Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T96-68                                        Arthur Whitmore
October 7, 1996                               (202) 205-4144
     We have been receiving inquiries regarding the safety
of Monsanto Corp.'s soybean variety genetically engineered for
resistance to the herbicide glyphosate and Ciba-Geigy Corp.'s
corn variety genetically engineered for resistance to the
European corn borer.  Both companies consulted with FDA prior to
marketing their product, and the agency found no reason to
suspect that the products are unsafe for use in animal or human
food products.  The following may be useful for answering
     FDA requests developers of genetically engineered plant
varieties to submit summaries of nutritional and safety data on
the new varieties for review by the agency to ensure that
relevant scientific and safety issues are resolved before the
products are marketed.
     This request and agency review is consistent with FDA policy
guidelines on new plant varieties issued in 1992.  The 1992
policy is based on existing food law and requires that
genetically engineered foods meet the same rigorous safety
standards required for all other foods.  The law places a
responsibility on producers and sellers to offer only safe food
products to consumers.
     Federal food law requires premarket approval for food
additives, whether or not they are the products of biotechnology.
FDA treats substances added to food products through recombinant
DNA techniques as food additives if they are significantly
different in structure, function or amount than substances
currently found in food.
     However, if a new food product developed through
biotechnology does not contain substances that are significantly
different from those already in the diet, it does not require
premarket approval.  Products that are genetically engineered to
provide pesticide traits, such as resistance to the corn borer,
are also subject to regulation by the Environmental Protection
      Monsanto initiated consultations with FDA about its new
herbicide-tolerant soybean variety in June 1993.  Ciba-Geigy
initiated consultations with FDA about its new corn-borer
resistant corn variety in March 1995.
      For both products, FDA biotechnology teams reviewed
summary data and discussed scientific issues with company
officials.  The FDA teams included experts in chemistry,
molecular biology, toxicology, human and animal nutrition,
environmental science and the regulation of food ingredients.
Data presented by the companies addressed intended use,
mechanisms of intended effect, molecular alterations, safety,
composition and wholesomeness.
     Based on the data, FDA has found no basis to disagree with
the developers' determinations that neither product was
significantly altered from varieties of soy and corn with a
history of safe use, and that both products are safe for
introduction into the marketplace.  The agency has received no
additional data that would cast doubt on that assessment.

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