Food Safety - The Oxford Topic of Food, Politics, and Society - page 587

A Short History of Recombinant DNA
[rDNA] in Food Crops
The roots of modern biotechnology can be traced to the first report of recombinant DNA
(rDNA) having been transformed into a bacterium in 1973 (Chassy, 2007).4 In little more
than a decade, researchers succeeded in transferring genes isolated from a diversity of
species into numerous plant, animal, and microbial species, which opened the way for
production of transgenic organisms, and products derived from them, that promised
to be useful in medicine, agriculture, and the food and chemical industries. Skeptics
warned that moving genes across species barriers in the laboratory violated nature, was
fraught with uncertainties, and likened rDNA technology to opening Pandora's Box. It
was, however, the precautionary approach of the scientific community itself that led to
the development of NIH rDNA guidelines in the United States; similar kinds of regula-
tions for the safe handling of rDNA and rDNA-containing organisms were introduced
in other countries. Over time, rDNA guidelines were considerably relaxed as it became
clear with experience that rDNA posed no intrinsically novel risks.
In the early 1980s, transgenic herbicide-tolerant plants that had great potential utility
for weed management in agriculture were developed. Insect resistant crops were devel-
oped in the same timeframe. Since it was now clear that transgenic plants could be devel-
oped and introduced into the marketplace, the U.S. Office of Science and Technology
Policy (OSTP) requested the National Academy of Science (NAS) to consider the issue
of the safety of transgenic crop plants and to make recommendations regarding the
need for regulation of the safety of genetically engineered crops. The NAS and National
Research Council (NRC) responded (NAS, 1987) that:
1. Transgenic crops pose no novel risks, on the principle that techniques of biotech-
nology are not inherently risky.
2. It is the safety of the product that is of concern and not the process used to produce
it.
3. No new laws were needed to give government agencies the authority to ensure
the safety of consumers, agriculture, and the environment since the risks were
“the same in kind” as those presented by organisms bred using older conventional
methods.
In spite of the science-based recommendation of the NAS that the mere fact that an
organism has been genetically engineered should not be the reason for special regu-
latory review, the OSTP published the Coordinated Framework for the Regulation of
Biotechnology (OSTP, 1986; Chassy et al., 2001), which empowered the U.S. EPA, U.S.
FDA, and U.S. USDA to play defined roles in regulating crops produced using biotech-
nology. The regulation of food safety fell largely to FDA with EPA taking the lead role
in plants containing pesticidal properties. The EU (Kuntz and Ricroch, 2012) chose to