The Inºuence of the Cartagena Protocol on Biosafety

The Inºuence of the Cartagena Protocol on Biosafety
Aarti Gupta and Robert Falkner

Research Articles

The Inºuence of the Cartagena Protocol
on Biosafety: Comparing Mexico, China
and South Africa
•
Aarti Gupta and Robert Falkner*

Introduction

The introduction of genetic engineering to agriculture has produced a range of
new governance challenges in the ªelds of environmental safety, human health,
trade and development. The use of genetic engineering is rapidly expanding in
key sectors of food production, particularly in globally traded commodity crops
such as maize, canola, soybean and cotton. In the last decade, a growing web of
global rules and institutions has been created to govern agricultural biotechnol-
ogy. The most recent of these is the Cartagena Protocol on Biosafety negotiated
under the auspices of the Convention on Biological Diversity (CBD), which reg-
ulates transboundary transfers of genetically modiªed organisms (GMOs).1 It
was negotiated from 1996–2000 and entered into force in 2003, and is now be-
ing implemented in a growing number of developing countries.

The Cartagena Protocol calls for the advance informed agreement of an
importing country prior to trade in certain GMOs.2 It was negotiated at the in-
sistence of developing countries, most of whom were not yet participating in the
GMO trade and feared the entry of novel transgenic products into their coun-

* This study has been supported by a Research and Writing Grant from the John D. and Catherine
T. MacArthur Foundation. The authors thank interviewees in Mexico and South Africa (visited
by Aarti Gupta) and China (visited by Robert Falkner) for the time taken to address our queries.
In particular, Aarti Gupta thanks Amanda Galvez, Michelle Chauvet and Yolanda Massieu in
Mexico, and Rosemary Wolsen and Mariam Mayet in South Africa. Robert Falkner acknowl-
edges institutional assistance from Fudan University in Shanghai and Renmin University in
Beijing and thanks Xu Ang, Chris Hughes, Brendan Smith and Chen Zhimin. We also thank
participants in the 2004 CAT&E conference in Amsterdam and the 2005 WISC conference in Is-
tanbul, as well as Frank Biermann, Kees Jansen and four anonymous reviewers for useful com-
ments and feedback. We remain responsible for all errors.

1. GMOs are called “living modiªed organisms” (LMOs) in the Cartagena Protocol.
2. Advance informed agreement is the terminology used in the Protocol instead of the better
known “prior informed consent” which underpins global treaties regulating trade in hazardous

Global Environmental Politics 6:4, November 2006
© 2006 by the Massachusetts Institute of Technology

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24 •

The Inºuence of the Cartagena Protocol on Biosafety

tries without their knowledge. These countries pushed for a global agreement
that would make biosafety information-sharing mandatory on GMO exporting
countries and would legitimize an importing country’s right to restrict GMO
trade in the face of scientiªc uncertainty about risk or potential adverse socio-
economic impacts. The Cartagena Protocol has, in fact, been hailed by its sup-
porters as one of the key global environmental agreements to institutionalize a
precautionary approach to risk governance.

Since its negotiation, there has been growing scholarly interest in this
global biosafety regime. Much attention has been devoted, in particular, to po-
tential conºict with world trade rules.3 However, few analyses exist of whether
and how the Cartagena Protocol is inºuencing domestic debates and policy
choices, particularly in developing countries.4 It is this dimension that we ad-
dress here.

The impact of global regimes on domestic policy has long been the subject
of scholarly study. In international relations, this is a well-established area of in-
quiry via analyses of regime implementation, compliance and effectiveness.5 In
our study, we use the term “inºuence” rather than implementation or compli-
ance, which often refer more narrowly to a treaty’s obligations and provisions
alone. Under “inºuence,” we can include discursive changes associated with
global regime creation and implementation as well.

We also prefer to assess inºuence rather than “effectiveness” of a global re-
gime. The concept of effectiveness necessarily presupposes certain shared and
clear-cut regime objectives which, if complied with, can change actor behavior
in a domestic context and ultimately contribute to improved governance of an
environmental problem. In controversial areas such as agricultural biotechnol-
ogy, however, key elements of a global regime may remain contested. If so, as-
sessing regime effectiveness becomes normatively problematic, requiring as it
does the analyst to judge which of a regime’s contested provisions, if complied
with, would make for an “effective” global regime.

Our goal instead is to assess inºuence, via analyzing domestic discursive
and/or institutional changes stimulated by a regime, notwithstanding persisting
global-level conºicts. By discursive change, we refer to changes in the normative
context surrounding agricultural biotechnology policy, which can result in
legitimizing diverse perspectives and empowering different actors than might
otherwise be the case. Under institutional change, we include regulatory, ad-
ministrative, institutional and/or procedural changes stimulated by domestic
implementation of a global regime.6

waste and chemicals. For an analysis of how this changed language reºects conºicts over the na-
ture of the global regime, see Gupta 2000a.

3. Kim and Chambers forthcoming; Oberthür and Gehring 2006; Isaac and Kerr 2003; and Safrin

2002.

4. For an early analysis of the relevance of the Cartagena Protocol in India, see Gupta 2000b. For
biosafety regulations in developing countries and their compatability with the WTO, see
Baumüller 2003.

5. Young 2001; Weiss and Jacobson 1998; and Victor, Raustiala, and Skolnikoff 1998.
6. Clearly, the two are interlinked in that institutional change is likely to include discursive change

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Aarti Gupta and Robert Falkner

• 25

In assessing the inºuence of the Cartagena Protocol, we identify three ele-
ments of this global regime that are likely to stimulate discursive and/or institu-
tional change in a domestic context. While the Cartagena Protocol contains ob-
ligations for both GMO exporting and importing countries, we focus here on
elements that are most likely to exert inºuence in a potential GMO importing
country, given that most developing countries fall within this group.

These three elements—or avenues of inºuence, as we refer to them here—
include: enhanced choice regarding GMO imports, via the Protocol’s legitimiza-
tion of a broad set of decision criteria underpinning regulatory choices (includ-
ing scientiªc evidence of harm, a precautionary approach, and socio-economic
concerns); enhanced access to biosafety information from exporting countries, re-
quired by the Protocol; and enhanced capacity to regulate and ensure biosafety
domestically (via ªnancial assistance, training, sharing experiences, and learn-
ing from other contexts etc.).

In considering whether these avenues of inºuence are contributing to dis-
cursive or institutional change in a domestic context, we focus on three promi-
nent developing/emerging economies: China, Mexico and South Africa. Our
case selection is guided by two criteria: (a) participation in the global biosafety
regime creation process; and (b) established capacity and active encouragement
of domestic biotechnology research and commercialization as well as current
participation in the GMO trade as importers. In short, we have selected what are
often described as biotechnological leaders in the developing world,7 where ag-
ricultural biotechnology is a key economic, environmental, political and social
issue.

Our three countries are similar in this important respect, yet they also ex-
hibit key differences. They vary particularly in the nature of their domestic polit-
ical system: Mexico and South Africa are (nascent) democracies with a market
economy, whereas China is undergoing a profound and rapid process of eco-
nomic transformation and liberalization, although without corresponding po-
litical reform. Mexico is strongly integrated into global and regional trade and
safety regimes, and is linked to leading industrialized countries of North Amer-
ica through membership in the North American Free Trade Agreement
(NAFTA). South Africa has, since its re-admission into the global community in
the early 1990s, participated enthusiastically in global regimes. China’s version
of a “socialist market economy” embraces international economic links and is
concerned with international competitiveness, most notably symbolized by
the country’s accession to the World Trade Organization (WTO). However, it

as well. We make the distinction here in order to capture inºuences of a global regime that may
not result in concrete institutional change but only in a more open discourse or debate.

7. Although Mexico is a member of the OECD, in areas of relevance for agricultural biotechnol-
ogy, it exhibits key characteristics of a developing country. Observers note the existence of “two
Mexicos”—an industrialized North and an impoverished South—in analyses of the ongoing
devastation of the peasant sector, partly resulting from the neoliberal reforms associated with
NAFTA. The country still has a relatively large proportion of the population engaged in agricul-
ture, particularly subsistence farming, and is a center of origin and/or diversity of key crops sub-
ject to genetic engineering, such as maize and cotton.

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26 •

The Inºuence of the Cartagena Protocol on Biosafety

still places high priority on policy autonomy and insulation from external
inºuences.

Notwithstanding these differences, it is the similarities that guide our
choice: all three countries prioritize and encourage domestic biotechnology de-
velopment and commercialization and are current importers of transgenic
crops. In all three countries, encouragement of new agricultural technologies is
part of an overall effort to promote economic liberalization and greater compet-
itiveness in international markets. A key motivation underlying agricultural bio-
technology policy is fear of being left out of the next technological revolution,
with consequences for international competitiveness. If so, we would expect the
Cartagena Protocol—given its justiªcation of a precautionary approach to GMO
imports—to have relatively less inºuence in these countries.

Yet all three countries have also participated actively in negotiation of the
Protocol and all have ratiªed and begun to implement it. If so, in the face of po-
tentially competing trade, market access and competitiveness concerns, what
inºuence is the Cartagena Protocol having in these countries, if any? Our coun-
try selection is thus guided by the “most difªcult” cases approach: if we can as-
certain inºuence of this global regime in countries where one would least expect
it, we can extrapolate that such inºuence is likely to be present in smaller devel-
oping countries, which are only now beginning the processes of biotechnology
research, commercialization or regulation.

