(GEOs or GMOs). In response to this, governments around the world rushed to assure the
public that “something was being done to protect the public and the environment from the
hazards of genetic engineering” and establish regulatory mechanisms to oversee GE as
applied to agriculture and food production.
12.2 History of Genetic Engineering and its Regulation
Genetic engineering, recombinant DNA, is much older than most people realize. The first
successful DNA “recombination” or human-mediated hybridization between two specific
but diverse DNA strands was reported by Boyer and Cohen in 1973 (Cohen et al. 1973).
At first, the scientific community itself recognized that the great power of the new technol-
ogy also implied risk (Berg et al. 1974), and in 1975 a group of leading scientists convened
at Asilomar, California to discuss the issues. They called for a largely self-regulated set of
guidelines to cautiously assess the risks with the emerging technologies. In the United
States the National Institutes of Health (NIH) in 1976 took the next step when it formalized
and established strict rules to regulate rDNA research activities. Although the NIH guide-
lines applied only to federally funded rDNA research programs, many agencies [including
the Environmental Protection Agency (EPA), Food and Drug Administration (FDA), and
the US Department of Agriculture (USDA)] adopted the rules as sensible precautionary
policy. The voluntary NIH guidelines thus became, in effect, mandatory for virtually all
rDNA research conducted in the United States and internationally.
With the scientific community enthusiastic about the applications of rDNA and other
forms of biotechnology, bureaucracies recognized the impending certitude that biotechnol-
ogy would not remain an academic and laboratory novelty, and that manufacturers of
products developed using the new technologies would eventually be seeking market and
environmental release. Consequently, they began gearing up to deal with potential
hazards. One of the first papers was from the Organization for Economic Cooperation
and Development (OECD), which provided a standardized and workable definition of
“biotechnology...the application of scientific and engineering principles to the processing
of materials by biological agents to provide goods and services” (OECD 1982). Although
the definition is unwieldy and captures virtually everything involving biological systems,
including products of conventional breeding and food production systems, it remains
widely used today and provides the basis for regulations in many countries. The OECD
report also noted the necessity of regulating products of biotechnology, assuming that
they, like everything else, were not inherently risk-free. By the mid-1980s, the living organ-
isms generated as a result of rDNA research [also known astransgenic organisms,geneti-
cally modified organisms(GMOs), orgenetically engineered organisms(GEOs)] were
being generated and attracted attention because of their own potential for risk, particularly
as potential threats to the environment and as food/feed safety hazards. In 1986, the US
Office of Science and Technology Policy (OSTP) investigated the regulatory milieu and
compiled aCoordinated Framework for Regulation of Biotechnology. This document coor-
dinated the existing regulatory bureaucracy with relevant studies coming from the scientific
community. They recommended adapting existing legislation and regulatory authority to
encompass products of biotechnology, tapping existing regulatory expertise in relevant
agencies, particularly the USDA, FDA, EPA. Thus, GMO plants would be regulated for
food and feed safety concerns by regulators with appropriate expertise in FDA, those
GMO plants with pesticidal properties by EPA, and those with plant pest potential
12.2. HISTORY OF GENETIC ENGINEERING AND ITS REGULATION 293