Business Potential for Agricultural Biotechnology - Asian Productivity ...

Commercialization of Agricultural Crop Biotechnology Products
ment whereby conventional foods that have a history of safe use and consumption serve as a
reference point for all safety testing.
Testing for Food and Feed Safety
Before any food crop produced using modern biotechnology can be marketed, the food
product must undergo multiple years of rigorous safety assessment. In meeting stringent food
safety requirements and standards, biotech foods are among the most thoroughly tested foods
available. No other food crops in history—including foods currently available on grocers’
shelves—have been tested and regulated as thoroughly as have foods developed through biotechnology.
The safety of these foods is reviewed by regulatory agencies around the world according
to internationally agreed-upon safety assessment guidelines.
Data are collected systematically to assess food safety. The five main categories of testing
are the safety of the new trait (most often the introduced protein), a comparison of the agronomic
characteristics of the new plant to conventionally bred plants, also called “agronomic equivalence,”
a comparison of the nutritional and biochemical composition of the new food with conventional
food, also called “compositional equivalence,” the safety of the resulting food or feed
established by comparative animal feeding studies, and the nutritional wholesomeness of the
new food or feed established by testing in farm animals.
Safety of the new trait (introduced protein). The safety assessment of products derived
through biotechnology is unique in that the DNA inserted into the plant is well defined and well
characterized. Therefore, the newly produced protein(s) will be clearly identified. It is also
important that the new substance produced in most biotech crops is a protein because very few
proteins are harmful to humans and the specific protein(s) produced can be directly assessed for
safety.
Each introduced protein is extensively characterized to understand how it functions and
assess its similarity to proteins already present in foods. For example, the protein used to confer
tolerance to Monsanto’s Roundup® herbicide, a member of a family of proteins present in most
foods, has a well-defined function and is “generally recognized as safe” due to its history of safe
consumption. The amount of the introduced protein is measured in key raw agricultural commodities
to evaluate consumption levels and patterns. Comparison of the amino acid sequence of
the introduced protein(s) to known toxins and allergens assures that the protein is neither a toxin
nor an allergen nor closely related to either.
Since proteins are a key component in food and are typically rapidly digested, the digestibility
of the protein plays an important role in predicting safety. All proteins that have been introduced
into biotech crops have been rapidly digested. To assess the potential to cause harm,
animal toxicology studies are conducted with each new protein at high levels (thousands to hundreds
of thousands of times greater than the highest predicted consumption). Not surprisingly,
given the nature and digestibility of proteins used as well as the history of safe consumption, no
adverse effects have been observed in these studies.
The likelihood of the protein being an allergen or becoming an allergen is commonly
assessed in detail according to international standards. The proteins used in commercial crops
share none of the important characteristics that are common among known allergenic protein:
none of these proteins is derived from allergenic sources or related to known allergens, the
proteins are rapidly digested, and they are produced at low levels in the portions of the plant that
are consumed. Therefore, it has been concluded that these proteins pose no significant allergenic
concerns.
Agronomic equivalence. As part of the overall safety assessment of a crop developed via
biotechnology, numerous agronomic and phenotypic parameters of the crop are compared with
those of its conventional counterpart to assure that there are no meaningful changes caused by
the transformation process or the introduced genes or trait. The morphology, yield, and other
agronomic parameters are sensitive indicators of changes in the metabolism or physiology of the
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