We proceed as follows: Section two elaborates further on the Cartagena
Protocol’s three avenues of inºuence and places this regime within the larger
context of global GMO governance and trade conºicts. The following three sec-
tions present detailed contextual analyses of biosafety debates and decision-
making in Mexico, China and South Africa. Our analysis is based on ªeldwork
in each country and interviews with policy-makers representing diverse inter-
ests, including agriculture, environment, health, economy, science and technol-
ogy, foreign affairs and trade, as well as stakeholder representatives including
scientists, NGOs (where they exist) and the private sector. In the last, conclud-
ing section, we compare our ªndings and assess their relevance for other devel-
oping countries.

Cartagena Protocol: Avenues of Inºuence and Global Context

Global Context: The Governance Challenge

Although data about the spread of genetically modiªed (GM) crops worldwide
is difªcult to come by, ªgures compiled by the International Service for the Ac-
quisition of Agri-biotech Applications (ISAAA) claim that, from 1996, when ge-
netically modiªed varieties were ªrst grown commercially, the global area
planted to such crops has increased over 50-fold, from 1.7 million hectares to
90.0 million hectares in 2005. Biotech crops are now grown in 21 countries. Of
these, the leader is the United States, with 49.8 million hectares, followed by Ar-

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Aarti Gupta and Robert Falkner

• 27

gentina (17.1 million ha), Brazil (9.4 million ha), Canada (5.8 million ha),
China (3.3 million ha), Paraguay (1.8 million ha), India (1.3 million ha) and
South Africa (0.5 million ha). Mexico and twelve other countries make up the
rest, with less than 0.3 million hectares each.8 It is important to note that, al-
though both developed and developing countries are growing transgenic crops,
the United States alone accounts for over half of the total area devoted to such
crops.

Apart from the few developing countries growing transgenic crops in com-
mercial quantities, others are still carrying out ªeld testing and experimental re-
search, if they participate in the process at all. However, irrespective of whether
countries grow transgenic crops, most have to contend with an increasingly
global trade in agricultural commodities and food containing genetically modi-
ªed material. The growth of a globalized biotechnology industry and of trade in
biotech crops requires countries to develop regulatory systems, forcing them to
consider the impact that the spread of GM seed and crops to their countries
might have on the sustainability of their agricultural systems, on the prospects
for biosafety and food security, and on their current and future position in
global agricultural trade.9

The need for global governance of genetic engineering has thus been rec-
ognized since the late 1980s, when the ªrst calls were made for an international
biosafety treaty. It took until January 2000 for an agreement to be reached on
the Cartagena Protocol on Biosafety, after nearly four years of increasingly con-
tentious negotiations.10 The Protocol is the center-piece of the emerging global
governance architecture for genetic engineering in agriculture. Other key ele-
ments of this governance architecture include the WTO’s Agreement on the Ap-
plication of Sanitary and Phytosanitary Measures (SPS Agreement) and Agree-
ment on Technical Barriers to Trade (TBT Agreement). Furthermore, the Codex
Alimentarius Commission, a global food safety standard-setting body, is debat-
ing global safety standards for food produced via use of genetic engineering.

This emerging governance framework has to contend with a wide range of
concerns (including ecological, human health, social and ethical) associated
with genetic engineering in agriculture. The governance challenge is made more
complex by the fact that the existence, nature and manageability of risks remain
deeply contested. Moreover, the emerging system of rules and institutions is far
from coherent or consistent. Instead, it remains unclear how components of
this rapidly expanding set of global rules interact with and inºuence one an-
other.11 This is partly because these regimes are still evolving, and their obliga-
tions are still being interpreted or expanded within global fora, as well as via na-

8. James 2005. Given the difªculty of obtaining data on transgenic crop expansion in developing

countries, a recent report questions the ubiquitous ISAAA statistics. See FOEI 2006.

9. For business and biotechnology, see Newell and Glover 2004; for agribusiness in general,

Jansen and Vellema 2004.

10. For a detailed history of these negotiations and the range of issues covered by the Cartagena

Protocol on Biosafety, see Falkner 2002, 2006; and Gupta 2000a.

11. See Kim and Chambers forthcoming, for an analysis of global biosafety regime inter-linkages.

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28 •

The Inºuence of the Cartagena Protocol on Biosafety

tional interpretation and implementation.12 It is also because of the potential
for conºict between the Cartagena Protocol’s obligations and WTO agree-
ments.13

This biotechnology governance challenge is rendered yet more complex by
the long-standing trade conºict between the United States and the European
Union over the EU’s policy towards GMO imports. The conºict was fuelled by a
de facto EU moratorium since 1999 on approvals of transgenic crops, while it de-
bated amendments to its regional GMO directives. Although recently lifted, this
moratorium led to a WTO complaint by the US in 2003 and a WTO Panel deci-
sion in favor of the US in 2006.14

This transatlantic GMO conºict underlines the fact that no shared global
approach to biosafety regulation currently exists, which might be diffused to
different domestic contexts via a global governance regime. Instead, two domi-
nant regulatory approaches persist, one serving as a model for comprehensive
and precautionary biosafety regulation (the EU model), the other emphasizing
a “sound science” approach to biosafety, whereby restrictive regulatory action is
justiªed only in the face of scientiªc evidence of harm (the US model).15 In the
absence of such evidence, the US model assumes the “substantial equivalence”
of GM and non-GM varieties of seed and food crops.

The two regulatory approaches also differ with regard to labeling, segrega-
tion,
traceability and threshold requirements for domestically authorized
GMOs (all of which are either mandatory or more stringent in the EU, as com-
pared to the US). There are no signs of these two models converging towards
one consensual regulatory model. Instead, negotiation of the Cartagena Proto-
col has provided one more site where these conºicts have played out, and its
inºuence must therefore be considered within this larger context.

The Cartagena Protocol: Avenues of Inºuence

The Cartagena Protocol was negotiated to allow for the “advance informed
agreement” of an importing country prior to trade in certain GMOs. In assessing
its inºuence in a domestic context, we identify three avenues through which
such inºuence might be felt: enhanced domestic choice about GMO imports, via
the Protocol’s legitimization of a broad set of domestic decision-criteria; en-
hanced access to information from GMO exporting countries about transgenic
crops in international trade; and enhanced capacity to regulate and ensure
biosafety domestically (via the Protocol’s encouragement of ªnancial assistance,

12. For an analysis of the decisions taken at the ªrst Meeting of the Parties to the Cartagena Proto-

col in February 2004, see Falkner and Gupta 2004; and Falkner 2004.

13. Winham 2003; Isaac and Kerr 2003; Koester 2001; and Kim and Chambers forthcoming. For a

general analysis of trade-environment linkages in the WTO, see Biermann 2001.

14. Brack, Falkner, and Goll 2003; and Financial Times 2006.
15. Young 2003.

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Aarti Gupta and Robert Falkner

• 29

training, sharing experiences, and learning from other contexts etc.). We elabo-
rate on these avenues of inºuence below.

Enhanced Choice via Broad Decision-Making Criteria
In operationalizing “advance informed agreement,” the Cartagena Protocol
mandates that importer decisions about GMO trade should be based upon a
scientiªc risk assessment. This decision-criterion has been designated “sound
science” by its proponents, which include leading biotechnology and GMO-
exporting countries. These groups have argued that it should be the only basis
for decision-making about GMO imports, with the hope that the Protocol will
become a vehicle to diffuse such a regulatory approach to developing countries
and harmonize regulatory outcomes relating to GMO trade.

However, at the insistence of the European Union and developing coun-
tries, the Protocol also allows for precautionary (trade restrictive) decisions in
the face of scientiªc uncertainty about harm posed by a traded GMO. Finally, as
a third criterion, the Protocol permits consideration of socio-economic factors
in decision-making about GMO imports, a demand from developing countries.
However, it restricts such considerations to impacts on biodiversity and consis-
tency with other international obligations (such as the WTO).

The relationship between these decision-criteria and WTO rules was a key
stumbling block during Protocol negotiation, and remains one of the most con-
troversial aspects of regime evolution and implementation today. Developing
countries and the European Union are concerned that WTO disciplines will
trump domestic biosafety measures based on the Cartagena Protocol, and have
been keen to ensure that the Protocol’s inconclusive language on this issue—the
preamble speaks of “mutual supportiveness” between the Protocol and other
international agreements—cannot be interpreted as subordinating the Protocol
to the WTO.

Areas of conºict with the WTO exist, in particular, with regard to precau-
tionary trade restrictions under conditions of scientiªc uncertainty. The
Cartagena Protocol’s language on precaution has been interpreted by some as
going beyond what the WTO-SPS Agreement calls for, although this remains an
issue of much debate and controversy.16 The SPS agreement allows precaution-
ary measures to be taken only on a preliminary basis with the aim of generating
scientiªc evidence about risks. This can be seen as more restrictive than the
Cartagena Protocol’s implicit recognition that scientiªc uncertainty is a perva-
sive aspect of biosafety regulation, making precaution legitimate in this area.
Furthermore, the Protocol puts no limitation on the duration of precautionary
measures and there is no explicit requirement that a review of the scientiªc basis
for decisions be undertaken.

