- (a) A commercial feed manufacturer that produces commercial feed that contains additives, such as drugs, other special purpose additives, or nonnutritive additives, may be required to submit evidence to prove the safety and efficacy of the commercial feed when used according to the directions furnished on the label.
(b) The following are satisfactory evidence of safety and efficacy of a commercial feed:
(1) When a commercial feed contains additives that comply with the applicable requirements of 21 CFR, or the additives are:
- (A) prior-sanctioned;
- (B) informally review-sanctioned; or
- (C) generally recognized as safe for that use.
(2) When a commercial feed is itself a drug as defined in section 6 of this chapter and is:
- (A) generally recognized as safe and effective for the labeled use; or
- (B) marketed subject to an application approved by the Food and Drug Administration under 21 U.S.C. 360(b).
- (3) When one (1) of the purposes for feeding a commercial feed is to impart immunity (that is to act through some immunological process) the constituents imparting immunity have been approved for that purpose through the federal Virus, Serum, and Toxin Act of 1913, as amended.
(4) When the commercial feed is a direct fed microbial product, including the following:
- (A) The product meets the particular fermentation product definition.
- (B) The microbial content statement, as expressed in the labeling, is limited to the statement, "Contains a source of live (viable) naturally occurring microorganisms.". This statement shall appear on the label.
- (C) The source is stated with a corresponding guarantee expressed in accordance with section 26.6 of this chapter.
(5) When the commercial feed is an enzyme product, including the following:
- (A) The product meets the particular enzyme definition defined by the Association of American Feed Control Officials.
- (B) The enzyme is stated with a corresponding guarantee expressed in accordance with section 26.6 of this chapter.
As added by P.L.16-2026, SEC.27.