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GMOs, safety concerns and international trade: Developing

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Article  in  Journal of International Trade Law and Policy · September 2011

DOI: 10.1108/14770021111165535

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GMOs and
GMOs, safety concerns and international
international trade: developing trade
countries’ perspective
281
Lekha Laxman
Department of Management, Universiti Teknologi Malaysia,
Johor Bahru, Malaysia, and
Abdul Haseeb Ansari
AIKOL, International Islamic University Malaysia, Kuala Lumpur, Malaysia

Abstract
Purpose – This paper seeks to provide an in-depth discussion on the impact of agricultural
biotechnology in developing and least developed countries (LDCs) as well as the concomitant biosafety
concerns that might have an impact on trade and the environment whilst highlighting the importance
of choosing development pathways that are conducive to the specific needs of these nations without
endangering the biodiversity and affecting people’s health.
Design/methodology/approach – The paper adopts a socio-legal approach by undertaking a
content analysis of decided cases, relevant treaties and existing studies conducted in areas related to
agricultural biotechnology within the framework of sustainable development imperatives.
Findings – The paper suggests that developing countries venturing into agricultural biotechnology
need to enrich the technology according to their needs and capabilities in order to be able to weigh the
benefits against the risks in the production and import of genetically modified organisms (GMOs)
specifically via the implementation of the “precautionary principle” and viable “risk assessment”
techniques which conform to their existing international law obligations in view of the findings that
most of these nations have not formulated adequate legal and institutional frameworks supported with
the necessary expertise to regulate, monitor, and ensure safety of agricultural GMOs produced and/or
imported by them.
Practical implications – The issues and suggestions in this paper will enable the development
process of developing and least developed economies to conform to the tenets of sustainable
development and minimize the loss of Earth’s biodiversity.
Originality/value – The paper is of practical use to stakeholders and policymakers alike venturing
into agricultural biotechnology. It pools the findings of a cross-section of studies to look at the
implications therein and the arising biosafety and trade issues with special reference to developing
and LDCs.
Keywords Sustainable development, Biodiversity, Biosafety, Agricultural biotechnology, GM crops,
Genetic modification, International trade, Developing countries
Paper type Research paper

1. Introduction
History has taught us that the development of mankind occurs at a costly price as
economically short-term gains induced activities inevitably damage natural Journal of International Trade Law
environment in such a way that its essential ecological functions are impaired. Science and Policy
Vol. 10 No. 3, 2011
and technology have brought tremendous changes in the quality of life that we warrant pp. 281-307
today facilitating us to undertake simple tasks with such ease and broadening our q Emerald Group Publishing Limited
1477-0024
understanding and knowledge in many areas of our lives. Nevertheless, our inadequate DOI 10.1108/14770021111165535
JITLP understanding of the complexities of life forms and their interactions with environment
10,3 and the undiscovered benefits make it crucial for us to exercise due care while dealing
with developing and trading in genetically modified organisms (GMOs) that is
continuing to expand otherwise there might be irreversible loss to the biodiversity
incurable diseases to the human mass (Lee, 2001). It has been pointed out that the
environmental degradation of the twenty-first century may equal or exceed the losses
282 of its predecessors (Lee, 2001). These events have been aptly referred to by
Weiss (1990, p. 198) as “the growth of transnational environmental harm” which she
pointed out as simultaneously “leading to new obligations between the states” whilst
“recasting democratic accountability for the cross boundary performance of public and
private actors”. Multilateral environmental and other agreements reflect the urgency of
addressing the problem of rapid environmental degradation mostly brought about by
unsustainable development practices by all nations in various degrees, including
production and consumption of safe GMOs. At the Earth Summit held on June 13, 1992 in
Rio de Janeiro, Brazil, a forum was held for developing a plan of action to confront
and overcome the most pressing environmental, health, and social problem issues
facing the planet and a consensus was finally reached on the need to maintain the
ecological integrity of the Earth’s global and local eco-systems. Of which, Agenda 21 is
the agreement adopted by virtually every nation on the Earth thereby creating an
unprecedented global partnership to reverse the environmental degradation of the
planet. It was also emphasized by Principle 15 the Rio Declaration. It is, thus, imperative
for the global community to show solidarity at this critical moment in history and seek a
new beginning – this compels us to move away from destructive habits and practices
that not only deplete the global environment’s finite resources but threatens the very
foundation of global security which is wrought with dangers of war, social and economic
injustice as well as environmental devastation (The Earth Council, 2000).
The process of rapid development inevitably occurs at the expense of biodiversity
and general environmental degradation. Loss of biodiversity which are occurring in
many parts of the globe at a rapid pace can be measured by loss of plant and animal
species and microorganisms. Under the Convention on Biological Diversity (CBD),
all member states are required to take measures to preserve both native and agricultural
biodiversity. Agricultural biodiversity encompasses the variety and variability of
animals, plants, and microorganisms which are necessary to sustain key functions of the
agro-ecosystem, its structure and processes for, and in support of, food production and
food security (Mulvany, 2001, p. 1). There is a growing recognition that biodiversity
conservation is one of the pillars of sustainable development and that it should be
integrated into the overall development process (Kumari et al., 1997). It is for this reason
that in 2002 world leaders attending the World Summit on Sustainable Development
in Johannesburg addressed biological diversity issues (Chapter IV, paragraph 44 of the
Johannesburg Plan of Implementation) and agreed to achieve, by 2010:
[. . .] a significant reduction in the rate of loss of biodiversity at global, regional and national
levels as a contribution to poverty alleviation and to the benefit of all life on Earth.
This endorsement was in line with what was adopted at the sixth meeting of the CBD
Conference of Parties. This commitment was reiterated at the 2005 World Summit. The
2010 biodiversity target is now fully integrated into the framework of the Millennium
Development Goals (MDGs) and, as a sign of further support, the international
community decided to declare 2010 as the International Year for Biological Diversity GMOs and
(The Earth Council, 2000). The MDGs reflect the development aspirations of the world. international
Another important international instrument is the Earth Charter[1] which aptly
provides the global community with an ethical framework of values and principles for a trade
more just, sustainable and peaceful world whilst contributing to the building of a “global
moral community” that is the foundation of the next generation of legal instruments,
institutions and processes of global governance. The 16 interdependent principles 283
provide the whole Earth community with a “common standard” for a sustainable way of
life “by which the conduct of all individuals, organizations, businesses, governments,
and transnational corporations” will be guided and assessed. It is rightly said that the
Earth Charter is deemed as providing a more suitable framework than Agenda 21 since
the focal point of concerns for sustainable development in the Earth Charter is the
“community of life” (Principle I) and not “human beings” as identified in Principle 1 of
the Rio Declaration (Bosselmann, 2004, p. 5). The former also has a broader consensus
amongst the global civil society on that one should constitute global principles – the
interaction of well established concepts in international law[2] such as ecological
integrity, precautionary principle, and democratic decision making should rest. Human
rights, including the right to a healthful environment, have also been protected in the
World Charter (Bosselmann, 2004, p. 5). We will discuss in this paper the surrounding
controversies and debates with regards to environmental governance[3] in the context
of production, use and export of GMOs and the biosafety imperative, especially in light
of the guiding principles of the Earth’s Charter in order to achieve its mission:
[. . .] establish a sound ethical foundation for the emerging global society and to help build a
sustainable world based on respect for nature, universal human rights, economic justice and a
culture of peace (The Earth Council, 2000).
In an era where global governance is perceived by many as undergoing a crisis of
major proportions, the transnational, cross-cultural, inter-denominational approach
adopted by the said Charter is most appropriate (Bosselmann and Taylor, 2005, p. 171)
to bring forth a sustainable global society. It requires for production, use and export of
safe GMOs, living and non-living, and practice restraint on short-term monetary gain
or fame. The paper discusses these aspects also with reference to agricultural
biotechnology.

