consider not only human health hazards (as had been HSE’s
restricted perspective), but also environmental concerns. Consequently, the Sub-
Committee included representatives from the Department of Environment (DoE), the
Ministry of Agriculture, Fisheries and Food (MAFF), the Department of Health, the
Nature Conservancy Council and Natural Environmental Research Council. In 1989, the
Sub-committee’s designation was changed to the Intentional Introduction Subcommittee.
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In addition to the HSE Sub-Committee, the Department of the Environment
established its own Interim Advisory Committee on Introductions (IACI). DoE
instructed the IACI to advise it on the environmental risks of proposed releases. While
the HSE’s Sub-Committee included broad representation of parties involved in deliberate
release, IACI membership was limited to experts from associated scientific fields. In
April 1990, soon after publication of a Royal Commission on Environmental Pollution
(RCEP) report, discussed at length below, these two separate committees were united
under a single entity, the Advisory Committee on Releases to the Environment (ACRE).
ACRE continues to oversee deliberate release activity.2
III. The Roval Commission on Environmental Pollution
In 1970 the British established the Royal Commission on Environmental Pollution
to advise the government on environmental issues.3 As the British ministries concerned
with biotechnology reorganized themselves institutionally, in 1986 a Royal Commission
on Environmental Pollution (RCEP) began review of “the release of genetically
engineered organisms into the environment.” Members of the RCEP initially believed
that the report would require 1 to 2 years to complete, but found the issue sufficiently
complicated to extend the review into a third year.4 The RCEP is analogous to the
Enquete Commission’s work in that it provides regulatory recommendations for
parliamentary consideration; it differs, however, in that its attention is limited to
deliberate release. In July 1989, the RCEP presented its report, setting out its findings
2 For a discussion of the evolving committee landscape, see RCEP (1989: ch 7, “The Present Framework of
Regulation”). See also Beringer (1991:59-61). Beringer originally chaired the PRS, and currently serves
as Chairman of ACRE.
3 Gottweis (1998:293).
4 Newmark (1989b: 84).
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concerning deliberate release. The RCEP provides the government’s most thorough
treatment of deliberate release, and therefore merits substantial attention.
Several conceptual similarities link the RCEP’s report to those previously
considered in this study. The RCEP - among others - equates risk with hazard, and
contrasts risks with benefits.5 This conceptualization appears as universal as it is
misguided. The RCEP acknowledges that other countries were addressing the deliberate
release issue.6 In addition, the RCEP consciously expresses the hope that its
recommendations would enjoy a regulatory impact beyond Britain. This belief - echoed
by American, German and British officials - is important for a study of regulatory
contagion, because it indicates that authorities themselves believed their regulatory
decisions would have an impact beyond their national jurisdictions.
A. Sources of Contagion
The RCEP acknowledges that its study benefits from consideration of foreign
approaches to deliberate release. At some points it emphasizes its concern with European
5 The following citations cite the chapter and paragraph from the Royal Commission on Environmental
Pollution, The Release o f Genetically Engineered Organisms to the Environment (London: Her Majesty’s
Stationery Office), 13d 1 Report, July 1989. “As in many other fields of technological innovation, potential
benefits bring potential risks” (ch.l para. 3). This rhetoric is seen throughout British scholarship on
biotechnology. For example, “the term ‘risk management’ usually denotes a procedure for keeping risks
within acceptable limits, while balancing risks with benefits” Levidow (1994:273). David Bishop claimed
his caterpillar releases (discussed below) were “without detectable risk” “Britain Awaits Verdict (1989:
29).
6 “We have considered the national and international dimensions of the problem and the legal implications
[of deliberate release]” (ch.l para. 4). “Many countries are examining the impact that genetic engineering
may have on their commercial future, environmental well-being and society. The European Community
and the Organization for Economic Co-operation and Development are developing legislation and
guidelines for their member states in an attempt to achieve consistent approaches. United Nations agencies
are involved in promoting the technology of genetic engineering and the assessment of its safety” (ch. 1
para. 7).
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field test developments.7 But elsewhere it emphasizes a preoccupation with American
developments, noting
During the course of our study a number of authoritative reviews have been
published of the risks associated with the release of GEOs. These include a
statement by committees of the International Council of Scientific Unions, and
reports by the United States National Academy of Sciences, the US Congress
Office of Technology Assessment, the Ecological Society of America and a
number of others.8
One can infer from the footnotes what these “other” reports are, several more of which
are also American.9 The OECD offers a final source of regulatory contagion. Reports at
the time suggest the RCEP was basing its own perspective in large part on analysis
conducted by the OECD.1 0
As the last chapter shows, German governmental documents cite English-
language publications on deliberate release. Similarly, the RCEP indicates that it too has
benefited from reviewing the work of others. Rather than reinvent the wheel, British
authorities familiarized themselves with the analysis of their foreign - and especially
American - colleagues.1 1 Since publication of the RCEP post-dates the Enquete
7 “We also make proposals for allowing the maximum disclosure of information to the public and for
minimizing the risk of damage from accidental release of GEOs. In doing so we have noted developments
internationally, especially in Europe” (ch.l para 10).
8 (ch.5 para. 2).
9 These are Report o f Commission ofEnquiry on Prospects and Risks o f Genetic Engineering, German
Bundestag, 1987; M. Mellon, Biotechnology and the Environment, National Biotechnology Centre and
National Wildlife Federation, USA, 1988; M. Sussman et al., Proceedings o f the First International
Conference on the Release o f Genetically-engineered Micro-organisms, 1988; and J. Hodgson et al.,
“Planned Release of Genetically Engineered Organisms,” Trends in Biotechnology, 1988.
1 0 “In the next few weeks, a major report should appear by the Organization for Economic Cooperation and
Development in Paris on ‘safety considerations in the use of recombinant DNA.’ It is said to by those who
have seen it to be a ‘very reassuring report,’ arguing that risks are small. Britain is expected to base its own
guidelines on the OECD recommendations” Walgate (1986:297).
' 1 Elsewhere, the RCEP emphasizes the United States when cataloguing foreign experience with deliberate
release. “The interest of governments world-wide reflects concerns about the release of genetically
engineered organisms. In the USA action by local and national groups has delayed or prevented some
release experiments, Denmark exerts tight statutory controls on releases of GEOs and a report to the West
German Parliament has recommend a moratorium on the release of certain genetically engineered micro-
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Commission by two years, it is not surprising to see the latter’s findings included in the
analysis.
B. Regulatory Differences
Despite its reference to a number of foreign sources, the RCEP draws some
conclusions that distinguish it from other reports. Five important differences are
highlighted here: process-based sympathies, the goals of release, the status of gene
deletions, the analysis of viruses and the analysis of protoplasts. Each of these topics is
treated in turn.
1. Product v . Process Based Analysis
As noted earlier (chapter 3), the product v . process debate has been referred to as
biotechnology’s “seminal issue.”1 2 While the RCEP does not explicitly frame the
discussion in terms of product and process, it does allude to the issue at several points.1 3
The conclusion provides the strongest statement concerning this distinction: “Genetic
engineering allows genes from almost any organisms to be introduced into almost any
other organism, regardless of sexual compatibility or evolutionary relationship. In this
respect it is qualitatively different from traditional breeding techniques” (11.6, my
emphasis). Because of this qualitative difference, the RCEP recommends an “initially
cautious approach” to deliberate release.1 4 On this point, the RCEP articulates greater
organisms. In a number of countries including the UK, voluntary systems of control directed specifically at
the release of GEOs have been introduced to supplement existing product and other controls” (ch. 1 para. 8).
1 2 Miller (1997: ch. 1).
1 3 Science reporters at the time picked up on this: “[The report] says that genetically engineered organisms
cannot be treated simply as products. The central thrust of the report is that the government... must take
account of the process used to produce a genetically engineered organism as well as of the organism itself.”
Watts (1989a: 32).
1 4 “As large gaps still exist in knowledge about behaviour of organisms in the environment, an initially
cautious approach, taking account of the ingenuity that scientists will apply in the development of new
organisms, is the responsible way forward” (ch. 11 para. 23). This quote would further suggest that the
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affinity for German precaution, and stands in contrast to the American and OECD
positions on agricultural biotechnology.1 5
Tait, a British scholar of biotechnology, downplays the RCEP’s distinction
between product and process. To make her point, Tait purports to review reports from the
RCEP, the American National Research Council, the Ecological Society of America and
the National Academy of Sciences with regard to the product and process issue.1 6
Among other errors of analysis, she concludes that there is little disagreement among
these reports with regard to the product v. process distinction. The RCEP’s “extra degree
of scrutiny” clause (11.30) refutes this claim. Tait further argues that product and process
differences “may be based more on rhetoric than on reason and scientific principle.” This
is substantiated neither by the reports she references, nor by the definitions she provides.
Rather, they represent basic assumptions made before risk analysis proceeds.1 7 In
RCEP favors a process approach to risk analysis, since it emphasizes “the ingenuity that scientists will
apply.” These would appear to apply to processes, though the passage is sufficiently vague so as to be
debatable. Elsewhere, the RCEP suggests that recombinant organisms should be considered guilty until
proven innocent: “The extent to which genes, especially novel genes, may spread to other organisms is an
important uncertainty in assessing the risks in the releases of GEOs. It will be prudent to begin with the
assumption that an introduced gene could spread widely and then to challenge that assumption” (ch.l 1
para. 20). The problems of proving a negative have already been addressed.
The U.S. National Research Council (1989:124) study of biotechnology asserts: “The [proposed]
framework is product- rather than process-oriented, focusing on the properties of the microorganism rather
than on the methods by which it is obtained.” The OECD (1986:31) also takes the position that “any risks
associated with applications of rDNA organisms may be assessed in generally the same way as those
associated with non-rDNA organisms.”
1 6 “A process-based approach can be defined as one where: (i) all products derived from the process of
genetic manipulation, and designed to be released into the environment, are considered to have the potential
to give rise to a unique range of environmental hazards, not possessed by previous generation of products;
and (ii) we need to devise new types of environmental oversight and regulation to ensure that any products
giving rise to such environmental hazards are excluded from further commercial development A . product-
based approach is defined as one where: (i) it is assumed that GMOs do not present any unique
environmental hazards arising from the process by which they were developed; and (ii) any environmental
hazards that they do possess can be regulated effectively by die existing systems set up to deal with foods,
drugs and pesticides” Tait (1990:187 & 9).
1 7 “Superficially there would not appear to be a scientific consensus about the level of scrutiny required for
the field testing and regulation of GMOs. Nevertheless, each of the above reports [RCEP, NRC, NAS,
ESA] does claim to favour a product-based rather than a process-based approach to biotechnology
regulation. The product-based concept appears to have originated in the United States, partly as a result of
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contrast to Tait, Miller and others highlight the difference between the British/European
and the American/OECD concern with biotechnology products and processes.1 8
2. Gene Deletions
Levidow, another scholar of British biotechnology, emphasizes that when the
RCEP recommendations were translated into regulations, these were strongly “process-
based,” and therefore, “precautionary.” This element sets apart the British regulatory
approach.1 9 This precaution is further echoed by the RCEP’s discussion of modified
gene-deletion organisms, such as ice-minus. On the issue of gene deletions, the RCEP
observes that,
It is sometimes argued that organisms that have had a gene deleted by genetic
engineering should be considered as safe because gene deletions occur commonly
in nature. We do not share this view. A deletion could profoundly alter the
behaviour of an organism. For example, deletion of a promoter, enhancer or
suppressor could alter the extent, timing and location of the expression of a gene.
(5.17)
While the RCEP does not specifically cite those who argue that deletion-organisms pose
minimal hazard, there are several obvious candidates. AGS argued the ice-minus release
was especially safe because it constituted a gene deletion. Steve Lindow from the
University of California testified before Congress that gene deletions were “not
fears that the emerging biotechnology industries would be stifled by draconian regulation. Fiskel and
Covello (1986: xi), for example, refer to the formulation of a framework for the regulation of
biotechnology that is directed at the product, and not the process of recombinant DNA... The argument for
a product-based approach within the United States appears to be largely uncontested [!]. In Europe the
situation is still fluid, with both cases being argued much more vigorously. However, the argument may be
based more on rhetoric than on reason and scientific principle, and in practice, there may be little difference
between systems claiming to be product-based and those claiming to be process-based.” Tait (1990)
ignores 4 years of regulatory battle in the American case.
‘Industry spokesmen are critical not only of specific rules, but also the underlying regulatory philosophy
adopted by the EC, in which genetically engineered products are considered as a special category. They
contrast that approach with the one they perceive in the United States...” Balter (1991:1367).
1 9 “The UK established a statutory procedure for issuing ‘consents’ (licenses) for GMO releases, as part of
the 1990 Environmental Protection Act Part VI. The act’s precautionary terms went beyond even those of
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inherently hazardous.”2 0 The Reagan administration’s December 1984 Coordinated
Framework provides an exclusion for gene deletion-organisms based on their presumed
“safety.”2 1 The May 1986 OECD publication on biotechnology safety considerations
argues that gene deletions merit less concern than other possible modifications.2 2 In
October 1986 the American RAC relaxed the rules governing release of gene deletions.2 3
The Enquete Commission also considered gene deletions to be less hazardous than other
modifications, ceteris paribus.2 4 Thus, the RCEP reaches conclusions concerning gene
deletions that differ from those of both the Americans and the Germans.
the EC Deliberate Release Directive. For example, the 1990 Act.. .adopted an even broader process-based
definition of GMOs” Levidow (1994:278).
2 0 “Deletion engineering, the removal of specific DNA sequences by recombinant techniques... in our
opinion should not be inherently hazardous” (U. S. Congress 1984a: 68).
2 The BSCC definition of a new organism encompasses ‘those organisms deliberately formed to contain an
intergeneric combination of genetic material’.... The definition of a new organism excludes intergeneric
genetic material ‘that is well characterized and contains only non-coding regulatory regions’ such as
promoters and terminators.... The lack of agency review of gene deletions also troubles some outside
observers” Gibbs (1986:690).
2 2 “Compared to other kinds of manipulations, the use of a deletion technique would ordinarily suggest
lesser concern about safety since a deletion typically makes smaller and more precisely defined changes,
while also typically enfeebling the organism, and no new genetic information has been added to the
parental organism. Deletions are also likely to mimic mutations that occur in organisms naturally.
However, appropriate consideration should be given to the possibility of the expression of unanticipated
functions particularly in the case of other types of modifications” OECD (1986:26).
2 3 “RAC stopped reviewing laboratory research with such engineered microbes years ago, and now claims
there is not scientific basis for discriminating against the deliberate release of recombinant organisms
whose minor genetic alterations could arise through natural processes. The committee determined that
deletions and rearrangements of non-chromosomal or viral DNA would not pose a risk any greater than that
introduced by recombination in nature. Investigators wanting to release such organisms into the
environment need no longer notify the RAC of their intentions. But most experiments will still require the
scrutiny of other regulatory agencies [e.g., EPA, USDAJ” Wright (1986:480). “Professor William Jarrett
of Glasgow University, a leading researcher in vaccine research, has severe apprehensions about his former
plans to engineer a hybrid HIV-adenovirus vaccine because he now believes that there is alarming evidence
which indicates that such an approach to vaccine development is potentially extremely hazardous. The
deletion of portions of the adenovirus genome in order to insert H T V antigen genes creates a strain of
adenovirus which has proved to be more virulent than its unadulterated parent strain. This is an instance
which illustrates that deletion mutants cannot be assumed to be less harmful than their parent strains.
Clearly this calls into question the regulatory decision in the USA that gene deletion mutants should no
longer be referred for higher review” Wheale and McNally (1988:172).
2 4 “Ein wichtiger Parameter wird die Art der genetischen VerSnderung sein. In diesem Zusammenhang
sind die Deletion eines Gens oder die erhote Expression eines bereits vorhandenen Gens anders zu
berwerten als die EinfOrung von Genen, die die Organismen zu Leistungen befthigung, zu denen sie
normal weise niemals gekommen wSren....Ein Beispeil dafhr waren durch genetische Eingriffe hergesteiite
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3. Protoplast Fusion
It will be recalled that protoplast fusion is one method for creating plant varieties
with novel genotypes. The RCEP takes a more precautionary position with regard to
protoplasts than other committees. The RCEP distinguishes between two classes of
protoplast fusion - those that are intraspecies and those that are interspecies - noting that
the latter generates organisms otherwise beyond the scope of traditional crossbreeding.
The RCEP makes clear that protoplast fusion - like gene deletions - deserves regulatory
attention similar to that accorded recombinant techniques.2 5 Consequently, one of the
first release proposals ACRE reviewed was a potato plant derived from a cell fusion
between two species of potato.2 6 Beringer, head of ACRE, notes elsewhere the
distinction between the US and Britain with regards to protoplast fusion, and therefore
indicates his familiarity with American guidelines.2 7
4. Exotics
The RCEP also employs the metaphorical comparison between crossbreeding and
biotic invasions. The RCEP distinguishes between genetically engineered organisms
whose non-engineered cousins would be considered “exotic,” and genetically engineered
organisms whose non-engineered cousins would be considered native. This suggests
“Eis-Minus”-Bakterien, wenn sie sich von den als Wildtyp betrachteten “Eis-Plus”-Bakterien durch eine
bloBe Deletion des Gens ftlr das an der Eiskrystallbildung beteiligte Protein unterschieden und dardber
hinaus als solche auch in der Natur vorkfltnen. Deren Freisetzung mQflte analog zur Freisetzung
konventioneil verSnderter Mikroorganismen bewertet werden” Chancen und Risiken (1987:234).
2 5 “We consider that the use of protoplast fusion by traditional plant breeders is not in itself sufficient cause
for excluding it from the coverage of our definition [of genetic engineering]” (ch. 2 para. 14).
2 6 Beringer (1988:174).
2 7 “Protoplast fusion in plants....is not considered to be genetic engineering in the USA, and thus the
experiments listed can be done without regulatory approval there. The UK position to date is that it is
better to cast the net too wide at this stage than to be too lax” Beringer (1991:61).
2 8 “If a genetically engineered organism were released into an environment in which the unmodified
organism was not native, experience with exotics could be highly relevant” RCEP (1989:21).
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that exotics differentiate into two separate categories. The difference between genetically
and non-engineered strains is used to worry about the potential effects on research.2 9
Like others, the RCEP notes that exotics might provide a useful metaphor for
contemplating the unwanted effects from deliberate release. To evaluate the biotic
invasion metaphor, the RCEP relies on a literature review published in the journal,
Swedish Wildlife Research. What stands out in the RCEP’s discussion of exotics is the
reliance on examples from the British Commonwealth. Among these are in Britain
Rhododendron, Dutch elm disease, pine blister rust, and Myxoma virus for rabbit-control;
Nile Perch in Lake Victoria;3 0 in Australia the grass Vulpia and rabbits; and in South
Africa a species of Hakea, pine trees and acacias into the Cape Floral Region. It should
come as little surprise that the discussion of exotics should rely mainly on those with
which a British MP might be familiar (as opposed to the Zebra mollusks of the Great
Lakes). It does, nonetheless, provide a biased sample (4.19).
The RCEP relies on another review of non-native introductions into the British
Isles, which concludes that only 1 in 10 exotics become established. Of the 10% that
became established, the study concludes that 1 in 10 become pests of varying severity
2 9 “We are conscious that the imposition of strict controls on the release of genetically engineered
organisms may increase incentives to select and develop non-engineered organisms, particularly micro
organisms. The impact of naturally occurring organisms in new environments can be major.... This
potential may become greater as technologies for the selection, development, production and use of non-
engineered organisms becomes more refined. The result could be a threat to the environment as great as
that posed by some GEOs and we recommend...that this should be considered further” (ch.5 para. 49).
3 0 An American congressional report (U. S. Congress 1984a: 17) also makes reference to the Nile Perch
example, but in starkly different terms, misidentifying the location and effects of release: “Two past
instances of exotic introductions can be used to illustrate the value of accurate predictions of the impact of
a new organism on an ecosystem. One involved the introduction of striped bass into a Guatemalan lake;
the other involved the introduction of Nile perch into a lake in Uganda. In the first case, a prediction of
disaster was correct; the bass destroyed the native fishery. In the second case, however, a similar
prediction of catastrophe was totally in error the perch flourished and provided needed food and economic
benefits to the people in the region. If the advice of the biologists had been followed in the first case, the
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(5.6). From this the RCEP concludes “most failed invasions, particularly of smaller
organisms, are likely to go unrecorded so that the probability of an invader becoming
established is much less than these figures suggest” (5.8). The problem here is that no
analysis is provided concerning the size or frequency of the non-native introductions,
critical parameters for their establishment. The RCEP later acknowledges the importance
of these parameters, and their consequent threshold effects, and subsequently advises that
the quantity of release not be “excessive” (5.12).
5. Viruses
Like the Enquete Commission before it, the RCEP notes that “viruses arouse
special concern.” It basis this position on their association with serious disease and the
limited means to fight them.3 1 It also bases it on the relatively small size of viral
genomes. This leads the RCEP to conclude that even minor viridian modifications pose a
marginally greater possibility of unintended and unwanted effect.3 2 The RCEP cites
scientific research showing that a single gene change extends the host-range of at least
environment - as well as the economy - of the affected area would not have been damaged. If the
biologists’ advice had been followed in the second case, many great benefits would have been missed.”
3 1 “Viruses arouse special concern because some are associated with serious diseases in man, in other
animals or in plants” (ch. 5 para. 31). Among those limited means are exposure to attenuated strains, the
approach pioneered by Joseph Salk. Such inoculation permits the body to develop appropriate antibodies
to fight off subsequent exposure to virulent strains. This approach would prove of limited value for
addressing a genetically engineered vims that was unexpectedly virulent. The other approach has relied on
protease inhibitors, which inhibit the replication processes of viruses within cells. Protease inhibitors are
currently the main approach to treating patients who have Acquired Immune Disease Syndrome (AIDS).
3 2 “The release of viruses offers potential benefits. Because the genome of a virus can be so small,
however, its manipulations may have a more significant and unexpected effect than the manipulation of a
plant or animal. Viruses, particularly retroviruses, are also useful as vectors in genetic engineering,
particularly of animals. The use of retroviruses poses risks, however, and the release of retroviruses or of
organisms manipulated using them should be approached with the utmost caution” (ch. 11 para. 22).
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one virus.3 3 Further, single gene changes can increase the virulence o f a virus.3 4 In fact,
increased virulence would be one of the goals, in order to increase a virus’ effect against
agricultural pests. The RCEP also speculates that increasing virulence in such fashion
may impact non-target organisms, especially other insects.3 5 In fact, around the world
honeybees- critical for pollination of flowering agricultural products - are currently
suffering the effects of a virus.3 6 Finally, different viral strains have been shown capable
of recombining in a host cell. This opens the possibility that an introduced sequence
could be laterally transferred to a different viral strain, extending the sequence’s range
and effect.3 7
The RCEP also documents the previous use of non-engineered viruses to control
agricultural pests. In both Britain and Australia non-native rabbits have proved significant
agricultural pests. In the 1950s Myxoma virus was introduced into Australian
3 3 “A laboratory study of a pathogenic plant virus showed that it was possible, by altering a single gene, to
change the range of insects that could carry it. Since certain insects prefer certain plants, this could enable
the virus to come into contact with previously unaffected plants species. Other indirect mechanisms which
widen the target range may also exist” (ch. 4 para. 4).
3 4 “Manipulation of a virus for a particular purpose could alter other characteristics in a harmful and
unintended way. It might, for example, unintentionally alter its virulence...” (ch. 4 para. 3).
3 5 Note that the hazard is conceived to include organisms other than insects: “The manipulation of an insect
virus is likely to be a potential risk mainly to other insects, though this might include beneficial insects such
as pollinators. This specificity cannot, however, be relied upon. Some viruses, such as those causing
influenza and rabies, infect a much broader range of species” (ch.4 para. 3).
3 6 Brown (1999:13). The mite transmits a virus (a double-whammy) to honey bees in Europe and the
United States (Higgens 1999:2E).
3 7 “There is evidence that in nature, viruses may, to a limited extent exchange genetic material with related
viruses, but for this to happen they must be infecting the same cell. The frequency depends on several
factors including the type of virus, its host range and its infectivity. For the exchange of genetic material to
occur the viruses must have a similar gene structure and for the exchange to be significant the viruses must
either have other unshared hosts and/or function differently after the exchange” (appendix 4, para. 5). This
form of recombination - “antigenic shift” - is held responsible for creation of pandemic strains of
influenza. “The best-studied process leading to antigenic shift involves the mixing of two viral strains in
one host cell, so that the genes packaged in new viral particles (and their corresponding proteins) come
partly from one strain and partly from the other. This reassortment can take place easily because the
genome...of the influenza virus consists of eight discrete strands of RNA... [which] are easily mixed and
matched.” For a discussion of novel influenza therapies, see Laver, Bischofberger and Webster (1999).
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environment to control the feral rabbit population. It was later introduced as well into
Britain to control rabbits there.3 8
While the effort resulted in the reduction of feral rabbit populations, the RCEP
recounts a number of unanticipated effects. These were broad, frequently unwanted, and
show that the eradication of an established non-native can have significant effects on
ecosystems. The example also demonstrates the enormous effect that an introduced
organism as simple as a virus can have on an ecosystem. The RCEP’s description of
these effects provides a useful summary of release concerns.3 9
Despite this account, the RCEP rejects the idea of a moratorium on the deliberate
release of genetically engineered viruses. It makes this recommendation with specific
reference to the West German moratorium, while emphasizing the need for particular
caution when considering their release.4 0 In part, this reflects the relatively weak position
3 8 This episode is mentioned briefly in the table under 2.19. For a further discussion, see Zilinskas (1981:
338-48). He uses Myxoma as an analogy for the ideal properties of a biological agent.
3 9 It is purposeful, therefore, to provide the entirety of their conclusions. “The removal of rabbits markedly
changed the structure and composition of vegetation, with a wide variety of effects on other species. Some
of the examples are anecdotal but serve to illustrate the kind of complex and unexpected things that can
happen. As grassland sward became taller and thinker, ant populations declined. These ants are important
prey for green woodpeckers, and a decline in green woodpecker numbers has been attributed, at least in
part, to the effects of removing rabbits. It is not known whether any prey of green woodpeckers such as
wood-boring beetles then increased but it is possible that some did. It would not have been easy, prior to
the release of Myxoma virus in Britain, to predict the consequences for woodpeckers or indeed for the
wood-boring beetles. Better documented examples include the decline of open country or heathland
species of high conservation importance, such as stone curlews and the large blue butterfly. As rabbit
populations collapsed predators, such as buzzards and foxes, turned to alternative prey, for example mice
and voles. The indirect effects on other organisms of this increased predation on rodents is unknown. In
woodlands, due to the lack of rabbits, sycamore seedlings survived in unprecedented numbers. The first
few years after the introduction of the Myxoma virus saw a whole generation of this introduced tree
dominating in woodland glades and shading out existing plants.” See the table under (ch.4 para. 23). David
Bishop (see below) offers a criticism of an American volume devoted to analysis of deliberate release of
