12 KAR 2:031. Directions and precautionary statements for feed containing additives.


      RELATES TO: KRS 250.501, 250.531, 250.551(1), (2), 21 C.F.R. 225.80, 225.180

      STATUTORY AUTHORITY: KRS 250.521(2)(e), (f), 250.571(1)

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural Experiment Station to promulgate administrative regulations necessary for the efficient enforcement of KRS 250.490 to 250.631. This administrative regulation requires that directions for feeding and precautionary statements be provided with feed containing additives to ensure safe and effective use of the product.


      Section 1. Directions for use and precautionary statements on the labeling of a commercial feed and customer-formula feed containing an additive, such as a drug, a special purpose additive, or nonnutritive additive shall:

      (1) Be stated in a manner that informs of the safe and effective use of the product for its intended purpose; and

      (2) Include all information prescribed by:

      (a) Applicable federal regulations under the Federal Food, Drug and Cosmetic Act, which is codified as 21 USC 301 to 397; and

      (b) 12 KAR 2:036, for feed containing nonprotein nitrogen.


      Section 2. Adequate directions and precautionary statements necessary for safe and effective use shall be placed on commercial feeds distributed to supply particular dietary needs or for supplementing or fortifying the usual diet or ration with a vitamin, mineral, or other dietary nutrient or compound. (AES-2 (1973)-6; 1 Ky.R. 1000; eff. 6-11-75; Am. 25 Ky.R. 892; 2355; eff. 4-14-99.)