(environmental risks) by USDA. This coordinated effort and allocation of responsibility to
different agencies continues today in the United States.
At about the same time, the OECD released a major study (based on its own rec-
ommendation in the earlier 1982 report) on biosafety related to biotechnology, often
called simply the “Blue Book” (OECD 1986), which also remains widely quoted and
cited today for its fundamental commonsense approach to risk assessment. It was the
first scientific analysis to consider environmental hazards that might be posed by trans-
genic organisms, and served as a standard from which many governments and regulatory
agencies have based their procedures for assessing risks with products of biotechnology.
It remains, even after 20 years, “fresh” in the sense that it was prescient, identifying
legitimate risk concerns with rDNA technologies even before transgenic organisms
were let loose on the environment.
In contrast, some other jurisdictions, notably those in the European Union (EU),
believing rDNA to be so novel and potentially hazardous that existing legislation and
regulatory expertise was not capable of handling it, created entirely new bureaucracies to
regulate GMOs.
By the end of the 1980s, the US National Academy of Sciences issued a “white paper”
declaring, among other things, that rDNA produced no new categories of risk, and that risk
assessment should be based on the physical features of the product, not on the process by
which it was developed (NRC 1987). Subsequent studies from the National Academies of
Science [via the National Research Council (NRC)] on increasingly specific points dealing
with risks posed by rDNA all came to the same general conclusion, that all methods of
genetic manipulation can generate potentially hazardous products, that rDNA is not inher-
ently hazardous or invariably generates products with higher risk than do other methods,
and that risk assessment should focus on the final product, regardless of the method of
breeding (NRC 2000, 2002, 2004).
Back at the lab, the techniques of gene splicing, as it has become known, have been
applied to a wide range of products, including medical, industrial, and, yes, agriculture
and food production. In the late 1970s, the early experimental successes saw genetically
engineered microbes produce proteins from rDNA transferred genes, and the technical
advances were quickly adapted to commercial applications, including generating human
therapeutics. Human insulin produced by rDNA from the human gene transferred to
bacteria was reported in 1978. This development led to the first approval for the first
commercial application of rDNA technology, the diabetes drug insulin (trade name:
Humulin, from Genentech), in 1982. Many other pharmaceutical products developed
using rDNA quickly followed.
Transgenic plants made their lab and greenhouse appearance in 1983, as three indepen-
dent groups reported their developments at the Miami winter symposium, and other groups
followed quickly.
In Belgium, Jeff Schell and Marc Van Montagu produced tobacco plants resistant to
kanamycin and methotrexate (Schell et al. 1983, Herrera-Estrella et al. 1983). At
Monsanto in St. Louis, USA, Robert Fraley, Stephen Rogers, and Robert Horsch generated
transgenic petunia plants resistant to kanamycin (Fraley et al. 1983a, 1983b). And in
Wisconsin, John Kemp and Timothy Hall inserted a gene from beans into sunflower
(Murai et al. 1983).
The first open-air field trials of transgenic plants were planted as early as 1985, but the
numbers of trials, species, traits, and countries climbed dramatically in the late 1980s and
early 1990s.
294 REGULATIONS AND BIOSAFETY