genetically modified viruses that centers on this history: “It was, for example, a major oversight of the
organizers that there is a detailed report neither of the South American myxomatosis virus to control rabbit
populations, nor of the domino effects of the introduction of the virus to continental Europe and the United
Kingdom” Bishop(1986a: 321)
4 0 “Concerns about viruses have led some, including a Commission of Enquiry in West Germany, to
recommend that genetically engineered viruses, other than vaccines, should not be released at all at present.
Not all viruses cause disease however. Provided that the release of retroviruses, or of organisms
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and priorities of British Greens.4 1 Symbolic of this is that the UK Genetics Forum
organized only a week before the RCEP released its report.4 2 Given the RCEP’s explicit
concern, it would be logical to assume that released viruses had a difficult time receiving
authorization. The report recognizes, however, that a genetically engineered baculovirus
constitutes one of the initial approved British releases.4 3 This release receives closer
attention below.
C. Significant Omissions
While the RCEP analysis is generally thorough, several substantial omissions
stand out. Omissions are to be expected of any report that summarizes a regulatory issue
as complicated as deliberate release. Thus, individual omissions are not the problem per
se. The problem is that the omissions seem to overlook in systematic fashion
controversial elements of the deliberate release question.
1. Scientific Content o f Ice-Minus Experiment
Earlier it was argued that the ice-minus field test yielded limited scientific
information. Its scientific content pails in contrast to the symbolic function served in
advancing field tests. It was further shown that the ice-minus test - as the first authorized
manipulated using retroviruses, is approached with the utmost caution, we see no reason for imposing new
restrictions relating specifically to genetically engineered viruses” (ch. 5 para. 34).
4 1 “Until recent years, there was a conspicuous absence of lobbying regarding biotechnology in the U.K. -
the principal green group, Friends of the Earth, preferring to use its limited resources to attack nuclear
power. In part, the lack of activity reflected the feet that [GMAG] included two public interest
representatives. In consequence, the committee enjoyed public confidence, as well as that of the scientific
establishment. This arrangement ended in 1984, when a body without public representation [ACGM]
supplanted the earlier group. However, largely as a result of Julie Hill’s work on the Environmental
Protection Act, she was asked to join [ACRE]” Dixon (1993:47).
4 2 “The green lobby has a new voice [for biotechnology] through the UK Genetics Forum, launched last
week” “Britain Awaits Verdict”(1989:29). According to Gottweis (1998:299), however, they testified
before the RCEP calling for a moratorium except for the purposes of research.
4 3 “One of the first releases of a GEO in Great Britain was of a genetically engineered virus. The
unmodified virus attacks only specific caterpillars and has been used safely as a biological insecticide for
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deliberate release of a genetically engineered microbe - received substantial attention
around the world. Thus, it should come as little surprise that the RCEP reviewed that
episode.
At several points the RCEP encourages scientific review and follow-up of all field
tests to rationalize their regulation. According to the RCEP, post-release scrutiny can
improve the scientific basis for reviewing subsequent releases.4 4 While the RCEP
considers the ice-minus test worthy of its attention, it ignores the paucity of scientific
results generated by the test. In doing so, the RCEP appears to ignore its own
recommendation. Alternatively, if they were aware of the ice-minus test’s scientific
shortcoming, they chose not to communicate their concerns.
In addition, at several junctures the RCEP’s ice-minus account is factually
inaccurate. At best, these oversights can be dismissed as a lack of attention by staff to
detail. Worse yet, these oversights may have been an effort to portray the ice-minus
episode in a positive light. For example, the RCEP claims that approval to release ice-
minus was first sought in 1984, whereas Lindow and Panapolous approached the RAC in
1982. This error suggests that regulatory authorization in the United States required 2
fewer years than it did in actuality. No reference is made of the substantial bureaucratic
roadblocks - at the federal, state and local levels - ice-minus encountered en route to
release. The RCEP also reports that a later ice-minus test site was vandalized in May
years but, in comparison with chemical pesticides, it is slow acting. The release was carefully assessed to
ensure it posed no unacceptable risks” (cb. 1 1 para. 12).
4 4 The RCEP advocates creation of a Release Committee, which “should identify certain categories of
information about the results of release experiments which it will expect to receive on completion of or
possibly even during experiments. The committee should cany out regular reviews of the information it
has obtained about the outcome of releases. International exchanges of information between assessment
bodies could also provide valuable material to assist in assessing release proposals” (ch.l 1 para. 40). See
also (ch.6 paras. 45 & 46).
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1987. While this is true, the site of the original test was similarly vandalized.4 5 Finally,
the RCEP reports that ice-minus tests followed “extensive local consultation,” a claim
that substantially misrepresents events. AGS initially kept the location of the test site
confidential. It also misled the EPA about the proximity of the test site to local
dwellings. This proximity - once it became public - eroded local confidence in AGS’s
test and forced an eventual relocation.4 6
The RCEP’s portrayal suggests that American field tests were rapidly approved,
scientifically substantial, and elicited little public or regulatory controversy. This
treatment of the ice-minus episode is further complicated by its standing as a field test of
a gene-deletion. The RCEP’s competing perspective on gene deletions would seem to
* 5 Barinaga (1987: 819).
4 6 The following provides in entirety all reference made by the RCEP to the ice-minus debate. In light of
the discussion presented above in chapter 3, imagine how the ice-minus episode might be portrayed if
emphasis were placed on the problems. “Different issues were raised by die release of ‘ice-minus’ bacteria
in die USA, described in Appendix S paragraphs 18 and 19. These genetically engineered micro-organisms
were sprayed experimentally onto strawberries and potatoes in California to compete with micro-organisms
that induce ice formation and so to prevent frost damage. There was some concern that, if the use of such
GEOs eventually became so widespread that they became prevalent in the atmosphere, their action might
also lead to changes in local climate by preventing the formation of rain droplets. Following two studies
commissioned by the U.S. Congress Office of Technology Assessment (OTA) it was concluded that the
likelihood of climatic change was negligible even in the event of large-scale agricultural use of this GEO.
The example, nevertheless emphasizes the need for care to be taken about possible environmental
consequences” ch.4 para. 8. “Plant pathologists from the University of California, engaged in elucidating
the mechanisms of plant frost damage, proposed to treat potatoes with a genetically engineered bacterium
Pseudomonas syringae from which the gene for ice-nucleation protein had been deleted. When this protein
was produced by the bacteria it helped the formation of ice on plants causing frost damage. The engineered
ice-minus bacteria were designed to reduce the risk of this happening by competing with ice-nucleating
bacteria for available sites on the plants. Approval for the field trial, first sought in 1984 [sic], was given in
May 1986. After extensive local consultation the trial was begun in April 1987 on a 0.5 acre [sic] site at the
University field station in Northern California. The site was vandalized in May 1987. Apart from testing
the ability of the ice-minus bacteria to protect the potatoes from frost, the mobility and persistence of the
bacteria in the environment was also assessed. The United States Environmental Protection Agency (EPA)
at the same time conducted experiments to evaluate their strategies for sampling and studying the air
dispersal of genetically engineered micro-organisms released on a small field trial site. Some ice-minus
bacteria were found in the fallow buffer zone around the trial site, but none were found on neighbouring
vegetation or surface water. The bacteria persisted for about 1 week after spraying, in soil on the site. The
results of the field trial bore out those obtained from contained laboratory and greenhouse experiments”
(appendix 3 paras. 18 & 19). “Advanced Genetics Sciences Inc. (AGS) carried out trials of ice-minus
bacteria on strawberry plants in California in 1987” (appendix S para. 19).
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call for even greater scrutiny on their part If such scrutiny occurred, the committee does
not communicate its findings. A cynic might suspect that the RCEP purposefully
whitewashed the ice-minus episode of its controversial elements.
2. History o f Unauthorized Releases
The possibility that the RCEP’s treatment of ice-minus is preferential - and not an
oversight - is supported by its treatment of unauthorized releases. As noted earlier (ch.
3), there were several highly publicized unauthorized releases of genetically engineered
organisms in the period before their regulation. AGS’s rooftop test is among these.
Despite explicit reference to AGS, the RCEP offers no account of the company’s
unauthorized release from the roof of its Oakland headquarters. Consequently, the RCEP
does not refer to the EPA and Federal court’s suspension of the “frostban” test, nor
EPA’s rebuke and fining of the firm. The RCEP omits these elements entirely from its
report to Parliament.
The Discussion of Dutch elm disease provides a similar example. On several
occasions, the RCEP refers to Dutch elm disease as an ecologically damaging biotic
invasion. Dutch elm disease serves the British much the way that Kudzu serves an
American audience: as a familiar example of the hazards posed by non-native invasive
species.4 7 Consequently, the RCEP provides Dutch elm disease a separate “text box” for
specific attention.4 8 Despite this treatment, no reference is made to an unauthorized
release in Montana involving Dutch elm disease.4 9 Again, this may represent an
4 7 Thus, the following Nature editorial appears the week of the RCEP’s: “Dutch elm disease is fresh in
most people’s minds, and has plainly been a disaster” “Engineering Organisms for Release” (1989:81).
4 * For references to Dutch elm disease as an exotic, see (ch.4 para. 18). For the RCEP’s table devoted to
this tree-pathogen, see (ch.4 para. 21).
4 9 On June 13, 1987, Gary Stroble a professor of plant pathology at Montana State University. Injected
recombinant Pseudomonas syringae into fourteen elm trees, hoping that the bacteria would protect against
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oversight, or a conscious decision that the episode in Montana was irrelevant. Similarly,
the RCEP makes no reference to the USDA porcine vaccine episode. Ignoring these
episodes of unauthorized release is curious given the RCEP’s stated recommendation to
learn from previous releases.
The RCEP does make reference to the final unauthorized releases discussed
earlier - the Argentine rabies tests. It refers to this episode in the peculiar context of
developing country regulations. The lesson drawn from the Argentine episode is that, if
regulations are too restrictive in the developed world, then researchers are more likely to
pursue deliberate releases in the developing world. Because releases in the developing
world will be subject to less stringent review, the likelihood of a hazardous release
increases. The way to bring such releases under review is to permit them in the developed
world; otherwise the pressure to pursue the tests abroad will remain.so
According to this logic, authorities in the developed world should permit all
releases. Experience shows, however, that the danger of unauthorized releases -within
developed countries was as important as the possibility that release activity would shift
from the developed to the developing world. The RCEP can reach this conclusion,
however, since it does not provide a thorough, possibly even-handed account of
unauthorized releases. While articles from the British scientific press emphasize that
Dutch elm disease. He had not applied for an EPA permit because he believed: 1. It would take too long, 2.
He would lose a year’s work waiting for next season to come around. He claimed to be committing an act
of civil disobedience. See Fox (1992:57). See also Ezzel (1987:659).
5 0 “Our concern has focused on the prospect that restrictive regulation in some countries, notably those in
the industrialized West, will encourage companies and research institutes to take advantage of less strict
frameworks of control elsewhere. If any country allows releases to be carried out without thorough
scrutiny, control and monitoring there will be a consequent risk to the environment and to health in that
country and more widely. Recent publicity given to trials of rabies vaccine in Argentina, allegedly without
the approval of the national authorities, has highlighted this problem. This lends greater importance and
urgency to the work being done in the OECD and under the auspices of the UN...” (ch.9 para. 32).
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European firms were considering relocating their field tests to the more permissive
environs of the United States and the Soviet Union, these post-date publication of the
RCEP.5 1
IV. Post-RCEP Developments
Much as in the United States and Germany, bureaucratic turf battles accompanied
review of deliberate release. Shortly before the RCEP published its findings, the DoE
had published its own consultation paper, advocating a notification system, and a
principle that the “polluter pays.” The DoE’s proposals were intended to bolster weak
statutory oversight for environmental protection. While the Wildlife and Countryside Act
of 1981 made it an offense to release any new animals into the wild, there were doubts as
to whether this act could be used to regulate deliberate releases. The issues were
familiar: Could the term animal be extended to include viruses and microorganisms?
Was a non-exotic organism possessing a single novel gene new?5 2 At the same time, the
HSE’s ACGM had overseen all the British releases through 1989. The RCEP, however,
proposed the formation of a new body, which HSE officials saw as a threat to their own
authority.5 3
The British government enacted the EC deliberate release directive with passage
of the Environmental Protection Act of 1990, part VI of which is devoted to the question
5 1 “A report to be published by a group of scientists from government, academia and industry following
their visit to the USSR last September...says that the European Commission should take into account the
possibilities open to the West’s biotechnologists in the Soviet Union as the commission formulates its
politics on field tests of genetically engineered organisms and products.” The article also provides an
environmentalists rejection of the logic stated above: “Environmentalists, now represented in Britain by
the newly formed umbrella organization, the UK Genetic Forum, argue that the position adopted by other
countries on releasing genetically engineered organisms should not lead to relaxation of rules within the
European Community...” Watts (1990:22).
5 2 Newmark (1989c: 499).
5 3 Webb (1989: 7).
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of deliberate release. The act - which came into power in 1992 - indicates DoE and HSE
as the competent authorities of deliberate releases.5 4 ACRE is the specific agency that
reviews individual deliberate release petitions.5 5 Almost immediately, British field test
regulations came under attack. With researchers complaining about the burdens of red
tape, the House of Lords Select Committee on Science and Technology issued a report
lambasting the British and European rules governing deliberate release as “excessively
precautionary,” “obsolescent” and “unscientific.”5 6 In 1994, ACRE proposed - and DoE
adopted - a streamlined review process for field tests.5 7
The revised approach divided release petitions into three categories according to
the degree of hazard posed. The least hazardous would enjoy “fast track” 30 day
approval; the most hazardous would still require the full 90 day review; while medium-
hazard releases would require S O days. ACRE Secretary Beringer placed only plants in
the fast track group that were indigenous to the UK.5 8 Unsurprisingly, a significant up
tick in field test activity followed ACRE’S modification.
3 4 “Those seeking to release genetically manipulated organisms will need to provide an assessment of the
environmental hazards posed by the release, and must then wait for consent to be granted by the HSC and
the Secretary of State for the Environment (in some cases, the Ministry of Agriculture may be also
involved)” Aldous (1990b: 4).
5 5 “In February 1993, at the time of coming in force of the Genetically Modified Organisms (Deliberate
Release) Regulations 1992 (amended in 1995), we were reappointed as a statutory advisory committee of
independent experts under the Environmental Protection Act 1990 (EPA90). The legislative framework
consisting of Part VI of the EPA90 and the Deliberate Release Regulations implement the Council
Directive 90/220/EEC, and subsequent amendments, on the deliberate release into the environment of
GMOs. These regulatory controls give a European Community wide safety regime for the release and
marketing of GMOs.... The purpose of the legislation is to prevent or minimise damage to the environment
which may arise from the escape, or release from human control, of GMOs. Considerations on human
health and environmental safety fall within the scope of the legislation.”
http://www.environment.detr.gov.Uk/acre/annrep4/l.htm (July 15,1999).
5 6 Kenward (1993:25).
3 7 A summary of British field test regulations developments is available at
http://binas.unido.org/binas/regulations.html (July 16,1999).
5 8 Coghlan (1993: 5).
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A. The Oxford Baculovirus Controversy
Whereas American proposals to release Pseudomonas immediately generated
opposition, the first British microbial field test generated little initial controversy.5 9 The
host organism in question was the baculovirus Autographa califomica. Baculoviruses are
microorganisms that can infect and kill insects. They have consequently been used for
decades as an agricultural pest control agent6 0 As such they enjoy a good safety record,
with no known effect on vertebrates. The hope is that such agents can be engineered with
specific host range, increased virulence, and diminished environmental persistence to
increase their effective use for biological pest control.6 1
The baculovirus offers an attractive alternative to chemical insecticides, which
often kill non-target insects. To have its effect, a caterpillar must first ingest the
baculovirus. Thereafter, the virus infects cells in the caterpillar’s gut, where they
replicate and spread to neighboring cells. Late in the infection cycle, the host cells lyse
(burst), destroying intestinal cells and releasing more virus. Released virus is then
capable of initiating new infection cycles. As a biological control agent, the baculovirus
suffers one draw back: it requires several replication cycles - and consequently several
days - to kill individual pests.
Dr. David Bishop of Oxford’s National Environmental Research Council’s
Institute of Virology focused on modifying baculovirus. His Institute pursued a research
program meant eventually to introduce specific toxin genes - from bacteria or scorpions
5 9 “[David Bishop’s release] was given widespread publicity but aroused little controversy - even though it
was the first publicly approved release of a genetically altered organisms in Europe” Dickson (1987b: 18).
6 0 “Worldwide, about a dozen baculoviruses are registered for use as biological insecticides in forestry and
agriculture. This number seems small with regard to their considerable potential”(Huber 1988:67).
6 1 Note that these define the optimal characteristics of a biological weapons agent.
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- into the baculovirus. This, it was hoped, would accelerate the killing of pests. Initially,
however, Bishop modified the baculovirus so that it contained a marker gene that would
distinguish it from parent strains.6 2 In the lab, Bishop assiduously investigated the
modified baculovirus to ensure that its virulence remained constant, and that it remained
genetically stable. He then investigated whether the modified agent affected any one of
90 different British insect species. These tests showed that the modification had not
altered the baculovirus host range. He hoped his enhanced virus could eventually be used
to control Panolis flammea, a moth responsible for substantial damage among lodgepoll
pines planted in the Scottish hills by the British Forestry Commission.
In December 1984, Bishop approached the MAFF and ACGM for approval to test
whether the modified version with the genetic marker behaved differently from the
natural strain when released into the environment.6 3 In February 1986 the ACGM and the
HSE (with input from the Nature Conservancy Council, Ministry of Agriculture,
Fisheries and Food, and the Department of the Environment) approved the release. In
contrast to the American RAC, neither ACGM membership nor minutes from its
meetings are made public.6 4 At a conference sponsored by the Ciba Foundation,
audience members questioned Brian Agar, the ACGM Secretary, about the deliberations
behind release authorizations. They sought to know who was on the committee and how
6 2 “To genetically mark AcNPV, a non-coding synthetic oligonucleotide sequence (about 80 nucleotides
long, with stop codons in all six reading frames and no ATG codons) was placed in an intergenic region of
the viral genome at a position that deletion experiments have shown is non-regulatory and expendable. To
make the marker harmless, its composition and place of insertion were such that it neither added to, nor
detracted from, the coding or regulation of any viral gene product” Bishop (1986b: 496).
6 3 Dixon (1986:391).
6 4 Newmark (1986). He also notes in that article: “The guidelines...are intended to evolve on a case-by-
case basis. It will not be compulsory either to notify ACGM of planned releases or to heed their advice, but
the expectation is that nobody will risk bypassing the voluntary procedures.” Note that the voluntary nature
echoes the American approach, except for publicly funded research.
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they had reached their conclusions. Secretary Agar, however, was not permitted to
answer their questions, or even to identify subcommittee members.6 5 Agar, who later
went on to head the main European biotechnology lobby, indicates elsewhere the
OECD’s influence on British field test review.6 6
Despite the fact that unmodified strains are nontoxic to humans and have been
used agriculturally for decades without any known negative effect, critics voiced concern
that modified strains could provoke unforeseen and unwanted consequences.6 7 The
RCEP’s identification of viruses for special focus would appear to echo this concern.
Furthermore, the RCEP notes that distinguishing between native and non-native
engineered organisms should contribute to the analysis of release; the virus with which
Bishop worked was native to the United States, not to Europe. These contradictions
aside, Bishop challenged the view that viruses merit special concern, arguing that they
are unable to replicate outside a proper host-cell. Because of this, he argued, engineered
viruses are probably less dangerous than other organisms which can reproduce
6 5 Dixon (1986b: 391).
6 6 Agar became Director of the Senior Advisory Group on Biotechnology, the main biotechnology lobby
organization in Europe (Balter 1991: 1368). In a conference devoted to deliberate release in June 1987,
Agar presents the British perspective as thus: “This presentation outlines the arrangements for the oversight
of planned release in the UK. These have been influenced by the recently issued major international study
set up by the Organization for Economic Cooperation and development on recombinant DNA safety
considerations” Agar (1988:241).
6 7 “Microbial pesticides, such as AcNPV, are living organisms with the potential to reproduce, mutate,
migrate and affect non-target species. Once released, they cannot be recalled, and should they have
deleterious effects on non-target species their removal from the environment cold prove more problematic
than the removal of residues from chemical pesticides” Wheale and McNally (1988: 155). Wheale and
McNally’s observation - of reproduction, mutation and migration - is true of all microbes released into the
environment. They do not, however, condemn the use of natural strains of ACNPV, Rhizobium, or other
commercially licensed microbes, but limit attack on engineered strains. “The ecological consequences of
the release of micro-organisms with major novel metabolic capabilities into new environments is therefore
very difficult to assess and should be undertaken only with extreme caution” (1988:157). This would
appear inconsistent.
“Bishop’s baculovirus was discovered in 1969 in a moth called the alfalfa looper which is native to the
US, not Europe” Coghlan (1994c: 25).
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independently. He also argued that this limits the ability to extrapolate from the
experience of releasing engineered viruses to field tests with other microorganisms.6 9
Despite his view, the ACGM required construction of an elaborate netted, fenced, plexi
glass enclosure to limit spread from the 10m2 site.
With authorization and these security measures in check, Bishop released a
number of infected caterpillars into the enclosure. After they were permitted to die, the
site was repeatedly tested for persistence of the baculovirus. As expected, virus strains
possessing the genetic marker were recovered from the site for 6 months. At the
completion of the experiment, the foliage was removed, and the site was cleared and
treated with a sterilizing agent. Thus, much like the ice-minus episode, while insisting on
safety, elaborate precautions were taken.
In 1987 Bishop received permission to conduct a second series of tests on a
crippled version of the baculovirus. In this case, a genetically marked strain lacking the
protective protein coat was used to infect caterpillars. This crippled virus was more
susceptible to UV degradation. Again, the infected caterpillars were released at the site.
As expected, the crippled virus was less capable of persisting - no virus was recovered
from the site after 1-2 weeks. In 1988 two more releases were conducted. These involved
both the original crippled strain, and a second crippled strain possessing a bacterial gene
coding for beta-galactosidase. The purpose here was to investigate whether caterpillar
moths infected with the crippled hybrid virus would screen for beta-galactosidase. After
6 9 “Baculoviruses, like all viruses, are capable of reproduction only when inside a living cell of their
permissive host species. Outside of such cells, viruses remain inert in the environment, unable to replicate,
and eventually degrade. In this regard viruses differ from most bacteria and other free-living
microorganisms and are therefore not models for assessing the risks involved with genetically engineered
free-living organisms, such as bacteria” Bishop (1990: 119). This chapter provides a detailed account of
the first four releases Bishop conducted.
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pursuing the same pre-release screening, the field test was conducted. The test was a
success, since as expected beta-galactosidase was recovered from the caterpillars.
All these tests were conducted without any public controversy. Bishop proceeded
to the next stage of his research by engineering a baculovirus to contain a gene coding for
scorpion toxin. The goal was to accelerate its effects, and thereby enhance it utility as a
biological pest-control agent. He conducted the first of these experiments in 1993
without incident, and again received permission to do so in 1994. Bishop announced his
1994 test in the local Oxford Mail as required by British regulation. Although earlier tests
had not provoked controversy, a local gentleman read the advert and immediately
contacted the DoE. The problem was that Bishop’s test site was 100 meters from a
nature reserve inhabited by rare British moths. This initiated a minor international
scientific dispute concerning the bacculovirus’ host-range, its environmental persistence
and the possibility for the scorpion gene’s lateral transfer.7 0 ACRE officials stood behind
Bishop, who proceeded with the test in the face of local opposition.7 1
B. Mad Cow Disease and the Furor over Modified Crops and Food
The story of German biotechnology regulation was one of furor followed by
regulatory relaxation. In Britain, the real furor with regard to biotechnology erupted in
the second half of the 1990s. The explanation for this lies with the outbreak of bovine
spongiform encephalitis (BSE). In 1996 the government of Prime Minister Major was
rocked by evidence that British beef was contaminated by BSE. Consumption of BSE-
7 0 Coghlan 1994c: 14.
7 1 Bishop asserts that the scorpion gene poses limited hazard. It kills caterpillars more quickly, and
therefore does not permit the host to generate multiple copies of the virus. Caterpillars so killed also
remain intact, and therefore are not fed upon by other caterpillars, thereby limiting the spread of the
scorpion gene (Coghlan 1994c). Through the end of 1994, ACRE bad not refused a single petition for
release (Coghlan 1994a: 5).
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contaminated beef is now linked with a variant of Creutzfeldt-Jakob disease, known more
popularly as Mad Cow Disease. The disease itself is probably caused by a new class of
proteins called prions, a differently-folded version of a normal protein. Although much
remains to be understood about both prions and BSE, the current theory holds that these
misfolded proteins catalyze the further misfolding of similar proteins. These accumulate
in the central nervous system, resulting in death.7 2
The original source of the disease in British beef is still unclear. One explanation
relies on the widespread use of livestock as a protein supplement for farmers raising
cattle. In 1979, British health authorities changed the techniques used to treat such
animal-protein supplement. It is believed that scrapie-infected sheep were fed to British
cows, resulting in the development of BSE in cows. Another theory holds that a cow
spontaneously developed BSE; this is similar to the disease’s spontaneous occurrence
among humans. If an infected cow were used for cattle feed, then the disease would have
been amplified. A single infectious cow could have thereby launched the epidemic.
When deaths were linked to contaminated British beef, a political firestorm erupted. In
March 1996 a three-year ban was imposed on British beef exports (with an estimated loss
of over $2 billion).7 4 Ranchers were forced to slaughter 3.7 million head of cattle. The
BSE episode shook British confidence in food safety and eroded support for MAFF.7 5
7 2 For an overview of BSE that will put you off your beef, see Shell (1998).
7 3 “The Science of BSE” (1998).
7 4 The BBC supports a web-site devoted to BSE. See,
http://news2.thls.bbc.co.uk/scripts/queiy.idq?CiRestriction=mad+cow&CiMaxRecordsPerPage=32&CiSco
pe=%2FHi&TemplateName=query&CiSort=rank%5Bd%5D&HTMLQueryForm=query.htm (July 11,
1999).
7 5 http://www.newscientist.com/nsplus/insight/bse/ministerl05a.html (July 14, 1999). New Scientist
maintains a valuable archive of biotechnology-related stories on the internet; articles without page
references were secured from this site.
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It was in this environment that the large agricultural biotechnology giants (e.g.,
Monsanto, Dupont, Novartis) expanded their commercialization of genetically modified
crops and food. The precautionary disposition of European regulatory authorities was
already going to complicate their introduction. The agricultural firms may have believed
that they would enjoy British support in intra-EU debates concerning the safety of these
products. After all, Britain was the only EU member state to vote against a ban on a
recombinant growth hormone that increases milk yield in dairy cows (discussed in the
next chapter).
After BSE, however, the British public became highly skeptical of safety claims
made of their food by government officials. These concerns reached a heightened pitch in
June 1998, when Prince Charles and Monsanto officials engaged in a public debate about
genetically modified crops and food. The Prince wrote in the Daily Telegraph about the
dangers of such crops, questioned the ethics of genetic engineering, and called for British
consumers to boycott novel food. He thereby initiated a personal campaign against
agricultural biotechnology, and in support of organic foods and farming. Then in August
