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OCR Page 1 of 35DRAFT September 8, 1999
LABELING OF FOODS DERIVED FROM CROPS DERIVED THROUGH GENETIC
ENGINEERING: DOMESTIC AND INTERNATIONAL IMPLICATIONS
Consumer concern in some countries and regions, especially in the European Union (EU), has
resulted in major trade issues for U.S. firms that export agricultural products, particularly corn and
soybean. For example, last year shipments of corn products were refused in Europe due to the
possibility that the products might contain some amount of (or be "contaminated" with)
bioengineered material. Approvals of new bioengineered agricultural products in Europe have
been stalled since March 1998.
This paper summarizes the Food and Drug Administration's (FDA) responsibility for food safety
and labeling requirements in the U.S., explains why the U.S. had not required special labeling for
bioengineered foods and food ingredients, discusses the safety and labeling requirements of other
countries for bioengineered foods and food ingredients, and highlights some of the complex issues,
domestic and international, for considering special labeling requirements for these products.
U.S. Food Safety and Labeling Requirements: Foods Derived from Crops
FDA is the agency charged under the Federal Food, Drug, and Cosmetic Act (FDCA) with the
responsibility for overseeing the safety and labeling of prepackaged food and feed products,
domestic and imported, that are derived from crops. FDA has established comprehensive scientific
guidance for producers to assist them in meeting their legal duty to ensure the safety of the foods
they market, and firms have consulted with FDA on safety and labeling issues regarding over forty
bioengineered food and feed products. In general, special labeling has not been required because
the products do not exhibit substantial differences from conventional food and feed products. Two
of these products, high oleic soybean oil and laurate canola, were given new common/usual names
because the products differ substantially in composition and use in food.
Labeling includes the information contained on the package label and any accompanying
informational material. The FDCA requires that labeling be truthful and not misleading and that
the label bear the "common or usual" name of the food (e.g., potato). If the food product is
fabricated from two or more ingredients, the ingredients must be listed in descending order of
predominance. The FDCA also specifies certain other information that must be included in
labeling. Labeling must reveal information that is material to representations made or implied
about the food or information that is material to consequences for the consumer that may arise
from consuming the food.
As is the case for other foods, the labeling of a bioengineered food product must comply with all
requirements of the FDCA. For example, substantial changes in composition, nutritional value, or
new requirements for storage, preparation, or cooking or the presence of a new allergen must be
disclosed in food labeling.
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