W. Va. Code R. § 61-5-13 - Drug and Feed Additives

13.1. The Commissioner may require a distributor to submit evidence to prove the safety and efficacy of a commercial feed when used according to the directions furnished on the label, before granting approval of a registration application and/or approval of a label for commercial feed which contain additives (including drugs, other special purpose additives, or non-nutritive additives).

13.2. Satisfactory evidence of safety and efficacy of a commercial feed may be:

13.2.a. When the commercial feed contains 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 that use;

13.2.b. When the commercial feed is itself a drug defined in W. Va. Code § 19-14-2(j) and is generally recognized as safe and effective for the labeled use or is marketed subject to an application approved by the Food and Drug Administration under Title 21 U.S.C. 360 b;

13.2.c. 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 Toxin Act of 1913, as amended;

13.2.d. When the commercial feed is a direct fed microbial product and:

13.2.d.1. The product meets the particular fermentation product definition;

13.2.d.2. The microbial content statement, as expressed in the labeling, is limited to the following: "Contains a source of live (viable) naturally occurring microorganisms." This statement shall appear on the label; and

13.2.d.3. The source is stated with a corresponding guarantee expressed in accordance with subsection 8.7 of this rule; and

13.2.e. When the commercial feed is an enzyme product and;

13.2.e.1. The product meets the particular enzyme definition defined by the Association of American Feed Control Officials; and

13.2.e.2. The enzyme is stated with a corresponding guarantee expressed in accordance with subsection 8.8 of this rule.

Notes

W. Va. Code R. § 61-5-13