Business Potential for Agricultural Biotechnology - Asian Productivity ...

Commercialization of Agricultural Crop Biotechnology Products
steps may vary by country, depending mainly on the regulatory regime in place for biosafety and
food/feed safety.
Typically, a discovery group identifies a valuable protein which helps to confer a useful
trait, such as insect resistance. The Bt protein is an example. At this stage, many questions are
asked about the history of the protein, especially its safe use in its conventional form. When the
history of safety is satisfied, a next step commonly is for molecular biologists to develop artificial
constructs of the gene which makes the protein. These steps may take up to a year. So far,
there is little biosafety consideration.
The insertion of the artificial gene construct into target plant cells is next accomplished
through a process commonly called transformation. The target cells are from plant varieties with
desirable commercial traits as well as being useful parents in a breeding program. Several transformation
techniques are in use in labs worldwide; the biolistic or particle bombardment technique
and agrobacterium insertion are the most common. The success fraction of transformations
is very low, hence in some laboratories facilities are developed for automation. Successfully
transformed cells containing the desired gene are then grown to whole plants using tissue culture
techniques. All the above is done under biosafety regulatory purview, usually by means of an institutional
biosafety committee made up of representatives from research, government, and
society.
Next comes testing the plantlets or whole plants to determine if the desired trait is expressed
in strong enough levels to justify a useful product. For example, a plant purported to
contain the Bt gene may be tested by exposing it to insect larvae from the pest which it was developed
to resist. This screening process again is often done en masse under biosafety supervision
in greenhouses and may take one to three years.
When a crop variety containing the desired improved trait has been obtained, enough seed
is prepared for field tests, commonly starting with a single location and progressing to multiple
locations and crop seasons. All this is done in compliance with the existing biosafety regulations
of the country concerned. Countries typically also require public notification and hearings to
enable the proponents of the technology to dialogue with communities. At the same time that
this is taking place, companies or public institutions proposing commercialization or release of
the biotech crops in question are also accumulating evidence on the food/feed safety of the biotech
crop. After two to three years of field evaluations and food/feed safety testing, the government
body empowered to make a decision to approve the product must weigh all the evidence
and render its decision.
In Asia, only the Philippines and India have had significant experience with the full cycle
of commercialization. An important question to be asked is whether governments will expect
public institutions to be subject to the same long, expensive process of testing a biotech crop before
it is approved. In North America, regulatory agencies are willing to allow data sharing
between products, on a scientific basis, so that the process is less cumbersome.
Regulatory Approval (Biosafety, Food/Feed Safety)
Regulatory approval is typically required for biosafety (environmental safety) and food/
feed safety before any biotech crop can be released for commercialization. The status of biosafety
approvals in Asia is shown in Table 3.
Table 3. Stage of Development of Biotech Crops, Asia, May 2005
Country Laboratory Field Precommercial (+) or
experiments commercial cropping (++)
China + + ++
Australia + + ++
Japan + + +
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