2. The impact of biotechnologies in the agricultural sector – the scenario in

developing countries
The industrial transformation of agriculture and biotechnological developments are
also influencing each other – they jointly and severally do have an impact on the
biodiversity generally and the agricultural biodiversity specifically. Biotechnology
today is embedded in specific social processes and not only is it entwined with culture
and socio-ethical values but has also been enriched by inputs from genomic research
thereby emerging to be a major force for development in all countries. Nevertheless,
as in the case of any complex technology impacting wide range of processes and
developments, gains from modern biotechnology are accompanied with certain
negative impacts (Singh, 2000, p. 1). It has been established that the nature and extent
of the positive and negative impacts will depend on the choice of the technique, place
and mode of application of the technique, ultimate use of the product,
JITLP concerned policies and regulatory measures, including risk assessment and
10,3 management ability, and finally on the need, priority, aspiration, and capacity of
individual countries (Singh, 2000, p. 1). What is applicable for commercial commodities
in the USA, Europe, and Japan may not be true for countries suffering food-deficit and
low-income (Singh, 2000, p. 1). It is highly warranted for the developing nations to plan
and work for advancement of biotechnology, especially for developing new varieties of
284 crops, by making it a priority area and providing all possible technological and
financial inputs to it. This is the way they can reduce their dependency on genetically
modified (GM) agricultural varieties imported from developed or technologically
advanced countries. Also they can be able to build capability to determine safety of the
GMOs locally developed and intended to be imported. Once they develop these qualities
in themselves, they can get financial gains by exporting GMOs developed by them to
foreign countries. India is the best example. It has to compete with the USA in growing
Bt cotton in the area of growing, consuming, and exporting. The country is now
competent enough to grow sufficient Bt cotton for local consumption and also to export
it to some extent. If the USA does not give subsidy on its Bt cotton, India can very well
compete with it. It is a different thing that few worms develop resistance. It requires
that research on Bt varieties have to undergo continuous research (Dinesh, 2010).
Despite the fact that the arguments revolving around biotechnology are seemingly
divided into those who are in favor of the said technology versus those who are skeptical
and concerned about it, the truth of the matter is that the science of biotechnology per se
is not the subject of controversy, but the mode and nature of its application, through
techniques and technologies, which could stir contradictions (Dinesh, 2010, p. 2).
If applied appropriately, biotechnology has the potential to solve the impending global
crisis that impede national development and threaten peace in the developing world
(Da Silva et al., 2002). It is no wonder that biological diversity is gaining in importance in
the area of agriculture, medicine, and resource mobilization (Ansari, 2000, p. 137) to
address issues such as global food insecurity and production, water insecurity,
malnutrition, hunger, poverty, the advent of new and re-emergent diseases, as well as
global wellness. However, the lack of facilities and professional skills limits R&D
initiatives in the developing world and the least developed countries (LDCs) and restricts
their full participation in take-off activities in national and self-reliant regional ventures
in sustainable development (Da Silva et al., 2002, pp. 1-2) which potentially provide
entrepreneurial opportunities for the technological progress of the developing world[4].
The rapid increase in the development of biotechnologies for the expansion of GM
crops during the past decade is attributable to two key influences, i.e. the expansion of
the scope of intellectual property (IP) protection to plant varieties which has provided
the impetus for large investments in agricultural biotechnology (Sampath, 2004, p. 7)
and the possible accruing of increased profits for farmers (Sampath, 2004, p. 3) due to
increased yields as well as promises of improving health, nutrition, and environment at
the global level (Sampath, 2004, p. 7). However, this does give us the complete picture
for there are inevitable tradeoffs in the adoption of GM crops – indeed there will be
reduction in fixed costs such as costs of insecticides to farmers but there is also an
increase in other costs such as seed costs as well as costs associated with adverse
long-term environmental impacts which are unascertainable at the outset not to
mention economic, social, and human costs of various kinds particularly for developing
countries (Sampath, 2004, p. 7). Additionally, the economic concentration in the seeds
sector has reached an unexpectedly high level and the relationships between farmers GMOs and
and seed companies and between farmers and food processing companies are international
changing. GM crops abound knowledge and information, which were once public
property, are now privately patented; and, as an extension of this, much public trade
research has become privatized (Hannah Piek, 2003, p. 2). The Report of the Panel of
Eminent Experts on Ethics in Food and Agriculture acknowledged that there was
indeed an impact of the Agreement on Trade-related Aspects of Intellectual Property 285
Rights (TRIPS) under the World Trade Organization (WTO) on food and agriculture
which has direct bearing not only on ethical issues such as the transfer of important
knowledge from public to private domain controlled mostly by corporations but also
on the livelihood of poor farmers and rights of consumers with limited income towards
sustainable access to affordable, safe, and nutritious food as well as environmental
impact, including effect on biodiversity (FAO, 2001). A recent report indicated that the
UN Food and Agriculture Organization’s food price index (includes grains, meat, dairy,
and other items) was up by 22 percent in March from a year earlier though still below
2008 levels (McDonald, 2010). But in some Asian markets, rice and wheat prices have
risen by 20-70 percent above 2008 levels despite the fact that prices dropped fairly
dramatically toward the end of 2008 on international markets (McDonald, 2010).
These surging costs have had a detrimental effect on food security in poorer
developing nations thereby dragging more people into poverty and fuelling political
tensions and threatening to worsen malnutrition (McDonald, 2010). Even with
advanced technologies at our disposal, the access to food is still problematic with
developing nations being more vulnerable to an array of problems that lead to the
soaring of food prices. The International Union for Conservation of Nature (IUCN,
2004) for instance has discovered that despite the annual increases in the volume of
land devoted to GM crops, there was also a significant drop in world production of
cereal grains in 2001. According to FAO, 100 million people have been pushed into
poverty due to the double blow of the global recession and high food prices (IUCN,
2004). These figures indicate that something is amiss and advanced technology per se
will not resolve food security problems.
Some interesting figures may shed light on the depth and scope of the impact of
modern biotechnology on developing nations. In 2005, the land area planted with GM
crops using modern biotechnology techniques in developing countries is merely
34 million hectares which represents 30 percent of the area planted globally with GM
crops of which three countries (Argentina, Brazil, and China) account for 87.8 percent of
all the GM crop adoption in developing countries (Zepeda, 2006, p. 1200). However, in
2009, the share of global biotech crops planted in developing countries increased
to 61.5 million hectares which is almost half (46 percent) of the global hectarage of
134 million hectares; five developing countries representing all three continents of the
South were found to be a formidable force exerting strong global leadership in the global
adoption of biotech crops, i.e. Brazil, Argentina, India, China, and South Africa who
jointly planted approximately 57 million hectares (43 percent) of the total global
hectarage of 134 million hectares (Clive, 2009, p. 10). It is worthwhile to note that trends
of the past continue whereby the percentage growth of 2009 in biotech crop area
continued to be significantly stronger in the developing nations (13 percent and 7 million
hectares) than industrial countries (3 percent and 2 million hectares) (Clive, 2009, p. 10).
In view of this, an important question comes to our minds while reviewing these figures:
JITLP what will the impact be on global biodiversity given the exponential increase of biotech
10,3 hectarage taking place predominantly in the developing nations in view of the fact that
80 percent of the ecological mega-diversity of the world is concentrated in Latin America,
the Caribbean, Asia, and the Pacific (Ammann, 2004, p. 7)? The concern arising from GM
crops lies in their potential to pose serious threats to biodiversity conservation and
sustainable agriculture is because of the contamination of in situ preserved genetic
286 resources threatening a strategic resource of the world’s food security. The release of
these “truly biological novelties” into the environment poses concerns about their
unpredictable ecological and evolutionary responses that GM species themselves and
the interacting ecosystems may arise in the medium and long-term. Particularly,
vulnerable regions are the mega-diversity countries and centers of origin and/or
diversity of crop species that may experience “a generalized contamination of natural
flora by GM traits and a degradation and erosion of the commonly owned genetic
resources available today for agricultural development” (Garcia and Altieri, 2005, p. 335).
In addition, the increased landscape homogenization which could result from GM crops
will exacerbate the problem already associated with monoculture agriculture (Garcia
and Altieri, 2005, p. 346). A study which focused on the currently available GM crops
that could be relevant for agriculture in Western and Central Europe (maize, oilseed rape,
and soybean), and on the two main GM traits (herbicide tolerance and insect resistance),
reviewed the scientific knowledge on environmental impacts of GM crops on
biodiversity, derived from ten years of worldwide experimental field research and
commercial cultivation (Sanvido et al., 2006, p. 1). The study reported that based on the
available data so far there was no scientific evidence that the commercial cultivation of
GM crops had caused environmental harm (Sanvido et al., 2006, p. 5; Ansari and
Mahmod, 2008). However, it cautioned that there were controversies surrounding the
interpretation of scientific data on ecologically relevant effects of GM crops on
the environment due to the inherent uncertainties[5] prevalent in scientific data and the
difficulties surrounding predictions on potential long-term or cumulative effects. This is
attributable to the absence of a defined baseline to evaluate the environmental effects of
GM crops in the context of modern agricultural systems (Sanvido et al., 2006, p. 5), and
this necessitates the development of standardized set of scientific criteria to assist
regulatory authorities to make appropriate decisions which balance the interests of trade
against those relating to conservation of biodiversity. Thus, there is a clear need to
further assess the potential risks associated with the use of transgenic crops until
concrete findings are obtained with regards the severity, magnitude, and scope of risks
associated with their use, a moratorium on transgenic crops based on precautionary
principle should be an option as a global bio-security measure to avoid the future of
sustainable agriculture from being irreversibly jeopardized from the contamination
of in situ preserved genetic resources and human health (Garcia and Altieri, 2005, p. 346).
Biotechnology undoubtedly can contribute to sustainable agriculture since the
multiple uses of the said technology including new varieties and breeds developed
via genetic modifications, is an essential, but not, the only element of sustainable
agriculture given that the non-technological elements such as governmental policy and
political will, institutional and infrastructural support, technology sharing and transfer
mechanisms as well as people’s attitudes and awareness are equally, if not more,
