Business Potential for Agricultural Biotechnology - Asian Productivity ...

– 29 –
Why Agricultural Biotechnology?
Pacific countries, including China and India, the regulation of traits combined by conventional
breeding is under consideration.
In contrast, the European Union and Argentina consider combined-trait products to be
novel or unique and therefore require a new submission or the inclusion of the foreseen combined-trait
products in the submission of one of the parents. Extensive bridging regulatory data
on the combined-trait products needs to be generated. No combined-trait products produced
through conventional breeding have been approved to date in either the EU or Argentina.
A reasonable regulatory approach for combined-trait products is set forth in a document
prepared by scientists and regulatory specialists from member companies of CropLife International
(CropLife International, 2005). Separate safety assessments should not be required if the
individual traits are unrelated and the individual traits were previously approved. However, to
confirm the presence of the individual traits in the combined-trait product, regulatory agencies
might request greenhouse or field bioefficacy data or gene expression levels. Data from any one
of these sources would be appropriate to demonstrate that the individual traits are present and
functioning as intended in the combined-trait product. Additional safety data are scientifically
justified only when the traits target the same metabolic pathway or they are otherwise expected
to have interactions. On a case-by-case basis, studies may be required to determine whether there
are any interactions, either synergistic or antagonistic, between the traits, or to assess the products
of the metabolic pathway.
Reasonable rules for the review of crops with biotechnology-derived traits combined by
conventional breeding will preserve the significant benefits of these technologies. For example,
combining traits by conventional breeding would allow the combination of traits that have
region- or country-specific uses but may not justify the expense of separate development through
plant transformation. Additionally, reasonable regulations that are consistent between trading
countries and regions will facilitate the movement of commodities containing these traits.
CONCLUSION
As described herein, crops developed through agricultural biotechnology have provided
demonstrable economic, environmental, and social benefits globally. Within the Asia–Pacific
region, five countries have grown biotechnology-derived crops commercially: Australia, China,
India, Indonesia, and the Philippines. Specific examples described insect-protected cotton in
China, Australia, and India, insect-protected maize in the Philippines, and herbicide-tolerant cotton
in Australia. Future uses in the Asia–Pacific region include more widespread adoption of
herbicide-tolerant crops currently grown elsewhere, including herbicide-tolerant maize. In addition,
China and India have very active crop biotechnology research and development programs
in a diversity of crops (including chickpea, rice, cotton, maize, mustard, and potato) and biotechnology
traits (including insect, disease, and virus resistance, herbicide tolerance, stress tolerance,
oil improvements, and fruit ripening). Other biotech-derived traits will improve food and
feed nutrition, including vitamin and mineral enhancement, increased essential amino acids and
altered fatty acid composition. However, the successful development and commercialization of
biotech-derived crops will be impacted by the costs of doing so, and the costs of regulatory
approvals have become an increasingly significant part of the total product development and
commercialization equation. Regulators and the scientists who support them must make take
care to assure that data requirements are reasonable and designed to address true food, feed, and
environmental risks.
REFERENCES
Alia Hayashi H., Sakamoto A., Murata N. Enhancement of the tolerance of Arabidopsis to high
temperatures by genetic engineering of the synthesis of glycinebetaine. Plant Journal 1998;
16: 155–161.