Consistency with the WTO relating to socio-economic factors as a

16. Gupta 2002; and Kim and Chambers forthcoming.

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30 •

The Inºuence of the Cartagena Protocol on Biosafety

decision-criterion also remains disputed. Some socio-economic concerns
voiced by developing countries, such as adverse impacts of traded GMOs on tra-
ditional livelihoods or increased dependence on GM seed, may well run afoul
of world trade rules, if used as a justiªcation to restrict imports. However, it re-
mains contested and unclear whether such key socio-economic concerns as the
lack of domestic capacity to monitor, segregate or label imported GMOs would
be acceptable reasons to restrict imports.

Although much debate has centered around the Protocol’s decision-crite-
ria and potential conºicts with WTO, little is currently known about whether
similar debates about science, precaution and/or socio-economic concerns are
at the center of conºict and controversy in a domestic context, or how such cri-
teria are interpreted by countries in formulating biosafety regulations. We ana-
lyze whether the decision-criteria legitimized by the Protocol are leading to in-
stitutional and/or discursive change in a domestic context.

Enhanced Access to Information from GMO Exporters
Another key avenue of Protocol inºuence relates to its obligation to share
biosafety information between countries. GMO-exporting countries are re-
quired to provide biosafety information to potential importing countries, either
directly or via a global information clearing house. The nature and extent of in-
formation to be shared depends upon intended use of a GMO in a domestic
context. This right to information is seen as critical in making the GMO trade
more transparent—and hence is of key relevance for potential GMO importing
countries.

One particularly contentious issue has been the extent of information to
be shared about GM varieties in the bulk agricultural commodity trade.17 Fol-
lowing protracted negotiations, the Protocol calls for bulk agricultural com-
modity shipments to state only that they “may contain” GMO varieties (rather
than specifying which ones), a compromise reached in the last hours prior to
Protocol adoption.

This general statement is to be elaborated in future meetings, with greater
speciªcity to be negotiated regarding the form of documentation, the extent of
information to be shared about particular GM varieties, and the thresholds to
apply in identifying GMO content in bulk commodity shipments. Most devel-
oping countries and the European Union are demanding clear identiªcation
and detailed information sharing about speciªc GMO varieties in the commod-
ity trade. Exporting countries and producers strongly resist these demands, argu-
ing that they pose an unfair burden on trade.

The issue has been a bone of contention at each meeting of the Parties to
the Cartagena Protocol since its adoption and coming into force (the third such
meeting was held in March 2006). This last meeting was also unable fully to re-

17. Falkner and Gupta 2004.

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Aarti Gupta and Robert Falkner

• 31

solve differences or to replace the “may contain” language in this key category of
GMO trade.18 Whether and how global disputes over biosafety information-
sharing are inºuencing domestic discursive and/or institutional change is ad-
dressed via our case analyses.

Enhanced Capacity to Regulate and Ensure Biosafety
The Cartagena Protocol also calls for capacity-building to help countries de-
velop national biosafety frameworks and expand scientiªc, regulatory and ad-
ministrative capacity. In particular, the Global Environment Facility (GEF) has
been mandated, together with its hosting agencies, the World Bank, the United
Nations Development Programme (UNDP) and the United Nations Environ-
ment Programme (UNEP), to support biosafety capacity building activities in
developing countries. The Protocol also encourages private sector involvement
in capacity building.

A range of biosafety capacity-building initiatives are thus currently under-
way in the developing world, led by United Nations agencies, bilateral aid agen-
cies or the private sector in collaboration with international organizations.
However, this decentralized approach to capacity-building has allowed different
interests and regulatory approaches to be promoted. The jury is still out on
which of the currently contested biosafety governance approaches might be
spread to the developing world via such efforts.

In recent years, there has been a strong push by the biotechnology indus-
try and the United States Agency for International Development (USAID) to
support capacity building in Africa, which has raised concerns amongst those
advocating a more cautionary approach to GMO uptake in African agriculture.
We examine whether and how capacity building initiatives stimulated by the
Protocol are inºuencing discursive and/or institutional change in our three
countries.

Regime Inºuence: Harmonization or Regulatory Diversity?

On the face of it, then, the Cartagena Protocol is a multilateral agreement that
seeks to strengthen national prerogative in biosafety decision-making for GMO
importing countries. It does so via emphasizing enhanced choice, access to in-
formation and capacity in domestic decision-making processes. At the same
time, however, market access and trade competitiveness concerns are a strong
counterforce (and hence a key source of inºuence on domestic policy), espe-
cially in countries at the leading edge of agricultural biotechnology. In analyz-
ing Protocol inºuence in a domestic context, we consider the interactions be-
tween its avenues of inºuence and trade/market pressures.

18. See the Earth Negotiations Bulletin reports on the third Meeting of the Parties to the Cartagena

Protocol at http://www.iisd.ca/biodiv/bs-copmop3/.

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32 •

The Inºuence of the Cartagena Protocol on Biosafety

In particular, the transatlantic trade conºict between the US and the EU is
likely to shape the inºuence that the Cartagena Protocol might exert in coun-
tries. This conºict raises legitimate fears among GMO-importing countries that
they may not be able to apply precautionary trade restrictive measures without
repercussions from GMO producer/exporter countries, notwithstanding the
Protocol.

In fact, no GMO-exporting country, including the US, Canada and Argen-
tina, has to date ratiªed the Protocol. At the same time, these countries continue
to participate in further regime negotiation and evolution, in an on-going effort
to steer its avenues of inºuence towards science-based harmonization of domes-
tic regulatory policies, instead of a strengthening of national prerogative and
persistence of regulatory diversity. Via our analysis, we thus also comment on
whether the Protocol’s inºuence in a domestic context is, indeed, strengthening
national prerogative, or whether such inºuence is steering countries in the di-
rection of science-based harmonization of regulatory policy.

We turn next to our case analyses of agricultural biotechnology and
biosafety policy evolution in three countries and the inºuence of the Cartagena
Protocol therein.

3. Domestic GMO Governance: The Experience of Mexico

Mexico is often held up as a dramatic example of a country that has moved in a
relatively short period of time from being a closed and protected economy to
one of those most closely integrated into regional and global markets, including
in agriculture. Until the 1970s, Mexico prioritized (and largely attained) self-
sufªciency in the production of basic food grains. The 1982 debt crisis changed
this long-standing agricultural policy, with the country embracing trade liberal-
ization and privatization, and scaling back long-established programs of state-
led price supports and direct subsidies to the small-scale agricultural sector.
Mexico acceded to the General Agreement on Tariffs and Trade (GATT) in 1986,
became part of NAFTA in 1992, and the Organization for Economic Coopera-
tion and Development (OECD) in 1994. Biotechnology policy in Mexico is in-
extricably tied into this thrust towards trade liberalization and integration into
world markets.

Trade Policy Dimensions

The use of genetic engineering in agriculture remains a hotly contested issue in
the country, as is evident from recent conºicts over genetically modiªed maize,
a crop which is at the center of the national diet and is thus of overwhelming
importance in Mexico. Imports of transgenic maize from the United States (for
the animal feed and food processing industry) have, in particular, become a
lightning rod for conºict. The ªrst manifestation of this conºict was a morato-
rium on release of transgenic maize into the environment, declared by executive

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Aarti Gupta and Robert Falkner

• 33

decree in 1998 but lifted in mid-2004 (since its lifting, however, no new trans-
genic maize varieties have been approved for ªeld-testing). Transgenic maize in
Mexico received worldwide attention in 2001 following an article in Nature
magazine by David Quist and Ignacio Chapela, alleging transgene ingression
into indigenous maize varieties in the Chiapas region of Mexico.19

The conºicts over imports of transgenic maize reºect, indeed, a more fun-
damental conºict over the neo-liberal model of economic development em-
braced since the late 1980s and through the 1990s by a succession of Mexican
governments. Mexico’s appetite for bilateral and regional free trade agreements
is also evident from the fact that it became the ªrst country in Latin America to
sign a free trade agreement with the European Union—its second most impor-
tant trading partner after the United States. In addition, the country has also
participated actively in negotiating the Cartagena Protocol on Biosafety, which
it ratiªed in 2003.

Participation in Cartagena Protocol Negotiations

Mexico participated in Protocol negotiations as part of the so-called Compro-
mise Group of countries (consisting of OECD countries that were neither part
of the European Union, nor the Miami Group of GMO-exporting countries
largely opposed to a stringent global biosafety regime).20 Given that its NAFTA
partners, the US and Canada, were vocal members of the Miami Group and nei-
ther has since ratiªed the Protocol, it can appear puzzling why Mexico chose to
ratify. One key reason, as acknowledged by diverse actors, was to give domestic
policy-makers the option to withstand NAFTA and trade imperatives through
reference to their global biosafety rights and obligations, should the need to do
so arise. Ratiªcation was also stimulated by the newfound potential to inºuence
Mexican legislators during parliamentary debates about whether to ratify the
agreement, which environment ministry representatives pushing for ratiªcation
were able to successfully do.21

Mexico’s obligations under NAFTA and WTO Agreements, together with
its ratiªcation of the Cartagena Protocol, and the continuing controversy over
maize, have shaped on-going efforts to develop a domestic policy on agricul-
tural biotechnology.

An Evolving Regulatory Framework

Mexico has permitted ªeld-testing of transgenic crops since 1988, when the ªrst
government approval was issued to Monsanto for its transgenic (Bt) cotton.

