Agriculture Reference
In-Depth Information
ensure quality control. Thus, the drug evaluation branch of the agency
must review new vaccines and other drugs derived in whole or part from
GM crops designed for this nonfood purpose. Food product companies
and food retailers have expressed great anxiety that GM drug-producing
crops could contaminate both GM and non-GM food crops intended for
human consumption, as in the Prodigene incident previously mentioned,
and threaten consumer health and the food system. Although medicinal
or industrial GM crops do not fall under the authority of the agency's
food review branch, the seriousness of the threats they pose have caused
the agency to work more closely with APHIS and EPA on how to iden-
tify, prevent, and respond to such contamination.
To return to GM foods, FDA claims it lacks authority to carry out
postmarket examination of food company records for evidence of food-
caused harms, or to order recalls of unsafe foods. Thus, it has not car-
ried out systematic postmarket oversight of GM foods and looks to
APHIS for addressing postmarket contamination issues.
44
However, the
StarLink Corn incident illustrates how postmarket contamination has
implications for FDA. The pesticidal corn had been found in taco shells,
a consumer food product. Because EPA had approved the corn for use as
animal feed but not for human food because of its suspected human aller-
genic potential, EPA enforcement and sanctions followed in due course.
In addition, the presence of the corn in human food caused the food to
be “adulterated” and prompted enforcement action by FDA as well.
The StarLink case is discussed again later in this chapter for its lia-
bility implications. Briefly here, the incident was followed by lawsuits
brought by growers of conventional crops against Aventis, the maker and
seller of the StarLink seed. These growers claimed that prices for their
crops had fallen and contracts for their crops had been cancelled because
customers suspected that the conventional crops they had ordered were
contaminated. Aventis eventually negotiated an out-of-court settlement
44
Michael Taylor & Jody Tick, Pew Foundation, Post-Market Oversight of Biotech
Foods-Is the System Prepared? (2003).
