407

Risking Regulation, Regulating Risk: Lessons from the

Transatlantic Biotech Dispute
Noah Zerbe1
Humboldt State University

Abstract
Debates over the future of new technologies frequently implicate governmental policies and regulation, the
purpose of which has traditionally been to mitigate the dangers of new technologies through promotion of
conditions of safe use. It is increasingly recognized, however, that regulation is predicated on a particular
conception of the nature of risk which may or may not correspond to the views and beliefs held by society.
Here I explore three broadly related questions in the context of the debates around agricultural biotech-
nology. First, what are the implications of varying conceptions of risk for regulatory policy in the United
States and in the European Union? Second, what are the implications of differing conceptions of risk and
resulting regulatory policy for agricultural trade relations between the two giants of international trade?
And finally, what lessons might we draw from contemporary disputes over agricultural biotechnology?

KEY WORDS: genetically modified foods, regulation, risk, agricultural biotechnology

Introduction

As the relative merits and dangers of recent advances in biotechnology are

debated, questions of risk assessment and governance have become increasingly
important. The perceived uncertainty surrounding biotechnological developments
has instilled in the lay public a high degree of anxiety and apprehensiveness.
Particularly with respect to food, which is such a fundamental requirement for
human survival, the call for strong regulatory frameworks to govern the new
technology and to protect human health and the environment has been wide-
spread. Efforts to develop such regulatory regimes, however, necessarily raise a
number of important questions: How do we conceptualize, measure, and assess
risk? What level of risk is acceptable? And how do we develop and maintain
regulatory structures of governance that will ensure any future developments in
biotechnology achieve their intended purpose without unanticipated or undesir-
able consequences? These are the questions at the heart of efforts to develop new
regulatory frameworks for biotechnology, and their importance is recognized not
just by a skeptical public, but by biotechnology’s advocates as well, for whom such
regulatory regimes might serve to allay growing public concerns. For example,
Perry Adkisson, Chair of the U.S. National Academy of Science’s Committee on
Modified Pest-Protected Plants, argues that “Public acceptance of these [biotech]
foods ultimately depends on the credibility of the testing and regulatory process”
(National Academies of Science, 2000). Similarly, Dan Glickman, U.S. Secretary of
Agriculture under the Clinton administration, noted that “With all that biotechnol-
ogy has to offer, it is nothing if it’s not accepted. That boils down to a matter of
trust—trust in the science behind the process . . . trust in the regulatory process”
(Glickman, 1999).
Already new regimes have been established at the international level to coordi-
nate divergent national policies and address some of the questions of biotech
governance in fields as diverse as intellectual property rights (e.g., the Trade
Review of Policy Research, Volume 24, Number 5 (2007)
© 2007 by The Policy Studies Organization. All rights reserved.
408 Noah Zerbe

Related Intellectual Property Rights Agreement and the Union for the Protection of
New Plant Varieties), access and benefit sharing (e.g., the Convention on Biological
Diversity), and biosafety (e.g., the Cartagena Protocol). But national governments,
particularly in the developing world, continue to face substantial challenges in their
effort to balance legal, political, commercial, social, ethical, and environmental
priorities and obligations. Weak capacity undermines efforts to establish strong
domestic regulations, while small but vocal lobbies on both sides of the biotech issue
have polarized debates. In such a complex regulatory environment, frameworks to
govern biotechnology and establish access and benefit sharing regimes over biodi-
versity, not surprisingly, have been slow to develop.
At the same time, the complexity of the policy environment within which new
governance arrangements are developing is beginning to be recognized, and tra-
ditional models of regulation—and more broadly of the role of science in public
policy—are increasingly subject to intense critique. The academic literature on the
topic has long recognized that regulation is not merely a technical activity in which
scientific assessment is unproblematically applied to a specific issue-area to develop
frameworks that minimize potential risks and dangers (Blowers, 1997; Bradbury,
1989). Instead, regulation necessarily involves ethical judgments concerning the
nature of risk and scientific knowledge and implicates broader questions of social
organization and structure (Beck, 1992; Leach, Scoones, & Wynne, 2005; Levidow
& Carr, 2000). Debates over policy are framed by the media and political actors, as
each side attempts to set the terms of the discussion in ways that favor their
preferred outcome. Further, as the literature from the field of risk communication
reminds us, even where there is general scientific agreement regarding the poten-
tial dangers posed by a specific technology, it may be difficult to convince the lay
public of the accuracy of the scientific frame, as the public often employs a funda-
mentally different conception of risk than do the scientists and policy makers
(Groth, 1998; Scholderer & Frewer, 2003; Slovic & Fischhoff, 1982; Slovic, 1987;
Slovic, 2001). Indeed, the greater the uncertainty, and the more involuntary and
invisible the danger, the more hesitant the public is to accept that risk—regardless
of the likelihood or magnitude of the risk event (Kasperson & Stallen, 1991; Slovic,
1992). Governance structures have consequently been slow to adapt and, in
general, regulatory practice continues to be founded on the perception of scientific
neutrality and expertise to the exclusion of lay knowledge and the artificial sepa-
ration of science and policy making (Marris, Wynne, Simmons, & Weldon, 2001;
Ravetz, 2005).
An analysis of the process by which regulatory frameworks to govern biotech-
nology are developed thus affords a unique opportunity to assess both the nature of
risk and the role of science and participation in policy formation in an environment
characterized by complexity and uncertainty. To that end, I take as my point of
departure the emerging debates around the nature of regulation and the role of
science in policy formation. In the context of biotechnology, such debates have
largely been articulated in the form of trade disputes between the United States and
the European Union over the justification for restrictions on trade in genetically
engineered foods and food products. I begin by briefly contrasting the nature of
and justification for regulatory frameworks in the United States, which legitimizes
its policy through discursive claims to “risk management” and “sound science,” and
 Lessons from the Transatlantic Biotech Dispute 409