19. Quist and Chapela 2001.
20. The compromise group comprised of Japan, Mexico, New Zealand, Norway, Singapore, South
Korea and Switzerland. The Miami Group consisted of Argentina, Australia, Canada, the United
States and Uruguay.

21. Interviews.

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34 •

The Inºuence of the Cartagena Protocol on Biosafety

Since then various transgenic crops, produced primarily by the private sector,
have been approved for ªeld-testing. While the private sector has concentrated
on the same crops in Mexico that are the focus of genetic manipulation else-
where, such as corn, canola, cotton and soybean, biotechnology crop develop-
ment is also under way in the public sector.22

This research trajectory dating back to 1988 has necessitated the develop-
ment of an institutional and regulatory framework for biosafety oversight. The
ªrst law governing transgenic crops in Mexico was a set of standards (the Mexi-
can Ofªcial Standard NOM-056-FITO-1995, or NOM-056 for short) developed
under the jurisdiction of the Ministry of Agriculture and in force since 1995.23
The Ministry of Agriculture was the key locus for regulatory oversight for trans-
genic crops throughout the 1990s, with other government representatives, in-
cluding from the Ministry of Environment, only seeking a more active voice
from 1998 onwards. This greater attention to biosafety issues domestically coin-
cided with the escalation in global GMO conºicts and their reverberation in ne-
gotiations of the Cartagena Protocol.

The NOM-056 established procedures for ªeld-testing of transgenic crops
but was silent about large-scale planting and commercialization. This gap in the
regulatory framework was addressed by creatively interpreting the law to portray
large areas (even exceeding 10,000 hectares) as experimental ªelds, which still
required biosafety measures. This was the approach used to permit large-scale
planting of Bt cotton, the only transgenic crop currently being grown in com-
mercial quantities in Mexico. Bt cotton is conªned to the industrialized north of
the country, relatively far removed from centers of diversity for cotton, and
hence has generated less controversy domestically.

Sentiments and controversies over transgenic maize have been much more
intense.24 Fears about transgene ingression into indigenous maize varieties re-
sulted, for example, in an unusual regulatory step: an amendment, apparently
without much debate or consultation, to the Mexican Penal Code in 2002, mak-
ing it a criminal offence to store or release transgenic crops into the environ-
ment. This scared the country’s leading public-sector biotechnologists into ac-
tion, converting some of them into active proponents of a comprehensive
biosafety law which would clarify permissible from impermissible activity and
prevent what they perceived as “a shut-down of biotechnology research” in
Mexico.25

Such a biosafety law was passed in March 2005 and is the most important
regulatory development in biotechnology policy in Mexico in recent years. The
main architect of the biosafety law, which replaces NOM-056, is the Mexican
Academy of Science, with two prominent Mexican scientists playing a key role

22. Herrera-Estrella 1999; see also Massieu et al. 2000 for a more critical perspective.
23. For an overview of biosafety-related legislation, see also Chauvet and Galvez 2005.
24. See, for example, ETC Group 2002.
25. Interviews.

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Aarti Gupta and Robert Falkner

• 35

in its drafting.26 It is fairly unprecedented that the scientiªc community should
take the lead in developing a politically fraught piece of legislation. This high-
lights the sometimes controversial role played by scientiªc experts in norma-
tively contested areas of domestic policy-making such as biotechnology, espe-
cially if such experts are themselves producers of the regulated technology.

Inºuence of the Cartagena Protocol

The architects of the biosafety law have not, however, been able to ignore a key
global development occurring at the same time—the negotiation and coming
into force of the Cartagena Protocol. Mexico’s ratiªcation of the Protocol in
2003 obliged it to implement the agreement via its national biosafety frame-
work. The scientiªc drafters of the new biosafety law claim that it meets Mex-
ico’s obligations under the Protocol. Its critics within the NGO community
allege, however, that it does not include basic elements necessary to imple-
ment the Protocol, such as advance informed agreement prior to imports of cer-
tain GMOs. The biosafety law is also criticized for promoting biotechnology
rather than operationalizing a precautionary approach—as legitimized by the
Protocol—to transgenic crop use in the country. This remains disputed, since
the law also calls for a special regimen for transgenic maize, to prevent release
into areas of the country which are centers of origin. This could require demar-
cation of GMO-free zones, which supporters of the law see as a clear manifesta-
tion of a precautionary approach.

Despite quite severe criticism of the law, a view shared by almost all stake-
holders is that having a domestic biosafety law, although ºawed, is better than
having no regulation at all. Signiªcantly, the Ministry of Environment gains
from passage of the new law, in that it now has (together with the Ministry of
Agriculture) a stronger voice in approving transgenic crops for deliberate re-
lease. Under the earlier NOM-056, the Ministry of Environment had merely an
advisory role, with the ªnal decision resting with the Ministry of Agriculture.

Another key institutional development in Mexican biosafety governance
has been the establishment of an inter-agency commission to coordinate and
develop biotechnology policy. This commission, La Comisión Intersecretarial
de Bioseguridad y Organismos Genéticamente Modiªcados—the Inter-Sectoral
Commission on Biosafety and Genetically Modiªed Organisms—(CIBIOGEM),
was created in 1999, partly in response to the temporary collapse of the
biosafety protocol negotiations in Cartagena in the same year. However,
CIBIOGEM has had a chequered existence, with critics alleging that it has
missed an important opportunity to outline a vision for appropriate use of bio-
technology in Mexican agriculture. This contributes to the somewhat cynical as-
sessment of CIBIOGEM by some critics that “a commission is set up when no

26. Interviews.

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36 •

The Inºuence of the Cartagena Protocol on Biosafety

action is desired.”27 Nonetheless, it has to date provided a site for the airing of
diverse state and nonstate actor views, and is now responsible for administering
the new biosafety law.

Another signiªcant outcome of Mexico’s ratiªcation of the Cartagena Pro-
tocol has been the signing of a controversial “Trilateral Arrangement” between
Mexico and its NAFTA partners, the US and Canada. The arrangement is in-
tended to implement the Protocol’s requirement that bulk commodity ship-
ments state that they “may contain” transgenic varieties. This trilateral agree-
ment was negotiated by a representative of the Ministry of Agriculture without
sufªcient consultation and it does not enjoy the unequivocal support of all
branches of government, much less civil society.28

A key reason is the trilateral arrangement’s controversial clause stating that
the “may contain” declaration is only to be triggered in cases where the content
of transgenic material is above a threshold of 5%. This threshold level is seen as
too high by those advocating caution and is criticized by civil society groups as
counter to the spirit, if not (yet) the letter of the Cartagena Protocol (given that
the debate about thresholds is yet to take place in the global context). A techni-
cal annex to the Trilateral Arrangement is, notwithstanding its “technical” label,
more politically useful in its demand for speciªc information from exporters
about traded GM varieties that might be entering Mexico. Ironically, Mexican
negotiators have sought via this annex to obtain precisely the kind of informa-
tion about traded agricultural commodities that developing countries were de-
manding during a Meeting of the Parties to the Protocol in Kuala Lumpur in
February 2004, but which Mexico blocked under pressure from its NAFTA trad-
ing partners.

It is important to note, however, that Mexico’s membership in NAFTA has
also been used by indigenous groups and environmental NGOs to press their
case for caution relating to transgenic maize imports into Mexico. These groups
successfully petitioned NAFTA’s Commission on Environmental Cooperation in
2002 to undertake a comprehensive analysis of the impacts of transgenic maize
on Mexican biodiversity, health and socio-economic practices. This resulted in
an inºuential and controversial study released by the CEC in 2004, which rec-
ommends, among other things, that the current moratorium on commercial
planting of transgenic maize be maintained, and even strengthened via mini-
mizing transgenic maize imports into the country.29 In doing so, the report also
makes reference to Mexico’s obligations under the Cartagena Protocol, in addi-
tion to mentioning its NAFTA and WTO-SPS obligations relating to trade.

A number of other domestic institutional developments have been di-
rectly stimulated by the Cartagena Protocol. One is the development of a do-

27. Interviews.
28. Interviews.
29. CEC 2004. Whether these recommendations have been or will be taken up remains a matter of

constant domestic controversy and vigilance by NGOs.

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Aarti Gupta and Robert Falkner

• 37

mestic roster of experts in biosafety, modeled along the Protocol’s global roster
of experts, which can be drawn upon to evaluate and advise on transgenic crop
approvals as necessary. The other is the launching of a project on capacity-build-
ing for biosafety regulation.

Mexico is one of twelve countries where a model UNDP-GEF project on
capacity building for national biosafety frameworks is being implemented. De-
spite the raison d’etre of such a project to assist with development and imple-
mentation of domestic biosafety frameworks, the GEF project in Mexico has not
had this impact. While it is credited with bringing various members of govern-
ment together to discuss approaches to biosafety and of playing an important
role in training personnel to undertake biosafety assessments, it has not exerted
discernible inºuence over the development and content of the new biosafety
law, which has been mired in a messy domestic political process.

Outlook

In Mexico, then, an overall promotional approach to biotechnology at the high-
est political levels and a general neo-liberal economic stance (whose most vocal
adherents are the Ministry of Agriculture and Ministry of Economy, supported
by high-proªle public-sector scientists) has most inºuenced the direction of
biotechnology policy. This coalition has, however, encountered resistance from
those advocating a more restricted approach. Organizations such as Green-
peace, as well as peasant and labor unions, exercise considerable inºuence over
the hearts and minds of the general public, especially in rural areas and particu-
larly in relation to the cultural, social and political signiªcance of maize. The
Ministry of Environment, with its mandate for biodiversity conservation and
sustainable use, has continued to emphasize the need for caution.