1998, a British television documentary reported a study by Arpad Pusztai, a scientist in
Scotland, linking genetically modified potatoes to stunted growth and weakened immune
systems in rats.
Pusztai was later suspended and forced to resign when word surfaced that the rats
had not in fact eaten GM potatoes, but rather the toxin planned for introduction.7 6 But the
public relations damage had been done. Monsanto, which had taken the offensive in June
7 6 Coghlan (1998). “The British Medical Association, the Royal Society and a select committee have all
weighed in on the potato episode and GM foods” “The Name of the Game” (1999).
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1998 with a £1 million public campaign effort to calm growing British fears concerning
GM crops and food, found itself again on the defense.7 7 Monsanto’s public relations
campaign has apparently been for naught: in fact it may have been counterproductive.
Tepid British rejection of GM foods has turned to a complete rout, with only 1% of the
British public responding positively to modified food.7 8 Major British supermarket
chains are establishing “GM-free” shelves. Through 1999 both protestors and farmers
themselves destroyed fields of modified crop. The final chapter of this study takes up the
issue of GM crops and foods, noting recent developments and speculating on the future
of agriculture.
IV. Conclusion
British authorities exhibited greater precaution than their American counterparts
when faced with the challenge of regulating deliberate releases. They began analysis by
assuming the worst-case scenario:
Traditionally bred crops frequently have traits such as disease and insect
resistance bred into them. Despite the ability of pollen to transfer the relevant
genes to other plants (which would then have a selective advantage) problems
such as insect resistance are not known to have emerged. Nevertheless with any
newly engineered organism it will be prudent to begin with the assumption that an
introduced gene is capable o f spreading widely and then to challenge that
assumption” (32).
This conclusion stands in stark contrast to that offered by the American National
Research Council.7 9
7 7 Cookson and Tait (1998:20).
7 8 “Even before the recent furore, roughly 25% of Britons were opposed to GM food. Now, according to a
recent MORI poll, only 1% of them believe that it offers any benefit at all” (“Food for Thought” 1999).
7 9 The NRC report concludes that, “crops modified by molecular or cellular methods should pose risks no
different from those modified by classical genetic methods for similar traits.”
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The RCEP’s recommendations were eventually given legislative standing in Part
VI of the Environmental Protection Act of 1990. Part VI codified what had been
previously voluntary guidelines for deliberate release. Again, the Act was not simply the
f in
product of domestic politics, but also bears the influence of the EC and the OECD. It is
also different in that it sustained the inclusion of protoplast fusion as a regulated activity,
thereby broadly defining deliberate release.
These differences challenge the hypothesis of regulatory contagion. After all, the
hypothesis provides expectation for the adoption and adaption of foreign rules governing
an activity if policy makers are aware of those rules. In this case, the RCEP’s frequent
use of the phrase “it is sometimes argued” draws attention to its familiarity with
developments abroad. The RCEP in these cases focused on what it perceived to be
shortcomings of the foreign regulatory approaches. It used these differences to contrast
its own approach to field tests.
8 0 “As well as the DoE consultation paper, the EPA drew upon documents from the RCEP, the European
Commission and the OECD” Levidow and Tait (1992:95).
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Chapter 7 - Transgenic Agriculture Conies of Age
I. Introduction: The Emergence of Global Agricultural Biotechnology
Thus far, this study has explored the transnational context in which the initial
prohibition and subsequent field test regulations developed in the United States, Germany
and Britain. This chapter attempts to answer the questions: How has the industry evolved
in view of the regulatory framework described here? What products has it produced?
What products does it promise? In doing so, it offers an overview of agricultural
biotechnology at the start of the 21st century.
Two themes dominate the discussion. One is the speed at which molecular
genetics has transformed agriculture. This transformation is best illustrated with
reference to the spread of transgenic crops across the American landscape. Some
estimate that of the 1998 American harvest, 55% of soybeans, 50% of cotton and 40% of
com relied on GM seed. While other countries have also adopted GM crops, they have
done so at a much slower pace.1 Concurrent with the growing use of GM crops is a
growing reliance on GM food ingredients. These have ignited a firestorm of controversy
in Europe that has spread to both North America and Asia.
The second theme is the continuing - and growing - impact that transnational
forces are having on the industry’s regulatory development. Whereas documenting these
forces in the 1970s and 80s requires reference to government reports, doing so in the 90s
frequently requires little more than opening the newspaper. Public discussion of and
1 The USDA does not keep official data on GM crop use in the United States, forcing a reliance on
estimates. According to The Economist, “the other main converts to genetic modification: America,
Argentina, Australia, Canada, China and Mexico. In Europe, though, things are different Although there
are small-scale field trials in all European Union member states, only Spain has sizeable plantings of GM
maize...” “Special: Food For Thought”
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interest in agricultural biotechnology has increased dramatically. At the same time, it has
become for all practical purposes impossible to consider agricultural biotechnology
developments in national isolation. Rather, to appreciate recent developments one must
remain acutely sensitive to transnational forces.
The current controversies surrounding GM crops and food echo those of the
earlier deliberate release and biohazard debates. Proponents argue that transgenic
agriculture promises benefits well in excess of its hazards.2 Critics, on the other hand,
argue that the ecological effects of planting transgenic crops are uncertain.3 They
consequently argue for precautionary regulation.4 Proponents assess the hazards of
transgenic food in a conceptual fashion similar to that used to assess novel organisms for
deliberate release.5 They assert that no substantial hazard attends the introduction of
novel traits into foods.6 Opponents argue that novel foods pose uncertain hazards to
consumers. This chapter reviews these commercial developments, and provides an
2 “Rapid strides in molecular genetics and other research have opened up opportunities for promoting an
ever-green revolution, rooted in the principles of ecological, economic and social sustainability”
Swaminathan (1999). “Agricultural biotechnology can be used to help Third World farmers produce more
by, for instance, developing new crop varieties that are drought-tolerant, resistant to insects and weeds and
able to capture nitrogen from the air." Andersen (1999: A31).
3 The Prince of Wales entered the fray when he opined, “We simply do not know the long-term
consequences for human health and the wider environment of releasing plants bred in this way” Cairns
(1998:5).
4 The following passage indicates how little the rhetoric of biotechnology regulation has varied. “It is
difficult to know the extent to which past experience with traditional breeding is a valid predictor of the
risks this new technology poses. The complexity of ecological processes, and humankind’s incomplete
knowledge of how they operate, lead us to believe that sufficient resources must be devoted to risk
assessment of such crops before that are commercialized and that decision makers should err on the side of
caution in the face of uncertainty” Rissler and Mellon (19%: xii).
5 “The host plant is a benchmark for considering modifications that may affect the safety of food derived
from new varieties.... Uncertainty may exist about the safety for consumption of a protein that has not been
a constituent of food previously (or has not counterpart in food that would serve as a basis for comparison
of safety)” Kessler et al. (1992: 1748).
6 “There is no sound rationale for such labelling requirements. A broad scientific consensus holds that
modem techniques of genetic engineering are essentially a refinement of the kinds of genetic modification
that have long been used to enhance plants, micro-organisms and animals for food” Miller (1999: 16).
227
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overview of the agricultural biotechnology industry in the decade after the first
authorized deliberate releases.
II. Field Test Activity in the Wake of Controversy
The three previous chapters document how the field test controversy evolved and
was resolved in the United States, Germany and Britain. On either side of the Atlantic,
authorities established regulatory systems to govern field tests. Unsurprisingly, field test
activity increased. Figure 7.1 documents field test activity among OECD members in the
decade following the initial test of ice-minus.7
Figure 7.1: Total Number of Field Tests within the OECD, 1986-96.
1600 !
1400 - i
j
1200 - !
1468
1248
1000 - I
734.
800 -
600 - j
400 i
2 0 0 - j
673
316
176
145
Year
Source: OECD
The S-shaped curve is a familiar component of technology diffusion studies. There is a
difference here, however. Diffusion studies have generally focused on the adoption of
innovations-as-things (e.g., cell phones, programs, fashions) by an increasing number of
individuals with normally distributed thresholds.8 In this case, however, the S-shaped
7 The OECD has not updated its field trial data base since April 1998. The data are only reliable through
1995. See “OECD's Database of Field Trials.”
8 “The threshold for adoption varies for different individuals in a system, which explains the S-shaped
diffusion curve. The innovators who adopt an innovation first have a very low threshold for adoption,
attributable to their venturesomeness. Later adopters have higher thresholds (that is, stronger resistance to
228
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curve cannot be explained with reference to individuals with varying thresholds. Rather,
an S-shaped curve more likely reflects changing attitudes among individual regulators.
Every release that fails to produce something unexpected should diminish the reluctance
of regulators to prohibit subsequent releases.
Figures 7.2, 7.3 and 7.4 present the number of approvals in the United States,
Britain and Germany. Two things are apparent. First, the United States overwhelmingly
dominated global field test activity. Second, the United States is the only case among the
three to exhibit the S-shaped curve. Thus, field test approvals - either nationally or
globally - appear to have increased the marginal likelihood of subsequent approvals.
Further, observing the substantial activity in the United States would also tend to
diminish foreign regulators’ marginal propensity to deny approval.
Figure 7.2: Annual Field Tests in the United States, 1986-96.
1200 1115
923
1000
800 j
600
523
400 4
200 i
Year
the innovation) that are reached only when many other individuals in their personal network have adopted.
Whereas later adopters are much more heavily socialized into the local system, innovators, due to their
cosmopolite orientation, are almost social isolates in the system. Individual thresholds for adoption are
normally distributed, thus creating the S-curve of diffusion” Rogers (1993:322).
229
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Figure 73: Annual Field Tests in Germany, 1986*96.
25
,2 20
86 87 88 92 95 89 90 91 94 96 i 93
Y«ar
Figure 7.4: Annual Field Tests in Britain, 1986*96.
50 " j
43
40 i
I
35 - i
25.
14.
95 86 87 92 94 93
Y«ar
Source: OECD
Because of the broad discrepancy in field test activity between the United States
and the rest of the OECD, it is sensible to consider American tests in greater detail.9
Figure 7.5 provides an overview of the different phenotypic traits tested in the United
States as a share of total tests. Two traits - herbicide tolerance and insect resistance -
9 The following presentation relies on USDA data at "Field Test Releases in the U.S."
http://www.nbian.vt.edu (October 19,1999). The USDA data are more up-to-date than that provided by
the OECD, but the two sets are in general agreement
230
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dominate, constituting nearly half (47%) of all field test activity. This reflects a focus
during the first decade of developing commercial GM crops to combat losses suffered
from weed and insect infestation.
Figure 7.5: Traits Tested as Percentage of Total American Tests, 1987-99.
Figure 7.6 provides the total number of authorized field tests per year in the
United States, categorized by the main traits of interest. This figure reveals two important
elements about American field tests. First, herbicide tolerance and insect resistance are
the two traits that have dominated field test activity year after year. Second, there is a
substantial increase in field test activity in the years following 1992. What explains this
increase?
3% 1%
15%
□ Herbicide Tolerance (H T)
U Insect Resistance (IR)
U Product Quality (PQ)
■Vims Resistance (VR)
□ Fungal Resistance (FR)
■Agronomic Properties (AP)
■Other (00)
■Marker Gene (MG)
■ Bacterial Resistance (BR)
Source: USDA
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Figure 7.6: American Field Tests by Trait, 1987-99.
1000
800
;DHT
■ IR
■ PQ
■ VR
■ FR
■ AP
■ OO
■ MG
□ BR
0
1987 1988 1989 1990 1991 1992 1994 199S 1996 1997 1998 1999
Source: USDA
In September 1992, while Europe debated relaxing the rules for experimental field
tests, an editorial in the journal Science called for overhaul of USDA’s oversight of field
tests.1 0 In March 1993, the newly arrived Clinton administration responded to this call
and deregulated field tests of six commercial GM crops - cotton, com, potatoes,
tomatoes, soybeans and tobacco - replacing permits with a simpler system of
notification.1 1 Field tests of these six crops predictably exploded.1 2 Figure 7.7 provides
an overview of American field test activity by individual crops. As is apparent, the six
1 0 “The extensive information base derived from research on rDNA-modified plants has verified the
scientific predictions of the 1980s - crops thoughtfully modified by rDNA do not become or create new
plant pests. There is an urgent need to revise the USDA-APHIS regulations to focus on the behavior of
rDNA-modified plants and not on experimental protocols. This would make the regulations compatible
with recommendations of the National Academy of Sciences, the National Research Council, and the
February 1992 White House policy on field research to increase U.S. competitiveness” Amtzen (1992:
1327).
" “Under the new final rule on notification procedures issued by the Clinton Administration, researchers
would have to give the department 30 days notice that they plan to begin a field trial, so state and the
Federal government can decide whether additional reviews or inspections are needed. Industry and
Environmentalists...” (1993: 15). “Plants used to produce drugs are not eligible for the one-month
notification” Lehrman (1993:483).
1 2 “In the first 14 months of the expedited process [APHIS] issued 542 permits, compared to 511 for the
preceding seven years” Baker (1994:527).
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deregulated crops (and rapeseed) constitute over 80% of American field test activity since
the first release of ice-minus. It is with this background that it is worth considering
further the development of GM crops.
Figure 7.7: Contribution of Seven Crops to Total American Field Tests, 1986-1999.
Remaining (75)
18%
Tobacco
3%
Cotton
6%
Tomato
9%
Soybean
9%
Potato
11%
Source: USDA
III. Novel Crops: Developing. Protecting and Distributing Traits
The most convenient way to organize a discussion of GM crops is by
differentiating between output and input traits. Simply put, output traits are
modifications of interest to consumers, such as flavor, appearance, shelf-life and
nutritional content. Input traits are modifications of interest to farmers and food
processors, such as enhanced yield, pest-resistance, climatic tolerance and uniformity of
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size.1 3 Molecular geneticists are rapidly identifying the genes responsible for these traits,
and agricultural biotechnology firms are shifting them into seeds for commercial
farmers.1 4
A. Output Traits - The Flavr Savr Tomato and Antisense Technology
The first GM food approved for sale in the United States was Calgene’s Flavr
Savr tomato. To modify the tomato, Calgene used antisense technology, a means of
switching off gene expression.1 5 To understand Calgene’s approach, one must know a
little about how a tomato ripens. Polygalacturonase (PG) is an enzyme associated with
the ripening process in tomatoes. Increased levels of PG are associated with faster
ripening. Diminished levels are associated with slower ripening. Normally toward the
end of a tomato’s development, the PG gene is transcribed, or the DNA sequence coding
for PG is converted into messenger RNA (mRNA). This mRNA then passes from the
nucleus to the cytoplasm where it is translated into the enzyme associated with ripening.
1 3 Although the discussion here focuses on food crops, the analysis also applies to agricultural livestock and
marine life. Chinese researchers are busy at work establishing genetic maps of chickens with the goal of
eventually modification for a host of characteristics (“A Genetic Game of Chicken” 1998: 72).
Alternatively, much research is being done on GM cotton. For instance, one Agracetus has developed an
experimental GM cotton plant that produces plastic nodules amid the cotton fibers. This GM cotton is
more effective at insulating and retaining heat (Coghlan 1996c). Calgene enjoys a patent for controlling
color pigment in GM cotton (“Calgene to Grow Colored Cotton” 1996: E2). For an overview of marine
biotechnology, see Colwell (1994).
1 4 “The [USDA’s] National Research Initiative... marks the beginning of a ten-year, $500 million project to
map the genomes of key food plants, an effort that will run in parallel with NIH’s Human Genome Project”
Anderson (1990: 184).
1 3 “It is now becoming realistic to think about selectively turning off or modifying the activity of any given
gene. One method is [to] create antisense RNA or DNA molecules that bind specifically with a target
gene’s RNA message.... The ability to deactivate specific genes holds great promise for medicine. For
example, it may someday be possible to fight viral diseases with antisense RNA and DNA molecules that
seek and destroy viral gene products inside a person’s cells.... Antisense technology is contributing to the
birth of a new field, reverse genetics. Classical genetics usually studies the random mutations of all genes
in an organism and selects the mutations responsible for specific characteristics; reverse genetics starts with
a cloned gene of interest and manipulates it to elicit information about its function” Weintraub (1990:40).
“...only one of the [the strands of the double helix] makes sense - that is, only one of them holds
meaningful genetic information. The other, the antisense strand, is just a molecular image, carrying an
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Calgene scientists isolated and sequenced the gene responsible for PG production.
They assembled an antisense gene - one that reversed the coding associated with the PG
gene - and inserted it into the tomato’s genome. Calgene’s antisense tomatoes express
not only the PG gene, but also the antisense PG gene. This gene is also transcribed, and
the antisense mRNA passes from the nucleus to the cytoplasm in normal fashion.1 6
Antisense mRNA complements PG mRNA, meaning the two share a natural
bonding affinity for one another similar to the two strands of a double helix.
Consequently, in the cytoplasm the complementary strands of mRNA can bind together.
This binding reduces translation of the PG mRNA into protein, thus diminishing the
levels of the ripening agent. Calgene’s antisense approach has two effects. First,
antisense tomatoes ripen more slowly, and enjoy an extended shelf life. Second,
tomatoes are usually picked green, and ripen off the vine. Antisense tomatoes can remain
on the vine longer, since they ripen more slowly. This allows the tomato to accumulate
more sugar while on the vine, resulting in a sweeter fruit.
1. Labeling and the Hazards Posed by Novel Foods
In May 1994, after five years of regulatory review, the FDA granted Calgene
approval to market the Flavr Savr. Industry greeted the FDA’s approval with great
enthusiasm. American industry viewed Flavr Savr as opening the regulatory pipeline to
inverted message that the cell doesn’t use” “Antisensical” (1996:81). The second use of the term message
in this context is misleading.
1 6 Calgene was not the only firm interested in this application. “In a different approach, Monsanto scientists
Kishore and Harry Klee have introduced a gene into tomato plants that induces them to manufacture an
enzyme [which] degrades the precursor compounds that form ethylene, thus retarding spoilage” Gasser and
Fraley (1992:69). “Antisense expression vectors have been injected into petunias to inhibit an enzyme that
produces pigment in the flowers. The resulting flowers display unusual pigment patterns” Mullis (1990:
46). The first German deliberate release in 1989 involved antisense petunias.
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GM products much as ice-minus had opened the pipeline to field tests 7 years earlier.1 7
Calgene had invested more than ten years and $20 million to move the tomato from the
lab to the grocer’s shelf.1 8 Despite the investment, Flavr Savr never provided Calgene its
expected return. Farmers found the Flavr Savr provided inadequate yield and lacked
important disease-resistance. Calgene pulled it from the market in 1996. Other efforts at
producing novel, slow-ripening foods - such as DNAP’s Endless Summer Tomato - were
also unable to establish a market foothold.1 9
Flavr Savr initiated a dispute over the labeling of GM foods. Opponents of GM
foods supported labels to alert consumers. In May 1992, however, the FDA ruled that
GM foods were “substantially equivalent” to foods modified by traditional cross
breeding. According to the FDA, GM foods would only require labels if their nutritional
value were diminished, or an added sequence came from a known allergen or toxin.
Despite a public campaign by opponents demanding labels, the policy remained in
place.2 0
Biotechnology opponents argue that GM foods present possible hazards to the
public. The most obvious concern is that GM foods will produce allergens, a substance
that invokes an immune system response. This possibility was borne out in 1996 when
researchers from Pioneer Hi-Bred International, Inc. engineered a soybean to possess a
gene from the Brazil nut. The goal was to augment the soybean’s protein content and
improve its use in animal feed. Nuts are capable of invoking severe, sometimes fatal
1 7 Baker (1994).
“ Walters (1994: Al); Baker (1994:527).
1 9 Marshall (1999:18 & 60). “Tomatoes are big business. Sales exceed those of potatoes or lettuce,
amounting to over $3.5 billion in 1993” Reiss and Straughan (1996: 132).
2 0 Phillips (1994:687).
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allergic reactions in humans. Tests revealed that the novel soybean invoked a reaction
similar to that caused by Brazil nuts. The transfer of the protein-enriching gene also
resulted in production of the responsible allergen. Opponents pointed to this as an
example of the threats posed by GM foods. Proponents, on the other hand, argued that
the system worked: the episode revealed that the screening of novel foods for allergens is
effective.2 1
Opponents press the issue further. The recombinant revolution facilitates
movement of genes into food from any source. For instance, researchers have shifted a
flounder gene into potatoes to increase their resistance to cold temperatures.2 2 This
research raises concerns not only for those with dietary prohibitions (e.g., kosher
restrictions among Jews and Muslims, and vegetarian restrictions among Hindus).2 3 It
also raises concern about the creation of novel allergens when animals, bacteria or fungi
donate the novel sequence. Echoing the theme that has dogged both this study and
biotechnology, an editorial from the New England Journal ofMedicine warns that, “the
allergenic potential of these newly introduced microbial proteins is uncertain,
unpredictable, and untestable.”2 4 The British Medical Association has also published its
concerns regarding GM foods.2 5
2 1 Phillips (1994:676). “Not a single consumer was exposed to or injured by the newly-allergenic
soybeans. In what might be considered a ‘positive control,’ the system worked” Miller 99. For a
discussion of the episode, see Weiss (1999c). In Britain, one researcher’s highly contested study suggests
GM potatoes diminish the immune system (Weiss 1999d).
2 2 Reiss and Straughan (1996: 153). The crop lost to frost during the Central Valley cold-snap in California
during the 1998/99 winter was estimated at $656 million. This encourages agbiotech firms to pursue
strategies to confer cold-resistance (Groves 1999: Cl).
2 3 “The scientific issues pertaining to proteins that are derived from other food sources, or that are
substantially similar to proteins that are derived form food sources, are known toxicity, allergenicity, and
dietary exposure...” Kessler et al. (1992:1749).
2 4 Nestle (1996: 726).
2 5 (Leighton 1999). American Senators portrayed the report as veiled protectionism (Weiss 1999a).
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In addition to these hazards, some fear GM foods will exhibit pleiotropic effects.
As discussed earlier, the techniques involved in modifying plants are still under
development. While researchers can successfully transfer novel genes into a plant’s
genome, they frequently cannot control precisely where that sequence will insert itself.
Transposons are frequently the vector of choice. Because transposons randomly insert
themselves into the chromosome, they can have secondary effects by activating or
inactivating local genes. Theoretically, this can result in the increased expression and
accumulation of toxins already present in many foods.2 6
Allergens and toxins are factors that can be potentially screened before a GM
food is brought to market. This is to adopt the additive approach - that well-
characterized genes introduced into well-characterized hosts yield well-characterizable
foods. An OECD publication on GM foods advances the proposition that, “If a new food
or food component is found to be substantially equivalent to an existing food or food
component, it can be treated in the same manner with respect to safety. No additional
safety concerns would be expected.”2 7 Unsurprising for this study, this echoes the
philosophy of FDA officials. It repeats the pattern of harmony between OECD and
American approaches to biotechnology regulation.
As we have seen before, some critics reject an additive approach to the
assessment of biotechnology’s hazards. They warn that the “substantial equivalence”
standard will fail to prevent and guard against unexpected effects. Critics point to the
2 6 “Even foods that are an important component of the human diet contain potentially toxic compounds:
protease inhibitors in legumes; goitrogens in canola species; cyanogens in casava, sorghum and lima beans;
glycoalkaloids in potatoes...” Phillips (1994:68S).
Organization for Economic Cooperation and Development (1993:16).
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example of Lenape potatoes introduced in 1967. The Lenape was bred through
traditional means for high solids content, a characteristic valuable for potato chip
processors. Two years after its introduction, a farmer who consumed the potatoes fell ill.
Research showed that in addition to the high solids content, the Lenape contained high
levels of a glycoalkaloid toxin. It was subsequently withdrawn. The Lenape potato
serves as an example of the possibility for unintended consequences.
Critics further argue that the widespread use of antibiotic markers in gene
constructs poses another hazard. Antibiotics are frequently coupled with a gene sequence
of interest destined for movement into a target genome. The antibiotic serves as a genetic
marker. Researchers can expose a tissue culture to the antibiotic, killing those cells that
have not taken up the novel gene of interest. Some fear this widespread practice may
enhance antibiotic-resistance among human pathogens over time.2 9
B. Input Traits - rBST, Roundup Ready and Bt Crops
1. Recombinant Bovine Somatotropin
The Lenape episode provides an example of how traditional breeders can alter a
characteristic of interest to food processors. Except in rare cases where problems arise,
the consumer is otherwise unaware of the changes. Biotechnology offers a range of
2 8 Phillips (1994:685). A traditionally modified celery provides another example: In the mid-1980s, celery
growers in the U.S. introduced what they thought was a wonderful new strain. Highly resistant to insects, it
promised to boost yields dramatically.... People who handled the celery sticks began complaining of severe
skin rashes. Dermatologists discovered that the celery was shedding psoralens, natural chemicals which
become irritants and mutagens when exposed to sunlight” Brookes (1998).
2 9 “’Marker genes’ are another worry. Friends of the Earth claim that scientists add genes that offer
resistance to antibiotics, so that they can tell whether plants have successfully adopted new traits. It argues
that these genes could transfer to bacteria in the soil or the guts of animals and humans. In time, say
Friends of the Earth, this may seriously affect our ability to treat disease. The British Medical Association
has called for a ban on these types of marker genes” Callaghan (1999). The U.S. FDA (1998) takes a more
sanguine view of the hazards.
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modifications that appeal to those who plant, harvest, transport and process foods. These
characteristics are referred to as input traits.
One of the first biotechnology products approved for agricultural use was
recombinant bovine somatotropin (rBST). Somatotropins are a type of growth hormone.
After isolating and characterizing the somatotropin gene, it was a simple matter for
researchers to introduce the sequence into a plasmid vector, and introduce the vector into
a bacterium. Bacteria expressing the gene for somatotropin can be cultivated in vats.
There, they produce somatotropin that can be subsequently isolated.
Monsanto discovered that dairy cows injected with bovine somatotropin produce
up to 20% more milk. They began rBST production and initiated plans to market it under
the trademark, prosilac. Cows undergoing the prosilac regime are injected with it once
every two weeks. rBST confers no nutritional, taste or quality advantage - it is only of
interest to dairy farmers seeking to increase yields and profits. After several years of
testing, FDA approved use of rBST in November 1994.
Opponents raised several concerns about rBST milk. First, dairy cows so treated
exhibited elevated incidence of mastitis, an infection of the udder. To offset this effect
dairy farmers could rely on antibiotics. Such use, however, increases antibiotic trace
levels in a cow’s milk. Low level antibiotic exposure is associated with development of
resistant strains, an important negative health issue. Some research suggests that the
widespread use of antibiotic markers in genetic experiments poses a hazard, especially
for the use of GM foods as animal feed.3 0 In addition, some studies linked rBST use with
3 0 “Fears that genes for antibiotic resistance could jump from genetically modified foods to bacteria in the
gut may be fuelled by new research [that] shows that DNA lingers in the intestine, and confirm that
genetically modified bacteria can transfer their antibiotic-resistance to bacteria in the gut.... One concern
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elevated levels of the growth factor IGF-1 in milk. Some studies have linked IGF-1 with
colon and breast cancer, though during its own scientific review FDA rejected these
findings.3 1
Public protests accompanied rBST’s introduction, and added fuel to the labeling
controversy. As concern mounted, several companies - most notably, Ben & Jerry’s Ice
Cream - announced plans to label their own foods as “rBST-free.” The FDA challenged
these plans, noting that all milk contains traces of bovine growth hormone. Instead, the
FDA required labels to indicate that the milk was from cows that had not been treated
with rBST. Public interest groups were incensed by what they viewed as FDA’s
intervention on behalf of industry. Jeremy Rifkin launched the Pure Foods Campaign to
generate public opposition to novel foods. Despite his effort an estimated 30% of dairy
cows were receiving the prosilac regime by 1997, suggesting the limited impact of public
anti-biotechnology campaigns in the United States.3 2 In contrast, European anti
biotechnology groups succeeded in imposing a moratorium on rBST use.3 3
about some GM crops, such as maize used as animal fodder, is that they include a gene for antibiotic
