Business Potential for Agricultural Biotechnology - Asian Productivity ...

Business Potential for Agricultural Biotechnology Products
India + + ++
Indonesia + + + (++)
Thailand + + +
Philippines + + ++
Vietnam + + –
Malaysia + – –
Singapore + – –
Iran + + ++
Biosafety
The commercialization of any biotechnology product in agriculture produced using genetic
engineering (R-DNA technology) requires that policies and procedures be in place to ensure that
these products are environmentally safe. Such policies and procedures have come to be known
collectively as biosafety. Biosafety is now the subject of an international protocol, called the
Cartagena Biosafety Protocol (CPB) under the Convention for Biological Diversity. The CPB,
ratified by 119 countries, provides the international legal basis for the movement of biotech
products such as genetically modified (GM) seeds used for food, feed, or processing. Trade in
GM products is worth several billion USD per year, and worldwide over 85 million hectares of
GM crops are grown in some 17 countries, including countries from the developing world, such
as Brazil, Argentina, South Africa, China, India, and the Philippines.
The CPB requires that countries have clear and transparent national policies and procedures
to deal with research and development involving modern biotechnology. It also requires that risk
assessments be carried out before laboratory and field experiments are conducted using GM
seeds and that frameworks be established for performing biosafety evaluations prior to the commercial
release of any GM product for food or feed. Key issues revolving around biosafety are
liability and redress, risk assessment/management techniques, economic considerations, public
awareness, handling and packaging of GM products, and notification and labeling requirements.
A science-based approach is endorsed under the CPB. A Second Meeting of Parties (MOP-2) in
Montreal, 30 May–3 June 2005, will discuss procedures for implementation of the Protocol.
Biosafety issues therefore need to be effectively handled if they are not to become nontariff
barriers to trade.
Biosafety is assessed using a process called risk assessment (Hancock, 2003). This takes
into consideration the properties of the biotech plant, the ecosystem in which it is to be grown,
and societal concerns, as well as economic benefits. Some issues concerning biosafety will be
discussed in a later section of this paper.
Food Safety Criteria
National and international regulatory authorities require that food produced through biotechnology
must meet the same safety standards as food grown conventionally; that is, there
must be “reasonable certainty that no harm will result from intended uses under the anticipated
conditions of consumption.” The safety standard for biotech food, therefore, is that these foods
must be “as safe as” food produced by conventional methods. This standard of “reasonable certainty
of no harm” is critical, since foods in general are not absolutely safe, and many current
food products would not meet an absolute safety standard. The World Health Organization and
the Organization for Economic Cooperation and Development have established a safety assessment
process called “substantial equivalence” to ensure that foods derived from new processes
are as safe as foods produced from conventionally bred crops. This process considers two main
categories of risk: the properties of the introduced trait and any effects generated by the introduction
or expression of the new trait in the crop or food. This is a comparative safety assess-
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