Equally important, Mexican legislators are discovering that they can actu-
ally debate legislation and are not required to rubber-stamp executive decisions,
as earlier. However, the transition to (a functioning) democracy and public ac-
countability is recent in Mexico, with the sentiment expressed that while pre-
vious regimes were authoritarian and corrupt, the administration of Vincente
Fox was well-meaning but inept, with adverse consequences for a coherent bio-
technology policy.

This mix of actors and inºuences has resulted in a domestic policy towards
transgenics that is both open as well as, in certain ways, restrictive and caution-
ary. The moratorium on environmental releases of transgenic maize is a
reºection of the latter, although it is seen, even by its supporters, as “having
failed,” since imports of transgenic maize from the US continue unabated, with
few oversight systems in place to ensure that imported transgenic maize will not
inadvertently enter the food chain or farmers ªelds. Elements of the new
biosafety law, when implemented, may well introduce some cautionary ele-
ments into biosafety governance. However, this will depend upon the extent to

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38 •

The Inºuence of the Cartagena Protocol on Biosafety

which, for example, the Ministry of Environment and its associated research
and assessment institutions are willing (through their authority over approvals)
to slow down the impetus from higher echelons of power to encourage use of
agricultural biotechnology. In such a scenario, the Cartagena Protocol has pro-
vided additional justiªcation and has given greater visibility to those advocating
a cautionary approach.

4. Domestic GMO Governance: The Experience of China

Genetic engineering has been an integral element of China’s agricultural strat-
egy since the mid-1980s. In an effort to boost agricultural productivity and
scientiªc capacity, the Chinese state has expended the largest public spending
program on biotechnology in the developing world and is now in a leading po-
sition in advanced biotech research outside the industrialized world. Over 150
national and local research laboratories are in operation today, and 2,690 scien-
tists were estimated to be working in the ªeld of plant biotechnology in 2003,
up from 740 in 1986.30 Despite some waste in public research funding and lack
of private investment, China has managed to produce 141 different types of GM
crops by 2002, of which 65 have entered the stage of ªeld trials.31

The absence of any biosafety regulation during the 1980s played into the
hands of Chinese researchers, who in the late 1980s were the ªrst worldwide to
grow a GM crop in commercial quantities, a virus-resistant tobacco plant.32 Af-
ter the introduction of China’s ªrst safety rules for GMOs in the mid-1990s, 12
GM crops were approved for large-scale ªeld trials, of which three (cotton, to-
mato, petunia) passed the safety tests for commercial planting in 1997. Of the
GM crops approved for introduction to the market, only GM cotton has since
been grown on a large scale, accounting for 58 per cent of the total cotton pro-
duction in 2003. An estimated 5 million farmers are now using Bt cotton, in-
cluding also varieties developed by Monsanto, the ªrst and so far only multina-
tional to sell GM seeds through a joint venture with a Chinese ªrm.33 New GM
crop developments (e.g. rice, potatoes) have since entered the regulatory ap-
proval process, but an informal moratorium on GMO authorizations, imposed
in 1999, has so far held back efforts to expand the use of genetic engineering in
Chinese agriculture.34

China’s headlong rush into modern biotechnology proceeded largely un-
encumbered by any regulatory burden. In 1993, the Ministry of Science of Tech-
nology (MOST), as the then lead agency in the ªeld of biotechnology, estab-
lished the Safety Administration Regulation on Genetic Engineering, a set of
general safety rules drafted largely by scientists for scientists. In 1996, the Minis-

30. Huang and Wang 2002; and Huang, Hu, Pray, and Rozelle 2004, 7.
31. Huang and Wang 2003.
32. Paarlberg 2001, 128.
33. Huang and Wang 2003.
34. Paarlberg 2001.

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Aarti Gupta and Robert Falkner

• 39

try of Agriculture (MOA) followed this up with Implementation Guidelines and
became the lead agency in the regulatory process. The MOA guidelines were
equally informed by a desire to promote biotechnology and concentrated on
scientiªcally demonstrated risks35—a position that, as critics argue, tended to
downgrade the importance of long-term and uncertain threats from GMOs to
human health and environment. Given its close links with the agricultural and
biotech sectors, MOA is widely seen to favor the rapid commercialization of GM
crops.36

Participation in Cartagena Protocol Negotiations

China’s participation in the negotiations on the Cartagena Protocol provided an
important external stimulus for the creation of a domestic biosafety agenda. Be-
cause the negotiations were held under the auspices of the Convention on Bio-
logical Diversity, China’s equivalent to an environmental ministry, the State En-
vironmental Protection Agency (SEPA), became the lead agency in the biosafety
talks. This ensured that greater weight was given to environmental concerns in
developing China’s position and allowed SEPA to move out of its relative
marginalization in domestic biotechnology regulation.

In keeping with diplomatic tradition, China sided with the group of devel-
oping countries that was the key demandeur for stringent international biosafety
rules. Although maintaining a low proªle in the talks and appearing to be more
conciliatory than others, China sided with the Like-Minded Group of develop-
ing countries (formed in 1999) in pushing for a comprehensive and precaution-
ary system of international GMO regulation.37 China signed the Protocol in Au-
gust 2000 but did not ratify the agreement until June 2005, owing in part to
intensive domestic debates about the impact of the Protocol on China’s bio-
technology policy.

The creation of the international biosafety regime had an important effect
on China’s biosafety policy. Chinese scientists and regulatory experts participat-
ing in the biosafety talks were able to tap into the rapidly expanding global
biosafety agenda and became key agents for domestic policy change, importing
international biosafety concerns and risk assessment and management ap-
proaches into the domestic context.38

The biosafety negotiations also led to a range of international capacity-
building initiatives, of which China became the biggest recipient country in the
late 1990s. These efforts included the creation of a national biosafety frame-
work in China, funded by UNEP and GEF, which gave SEPA a lead role in the
drafting process and promoted a more comprehensive approach to GMO regu-
lation.39 The impact of the framework was of a more limited nature, however: it

35. Paarlberg 2001, 129.
36. Interviews.
37. Lijie 2002.
38. Wang 2004, 902.

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40 •

The Inºuence of the Cartagena Protocol on Biosafety

failed to change the existing regulatory framework, largely owing to resistance
by MOA and MOST ofªcials, but further strengthened regulatory debates about
the need for comprehensive and precautionary GMO regulation. Efforts are now
under way to create the ªrst comprehensive biosafety law in China, which
would replace the existing system of regulations.40

Shift Towards Greater Precaution

The shift in China’s domestic biosafety debate came to be felt for the ªrst time
in 1999, when a de facto moratorium on new GMO releases was imposed. The
timing of this move—shortly after the introduction of the European Union’s
moratorium in October 1998 and shortly before the adoption of the Cartagena
Protocol in January 2000—is highly signiªcant. It signaled the growing impact
that the international GMO debate and the biosafety negotiations were having
on regulatory developments in China. For the ªrst time, Chinese authorities im-
plicitly acknowledged shortcomings in the existing regulatory framework and
quickly moved to create new domestic regulations.

With the adoption of a new national seed law in 2000, the ªnal manage-
rial authority over all new GM crop varieties passed to the State Council, a cen-
tral decision-making body at cabinet-level. The State Council’s new Regulation
on Safety Administration of Agricultural GMOs of 2001 was followed in 2002
by three implementing regulations issued by MOA, covering the areas of
biosafety evaluation, import safety administration and GM food labeling. These
new acts provided a more comprehensive system of risk management, for the
ªrst time regulating imported GMOs and providing consumers with some de-
gree of choice over GM food content. They signiªed a shift away from the pre-
vious product-based risk assessment of GMOs, as favored by the leading biotech
country, the United States, towards a more process-based approach as practiced
in the EU. They also adopted key approaches and methodologies of risk assess-
ment and management from the Cartagena Protocol and thus provided the ba-
sis for its domestic implementation.

Trade Policy Dimensions

The move towards a more comprehensive and precautionary approach to
biosafety regulation has been heavily contested and provoked debates on its im-
pact on China’s trade policy. On one side of the debate are advocates of agri-
biotechnology and importer interests who fear that the new emphasis on
biosafety would slow down the future adoption of GM crops and impede agri-
cultural trade liberalization. On the other side are agricultural exporters to mar-
kets with GMO restrictions (e.g. Europe, Japan and South Korea), who consider

39. Interviews.
40. Interviews.

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Aarti Gupta and Robert Falkner

• 41

stricter biosafety rules necessary to preserve China’s GM-free status in key areas
of trade. As in other developing countries, the balance of inºuence between ex-
porter and importer interests has become a critical factor in the evolution of
China’s biotechnology policy.

