Agriculture Reference
In-Depth Information
National Research Council report explicitly supported the Coordinated Framework's
product-based approach, and the dominance of this scheme hampered the EPA's effort
to introduce a more comprehensive, process-based approach (Jasanoff 1995).
As the prospects of commercially viable GM crops grew imminent in the early 1990s,
the government maintained the Coordinated Framework, making adjustments that fur-
ther strengthened its product-oriented approach and weakened the distinction between
GM and conventional food. In particular, a 1992 Food and Drug Administration (FDA)
policy statement was significant in establishing that, as a rule, GM crops would be given
“generally recognized as safe (GRAS)” status and subject to no special rules or additional
testing. The statement upheld the “substantial equivalence” doctrine posited by the
Organisation for Economic Co-operation and Development (OECD) and maintained
that GM food, as a category, did not present different or greater safety concerns than
conventional food.11 No labeling would be required unless GM food contained safety
risks such as known allergens. Safety assessments were not mandatory: the responsi-
bility of safety testing was left with the manufacturer of the product, who could con-
sult with the FDA about the product on a voluntary basis. Prior to the statement, some
within the FDA had called for a mandatory safety assessment of each new GM food
product for possible novel toxins produced from genetic modification. However, under
the heavy influence from a White House keen on economic competitiveness, the agency
concluded that such procedures would be too costly and onerous for this promising
new technology (Pelletier 2005, 2006; Pringle 2003; Kurt et al. 2001). This development
prompted Rifkin to renew his efforts and launch the Pure Food Campaign, together
with organic farmers, environmentalists, and consumer activists, to call for mandatory
labeling of, and ultimately a moratorium on, all GM food.
GM products entered American food chains as the FDA began approving them in
1993, but not without contention. When the agency approved Monsanto's recombi-
nant bovine growth hormone (rBGH), intended to increase milk production, opposi-
tion emerged for various reasons beyond its safety concerns, such as its effects on small
farmers unlikely to benefit from it and on the welfare of dairy cows (Jassanoff 2005).
Responding to a demand for labeling of rBGH milk, the FDA argued that labeling
should be about special health risks, which it did not recognize in rBGH, and it even
insisted that labels could mislead consumers to believe that there was any reason for
concern. In the context of the product-oriented, risk-centered policy framework, advo-
cates and opponents resorted to scientific evidence in debating whether rBGH was
harmful for human and animal health or merited a distinction from BGH, but the FDA
considered issues other than human consumption risks to be beyond its regulatory
jurisdiction (Jassanoff 2005).
The first GM crop, Flavr Savr tomatoes—engineered to have a longer shelf life—was
approved in May 1994 after three years of assessment that involved a public hearing and
intense exchange between the FDA and the Californian developer Calgene, even though
such an extensive review was not officially required (Pringle 2001; Martineau 2001). In
1994 and 1995, the FDA approved a number of GM crops, including corn, soybeans,
potatoes, and canola, many of which contained pesticide and/or herbicide-resistant
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