important in providing the needed conditions for absorption and successful exploitation
of the technology toward sustainable agriculture. The challenges of agricultural
biotechnology for developing countries lies in the fact that whilst facing the dilemma GMOs and
of having to prioritize the providing of basic amenities and food, they are facing severe international
limitations in terms of sophisticated technologies and scientific personnel as well as
finance for scientific research and development despite the fact that these countries, trade
especially those located in the tropics, are generally very rich in bio-resources and
biodiversity (FAO, 2001). While joining in the biotechnology race, especially in the
agricultural sector, it is important for the developing nations to make efforts to acquire 287
modern technology and expert personnel for developing safe and useful GMOs.
They should also develop capabilities to aptly conduct risk assessments of locally
developed and intended to be imported GMOs. Not only do we need to consider the
potential threats to biodiversity by biotechnology but we also need to consider other
imperatives such as sustainable development so that our activities do not deprive the
future generations of their rightful legacy from the rich bountiful nature. According to
the Addis Ababa Principles and Guidelines:
[. . .] our continued deriving of benefits from biodiversity both now and for future generations
will depend on how we use it and how our activities impact upon ecosystem functioning and
goods and services. The use of destructive practices and intensive technologies increase
environmental degradation, and lead to declines in the local economies and societies they
support (Convention of Biological Diversity, 2004).
The applications of any new technology are very much influenced by the particular
needs and exigencies of the nation where it had originated from. In other words,
technology is affected at a fundamental level by the social context in which it develops
(MacKenzie and Wajcman, 1999). Many discussions and debates regarding technology,
including biotechnology, have focused on the effects of technology on society, and
tended to ignore the more fundamental question of what shapes technology in the first
place will take to render desired services to the society. It is inevitable and unsurprising
then that biotechnology too will encounter such effects being a byproduct of
developed and industrialized nations. FAO has been conducting a worldwide inventory
of agricultural biotechnology applications and products, with special reference to
developing countries and concluded that current GMO crop releases were still very
narrow in terms of crops and traits and have failed to address the special needs of
developing countries (Fresco, 2001). In view of the increase in the portfolio of GM
applications, it has recommended that the international community needs to ensure that
GM crops make an optimal contribution to world food security, to food safety and food
quality, and to sustainability, and that they remain available to the public at large
(Fresco, 2001). However, FAO’s inventory suggests that genomics and related research
are not being directed to meeting these key challenges. Indeed, the perceived profit
potential of GMOs has already changed the direction of investment in research and
development, in both the public and private sectors, away from system-based
approaches to pest management, and towards a greater reliance on monocultures
(Fresco, 2001). The possible long-term environmental costs of such strategies should not
be overlooked (Fresco, 2001). Additionally, the recent trends of mergers and takeovers
between breeding companies, seed traders, chemical and food companies, health related
companies, and genetic engineering companies have resulted in the monopolistic control
of the world’s seed market and other GM products thereby influencing the availability of
and access on the part of small and resource-poor farmers, who are the majority,
to desired seeds, genetic vulnerability and food security (Singh, 2000, p. 10).
JITLP It is also pertinent to enquire why the cultivation of GM crops are so successful in
10,3 some countries but not in others? Farm-level profitability ultimately determines whether
farmers adopt and retain a new technology, but this depends on much more than
technical performance. Some of the recent economic studies in developing countries find
positive but highly variable economic returns to accepting transgenic crops (Raney,
2006, p. 3). These studies confirm that institutional factors such as national agricultural
288 research and regulatory capacity, environmental and food safety regulations, effective
IP rights management, and agricultural input markets, especially for seeds, matter at
least as much as the technology itself in determining the level and distribution of
economic benefits (Raney, 2006, p. 3). Hence, a fairly high level of national institutional
capacity is required to ensure that farmers have access to safe and productive without
affecting the traditional varieties innovations on competitive terms. Equally important
is the fact that the input of farmers is obtained to ensure that the application of
biotechnology in agricultural research is adapted to local conditions and needs. Indeed,
the economic results so far do suggest that farmers in developing countries can benefit
from safe and economically viable transgenic crops (Raney, 2006, p. 3). However,
enabling access for the poorest farmers in the LDCs, where institutional conditions are
weak, will constantly be an uphill and formidable challenge (Raney, 2006, p. 3).
An illuminating study which took place between 2001 and 2003 as a joint effort of
partners from 15 developing nations on three continents (seven from Asia, four from
Latin America, and four from Africa) and the International Food Policy Research
Institute (IFPRI, Washington, DC) was undertaken to analyze the current state of
research, regulation, genetic resources, and institutional roles in developing GM crops
(Cohen, 2005, p. 27). First, it is interesting to note from the findings that the public
sector was a competent, but largely unproven, player for GM crop production in
developing countries thereby indicating that the public sector is an untapped goldmine
and could be the key player to address food security problems whilst providing crucial
assistance to small and medium scale farmers whose input could be used for
cross-cutting innovative research to develop new varieties of safe and economically
viable transgenic crops (Cohen, 2005, p. 27). However, it was unclear from the study
whether national policies in these countries stimulate or deter research and technology
for publicly developed GM crops (Cohen, 2005, p. 32). This essentially indicates that
developing nations need to choose appropriate development pathways to tap the
benefits of biotechnology. Countries in the ASEAN region such as the Philippines,
Malaysia, Thailand, and Indonesia have augmented numerous efforts to accelerate
the nation’s growth engine by increasing their fiscal allocation in the area of
agricultural biotechnology but sadly these nations are unable to enjoy the fruits of the
said technology due to a dearth of expertise in the said area. According to Cohen (2005,
p. 32), as scientific capabilities and the number of research institutes increase, so will
the diversity of crops and phenotypes. If more efforts are not directed to close in on the
gap in relation to resources and knowledge for specific events in order to complete
efficacy and safety testing, GM crops will predominantly remain in preliminary testing
as was revealed by the findings (Cohen, 2005, p. 32). In contrast to achievements in
R&D, most of the developing countries have only limited experience in compiling
regulatory data; in fact, it has become difficult to complete all regulatory requirements
(Cohen, 2005, p. 32). Overall, the study found that many research trends observed were
positive, with Asian countries leading in biotechnology research having products
in all stages of the research pipeline (Cohen, 2005, p. 28). However, few of the GMOs and
transformed crops from these nations have been released from confined into international
pre-commercial testing or into use (Cohen, 2005, p. 32). Only the Philippines, India, and
China have approved to commercialize only a few agricultural produce. China allowed trade
the cultivation and use of publicly developed transgenic vegetables and Indonesia has
approved commercial GM cotton but was later taken off the market (Cohen, 2005, p. 28).
Cohen (2005) attributed this phenomenon to several factors: first, the overall isolation 289
of public research institutes; second, the inability of public research to meet food safety
and environmental regulatory requirements and confusion regarding regulatory
standards between confined versus open trials; third, lack of regional abilities to
exchange and evaluate regulatory data on specific transgenes and crops; fourth,
expertise with public genetic resources but few opportunities to use or evaluate
proprietary germ plasm; fifth, difficulties in planning for advancement of specific
products; sixth, limited progress in determining authorities and frameworks for
science-based decision making; seventh, implementing processes arising from the
international level (e.g. the Cartagena Protocol for Biosafety) as well as at the regional
level (e.g. special needs confronting Africa); and eight, external political barriers that
either halt regulatory review (e.g. moratoriums in Thailand) or have implications for
world trade (e.g. impasse over GM crops between the USA and Europe).
The findings of the above study further revealed that access to proprietary genetic
resources (plant varieties protected by patents) in developing countries were extremely
limited which may either indicate a high reliance on public genetic resources or
alternatively a deliberate independence from protected varieties or commercial
germ-plasm (Cohen, 2005, p. 32). Either way using high-performance GM public
germ-plasm would pave the way for greater public and farmer acceptance of GM crops
without them being potentially under monopoly pricing (Cohen, 2005, p. 32). Some of the
recommendations arising from the study are that the GM crop research in developing
countries must serve public good with close examination on potential benefits and
genetic resources being carried out to determine if local (genetic) resources or adapted
genetic genes need IP protection – this would enable benefit distribution, accounting
for the success in transforming local genetic resources, which then forms the basis
for agreements between public institutions, farmer organizations, and commercial
producers (Cohen, 2005). The study had also discovered that successful public-private
partnerships in plant biotechnology were generally rare even at international research
centers and pointed out that local and multinational companies could play key role for
specific local GM crops given the experience of the latter with commercialization and
regulatory information as well as environmental and food safety studies (Cohen, 2005).
In relation to creating adequate efficiencies and competencies in gene technology,
it was revealed not only that limited collaboration occurred between developing
countries and Western companies but also that the developing countries did not forge
any collaboration among themselves despite the fact that partnerships with countries
with economic parity would create efficiencies through knowledge sharing in relation
to specific crops, traits, and regulatory dossiers (Cohen, 2005). Such joint studies will
eventually reveal suitable partnership models to address the needs best suited for
such endeavors in addition to providing valuable information regarding the selection
of transgenes, regulatory requirements and the availability or suitability of specific
genetic resources derived from examining crops at a particular stage in their regulation,
JITLP their required safety information and results from efficacy and lab and field
10,3 safety testing. Cohen’s study concluded by emphasizing that although commercially
developed GM crops may still have a role to play, the special circumstances of
developing nations make GM crops developed by public research institutes more
relevant to local needs despite the fact they face greater difficulties when seeking
regulatory approval in comparison to GM crops preapproved in Western markets. It is
290 however important to ensure that locally produced GM crops are able to meet the
demands of local farmers who also have the option of cultivating GM crops that failed to
gain regulatory approval.

