12.3.4 International Perspectives
Regulatory agencies worldwide recognize that products of biotechnology can pose risks,
the same as can similar products from other means of genetic manipulation, including
traditional breeding. Simply because they are generated using rDNA does not make them
benign; they may have food or feed safety issues, and they may have features enabling
them to threaten ecosystems.
Food safety is a common fear, and food safety regulatory agencies worldwide consider
the possibility that the regular food has intentionally or unintentionally become adulterated,
toxic, or allergenic during the breeding process, or has significantly reduced (or enhanced)
nutrients. All such agencies question the source of an introduced gene, to determine
whether, for example, that source is allergenic. Because of the earlier work showing the
allergenic Brazil nut storage protein to be allergenic even after gene transfer and expression
in soybean (Nordlee et al. 1996), we know that allergenic proteins do not need their “home”
genetic or physiological background to elicit an allergenic response. Similarly, food safety
agencies are concerned with the potential for the transfer of potential toxic and other
antinutritional substances from donor species, and the possibility that the transfer of even
benign genes and proteins might exacerbate production of endogenous toxins, allergens,
and antinutritional substances in the recipient species and foodstuffs.
Fortunately, both traditional and biotech crop and food developers also appreciate these
real risks and conduct premarket testing to convince themselves (if not everyone else) that
their new variety carries no additional toxic, allergenic, or antinutritional substances. Any
breeding lines exhibiting such problematic substances are eliminated from consideration for
commercialization long before any regulatory agency sees them. No company wishes to
face the liability of releasing a true threat to health.
Also fortunately, human physiology being what it is, a toxin, allergen, or other anti-
nutritional substance will pose the same risk to virtually everyone, worldwide. While
there may be some differences in exposure, due to cultural or cuisine preferences or prep-
aration methods, a toxin to western Europeans will also be toxic to Indians. This means that
the basic safety testing will be common to all, so the questions asked and answers
demanded by the US FDA or EFSA in Europe will be of interest to consumers worldwide,
and food safety regulators need not duplicate the entire (and expensive) food safety
bureaucracy, but may instead concentrate on local variations in cuisine, including consider-
ation for method of preparation (e.g., cooked vs. raw) or overall exposure (e.g., a food may
be a major dietary component in one culture and minor elsewhere).
The other main scientific concern for regulatory action, environmental risks, is more
variable. Consensus in the scientific (if not always in the regulatory or political) community
recognizes the factors in environmental risk is not the method of breeding but the species in
question, the trait, and the region of release. While human physiology is much the same
worldwide, ecosystems vary widely, such that a plant deemed benign by USDA APHIS
for release in the United States might be wreak ecological havoc when released in the
Amazon basin. Because of the environmental variation, regulatory agencies worldwide
concerned with ecological effects cannot rely entirely on determinations made by regulators
in a different environmental region. As not all countries or regions enjoy the regulatory
resources of the United States, Canada, or the European Union, international efforts and
regional coalitions attempt to economize biosafety review of potential threats to the
environment.
12.3. REGULATION OF GE 301