such as enhanced nutritional profiles and removal of allergenic or other antinutritional
proteins and substances. One reason why these “consumer-oriented” GE products are not
available today is the long and expensive regulatory process. One point worth remembering
is that all GE crop cultivars receive far more regulatory oversight and safety assessments
than do similar crops with similar traits and therefore posing similar risks.
12.3 Regulation of GE
Effective regulations protect the public and the environment from threats of harm. Also,
because all regulatory bureaucracies have limited financial, human, and other resources,
they must, in order to be effective, apply the regulatory maxim: things posing the greatest
threat receive the greatest scrutiny.
Of course, regulatory bureaucracies, like all bureaucracies, do not always work effi-
ciently or effectively. Political expediency often interferes with the strict adherence to the
scientifically sound maxim. Below we explore how some regulatory bureaucracies apply
their allocated resources to agricultural biotechnology.
12.3.1 United States
Discussion of regulatory policy for products of biotechnology in the United States started
relatively early. As mentioned above, the Office of Science and Technology Policy
(OSTP), recognizing that potential risks and regulatory expertise were distributed across
several bureaucracies, developed a coordinated framework to assign responsibilities to
those relevant agencies (OSTP 1986). Within this,regulated articles(as they are called)
were assigned to the different agencies according to their intended use, but also recogniz-
ing that some articles—and, in practice, most—were captured for regulation by more than
one agency. As a result, FDA was given primary responsibility for regulating risks to food
and feed, EPA to regulating products with pesticidal properties, and USDA to biotechno-
logically derived plants with potential to become agricultural pests. In many cases, all
three agencies evaluate a product; for example, a food crop with rDNA-mediated novel
herbicide resistance would trigger review by USDA for plant pest potential, EPA for
the new herbicide aspects, and FDA for any changes to the quality of the derived food
and feed.
Other products, for example, an ornamental (nonfood/feed) plant with an altered flower
color, might avoid regulatory review by EPA and FDA, but will be captured by USDA. In
fact, to date all rDNA plants seeking deregulation were captured and regulated by USDA.
All commercialized rDNA-derived food crops were also reviewed by FDA, even though the
food itself was unchanged and thus the FDA assessment was considered “voluntary” (much
to the dismay of some, who believe that FDA should regulate all biotech products as a
mandatory exercise).
The United States conducts regular evaluations of its own regulatory procedures, to
ensure that the regulators remain aware of the most recent developments in the technology,
and may adapt regulatory procedures to account for those developments. The scientific
foundations are often reviewed by committees (“panels”) of the National Research
Council under the administration of the National Academies of Science. Administrative
procedures are also frequently reviewed, usually involving solicitation of public input
and suggestions for improvement. In addition, public input is sought at several stages of
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