15 
The division of regulatory powers between the FDA and 
the Department of Agriculture (e.g., Animal and Plant Health 
Inspection Service, APHIS) is not entirely clear in regard to 
the development of new plant strains, animal biologies, and 
drugs developed through modern genetics. For example, the FDA's 
Bureau of Foods would become involved it crown gall tumor viral 
genes were used to transform plants and code for nitrogen 
fixation. This Bureau would determine whether the tumor genes 
also produced a toxin of any kind that would be present in the 
edible tissues of the plant. APHIS would be involved only if 
such a nitrogen-fixing plant should become a carrier of a plant 
disease. 
Products that may be manufactured using rDNA 
techniques include food additives. The Bureau of Foods requires 
pre-market review of all food additives which are defined as 
substances that, through their intended use, can become a 
component of food or otherwise affect the charac t er ist ics of 
food. The Delaney Clause prohibits the use of any food additive 
that has been shown to induce cancer when ingested in man or 
animal . 
The Bureau of Medical Devices reviews products defined 
as any health care product that does not achieve its purpose by 
chemical action in or on the body or by being metabolized. 
Diagnostic kits are classified as medical devices and might 
include products of genetic technology. They would require 
approval for safety and ef f ect i veness before they could be 
marketed . 
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