1. (a) In order to distribute a commercial feed which contains additives (including drugs, other special purpose additives, or nonnutritive additives) the distributor 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.

2. (b) Satisfactory evidence of safety and efficacy of a commercial feed may be:

   1. (1) When the commercial feed contains such additives, the use of which conforms to the requirements of the applicable regulation in the Code of Federal Regulations, Title 21, or which are "prior sanctioned" or "informal review sanctioned" or "generally recognized as safe" for such use;
   2. (2) When the commercial feed is itself a drug as defined in Section 3(h) of Acts 1997, No. 726, and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the United States Food and Drug Administration under Section 512 of the Federal Food, Drug and Cosmetic Act; or
   3. (3) When one 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 the purpose through the Federal Virus, Serum, and Toxins Act of 1913, as amended;

   4. (4) When the commercial feed is a direct fed microbial product, and the:

      1. (A) Product meets the particular fermentation product definition;
      2. (B)

3. (i) Microbial content statement, as expressed in the labeling, is limited to the following: "Contains as source of live (viable) naturally occurring microorganisms".

   1. (ii) This statement shall appear on the label; and

      1. (C) Source is stated with a corresponding guarantee expressed in accordance with 2 CAR § 25-104(g); and

   2. (5) When the commercial feed is an enzyme product and the:

      1. (A) Product meets the particular enzyme definition defined by AAFCO; and
      2. (B) Enzyme is stated with a corresponding guarantee expressed in accordance with 2 CAR § 25-104(h).

Codification Notes: Section 512 of the Federal Food, Drug, and Cosmetic Act referred to in this section is codified at 21 U.S.C. § 360b. The Federal Virus, Serum, and Toxins Act of 1913, as amended, referred to in this section is codified at 21 U.S.C. §§ 151–158.