Biotechnology > Statement of Policy - Foods Derived from New Plant Varieties

Biotechnology > Statement of Policy - Foods Derived from New Plant Varieties

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.