Food for human consumption and animal drugs, feeds, and related products:
Foods derived from new plant varieties; policy statement, 22984
Vol. 57 No. 104 Friday, May 29, 1992 p 22984 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 92N-0139] Statement of Policy: Foods Derived From New Plant Varieties Agency: Food and Drug Administration, HHS.
Summary: The Food and Drug Administration (FDA) is issuing a policy statement on foods derived from new plant varieties, including plants developed by recombinant deoxyribonucleic acid (DNA) techniques. This policy statement is a clarification of FDA's interpretation of the Federal Food, Drug, and Cosmetic Act (the act), with respect to new technologies to produce foods, and reflects FDA's current judgment based on new plant varieties now under development in agricultural research. This action is being taken to ensure that relevant scientific, safety, and regulatory issues are resolved prior to the introduction of such products into the marketplace. Dates: Written comments by August 27, 1992.
E. Allergenicity All food allergens are proteins. However, only a small fraction of the thousands of proteins in the diet have been found to be food allergens. FDA's principal concern regarding allergencity is that proteins transferred from one food source to another, as is possible with recombinant DNA and protoplast fusion techniques, might confer on food from the host plant the allergenic properties of food from the donor plant. Thus, for example, the introduction of a gene that encodes a peanut allergen into corn might make that variety of corn newly allergenic to people ordinarily allergic to peanuts. Examples of foods that commonly cause an allergenic response are milk, eggs, fish, crustacea, molluscs, tree nuts, wheat, and legumes (particularly peanuts and soybeans). The sensitive population is ordinarily able to identify and avoid the offending food. However, if the allergen were moved into a variety of a plant species that never before produced that allergen, the susceptible population would not know to avoid food from that variety.