Business Potential for Agricultural Biotechnology - Asian Productivity ...

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Why Agricultural Biotechnology?
fruit ripening) are being pursued (Sharma et al., 2003). The hope is that the efforts in these
countries will provide a number of products of value for these nations and the region.
The future role of biotechnology in the developing world has been examined. A recent
FAO report (FAO, 2004) reinforced the potential value of agricultural biotechnology in helping
the poor. Since the technology is scale-neutral, even small farmers in developing countries can
gain economic, environmental, and social benefits from the adoption of crops improved by biotechnology.
CHALLENGES FACING AGRICULTURAL BIOTECHNOLOGY
As described in the previous sections, biotechnology-derived crops have provided significant
value to growers, the environment, and the public and have the potential to provide even
greater value with the traits currently in the developmental pipeline. However, there are some
challenges that will impact the introduction of these products. One of these is the significant
costs and time associated with obtaining regulatory approvals.
Impacts of Regulatory Requirements and Processes
The regulatory requirements for products produced by recombinant DNA techniques are
considerably greater than those required by techniques that are considered to be part of conventional
breeding, even though conventional breeding may utilize techniques that are comparably
sophisticated and “modern” (e.g., mutagenesis by gamma irradiation and plant tissue culture and
regeneration) and can have comparable results. Crops that have been developed with tolerance to
imidazolinone- and sulfonylurea-based herbicides (e.g., IMI maize 1 and Clearfield ® wheat) are
examples. These herbicide-tolerant crops have required considerably less regulatory review than
the herbicide-tolerant crops containing a gene from a glyphosate-tolerant strain of Agrobacterium
(e.g., the various Roundup Ready 2 crops).
The additional regulatory requirements for biotechnology-derived crops have increased the
costs (both pre- and post-commercial) and time to market compared to conventionally developed
crops and have reduced the number and types of products being developed. Although there are
no studies known that have specifically examined this issue in detail, this is a widely-held view
among many academic and industry scientists 3 (Damodaran, 2004; De Greef, 2004; Kalaitzandonakes,
2004) and is credited with the current delays in the development of golden rice
(Potrykus, 2004).
Current Status of Regulatory Requirements for Biotech Traits Combined by Conventional
Breeding
Regulations proposed to cover biotechnology-derived traits that have been combined by
conventional breeding (termed “combined-trait products” or “stacks”) are a more recent example
of the expansion of regulatory requirements for biotechnology-derived crops. The combination
of separately selected traits is routinely used in seed variety development by conventional breeders.
For example, in maize a number of mutants have been identified that affect carbohydrate
metabolism. 4 The genes carrying these mutations have been combined by conventional breeding
to produce sweet corn and field corn varieties with multiple and different food and feed uses
1 IMI corn (maize) was developed by American Cyanamid and first marketed by Pioneer in 1991 (Ritchie, 1998).
® Clearfield is a registered trademark of BASF Corporation. Clearfield wheat was developed through mutagene-
sis (Lyon, 2003).
2 Commercial Roundup Ready crops include maize, soy, canola, and cotton.
3 Nicholas Kalaitzandonakes, professor of agribusiness and director of the Agribusiness Center at the University
of Missouri at Columbia, is planning such a study and has communicated that this view is consistent with his
interactions with scientists to date.
4 e.g., shrunken2, sugary1, sugary enhancer1, brittle2, amylose extender1, dull1 and waxy1.