resistance...used to track the uptake of modified genes. While some scientists fear that these genes could
jump into bacteria in the guts of livestock and create antibiotic-resistant pathogens, others have said there is
no such risk because the modified DNA breaks down quickly. The [recent] results cast doubt on these
assurances” Mackenzie (1999).
3 1 Phillips (1994:677).
3 2 Marshall (1999:15).
3 3 “In December 1994, the EU Agricultural Council voted to extend its moratorium on commercial use of
bST until December 31, 1999. However, the EU permits the importation of dairy products from countries
such as the United States which use the product extensively.... Thus, EU policy makers have created what
is, in effect, a reverse nontariff trade barrier: that is, they’ve disadvantaged European dairy products in their
own markets!” Miller (1997:161). Of course, it deserves mention that milk surpluses have been a staple of
the European Unions common agricultural policy. Opponents frequently pointed this out, arguing that milk
surpluses rendered this an unnecessary product According to Reiss and Straughan (1996:110), “Britain
alone advocated lifting the ban, but was outvoted 1 1 to 1.” The British vote preceded the BSE controversy.
The EU recently considered extending the moratorium (Kilman 1999a). In October 1999, the EU renewed
its ban.
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2. Weeds and Round-up Ready Crops
Green plants possess chloroplasts, specialized organelles that convert sunlight
into energy via photosynthesis. Chloroplasts permit the growth of both crops and weeds,
the latter which significantly diminish agricultural yields. One of the most successful
agricultural inputs in recent times is Monsanto’s herbicide Roundup. Roundup is the
trademark name for glyphosate, a chemical that disrupts one of the metabolic pathways
involved in photosynthesis. Among agricultural chemical inputs, glyphosate enjoys a
relatively good reputation. This is because it breaks down quickly, does not
bioaccumulate, and is less toxic than other chemical alternatives.3 4 Its major
disadvantage is that it affects crops, since they too possess the enzyme that glyphosate
disrupts.
In the mid-1980s researchers discovered that certain petunias and bacteria possess
genes that express large quantities of the glyphosate-vulnerable enzyme. Monsanto’s
approach has been to engineer this gene into commercial crops, thereby providing a
buffer to glyphosate exposure. Roundup ready crops are not immune to the herbicide.
Rather, they exhibit greater levels of tolerance to its effect relative to other plants and
weeds.3 5 This permits farmers to apply Roundup during the growing season. It also
requires that the herbicide be applied less frequently, reducing input costs and increasing
profitability. The technology assures Monsanto a market for both its engineered seed and
3 4 “The herbicide paraquat...breaks down quite rapidly and has a low leaching potential. However, it is
toxic to a wide range of animals.... Atrazine has a low toxicity, but lasts for a long time in the soil before
breaking down” Reiss and Straughan (1996:140).
3 5 “Glyphosate normally works by inhibiting the activity of the plant enzyme S-enol pyruvyl shikimate-3-
phosphate synthase (EPSP). But company researchers have amplified EPSP expression some 30-40 times,
thereby creating resistance to glyphosate. Importantly, the enzyme coded by the newly inserted EPSP gene
seems to be processed by the cell just like natural EPSP. This means that it is transported to the
chloroplasts where it catalyzes the reaction” Klasner (1986c: 408).
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its herbicide Roundup, whose patent expires in 2000.3 6 As the data earlier revealed,
herbicide tolerant crops have initially dominated field test activity.3 7
Environmentalists condemn the development of herbicide tolerant crop strains for
fear that such genes will be carried by pollen to wild relatives. This will permit weedy
relatives to invade agricultural fields, and increase the likelihood for further lateral
genetic drift.3 8 Organic farmers fear that pollen from GM crops will unintentionally
pollinate their own fields, undermining the crops’ organic status.3 9 Recent research of
GM oilseed rape shows its pollen can fertilize plants 400 meters away, as well as
hybridize with other crops.4 0
3 6 “Prior to using Roundup, he applied herbicides four to five times during a season, whereas the latest
technology requires that Roundup be applied only twice a growing season. This decrease in herbicide and
labor needed for his crops means more money...in a given growing season” Lapp6 and Bailey (1998: 56).
3 7 “Approximately 90-95% of the area of land used to grow crops in Europe and the USA is treated with
herbicides each year” Reiss and Straughan (1996:139). “Currently, breeding crops for herbicide resistance
dominates agricultural biotechnology, and in field trials of engineered organisms, more than 40% of test
releases emphasize herbicide-tolerant crops” Pimental (1997: 17).
3 8 For a discussion of the risks posed by herbicide tolerant crops, see the United Nations Food and
Agriculture Organization (1999). Researchers have discovered an intron possessed by both fungi and a
number of crops. This suggests that it was laterally transferred (as opposed to vertically transferred through
inheritance). “‘We think there was at least one original donation from a fungas to a plant,’ says Palmer
[who directed the research]. Since then, it may have been shuttled from plant to plant by aphids or viruses”
Coghian (1999b). One proposed solution to the hazards of genetic drift is to engineer traits into
chloroplasts. Much as human mitochondrial DNA is inherited only maternally, chloroplasts are also
exclusively maternally inherited. Since only males produce pollen, traits engineered into chloroplasts will
not be able to spread. While this approach has been demonstrated in tobacco, it remains to be seen if it can
enjoy wide commercial use (Gray and Raybould 1998; Kleiner 1998a; Chevre et al.1997).
3 9 The U.S. organic food industry has grown to $3.5 billion/year. Originally, the USDA tried to include GM
crops among those that could be labeled organic. The grassroots response was overwhelming, and GM
crops and now cannot receive an organic label (Groves 1997a: Al; Groves 1998: D3).
4 0 Coghian (1999c). British law requires firms experimenting with oilseed to use buffer zones of 100
meters. HSE inspectors charged Monsanto with having neglected this requirement in at (east one field test
(“Gene Crop Charges” 1998). “Agricultural botanists in France have now shown that genes for herbicide
resistance engineered into oilseed rape can persist for several generations in hybrids between the transgenic
rape and wild radishes.... The escape of genes into wild plants has always been the main worry
surrounding transgenic crops” “Call for a Spin Doctor” (1997).
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3. Insects and Bt Crops
The second major commercial GM crops produce their own insecticide.4 1 Bacillus
thuringiensis (Bt) is a unique soil bacterium that kills some insect pests. The bacterium
produces a crystalloid protein that acts in a similar fashion as Bishop’s baculovirus in
Britain (ch. 6). When an insect ingests Bt bacteria, they reproduce in the host’s gut.
There, the bacteria produce a protein that destroys the cells lining an insect’s digestive
tract.4 2 This results in death.
Since the 1930s, farmers have applied Bt to fields to control some insects. As a
pest-control agent, Bt has a number of attributes. It is safe to humans and other
vertebrate, and different strains are highly host-specific. Organic farmers frequently use
it as an alternative to chemical pesticides, the latter of which 500 million kilograms are
used each year in the United States alone.4 3
Agricultural biotechnology firms have successfully engineered a variety of crops
to express the Bt gene that codes for the insect toxin. The advantage to farmers of Bt
crops is that they continuously express the toxin; when Bt is applied to crops in
traditional fashion, it quickly breaks down. EPA granted market-approval for Bt com in
August 1995.4 4
4 1 “Worldwide, around a third of ail potential crop production is lost through pests” Reiss and Straughan
(1996: 145).
4 2 “ Bt produces an insecticidal protein that binds to specific receptors located on the gut membranes of the
target insects. The binding interferes with ion transport in the epithelial cells of the gut, thus disrupting the
insect’s ability to feed. These natural insecticides have no toxicity to mammals or even to any other species
or insects” Gasser and Fraley (1992:62). Gasser and Fraley collaborated for five years on crop
improvement research at Monsanto.
4 3 “Pest insects destroy approximately 13% of potential crop production, despite the use of large quantities
of toxic insecticides and various nonchemcial controls” Pimental (1997).
4 4 “This EPA approval is the final regulatory hurdle for modified com, as the U.S. FDA has cleared it on
safety grounds. The USDA, meanwhile, says it will treat genetically modified com seed in the same way
as com hybrids bred by conventional means” Ward (1995: 544).
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Both Roundup Ready and Bt crops represent the first generation of agricultural
biotechnology crops for commercial use. While estimates of their use vary, all observers
agree that their adoption by American farmers is nothing short of stunning, despite the
premium charged for their seed.4 5 Farmers in Canada and Argentina - two other
important grain exporters - have also aggressively adopted GM crops, as table 7.1
reveals.4 6
Table 7.1: Percent of Acreage Planted with GM Crops in Three Countries.
1996________ 1997________1998
United States
Com 13% 26% 50%
Cotton 9% 16% 39%
Soybeans 7% 23% 48%
Canada
Canola 5% 35% 47%
Com 0% 3% 38%
Soybeans 0% 0% 6%
Argentina
RR Soybeans 2% 23% 50%
Cornell researchers in 1999, however, suggested that Bt crops may pose a threat
to the Monarch butterfly, which breeds among other places in the Midwestern com belt.4 7
Other research suggests Bt can bio-accumulate, having toxic effects on non-target
4 5 “The $30-a-bag premium originally charged for Bt com seed has shrunk, in part because fanners aren’t
used to paying a lot on insecticides to kill that bug....Novartis...said yesterday after Monsanto’s
announcement that it is also field-testing rootworm-resistant com....Mycogen Corp. and Pioneer Hi-Bred
International Inc. are jointly trying to genetically engineer a rootworm-resistant com using genes from [Bt]
(Kilman 1998b: A2). Rootworm causes an estimated $1 billion in damage each year.
4 6 Mitsch and Mitchell (1999:20).
4 7 Losey, Rayor and Carter (1999) published the research. The hazard is indirect. A Cornell researcher
distributed Bt maize pollen on milkweed, an important part of the Monarch’s diet as a caterpillar. He found
that the pollen was toxic, killing half the caterpillars tested. Bt maize constitutes a quarter of the U.S. com
crop (Kleiner 1999). “The European Commission said on Thursday it would freeze the approval procedure
for a genetically modified maize developed by U.S. company Pioneer Hi-Bred International following a
U.S. study which found that a similar pest-resistant grain could kill butterflies” Mann (1999).
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organisms,4 8 and that it can persist for months in the field in the roots of Bt plants 4 9 The
most contentious issue, however, is that Bt crops will result in Zfr-resistant pests.5 0 This is
because broad use of such crops increases the selection pressure on insects: those that
develop resistance through random mutation enjoy a selective advantage. Contemporary
experience with antibiotic strains reveals that resistance is an advantage that can pass
rapidly through a population. To offset this, the EPA requires farmers using Bt crops to
set aside 4% of their fields with non-Zfr crops that are not to be treated with pesticides. If
they continue to use other pesticides, then they must set aside 20% of their fields. These
are to serve as natural pest refuges, and to forestall the emergence of resistant strains.5 1
According to one report, farmers are hard pressed to understand why they should
establish refuges for pests that otherwise ravage their crops. The self-interest advantage
from defecting from this requirement are obvious.5 2
4 8 “Angelika Hilbeck and her colleagues at the Swiss Federal Research Station for Agroecology and
Agriculture near Zurich raised plant-eating insect larvae on Bt maize, developed by the Swiss company
Novartis.... When they fed the plant-eaters to the larvae of green lacewings, a major predator of maize
pests, the death rate among the lacewings nearly doubled. Worryingly, this happened even when the
lacewings ate larvae from a species that had been feeding on Bt maize but was not affected by the toxin.
Such fir-resistant insects could transfer the toxin to insect-eaters throughout the growing season”
MacKenzie (1998a). Others dispute this research: see for example Concar (1999). “We find that...wasp
parasitoids that had attacked Bt-resistant moth larvae on transgenic plants suffered no measurable adverse
effects of Bt toxins on their behaviour as adults or on the survival of their larvae” Schuler et al. (1999:
823). Other research suggests that rape seed engineered with protease inhibitors that are fatal to insect pests
may also affect beneficial insects, such as honeybees (Crabbe 1997).
4 9 “Study: Gene-Modified Com...” (1999).
5 0 “Already, heavy use of directly applied Bt insecticides has led to the emergence of resistant insect
populations, for example diamondback moths in Hawaii and potato beetles in Florida and New York.
According to other reports, fir-resistant insects are now found on crops in Japan, the Philippines, Thailand
and Taiwan” Fox (1991:827). A more infrequently expressed fear: “It is also easy to imagine a fir-
protected plant becoming invasive because the absence of herbivores increases the plant’s reproductive rate
and vigour so much that the plant runs wild” Kareiva and Stark (1996: 52). It should be recalled, however,
that centuries of traditional breeding have frequently produced crops that cannot survive without human
intervention.
5 1 Kleiner (1998b).
5 2 Pollan (1998:62).
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The development of Bt resistant pest strains would hit organic farmers particularly
hard. This is because organic fanners rely significantly on the toxin for pest-control; the
use of equivalent chemical pesticides would nullify their products’ organic status.
Biotechnology advocates claim that there are a variety of Bt strains, so that when
resistance develops to one, then both organic and GM farmers can switch to a different
one.5 3 Some research suggests, however, that resistance develops more quickly than
previously believed, and that the development of resistance to one strain confers
resistance to a broad range of Bt toxin.S 4 This and other research leads some to call into
question the refuge strategy.5 5
Further into the future, some envision the use of modem biology to develop
transgenic strains of insects. Beneficial insects could be engineered for resistance to
commonly used pesticides. Strains of sterile male insects have already been released into
fields in eradication efforts; research continues apace to engineer similar females.5 6
Finally, as Figure 7.5 (above) reveals, nearly 15% of field tests conducted in the United
States have involved virus-resistant crops. Commercialization of these crops has been
slower than Bt or herbicide tolerant varieties. Some research suggests that GM virus-
resistant crops will accelerate the emergence of novel crop-viruses.5 7
5 3 For example, research by Bowen et al. (1998:2131) suggests that “Pht toxins are as potent as the [small
delta, Greek]-endotoxins of B.thuringiensis and therefore may provide useful alternatives to the
deployment of Bt toxins in transgenic plants.”
5 4 “Researchers in Tucson...have found that in one pest - the diamondback moth - a single gene change
can confer resistance to four different Bt toxins. That means the scope for rapid spread of resistance might
be much higher than thought” “A Growing Irony” (1997).
5 5 Liu et al. (1999); Huang et al. (1999); Crawley (1999).
5 6 “Insecticide resistance is only the most obvious useful phenotype that could enhance the effectiveness of
some beneficial arthropods. Other desirable qualities that could be engineered into insects with transgenic
technology include pathogen resistance, general environmental hardiness, increased fecundity and
improved host-seeking ability” O’Brochta and Atkinson (1998:95).
5 7 One approach has been “to vaccinate plants by inserting into them pieces of genes from plant viruses.
Most scientists considered this safe. They also believed it would enable farmers to reduce the use of
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IV. The Transnational Politics of GM Crons and Food
The widespread adoption of GM com and soybeans generated substantial
worldwide controversy, because both are primary inputs for the processed food industry.
Soybeans are an important source of protein, and are frequently used as a protein
supplement. Com is frequently used through com syrup as a sweetener. The Economist
estimates that 60% of processed foods in the United States qualify as GM foods. Since
the FDA’s May 1992 GM food ruling, such foods have not required labels.
In Europe, the issue has been treated quite differently. Five years after the FDA’s
label decision the EU Commission instructed in July 1997 that products containing
genetically engineered com and soybeans would require labels indicating them as such.5 8
This initial ruling did not clarify all issues. For instance, food processors which strive to
assure non-GM sources for their inputs can discover traces of GM ingredients in their
product. This is because the inputs for both GM and non-GM ingredients frequently
intermingle through the process from the field to the table, whether in grain elevators or
barges. In October 1999 the Commission clarified the standards to govern processed
foods that suffer such “accidental contamination.” To avoid the EU label requirement,
food items must possess less than 1% GMO per individual ingredient. For example, if a
pesticides to kill insects that carried the viruses. Dr. Allison’s research, which was jointly sponsored by the
Department of Agriculture and the Monsanto Company, showed that the inserted genes can recombine with
natural plant viruses and produce wholly new viruses at a rate higher than had been theorized by experts at
the E.P.A and the Department of Agriculture. The implication of the research, said Dr. Allison, was that
engineering plants to be resistant to viruses might lead to entirely new types of viruses that could cause
widespread damage to American crops” Schneider (1994: A14). Yoon (1991: Al) reveals that the
controversy has recently reemerged. Falk and Bruening (1994:1396) play down such fears: “The potential
benefits of engineered resistance genes far outweigh the vanishingly small risk of creating new and harmful
viruses in significant excess over being created by natural processes.”
3 8 “The ruling will increase market access. Austria, Italy and Luxembourg ban the import and sale of
GMOs. France refused to allow imports until a labelling scheme was in place. Under the single market,
restricting imports on a national basis is next to impossible” “Labelling the Mutant Tomato” (1997:60).
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product contains 1% cornstarch, then no more than 1% of that cornstarch can be derived
from GM sources.5 9 Some have asked important questions about the ability to test at
these levels.6 0
In addition to evolving standards for GM foods, EU officials have struggled to put
in place a system for authorizing GM crops. According to the EU’s GMO Directive of
April 1990, any member state can provide a GM crop marketing approval, which is to be
valid throughout the EU. Other member states can challenge an authorization, however,
and impasses are to be settled by majority vote. This procedure has never worked
effectively, with delays running two years or more.6 1 The system broke down entirely in
the face of mounting consumer concern over GM crops and food during the late 1990s. In
June 1999 EU Environmental Ministers agreed to more strict licensing guidelines, which
are not expected to be in effect until 2002, effectively freezing the approval process.
“In April 1997 20% of Austrian voters signed a petition to keep genetically modified crops out of Austria”
MacKenzie (1997c).
5 9 The European Union (1999).
6 0 “The Laboratory of the Government Chemist, and independent UK body says that extracting DNA from
highly processed food in a form suitable for reliable PCR testing can be ‘challenging and unpredictable’”
Whitehouse (1999). See also Byrnes (1999).
6 1 For example, the Swiss firm Ciba-Geigy (now Novartis) engineered a com with the Bt toxin and resistant
to its glufosinate-ammonium herbicide Basta. Such multiple characteristics are said to be “stacked.” While
the product received approval in the United States and Canada, it generated controversy within the EU.
Ciba-Geigy had originally applied to - and received from - French authorities marketing approval. But
under the terms of the GMO Directive, other countries can protest a country’s authorization, and impasses
are decided by majority vote.
British experts expressed concern with Ciba-Geigy’s com. The problem was not with the Bt gene
or the herbicide resistance, but the use of the antibiotic ampicillin as a genetic marker. A member of
Britain’s Advisory Committee on Novel Foods and Processes argued that the marker increased the hazard
of spreading antibiotic resistance among livestock and human pathogens. When European approval was
put to a vote Britain, Sweden, Austria and Denmark opposed the com, while Germany, Italy Luxembourg
and Greece abstained from voting. The controversy was submitted to a scientific panel of the European
Commission, which ruled the com to be safe.
Opponents, however, remained doubtful, and Austria, Luxembourg and Germany announced an
import ban. The labeling issue generated greater public concern in Europe than in the United States.
Several member states of the European Union - Luxembourg, Austria, Germany - moved to ban the import
and sale of novel foods. For a discussion of this episode see Coghian (1996a), Patel (19%), MacKenzie
(1997a), MacKenzie (1997b) and MacKenzie (1997d).
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As the GM debate in Europe reached its crescendo at the end of the decade, it
began to have a significant transnational effect. It set the stage for further transatlantic
agricultural frictions. American trade officials identified the EU’s increasingly restrictive
GMO polices as “the single greatest trade threat that we face.”6 2 European fears of GM
food resulted in an estimated loss to American farmers of some $200 million in annual
com export sales in 1998 and 1999.6 3 Ominously for the agricultural biotechnology
industry, a two-tiered grain market emerged in the spring of 1999. Industry analysts
reported that non-GM soybeans and com were fetching a premium to satisfy European
and other foreign demand. Archer Daniel Midlands (ADM), a giant food processor,
announced it too would offer a premium for non-GM grain. Food processors throughout
the world (e.g., Heinz, Gerber, Kirin,) made public pledges to avoid the use of GM
ingredients.6 4
Europe was not alone in experiencing GM fears. In August 1999, Japan
announced that 30 food products using GMOs would require labels beginning in 2001.
In contrast to the EU level, the Japanese adopted a more permissive 5% threshold. Food
6 2 “The European Union’s resistance to genetically-modified foods and agricultural products is the biggest
trade threat faced by the United States, Stuart Eizenstat, the nominee for the second-highest job at the U.S.
Treasury Department, said Tuesday. ‘Almost 100 percent of our agricultural exports in the next five years
will be genetically-modified or combined with bulk commodities that are genetically modified,’ Eizenstat
testified before the Senate Finance Committee. The EU’s fear of bioengineered foods and farm
commodities is ‘the single greatest trade threat that we face,’ he added” “EU Biotech Food Fear...” (1999).
6 3 “The European Commission said on Friday it was confident it could defend its revised approval process
for genetically modified crops against U.S. criticism at the World Trade Organization ii need be. EU
environment ministers on Friday signed up to strict new licensing guidelines for GM products, effectively
halting all new GMO approvals until the new licensing law is in place, probably not before 2002. No GM
crops have been approved in the EU since April 1998 because of shortcomings in the existing approvals
system” Osborn (1999). See also Masood (1999:641).
Mitsch and Mitchell (1999). “The Kirin Brewery Company announced that starting in 2001 it would use
only com that has not been genetically engineered. A day later, Kirin’s competitor, Sapporo Breweries,
announced that it, too, would revert to traditional com, which is an ingredient in some types of beers.... In
Mexico, which bought SSOOm illion of American com last year, Grupo Maseca, that company that is the
leading producer of com flour, said recently that it would avoid importing genetically modified grain”
Petersen (1999).
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producers were to be required to label their products “GM-based” or “GMOs not
segregated.” A final labeling of “GM-free” may be used voluntarily, provided the non-
GM sources are authenticated.6 5 Also in August, the Australia and New Zealand Food
Standards Council “agreed to require mandatory labeling of foods produced using gene
technology and foods containing genetically modified ingredients.”6 6 Meetings were
scheduled for early 2000.6 7 Similar concerns and review followed in Thailand and
jr O
China. A growing wave of concern spread rapidly around the globe, and proposals for
labels soon followed.
Amid these growing global developments, the American FDA announced a series
of public meetings around the United States. The FDA wished to share its approach to
GM food regulation and to solicit views on whether the current regulatory process needed
modification.6 9 Whereas this history of agricultural biotechnology regulation generally
places the United States at the forefront with other countries following suit, in the case of
labels the FDA appeared to be playing catch-up with an increasingly global trend. FDA
authorities may have hoped that their May 1992 “substantial equivalence” principle
would pass through the OECD to the industrialized world. Instead, the European push
for labels appeared to reverberate around the world and back to the FDA’s Washington
offices.7 0 A bipartisan group of US Representatives pledged to introduce legislation
6 5 Takada (1999) and Dawson (1999: 16). For further discussion of Japanese, Australian and New Zealand
rules, see Evans (1999).
6 6 “Health Ministers Agree...” (1999).
6 7 “Health Ministers Agree...” (1999).
6 8 “Thailand...” (1999); Treerapongpichit (1999: 1).
6 9 “Notices” (1999: 57470). Claiborne (1999: A3).
7 0 “European fear of GM foods has begun to creep across the Atlantic in recent months, creating a growing
controversy that US authorities could no longer ignore” Dunne (1999:4). American firms organized their
own effort to head-off any public concern (Barboza 1999: Al).
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requiring the labelling of GM foods.7 1 Poll data suggested Americans’ confidence in the
technology wavered.7 2
V. Industry Concentration. Hybrids. Seeds. Germplasm & Terminator Technology
For agricultural biotechnology firms, genes constitute the basic resource.
Recombinant techniques permit firms to shift commercially attractive traits into seeds for
sale to farmers. Several large firms have dominated the emerging agricultural
biotechnology industry, perfecting the requisite techniques and developing novel
agricultural products. These large firms have acquired an increasing share of the global
industry in seed production and distribution. In doing so they have assumed control not
only of these smaller firms’ marketing experience, but also that which generations of
farmers pursuing commercial advantage have found so attractive: germplasm.7 3
7 1 ‘ “Today’s limited scientific knowledge warrants allowing consumers to make a better, more informed
choice,’ said Rep. Dennis Kucinich, D-Ohio, leader of an effort to identify for the marketplace all
genetically altered food” Rizzo (1999). See also his testimony before the Senate Committee on
Agriculture, Nutrition, and Forestry, available from
http://www.usia.gov/topical/global/biotech/991 00701 .htm (November 4, 1999).
7 2 Thomas Hoban of North Carolina State University has tracked American attitudes toward plant
biotechnology. According to him, “The surveys I have conducted over almost a decade document that
between two-thirds and three-quarters of American respondents are positive about plant biotechnology.
For three years (1992, 1994 and 1997), just over 70 percent of American consumers supported agricultural
biotechnology.” http://www.informinc.co.uk/LM/LMl 19/LM 1 l9_GMO_Hoban.html (December 16,
1999). According to a Gallup Poll conducted in September 1999 following the furor in Europe, “51 percent
support [GM] foods and 41 oppose them. Eight percent had no opinion” Steyer (1999: A16).
7 3 The term germplasm invokes a number of complicated intellectual property issues. “Land races and
primitive cultivars have been developed by peasant farmers. They are the product of human labor....
Simmonds observes, ‘Probably, the total genetic change achieved by farmers over the millennia was far
greater than that achieved by the last hundred or two hundred years of more systematic science-based
effort’.... Perhaps the simplest and most palatable solution would be a commitment by the advanced
industrial nations to provide financial support for Third World nation breeding programs and germplasm
preservation and development. Such an arrangement could even fit within the FAO’s undertaking”
Kloppenburg, Jr. and Kleinman (1987: 197). According to the Chairman of the Consultative Group on
International Agricultural Research (CGIAR), biotechnology patents will create a “scientific apartheid,”
which locks the developing world out of sharing in the bounty. These fears have been heightened in the
early years of biotechnology, as companies acquire broad patent protection. Agracetus, for example,
received a patent for its gold-biolistics technology for modifying soy. It received a European patent,
however, covering all GM soya, which it subsequently sold to Monsanto (Pearce 1996). These have led to
a number of lawsuits throughout the industry (Stone 1995:6S6). For a critical view of the patent issue,
“bioprospecting” and “biopiracy,” see Shand (1994).
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The two most important American firms - DuPont and Monsanto - were formally
dominant players in the chemical sector. But both these and other companies have
followed a similar path in the 1990s by shedding their chemical divisions, reinventing
themselves as “life-science” firms, and going on a germplasm acquisition binge.7 4 The
concentration of germplasm into a handful of multinational corporations had both
traditional opponents and proponents of agricultural biotechnology occasionally
agreeing.7 5 These fears were heightened by the frequent rumor of a possible merger
between Monsanto and DuPont.7 6
Crops beget seeds; seeds beget crops. Such a fact would seem to present an
obvious problem for the agricultural industry, since a farmer could save seed from one
7 4 “DuPont announced that it would sell up to 20% of its $22 billion Conoco subsidiary and plow the
proceeds into its iife-sciences business, which use biotechnology to develop genetically engineered crops,
new drugs, and innovative methods for manufacturing chemicals. Monsanto moved still further from its
origins as a chemical company and into a biotech future by buying DeKalb Genetics and the Delta & Pine
Land Co.... Monsanto paid $2.3 billion for DeKalb, a com and soybean producer, or $100 a share, which
was fully three times DeKalb’s share price. Losing out in a bidding war for DeKalb was rival Novartis, a
Swiss company with similar drug, agriculture and chemical businesses” Brownlee (1998:48). “Not far
behind, Hoechst finalized plans [in summer 1997] to sell off its chemical operation by 2000 to focus on its
extensive life science operations. In October, Rhone-Poulenc announced plants to split off chemicals,
fibers, and polymers. Others are keeping chemical operations but increasing their life science activities. In
May, Dow Chemical spent $1.2 billion to become sole owner of DowElenco, buying out its joint venture
partner Eli Lilly. Dow renamed the agchem unit AgroSciences and says it expects to double AgroSciences
sales by 2005, largely based on increased opportunities in biotech” “Global Forecast ’98...” (1998: 28).
“The Monsanto Company said yesterday that it had agreed to buy Holden’s Foundation Seeds Inc, a major
com seed producer, and two Holden seed distributors, for $1.02 billion.... By acquiring Holden’s
Monsanto will become the biggest American producer of foundation com, the parent seed from which
hybrids are made; it will also have an important distribution network for its own genetic plant technology”
Gilpin (1997: D8). “Monsanto is to pay $240 million for Asgrow Agronomics, the second largest soybean
seed producer in the US” Morse and Crawford (1996: 37). “Hoechst has reinforced its commitment to both
the agricultural and biotechnology sectors with the acquisition, through its agrochemcials unit AgrEvo, of