The fear of being shut out of markets with GMO import restrictions ªrst
surfaced in the early 1990s. At that time, the country’s ªrst experiments with in-
troducing GM tobacco plants were scaled down as soon as international buyers,
mainly from the USA, rejected the transgenic variety.41 The experience with GM
tobacco did not in itself put an end to GMO commercialization but provided a
ªrst example of how international market reactions could inºuence domestic
biotechnology strategy. China concentrated instead on a new range of GM
crops. In 1997, insect-resistant GM cotton varieties passed regulatory hurdles
and were introduced in four provinces (Hebei, Henan, Shanxi, Shandong), in-
cluding the ªrst and so far only foreign-owned GM plant variety, Monsanto’s Bt
cotton. Because cotton was primarily grown for the domestic market and did
not enter international trade, trade concerns did not stand in the way of rapid
commercial introduction of the GM varieties, which were grown on 3.7 million
hectares and accounted for 66 per cent of China’s cotton area in 2004.42

The threat of exclusion from export markets resurfaced, however, when in
2000 GM content was detected in Chinese shipments of soy sauce, leading to a
temporary ban on such shipments to the EU. Although soybean production was
ofªcially GM-free, China had been importing transgenic soybeans from the
United States, mainly for animal feed and processed food production, and was
testing domestically developed GM soybean varieties for market introduction.
The suspicion was that either imported or illegally planted domestic varieties of
GM soybeans were spreading into the major soybean-producing areas in North-
ern China, calling into question the domestic regulatory system. The experience
with the temporary EU trade ban is widely cited to have contributed to the con-
tinuing moratorium on authorizations of GM soybean and other GM crops.43

Whereas the threat of exclusion from international markets was a driving
force behind the tightening of China’s biosafety regime, domestic demand for
agricultural imports was pulling in the opposite direction. Owing to rapidly
growing domestic consumption and the liberalization of agricultural trade,
China has now become the world’s largest importer of GM soybeans, mainly
from the United States. The introduction of new biosafety rules in 2002, how-
ever, threatened the continuous import of soybean shipments on which many
domestic operators of crushing and processing plants, mainly in the Southern
ports of China, had come to rely. The new biosafety rules, which entered into
force in early 2002, only months after China entered the WTO, stipulated that
every shipment of GM crops had to be issued a safety certiªcate based on risk as-

41. Paarlberg 2001, 128–129.
42. Huang and Wang 2003, 11.
43. O’Neill 2001; and interviews.

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42 •

The Inºuence of the Cartagena Protocol on Biosafety

sessment. Owing to the short time-frame within which the rules were intro-
duced, US shipments of soybeans were held up temporarily, leading to a notice-
able fall in US soybean exports.44

The US government accused China of “back-door” protectionism aimed at
manipulating the burgeoning trade in soybeans and complained about the un-
certain nature of the new biosafety rules, which in their view failed to give clear
guidance to traders on the documentation requirements and allowed Chinese
authorities to delay a decision for up to 270 days (the timeframe given in the
Cartagena Protocol). China eventually gave in to sustained diplomatic pressure
from Washington and issued interim safety certiªcates to facilitate uninter-
rupted imports of soybeans before issuing formal three-year certiªcates in Feb-
ruary 2004.45 The climb-down by the Chinese authorities underlined the
difªculties involved in implementing the provisions of the Cartagena Protocol,
which at that time had not yet entered into force but served as a blueprint for
regulating GMO imports. The signiªcance of this episode for the biosafety ef-
forts of less powerful trading partners was widely noted in the developing
world.

Outlook

The experience of GMO regulation in China has shown that the Cartagena Pro-
tocol has had an important impact on domestic biosafety governance. Interna-
tional biosafety debates and participation in the negotiations have helped to
upgrade biosafety concerns on the domestic agenda. This has been further
ampliªed by the spread of GMO import restrictions in key export markets for
Chinese agricultural products. While China has adopted important elements of
the Cartagena Protocol, environmentalists point, however, to the many failings
of the system in preventing unauthorized releases of GMOs into the environ-
ment and the central role played by pro-biotech scientists and regulators in the
GMO approval process.46

The future direction of China’s biosafety policy remains to be seen. While
China’s regulatory approach has evolved from being largely promotional and
product-based in the 1990s to a more comprehensive, precautionary and pro-
cess-based model that is closer to that of the European Union than the United
States, support for basic and applied research in agricultural biotechnology has
not ceased and new GM crop developments (e.g. rice) are tipped to enter the
market in the near future. Whether this will actually happen any time soon de-
pends on a cost-beneªt calculation that many observers expect to be undertaken
at a high political level, and that will take into account the conºicting impera-
tives of technological innovation, agricultural growth and impact on export in-

44. Rugaber 2002.
45. China Daily 2004.
46. Keeley 2003; and interviews.

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Aarti Gupta and Robert Falkner

• 43

terests, in addition to environmental risk assessment. The often conºicting in-
ternational inºuences that have shaped China’s regulatory policy have thus
been employed by domestic interest groups—within and outside the core
state—to shape GMO policy. The Cartagena Protocol has helped to shift domes-
tic policy in the direction of greater caution but domestic battles continue over
the precise direction of China’s biotechnology strategy.

5. Domestic GMO Governance: The Experience of South Africa

The direction that biotechnology policy takes in South Africa holds signiªcance
that goes beyond that country’s own borders. Policy developments in South Af-
rica are often seen, whether legitimately or not, as the litmus test for how things
may develop in the African continent as a whole. Its potential to be a “gateway”
to the rest of Africa for transgenics, as well as for biosafety regulations, makes
developments in South Africa of particular interest to both proponents and op-
ponents of the technology alike.

Biotechnology and its use in agriculture receive strong support from the
highest echelons of the South African government. State encouragement of bio-
technology goes back to 1978, when a South African Committee for Genetic Ex-
perimentation (SAGENE) was constituted to encourage research in molecular
biology and biotechnology.47 In the 1980s, with support from the government,
new biotechnology research centers were established. Beginning in the 1990s,
South Africa became one of the ªrst countries to undertake ªeld trials and envi-
ronmental releases of transgenic crops. Government support of modern bio-
technology remained strong through the dramatic political changes in South Af-
rica in the early 1990s, with the fall of apartheid and the coming to power of the
African National Congress. South Africa is now one of the few developing coun-
tries, and the only one in Africa, to grow transgenic crops commercially.

Participation in Cartagena Protocol Negotiations

With an overall political environment that supports rapid development of the
biotechnology sector, it can appear puzzling why South Africa has chosen to rat-
ify the Cartagena Protocol—which is seen as a potential hurdle to rapid biotech-
nology uptake by supporters of the technology. South Africa participated in Pro-
tocol negotiations as part of the so-called Like-Minded group of developing
countries. In initial stages of the negotiations, tensions were evident between its
domestic priorities and the negotiating positions put forward by the Like-
Minded Group, and particularly by the African Group of countries within it,
who were calling for a stringent global biosafety regime.

That South Africa remained a part of the Like-Minded Group throughout
the negotiations and subsequently ratiªed the agreement is explained by ob-

47. Sasson 2000.

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44 •

The Inºuence of the Cartagena Protocol on Biosafety

servers as politically unavoidable, given the country’s emphasis on multilateral-
ism since the early 1990s, and its desire to show solidarity with other African
countries. The timing of ratiªcation, August 2003, is also linked to the then-
upcoming Johannesburg Earth Summit. With South Africa playing host to the
key sustainability event of the decade, it was yet more important to demonstrate
support of multilateral environmental processes.48

An Evolving Regulatory Process

transgenics remains largely the domain of

Unlike in China, in South Africa (as in Mexico) development and commercial-
the private sector.
ization of
Crops approved for commercialization since 1997 include insect-resistant and
herbicide-tolerant varieties of maize, cotton, and soybeans, with all but one de-
veloped by Monsanto.49 South Africa is also the ªrst country to commercialize
transgenic white maize, a staple food crop of its population. While the public
sector is involved with transgenic research (focusing on crops such as transgenic
potato, sugar cane, maize and strawberries), its products have yet to reach the
commercialization phase. Even though the bulk of research and development is
underway within the private sector, public-sector scientists remain inºuential
players, primarily via their participation in the biosafety regulatory process.

This regulatory process dates back to the late 1980s. At the time, with no
biosafety law in place, research and ªeld testing of transgenics was regulated un-
der the 1983 Agricultural Pests Act, with a reconstituted SAGENE serving as the
scientiªc advisory body on environmental releases of GMOs.50 The ªrst general
release of transgenics occurred in South Africa in 1997.51 This coincided with
adoption of a separate biosafety law, also pushed for by SAGENE members,
many of whom were engaged in biotechnology research themselves.52 This is in
keeping with the trend seen elsewhere, notably in Mexico, where scientists en-
gaged in biotechnological research have felt the need for biosafety laws and
have led the way in developing them.

The Genetically Modiªed Organisms Act (henceforth GMO Act) was
passed in 1997 and implemented in 1999.53 The GMO Act is administered by
the Ministry of Agriculture and establishes procedures and an institutional
structure for regulating transgenics in South Africa. This includes an Executive
Committee consisting of representatives of agriculture, health, environment,
science and technology and trade, as well as a Scientiªc Advisory Council
(which replaced SAGENE, although some members remained the same).

