Over 2,000 tolerances have been established, considering the different levels and 
the various crops, involving over 100 pesticide chemicals. 
The Food Additive Amendment enacted in September 1958 became fully effective 
on March 6, 1960. The term ‘‘food additive’’ means: Any substance the intended use of 
which results--or may be expected to result--in its becoming a component or otherwise 
affecting the characteristics of any food-- 
IF such substance is not generally recognized by experts qualified by scientific training 
and experience as having been shown through scientific procedures to be safe (or 
re substances used prior to January 1, 1958, through either scientific procedures 
or experience based upon common use in food). 
It does not include pesticide chemicals on raw agricultural commodities (they 
are regulated under the Pesticide Amendment) nor does it include substances which 
enjoy prior sanctions under the Food, Drug, and Cosmetic Act, Poultry Products 
Inspection Act, and Meat Inspection Act. 
The term ‘‘food additive’’ does, however, include any substance intended for 
use in producing, manufacturing, packing, processing, preparing, treating, packaging, 
transporting, or holding, and, any source of radiation intended for any such use. 
Uses of chemicals in the treatment of manufactured or semimanufactured agricultural 
products--such as dried fruits; prepared feeds; packaging materials for dairy products; 
applications to food animals that might place residues in food products--are examples 
of applications in agriculture that may call for regulations under the Food Additive 
Amendment. 
The procedure for obtaining a Food Additive regulation is similar to that fora 
pesticide tolerance. There is, however, no provision for review by an advisory com- 
mittee and the time for evaluation of a proposal can be extended an additional 90 days, 
if necessary. The amendment contains these significant directives: If a tolerance is 
required to assure safety: 
1. It shall not be at a level higher than reasonably required to accomplish the 
physical or other technical effect intended; and 
2. Regulation shall not be established if data do not establish that the use would 
accomplish intended effect. 
No regulation shall issue if the data: 
1. Fail to show that proposed use will be safe 
Proviso--(Delaney clause) No additive is deemed safe if found to induce cancer 
when ingested by man or animal, or if it is found, after tests which are appro- 
priate for the evaluation of the safety offood additives, to induce cancer in man 
or animal. 
2. Show that the proposed use would promote deception of consumers or otherwise 
result in adulteration or misbranding under this Act. 
There are two other sections of the Food, Drug, and Cosmetic Act on which I wish 
to make brief comment. One deals with antibiotics that are subject to certification, that 
is penicillin, streptomycin, chlortetracycline, chloramphenicol, and bacitracin, and 
derivatives. 
Batches of drugs containing these antibiotics are subject to certification. The 
regulations established under this provision of the law are intended to insure the safety 
and efficacy of use of these drugs. Many veterinary preparations for use in farm animals 
have been the subject of antibiotic regulations or exemptions. 
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