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Business Potential for Agricultural Biotechnology Products
transgenes to related and unrelated species of the GM organism, negative effects on nontarget
organisms, and the development of “super-pests,” and also techniques of risk assessment, the
containment or amelioration of risk, and the conduct of field experiments using GM organisms.
Much has been written on these topics (NRC 1989; Teng and Yang 1993). Common steps to
ensure biosafety in developing countries are:
Researchers develop a proposal in accordance with the relevant biosafety guidelines of a
national committee on biosafety. The proposal is reviewed by the relevant authorities. Risk
assessments and other required information are provided. The proposal is submitted to an
institutional biosafety committee for review, approval, and endorsement to the national committee.
The proposal is reviewed by the national biosafety committee for possible revision or approval,
and research starts only after notification of approval by the national committee. Biosafety
regulations that govern the conduct of experiments under containment and in “open” field
experiments are in place in a growing number of developing countries, including China, India,
Indonesia, Malaysia, the Philippines, Thailand, Mexico, Argentina, and South Africa. These
regulations commonly require that before any experiment involving recombinant DNA techniques
is done, a formal application must be made, accompanied by site visits and public hearings
involving nonscientists. In North America, the earliest region to approve and commercialize
GM crops, it has been seen that with increased experience by regulatory agencies and greater
public acceptance through more exposure to biotechnology, the process has gradually become
more routine and attracted less interest from the public. The process of developing a transgenic
plant with the desired trait is as long as, if not longer, than the equivalent process required to
take a pesticide to market—typically about a decade. Safeguards and rigorous testing are in
place throughout this process. Developing countries which have deregulated GM crops include
China, Argentina, Mexico, and South Africa.
Between 1986 and 1998, more than 25,000 field trials of transgenic plants from more than
60 important agricultural crops were approved by 45 countries (James, 2004). In the U.S.,
several transgenic products for use in crop protection were no longer subject to regulation as of
September 1997: Bt corn, herbicide-resistant cotton, Colorado Potato Beetle-resistant potato,
virus-resistant squash, herbicide-resistant soybean, and virus-resistant papaya. Public perception
has improved, and concern about field trials involving transgenic crops has significantly decreased
in North America with the establishment of transparent regulatory processes.
Food Safety and Health Issues
Most agricultural crops that have been genetically modified end up as food or feed. Public
acceptance or rejection of any GM product is therefore a strong consideration of its selection as a
crop production or pest management tool. To provide assurance that biotechnology will generate
food as safe as that produced by traditional breeding programs, safety assessment strategies have
been developed for products of plant biotechnology which are more thorough than those used to
evaluate new foods using conventional breeding techniques.
The process used by Monsanto, one of the pioneers in applying biotechnology, is illustrative
of the steps taken to assure the safety of genetically-modified plants for use as food:
molecular characterization of the genetic modification, agronomic characterization, nutritional
assessment (key nutrients), toxicological assessment (key antinutrients, toxicants), and safety
assessment of the gene expression product. The overall goal of this assessment is to determine
whether the genetically modified plant is substantially equivalent to food derived from a conventional
source which has a history of safe use (OECD, 1996). A substantial equivalence evaluation
focuses on the product rather than the process used to develop the food or feed. If the new
product is substantially equivalent to the conventional food or feed, then the biotechnologyderived
product is considered as safe as the nontransgenic counterpart.
When a genetically modified food crop has been shown to be substantially equivalent to the
conventional crop with the exception of the introduced trait(s), which may impart one or more
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