the European Union, which relies on the “precautionary principle.” In addressing

competing justifications for regulatory policies in the developed world, I seek to
demonstrate that, despite regular and repeated reference to the need for “scientific
neutrality” and “expertise” in policy formation, policy decisions vis-à-vis biotech-
nology are fundamentally political decisions grounded in the specific social forma-
tions, histories, and political economies of individual countries and regions. Local
social values thus play a key role in shaping decisions of technology management
and regulation. While such norms and preferences may be mutable, unstable, and
even subject to manipulation by the media or political actors, they nevertheless
must represent the beginning point for any discussion of food safety and regulation.
If it is to be recognized and accepted as adequate by the lay public, regulatory policy
must transcend simple discursive claims of “expertise,” or even more general
assertions regarding the potential benefits of biotechnology, and must instead build
from existing social norms, judgments, and preferences.

Science and Public Policy in the United States and in the European Union
The development of regulatory frameworks governing agricultural biotechnology
in Europe and in the United States has proceeded along apparently antithetical
paths. Although the two regulatory regimes share the common objectives (e.g.,
ensuring a safe and plentiful supply of food, encouraging rural development, and
promoting environmental sustainability) and have similar discursive formations
(e.g., basing regulation on risk measured through established scientific assessment
procedures), the regulation of biotechnology in the United States and in the Euro-
pean Union has, since 1990, diverged significantly in practice. While the United
States has encouraged continued private innovation in agricultural biotechnology,
strong public resistance in the European Union encouraged the development of
stricter regulatory standards and consequently slowed adoption and acceptance of
some biotechnological innovations. As a result, debates over the nature of risk and
uncertainty, particularly in the context of agricultural biotechnology, have become
increasingly common. The transatlantic rift over trade in genetically modified food
therefore appears to be intensifying.
Perhaps the most significant institutional difference between the United States
and the European Union rests in the choice of the lead regulatory agency for
agricultural biotechnology. Rather than imposing strict regulations on biotech
research, U.S. regulatory policy was intended to promote the widespread produc-
tion and adoption of biotechnology—especially agricultural biotechnology—as an
area of U.S. competitive advantage. Strict regulation, it was felt, would create
unnecessary and counterproductive barriers to the commercialization of biotech-
nological innovations. Industry representatives and academic researchers strongly
lobbied congress against such regulations, and by the late 1970s, the initial push for
strict regulatory frameworks to govern biotechnology in the United States had
waned (Wright, 1994). In 1986, the Reagan administration issued its “Coordinated
Framework for the Regulation of Biotechnology,” in which the U.S. Department of
Agriculture (USDA) was granted primary regulatory authority over genetically
modified (GM) crops. The Food and Drug Administration and the Environmental
Protection Agency were afforded secondary and supporting roles.
410 Noah Zerbe

The division of regulatory authority established by the Reagan administration’s

“Coordinated Framework” rested on two key assertions regarding the nature of
biotechnology. First, the policy assumed that existing institutions were sufficiently
prepared to regulate the new technology. Second, and perhaps more significantly,
it assumed that innovations in biotechnology posed no new or fundamentally
different risks than conventionally produced products. In evoking these founda-
tions, the U.S. government relied on the doctrine of substantive equivalence, which
holds that the process by which an individual product was created does not affect
the degree of regulatory oversight—only the product itself is an issue. The practical
implication of the substantive equivalence doctrine was that no new regulatory or
institutional frameworks were necessary; transgenic crops would be regulated
under existing guidelines and institutions.
This division of authority clearly reflected the commitment of the Reagan White
House to promote biotechnology rather than regulate it. However, the administra-
tion’s conceptualization of biotechnology as a key area of American competitive
advantage was hardly new. Indeed, U.S. policy had, for a number of years, focused
on the promotion of biotechnology and other high-tech sectors and focal nodes for
future economic development, designed to offset competition from the developing
world over areas of labor-intensive production. This focus was exemplified by
numerous acts passed by the congress: the Bayh-Dole Act of 1980, which promoted
technology transfer between public universities and the private sector, the Eco-
nomic Recovery Tax Act of 1981, which awarded tax credits for research and
development activities, the 1984 Patent Term Restoration Act, which extended the
term of patent production for certain products, and the 1984 Cooperative Research
Act, which limited antitrust liability for joint research projects. Collectively, these
actions along with numerous others passed in the late 1970s and early 1980s,
reflected both the perceived importance of the high-tech sector to the American
economy and the centrality of state involvement in the development of that sector.
In choosing the USDA as the lead regulatory agency for agricultural biotechnol-
ogy, the Reagan White House was helping to promote the rapid development of the
technology. However, the choice of the USDA as the lead regulatory agency for crop
biotechnology presented the agency with an apparent conflict of interest. On the
one hand, one of the central missions of the USDA has been to promote techno-
logical innovation in agriculture, including biotechnology, in order to facilitate the
development of American agricultural production. In this capacity, the USDA has
become one of the most outspoken advocates of agricultural biotechnology and,
through the Foreign Agricultural Service and the U.S. Agency for International
Development, has promoted greater international acceptance of food biotechnol-
ogy. On the other hand, the USDA’s mission also includes the regulation of the very
technologies it so actively promotes.
Regulation of agricultural biotechnology in the European Union developed
along a fundamentally different path and according to different philosophical
principles. In the European Union, regulatory oversight for biotechnology fell
under the Directorate General XI (DG Environment), which established relatively
strict guidelines governing the production and consumption of GM foods based on
the philosophical justification of the precautionary principle. By locating regulatory
authority in the DG Environment, a particular set of values were privileged: envi-
 Lessons from the Transatlantic Biotech Dispute 411

