Title 012 | Chapter 002 | Regulation 041REG
PROPOSED
This document is not yet current.
PREVIOUS VERSION
The previous document that this document is based upon is available.
AGRICULTURAL EXPERIMENT STATION
(Amended at ARRS Committee)
12 KAR 2:041.Drug and feed additives.
Section 1.
Before approval of a registration application or approval of a label for a commercial feed containing an additive, including a drug, another special purpose additive, or non-nutritive additive, the distributor shall, upon request by the director, submit evidence to prove the safe and effective use of the commercial feed ifSection 2.
Satisfactory evidence of safe and effective use of a commercial feed shall be one (1) of the following:(1)
(2)
(3)
(4)
(a)
The product is defined as a "fermentation product" in the Official Publication of the Association of American Feed Control Officials, incorporated by reference in 12 KAR 2:006; and(b)
The microbial content statement:1.
Appears on the label;2.
States "Contains a source of live (viable), naturally occurring microorganisms"; and3.
includes the source(5)
If(a)
Defined as an "enzyme" by(b)
Guaranteed according to the provisions of 12 KAR 2:021, Section 8.Section 3.
(1)
(2)
FILED WITH LRC: March 9, 2026
CONTACT PERSON: G. Alan Harrison, Feed & Milk Director, University of Kentucky Division of Regulatory Services, 103 Regulatory Services Building, Lexington, Kentucky 40546, phone (859) 257-2785, fax (859) 323-9931, email alan.harrison@uky.edu.
AGRICULTURAL EXPERIMENT STATION
(Amended at ARRS Committee)
12 KAR 2:041.Drug and feed additives.
Section 1.
Before approval of a registration application or approval of a label for a commercial feed containing an additive, including a drug, another special purpose additive, or non-nutritive additive, the distributor shall, upon request by the director, submit evidence to prove the safe and effective use of the commercial feed if used according to the directions furnished on the label.Section 2.
Satisfactory evidence of safe and effective use of a commercial feed shall be one (1) of the following:(1)
Commercial feed that contains additives, the use of which conforms to the requirements of the applicable regulation in Title 21, Code of Federal Regulations, or that are "prior sanctioned,""informal review sanctioned," or "generally recognized as safe" for use;(2)
Commercial feed that is a drug as defined by 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 pursuant to an application approved by the Food and Drug Administration under 21 U.S.C. 360b;(3)
Commercial feed, one (1) purpose of which is to impart immunity (that is to act through some immunological process) if the constituents imparting immunity have been approved for the purpose under 21 U.S.C. 151 – 159;(4)
Commercial feed that is a direct-fed microbial product if:(a)
The product is defined as a "fermentation product" in the Official Publication of the Association of American Feed Control Officials, incorporated by reference in 12 KAR 2:006; and(b)
The microbial content statement:1.
Appears on the label;2.
States "Contains a source of live (viable), naturally occurring microorganisms"; and3.
includes the source stated with a corresponding guarantee expressed in accordance with 12 KAR 2:021, Section 7; or(5)
If the commercial feed is an enzyme product and is:(a)
Defined as an "enzyme" by the Official Publication of the Association of American Feed Control Officials; and(b)
Guaranteed according to the provisions of 12 KAR 2:021, Section 8.FILED WITH LRC: March 9, 2026
CONTACT PERSON: G. Alan Harrison, Feed & Milk Director, University of Kentucky Division of Regulatory Services, 103 Regulatory Services Building, Lexington, Kentucky 40546, phone (859) 257-2785, fax (859) 323-9931, email alan.harrison@uky.edu.