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Business Potential for Agricultural Biotechnology Products
are produced, only one is selected, based on stringent performance standards, as the source for
all the varieties eventually sold commercially. Before any food crop produced using modern biotechnology
can be marketed, the food product must undergo multiple years of rigorous safety
assessment. Steps in taking a proof of concept from the laboratory to the market include those in
the R&D phase—desired traits identified, genes tagged and mapped, transformation process
under biosafety purview, phenotype evaluation in contained environment, open field tests under
supervision of biosafety regulators—and the commercialization phase—deregulation approval
based on scientific review of data and public hearings, incorporation into commercial variety,
multilocation performance trials, seed certification boards’ approval for multiplication use, and
food/feed use approval for consumption. 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 food safety standard for
biotech food therefore is that these foods must be “as safe as” food produced by conventional
methods. The comprehensive safety testing described above provides a thorough assessment of
potential risks relevant to food safety, all in a comparative assessment with foods derived from
conventional crop varieties. It is through this holistic approach that regulatory agencies around
the world have repeatedly concluded that foods derived from biotech crops are as safe and nutritious
as foods developed through other technologies. Above and beyond regulatory requirements,
producers of GM crops assure the biosafety and food safety of their products through product
stewardship by providing the subsequent after-sales support to ensure that the product is
properly used, including, among other things, resistance management schemes especially for the
insect-protected products (Bt corn, Bt cotton), and detection techniques. There have been about
25,000 field trials in 45 countries on 60 crop species without a single ecological accident—an
impeccable record of government-supervised field trials.
Successful commercialization of crop biotech requires not just sound technology relevant to
farmers’ needs, but also a supporting environment. Public knowledge, attitudes, and perception
of GM products are very important factors that ultimately determine whether GM crops will
make an important contribution to the world’s food supply. It is important that public concerns
be recognized and properly addressed. Some of these have to do with the environment—regulation
of field releases, outcrossing, and effects on nontarget organisms—and food safety—the
safety assessment process, regulation, the presence of allergens or toxins, nutritional value, and
the presence of antibiotic resistance markers. Being aware of the issues helps the scientist understand
and generate data to address them. Science currently addresses these concerns very well.
There are elements of risk, but these are far outweighed by the benefits.
HIGHLIGHTS OF THE COUNTRY PAPERS
Marching Towards the Market: The Business Potential of Agricultural Biotechnology in
the Republic of China
Due to its high application potential, and in order to accelerate its development, biotechnology
was included by the government in 1982 among the eight key areas of research. Many
related education and training programs were also initiated at this time. The Development Center
for Biotechnology (DCB), the first autonomous and nonprofit organization specifically for biotechnological
research, was established in 1984. After nearly a decade of effort, the research
gradually proceeded to more practical and important activities, including the development of
transgenic plants and animals, DNA-based genotyping for breeding, and the development of biopesticides,
biofertilizer, and animal vaccines. From the late 1980s to the middle 1990s, important
regulations and guidelines concerning biotechnology and biosafety were established by the government.
The Experimental Rule of Recombinant DNA was issued by the National Science
Council (NSC) and the Guidelines for Risk Assessment in GM Plants and GM Animals by the
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