ronmental questions were to be considered ahead of trade concerns, and potential

risks and uncertainties were, in principle, to be given a more comprehensive
consideration than was the case in the United States. Precaution and process-based
considerations were to be the guiding principles of regulation in the European
Union.
The decision to charge governance of agricultural biotechnology to environmen-
tal rather than agricultural bureaucracies in Europe may have been reflective of the
distinctive nature of European politics, in particular the capacity of what Prakash
and Kollman (2003) term “environmental leader states” (e.g., Germany, Denmark,
the Netherlands, and Sweden) to transfer strong domestic environmental protec-
tions to the European level. Such protections have historically been popular among
European Union citizens who—in light of several recent food scares, including the
mad cow/bovine spongiform encephalopathy (BSE) scare in the United Kingdom,
the dioxin-chicken scare in Belgium, and the outbreak of hoof-and-mouth disease
across Europe2—have demanded stricter state regulation of the food sector than has
been the case in the Untied States (Friedberg, 2004; Levidow & Morris, 2001;
Wynne, 2001).
Differences between U.S. and EU consumers regarding the perceived levels of
risk posed by the new technology thus provided one impetus for the development
of divergent regulatory frameworks in the United States and in the European
Union. The literature on risk communication and contingent valuation offers some
interesting insights here. The demand for stricter regulatory frameworks in Europe
is based on a belief among European consumers that the current generation of GM
crops offers few direct consumer benefits. With the exception of gender-based
differences, most studies of the subject find that sociodemographic variables offer
little insight into attitudes toward genetically modified organisms (GMOs). Rather,
subjective risk perceptions seem to be key (Burton, Rigby, Young, & James, 2001).
Such perceptions are influenced by a number of variables, but the most important
appear to be the level of trust placed in government regulations to protect the food
supply, attitudes toward science, and the influence of media coverage (Curtis,
McCluskey, & Wahl, 2004). Not surprisingly, attitudes toward GMOs therefore vary
greatly both within and between countries. Moon and Balasubramanian (2001),
for example, find that consumers in the United Kingdom were more likely than
consumers in the United States to pay a premium for breakfast cereals made of
GMO-free grains. Similarly, Lusk et al. (2004) found that English and French
consumers were less likely than American consumers to consume cookies made
from GM ingredients, while Carlsson, Frykblom, and Lagerkvist (2004) found that
Swedish consumers are willing to pay a significant premium for a non-GMO
products while U.S. consumers are not. Other studies confirm that U.S. consumers
are unwilling to pay such a premium (cf., Li, McCluskey, & Wahl, 2004). European
consumers tend to be more cautious in their attitudes toward agricultural biotech-
nology and, absent any significant counterveiling domestic pressures, European
regulators have responded to demands for structure policies governing GM foods.
Equally importantly, European regulators also faced a much-less-influential agri-
business sector than did American regulators. Where U.S. life sciences firms in the
late 1990s employed more than 150,000 people, earned more than $18 billion in
annual revenues, and invested more than $9.9 billion annually in research and
412 Noah Zerbe

development, the European life sciences industry employed fewer than 40,000
people, earned approximately $3 billion annually, and invested $2.2 billion in
research and development (Prakash & Kollman, 2003, p. 627). Furthermore, Euro-
pean research and commercialization efforts tended to be concentrated in pharma-
ceutical biotechnology, which enjoyed wider popular support in Europe than its
agricultural counterpart (Gashkell, Allum, & Starrs, 2002). Given the relative weak-
ness of the agricultural biotechnology industry in Europe, EU regulators faced no
real domestic lobby pushing for the approval of GM crops. Indeed, quite to the
contrary, what pressure was placed on European regulators was demanding
stricter—not weaker—regulation. This historical composition of social forces thus
helps to explain the regulatory frameworks deployed to govern agricultural bio-
technology in the United States and Europe.
That is not to say that the designation of the DG Environment as the lead
regulatory authority for GM crops in the European Union has insulated EU policy
from many of the same debates that occurred in the United States. Indeed, the DG
Environment has encountered some opposition, particularly from the other DGs,
most notably DG Trade and DG Agriculture, which desired more liberal, less
intrusive, and less trade-restrictive environmental policy. Debates over the applica-
tion of the precautionary principle in Europe, however, reflect both disputes
between DG Environment and the other DGs, as well as the surprising success of
DG Environment in implementing its policies in the face of opposition from the
other directorates.
The precautionary principle was established as the foundation for environmental
policy in the European Union in the Maastrict Treaty (1992), which holds that

Community policy on the environment shall aim at a high level of protection taking into
account the diversity of situations in the various regions of the Community. It shall be
based on the precautionary principle and on the principles that preventative action should
be taken, that environmental damage should as a priority be rectified at source and that
the polluter should pay (Title XVI, Article 130r 2).