3. The multiple dimensions of biosafety: ensuring the safe application

of biotechnology in agriculture and mitigating its effect on the environment
and human health
It is to be noticed that the advancement of human activity has reached a point where
potential risks are assumed and tolerated even though its magnitude cannot be
fully predicted, valued or even completely understood in advance of the activity
(IUCN, 2004, p. 12). Thus, we witness the development and the continual evolution
of the valuation of the most critical, component of the cost side of the equation,
i.e. physical and environmental risks with which the relevant political, social, and
economic issues of GMOs are often examined (IUCN, 2004, p. 12). Although GMOs are
used in a wide variety of ways, the risks to the environment are significantly greater if
they are not used in controlled conditions (IUCN, 2004, p. 14). In order to realize the
advantages of GM crops, minimization of potential adverse environmental and social
impacts of GM crops must be a condition precedent (Sampath, 2004, p. 7). GMOs,
then refers to “the safe and environmentally sustainable use of all biological products
and applications for human health, biodiversity and environmental sustainability in
support of improved global food security and livelihood” (Singh, 2000, p. 6). It is for this
reason that biosafety involves the dealing with the environmental and human impacts
of biotechnological products and the Cartagena Protocol on Biosafety (hereafter
referred to as Biosafety Protocol), which came into force on 11 September 2003, is the
key international agreement which mainly regulates the safe transfer, handling, use
and trans-boundary movement of GMOs (Myhr, 2007, p. 457) and provides guidelines
to national governments on ways to deal with issues of biosafety within their national
boundaries (Sampath, 2004, p. 7). With regard to GMO regulations, a precautionary
approach plays an important role in the Biosafety Protocol which is articulated in
Article 1 specifying the objective of the protocol:
In accordance with the precautionary approach contained in Principle 15 of the
Rio Declaration on Environment and Development, the objective of the protocol is to
contribute to ensuring an adequate level of protection in the field of the safe transfer, handling
and use of living modified organisms resulting from modern biotechnology that may have
adverse impacts on the conservation and sustainable use of biological diversity, taking also
into account risks to human health, and specifically focusing on transboundary movements.
The net effect of the above provisions is that the protocol basically allows countries
to use the precautionary principle to limit the use and release of GMOs in situation
of scientific uncertainty with regard to potentially adverse ecological and health effects
(Myhr, 2007, p. 457). The precautionary principle is a normative principle for making
practical decisions under conditions of scientific uncertainty with four central GMOs and
components which are supposed to: international
(1) initiate preventive action as a response to scientific uncertainty; trade
(2) shift the burden of proof to the proponents of a potential harmful activity
(e.g. those who are proposing the introducing of the novel GM crop);
(3) explore alternative means to achieve the same goal; and 291
(4) involve stakeholders in the decision-making process (Myhr, 2007, p. 458).

