12 KAR 3:037.
RELATES TO: KRS
250.501, 250.511, 250.541(1)(a), (b), (c), (d), (e), (f), (j), (2)(c), (d),
(e), 21 C.F.R. Parts 70, 71, 73, 74, 80, 81, 82, 501.22, 570.3(1), 570.30, 582,
21 U.S.C. 360(b)
AND CONFORMITY: KRS 250.571(1) authorizes the Director of the Agricultural
Experiment Station to promulgate administrative regulations necessary for
efficient enforcement of KRS 250.491 to 250.631. KRS 250.541 defines
adulterated commercial feeds and states how they may be adulterated by
additives. KRS 250.551(1) and (2) prohibits the manufacturing and distribution
of adulterated products as animal feeds. This administrative regulation
establishes requirements to ensure that a drug or additive used in pet food is
safe and effective for its intended purpose.
Section 1. An
artificial color may be used in a pet food if it has been shown to be harmless
to pets. The permanent or provisional listing of an artificial color in 21 CFR
Part 70, 71, 73, 74, 80, 81, or 82, or 501.22 as safe for use, together with
the conditions, limitations, and tolerances, if any, shall be satisfactory
evidence that the color is harmless to pets.
Section 2. Before
approval of a label and a registration application, the distributor of a pet
food, containing an additive including a drug, another special purpose
additive, or a nonnutritive additive shall, upon request of the director,
submit evidence to prove the safety and efficacy of the pet food if used
according to label directions. Satisfactory evidence of the safety and efficacy
of a pet food shall be:
(1) If the pet food
contains an additive that conforms to 21 CFR 570.3(1), 570.30, or Part 582; or
(2) If the pet food
is a drug as defined in KRS 250.501(7) and is generally recognized by the Food
and Drug Administration as safe and effective for its labeled use or is
marketed subject to an application approved by the Food and Drug Administration
under 21 USC 360(b).
Section 3. The
medicated labeling format recommended by the Association of American Feed
Control Officials in its Official Publication shall be used to insure that
adequate labeling is provided.
Incorporation by Reference. (1) "Official Publication", (1998
Edition), Association of American Feed Control Officials, is incorporated by
(2) This material
may be inspected, copied, or obtained at the Division of Regulatory Services,
103 Regulatory Services Building, College of Agriculture, University of
Kentucky, Lexington, Kentucky 40546-0275, Monday through Friday, 8 a.m. to 4:30
p.m. (AES-2 (1973)-PF 7; 1 Ky.R. 1003; eff. 6-11-75; Am. 23 Ky.R. 1618; eff.
1-10-97; 25 Ky.R. 900; 2364; eff. 4-14-99.)