Although the application of the precautionary principle in the European Union

has been uneven—generally applied where well-defined public demand for regu-
lation exists and few commercial economic interests exist to oppose them—the
European Union has strongly promoted the integration of the precautionary prin-
ciple into international environmental law, including the Cartagena Protocol
(Prakash & Kollman, 2003).
Building on the precautionary principle, EU regulatory policy places the process
of production squarely under regulatory consideration. Under process-based regu-
lation, the method of manufacture, rather than simply the nature of the product
itself, determines the necessity of regulation. Because GM foods are produced
through different techniques, different regulatory frameworks are justified. Thus,
unlike in the United States, in Europe, GM foods and conventionally produced
foods may be subject to entirely separate regulatory considerations.
The decision of whether to pursue product or process-based regulatory frame-
works implicates a broader discussion regarding the nature and role of biotechnol-
ogy in agricultural production. Product-based regulation implies that there is
nothing unique about the nature of biotechnology-derived products—that biotech
 Lessons from the Transatlantic Biotech Dispute 413

Table 1. Comparison of U.S. and E.U. Regulatory Processes for Agricultural Biotechnology

United States European Union

Regulatory agency U.S. Department of Agriculture has primary
regulatory authority, supplemented by the
Food and Drug Administration and
Environmental Protection Agency as
appropriate.
Philosophy of Substantive equivalence: genetically modified
regulation food and traditional foods are governed by
the same regulations.
Basis of regulation Product-based: all products are treated the
same regardless of the process used to
create them.
Directorate General XI (Environment) is the
lead regulatory agency.
Precautionary principle: uncertain risks
associated with biotechnology necessitate
specific regulatory frameworks for
genetically modified organisms, and the
absence of specific, scientifically-informed
threats should not preclude regulation.
Process-based: different processes used to
create products necessitates different
regulatory frameworks.

and conventional products are essentially the same. Process-based regulation,

however, implies that the biotechnology imposes a particular set of concerns, risks
and uncertainties which do not accompany conventional production methods.
Consequently, process-based consideration of biotechnology-derived products gen-
erally leads to calls for stricter regulation, frequently based on the precautionary
principle—as in the case of the European Union—whereas product-based assess-
ment generally leads to weaker regulatory standards based on the doctrine of
substantive equivalence—as in the case of the United States (see Table 1).
Unlike the U.S. regulatory system, which has been relatively stable since its
creation in the mid-1980s, the regulatory framework employed by the European
Union has evolved rapidly over the past ten years. While the DG Environment was
designated as the lead regulatory agency in 1990, the overall regulatory framework
was revised in 1997 and again in 2003 in response both to consumer demands
for stronger regulation of the new technology following several food scares and to
U.S. pressure for a less restrictive trading regime. The exact weight to place on
the demand for regulatory reform in Europe, however, is difficult to assess. Yet it is
clear that the mad cow, hoof-and-mouth, and dioxin scares all undermined public
trust in the capacity of the government to protect them from risk, as is reflected
in various Eurobarometer surveys (cf., Gashkell et al., 2002). It is equally clear,
however, that the United States has pursued an aggressive policy to open European
markets to its agricultural exports. The European Union represents the fourth
largest market for U.S. agricultural exports, and the United States fears that
European resistance may inhibit U.S. exports to lucrative European markets and
may also encourage other countries outside of Europe to similarly resist the new
technology (Zerbe, 2004).
In 1990, the European Union issued directive 90/220/EC, which required assess-
ment and approval of all new GM crop varieties before commercial release or
open-field testing. Under the directive, some 14 GM plants satisfied the assessment
process and were approved for release. In 1997, the approval process was liberal-
ized by regulation EC258/97, which required that all foods containing GM ingre-
dients be labeled, while simultaneously establishing a simplified testing procedure
under which foods deemed to be “substantively equivalent” to existing non-GM
varieties could bypass the normal testing and approval procedure.
414 Noah Zerbe