the Belgian-Dutch company PGS International, a leader in plant technology with a broad portfolio of
patents covering genetically modified plants” “AgrEvo Buys Biotech Firm” (1996: 9).
5 “BIO’s and Monsanto’s collusive, anti-competitive behavior corrupts the basic principle of the free
market” Miller (1996: M5).
7 6 “DuPont and Monsanto Discussed Merger...” (1999: C3). These rumors have followed the two
companies for several years. “Through direct investment and alliances the two rivals are getting control of
seed producers for most major U.S. crops. Combined, they would control roughly half of the U.S. seed
market for soybeans and even more of the seed market for com- the nation’s two largest crops. Monsanto
alone stands to control a staggering 80% of the U.S. cotton-seed market, if pending transactions win
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year’s harvest to use for the next. Crops vary, however, according to their patterns of
sexual reproduction. Potatoes, for example, are tubers, and propagate vegetatively. A
consequence of this is that they are genetically similar, as the Irish tragically learned in
the late 19th century. Commercially exploiting an advantage introduced into a crop such
as the potato becomes difficult, since farmers need not return seasonally to purchase new
seed. On occasion, farmers will not return to a seed company for several years, perhaps
until the breeder has something new to offer. Other important crops for which this is the
case are wheat, rice, soybeans and cotton.
In the late 1990s, recombinant technology appeared to provide the means both to
generate new crops and to force farmers to purchase new seed before every harvest, the
best of both worlds from a corporate perspective. In March 1998 Delta and Pine Land
Company received a unique patent. They and researchers from the USD A (with whom
they share the patent) had invented a gene system that inhibits development of viable
seeds. To understand the technology, it is useful to remember that multicellular
organisms are organized systems of differentiated cells. Cells within multicellular
organisms express different genes and therefore produce different proteins. That is how
eyes differ from skin.
In addition, cells may express different genes and produce different proteins at
different points in time. Delta and Pine researchers discovered a gene that is expressed in
seeds at the late stage of development. Associated with this gene is a promoter, a
sequence that controls the expression of the gene. Metabolic cues within the cell trigger
regulatory approval” Kilman (1998: Bl). A $34 billion merger between Monsanto and American Home
Products collapsed in 1999 (“Monsanto and AHP... 1998:34).
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the promoter. Delta and Pine united the late-stage promoter with a gene that codes for
ribosome inhibitor protein (appropriately, RIP) from the plant Saponaria officinalis.
When RIP is present in small quantities, it inhibits the production of cellular proteins.
Linking the late-stage promoter to the RIP gene inhibited the production of viable seeds
in their final stage of development. Such a system could be used to kill the seeds that
farmers might otherwise retain for a subsequent year’s harvest.
It should quickly become apparent that such a system alone presents a Catch-22 to
seed producers. This is because if a firm successfully introduces the hybrid RJP-late-
stage promoter into a crop, then it would be unable to breed those crops to produce viable
commercial seeds. The system itself would appear to inhibit a seed company from
harvesting seeds for their eventual sale.
Delta and Pine circumvent this problem with a second repressor-promoter gene
system. To achieve this, they insert a blocking DNA sequence between the promoter and
the RIP gene. The blocking sequence inhibits the promoter from expressing the RIP
gene, and consequently permits a plant to produce viable seeds. On either side of the
blocking sequence is engineered a sequence susceptible to a specific enzyme (in this case
recombinase). In the presence of this enzyme, the blocking sequence is excised, reuniting
the promoter and the RIP gene, and leading to the production of nonviable seeds.
The enzyme responsible for removing the inhibitor is itself engineered into a
second repressor-promoter system. This repressor inhibits expression of the recombinase
enzyme. However, this repressor can be controlled (e.g., switched off) by a chemical
stimulus (in this case, tetracycline). These gene systems permit plant breeders 1. to grow
sufficient seeds for sale which express the RIP gene, and then 2. to activate the RIP gene
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prior to sale by treating them with tetracycline. Figure 7.7 summarizes this elaborate
system.
Delta and Pine’s patent attracted the attention of the Rural Advancement
Foundation International (RAFI), an international organization devoted to socially
responsible technologies for rural societies. They dubbed it “terminator technology” and
argued it ran counter to the ageless tradition of retaining seeds for subsequent harvest.7 7 It
subsequently emerged that the major agricultural biotechnology firms were pursuing
variations of terminator technology that aimed to wed farmers to annual seed purchases.7 8
Another approach involves engineering seeds to require specific chemical inputs in order
to mature, thereby linking a firm’s seeds and its chemical inputs.7 9 American firms
7 7 According to a RAFI spokesperson, “It’s terribly dangerous... Half the world’s fanners are poor and can’t
afford to buy seed every growing season. Yet they grow 15 to 20 percent of the world’s food.” A USDA
scientist involved in its development counters, “Our system is a way of self-policing the unauthorized use
of American technology... it’s similar to copyright protection” Edwards (1998). Early on, Monsanto used a
different approach: “To buy Monsanto’s patented Roundup Ready soybeans and Bt cotton seeds, farmers
must pay a $5 per bag ‘technology fee’ and sign a two-part agreement that ensures they will sell all the
crops they harvest. This is to prevent farmers from holding back some of the seed from their crops to plant
on their farm or sell to others. The agreement gives Monsanto the right to monitor farmers’ soybean crops
for three years to make sure they aren’t planting seeds that have been held back” Yates (1996: Cl).
7 8 They need not only protect GM crops. A New Zealand researcher recently announced that he had
engineered a relative of the cabbage to absorb gold dust through its roots, opening the possibilities for
“phytomining.” Other plants are being explored for their ability to absorb toxic metals from soil, a process
called phytoremediation (“Gilding Cabbages” 1998: 88). GM trees are also being explored. Research on
trees has been limited by the size of the genomes (roughly 10 times that of humans), and their slow
maturity (versus E.coli, for example). See “Gone is the Forest Primeval” (1998). Other work is being done
to change flower colors (such as a GM petunia that is blue), and to engineer normally scentless flowers
with fragrance (“Blooming Biotech” 1998: 76). An Australian firm, Florigene, has received permission to
market its GM violet carnations in the U.S. and EU (Coghian 1999a).
7 9 “The latest version of Monsanto’s suicide seeds won’t even germinate unless exposed to a special
chemical, while Astra/Zeneca’s technologies outline how to engineer crops to become stunted or otherwise
impaired if not regularly exposed to the company’s chemicals. A Novartis patent describes a process for
chemically regulating a number of developmental processes in plants - such as germination, sprouting,
flowering, fruit ripening, etc. The patent specifically mentions that the chemical regulator can be applied to
plants in combination with a fertilizer or herbicide” RAFI Communique (1999). “Pioneer Hi-Bred has
found a way of recombining genes with the potential to create seedless varieties of many fruits and
vegetables” “Right Genes... 1998).
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Figure 7.7: Terminator Technology.
The following gene systems would permit firms to protect their R&D investment. A repressor
normally inhibits a gene that codes for the recombinase enzyme. This enzyme recognizes and
cuts specific sites along the chromosome (indicated by the arrows). The RIP gene codes for a
protein that inhibits production of viable seeds, and it is linked to a late-stage promoter. A
blocking sequence normally prevents the promoter from expressing the RIP gene. This allows
plant breeders to grow multiple generations o f a crop to produce seeds for sale.
Repressor Recombinase Enzyme
Late-Stage Promoter Blocking Sequence RIP Gene
Recombinase Site Recombinase Site
Prior to their sale, seeds are treated with tetracycline, which deactivates the represssor. This
permits expression of the recombinase gene. Recombinase enzymes are produced, which cut the
sites flanking the blocking sequence. The blocking sequence is thereby excised, uniting the late-
stage promoter with the RIP gene. The RIP gene is expressed in the late stages o f seed
development, producing a toxin that kills the seeds grown from the farmer’s crop.
Tetracycline
-Q Q Q__________
ffrepjegspr__________ Recombinase Enzyme
O O O
RIP Gene Blocking Sequence Late-Stage Promoter
Recombinase Site Recombinase Site
Late-Stage Promoter RIP Gene
Non Viable Seed Seed toxin
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possess the lion’s share of the agricultural biotechnology patents such systems are
designed to protect.8 0
In May 1998, Monsanto moved to acquire Delta and Pine, not necessarily for the
terminator patent, but more so for the company’s cotton germplasm. In doing so,
however, they became the primary target of an international firestorm of protest that
arose regarding the terminator.8 1 RAFI pursued a global campaign against terminator
technology, and India announced an import ban on seeds containing it (though it had
never been commercialized).8 2 Somewhat ironically, terminator technology is analogous
to the biologically disabled strains of E.coli K-12 developed for early recombinant
laboratory work (ch. 1). In much the way that the early E.coli strains were engineered to
check their spread, terminator technology provides a means of inhibiting the spread of
GM genes. Although some environmentalists originally advocated “suicide genes” for
GMOs destined for release, they vilified its use to protect research investment.
Through 1998 and 1999, Monsanto came under increasing pressure from
environmental groups opposed to its aggressive GM strategy. Greenpeace organized
anti-GM protests throughout Europe. The leader of this effort, Benedikt Haerlin, had
previously served with the Green Party in the European parliament. His interest in and
8 0 “...56% were owned by American organizations. The top three patent owners were: Pioneer Hi-Bred (68
patents), Monsanto (62) and its subsidiary Calgene (49)” Fox (1999). For a discussion of Monsanto’s
acquisition of Calgene, see Groves (1997b). “Plants can be patented, according to a landmark decision
published by the European Patent Office last week.... In February the Technical Board of Appeal ruled that
although a patent could be granted for a method of producing herbicide-resistant plants and seeds, it could
not be granted on the pants and seeds themselves” “Patent Office Sets...(1995:667).
8 1 “Monsanto - which brought you Agent Orange, PCBs, NutraSweet and bovine growth hormone...”
Margaronis (1998).
8 2 Edwards 1998a.
8 3 Thus, one finds that “The [RCEP] urges the Release Committee to encourage the use o f‘suicide genes’
which can cause an organism to self-destruct after a certain length of time” Watts (1989c: 30).
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opposition to biotechnology followed a chance meeting to Washington DC in the mid-
1980s. During that trip, he met Jeremy Rifkin, who was then engaged in his effort to
prevent field tests. The meeting resulted in continued contact, and the gradual
establishment of an organization of anti-biotechnology coalition that pursued the cause
after the introduction of GM crops and food.8 4
In Britain, Monsanto sought to regain the initiative by spending £1 million in a
public relations campaign to assuage consumer fears about GM foods. These efforts
brought little return, especially given the Prince of Wales’ public condemnation of GM
crops and food. Meanwhile, the European rejection of agricultural biotechnology
deepened. Facing a complete route, Monsanto ended its confrontational strategy in the
summer of 1999, and agreed to conduct a public dialogue about transgenic agriculture
with non-governmental organizations and environmentalists.
As part of its new campaign, Monsanto organized a public forum, featuring its
board of directors, environmental opponents and Gordon Conway, President of the
Rockefeller Foundation. The Rockefeller Foundation has been active for decades in the
area of agricultural genetics. It provided much of the funding that facilitated the spread
of high-yield hybrids during the Green Revolution. It has taken the lead in financing
research on staple crops in the developing world, such as rice and cassava. The major
agricultural biotechnology firms had generally ignored research on these crops because of
8 4 Remarkably, Haerlin was in Washington DC for a meeting on social security reform. “[The meeting
with Rifkin] had a profound impact on Mr. Haerlin - and ultimately, on the world's agricultural and biotech
industries. Mr. Haerlin went on to lead Greenpeace’s international campaign to stop the production and sale
of bioengineered food. Mr. Rifkin began making regular trips to Europe, seeking more allies. What
emerged was an unusual coalition of environmental, consumer, farm, church and nature groups. And by the
time the European Union decided in April 1996 to allow Monsanto Co. to begin selling genetically
modified soybeans in Europe, an activist network was already well-versed on the issue and ready to
pounce” Stecklow (1999: Al).
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the limited expected return on investment. Monsanto officials apparently assumed that
Rockefeller Foundation officials would serve as allies in their meeting with
environmental groups. They were wrong.
In June 1999 Conway delivered a speech before assembled members of the
Monsanto board and NGO representatives. After treating the audience to some of his
foundation’s work, and expressing his hope for agricultural biotechnology, Conway
emphasized that GM controversies in the industrialized world had broad significance for
the developing world. He argued that they threatened to undermine support for field tests
in the developing world. This would undo the Rockefeller Foundation’s efforts to deploy
biotechnology to the benefit of the 800 million people who currently go undernourished.
But Conway retained his most potent criticism for terminator technology:
The agricultural seed industry must disavow use of the terminator technology to
produce seed sterility. Astra Zeneca [a British biotechnology firm] has apparently
promised to do so. You have said that you will not exploit these patents until
there has been a fill, independent review of the impact of the technology, but I
believe you should now follow Astra Zeneca’s example. The possible
consequences, if farmers who are unaware of the characteristics of terminator
seed purchase it and attempt to reuse it, are certainly negative and may outweigh
any social benefits of protecting innovation.... If I may be blunt, Monsanto needs
to speak and to act differently if [biotechnology] is to be a part of the solution to
the problems faced by the most disadvantaged and the most vulnerable of out
fellow human beings.8 5
Soon thereafter Monsanto publicly announced that it would not commercialize its
terminator technology. The persistent activism of NGOs - the Rockefeller Foundation,
RAFI, Greenpeace and Friend of the Earth among others - stands as an example of global
8 5 The complete text of Conway’s speech is available at http://www.biotech-info.net/gordon_conway.html
(October 27, 1999).
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pressure being brought to bear on the industry’s premier company outside the traditional
regulatory arena.
By the end of 1999, Monsanto’s previous efforts to acquire germplasm had
attracted the concern of the American Justice Department’s antitrust division, and a
global class-action lawsuit. A proposed merger between Monsanto’s Searle
pharmaceutical unit and Pharmacia & Upjohn foresaw a spinoff of the suffering
agricultural unit. The firm that had staked so much on agricultural biotechnology
prepared to distance itself from the industry.8 6 Reports also suggested that American
farmers were threatening to abandon their embrace of GM seeds.8 7
VI. GMOs and the Global Trading System
As GMOs suffered increasing notoriety in the developed world, nations increased
multilateral efforts to control their trade and commerce. Beginning in 1996, discussions
under the Biodiversity Convention aimed to develop a “Biosafety Protocol” to regulate
GMO commerce. The American failure to ratify the Rio Convention meant that the
United States had only observer status at these talks. Despite this, it led the Miami Group
of GM proponents (Argentina, Australia, Canada, Uruguay, and the United States) in
opposition to strict rules governing GMO commerce. Some developing countries, in
8 6 “The Company’s share price has fallen from more than $49 in March to less than $34 in
September...Searle, which makes Celebrex, and arthritis treatment, is valued at about $35 a share by
analysts, placing an implied valuation of about zero on [agricultural] biotech” Wrong and Tait (1999: 15).
“The suit, filed in federal district court in Washington, aleges that Monsanto didn’t adequately test the
safety of its genetically modified com and soybean plants, and that the St. Louis company’s patented genes
are giving it too much control over how staple crops are used” Kilman (1999c: A3). The Justice
Department was concerned with Monsanto’s acquisition of Delta & Pine Land and the implications that had
for control of cotton seed. After 18 months of review, and after the announced merger with Pharmacia &
Upjohn, Monsanto dropped its proposed acquisition of Delta & Pine Land (Kilman 1999d: B12). On the
merger, see, Kaiser (1999).
8 7 “Next year [2000] looks as if it will bring the first decline in sales of genetically altered seeds after three
years of heady growth. Many farmers remain fans of the seeds and don’t share consumers’ anxiety over the
safety of genetically modified crops. But they can’t afford to ignore these concerns” Kilman (1999b: A1).
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contrast, argued for "advanced informed consent” rules, which would require firms to
receive national authorization prior to importing GMOs. In February 1999 delegates
suspended negotiations over this disagreement, the Protocol’s eventual relationship to
WTO rules, and the products to be covered. Negotiations resumed in September 1999
with the EU working to broker a compromise between disparate positions.8 8
The United States and Canada also spearheaded efforts to introduce agricultural
biotechnology onto the world trade agenda. For half a century, agriculture has remained
the most difficult and contentious issue in multilateral trade negotiations. Governments in
the developed world lavish subsidies, establish price-floors and retain tariffs on a broad
range of agricultural products. Agricultural trade has been the subject of recurrent and the
most acrimonious transatlantic trade friction, as the most recent and on-going controversy
over hormone-treated beef reveals. The US-EU dispute over beef hormones deserves
attention because of its implications for international GMO commerce.
American cattlemen have used both artificial and natural hormones for decades to
encourage their cattle to gain weight more rapidly, and to produce more flavorful and
8 8 “The protocol has been under discussion since 1996. The goal is to allow countries to give ‘advanced
informed consent’ before allowing GM organisms onto their territories, and many developing countries
also want the rules to cover products made from GM organisms. But that is vigorously opposed by
exporters of GM crops, including the US, Canada, Argentina, Chile and Uruguay” Pearce (1999). The U.S.
enjoys only observer status at these talks, since it has failed to ratify the Biodiversity Treaty. For
discussion of earlier failed efforts, see Coghlan (1996c). “The main sticking point in the biosafety
negotiations was whether the requirement for advance approval by the importing nation should apply to
genetically altered agricultural commodities meant for eating or processing, as opposed to planting.
Washington and its allies argued that such a requirement would not protect biodiversity because
commodities like com and soybeans do not enter the environment. Developing nations and the European
Union argued that commodities should be included because they have seeds that can be planted. Some
developing nations even wanted the treaty to cover products made from genetic engineering, such as
cornflakes made from modified com, or blue jeans made from altered cotton, but this was dropped from the
final draft. Another unresolved point of dispute was Washington’s position that the World Trade
Organization should subordinate the Biosafety Protocol, to prevent other nations from using biosafety as an
excuse to erect trade barriers. The developing nations and Europe wanted the biosafety protocol to be equal
to WTO rules or take precedence over them” Pollack (1999). See also Masood (1999:6).
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tender meat. In December 1985 the EC initially prohibited the import of animals and
meat from animals which had been administered hormones. European authorities claimed
that such beef could present a threat to human health. It postponed enforcement of the
ban until early 1989.8 9
After attempting other means of settlement, the US brought the hormone case
before the WTO. After reviewing the scientific evidence concerning hormone use and
human health, a WTO Panel ruled that the EU ban was without scientific basis, and
consequently inconsistent with WTO principles. Article II of the WTO’s Sanitary and
Phytosanitary Agreement (SPA) holds that, “Members shall ensure that any sanitary or
phytosanitary measure is applied only to the extent necessary to protect human, animal or
plant life or health, is based on scientific principles and is not maintained without
sufficient scientific evidence.” Without a scientific justification, the EU was obliged to
import hormone-treated beef. Despite this ruling, the EU maintained its ban, and the
WTO authorized the US to enact countervailing tariffs.9 0
The beef hormone dispute is significant because it points to two different
approaches to public food safety. The WTO’s SPA requires scientific evidence of harm
to justify renunciation of trade obligations. American trade representatives seeking to
export American beef to Europe had repeatedly argued this position. In contrast,
European authorities emphasized the precautionary principle. This principle holds that
authorities should take positive action in the face of conjectural hazard. This reliance
8 9 A useful timeline of the hormone dispute appears at http://www.fas.usda.gov/itp/policy/chronology.html
(October 15, 1999). See also, “A Primer on Beef Hormones,”
http://www.fas.usda.gov/itp/policy/hormone2.html (October 15, 1999).
9 0 See “The US-EU Hormone Dispute,” httD ://www.fas.usda.gov/itp/policv/honnone 1 -html (October 15,
1999). See the World Trade Organization (1999).
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became more pronounced toward the end of the 1990s following a series of European
food and health scares (e.g., “Mad Cow” disease in Britain; dioxin-contaminated poultry
feed and chemically-contaminated Coca Cola in Belgium; and AIDS-contaminated blood
in France).
One of the fears concerning GMOs is that they may present a long-term threat to
human health. This has been a basis for stricter European biotechnology regulations. In
November 1999 Seattle was the venue for a WTO Ministerial Meeting. In the weeks
prior to the meeting, EU officials increased their call for greater inclusion of the
precautionary principle, and specifically for reconsideration of the SPA's emphasis on
scientific evidence.9 1 Such reconsideration might permit extension of the precautionary
principle to cover GMOs. The beef-hormone example suggests how such a principle
would function in practice.
Among the EU’s allies to this debate is Greenpeace, which employs a similar
definition of the precautionary principle:
As a sound approach to preventing possible environmental damage, the
precautionary principle has long been accepted by the international community.
In essence, its “better safe than sorry” concept allows for action to be taken to
prevent potential harm, even where there is no absolute proof the harm will occur
or of the cause of the harm. The use of the precautionary principle is especially
important in the case of GMOs, given the lack of scientific certainty or consensus
about their impacts.9 2
9 1 Consequently, news reports from early October have EU Commission President Romani pledging to
have the precautionary principle enshrined in any new WTO accord. Margot Wallstrom, the EU
Environment Commissioner, told the European Parliament’s environment committee in September 1999
that the EU would insist on a right to exercise the precautionary principle. She claims that the United
States, “doesn’t understand the thinking behind the precautionary principle. They put more emphasis on
scientific proof; we say you can’t always do that. It’s enough to think there may be a risk.” Such a
principle would hold world trade hostage to the perception of politicians; distinguishing between their
honest fears and their traditional effort to block imports would be impossible.
9 2 Greenpeace International (1999).
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“Better safe than sorry” may seem a sensible adage. Arguments have already been
advanced as to why the precautionary principle is an inadequate means for decision (see
chapter 2). From a practical standpoint, however, placing safety over regret permits
justification of any and all action. It places parties in the impossible position of proving
the “safety” of a good or activity.
The United States indicated that it would resist efforts to reopen the SPA. It is
hard to imagine that if such language were adopted that a WTO Panel would be able to
make a ruling such as that provided in the beef hormone dispute. Scientific certainty is
an impossible standard. If the precautionary principle is to govern the resulting
uncertainty, then all claims of hazard are defensible, and would serve to justify all
Members’ import bans.
Export subsidies, direct payments to farmers, and import barriers have
traditionally dominated the WTO’s agricultural agenda. In advance o f Seattle, member
states staked out competing positions for GMOs. Japan supported placing GMOs on the
agenda. Canada called for a Working Group on agricultural biotechnology. And in
contradistinction to the European position, the United States argued that global rules for
agricultural biotechnology should be governed by the four principles of sound science,
transparency, predictability and timely decision making.9 3 While reports from Seattle
suggest that developed countries agreed to consider agricultural biotechnology, the talks
collapsed on the issue of agricultural subsidies.
Shortly thereafter, in January 2000, negotiators from 130 countries resumed and
9 3 United States Trade Ambassador Charlene Barshefsky announced these principles in her October 20,
1999 testimony before the House Committee on Agriculture, American Agriculture in the New Round.
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successfully concluded the Biosafety Protocol in Montreal. This result required that the
Clinton administration drop the negotiating positions it had articulated for biotechnology
in the run-up to the Seattle Ministerial meeting. Having largely been assigned the blame
for the Seattle failure, and facing growing domestic concern over GMO’s, the
administration sought to avoid responsibility for yet another failed international
agreement in as many months.
Several passages from the Protocol deserve particular attention in light of this
study. Environmentalists celebrated its multiple references to the “precautionary
principle.” Specifically, Article 10, Paragraph 6 holds that
Lack of scientific certainty due to insufficient relevant scientific information and
knowledge regarding the extent of the potential 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 that
living modified organism intended for direct use as food or feed, or for processing
in order to avoid or minimize such potential adverse effects.
The treaty would thereby appear to grant parties a right to exclude GMOs on the basis of
scientific uncertainty, and thereby expose international GM commerce to the same
complications illustrated by the beef hormone dispute.
While environmentalists emphasized the broad profile provided the precautionary
principle, including in the Preamble, industry emphasized other language in the treaty.
Notable, the two final passages from the Preamble, which note that
Emphasizing that this Protocol shall not be interpreted as implying a change in the
rights and obligations of a Party under any existing international agreements,
[and] Understanding that the above recital is not intended to subordinate this
Protocol to other international agreements.
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This language implies that the rights and obligations of the Protocol are not to
subordinate those established under the WTO’s SPS Agreement. The reverse also holds
true, and consequently the two treaties appear to lay co-equal claim of authority over
transnational GMO commerce. At the same time the standards they establish as to the
scientific evidentiary requirements needed to levy trade barriers are at odds with one
another. This assures that transnational GM commerce will remain a heated topic for
international trade for years - if not decades - to come.
Finally, Annex II of the Protocol lays out guidelines for the risk assessment
procedures importing countries are supposed to follow. Section 6 echoes previous
considerations of GMOs from this study:
Risk assessment should be carried out on a case-by-case basis. The required
information may vary in nature and level of detail from case to case, depending
on the living modified organism concerned, its intended use, and the likely
potential receiving environment.
The “case-by-case” principle had passed through many years of national regulatory
consideration among OECD countries, and now was enshrined in an international treaty
as the agreed method for analyzing the consequences of releasing GMOs into the
environment. Despite nearly two decades of attention to the question of release, casuistry
remained the only viable method of analysis under such conditions of scientific
uncertainty.
VII. The Modem Pharm - Four-Legged Bioreactors and Other Innovations
While the GM products thus far described are in many ways remarkable, they
merely represent agricultural biotechnology’s first green shoots. It is anybody’s guess
what the marriage of agriculture with molecular genetics will produce during the several
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decades. One can surely expect that persistent international controversy will accompany
the astonishing products agricultural biotechnology will surely provide. This final
section is designed to provide some indication of where the revolution is headed.
While this study’s focus has been plants, livestock are also an important
agricultural component. Humans have long bred animals for food, milk, clothing and
transportation. In the 1980s, biotechnology yielded genetically modified mice that served
as useful models for medical study. In the 1990s, biotechnology is opening the door to
farm animals that supply medicines.9 4 The concept for developing such transgenic
mammalian bioreactors is simple. Researchers might isolate a human gene of interest,
say one that codes for a blood-coagulation protein. They then could attach that gene to a
promoter associated with a cow’s mammary glands. This allows them to introduce this
gene into a cow’s genome, raise the animal, collect its milk, and then isolate the protein
of interest. In 1987 Genzyme engineered mice to excrete tissue plasminogen activator
(tpa) in their milk, showing the feasibility of such technology.9 5
Through the 1990s, the costs of producing drugs in this fashion were generally
prohibitive.9 6 In February 1997, however. Dr. Ian Wilmut announced the successful
cloning of an adult sheep using a cell from its udder. Soon thereafter, the same technique
was shown to work with a host of other mammals.9 7 This feat - long believed impossible
- has opened the possibility of cloning mammals that have been engineered to produce
9 4 Techniques and possibilities are presented in. Velander, Lubon and Drohan (1997). For an overview of
PPL Therapeutics’ success in this area, see Giliis (1999: Al).
9 5 Powledge 1984c.
9 6 “Many human proteins carry sugar molecules on them (they are said to be ‘glycosylated’).... Proteins
made by bacteria lack them...but the protein that the mammal makes does have these sugars” Reiss and
Straughan(1996: 166-7).
9 7 Kolata (1997) and Weiss (1997: A26). The events are well documented in Kolata (1998).
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human proteins of medicinal value. Wilmut speculates that his mammalian cloning
techniques will make such possibilities cost-effective.9 8 His team has already had some
