Kentucky Administrative Regulations › Title 12 - AGRICULTURAL EXPERIMENT STATION › Chapter 2 - Commercial Feeds › Section 12 KAR 2:041 - Drug and Feed Additives

Current through Register Vol. 51, No. 1, July 1, 2024
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. 570.3(1),
				570.30,
				582,
				21
				U.S.C. 151-158,
				360(b)
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
				250.491 to
				250.631 regarding
				commercial feeds.
				KRS
				250.541 provides that a commercial feed or a
				material exempted from the definition of commercial feed shall be considered
				adulterated if it meets the conditions established in
				KRS
				250.541.
				KRS 250.551(1) and
				(2) prohibit the manufacture or distribution
				of an adulterated product as animal feed. This administrative regulation
				establishes the requirements to ensure the safe and effective use of commercial
				feeds containing 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 when 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) When the commercial feed
			 contains such additives, the use of which conforms to the requirements of the
			 applicable regulation in Title 21, Code of Federal Regulations, or which are
			 "prior sanctioned" or "informal review sanctioned" or "generally recognized as
			 safe" for such use;
(2) A
			 commercial feed that 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 Section 512 of the Federal Food, Drug, and Cosmetic
			 Act;
(3) When one (1) of the
			 purposes for a commercial feed is to impart immunity (that is to act through
			 some immunological process) the constituents imparting immunity have been
			 approved for the purpose through the Federal Virus, Serum and Toxins Act of
			 1913 as amended;
(4) When the
			 commercial feed is a direct-fed microbial product and:
(a) The product is defined as a fermentation
			 product in the Official Publication of the Association of American Feed Control
			 Officials; and
(b) The microbial
			 content statement:
1. Appears on the label;
			 and
2. States "Contains a source of
			 live (viable), naturally occurring microorganisms"; and
3. The source is stated with a corresponding
			 guarantee expressed in accordance with
			 12 KAR
			 2:021, Section 7; or
(5) When the commercial feed is an enzyme
			 product and is:
(a) Defined as an enzyme in
			 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.