The adoption of the substantive equivalence language by the European Com-

mission satisfied the United States but angered many environmental, consumer
safety, and farming advocates within the European Union. The groups, which had
already successfully mobilized against the introduction of GM foods in many Euro-
pean supermarkets, argued that the new foods represented risks for which there
were few, if any, corresponding consumer benefits. Indeed, according to Euroba-
rometer polling data, public support for GM foods declined substantially in every
EU member state except Austria and Sweden between 1996 and 1999. Polling data
from 2002 suggest some recovery, but levels of support remain low in France,
Germany, Greece, Italy, and Luxembourg (Gashkell et al., 2002).
The adoption of regulation EC258/97 sparked a firestorm of debate in national
legislatures and civil societies across Europe. Within a year, the governments of
Austria and Luxembourg had evoked the “safeguard clause” under directive
90/220/EC, which permits member states to temporarily ban the importation or
cultivation of genetically engineered crops to protect public health or the environ-
ment until such time as the safety of the crop variety can be determined. Subse-
quently, similar bans were evoked in Italy, Greece, and Germany, and, in 1998,
France moved to block the approval of any new GM crop varieties until the existing
labeling and safety regulations governing the crops were tightened. France’s deci-
sion formally marked the beginning of the European Union’s de facto moratorium
on the approval of new GM crop varieties, and ultimately sparked the filing of the
U.S. trade dispute at the World Trade Organization (WTO). In adopting the
language of “substantive equivalence,” the European Union appeared to be gravi-
tating toward the regulatory system preferred by the United States. But while the
regulatory structures for approval remained in place, consumer and citizen senti-
ment against the new technology appeared sufficient to pressure governments not
to introduce the technology, and the lack of any substantial corporate interests in
developing new commercial applications in Europe created no incentive for the
European Union to move forward.
Why the United States and European Union pursued such radically different
regulatory policies vis-à-vis biotechnology is a question that has been sharply
debated. Several explanations have been offered. Europeans may be more hostile to
agricultural biotechnology because of the impact of other food crises, such as the
dioxin crisis in Belgium, hoof-and-mouth, and mad cow/BSE. American policy
formation may be more transparent, making Americans less likely to challenge the
safety of food biotechnology and more willing to accept assertions by the U.S.
government that agricultural biotechnology is safe. The media in the United States
may have offered less coverage to critics of agricultural biotechnology, whereas the
European media has tended to sensationalize to a greater degree the potential risks
of agricultural biotechnology, framing the debate in ways which emphasized poten-
tial risks and downplayed potential benefits of GM foods. Commercial interests in
biotechnology may be smaller and less-well organized in Europe than in the United
States, where biotechnology was cast as an important area of American competitive
advantage. It is also possible that Europeans may tend to be more technophobic
than Americans, who generally accept and embrace technological innovation (cf.,
Gaskell & Bauer, 2001; Patterson & Josling, 2002; Vogel & Lynch, 2001). In truth,
it is likely some combination of all of these variables that fueled policy development
 Lessons from the Transatlantic Biotech Dispute 415

in Europe and the United States and led to the emergence of the current policy gulf
between the two regulatory frameworks.

The Transatlantic Trade Dispute

The European Union’s de facto moratorium was strongly opposed by the United
States and other GM crop exporters, who feared the loss of lucrative EU markets.
Before 1997, the European Union was a key market for U.S. corn and soybean
markets. But following the adoption of the moratorium, U.S. corn and soybean
exports to Europe collapsed. Corn exports declined from approximately $211
million per annum in 1997 to just $200,000 by 2005, as European markets increas-
ingly sought non-GM alternatives to U.S. corn exports. Soybean markets similarly
dried up, declining from $2.3 billion in 1997 to $511 million in 2005. (See Figures 1
and 2.) While most analysts agree that the ban on GM food products in the
European Union was the proximate cause of the decline in U.S. corn exports to
Europe, it is speculated that the loss of soybean markets were less a result of
European preferences for non-GM soybeans than of competition from lower cost
producers like Brazil (cf., Pew Initiative on Food and Biotechnology, 2005).
As Europe chose to source corn and soybeans from other exporters, disputes
between the United States and the European Union over the relative degree of
Value (in thousands of US

Volume (in thousands of

$250,000 2,000,000
$200,000 1,500,000

metric tons)
Dollars)

$150,000
1,000,000
$100,000
$50,000 500,000

$0 0
97

98

99

00

01

02

03

04

05
19

19

19

20

20

20

20

20

20

Value Volume

Figure 1. U.S. Corn Exports to the European Union (1997–2005)

$2,500,000 9,000,000
Volume (in MT 000,000)
Value (in US$,000,000)

8,000,000
$2,000,000 7,000,000
6,000,000
$1,500,000 5,000,000
$1,000,000 4,000,000
3,000,000
$500,000 2,000,000
1,000,000
$0 0
1997 1998 1999 2000 2001 2002 2003 2004 2005

Value Volume

Figure 2. U.S. Soybean Exports to the European Union (1997–2005) (Data source: U.S. Foreign Agricultural
Service, 2005)
416 Noah Zerbe

regulatory oversight, as well as the philosophical foundations for regulation, played

out in various international fora, setting the context for the development of an
international regime governing biotechnology. Questions regarding the relative
weight to be afforded the precautionary principle as the basis for regulating trade
in GM organisms have thus become increasingly common. At the same time,
questions around the role of “nonscientific” and social factors as the basis of
regulation remained unanswered, particularly in the context of North–South dis-
putes over the role of farmers’ and community rights in the context of biodiversity
and biotechnology.
These debates played out most sharply in the context of the 2003 trade dispute
filed against the European Union by the United States, Argentina, and Canada. The
dispute alleged that Europe’s de facto moratorium on the approval of GM crop
varieties represented “non-science based hurdles” that cost American farmers more
than $300 million per year in lost grain exports (BIO, 2003). The European Union
countered that “the EU, just like any WTO member, has a legitimate right to
establish a regulatory regime to ensure that GMOs are only put on the market on
the basis of careful assessment of risks, appropriate control and monitoring mea-
sures, and proper information to consumers” (EU, 2003). While the WTO ruled in
February 2006 in favor of the United States, debates over what constitutes a socially
acceptable level of risk remain unresolved in the context of the U.S.–EU discussion
of food biotechnology, raising a host of policy questions not just for the United
States and the European Union, but for countries in the developing world as well
(Paarlberg, 2001; Paarlberg, 2003; Thomas, Burke, Gale, Lipton, & Weale, 2003).