It should be noted here however that the actual content of the precautionary principle
and the practical implications of its implementations in policy issues are controversial
more so when it involves international trade matters.
Potential biodiversity loss inevitably requires innovative solutions – careful
application of new biotechnologies and new adaptive strategies, as some innovations
might inevitably pose risk, often in the form of possible harm to human health or the
environment. Gene technology involves uncertainties and evaluating these risks and
informing decision makers and members of the public is a daunting and challenging
task. While the mechanism for risk-benefit analysis has yet to be firmly established,
there is a general consensus that it should consider two key factors in applying such
analysis, i.e. the magnitude of each potential harm or benefit involved, and the
likelihood that it will occur (IUCN, 2004, p. 12). The magnitude question includes not
only the extent of potential damage, but also remediation costs if possible and many
other factors (IUCN, 2004, p. 12). However, it should be noted that it is difficult to assess
the risk magnitude of a particular activity or condition that has little or no “historical
antecedent” (IUCN, 2004) as may be the case with novel GM crops. Similarly, the
likelihood evaluation is typically based on experience with similar situations in the
past and therefore likelihood evaluations, although tend to improve over time, are least
valuable where they involve or science that is new or previously unmeasured (IUCN,
2004). Herein lies the crux of the GMO risk issue in terms of environmental impact and
biodiversity debate. Another matter that needs to be contended with is that fact that:
[. . .] biosafety data do not arise from an objective process of data and knowledge
accumulation, but represent the scientist’s choice of methods and the interpretational context,
as determined by the biological, ethical, political, and economic objectives, in which data
is produced (Nielson and Myhr, 2007, p. 120).
It is important to note that most of the risk assessments are inherently influenced by
the value judgments made by the risk assessors and is, thus, neither an exact science
nor a sound science as characterized by the WTO (Peck, 2010, p. 243). In spite of this,
the specificity of the USA’s risk assessment has been given recognition and its de facto
presumption of legitimacy in international GMO trade even though GMO trade and
related contamination is undeniably a reality (Peck, 2010, p. 245) with the discovery of
dozens of cases where GMOs were discovered in countries and in streams of commerce
for which they were not approved by law (GM Contamination Register Report, 2007).
The root of the legitimacy crisis in the international treatment of GMOs begins at
the national level when a country makes a decision to develop and market GMOs
domestically and internationally after carrying out its own risk assessment which
is shaped by values and culturally-specific framing of the scientific issues (Peck, 2010,
pp. 243, 245). Even within the USA, as evidenced in Geertson Seed Farms
JITLP v Mike Johanns[6] and Center for Food Safety v. Vilsack[7], courts have challenged
the failure to acknowledge the cultural and situational particularity of any risk
10,3 assessment. In Geertson, a federal district court held that the US Department of
Agriculture (USDA) could not deregulate GMO alfalfa without consideration of
biodiversity impacts despite the fact that USDA had determined that GMO alfalfa was
not toxic to humans or animals. In considering the potential to impact biodiversity by
292 eliminating non-engineered alfalfa, the court held that engineered and non-engineered
alfalfa were “unlike” and should be so treated. In Center for Food Safety, the court’s
findings followed the Geertson conclusion that biotech gene transmission was indeed a
“significant environmental effect” under the National Environmental Policy Act since:
[. . .] the potential elimination of farmer’s choice to grow non-genetically engineered crops,
or a consumer’s choice to eat non-genetically engineered food, and an action that potentially
eliminates or reduces the availability of a particular plant has a significant effect on the
human environment.
This approach of the district court in Geerston Seed Farm was upheld by the Court of
Appeal[8]. The current pedantic approach currently employed by the WTO for risk
assessment is in actual fact a far cry from the neutral exercise of sound science as often
characterized by the USA and the WTO. It is imperative that the effect of disparate
values – values shaping the knowledge production, biological risk assessment,
and governmental risk policy, respectively, – as well as bias in data production and
interpretation which form a core part of scientific knowledge production be explicitly
considered not only with regards to biological risk assessment but also in the sphere
of public or scientific discourse on how to most efficiently address safety concerns
in genetic engineering and GMOs (Nielson and Myhr, 2007, p. 117). It is, thus, prudent
that the WTO considers and acknowledges the inherent subjectivity and (disparate)
value components when the underlying values supporting the “science-based
approaches” to biosafety are not shared among the stakeholders in the global GMO
marketplace (Nielson and Myhr, 2007, p. 117). Geertson and Center for Food Safety
give a message that GMOs producing countries, especially the USA, should work
for developing more intensive laboratory and filed testing procedures with an
acceptable transparency so that developing importing countries have confidence in
them. The authors are of the opinion that this is going to happen in the near future. The
emerging pressures in USA to review the current risk assessment approaches, as is
apparent in the Geertson and Center for Food Safety cases, also indicate that it is timely
for the WTO to veer away from its current myopic approach towards risk assessment
when scrutinizing the trade restrictions imposed by GMO-importing countries to
protect health and safety by taking into consideration not only the biodiversity impacts
of GMOs but also the subjective components and broader uncertainties in the science
behind GMO safety assessment.
The instant the GM product enters the stream of international trade and commerce,
the countries that wish to employ precaution approach, when regulating the entry of
the products into their boundaries, is placed in the defensive position – these countries
in actual fact do not have the freedom of choice in determining the appropriate level of
risk as any trade barriers that they choose to put in place run afoul of the WTO rules.
Currently in a WTO proceeding, scrutiny is merely placed on the trade restricting
party’s risk assessment; the exporting party’s own risk assessment is not similarly
scrutinized or compared and its value judgments carry a presumption of validity
by virtue of the fact that they lead to the production and export of biotech products, GMOs and
which other countries are required to contend with through regulations, and at times international
with WTO challenges (and costs) (Peck, 2010, pp. 243, 264). The lack of scrutiny of
first-order risk assessment is especially problematic since all risk assessments are trade
influenced by not only the relative completeness of the knowledge of the risk assessors
but also by the “frames”, i.e. value judgments, assumptions, and policy decisions made
by the risk assessors which are linked to the economic, legal, social, cultural, and 293
environmental values of the risk assessors which are not necessarily shared by other
countries (Peck, 2010, pp. 249, 243). It has been proposed that the WTO should employ
a “sliding scale” to allow countries to take a more precautionary (i.e. trade restrictive)
approach where in the case of GMOs, there is low certainty about the possible
environmental impacts; this necessitates scrutiny on the risk assessments of both
the exporting and importing countries as well as making explicit the value judgments
in both in order to level the playing field between GMO producing and GMO importing
nations of the WTO (Peck, 2010, pp. 242-243). However, with the WTO rejecting the
sliding scale approach in the EC – Biotech case[9], an importing country may diminish
its ability to reject or restrict GMOs (Peck, 2010, p. 244) while a resolution is yet to be
seen in the horizon for the trade-environment deadlock. Under these circumstances, it is
crucial for the GMO importing countries to highlight their distinct but contextually
appropriate judgments and defend their risk assessments as supported by scientific
evidence informed by those context-appropriate judgments (Peck, 2010, p. 242).
Alternatively, it was proposed that countries defending GMO trade restrictions might
frame their argument based on harm to sovereignty rather than to health or the
environment (Peck, 2008).
When we are unable to quantify risks or the possible harm, reaching the right
decision is a complicated task and under these circumstances a hard look at potential
environmental impacts is required by all parties concerned, not only the research
managers but the regulatory agencies as well as the courts have the arduous task of
making just decisions. Under these circumstances, the regulatory agencies involved
should make an independent risks assessment of a novel transgene prior to its release
into the environment as opposed to merely relying on those made by those involved in
the biotechnology research. The courts ought to ensure that the environmental impact
statement reflects a careful consideration of the available science, and that the areas of
disagreement or uncertainty are flagged instead of ignoring them or alternatively
dismissing from consideration low probability risks of very serious harms at the
urgings of agencies (Faber, 2009, pp. 33-34). If possible, the judges should consider
alternative credible theoretical models for risk evaluation instead of the agency’s
favored models. In view of the fact that catastrophic risks generally have low
probabilities but extreme consequences, it is crucial that courts rigorously demand the
full revelations of all serious uncertainties (Faber, 2009). It is important to realize at this
juncture that virtually all the broader uncertainties in the science behind the GMO
safety assessment examined here are not unique to gene technology, but are present in
any modern technology assessment such as technologies involved in assessing climate
change. Technological advances are always made in the face of uncertainties which
should never be considered as barriers to scientific progress but instead are the main
drivers of new discoveries, creativity, and inventions (Neilson and Myhr, 2007, p. 120).
Scientists are in the unenviable position of not only ensuring progress for all segments
JITLP of society but also have the social responsibility of using precaution when considering
the impact of their innovations which inevitably pose risks in terms of harm to the
10,3 human health or the environment not only to the present but also the future
generations – the concept of intergenerational equity in this context arises in relation
ensuring that our activities do not deprive the future generations of their rightful
legacy from the rich bountiful nature. Hence, it is the duty of all scientists to identify
294 and challenge the paradigms, values, and assumptions shaping their scientific
approaches in a reflective and transparent way to ensure that their knowledge claims
continually strive for the highest quality thus ensuring the future public credibility and
trustworthiness of scientists active in the field of biosafety.
Developing nations that aspire to tap in the benefits associated with agricultural
biotechnology despite the controversies surrounding the said technology in relation to
the potential benefits and costs to societies in general and developing nations in
particular, need to be in a state of readiness to accept the challenges represented by it –
they need to make informed decisions on environmental risks associated with
agricultural biotechnology not only to devise optimal biosafety regimes but also to
ensure that this technology is adapted innovatively in accordance to the needs of the
people without turning a blind eye to the environmental concerns. Additionally, the
international regime created under the WTO and related agreements already prescribe
IP rights over plant varieties (in the Agreement on TRIPS, 1995) and their terms of
trade. According to Article 27(3)(b):
Members may also exclude from patentability, plants and animals other than
microorganisms, and essentially biological processes. However, Members shall provide for
the protection of plant varieties either by patents or by an effective sui generis system or by
any combination thereof.
Additionally, Article 2.2 of the WTO Agreement on Technical Barriers to Trade (TBT)
1995 may have a consequential effect on the national regulation of biotechnology in that
the agreement prohibits countries from applying national technical regulations that
have the effect of creating unnecessary obstacles to international trade. In order that the
barriers to trade are deemed technical and valid, they should be based on legitimate
objectives, namely: national security, prevention of deceptive practices, protection of
human health or safety, animal or plant life or health or the environment. Thus, the
developing nations need to ascertain how to go about regulating environmental impact
of GM technologies which depends largely on how and to what extent they are able to
create a balance between rights and obligations in the current IP regime on agricultural
biotechnology to minimize environmental damage (Sampath, 2004, p. 8). In fact, the two
most important international agreements that urge countries to strike a balance at their
national levels are the CBD and the Cartagena Protocol on Biosafety. The former lays
down a framework for countries to tackle sustainable use and conservation of biological
resources as well as ensure fair and equitable sharing of benefits arising out of the
commercialization of biological resources (Article 1); it importantly provides
recognition of sovereignty of countries over their genetic resources (Article 15), focus
on in situ conservation of genetic resources and protection of traditional knowledge
(Article 8(j)), and provides a clear mandate to member countries to ensure that IP rights
do not run counter to the objectives of the Convention. The Biosafety Protocol which
was negotiated under the CBD on the other hand has two centerpiece requirements –
Prior Informed Consent (AIA) and Precautionary Approach – to ensure an adequate
level of protection in the field of safe transfer, handling and use of living modified GMOs and
organisms (LMOs), which are a type of GMOs, resulting from modern technology, that
may have adverse effects on the conservation and sustainable use of biodiversity,
international
taking into account risks to human health and focusing on transboundary movements trade
(Article 4).
Considering the potential adverse environmental and/or human health
consequences arising from the introduction of genetically engineered, or transgenic 295
plants, specific regulatory regimes need to be developed to assess safety. It is, thus,
crucial to have in place an effective national biosafety systems as this not only enable
safety assessments to be made, but also encourage (or not):
.
the growth of domestic biotechnologies; and
.
access to new products and technologies developed elsewhere.
Signatories to the Biosafety Protocol need to ensure that their biosafety systems are in
compliance with the provisions of the said protocol that regulate the transboundary
movements of GMOs (Cohen and Paarlberg, 2004, p. 1563). Absence of efficient
regulatory frameworks hinders investments in biotechnology from development
agencies, and the public and private sectors, and impedes decisions on safety.
Biosafety systems also need to address information needs of stakeholders (Cohen and
Paarlberg, 2004). These can include non-governmental organizations, members of civil
society, and researchers that oppose biotechnology based on the perception that its
products are harmful to the environment, human health and to the socioeconomic
status of small farmers (Cohen and Paarlberg, 2004). Part of the concern and confusion
among stakeholders arises as changes can occur almost daily regarding biosafety
policy and practice, and more specifically, when determining commercialization or
release decisions (Cohen and Paarlberg, 2004, pp. 1563-4). Lack of public understanding
of these changing events, coupled with other external factors, can effectively limit seed
choices for farmers. Undoubtedly the testing and approval of GM crops in developing
countries, including crops developed through public sector research is wrought with
complications and thus there is an urgent need to fine tune the decision-making process
involved in the biosafety review (Cohen and Paarlberg, 2004, p. 1564). The GM crops
and food them need to undergo intensive biosafety review which might have:
.
internal factors including regulatory procedures, capacity, risk assessment,
frameworks, and how biosafety systems are implemented; and
.
external factors affecting operation of biosafety systems, such as political
governance and decision making, regional trade implications, and the impact of
advocacy groups (Cohen and Paarlberg, 2004).
Only this kind of review can develop confidence among importing countries. It will also
help those countries which are not technologically advanced to conduct risk
assessment at their level. They will rely on the intensive risk assessments conducted
by the producing/exporting countries, and thus will resort to stringent precautionary
measures.
Studies undertaken for IFPRI also revealed that biosafety procedures for GM crops
are not yet working well in a number of developing countries (Cohen and
Paarlberg, 2004). Even among states that could be leading GM crop development –
such as Kenya, Brazil, India, and China – few GM varieties have been approved.
JITLP Scientists, agricultural ministries, and private seed companies in these states have
10,3 worked consistently to help GM crops reach the field, yet even in these leading states
the uptake of the technology has been slow (Cohen and Paarlberg, 2004). This evidence
from the said field study provides an analytical basis for strengthening regulatory
systems and capacity, stimulating scientific risk assessment, and advancing efforts in
the areas of public acceptance, technology transfer and regulatory harmonization
296 (Cohen and Paarlberg, 2004, p. 1571). The seven actions below, as summarized from the
studies, focus on improving biosafety system efficiencies, capacity, and transparency
(Cohen and Paarlberg, 2004, p. 1571):
.
Emphasizing the central role of capacity. This basically requires us to adopt
strategies that stimulate the development of qualified individuals by providing
the necessary resources to enhance the knowledge and skills base available
for regulatory review and decision making.
.
Revising national biosafety guidelines. This involves providing greater clarity
by stating purpose and objectives of biosafety reviews as well as outlining
procedural and facility requirements. Additionally, a clear “road map” of approval
processes need to be provided and simultaneously examine the relationship
between approvals and legal authority with sanctions to ensure compliance. Such
work is supported through the UNEP/GEF project for developing biosafety
framework and guidelines for signatories to the Cartagena Protocol on Biosafety
(Briggs, 2001).
.
Enhancing the effectiveness of National Biosafety Committees. There is an urgent
need not only to stimulate open and effective dissemination of information
but also promote cooperation with national and international bodies as well as
provide database listings of applications.
.
Improving biosafety procedures and decisions. In order to increase the scientific
base for decision making, research needs must be identified and data collected
to support risk assessment. Realistic time frames must also be adhered to
for application decisions.
.
Building public awareness. This should be promulgated through information
campaigns and outreach activities. Additionally, institutional roles need to be
strengthened by defining and clarifying responsibilities among entities sharing
responsibility for environmental, food safety, and marketing reviews.
.
Enhancing transparency and efficiency. It is of utmost importance to clarify
review procedures to stakeholders. It is also prudent to distribute responsibility
for review of confidential business information between at least two biosafety
officials as well as organize “customer service” meetings.