48. Interviews.
49. Morris et al. 2005.
50. Sasson 2000.
51. Morris et al. 2005.
52. Interviews.
53. GMO Act 1997.

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Aarti Gupta and Robert Falkner

• 45

Decisions on approvals of transgenics are to be taken by consensus within
the Executive Committee—which ensures that all represented government de-
partments can, in theory, veto particular transgenic crop approvals. This is dis-
tinct from countries where the Ministry of Environment, for example, has less
ªnal authority than the Ministry of Agriculture over approvals. Critics note,
however, that the capacity to raise relevant concerns in the Executive Committee
varies greatly between government departments.54

This regulatory process has been accompanied by efforts to develop a co-
herent overall strategy for biotechnology development, as reºected in a 2001
National Biotechnology Strategy, which outlines a vision for biotechnology’s
role in ensuring South Africa’s technological leadership in the 21st century. The
strategy is a response, as stated in its executive summary, to an alleged failing to
“extract value” from the third generation of genetics and genomic sciences in
South Africa, and is designed to “make up for lost ground.” It mandates creation
of regional innovation centers, with Rand 400 million ($60 million) committed
to their establishment. It also calls for “suitable regulatory systems in order to
participate as exporters and importers in the international trade in biotechnol-
ogy products.”55 Yet, as noted by critics, it leaves unclear how use of biotechnol-
ogy in South Africa will address pressing rural development and food security
needs.56

Trade Policy Dimensions

South Africa is a net agricultural exporter, although it currently both exports and
imports certain commodity crops subject to genetic manipulation. The United
States and Argentina are key exporters of transgenic maize and soybean to South
Africa, and transgenic varieties of these two crops, once approved in these ex-
porting countries, have also largely received approval in South Africa (often, as
critics point out, on the basis of risk assessments generated elsewhere). Al-
though Europe is South Africa’s most important agricultural trading partner,
this is not the case for crops subject to genetic modiªcation. Of the transgenic
crops approved for general release in South Africa that may enter international
trade, only cotton is exported to Europe.57

Unlike in China, and to lesser extent Mexico, the transatlantic GMO trade
conºict between the US and the EU, and trade imperatives in general, have thus
been less of an inºuence on domestic regulatory developments in South Africa.
Where international inºuences have been important is in the debate in South
Africa and neighboring countries over food aid containing genetically modiªed
varieties, particularly from the US. In the food aid crisis in 2002, it was South

54. Interviews.
55. National Biotechnology Strategy (South Africa) 2001, ii and v.
56. See, for example, Aerni 2001.
57. Wolson 2005.

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46 •

The Inºuence of the Cartagena Protocol on Biosafety

Africa’s offer to mill maize in food aid (to prevent planting as seed) at its ports
of entry before it was sent onto other countries that defused the crisis to some
extent.58

Without strong trade pressures exerting a pull either way, the half decade
since the GMO Act has been in force has been a period of intense activity in re-
search, development and approvals of transgenics in the country. An ever-grow-
ing number of transgenics (including three varieties of cotton and maize and
one variety of soybean) have received general release approval, with another
eight varieties of maize approved for commodity clearance, i.e. importation for
use as food/feed.59

Inºuence of the Cartagena Protocol

Hand in hand with this, the domestic regulatory framework has been put to the
test and has evolved, stimulated also by a series of high-proªle legal challenges
by an active NGO community, who have also drawn upon the government’s
ratiªcation of the Cartagena Protocol to justify demands for greater accountabil-
ity and transparency in decision-making about transgenic crop approvals.

Most recently, a court case brought by the environmental organization
BioWatch against the government demanded access to a wide variety of infor-
mation about domestic transgenic crop approvals. BioWatch won the case,
with the Registrar of the GMO Act (the main repository of such information
within the Department of Agriculture) now required to make such information
available.60

Although a signiªcant victory, this has also raised the question of whether
civil society groups in developing countries have the capacity to sift through vast
quantities of biosafety information in an attempt to hold the government ac-
countable—although the domestic NGO community in South Africa has played
this role to date with aplomb, ªling detailed objections to an ever-increasing
body of transgenic crop permit applications.61 This focus on transparency is very
much in line with the spirit of the Cartagena Protocol, as envisaged by its sup-
porters and potential importing countries.

Ratiªcation of the Protocol has also provided an important additional
stimulus to amend the existing GMO Act. A draft amended bill is now under
consideration in parliament, yet it has come under sustained criticism from civil
society groups for failing to address environmental and social concerns around
transgenic crop use in South Africa and for failing to institutionalize a precau-
tionary approach.62 To the extent currently discernible, changes to the act di-
rectly stimulated by the Protocol include only certain procedural adjustments to

58. Zerbe 2004
59. Morris et al. 2005.
60. Dunn 2005.
61. See, e.g., the detailed objections by the African Center for Biosafety at www.biosafetyafrica.net.

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Aarti Gupta and Robert Falkner

• 47

time frames in the current GMO approval process. Discussions are also under-
way about how best to meet the country’s obligations to provide information
about domestic GMO approvals to the Protocol’s biosafety clearing house.63

Where unable to introduce desired changes into the GMO bill, the domes-
tic NGO community has sought to inºuence other related domestic regulations.
Particularly noteworthy is recent passage of the Biodiversity Bill, which permits
the Minister of Environment to require an environmental impact assessment
(EIA) for particular transgenic crops prior to approval, if he/she is convinced of
the need for it.

Such an EIA is distinct from the risk assessment called for by the GMO Act,
which can sometimes remain a desk-top study. Although it remains disputed
whether this is indeed a far-reaching regulatory change, the requirement for an
EIA is also seen by supporters as in keeping with the Cartagena Protocol, and its
inclusion in the Biodiversity Bill as a victory for those seeking attention to envi-
ronmental impacts of GMO releases. It also strengthens the hand of the Minis-
try of Environment in regulatory decisions.

While the NGO community’s actions are contributing to regulatory
change in South Africa, supporters of genetic engineering are not silent observ-
ers—far from it. The dominant pro-biotechnology group, AfricaBIO, sees itself
as a source of objective information about the use of genetic engineering in agri-
culture for the African continent as a whole. Most members are private sector
companies involved with production of transgenics. The group plays an active
role in capacity-building initiatives in the Southern African region, often in con-
junction with the USAID.64 US inºuence is prominent in such regional capacity-
building initiatives, raising concerns in the NGO community.

In its broadest contours, South African biosafety legislation has tended to
follow the permissive regulatory approach of the United States. This is also
reºected in the recently passed labeling legislation under the Ministry of Health,
which subscribes to the notion of the substantial equivalence of GM food with
non-GM food.65 This permissive approach to GMO regulation in South Africa
may also be politically feasible in part because there is currently little wide-
spread public knowledge or concern about transgenics. A recent survey carried
out on behalf of AfricaBIO claimed that a substantial majority of the popula-
tion is unaware or unconcerned about transgenic foods, a ªnding that subse-
quent government surveys claim to conªrm as well.66

This could be because, unlike maize in Mexico, no single crop subject to
genetic engineering has the cultural resonance around which public debate can
rally. However, maize is South Africa’s most important crop as well, and com-

62. See, for example, Mayet 2004.
63. Interviews.
64. Wolson 2005.
65. Interviews.
66. AfricaBIO undated.

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48 •

The Inºuence of the Cartagena Protocol on Biosafety

mercialization of transgenic white maize may well lead to future heated
debates67 also in conjunction with the food aid debate, since most South Afri-
can maize exports go to other African countries.

Outlook

For now, without immediate threats to its agricultural imports or exports, it is a
small but vocal domestic pro- and anti- GM lobby within South Africa that is
driving domestic regulatory developments. In an important development in late
2005, a policy decision was taken to halt approvals of applications for GMO
commodity imports, pending the outcome of a study by the Department of
Trade and Industry about the impacts of such imports on South African agricul-
ture and trade. Whether this signals a shift towards precaution or a temporary
aberration will only become clearer with time.

In general, however, the domestic coalition supportive of biotechnology
in South Africa is very similar to that in Mexico and China—it includes the bio-
technology industry, the Ministry of Agriculture, and public-sector biotechnolo-
gists as key players. Critics, including vocal environmental and public interest
NGOs, see the biosafety regulatory structure as crafted by this “coalition of the
supportive” and intended solely to facilitate quick approvals of transgenics.

In seeking to contest this, they have drawn upon the Cartagena Protocol to
bolster their positions and inºuence developments within the country and re-
gionally. Furthermore, as in both China and Mexico, the position of the Minis-
try of Environment in South Africa has been strengthened because of existence
of the Protocol, partly because of its role in regime negotiation and evolution,
and partly because of the increased legitimacy conferred upon a precautionary
discourse around biosafety.

For critics of the current biosafety policy direction in South Africa, what
the country needs, also in order to implement its obligations under the
Cartagena Protocol, is the African Model Law on Biosafety, which is seen as suit-
ably precautionary.68 This Model Law has been developed by the African Union
as a template for domestic biosafety regulations. Such a position is dismissed as
untenable by supporters of the technology, such as AfricaBIO. With many coun-
tries in Africa now at a key juncture in developing biosafety regulations, out-
comes in South Africa remain critical to watch.

6. Conclusion: Inºuence of the Cartagena Protocol

Our analysis of biotechnology policy evolution in Mexico, China and South Af-

67. For a view that sees this as a positive development for small farmers, see Gouse et al. 2005. For
an opposing view, see Biowatch at http://www.biowatch.org.za/docs/booklets/gebk4/chapt3
.pdf.

68. Mayet undated.

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Aarti Gupta and Robert Falkner

• 49

rica suggests that market and trade dynamics and/or a general overarching con-
cern with technological leadership and international competitiveness, are driv-
ing policy choices in the three countries. In a domestic environment largely
supportive of the use of transgenic technology in agriculture, the Cartagena Pro-
tocol has, nonetheless, inºuenced policy debates and regulatory and institu-
tional developments in these key countries. Their prominent role in agricultural
biotechnology application makes them important reference points for how the
Protocol might shape domestic policy choices. We highlight below our ªndings
with regard to the Protocol’s avenues of inºuence in these countries.