Emerging International Governance?

The international regime governing biotechnology encompasses a broad diversity
of agreements and debates that transcend trade disputes between the United States
and the European Union. Indeed, the interrelated questions of intellectual prop-
erty rights in biotechnology and access and benefit sharing arrangements govern-
ing biodiversity have been identified by many developing countries as key areas of
concern. Given the specific concerns of the Global South regarding control over
biodiversity, the emerging biotechnology regime must be viewed as encompassing
not just biosafety, but a broader set of institutions and principles which collectively
define the system of ownership, property rights, trade, access and benefit sharing
in biodiversity and biotechnology. The most important of these institutions include
the World Trade Organization, especially the Sanitary and Phytosanitary (SPS)
Measures Agreement and the Trade Related Intellectual Property Rights (TRIPs)
Agreement, the Union for the Protection of New Plant Varieties, the Convention
on Biological Diversity (CBD), and the Food and Agriculture Organization’s
International Undertaking on Plant Genetic Resources.
However the emerging international regime for biotechnology and biodiversity
is incomplete and fraught with contradictions and inconsistencies. In many ways,
disagreements between international frameworks and institutions reflect national-
level policy differences between various actors: between the United States and the
European Union, between the developed and developing countries, between pro
and antibiotechnology states, and between transnational corporations and nongov-
 Lessons from the Transatlantic Biotech Dispute 417

ernmental actors. The way in which such contradictions play out at the interna-
tional level provides the background for the development of local systems
governance for biotechnology around the world.
SPS rules are intended to ensure that a country’s food supply is safe to eat. In the
context of the WTO’s SPS Measures Agreement, national governments may estab-
lish their own standards for safety in the food supply. The WTO’s rules, however,
impose strict conditions on the exact nature of the restrictions imposed by national
governments: sanitary or phytosanitary restrictions must be nondiscriminatory—
that is, trade restrictions must not distinguish between products based on the
method or location of production; safety concerns must be based on sound scientific
evidence; members must use international standards, guidelines and recommen-
dations where available; while higher standards are permitted only when based on
appropriate assessment of risk; precautionary restrictions are permitted only as a
temporary measure while a scientific assessment of risks is conducted; and finally,
any SPS restrictions imposed on trade must be proportionate to the level of risk
represented by the good in question.
The rules established under the WTO for sanitary and phytosanitary restrictions
on trade echo the general trend in U.S. policy vis-à-vis biosafety. Risks are perceived
to be clearly identifiable, quantifiable, and discrete, and measures to reduce risk
must not unduly restrict international trade or the marketability of individual
products. While formally permitting national governments to pursue higher stan-
dards of protection, in practice, the SPS rules of the WTO make such restrictions
extremely difficult. In the vast majority of cases brought before the WTO’s dispute
resolution panel, higher levels of restrictions were ruled by the panel to represent
unfair trade barriers (cf., the WTO’s shrimp-turtle and tuna-dolphin rulings).
Perhaps the most famous example of this—and the case with the most direct
resonance for biotechnology—was the decision of the panel against the European
Union’s restrictions on the importation of beef and dairy from cattle treated with
Bovine Growth Hormone, in which the panel ruled that the application of the
precautionary principle may not override the general principles established in the
SPS Agreement. The dispute resolution board has also suggested that trade restric-
tions in multilateral environmental agreements, including the Biosafety Protocol,
might violate the rules of the WTO (Cors, 1999). Despite the ruling, the European
Union continues to maintain its restrictions on the importation of BGH-treated beef
and dairy, choosing instead to face countervailing sanctions against its own exports.
The BGH case provides potential clues regarding how the European Union might
react against a similar ruling by the WTO in GM crops.
Interestingly, the Cartagena Protocol on Biosafety offers a much more permissive
atmosphere for regulation of international trade and thus raises important ques-
tions regarding the compatibility of the two agreements in international law.3 Under
the rules established in the Biosafety Protocol, the regulation and restriction of
trade in GMOs is permissible even in the absence of scientific certainty regarding
the impact of the organism in question. The position articulated in the protocol
essentially holds that lack of scientific evidence of risk does not constitute evidence
of a lack of risk. Consequently, states may establish regulatory frameworks to
minimize potential dangers to human health or to the environment even before
such risks can be proven to exist. Importantly, particularly from the perspective of
418 Noah Zerbe

many developing countries, the protocol also broadens the conception of risk to
include threats to socioeconomic threats to a given country or community. Article 26
of the Cartagena Protocol permits states to take into account “socio-economic
considerations arising from the impact of living modified organisms on the conser-
vation and sustainable use of biological diversity, especially with regard to the value
of biological diversity to indigenous and local communities.” The expansion of the
scope of risk to include not just impacts on human health and the environment is
the first of its kind, and was the basis of the decision of the Mexican government to
prohibit the cultivation of GM maize. However, the United States is not party to the
Cartagena Protocol or to the Convention on Biological Diversity, and is therefore
not bound by the agreements. Nevertheless, the tensions between the conceptions
of risk embodied in the WTO’s SPS Agreement and the Cartagena Protocol raise a
degree of uncertainty surrounding the future of direction of any international
consensus on the questions surrounding trade in GMOs.

