News
05/26/1992

<TITLE>Biotechnology of New Foods that are Safe for Consumers</TITLE>
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P92-15                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Brad Stone - (202) 245-1144

    HHS Secretary Louis W. Sullivan, M.D., today announced a policy that      
will improve the variety of the U.S. food supply by promoting the             
development through biotechnology of new foods that are safe for consumers.
    The policy statement lays out a structure under which the Food and Drug   
Administration will regulate new varieties of whole foods developed through   
biotechnology by applying the same standards as for all other foods.
    Foods developed by biotechnology are not currently on the market, but     
companies are conducting extensive research in this area, and some of their   
products will soon be ready for commercialization.  Manufacturers have        
sought such a statement of how products would be regulated so that they know  
how to proceed.  FDA's development of this policy was expedited under the     
direction of the Biotechnology Working Group of the President's Council on    
Competitiveness.
    "These new technologies will benefit all Americans by providing foods     
that are tastier, more varied, more wholesome and that can be produced more   
efficiently," Dr. Sullivan said.  "The policy we are announcing today will    
ensure the safety of these foods while facilitating their availability as     
quickly as possible.
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                                          Page 2, P92-15, Food Biotech Policy
    "Fruits, vegetables and grains developed through biotechnology mark an    
evolutionary step in the production of new varieties.  They will give         
producers new tools through which to introduce improved traits in crops to    
benefit growers, processors and consumers." 
    "The American biotechnology industry leads the world in the development   
and application of recombinant DNA techniques," said FDA Commissioner David   
A. Kessler, M.D.  "We will soon see the same kinds of remarkable              
contributions to the food supply that the new biotechnology has brought to    
pharmaceuticals during the past decade.  This FDA policy is an example of     
this administration's commitment to both protect the public health and        
foster technological innovation," Dr. Kessler said.
    The policy, to be published soon in the Federal Register, describes the   
scientific basis for evaluating and ensuring the safety of new varieties of   
foods produced with any technique, including those of the new biotechnology,  
such as recombinant DNA or "gene splicing."  The scientific concepts          
described in the policy are consistent with those embodied in a food safety   
document about to be released by the Group of National Experts on Safety in   
Biotechnology of the Organization for Economic Cooperation and Development    
(OECD).  It also discusses the legal requirements for products that are to    
be marketed.
    The new biotechnology holds considerable promise for the development of   
new varieties of foods that are more palatable, more nutritious, or that      
possess other desirable traits.  The potential exists for many new or         
enhanced traits to be introduced -- for example, fruits and vegetables that   
are more resistant to cold or droughts, or that contain higher-quality        
protein.
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                                          Page 3, P92-15, Food Biotech Policy
    The Food, Drug, and Cosmetic Act requires producers to ensure that the    
foods they market are safe and allows FDA to take enforcement action against  
foods that may be injurious to health.  The act gives FDA authority to        
conduct pre-market review of new substances in food that raise concerns       
about safety or that under the act are food additives.
    FDA is one of the eight Public Health Service agencies within HHS.
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