Avenues of Inºuence: Findings in Comparative Perspective

Enhanced Choice as an Avenue of Inºuence
With regard to enhanced choice as an avenue of inºuence, we ªnd that existing
biosafety frameworks are being amended in all three countries partly in re-
sponse to the Cartagena Protocol. However, the nature of such amendments are
driven by domestic considerations that mediate how the Protocol’s decision-
criteria of scientiªc risk assessment, precaution and/or socio-economic factors
are interpreted or institutionalized.

The evolving regulatory frameworks in each of the three countries all have
scientiªc risk assessments at their center. Although a precautionary discourse
has gained greater credence in general, its incorporation into amended biosafety
laws remains disputed. This reºects on-going disagreements over the interpreta-
tion of precautionary actions in global fora as well. Furthermore, we ªnd that
socio-economic concerns over traded GMOs—a decision-criterion argued for by
developing countries during Protocol negotiations—are not ofªcially voiced as
a reason to restrict trade or domestic GMO releases. At the same time, such con-
cerns are constantly present as the backdrop to domestic application of
scientiªc risk assessment processes and decisions about uptake.

They remain key in disputes over transgenic maize in Mexico, for example,
and continue to be emphasized by civil society groups and within the larger dis-
course about agricultural biotechnology. In South Africa, it is noteworthy that
consideration of transgenic crop applications was temporarily halted in order to
consider the implications for the country’s agricultural trade priorities. Likewise
in China, the trade implications of any decision on GMO authorization,
whether for import or domestic commercialization, is uppermost on the minds
of state ofªcials. Socio-economic, rather than scientiªcally assessable safety con-
cerns alone, are thus never far from the surface of domestic biosafety decision-
making.

In general, our ªndings suggest that the Protocol’s inºuence is not discern-
ible via direct or uniform translation of its (still disputed) regulatory decision-
criteria into national biosafety frameworks. Instead, it is the ºexible interpreta-
tion of its perceived overall precautionary thrust that is stimulating limited in-

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50 •

The Inºuence of the Cartagena Protocol on Biosafety

stitutional and discursive change in diverse domestic contexts. As Jasanoff notes
in a study of regime compliance, in areas of technological and scientiªc contro-
versies, “policy agreement is maintained . . . by leaving room for locally variant
interpretations of centrally articulated, but ºexible, scientiªc concepts”.69 In the
case of biosafety, we ªnd that domestic inºuence is contingent upon such inter-
pretive ºexibility.70

Enhanced Access to Information as an Avenue of Inºuence
Concerning access to biosafety information, we see from the case analyses that
this avenue of inºuence has stimulated (or, in the case of South Africa, sup-
ported) certain domestic developments. China’s shift towards greater precau-
tion has been bolstered by the participation of Chinese scientists in interna-
tional biosafety debates, which has led to a kind of transnational “concern
transfer” into a domestic context of technology promotion. In South Africa, ac-
cess to information is a key aspect of domestic biosafety politics, mostly stimu-
lated by that country’s constitution and right to information laws. This has,
nonetheless, been given further impetus by ratiªcation of the Cartagena Proto-
col. In Mexico, we ªnd direct inºuence of the Protocol’s information-sharing
obligations in the controversial Trilateral Agreement negotiated with NAFTA
partners, which may result in greater access to information and associated pol-
icy change around transgenic maize imports in the future. These developments
have, at the very least, contributed to greater visibility and debate over biosafety
concerns domestically.

Enhanced Capacity as an Avenue of Inºuence
Capacity building projects stimulated by the Cartagena Protocol are intended
primarily to facilitate development and implementation of domestic biosafety
frameworks. In our cases, however, we ªnd that the well-endowed capacity-
building initiatives launched under the aegis of
the Protocol have not
signiªcantly inºuenced the content of domestic biosafety regulations. As seen
from the analyses, the projects have remained at the margins of political deci-
sion-making processes in both Mexico and China.

However, this is unlikely to be the case for developing countries where reg-
ulatory frameworks do not yet exist, or where concerns around transgenics are
related less to market access and international competitiveness, and more to
lack of capacity to manage potential risks. Here, the Protocol’s capacity-building
initiatives are likely to exert greater inºuence.

This is particularly the case for those countries where the prospect of hav-
ing an internationally funded capacity building project has served as a lure to
ratify and implement the Protocol. In others, however, capacity building is be-

69. Jasanoff 1998, 81.
70. The term “interpretative ºexibility” draws on work by scholars of science and technology such
as Bijker et al. 1987. For the need for local reinterpretation of global biosafety obligations, see
Gupta 2004.

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Aarti Gupta and Robert Falkner

• 51

ing supported by GMO exporting countries who have not ratiªed the Protocol
and who oppose the spread of its precautionary thrust. Capacity building as a
vehicle for diffusion of contested biosafety regulatory models thus requires ad-
ditional analysis and international scrutiny.

Regime Inºuence: Domestic Discursive and Institutional Change

In sum, although the Protocol has only been in force for a few years, the process
of its negotiation and domestic implementation has created greater awareness
of biosafety concerns in each of the three countries, and has strengthened do-
mestic constituencies pushing for greater caution in testing and commercializ-
ing transgenic products. By empowering such domestic actors, both within the
core state and in civil society, the Protocol has demonstrated the potential to
make domestic biosafety debates and decision-making more open and inclusive
than might otherwise have been the case. This applies to Mexico and South Af-
rica, with their present-day democratic polities, as well as to China, where envi-
ronmental policy-making remains tightly controlled by the core state.

Our analyses also emphasize, however, that the inºuence of the Cartagena
Protocol is intimately tied to international trade imperatives and is mediated by
domestic politics. Concerns over competitiveness, technological innovation and
international trade, as well as contestation among domestic interest groups, are
shaping the nature of biosafety policy and the approach to transgenic crop up-
take in each of these three countries. As seen, the Protocol’s avenues of inºuence
work within this larger context.

In fact, an important caveat arising from our analysis of Protocol inºuence
is that the relationship between biosafety concerns and market pressure is more
complex than might be commonly assumed. As seen in the case of China, trade
interests in favor of maintaining transgenic-free status have, for the moment, re-
inforced a shift towards more restrictive import and biosafety policies. In others,
such as Mexico, pressures for trade liberalization have served to counteract such
a trend. By comparison, South Africa’s regulatory path has to date followed
more closely a domestic logic, without being shaped by international trade con-
siderations to the same degree as the other two countries. Thus, the complex in-
terplay of state strategies, domestic interests and trade patterns creates country
speciªc conditions for the way in which the Protocol exercises inºuence, and for
the way in which biosafety concerns interact with market pressures.

Regime Inºuence: Harmonization versus Regulatory Diversity

As is also evident from the analyses, even though the Cartagena Protocol is be-
ing implemented in all three countries examined here, this process has not re-
sulted in a harmonization of domestic regulatory policies. Hence, the hope of
some GMO producer countries and industry that the Cartagena Protocol might

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52 •

The Inºuence of the Cartagena Protocol on Biosafety

result in diffusion of a narrow harmonized set of science-based domestic
biosafety regulations has not come to pass.

Instead, our analysis suggests that the prospects for countries to choose
their own paths in biosafety policy, shaped by domestic priorities and impera-
tives, are not diminishing. This is also in keeping with the original intent of the
Cartagena Protocol, which is to empower GMO importing countries to make in-
formed judgments about the impact of transgenic crops on their domestic eco-
logical, health and agricultural systems.

In fact, we ªnd that the absence of a shared global approach to GMO regu-
lation, combined with disunity among leading agricultural trading partners in
Europe and North America, has the potential to widen the policy space for au-
tonomous decision-making in key developing countries. This is partly because
such conºicts require countries which desire to trade with both sides to simulta-
neously combine openness and precaution towards transgenics in their domes-
tic policy choices. While this is a key challenge for many developing countries,
our analysis reveals that it can also have empowering consequences, by opening
up political space for those who were earlier sidelined in a scenario where pro-
motion of the technology was the dominant trend. This is a promising outcome
in controversial areas of governance such as agricultural biotechnology.

Of course, widened space for autonomous policy-making, and the em-
powering consequences of the transatlantic trade conºict, vary across the
developing world, depending not least on a country’s economic size, key trad-
ing partners, and political clout. In interpreting global biosafety rules, leading
developing countries are choosing different combinations of promotional and
cautionary elements, reºecting their position in global agricultural trade and the
domestic balance of interests. Where trade, market access and competitiveness
are not driving the directions of biosafety policy, as in many smaller developing
countries, the inºuence of the Protocol might be different, and in all likelihood
more pronounced, insofar as visibility to biosafety concerns is concerned.

Notwithstanding the Protocol, the controversies around global and na-
tional GMO regulations are unlikely to diminish in the near future, and instead
look set to escalate as the WTO weighs into the global debate via the transatlan-
tic GMO dispute. Nonetheless, our case analyses support the view that the glob-
alization of agricultural biotechnology currently coexists with regulatory diver-
sity in key developing countries—not least because such globalization (and
associated global regulation) itself remains heterogeneous.

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