Revisiting the European Regulatory Framework

In an effort to reconcile competing European positions on the issue, as well as to
resolve differences between U.S. and European regulatory frameworks that led to
the filing of the WTO dispute in 2003, the European Union issued regulation (EC)
1830/2003. The regulation enhanced labeling requirements under EU law and
established a strict traceabilty regime for all foods containing GM ingredients. At the
same time, in regulation (EC) 1823/2003 the European Union sought to simplify
the approval process for new GM foods and crop varieties.
Perhaps not surprisingly, the compromise position developed by the European
Commission satisfied no one. The United States strongly objected to the new
labeling requirements and is considering filing a second dispute before the WTO on
the grounds that such requirements constitute an informal trade barrier to U.S.
exports. An estimated 75% of proceed food produced in the United States currently
contains GM ingredients, primarily corn and soybean byproducts (Blackwood,
2004, p. 168). The EU regulations, which establish that any product containing
more than 0.9% GM ingredients be labeled as such, would likely make such prod-
ucts unpopular with consumers. Indeed, many European food producers have
already moved to source non-GM ingredients to avoid placing the required label on
their products for fear of consumer resistance.
Anti-GMO movements in Europe have also widely criticized the new regulatory
regime, arguing that the European Union has conceded too much to the demands
of the United States and other GM crop producers. For groups like Friends of the
Earth, the labeling laws do not go far enough to inform consumers and prevent
cross-pollination in European fields. They continue to press for a zero-tolerance
policy under which the threshold for labeling would be decreased to 0.5% or lower.
Finally, in perhaps the most interesting development, strong tensions have
emerged between the European Commission, which appears ready to move
forward with the approval of new GM crops and products under the framework
established in regulation (EC) 1823/2003, and the European Council which, in
representing the specific demands of individual member states, has adopted a more
cautious attitude. The dispute pits the European Union’s professional secretariat
 Lessons from the Transatlantic Biotech Dispute 419

and bureaucracy against the governments of many of the most influential EU

member states. The dispute centers on the evocation of the safeguard clause by five
EU member states (Austria, France, Germany, Greece, and Luxembourg) to block
the cultivation of genetically engineered corn and oilseed rape, which have already
received regulatory approval from the European Union. In April, 2005 the Com-
mission rejected the contention that the use of the safeguard clause by the five states
was warranted and ordered them to grant regulatory approval to the new crop
varieties. The five states appealed to the European Council, which rejected the
decision of the Commission, leaving the national bans intact. The question of the
balance of power between the European Commission and the European Council
remains unresolved and will likely play an important role in the evolution of the
European regulatory system for agricultural biotechnology.

Conclusion: Lessons from the Transatlantic Biotech Dispute

Although the outcome of the debates surrounding the evolution of the European
regulatory structure and the uncertainties associated with the competing agree-
ments regulating agricultural biotechnology at the international level remain unre-
solved, it is possible to draw several important lessons from the transatlantic trade
dispute.
First, the contestation of the regulatory environment in Europe and in the
United States highlight the many competing interests at stake. Consumers, farmers,
seed producers, pharmaceutical companies, governments, and activists all have an
interest in the outcome of debates over the emerging regulatory system. The
interlaced nature of the issues at stake (i.e., intellectual property rights, environ-
mental protection, competitive advantage in agricultural production, food safety,
and public health) serves to make the debates more complex. Indeed, transatlantic
debates around agricultural biotechnology signal that the technology may increas-
ingly be characterized as a wicked problem. Developed by Rittel and Webber (1973),
wicked problems are characterized by the following criteria: (1) they evoke com-
peting definitions of the problem among stakeholders; (2) there is no widely
accepted solution to the problem; (3) they involve normative judgments which
depend on stakeholder values and preferences; and (4) they are embedded in social
dynamics and contexts. Examples of wicked problems might include how to deal
with crime and violence in schools, where a new highway should be placed, or how
and why to regulate agricultural biotechnology. Unlike “tame problems,” which
Conklin (2006) suggests may be technically complex but are nevertheless well-
defined and stable with definite resolutions which can be objectively evaluated as
right or wrong, thereby avoiding the normative questions evoked by wicked prob-
lems, wicked problems cannot be solved solely by recourse to additional study, more
data, or expert opinion. Instead, addressing wicked problems generally involves a
discursive or dialogue-based approach which explicitly evokes normative questions
of what ought to be, and involves the construction of consensus rather than debate.
This has not been necessary in the United States, where the public has generally
already accepted the technology, thus removing the some of the “wickedness” from
the issue. But in the context of the transatlantic trade disputes over agricultural
biotechnology, such normative questions have not been addressed, and biotechnol-
420 Noah Zerbe