4. Implications of Biosafety Protocol on international trade – the

experience of developing nations
In general, the promotion of international trade is accompanied by a range of
environmental impacts such as: impacts from the production, use or disposal of specific
damaging or beneficial products; increased resource degradation from the overall
expansion in economic activity that trade promotes; shifts in the structure of economic
activity arising from new market demands; and environmental degradation flowing
from the transportation of traded goods (McDonald, 2007, pp. 524-5). These impacts
can no doubt be observed specifically in agricultural trade in view of the current GMOs and
global trend towards trade liberalization, as embodied in the Agreement on Agriculture, international
which forms part of the Final Act of the 1986-1994 Uruguay Round of trade negotiations
(Treweek et al., 2006, p. 303). The legal dimensions of the trade-environment linkage is trade
epitomized by inadequacies with its failure to address the larger impacts associated
with expanding production, consumption, and transport of goods associated with trade
liberalization, especially for countries which are predominantly in the export trade 297
where economic development takes priority over environmental protection (McDonald,
2007, p. 525). As a consequence, there has been a detrimental effect on the ability of the
international community and individual states to nurture the environmental regulatory
regime, particularly nation states that are predominantly importers (McDonald, 2007).
We are in effect witnessing the outcome of globalization wherein international law and
institutions play an increasingly significant and intrusive role, especially in relation to
developing countries which are compelled to cede economic, social, and political
sovereignty to international institutions such as the powerful WTO particularly
through trade sanctions (Chimni, 2005, pp. 802-3).
The WTO has been established with the main purpose of liberalizing trade with an
underlying presumption that this will lead to greater well being and prosperity for all
nations since all will have the opportunity to have a piece of the cherry pie. However,
time has proven otherwise and a handful of developed nations continue to have the
upper hand in trade negotiations with the trade involving GMOs being no different.
Although three out of four of the WTO members are less resourceful countries,
e.g. LDCs, the balance sheet indicates that there has been a disproportionate distribution
of profits in favor of rich countries[10] with the exception of advanced developing
countries such as Brazil, China, and India (Cho, 2007, p. 101). It is no wonder that many
developing countries view the WTO as having failed in delivering the expected benefits
from their membership (Bronckers, 2001, p. 43). Despite the potential of trade to
contribute towards the enhancement of human life as well as development, the said
potential remains a smoke screen due to the inherent problems in trade between
countries fuelled by a combination of unfair trade and structural inequalities both
within and in between countries (Mohanty et al., 2006, p. 39). Trade, thus, cannot be
a panacea to the global woes and neither can GMOs be the antidote to the problem
of food security. There are a large number of members who have considerable stake
in the rules of trade which governs the GMOs and they are unwilling to let their trade
and production goals to take a backseat to the maintenance and protection of
biodiversity (Phillips and Kerr, 2000). The developing and least developed nations are
indeed in a quandary for they are not only caught in the crossfire in the agricultural
trade battle at the WTO between the USA and the EU involving GMOs as well as food
aid, they are also under increasing pressure to safeguard the natural endowment of
biodiversity and natural resources whilst simultaneously working towards
development. The resultant effect is that the agenda on poverty-trade-environment
becomes convoluted and conflict ridden due to it being irresolvable on the face of it
based on competing interests. Although the WTO has the primary responsibility for
establishing rules for trade in goods and services and the international protection of IP
rights, a number of multinational environmental agreements (MEAs) include
provisions for the imposition of trade measures (Phillips and Kerr, 2000). The WTO
agreements with their focus on short-term economic priorities supported by industrial
JITLP and commercial constituencies will inevitably be at cross purposes with the MEAs’
10,3 intergenerational environmental objectives (Thomas, 2004, p. 15). The supremacy of the
trade regime has resulted in the so-called “chilling effect” on crucial intergovernmental
processes dealing with the trade and the environment and therefore it is unsurprising
that in any ensuing conflicts will have resulted in a stunting progress on the
environmental front (Thomas, 2004). This trend is extremely dangerous particularly for
298 developing nations for failure to test the compatibility of trade policies with goals
for protection of biodiversity and its maintenance in hotspots and centers of endemism
(both for wild and agricultural biodiversity) could result in exacerbation of risks to
biodiversity of global significance (Treweek et al., 2006, p. 301).
The Cartagena Protocol’s basic principles relating to biodiversity conservation and
sustainable use also apply, is a significant and timely environmental treaty by virtue of
being one of the first legally binding international agreements to govern the
transboundary movement of GMOs, primarily for use in agriculture. The justification
of international regulation of activities related to the modification of the genetic
make-up of organisms through biotechnology is associated with the fact that all
biodiversity is a common concern of humankind due to the essential services it provides
to sustain the life forms of this planet and international cooperation is necessary to
address a variety of issues, especially where there is scope for transboundary impacts,
as in the case of gene transfers (Cullet, 2006, p. 394). The protocol is revolutionary in
terms of its contribution to the development of environmental law due to the application
of precautionary principle in the regulation of GMOs not merely as the main
background principle in terms of their regulation per se but is also the context of the
adoption of specific procedures adopted to regulate their transboundary movements
(Cullet, 2006). One of the controversies surrounding the protocol revolves around the
fact that the main operative fact of the protocol provides a system for the regulation of
transboundary movements of GMOs from their international transfer to their handling
and use, by specifying conditions wherein trade can be undertaken in the form of a
procedure for AIA[11], which in essence gives the importing states the right to restrict
imports in order to minimize possible adverse effects on the conservation and
sustainable use of biodiversity of GMOs. However, it is important to note that the scope
of the AIA procedure has been significantly curtailed to seeds and microorganisms
which constitute only a small percentage of GMOs that are traded. Moreover, the AIA
procedure applies only to the first intentional transboundary movement and is
not pertinent to cases of transit or where GMOs are destined for contained use
(Cullet, 2006). Undoubtedly excluding commodities altogether from the provisions
will have implications in terms of the capacity of the Biosafety Protocol to regulate
transboundary movements of GMOs in agricultural commodity trade as well as
protecting the biodiversity hotspots predominantly found in the locations of developing
nations given that trade in commodities makes up the vast majority of transboundary
movement of GMOs. An irreversible loss of genetic diversity through the release of
GMOs is the most serious hazard to be confronted hugely impacting the farming
environment: in Canada 73 percent of the oilseed rape area is now GM, resulting in
almost complete contamination of non-GM stocks; a food company had to foot costs
amounting to $10,000 due to the post-harvest contamination of organic soya beans
while elsewhere the commercial release of the GM papaya has breached environmental
regulations alongside trade barriers (Dobe and Sen, 2009, p. 207). A UN Reports
further points out the inadequacies of Asia’s regulatory frameworks and failures to GMOs and
conduct the large number of tests necessary to approve GMO’s safe release have caused international
the irreversible loss of genetic diversity (Dobe and Sen, 2009, p. 206). This problem is
further exacerbated by the fact that international guidelines for safety assessment of trade
GMO are not adequately developed for environmental impacts in contrast to food
safety thereby resulting in wide variations in the essential components constituting
environmental impact assessments such as: the interpretation of data and what 299
constitutes environmental risks; the basis upon which comparison is made[12]; the
extent to which the small-scale laboratory and field trials can be used to make
inferences regarding large-scale effects (Dobe and Sen, 2009, p. 210).
Developing countries dependent on agricultural exports are generally far more
vulnerable to severe environmental disruptions than industrialized countries that can
easily alternate between different agricultural suppliers without paying much heed to
the former’s needs with an indifference toward multilateral environmental problems
(Thomas, 2004, p. 18). As a consequence, Asian countries have been reluctant to approve
new GMOs predominantly due to fear of export losses (Dobe and Sen, 2009). To date
there has yet to be a serious comprehensive effort directed at improving the developing
world’s trading positions due to what has been described by Eckersley as the “Big Chill”
in the trade and environment discussions where serious negotiations aimed at reducing
environmentally destructive subsidies and facilitating incentive measures are stalled by
the deadlock of the trade and environmental debate. Developing countries meanwhile
are caught in the radiating effects of the “Big Chill” and the rapid transformations
brought about by agricultural biotechnology due to a lack of coherence between the
various MEAs and WTO agreements which form the essential elements of the global
economic governance[13]. The earlier mentioned transatlantic trade conflict between the
USA and the EU is certain to have an impact on the influence of the Cartagena Protocol
particularly on GMO-importing countries who are plagued with legitimate fears that
they may not be able to apply precautionary trade restrictive measures where there is
scientific uncertainty without repercussions from GMO producer/exporter countries,
