Drug and Pet Food Additives

PURPOSE: This rules sets limits on the additives that may be used. Editor’s Note: The following material is incorporated into this rule by reference: 1) Office of the Federal Register National Archives and Records Administration, Code of Federal Regulations Title 21 (Washington: U.S. Government Printing Office, 1995); and 2) Office of the Law Revision Counsel of the House of Representatives, U.S. Code Title 21, 360(b) (Washington: U.S. Government Printing Office, 1995). In accordance with section 536.031(4), RSMo, the full text of material incorporated by reference will be made available to any interested person at the Office of the Secretary of State and the headquarters of the adopting state agency. (1) An artificial color may be used in a pet food only if it has been shown to be harmless to pets. The permanent or provisional listing of an artificial color in the United States Food and Drug Regulations, 2 CSR 70-30.085, as safe for use, together with the conditions, limitations, and tolerances, if any, incorporated therein, shall be deemed to be satisfactory evidence that the color is, when used pursuant to these regulations, harmless to pets. (2) Prior to approval of a registration application and/or approval of a label for pet food, which contains 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 pet food, when used according to directions furnished on the label. Satisfactory evidence of the safety and efficacy of a pet food may be— (A) When the pet food contains these additives, the use of which conforms to the requirements of the applicable regulation in the Code of Federal Regulations, Title 21, 2 CSR 70-30.085, or which are “prior sanctioned” or “Generally Recognized As Safe” for such use; or (B) When the pet food itself is a drug as defined in section 266.160(7), RSMo and is generally recognized as safe and effective for label use or is marketed subject to an application approved by the Food and Drug Administration under Title 21, U.S.C. 360(b) 2 CSR 70-30.085; and (C) The medicated labeling format recommended by the Association of American Feed Control Officials, 2 CSR 70-30.020 shall be used to assure that adequate labeling is provided. AUTHORITY: section 266.195, RSMo (1994).* Original rule filed Jan. 16, 1975, effective Feb. 1, 1975. Amended: Filed Sept. 15, 1976, effective Dec. 11, 1976. Amended: Filed May 13, 1986, effective Sept. 1, 1986. Amended: Filed Oct. 20, 1995, effective June 30, 1996. *Original authority 1972 amended 1993, 1995.