ogy remains best characterized as a wicked problem. Both the United States and the
European Union have sought to demonstrate that their position is correct—and the
other’s is incorrect—based on available scientific evidence. Such contentions fail to
address both the complexity of the issues at hand and the vast diversity of stake-
holder positions involved in the debates. Further, exclusive reliance on scientifically-
provable facts ignores the questions which should be central in debates over
regulatory governance: Who defines the risk? On what basis? And what trade-offs
does a particular regulatory system impose? In the context of agricultural biotech-
nology, such questions are necessarily normative. Both the pro- and anti-GM
lobbies lay claim to scientific evidence to support their position. But even if one
accepts the scientific data set out by one side as preferable, information can only
translate into regulation based on specific normative claims. Field trials may inform
our understanding of the rates of cross-pollination between GM and conventional
maize, for example. But what level of genetic drift is acceptable? Similarly, if we
posit that foods containing GM ingredients might be labeled, what level of GM
ingredients might trigger the label requirements? One percent? More? Less? Sci-
entific inquiry must clearly inform our dialogue. But in itself, science cannot answer
what are fundamentally social judgments. Indeed, as Stephen Jay Gould (1998,
p. 812) commented,
Human choice, not the intrinsic content of science, determines the outcome—and scien-
tists, as human beings, therefore have a special responsibility to provide council rooted in
expertise. The content of science can only enhance or potentiate choices rooted in our
social and ethical values. In the end, it is human choice and not the content of science that
determines the outcome.
This leads to the third and final lesson. The discourse on risk analysis has
increasingly emphasized the need to move away from the expert-driven risk assess-
ment process and to incorporate greater lay participation in the development of
regulatory structures. Such inclusion, it is posited, is not merely part of the “tyranny
of participation,” in which popular participation is cast as a magic bullet for democ-
ratization and development (Cooke & Kothari, 2001). Rather, greater citizen par-
ticipation in the development of regulatory frameworks accomplishes two goals.
First, it provides a mechanism to expand the scope of knowledge and information
on which to base decisions. The local knowledges of farmers in both the developed
and developing world, for example, may inform decisions around the future of
agricultural biotechnology more completely than any laboratory experiment.
Second, as a wicked problem, decisions concerning the scope and nature of
regulation of agricultural biotechnology evoke normative dimensions that escape
traditional scientific analysis but which nevertheless must be addressed before
innovations in agricultural biotechnology will be accepted by a skeptical public.
Such considerations typify the resistance to biotech foods among European con-
sumers, who feel that the current generation of agricultural biotechnology (e.g.,
pest-resistance and herbicide tolerance) offers few consumer benefits but raises a
host of unresolved concerns (e.g., health consequences of consumption, environ-
mental consequences of production, concentration in the seed industry, ethical
concerns around “playing God,” to name but a few).
Ironically, the transatlantic trade dispute not withstanding, the future of agricul-
tural biotechnology is likely to be decided not by government regulators but by
 Lessons from the Transatlantic Biotech Dispute 421

consumers. Science and scientific exerts must play a role in these discussions. But it
must be recognized tat the final decisions rest with citizens, consumers, and their
elected representatives. In Denmark, citizen juries were empanelled by the Danish
Parliament to debate the merits and dangers of agricultural biotechnology. Their
deliberations raised ethical, moral, social, and economic questions not traditionally
covered in scientific risk assessment, and provided the basis for the Danish regula-
tory system. The efforts of the Danish government were rewarded with a citizenry
that is, on average, better informed about and more accepting of biotechnology
than the average citizen elsewhere in Europe (Sclove, 1995; Sclove, 1996). If citizens
can be convinced that the regulatory framework in place is sufficient to protect
them from unnecessary risks, and if consumers can be convinced that agricultural
biotechnology can yield foods products with clear consumer benefits (e.g., low-fat,
low-calorie, and higher nutritional content in foods), then the technology may have
a future. If not, the consumer resistance which led to supermarket bans and strict
government moratoria and regulations seen in Europe will likely be the order of
the day.

Notes
1 This paper was originally presented at the 47th annual meeting of the International Studies Associa-
tion. I would like express my gratitude to the participants in that panel and to the editors and
anonymous reviewers at Review of Policy Research for their thoughtful input on this paper.
2 Mad cow disease, or bovine spongiform encephalopathy (BSE) is a fatal brain disease affecting cattle,
and has been linked to variant Creutzfeldt-Jakob disease (vCJD) in humans. BSE cases have been
identified in two-thirds of the EU member states, and more than 100 people, mostly in the United
Kingdom, have died from vCJD. A widespread outbreak of foot-and-mouth disease in the United
Kingdom in 2001 resulted in the slaughter of over four million sheep and cows. Both outbreaks
fundamentally shook European consumer confidence in both the food supply and in regulatory
structures designed to protect it (Berg, 2004).
3 At the insistence of the United States, the Preamble of the Cartagena Protocol asserts that “trade and
environment agreements should be mutually supportive.” Combined with the relatively weak enforce-
ment mechanisms embodied in the protocol compared to the countervailing duties imposed under the
WTO mechanism, there is sufficient reason to believe that the Cartagena Protocol will be viewed as
secondary to the WTO’s rules on sanitary and phytosanitary measures.

About the Author

Noah Zerbe is Assistant Professor of government and politics at Humboldt State University.
He is the author of Agricultural Biotechnology Reconsidered: Western Narratives, African Alterna-
tives and articles in Food Policy, Global Environmental Politics, and Third World Quarterly, among
others. His current research explores the social debates surrounding agricultural biotech-
nology and the role of community seed banks as a mechanism of seed exchange and food
security. He can be reached at noah.zerbe@humboldt.edu.

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