success in cloning lambs engineered with a human gene for a blood-clotting factor; they
have also succeeded in producing human proteins in cow’s milk.9 9 The advent of
mammalian cloning promises the development of medicine-yielding mammals.1 0 0
Cloning has also been proposed as a method for preserving endangered species, or
for even bringing extinct species back to life. One group of Japanese researchers
currently seeks to bring the wooly mammal back to life using DNA retrieved from cells
frozen in the Siberian tundra.1 0 1 In another biotechnology application researchers seek to
engineer medicines directly into common foods. DuPont has been especially active in this
area.1 0 2 Such an approach provides, among other possible benefits, an alternative to the
9 8 “The ability to make clones from cultured cells derived from easily obtained tissue should bring
numerous practical benefits in animal husbandry, and medicinal science” Wilmut (1998: 58).
9 9 “Unlike Dolly, the new lambs were made from sheep fetal cells.... The researchers inserted two new
genes. One was a human gene for a blood-clotting agent called factor IX...the second was a genetic
marker that confers resistance to an antibiotic, giving scientists a way to quickly sort the cells that take up a
new gene from those that do not” Holtz (1997: Al). “PPL Therapeutics has also had success in creating
cows which spike their own milk with human alpha-lactalbumin, a nutrient supplement or ‘neutraceutical’”
“Building to Order” (1997).
1 0 0 “It is now possible to conceive of a global life science economy in which the genetic, cellular and
organismic properties of life are harnessed to the exacting standards of mass production.... The life science
companies hope to mass-produce customized cloned animals for a range of commercial purposes, including
medical research, the harvesting of organs for xenotransplantaion and improved meat production. A new
generation of cloned animals - “pharm” animals - that will have designer gees customized into their
genetic makeup to serve as chemical factories” Rifkin (1998a: M5). “The molecular machinery responsible
for programming genes within the cytoplasm of an egg may be similar in all mammals. That offers the
possibility that eggs of one species can be used as a universal incubator for cloning any adult mammal cell,
including - theoretically, at least - those of human beings” Holtz (1998: Al).
I0 ‘ Stone (1999).
1 0 2 “[Dupont researchers have] figured out how to turn off a particular gene in soybeans, resulting in a
quadrupling in the bean of oleic acid, which makes a far healthier cooking oil...[in summer 1997] it paid
$1.5 billion for Protein Technologies International. DuPont’s own researchers had discovered a way to
make a soybean protein hold water, giving it the jelly like consistency of muscle. Protein Technologies,
meanwhile, had developed a way to refine soybean protein to remove its beany taste. With their combined
efforts, the companies claim to have largely overcome the two biggest complaints about veggie burgers:
texture and taste.... To get its technology into the hands of farmers, DuPont last summer paid $1.7 billion
for a 20% stake in Pioneer Hi-Bred International Inc., a 36% premium over the market value.... Monsanto
is genetically engineering crops to make healthier cooking oil and wheat flour fortified with vitamins. And
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vaccine shots administered to children: instead, in the future children may need only to
eat a GM banana.1 0 3 Alternatively, honeybees may be used to concentrate medicinal
proteins from the pollen of GM flowers.1 0 4 Others foresee GM crops with enhanced
nutritional - and ultimately, health — value in both the developed and developing
world.1 0 5 Symbolic of this is the development of a “golden rice” variety. This rice
contains enhanced levels of betacarotene, a precursor for Vitamin A. Work also is apace
to develop salt-tolerant and drought-resistant crop varieties that will open new land to
agricultural production, thereby reducing the slash and bum techniques that are so
environmentally destructive.1 0 6 The application of molecular genetics to agriculture
Novartis is trying to engineer food that wards off human ailments: one of its ideas is modifying com to
make amino acids that inhibit osteoporosis” Kilman (1998a: Al). “Encouraged by clinical trials, DuPont
expects that the federal Food and Drug Administration will certify health-benefit claims for soy products
within two years.... The DuPont-Pioneer joint venture will soon begin supplying...custom soy, genetically
designed to maximize disease-fighting qualities and improve taste” Sherrid (1998: 60). “Protein
Technologies International supplies about 75% of the worldwide market for soy proteins used in processed
foods” Deutsch (1997: 35).
1 0 3 “Biotechnologists at the Boyce Thompson Institute for Plant Research...are genetically engineering a
banana to produce an antigen found in the outer coat of the hepatitis B virus. Banana vaccines would be
ideal for developing countries because they would cost just a few cents per dose, compared to the $ 100 to
S200 per dose for traditional vaccines.... The Institute’s president] hopes they will be able to develop
bananas that can vaccinate against a range of different diseases, such as measles, yellow fever, diphtheria
and polio” Kieman (1996).
1 0 4 “Honey made by bees from the nectar of genetically modified (GM) plants could be used to give people
vaccines or new drugs, according to Dutch biologists. By using bees to concentrate the proteins produced in
the GM nectar, the costs of purifying and delivering new drugs would be substantially reduced, say a team
at the Centre for Plant Breeding and Reproduction Research in Wageningen in Holland, i t ’s a production
system that would require very little purification,’ says Tineke Creemers of the centre. ‘The protein is
concentrated by the bees, so it’s a very cheap production method’” Arthur (1999: 9).
1 0 5 “A pip-destroying gene that could be used to boost the nutritional value of fruit has been discovered by
Australian and Japanese scientists” “Fruitful Geneticists Take the Pip” (1997). “A strain of genetically
modified rice that is rich in iron could help banish anemia, according to the Japanese scientists who created
it” “The Crop that Pumps Iron” (1999). “American biologists...have found a way of genetically
engineering plants so that they carry out extra chemical conversions on their fatty acids, making what the
researchers call a ‘nutritionally superior’ vegetable oil” Bradley (1996). “In a nascent field called
nutriceuticals, DuPont and others are going further, learning how to genetically engineer plants so that they
have more vitamins or fewer calories, or even contain drugs that currently must be synthesized in
pharmaceutical labs” Deutsch (1997:35).
For a discussion of the rise’s promise, see Friedrich (1999). “The Rockefeller Foundation is sponsoring
research on so-called golden rice...[which is] expected to be for sale in Asia in as little as five years”
Easterbrook (1999: A19). Monsanto announced that its researchers developed a strain of rape seed that
produced beta-carotene enriched oil (“Scientists Demonstrate/Confirm...” 1999).
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probably holds its greatest probable benefit for the developing world, where it can
increase both food and environmental security.1 0 7
VIII. Conclusion - The Brave New World of Agricultural Biotechnology
It is striking the pace at which molecular genetics is transforming agriculture.
After little more than a decade after the first deliberate release of a genetically modified
organism, the planet’s agricultural base is in the throes of fundamental change. The
growing use of GM crops is resulting in the increasing consumption of GM processed
foods in the United States and beyond.1 0 8 This is only the beginning. Current
controversies diminish some of the industry’s momentum. But if this study of
agricultural biotechnology provides an indication, current controversies are unlikely to
derail this transformation.
Whether nationally or transnationally developed, regulations have accommodated
the commercialization of agricultural biotechnology. Over the past quarter century, a
persistent battle has raged over decisions made under conditions of scientific uncertainty.
Both sides have relied on familiar arguments, as the battleground has shifted from the
laboratory, through the field, to the farm and onto the dinner plate. Genetically modified
1 0 7 The International Food Policy Research Institute makes this case forcefully in the October 1999 issue of
its journal, 2020 Vision.
i°8 “Three-fifths of processed food, ranging from margarine to chocolate, contain soyabeans. And
packaged meals commonly feature vegetables which have been subject to genetic fiddling: tomatoes,
peanuts, squash or potatoes.... The food and biotechnology industries are relieved. The big suppliers are
Novartis, a Swiss-based maker of a maize seed that repels nasty com borers, and Monsanto, an American
firm that produces herbicide-resistant soyabean seed” “In Defense of the Demon Seed” (1997:60).
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organisms, initially feared as capable of unleashing a pathogenic pandemic, now stand
poised to become humanity’s staple in the 21st century.
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Chapter 8 - Conclusions: Regulations and the Study of Globalization
I. Review and Implications of a Regulatory Study of Agricultural Biotechnology
The application of molecular genetics to agriculture represents a turning point in
human history. The thesis here has been that one must be sensitive to transnational
dynamics to understand the domestic regulations that emerged to govern agricultural
biotechnology. This investigation was grounded theoretically in the possibility that
uncertainty contributes to a predisposition of authorities to adopt and adapt foreign
regulatory approaches. This study provides substantial evidence that such processes have
penetrated agricultural biotechnology regulation since its formative days.
All histories are partial. They are so in both senses of the term. They are
incomplete, since no subject submits to exhaustive account. They are also biased, since
no subject escapes its observer’s experiential lens. With these caveats provided, this
chapter is divided into two halves. The first half reviews and summarizes this study’s
findings. The second half offers a discussion of the implications this history might have
for the study of politics.
II. Reviewing the Evidence: Transnational Contagion and its Regulatory Effects
To guide a discussion of the findings, it is useful to recall the spectrum proposed
at the end of chapter 2 (figure 2.7) which proposes that regulations vary according to the
degree to which they are transnationally generated. At one end stand regulatory
outcomes that are exclusively the product of domestic political struggles. At the other
end stand regulatory outcomes that result entirely from a country’s position within a
transnational network. Between these two extremes stand regulations that reflect the
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interplay of domestic and transnational variables The terms invention, adoption and
adaption describe the political dynamic associated with these three ideal types.
A. Asilomar’s Transnational Ripples
The early recombinant era covered in the first chapter provides examples of each
of these dynamics. A common agenda emerged in both the United States and Britain. The
agenda at Asilomar was set by a small coterie of active research scientists. The original
decisions settled at Asilomar served as the basis for American recombinant regulations.
Subsequently, American and Anglo rules served as the basis for national regulations
throughout the developed world. Many countries either adopted wholesale the American
or British approach, or they adapted them to their particular national legal circumstance.
These rules centered on limiting the accidental release of genetically modified
organisms from research laboratories. Constructing the biohazard debate in such a way
privileged scientists interested in advancing their research. It renewed their access to
private gains (e.g., research grants, publications, disciplinary accolades, and ultimately
patents and commercialization) while limiting consideration of the public costs. The cost
frequently identified but systematically ignored was the potential for recombinant
techniques both to enhance biological weapons and to contribute to their proliferation.
This cost was consequently amplified through the international system.1
1 The international effort to sequence the entire human genome will undoubtedly yield further advantages
to those who would use organisms for nefarious purposes. This is not to argue that such efforts should not
proceed. It is noteworthy, however, that a small part of the multibillion dollar effort has been devoted to
research on the social implications of the research. Unfortunately, biological weapons issues have been
excluded from those areas worth funding, perpetuating the sin of omission established a generation ago.
While biological weapons are usually associated with human pathogens, they do have agricultural
application. These issues, understandably, receive much less attention, since they involve the loss of crops
and livestock, as opposed to the loss of human life. The potential for “agroterrorism” has recently captured
the attention of US representatives. See, “Experts Warn of Terrorism Via Farms.”
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A further consequence of these initial commitments was to impede the emergence
of agricultural biotechnology. The compromise emerging form Asilomar was that
researchers agreed to endorse regulatory conditions that limited the accidental release of
their recombinant organisms. A logical corollary of such an approach was to rule out
their intentional release.
In the years since, some have condemned the regulations emerging from
Asilomar, arguing that they indulged conjectural hazards. Such hindsight suggests that
less stringent regulations would have been more “appropriate” in the early recombinant
era. If this were the case, why then is there no example from the early recombinant era of
regulatory authorities embracing more relaxed - and presumably “rational” - standards?
The dynamics associated with decision making under uncertainty go some distance to
explain this homogeneity of outcome. Asilomar served to anchor the regulatory frame of
reference. Its transnational regulatory effects rippled across the planet. As chapter 1
shows, they even penetrated the Iron Curtain.
B. Evidence from the Deliberate Release Case Studies
This study provides substantial evidence that national authorities looked beyond
their own borders when wrestling with deliberate release regulation. Exposure and
familiarity with such information is a necessary, but not sufficient condition for the
proposed contagion effect. In addition, the evidence should demonstrate this information
at work. To make that case, three elements from the field test history are highlighted
here: moratoria proposals, the ice-minus episode and the OECD’s role.
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1. Moratoria - Denmark, West Germany, Monterey County and Beyond
At the same time that American authorities prepared to initiate field tests in early
1987, West German Bundestag members called for a moratorium. The proposed German
moratorium was not the first in Europe: the Danish parliament had voted a similar
moratorium in June 1986 a year before release of the Enquete Report. Thus, German
authorities possessed a regulatory model of moratorium to their immediate north. It is
instructive that two European neighbors developed a similar regulatory approach:
moratorium-with-exceptions.2
Clear links between European Greens and San Francisco-area activists have also
been documented. More significantly, however, is the contact of European and German
Greens with members of the Monterey County Board of Supervisors. AGS’s plan to
release ice-minus in Monterey ignited a firestorm of local protest. At public hearings
EPA officials and AGS employees had to defend themselves against concerned locals
who believed - rightly or wrongly - that the release of Frostbuster posed a hazard to the
local environment and public health. The Chairman of the County Board was
sympathetic to these concerns and was also in contact with European Greens. To the
consternation of both AGS and EPA officials, the Board imposed a temporary,
countywide moratorium on the deliberate release of genetically modified organisms.
Thus, one can arguably trace the idea of a moratorium from the Danish Parliament,
through the German debate, to the American West Coast. The Monterey moratorium
2 Frequently the Danish moratorium is portrayed as absolute, but this was not the case. “One of the main
features of [the Environment and Gene Technology Act, passed in 1986] is the world’s only explicit
prohibition on the deliberate release of genetically engineered organisms. But a rider adds that ‘the
Minister of the Environment may in special cases give an approval.’” Dixon (1989: 1001). The Danish
Minister of the Environment granted such an exception in June 1989. Newmark (1989a: 653).
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ultimately delayed the first American release for an entire year - and resulted in the test’s
relocation to Contra Costa County.
A moratorium almost became European policy. Members of the European
Parliament were active in biotechnology discussions, especially during periods when
Green parties enjoyed strong representation. Some European MPs entered politics
specifically because of their concerns about biotechnology.3 They made several
parliamentary efforts to curtail European biotechnology. Most dramatically, in June
1989, the European Parliament voted on a five year field test moratorium. German rules
provided the natural inspiration for such a call. The five-year proposal was defeated by a
single vote, reflecting European public unease with biotechnology.4
The five-year moratorium proposal therefore spread well beyond the geographical
confines of Germany. Remarkably, it continued to echo through the years. In the late
1990s agricultural biotechnology opponents increasingly took their cause onto the
Internet with the goal of rallying global public support. Among the more prominent was
the effort of a group who sought signatures for the “World Scientists’ Statement.” The
opening lines of the statement read,
We the undersigned scientists call upon our Governments to:
Impose an immediate moratorium on further environmental releases of transgenic
crops, food and animal-feed products for at least 5 years.5
3 Dixon (1993:48).
4 Wheale and McNally (1990: 110). “The moratorium... would have applied only to products and not to
scientific work.” Dickman and Coles (1989:413).
5 As ofOctober2l, 1999, the petition contains 136 scientists from 27 countries. The entire document
entitled “Calling for a Moratorium on GM Crops and Ban on Patents” is available at
http://www.twnside.org.sg/souths/twn/title/world-cn.htm.
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Much as Asilomar anchored perspectives in the early recombinant era, the five-year
moratorium served as a point of reference around which opponents rallied across time,
geographical and virtual space.
2. Ice-Minus - An Ambiguous Episode
It was earlier argued that the ice-minus test yielded precious little scientific
information. Furthermore, as a gene deletion, it was not the most representative example
of what one might expect of future transgenic organisms. Consequently, one could only
generalize from the ice-minus episode with analytic peril. Despite its marginal scientific
value, both German and British regulatory authorities devoted significant attention to the
American ice-minus field test. The Bundestag report explicitly identifies gene deletions
as intrinsically less hazardous than other possible modifications, thereby signaling
agreement with the decision of American authorities who approved the ice-minus tests.
This is in line with expectations. At the same time, however, the Bundestag endorsed a
moratorium-with-exceptions as the conceptual framework for regulating microbial
releases. This contrasts with the approach of American authorities who rejected a
moratorium.
The RCEP also provides the ice-minus episode substantial attention. British
authorities indicate no familiarity with the scientific inadequacies of the ice-minus field
test. And in several instances they simply get facts from the episode wrong. Rather than
endorse the American test, however, RCEP members used it as a foil to advance their
more precautionary approach. They voice disagreement with the view that gene-deletion
organisms pose minimal hazard. British authorities dismiss this assumption, arguing that
organisms derived from gene deletion (as well as protoplast fusion) require as much
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analysis as other transgenic release candidates. Seemingly, the ice-minus episode
contributed to regulatory debates in both countries, but it did not generate unambiguous
similarity in regulatory approach.
In addition to the ambiguity suggested by the two cases, another element must be
addressed. Both sides to the German field test controversy used the American ice-minus
episode to justify its position. The majority report indicates agreement with the
American decision to approve release, while Greens lambasted it in their minority report.
This evidence strengthens the idea that foreign episodes and decisions can become
important terms of reference for domestic debate. At the same time, however, it suggests
that contagion alone cannot explain all domestic regulatory decisions under uncertainty.
One must continue to grant institutional and cultural variation a role in explaining
regulatory outcomes.
It is clear from the three cases that transnational information networks emerged.
It is also clear that such networks do not entirely subordinate domestic politics; nor,
however are they irrelevant. They exact an effect in the middle of the spectrum proposed
in Figure 2.7. One might consider a number of counterfactuals to illuminate their
relevance.6 How might the analysis of the Enquete Report have differed in the absence of
English-language citations? How might the RCEP report have differed if access to
foreign documents and analysis had been impeded? How might the regulatory history of
deliberate release differed without the OECD’s participation?
6 “Counterfactuai statements cannot provide a substitute for empirical observations....They can clarify an
explanation.” Van Evera (1997:48).
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3. “Case-by-Case ” - The OECD s Harmonizing Role
This last question deserves further consideration. A compelling example of
contagion is the rhetorical invocation of the phrase case-by-case in discussions of
deliberate release. Levidow and Tait argue both that the OECD introduced this term, and
that it had an important effect.7 One should agree that its use was important: case-by-case
summarized the position of field test proponents, and became the rhetorical instrument
for asserting predictability and control over individual field tests. But history rebuts
Levidow and Tait’s claim that the OECD established this principle. While the OECD
may have been the main source for contagion, case-by-case appears in North American
discussions several years prior to its appearance in the OECD publication.8 It was a
conceptual cornerstone for American regulations, figuring explicitly in the federal
registry.9
7 “The OECD was also influential, having established the general principle of case-by-case review and
step-by-step release, ‘progressively decreasing physical containment.’ Its proposed risk-assessment criteria
became incorporated into the EC Directive and UK regulations, and the organization’s international
meetings have continued to develop these considerations” Levidow and Tait (1992: 96).
8 An early, widely cited document concludes, “There are too many uncontrolled and unknown factors at
this point to handle new situations on anything other than a case-by-case basis.” F. E. Sharpies, “Spread of
Organisms with Novel Genotypes: Thoughts from an Ecological Perceptive.” ORNL/TM-8473. Oak Ridge
National Laboratory, Oak Ridge, Tennessee, p. 40, (Reproduced in Hearing before the Subcommittee on
Investigations and Oversight and the Subcommittee on Science. Research and Technology, Environmental
Implications o f Genetic Engineering). “By experimenting and reviewing research literature, the EPA will
develop standards for case-by-case assessments, outlining high and low risk product areas.” Edwards
(1983c: 725). “The consensus at the [Canadian Environmental Law Research Foundation] conference was
that the best approach to regulation may be a case-by-case consideration...” Miller (1984: 1016).
9 “(1) Case-by-case assessments. Because of the very recent development of genetically engineered
microorganisms for environmental use, there is little direct experience for conducting risk assessments on
environmental releases of engineered microorganisms. In the absence of such experience, the Agency will
conduct case-by-case reviews by using information from various scientific disciplines and by directly
considering the features of specific genetically engineered microorganisms and their uses.” Statement of
the EPA, Federal Register, Vol. 51, No. 123, June 26,1986. Available at
http://gophisb.biochem.vt.edu/epasrc/enacted/epa.gui.txt (July 16, 1999). “APHIS retains the authority to
grant or deny a permit for release on a case-by-case basis.” Rules and Regulations Part II Department of
Agriculture Animal and Plant Health Inspection Service, Federal Register Vol. 52, No. 115, June 16,1987.
Available at http://www.aphis.usda.gov/bbep/bp/687rule.txt (July 16, 1999).
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The term case-by-case has American origins. The OECD seized upon its use in
its earliest publication on field tests. This study documents how the OECD’s deliberate
release analysis echoed the American government’s approach. Further, the Kohl
government used the OECD as “cover” for its efforts to deregulate biotechnology. In
addition to the usage already documented, the term case-by-case appears in British,
German, Austrian, Canadian and French documents. In fact, in some instances foreign
authorities do not even translate the term from the English.1 0 The OECD thereby appears
1 0 The RCEP concludes that, “Case by case assessment of every proposal to release a GEO is essential”
11.32. “The basic principle for running the regulatory process is that each proposal for a release is judged
on its merits; the case-by-case approach.” Beringer(l99l: 60). Beringer has headed ACRE since its
inception. The Enquete (Commission concludes, “Die Gewichtung der oben angegebenen Kriterien wird
dabei von Fall zu Fall verschieden sein. Bundestag (1987: 235). It should be recalled that a participant to
the Enquete (Commission explained that members viewed the American regulations as one of two options,
and referred to that position in English as case-by-case: “Hier standen sich in der (Commission am Anfang
zwei kontrdre Positionen gegenliber: Die Forderung nach einem totalen Moratroium einerseits sowie die
Freigabe filr den Einzellfall (‘case to case’), wenn vorher der Betreiber eine RisikoabwSgung vorgelegt hat
(der amerikanische Regelungsvorschlag). Hohlfeld (1990:210). The Austrian parliament empowered its
own Enquete Kommission. It employs the English term rather than the German. According to the published
recommendations, “Zentrale Kriterien bei der Entscheidung flber Freisetzungen mtlssen sein: Sicherheit
unter Beachtung synergistischer Wrikungszusammenhdnge, RQckholbarkeit und Okologische
Wirkungszussamenhdnge. Sollte es nach diesen Kriterien und unter Beachtung des Prinzips “case by case,
step by step,” zu Freisetzungen kommen, ist dabei begleitende Wirkungs- und Risikoforschung
vorzusehen.” Nationalrat (1992: 341). The phrase also appears in French as cas par cas. According to the
President of France’s Commission on Biomolecular Genetics (Commission du Genie Biomoldculaire), “Le
risque potentiel de la culture de telles plantes transgeniques ne peut etre apprdcid qu’au cas par cas.” Kahn
(1996:43; see also 11). According to a Quebequois survey of Canadian biotechnology, “La rdglementation
relative & la securite et d l'efficacitd des produits biotechnologiques est une responsibilitd federale.
Prdsentement, les principaux ministdres concemes soit Agriculture Canada et Santd et Bien-Etre social
Canada dvaluent les produits biotechnologiques en vertu des lois existantes s’appliquant a d’autres
produits. Les criteres promolguds par le sous-comitd sur la sdcuritd et les rdglementations, crdd avec I’appui
du ministdre d’Etat aux Sciences et d la Technologie en 1985, servent d prdciser, sur une base intdrmaire et
au cas par cas, quelles informations particulidres sont requises pour I’dvaluation” La Situation des
Biotechnologiques au Quebec (1991: 79-80). Another Canadian study commission for the Ontario
Ministry of the Environment offers: “It is recommended that, at least, initially, all approvals be done on a
case-by-case basis” (CELRF 1988: 5-17). While Canada was not a case study selected here, it would also
likely have been subject to transnational contagion from the United States. In this regard, it is worth noting
a passage from a Canadian newspaper: “Since normal and genetically engineered crops were deemed
substantially similar by Canadian and U.S. regulators, they could be mixed indiscriminately and no one
would be the wiser... ‘We have to look at [GM foods] on a case by case basis,’ says [ Bart Bilmer, a
biotechnology regulatory officer with the Canadian Food Inspection Agency.” Walkom (1999: 1).
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to have played a substantial role in setting the conceptual context for national
biotechnology regulations.1 1
Of perhaps greatest importance for the theory, regulatory contagion appears to
mark both the precautionary approach (i.e., five-year moratoria) and the proactive
approach (i.e., case-by-case). These competing approaches were contested through the
drafting process of the relevant European Directive governing GMOs. Early Directive
drafts contained a 5-year moratorium provision, whose logical inspiration was the
German/Danish approach. This provision, however, did not survive later review
procedures.1 2 In April 1990, the Council finally adopted a deliberate release directive.
The Final Directive’s introductory “Explanatory Memorandum” indicates that the
Commission was in contact with the OECD to help develop the document, and to ensure
harmony between the two.1 3 Case-by-case became a hallmark of the EC’s approach and
1 1 “UK regulatory bodies have been sensitive to international pressures affecting the control of this
technology and consequently have sought to influence policy through active participation in such
organizations as the European Commission [and] the OECD.... The OECD has provided the main
intellectual focus for debating scientific principles underlying this technology and has an ongoing
programme of work in safety in biotechnology which the HSE continues to support.... Many of the OECD
concepts have been implemented globally in specific legislation or published guidance. Indeed, many of
the recommendations of the OECD report on safety considerations have formed the basis of subsequent
European directives concerned with this technology” Jones (1992: 9). “Although recommendations made
by the OECD are not binding on Member Countries, there is little doubt that the report of this major
international study will have considerable influence on the development of regulations and guidelines
worldwide. Already we have seen the influence of the OECD report in several countries” Agar (1988:
242). The countries he alludes to in the footnote are the United States, Germany, Holland, and Japan.
Finally, while not included as a case study, it is worth noting that a Japanese participant to the Klingmueller
deliberate release symposium of 1988 notes “ “debates raised in the US on environmental releases of frost
microbes and others are also influencing public opinion in Japan. At the same time...the [OECD]
considerations suggested a provisional approach incorporating independent case-by-case review of a
proposal before applications....” Uchida (1988: 264).
“Schmid instead argued in his first report on the deliberate release directive for a 5-year moratorium on
releases of non-recoverable GMOs pending the outcome of further research. This was supported by the
Environment Committee, but not by Parliament’s plenary session in Strasbourg, possibly because of intense
lobbying by both the biotechnology industry and by the ‘orthodox’ scientific community of molecular
biologists” Lake (1991: 11-12).
1 3 “In 1986, the OECD Council issued a recommendation on safety considerations, for applications of
recombinant DNA. The Commission and the Member States participated in the preparations of this
Recommendation.... Because international experience in deliberate release is still limited, it is not possible
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is mentioned twice in the Directive’s preamble.1 4 Thus, the OECD also had an impact on
biotechnology regulations at the supranational level.1 5 Finally, its appearance in the
Biosafety Protocol shows its continuing impact. As the internationally agreed upon
instrument to govern GMOs, case-by-case has been amplified by treaty obligation
throughout the international system.
Despite the OECD’s efforts, important differences distinguish deliberate release
regulation on either side of the Atlantic. Whereas American regulation decided in favor
