Drugs and Feed Additives
(1)Prior to approval of a registration application and /or approval of a label for commercial feed which contains additives (including drugs, other special purpose additives, or non-nutritive additives) the distributor may be required to submit evidence to prove safety and efficacy of the commercial feed when used according to the directions furnished on the label. Satisfactory evidence to prove safety and efficacy of a commercial feed may include:
(a)When the commercial feed contains such additives, the use of the additive conforms to the requirements of the applicable regulation in the Code of Federal Regulations, Title 21 effective as of the date these rules are promulgated, or which are “prior sanctioned” or “informal review sanctioned” or “generally recognized as safe” for such intended use, or
(b)When the commercial feed is itself a new animal drug as defined in Code of Federal Regulations, Title 21, Part 510.3 (g) effective as of the date these rules are promulgated and is generally recognized as safe and effective for the labeled use or is marketed subject to an application conditionally approved by the Food and Drug Administration under Sec. 512 [21 U.S.C. 360 b] of the Federal Food, Drug, and Cosmetic Act, or
(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 Toxins Act of 1913, or
(d)When the commercial feed is a direct fed microbial product and:
(i)The product meets the particular fermentation product definition, and
(ii)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
(iii)The source is stated with a corresponding guarantee expressed in accordance with OAR 603-508-0140(7).
(e)When the commercial feed is an enzyme product and:
(i)The product meets the particular enzyme definition defined by the 2011 edition of the official publication of the Association of American Feed Control Officials, and
(ii)The enzyme activity is stated with a corresponding guarantee expressed in accordance with OAR 603-058-0140 (Expression of Guarantees)(8).
Rule 603-058-0190 — Drugs and Feed Additives,