notwithstanding the protocol (Gupta and Falkner, 2006, p. 32). A glaring fact that lends
credence to these fears is that so far none of the GMO exporting countries including the
USA, Canada and Argentina has to date ratified the protocol and yet continue to exert
their influence in further regime negotiation and evolution, in an ongoing effort to steer
its avenues of influence towards science-based harmonization of domestic regulatory
policies as opposed to strengthening the national prerogative in biosafety decision
making and enabling the regulatory diversity for GMO importing countries (Gupta and
Falkner, 2006, pp. 31-2) in accordance to their local circumstances. Ultimately, there will
be a differential effect on developing countries with respect to the regulation of the
international movement of germplasm and GM foods depending on whether they are
exporters (such as Argentina, Brazil, and Thailand) or alternatively importers, such as
most low-income developing countries, or both (Pinstrup-Andersen, 1999, pp. 216-217).
Inevitably, low-income developing counties planning to use an agricultural export-led
growth strategy have the dilemma of choosing between adopting modern
biotechnologies in agriculture or maintaining the possibility of a GM-free food export
to the European Union (Pinstrup-Andersen, 1999, p. 217). In view of the tremendous
importance of productivity increases in agriculture especially in low-income developing
countries, it is worthwhile for them to consider adopting an appropriate labeling
JITLP system to distinguish between GM foods and non-GM foods thereby enabling them
10,3 to concurrently capture the benefits from modern biotechnology and agriculture
for domestic consumption while maintaining the export markets for GM-free foods
(Pinstrup-Andersen, 1999). It is equally important for importing countries to have
a definite stand in relation to biosafety and food safety as well as product differentiation
and labeling for imported food considering that a significant share of food imported by
300 developing countries originates in the USA (Pinstrup-Andersen, 1999).
It is undeniable that the existing international trade institutions may be considered
as outdated in their design and outlook for they were not created to adequately cope
with the particular circumstances and exigencies of the biological revolution – this can
be evidenced from the WTO provisions in the General Agreement on Tariffs and Trade
articles relating to most favored nation rule, national treatment and customs
transparency, Agreement on the Application of Sanitary and Phytosanitary Measures
(SPS Agreement), TBT Agreement and the Agreement on Agriculture. The disputes
under SPS Agreement have centered on questions of scientific uncertainty: EC –
Measures Concerning Meat and Meat Products (EC – Hormones case)[14], Australia –
Measures Affecting Importation of Salmon (Australia – salmon case)[15] as well as the
Japan – Measures Affecting Agricultural Products ( Japan – varietals case)[16]. With
regards to the burden of proof, under the SPS Agreement it remains squarely on those
seeking to justify environmental measures as opposed to proponents of activities that
raise the threats of environmental harm where the standard of proof required – the
approach undertaken in these cases indicate that trade concerns are accorded more
relative importance than environmental issues and sheds light on the constraint with
regards to the degree of precaution provided for (Cooney, 2002, p. 6). Despite the fact
that the preamble of the SPS Agreement has explicitly provided recognition to the right
of every government to establish their own level of protection against environmental
risk, the interpretation of the provisions of the said agreement by the dispute resolution
body as well as the Appellate Body in cases such as EC – Hormones seem to negate this
right and have created serious obstacles to the ability of governments to establish
appropriate levels of protection (Wagner, 1999-2000, p. 855). Additionally, the SPS
Agreement’s requirement that trade measures are not maintained without sufficient
scientific evidence is highly circumscribed considering that the SPS Agreement has not
defined what constitutes “sufficient scientific evidence” (Cooney, 2002). Furthermore,
valid risk assessments under the SPS Agreement as interpreted in the Australia –
salmon will remain highly problematic for developing nations who are lacking in
expertise to carry out tests that set the bar extremely high for risk assessments to be
valid, in view of the vast numbers potentially invasive species, the level of information
surrounding them, and the resources available to carry out risk assessments
(Cooney, 2002, pp. 6-7). The problem becomes more acute especially in relation to
regulating pathways rather than intentional introductions where countries are unable
to present positive evidence in support of the measure but instead rely on more
theoretical long-term concerns (Cooney, 2002, p. 7).
In view of this, it is suggested that GMO exporting countries should perform risk
assessment much more intensively and should practice transparency. The approach
should be more towards precautionary approach, i.e. if scientists of that country
are not very sure about the safety imperative of any GMO, they should not allow it to be
introduced into the environment or to be consumed by man and animal, rather than
liberalizing international trade in it. It will lessen the burden of conducting GMOs and
risk assessment by importing countries. It will also ease up the job of the WTO. international
This approach is human as well as environment friendly. It will also be in the fitness
of the thing if provisions of the SPS Agreement pertaining to risk assessment trade
are interpreted in light of relevant MEAs and other international laws pertaining to
international trade and sustainable development. It would have been better if the Report
of the Appellate Body in US-Shrimp, which upholds this approach, should have been 301
followed in later WTO cases. It is unfortunate that in EC – Measures Affecting the
Approval and Marketing of Biotech Products[17] and in Australia – Measures affecting
the Importation of Apples from New Zealand[18] went back to WTOs previous position.
Another area that poses a challenge for developing nations is in respect to
the “provisional measure” provided for under Article 5.7 of the SPS Agreement which
focuses on the problem of scientific uncertainty surrounding the risks posed by
novel transgenes or alien species and in effect offers a qualified exemption to the Article
2.2 requirement not to maintain SPS measures without “sufficient scientific evidence”.
However, maintaining the said provisional measure require members to first obtain
additional information necessary for a more objective assessment of risk and second
review the sanitary or phytosanitary measure within a reasonable period of time. The
first country to invoke Article 5.7 was Japan in the Japan – varietals case, wherein Japan
argued that “varietal testing could be considered a provisional measure” (Charnovitz,
1999-2000, p. 288). In an important decision, the WTO panel suggested that the plaintiff
(in this case, the USA) has to establish that the defendant (in this case, Japan) had not
complied with Article 5.7. On the facts before it, however, the panel rejected Japan’s
argument and was upheld by the Appellate Body. The Appellate Body stated that Japan
had not obtained the (adequate) information for an objective assessment as to whether
different fruit varieties manifest dissimilar quarantine effects. Japan had also failed to
review its measure within a reasonable period of time. Thus, while the assessment of
what constitutes a “reasonable period of time” is to be determined on a case-by-case
basis, including difficulty of obtaining additional information for review and the
characteristics of the SPS measure, provisional measures have been found to be invalid
on this basis. The underlying problem related to the said requirement to seek further
information relevant for the evaluation of the likelihood of entry, establishment or
spread of pests, and associated costs, including the likelihood according to the SPS
measure imposed is that it may entail an onerous financial burden (Cooney, 2002)
especially for developing nations attempting to invoke the said provision. Such
information may neither be easily obtainable for many alien species nor gained by
experimental means. Similarly, the requirement for review within a reasonable period
of time may involve substantial ongoing costs, depending on what is considerable
reasonable (Cooney, 2002, p. 8).
There have been many intellectual discourses on the relationship of the
precautionary principle to the SPS Agreement. Despite the fact that there is no
explicit mention of precaution, or the precautionary principle in the SPS Agreement,
the precautionary principle was argued to provide a justification for trade restrictive
measure in the EC – Hormones case with the Appellate Body indicating that though the
principle finds reflection in the provisional measures of Article 5.7 this reflection does
not exhaust the relevance of the principle. Nevertheless, there are various constraints
for developing countries in adopting the precautionary approach under trade disciplines
JITLP which stem from formidable burdens of procedures relating to complex risk
10,3 assessments and the requisite justification that they entail involving major financial,
technical, and administrative resources (Cooney, 2002, p. 9). This will have significant
implications for biodiversity conservation in and by developing countries which house
the great majority of the world’s biodiversity whilst facing urgent immediate priorities
of poverty alleviation thereby unable to commit the needed resources to justify
302 precautionary measures. Thus, it is viable to consider the implementation of precaution
as the valid basis of decision making by reformulating the burden of justification for
SPS measures to an acceptable level as well shift the burden to the proponent of
activities in order to facilitate biodiversity protection for developing countries. It is also
crucial to consider the socioeconomic impacts of GMOs which ideally should be
taken into account during any assessment of their environmental risks (Dobe and
Sen, 2009, p. 210). The developing countries had extracted this concession with regard to
“the value of biological diversity to indigenous and local communities” which is to be
taken into account when making decisions on GMO imports[19]. The developing nations
also have articulated that there should be provisions in the protocol for compensation in
the event of accidents involving the transport of GMOs (Dobe and Sen, 2009). The lack of
agreement in these areas amongst others has intensified the conflict between trade and
environmental concerns.