of product over processed-based regulation, the EU Directive reversed these priorities.1 6
The substance of the final directive was stricter than earlier drafts, reflecting the effective
pressure Green European parliamentarians had brought to the issue.1 7 The legacy of these
contrasting approaches is bom out by the different levels of field test activity pursued on
to propose any general guidelines or testing requirements for the time being. The Commission is therefore
proposing a case-by-case notification-and-endorsement procedure which will be mandatory for industry
and research institutions, in line with the recommendations of the OECD report.” Council of the European
Community (1990:2 & 26). Lake (1991) emphasizes this link in his discussion of the politics behind
development of the two directives. “Both the directives were strongly influenced by the OECD guidelines
drawn up in 1986 and an attempt has been made since then to keep in step with the OECD on this issue”
(7).
1 4 “Similar to ad hoc procedures in effect at the U.S. Department of Agriculture and the Environmental
Protection Agency, all such releases must now be evaluated on a case-by-case basis, and none are allowed
without the approval of an evaluating committee” Balter (1991: 1367). “Whereas it is necessary to establish
harmonized procedures and criteria for the case-by-case evaluation of the potential risks arising from the
deliberate release of GMOs into the environment; Whereas a case-by-case environmental risk assessment
should always be carried out prior to a release” Council of the European Community (1990).
1 5 “Under the terms of the current draft of the directive, all applications for controlled release into the
environment would be initially evaluated... using a commonly agreed upon set of procedures. These would
be based primarily on proposals offered last year in a report published by the Paris-based Organization for
Economic Cooperation and Development” Dickson (1987b: 18). “The OECD is attempting to harmonize
international regulations [for deliberate release]” Watts (1989b: 32).
1 6 “One problematic aspect of the EC’s legislation is that rather than regulating the products of
biotechnology, it regulates the biotechnological processes by which these products are made” Szczpanik
(1993:620).
1 7 “During the passage of the directives the regulatory requirements were tightened in response to the
influence of the European Parliament and the Council of Ministers, notably through the demands of the
member states’ representatives from Germany and Denmark. While more radical opponents of the
technology in the EP did not achieve all of their goals, such as licensee liability for damage caused, the
final legislation was a disappointment for the industrial interests” Barling (1994:469-70).
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either side of the Atlantic. And as the last chapter shows, these differences left their mark
on American and European approaches to genetically modified crops and food.
In addition to levels of activity, field test purposes are also markedly different on
either side of the Atlantic. In Britain, Bishop’s baculovirus field test research was
methodically designed to generate scientific information about releases, and British rules
codified this purpose. In Germany, academic researchers also pursued the earliest field
tests. In the United States, in contrast, the ice-minus test contributed little valuable
scientific information concerning deliberate release. It was arguably more important for
sustaining commercial interest in agricultural biotechnology, than for providing data to
regulators with which to improve subsequent analysis. Whereas commercial researchers
dominated early American field test activity, academic researchers dominated early
European field test activity.
With regard to field test regulations, the United States and Europe began from
differing analytic starting points. Almost immediately, however, authorities on both sides
of the Atlantic pursued deregulation. The accumulating experience from non-eventful
field tests (i.e., those that failed to generate unwanted or unexpected consequences) was
one motor driving deregulation. Another motor was the widespread fear of sacrificing
national competitive advantage in this emerging technology.
C. Genetically Modified Crops and Food
The last chapter recounts the commercial development of agricultural
biotechnology in the wake of the field test controversy. This aspect of the history is
interesting on several levels. First, it defies the earlier dynamic of the gradual global
adoption and adaption of American regulatory approaches. In 1992 the Clinton
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administration streamlined the approval process for six important commercial crops.
Similarly, in 1994, the FDA ruled GM ingredients to be “substantially equivalent” to
their non-GM analogue. By the late 1990s, GM crops and ingredients quickly diffused
through the American agrofood system. Both of these events occurred with little initial
public scrutiny or concern. Neither of these developments generated any discemable
harm, to either consumers or the environment. Because of this, one might have expected
foreign authorities once again to adopt and adapt American perspectives.
On the contrary, the commercialization of agricultural biotechnology generated
considerable concern in Europe. European authorities had always viewed GM crops with
greater suspicion than had their American colleagues. But as European consumers
became aware of the approval and adoption of GM crops, they expressed increasing
concern. Several national governments - notably, Luxembourg, Austria and Germany -
responded by opposing and substantially slowing GM crop approvals within the
European Union.
The outbreak of mad cow disease, and other European public health scandals,
provided fertile ground for activists to launch campaigns against GM ingredients. These
efforts had particular effect in Britain, where public confidence in governmental
assurances was severely diminished. Amid such a backdrop, consumers exhibited greater
confidence in the concerns expressed by groups such as Greenpeace and Friends of the
Earth, than in assurances from officials at Monsanto or the Ministry of Agriculture,
Fisheries and Forests. European officials responded to the growing furor by suspending
approval of GM crops, banning the import of certain GM ingredients, and adopting
labeling rules.
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These decisions by European authorities generated regulatory ripples beyond the
Union’s borders. Reports of Europe’s opposition fed growing public concern with GM
crops and foods around the Pacific basin. Subsequently, Japan, New Zealand, Australia,
Korea, Thailand and China all announced plans to consider labeling of GM foods and
ingredients. In addition, growing international demand for non-GM ingredients resulted
in a two-tier market for soybeans in the United States, the world’s largest producer and
exporter. While farmers paid a premium for GM seed, processors paid a premium for
non-GM soybeans. Officials in Tokyo announced plans to trade GM and non-GM
soybeans in separate commodity contracts. Furthermore, representatives preparing for the
next round of World Trade Organization negotiations made clear that GM commerce
would require a place on the agenda.
American firms and authorities proved increasingly incapable of shielding
themselves against the global turbulence enveloping agricultural biotechnology.
Monsanto made initial efforts to contain damage in Europe through an aggressive public
relations campaign. This strategy ultimately failed. The company reversed tracks, but not
in time to prevent officials from the Rockefeller Foundation, a long-time benefactor of
agricultural genetics, from joining in on a condemn of Monsanto’s “arrogance.” In a
move symbolic of its growing global isolation, and of the success of global opponents,
Monsanto consented never to commercialize terminator technology.
Concurrent with Monsanto’s reversals, officials from the FDA scheduled a series
of public meetings to provide the pubic an opportunity to comment on the American
regulation of biotechnology. In Congress, American representatives announced plans to
advance legislation requiring labeling of GM foods. American com farmers, facing
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export bans on their GM products to Europe, appeared ready to abandon GM crops.
Industry fears grew that American fanners would begin the new century by reversing
their initial embrace of GM seed, and instead would return to non-GM varieties for the
2000 harvest.
Rather than see the adoption and adaption of the earlier American approaches to
GM crops and food, the late 1990s bore witness to American reconsideration of its own
agricultural biotechnology regulations. The direction of contagion appeared to have
reversed, and observers wondered when the American public would in turn exhibit the
concern about agricultural biotechnology that had gripped publics abroad.
By the end of the decade, a panoply of transnational forces made seeking the
national loci of regulatory change increasingly counter-analytic. Agricultural
biotechnology had become thoroughly transnationalized, and making any sense of events
required a global perspective. No single event better symbolizes this than the WTO
Ministerial Meeting held in Seattle. Agricultural biotechnology opponents descended on
Seattle determined to shut the meeting down. While not alone - the march of 30,000
demonstrators in support of core labor rights was the largest at Seattle - biotechnology
opponents enjoyed widespread media attention. Away from the chaos on the streets,
American and European negotiators reportedly agreed to place agricultural biotechnology
on the agenda, thereby providing the topic formal trade consideration. The collapse of
negotiations - over agriculture subsidies — rendered moot these efforts to establish WTO
rules for agricultural biotechnology. But if this study is any indication, transnational
dynamics will continue to buffet national efforts to regulate agricultural biotechnology,
regardless of the failure to launch a new WTO round.
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III. Domestic Regulations. International Norms and Globalization
Cognitive psychologists have made important observations about decision making
under uncertainty in experiments conducted in laboratory settings. Social scientists have
attempted to apply their observations to the processes of policy making. Many of those
conducting such work have warned of the complications of applying these observations
• * 1 8 ** •
to social reality. It is important to keep this warning in mind when deriving conclusions
about the contagion hypothesis proposed here. Only additional research will confirm or
disconfirm its importance.
Further, it was not this study’s purpose to provide a theoretical approach that
would replace institutional and cultural approaches. Among the safest of assumptions one
can make is that social phenomena are simply too complex to submit to a single
explanation. The purpose has been to suggest that transnational effects compliment the
theoretical analysis of those who focus on such national variation. These transnational
effects may not always be at work: the specific hypothesis here is that the scientific
uncertainty enveloping some new technologies is one area where one might expect such
an effect.
At the very least, this study makes it difficult to retain the notion that domestic
regulations arise in national isolation. This study has documented multiple transnational
1 8 An issue of Political Psychology is devoted to both applying and wrestling with the problems of prospect
theory and social science. “The most troubling problem, as well as one of the most difficult to address,
hinges on the differences between the context in which prospect theory was originally developed and the
environment in which it is being applied. One part of this problem... lies in the disparity between
conditions in the laboratory and those found in natural settings. As Levy points out, a number of the
difficulties related to applying prospect theory can be “effectively overcome under highly structured and
controlled experimental conditions, but... are much less tractable in the empirical study of international
relations....[Furthermore] prospect theory was developed as a theory of individual choice, whereas political
decision-making takes place in what is largely, if not exclusively, a group setting. Among other things, this
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information networks linking national jurisdictions. These networks channeled
experience in both directions with a real effect on policy. Regulatory contagion appears
unbound by borders, oceans, cultures or language, a point that previous scholarship on
policy diffusion has tended not to consider.1 9 Sometimes the substance of that experience
(e.g., the scientific value of the ice-minus test, or the lack of documented harm from GM
ingredients) may be less important than the simple fact that such experience is shared.
Shared experience and perspectives can effect the terms of reference, the terms of
domestic regulatory debate and ultimately the substance of national regulations.
There is every reason to believe that this dynamic will grow increasingly
important in the future. During the generation that this study covers the world has
become increasingly connected.2 0 A variety of innovations during the last three decades
have dramatically reduced the costs of transmitting information. Consider only a few of
poses potentially serious difficulties in applying the concept of framing to the analysis of political choice”
Famham (1992b: 325).
1 9 It has been thirty years since Walker (1969) first investigated the speed at which American states adopt
policy innovations, painting his “complex... picture of a national system of emulation and competition”
(897 & 8). Nowhere in his discussion, however, does he suggest that such processes may work across
borders. He does, however, make passing reference in a later review: “Before setting out to investigate the
diffusion of public policies among American states, one must make several important decisions about the
strategy and tactics of research.... [Such] questions would have to be dealt with in slightly different form, if
one were to study the international diffusion of innovations or the spread of new policies among cities or
counties” Walker (1973: 1191). Unfortunately, he offers no guide to what differentiated form such
questions might take. One early exception is Collier and Messick (1975). Otherwise, the literature is
empirically skewed toward investigation of the American federal system through quantitative methods. See
Gray (1973), Midlarsky (1978), Berry and Berry (1990), Berry and Berry (1992) and Minstom (1997).
2 0 I do not wish to leave the impression that 1 believe this observation to be at all original. Two decades
ago Keohane and Nye (1977), for instance, ground their discussion of interdependence in the “remarkable
advances in transportation and communications technology, which have reduced the costs of distance.
Using communications satellites, the cost of telephoning a person 12,000 miles away is the same as that of
telephoning someone much closer’' (39-40). More recently, Giddens (1990) places such developments at
the center of his definition of globalization. His following description captures much of the evidence
presented in this study: “In the modem era, the level of time-space distanciation is much higher than in any
previous period, and the relations between local and distant social forms and events become
correspondingly ‘stretched.’ Globalisation refers essentially to that stretching process, in so far as the
modes of connection between different social contexts or regions become networked across the earth’s
surface as a whole. Globalisation can thus be defined as the intensification of worldwide social relations
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these: Federal Express provides overnight document shipping; the facsimile machine
facilitates the near-instantaneous transmission of documents; the cost of overseas phone-
calls has collapsed; email use has skyrocketed. And most dramatically, the Internet makes
a vast array of documents, studies and perspectives instantaneously available. Around
the planet, regulatory staffs with but a modicum of technical sophistication can frequently
and increasingly track down the specific language, mission statements and justifications
for a host of foreign regulations on the World Wide Web. At the same time activists on
separate continents can establish and maintain contact, share and distribute information,
coordinate their pressure, and focus public attention on their interests of concern.2 1
Regulations have generally concerned stories of domestic actors competing in
domestic fora over domestic rules. Students of Political Science trained in interest group
and public choice analysis have dominated their study. Comparativists have recently
considered regulatory variation among states to draw broader conclusions about
institutions and culture. This study suggests, however, that a third approach is necessary:
one requiring synthesis. Increasingly, students of International Relations will have to
unite domestic and transnational analysis for a more complete understanding of how
regulations emerge.2 2
which link distant localities in such a way that local happenings are shaped by events occurring many miles
away and vice versa” (64).
2 1 Activists in this context should be understood broadly. The OECD, for example, maintains a website
entitled, “Harmonizing of Global Biotechnology Regulations.” Such a site serves an active political
function, by suggesting that biotechnology regulations have harmonized, or are harmonizing. The larger
message may be construed as the situation is under control. In contrast, the “Statement of Scientists”
(discussed above) marks a contrary message in cyberspace - the situation is out o f control.
2 2 Milner and Keohane (1996:257) support throwing out such distinctions: “For social scientists,
internationalization of the world economy should sound the death-knell to the anachronistic divisions,
institutionalized in universities, between ‘comparative politics’ and ‘international relations.’ Cross-national
comparisons are meaningless without placing the countries being compared in the context of a common
world political economy within which they operate. Likewise, theories of international relations that treat
all countries as fundamentally similar provide only limited insight into the variations in policy and
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Furthermore, they will also have to reconcile what this dynamic means for the
distinction between domestic regulations and international norms. Chapter 1 concludes
that the analytic distinctions separating individual preferences, domestic regulations and
international norms can at times be thin. Field tests of genetically engineered organisms
generated two competing regulatory models, the moratorium and the case-by-case
approach. If all countries had enacted moratoria, international relations scholars might
argue that a moratorium norm governed agricultural biotechnology, much as a non-use
one is said to govern biological and chemical weapons.2 3 In reality, one can argue that a
case-by-case norm emerged. It appears to have been a North American product,
publicized through the OECD and generally accepted in Europe.
While one may be tempted to make the link, several elements distinguish this
study from research conducted on epistemic communities, or “networkjs] of
professionals with recognized expertise and competence in a particular domain and an
authoritative claim to policy-relevant knowledge within that domain or issue-area.”2 4
First, research on epistemic communities seeks to understand and explain the emergence
of international cooperation. This study, in contrast, has sought to understand and
institutional change. Neither comparative politics nor international relations can be coherently understood
without aid from the other.” This study suggests that distinctions between domestic politics and
transnational politics are, in some instances, similarly tenuous.
2 3 Here, I rely on Krasner’s familiar definition: “Norms are standards of behavior defined in terms of rights
and obligations” (1982: 183). With regard to agricultural biotechnology, the apparent standard is to conduct
a case-by-case analysis prior to releasing a GMO into the environment. This analysis would appear to
confer the right. Klotz’s (199S: 451) definition for norm is similar though more general: “Norms...are
shared (social) understandings of standards for behavior.” With regard to the non-use norm, “biological and
chemical weaponry provokes a cultural aversion that goes beyond attitudes toward violence and warfare
and is associated with a revulsion toward reliance on poison and disease as weapons of war. (This aversion
is relative and varies from time to time, from place to place, and from individual to individual.) Although
unstable and inconsistent, these attitudes indicate a strong societal and cultural capacity to repudiate
warfare conducted with biological and chemical weapons” Falk and Wright (1990:332). See also Price
(1995: 74).
2 4 Haas (1992a: 3).
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explain the emergence of domestic regulations. That differing focus does not mean that
agricultural biotechnology was free from the influence of like-minded experts. Chapter 1
documents the assembly of like-minded experts at Asilomar. while chapter 3 documents
like-minded experts from both sides wrestling with the subject of deliberate release. This
latter point, however, further distinguishes the study from the domain of epistemic
community, because agricultural biotechnology was - and in many respects, remains -
scientifically contested.2 5
In contrast to epistemic analysis, one might venture path-dependent analysis: that
the case-by-case approach, once hesitantly enshrined in the domestic law of a single state
actor, was largely destined to become the controlling norm for field tests. To make this
case it helps to view domestic regulations much as Dawkins’ memes, the cultural
equivalent of genes.2 6 It was originally feared that genes engineered into organisms might
confer selective advantage. This would permit their host organisms to replicate and
spread, thereby spreading the genes through the population. Similarly, domestic
regulations might be viewed as enjoying selective advantages, which contribute to their
international reproduction. In this case, domestic regulations favoring deliberate release
activity enjoy a selective advantage over moratoria, and are consequently more likely to
replicate and spread though the international (eco)system. This is because agricultural
2 3 Thus, Haas (1992b) observes of efforts to address ozone depletion , “While others who were
ideologically opposed to the idea of regulation dismissed all predictions based on models, arguing that such
predictions were entirely dependent on the assumptions made by the modelers, they were eventually forced
to acknowledge accumulating scientific evidence that ozone depletion was occurring in Antarctica and
elsewhere and that speedy and stringent actions were required” (my emphasis) (223).
2 6 “Just as genes propagate themselves in gene pool leaping from body to body via sperms or eggs, so
memes propagate themselves in the meme pool by leaping from brain to brain via a process which, in the
broad sense, can be called imitation.... Imitation, in the broad sense, is how memes can replicate. But just
as not all genes that can replicate do so successfully, so some memes are more successful in the meme-pool
292
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biotechnology firms cannot prosper within regulatory jurisdictions that enforce moratoria.
Firms there cannot test their products. They are faced with three alternatives: relocate,
lobby or divest. In the 1980s agricultural biotechnology firms confronting regulatory
hurdles pursued all three strategies.
Countries enforcing a moratorium will observe their biotechnology investment
dry up. Such loss strengthens the relative position of industry in jurisdictions permitting
releases. This results in two separate industrial zones. One experiences a cycle of
regulation, diminishing competitiveness, and eventual industrial extinction. The other
experiences a cycle of deregulation, increasing competitiveness and industrial innovation.
States that sustain moratoria will lose their biotechnology industries. In losing
their domestic industries, they become observers to foreign commercial and regulatory
developments. They opt out of the system. During Bundestag hearings, Research and
Technology Minister Riesenhuber articulated this consequence when responding to the
proposed German moratorium:
Representative Catenhusen, I believe a field test moratorium is an unsuitable
instrument, since developments abroad continue apace. I support some form of
research of the hazards. But a moratorium excludes such research. I prefer
instead some strict review of individual cases. A moratorium, on the other hand,
results in our abstaining from development of European, or international
conditions [of release].-7
than others” Dawkins (1989: 192 & 194). My goal in this section is to offer a tentative mechanism for
meme-replication, and to link that discussion with the recent interest in path-dependency.
2 7 “Herr Kollege Catehusen, bei der Freisetzung halte ich ein Moratorium ftlr ein ungeeignetes Instrument,
denn die Entwicklung in anderen Ldnderen geht weiter. Ich halte etwas von Sicherheitsforschung. Wir
schreiben sie aus. Ich halte etwas von einer strengen Prilfung des Einzelfalles. Ein Moratorium filhrt
jedoch dazu, dafi wir uns auslinken aus der Mitgestaltung der europdischenen, der intemationalen
Bedingungen...” (Bericht 1990: 107).
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According to Riesenhuber, domestic moratoria result in international irrelevance. It is
this process that links domestic regulation though selective advantage to international
norms. It is a process of globalization.2 8
It remains in this context to be seen what results from the labeling of GM foods
and ingredients. Carl Feldbaum, President of the Biotechnology Industry Organization,
fears consumers might respond to GM labels as if they were skull and cross bones.2 9 If
this is the case, then labels - like a disadvantageous mutation - may confer selective
disadvantage to products with GM ingredients. As a result, consumers may choose to
avoid GM products, producers may choose not to avoid GM ingredients and farmers may
choose not to plant GM crops. Labels would disappear along with GM food products.
This is not a foregone certainty. Labels may facilitate entry of products onto
markets where they might otherwise have been excluded. One effect of the European
Union’s labeling directive was to relax the rules governing GM foods in Austria.3 0 Thus,
while some European consumers may select against the label, those same labels may
provide advantage to GM ingredients in markets where they would otherwise have been
excluded. The net result may be increased consumption of GM products. Alternatively,
2 8 This proposition responds to Legro’s (1997) complaint that “In order to understand how norms operate,
studies must allow for more variation: the success or failure, existence or obsolescence of norms. Research
on norms has tended to overlook the emerging rules, principles, prohibitions, and understandings that might
have had influence but did not. These cases, analyzed in conjunction with comparable cases of norm
effectiveness, are critical to the development of this line of thinking. Why norms did not emerge or were
not consequential is as important as why they did or were” (34). Checkel (1998) raises a similar complaint,
noting “a failure to explore how norms arise in the first pace (and the role of agency and power in this
process), and how, though interactions with particular agents, norms change over time” (340). Finnemore
and Sikkink (1998), in their review of norms, advance path-dependency as a possible analytic approach to
norm emergence. They propose that, “the relationship of new normative claims to existing norms may also
influence the likeliness of their influence” (908). The empirical problem with this path-dependent approach
is that one might easily overlook or ignore existent norms that should inhibit emergence of the new norm.
The path dependent proposal presented here does not rely on identifying such pre-existing norms.
2 9 The quote appears in Weiss (1999: 1).
3 0 “Sticky Labels.”
294
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labels may serve as a governmental imprimatur of safety. Customers may habituate to
their presence, and come to ignore them the way smokers do the health warnings on
cigarette packages. These possibilities remain to be played out.
IV. Conclusion: Regulatory Studies and Globalization
It remains for the reader to decide whether and to what extent the contagion-effect
suggested here contributes to our understanding of how and what kind of regulations
emerged to govern agricultural biotechnology. Some may conclude that despite the
evidence presented, domestic cultural and/or institutional variation remain necessary and
sufficient to understand the regulatory politics. Or alternatively that, while the dynamic
presented perhaps contributes to our understanding in this case, it is not generalizable. Or
that it will be of marginal importance in the future.
My own position is twofold. First, transnational effects were in this case, and
stand to become increasingly, an important component of domestic regulatory politics.
Synthetic analysis must be brought to bear in order to make sense of these effects. Such
analysis will simultaneously complicate, while rendering more accurate our
understanding of regulations.3 1 This has become a familiar refrain among those who
would bring the state “back in” to the study of International Relations. In defending her
theory of international cooperation, for example, Milner (1997: 3) observes,
Both scholars and policy makers will overlook key elements explaining a
country’s behavior if they fail to consider its domestic situation. Relaxing the
3 1 Rosenau (1980) observes back in 1973 that, “Technology is rendering the world smaller and smaller, so
that the interaction of national and international systems is becoming increasingly intense and pervasive.
The conceptual tidiness achieved through analyzing the two types of systems separately is thus no longer
compelling. There is simply too much evidence of overlap between them for analysts to conduct research
at one level blissfully ignoring developments at the other” (168).
295
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unitary state assumption generates new, fruitful observations about international
politics.3 2
A reformulated version of this passage can summarize this study’s conclusion:
Both scholars and policy makers will overlook key elements explaining a
country’s regulations if they fail to consider their transnational sources.
Relaxing the domestic-isolation assumption generates new, fruitful observations
about regulatory politics.
The proposed relationship between uncertainty and a propensity for transnational
regulatory contagion is only one theoretical possibility.
Second, scholars have generally defined globalization with reference to three
components: trade flows, financial flows and the activity of multinational corporations.
Where they consider regulations, scholars have associated globalization with a general
propensity toward deregulation.3 3 The conclusion here is that transnational regulatory
contagion is a vital component for understanding the rules that emerged to govern
agricultural biotechnology. Contagion appears during the regulation of the 1970s, the
deregulation of the 1980s, and the reregulation of the 1990s. If successful this study will
persuade those who study, and thereby define, globalization that domestic regulations
provide fertile ground for further research.
Finally, regardless of this study’s theoretical merit, it does provide a history of the
rules governing the emergence of commercial agricultural biotechnology. Like so many
other fields, molecular genetics is rapidly transforming human agriculture. It is still too
3 2 Evans, Reuschemeyer and Skocpol (1985) earlier observed that “states are intrinsically Janus-faced,
standing at the intersections of transnational and domestic processes” (350). This study asserts that
similarly, domestic regulators - sometimes intentionally, sometimes unintentionally - stand at a similar
intersection.
3 3 Frieden and Rogowski (1997) attribute to internationalization (or the increase in cross border trade and
investment) “impacts [which] are less obvious but perhaps even more profound, including widespread
repudiation of tax, regulatory, and macroeconomic policies that inhibit international competitiveness” (25).
296
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early to know what precisely that marriage will yield. It is safe to bet that molecular
genetics in the 21st century will revolutionize agriculture as much as did Mendelian
genetics in the 20th century. In the final analysis, molecular genetics will probably prove
the most important contribution to agriculture since humans stopped simply gathering
seeds, and learned instead to retain them from one generation to the next.
While this effect may be generally true, it theoretically directs attention away from regulations, while
failing to provide explanation for the reregulation of agricultural biotechnology documented in Chapter 7.
297
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Asset Metadata

