12 KAR 3:037.

Additives.

 

      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)

      STATUTORY AUTHORITY:

KRS 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

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.

 

      Section 4.

Incorporation by Reference. (1) "Official Publication", (1998

Edition), Association of American Feed Control Officials, is incorporated by

reference.

      (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.)