5. Conclusion
In view of the discussions in the foregoing paragraphs, it is apparent that the
modern biotechnology has both benefits and detriments and this has to be viewed in
conjunction with the existing “unsustainable economic inequalities” which will become
intolerable as the global trading community becomes increasingly integrated and
interdependent (Cho, 2004). It is imperative that the benefits of biotechnology should be
delivered to every corner of the world and the detriment to the environment mitigated
through the utilization of the precautionary approach. Biotechnology needs to be
adapted to the unique national circumstances and steps must be taken to ensure that
new biotechnological products are used safely in one’s country – in this regard it is
crucial that both policy makers and research managers of any organization involved in
biotechnological development are provided with the relevant guidance for the safe
application of biotechnology. Developing countries neither have adequate institutional
and/or biosafety regulatory frameworks to ensure the safe use of biotechnology and
the import of its products nor the necessary expertise to regulate, monitor, and counter
the irreversible damage to their ecosystem[20] (Zepeda, 2006, p. 1200). There are
sufficient scientific evidence indicating potentially serious adverse impacts of GM
crops on agricultural and non-agricultural biodiversity, and this requires governments
of developing nations that intend to exploit the benefits of biotechnology to enact
biosafety regimes that will cater to the environmental impacts of release of GMOs in a
comprehensive way (Zepeda, 2006). It is for this reason it is suggested that the GMO
producing countries must make such a regulation that compels GMO producing
companies to perform intensive lab and field testing before introducing any GMO.
Human health and conservation of the environment should not be compromised for
short-term monetary gains. In sum, the field of biosafety is an area where the activities
are ongoing, technological progress occurring rapidly and thus information has to be
updated regularly and frequently in order to be current and effective with effective
biosafety regimes that are able to protect the God given rich biodiversity of developing GMOs and
nations. There is also an urgent need for international regulatory bodies to work in a international
cohesive manner to iron out conflicts arising in the trade-environment dimensions by
bringing the various MEAs and WTO agreements which form elements of the global trade
economic governance into some form of coherence with sustainable development
providing the framework. In view of the rapidly changing circumstances of trade in the
face of newly evolving technologies with infinite environmental impact, it is important 303
for the WTO to reform itself in order for it to remain relevant and maintain its
legitimacy in the global scheme of events relating to trade and environment.

Notes
1. The Earth’s Charter which was called for creation in 1987 by the United Nations World
Commission on Environment and Development the final version of which was later
formulated by the Earth Charter Commission in March 2000.
2. Article 2(1) of the 1969 Vienna Convention on the Law of Treaties (VCLT), defines a treaty or
international law as an “international agreement concluded between states and persons or
entities in different states and encompasses three primary sources of international law:
treaties, customs and general principles”.
3. The concept of environmental governance encompasses the relationships and interactions
among government and non-government structures, procedures and conventions, where
power and responsibility are exercised in making environmental decisions ( Jeffrey, 2008).
4. UN HDR (2001), identified biotechnology as a key avenue for the socio-economic
advancement of the developing countries.
5. Uncertainties are either related to the “unknown”, i.e. circumstance that there is not yet
a sufficient data basis provided for an assessment of consequences, or to the “unknowable”,
i.e. circumstance where the questions posed are out of reach for scientific methods
(Source: Sanvido et al., 2006).
6. No. C 06-01075 CRB, 2007 WL 518624 (N.D. Calif. February 13, 2007).
7. No. C 08-00484 JSW, 2009 WL 3047227 (N.D. Calif. September 21, 2009).
8. Geerston Seed Farms and Others v. Mike Johanns, No. 07-16458, DC, filed on June 2009.
9. Panel Report, European Communities – Measures Affecting the Approval and Marketing of
Biotech Products, WT/DS291/R, WT/DS292/R, WT/DS293/R (September 9, 2006). Scholars,
as amicus curiae, submitted this argument to the Panel in EC – Biotech. Amicus Curiae
Submission from Lawrence Busch et al., European Communities – Measures Affecting the
Approval and Marketing of Biotech Products, WT/DS291/R, WT/DS292/R, WT/DS293/R
(April 30, 2004), available at: http://tiny.cc/6668g. The Panel declined to follow the analysis
suggested by the Amicus.
10. See: INCOME: Global Gap Rising, World Bank Study Shows, UN Wire, January 18, 2002
cited in Cho (2007).
11. The AIA procedure as laid down in Article 7, applies “prior to the first intentional
transboundary movement of LMOs for intentional introduction into the environment of the
Party of import”.
12. Comparisons are made either with conventional agricultural environments or with
non-cultivated environments (Source: Dobe and Sen, 2009).
13. EcoLomics broadly is a political concept which refers to the interaction between ecological
and economic considerations. Global EcoLomics refers to the interaction between the
JITLP protection of the global ecosystem and the economic globalization process, taking into
consideration poverty alleviation at the aggregate level (Source: Thomas, 2007).
10,3
14. Adopted February 13, 1998, WT/DS26/AB/R, WT/DS48/AB/R.
15. Adopted November 6, 1998, WT/DS18/AB/R.
16. Adopted February 22, 1999, WT/DS18/AB/R.
304 17. WT/DS291/R; WT/DS/292/R; WT/DS/293/R. The Report can be seen at the WTO web site.
18. WT/DS 367/R. Report released on 9 October 2010. The Report can be seen at the WTO web site.
19. See Article 26 of the Cartagena Protocol on Biosafety. See also endnote [16], at p. 308 in
Falkner (2000).
20. Biosafety regulatory frameworks include laws and regulations to assess, manage and
communicate the biosafety profiles of GM technologies (Source: Zepeda, 2006).

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Corresponding author
Abdul Haseeb Ansari can be contacted at: ahaseeb@iium.edu.my

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