Drug and feed additives

1. Prior to approval of a registration application or approval of a label, or both, for commercial feed which contain additives (including drugs, other special purpose additives, or nonnutritive additives) the distributor may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label. 2. Satisfactory evidence of safety and efficacy of a commercial feed may be: a. When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in title 21 of the Code of Federal Regulations or which are "prior sanctioned" or "informal review sanctioned" or "generally recognized as safe" for such use; b. When the commercial feed is itself a drug and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the food and drug administration under 21 U.S.C. 360(b); or c. When one of the purposes for feeding a commercial feed is to impart immunity (that is to act through some immunological process) the constituents imparting immunity have been approved for the purpose through the Federal Virus, Serum and Toxins Act of 1913, administered by the animal and plant health inspection service, United States department of agriculture. The reason for the amendment is because of a problem encountered by feed control officials in developing the basis for evaluation of such products that have a primary purpose to impart immunity. States, in many cases, are unable to make correct judgments on the effectiveness on such products. The committee feels that this will definitely have more uniformity and effectiveness in handling product registrations.