1.

THE WTO AND THE REGULATIONS PERTAINING TO BIO-SAFETY, BIO-

ETHICS AND BIOTECHNOLOGY

Further, the World Trade Agreement is a set of internationally binding Agreements negotiated
under the WTO. As of now, WTO has a membership of 146 countries and customs territories.
The WTO rules are designed to liberalize market by removing unnecessary, discriminatory and
protectionist barriers to free trade. The World Trade Organization (WTO), often accused of
insensitivity to bio-related problems and the new reality of global environmental governance,
and human health awareness has for many years been investigating ways of reconciling trade and
bio-friendly initiatives. One area in which such concerns have recently clashed with the trading
interests of states and corporations is that of biotechnology. WTO has been discussing the need
to address issues of environmental concerns of trade practices for a long time.

The WTO is the institutional framework of the international multilateral trading system. Every
member of the WTO has entered into commitments related to its trade policy regime and
measures with relation to its trade in goods among other things. The rights and obligations of the
WTO members can be enforced through a dispute settlement system. WTO obligations constitute
limits, or what has been termed “negative obligations,” upon its members to refrain from
enacting certain governmental regulations. The following agreements, and negative obligations,
have been reviewed because of their potential role in Biosafety measures.

“Technical Barriers to Trade” (TBT) and the “Sanitary and Phytosanitary Standards” (SPS)
Agreements were adopted to “further the objectives” and to “elaborate rules for the application
of the provisions” of the GATT. The TBT and the SPS both are exclusive from each other. If a
trade-related measure does not fall within the scope of the SPS Agreement, the TBT Agreement
can cover it. The TBT Agreement applies to all measures affecting the trade in any products that
are technical regulations or technical standards, as long as those measures do not fall under the
SPS Agreement. The most specific of the three Agreements is the SPS Agreement. This
Agreement, in simplest terms, governs all measures that may directly or indirectly affect
international trade in any product. The SPS Agreement was primarily intended to prevent the
imposition of trade barriers for sanitary and phytosanitary purposes unless they were grounded in
science. At the same time, the SPS Agreement must always be interpreted in a way that
recognises the rights of WTO members to take measures genuinely to protect themselves against
risks to human, animal and plant life and health. Unlike the SPS Agreement, the TBT Agreement
does not expressly require a Member to analyze its regulation on the basis of a risk.

Further, in the light of these developments, the adoption of the “Cartagena Protocol on
Biosafety” represents a significant achievement in trying to reconcile the respective needs of
trade and the environment. The Protocol establishes international rules for trade in genetically
modified organisms and reinforces the right of importing nations to reject GMO imports on
environmental or health grounds. While recognizing the potential benefits of biotechnology
trade, the treaty strengthens the application of the precautionary principle in this area and
explicitly states that trade and environment agreements 'should be mutually supportive'. The
Protocol contains a number of compromises, exemptions and omissions that may adversely
affect its effectiveness in safeguarding biosafety.

The Cartagena Protocol's major provision for regulating GM trade is the so- called AIA
procedure which, as laid down in Article 7, applies 'prior to the first intentional transboundary
movement of living modified organisms for intentional introduction into the environment of the
Party of import'. The central principle that informs the AIA procedure is the right of the
importing nation to refuse the transboundary movement of regulated goods, on the basis of a
system of risk assessment which takes into account threats to biodiversity and human health. As
in the case of the Prior Informed Consent (PIC) principle of the “Basle Convention on the
Control of Transboundary Movements of Hazardous Wastes and their Disposal,” the AIA
procedure effectively reinforces national autonomy in environmental and health regulation
against the erosive forces of economic globalization

Just the way the SPS and the TBT Agreements promote the use of science and risk assessment as
a means for justifying trade-related measures, the Protocol’s risk assessment procedures were
designed on the basis of scientific evidence. In analysis of the texts of the Protocol and the three
WTO rules, the following issues emerge that both the Protocol and WTO rules:

(1) recognize the impact of international trade activities on the environment and biodiversity in
which species are basic components;
(2) realize the importance and necessity to ensure the safety for human, animal or plant life and
health as well as environment

(3) recognize that risk assessment is rather critical to take appropriate measures to regulate the
transboundary movement of the products which contain harmful living organisms, including
LMOs and emphasized that the risk assessment must be based on scientific information and data,
as well as should take into account internationally recognized techniques and methodology

However, in many ways the Protocol represents an inconclusive compromise between the
interests of GMO exporters and importers, as was to be expected after the acrimonious collapse
of the biosafety talks in early I999. The agreement is unlikely to prevent future tension over
some important issues that remain unresolved: the precautionary principle has been defined only
insufficiently; and the provisions on trade and the environment, relegated to the preamble text,
leave considerable room for interpretation.