Creator Schulz, Evan Karl (author)

Core Title A theory of transnational regulatory contagion and its application to agricultural biotechnology in Europe and the United States, 1970--2000

Contributor Digitized by ProQuest (provenance)

School Graduate School

Degree Doctor of Philosophy

Degree Program International Relations

Publisher University of Southern California (original), University of Southern California. Libraries (digital)

Tag history of science,OAI-PMH Harvest,political science, international law and relations

Language English

Advisor Aronson, Jonathan (committee chair), [illegible] (committee member), Alker, Hayward R. (committee member)

Permanent Link (DOI) https://doi.org/10.25549/usctheses-c16-180283

Unique identifier UC11334721

Identifier 3054899.pdf (filename),usctheses-c16-180283 (legacy record id)

Legacy Identifier 3054899.pdf

Dmrecord 180283

Document Type Dissertation

Rights Schulz, Evan Karl

Type texts

Source University of Southern California (contributing entity), University of Southern California Dissertations and Theses (collection)

Access Conditions The author retains rights to his/her dissertation, thesis or other graduate work according to U.S. copyright law. Electronic access is being provided by the USC Libraries in agreement with the au...

Repository Name University of Southern California Digital Library

Repository Location USC Digital Library, University of Southern California, University Park Campus, Los Angeles, California 90089, USA