Section 16-250-095. Drug and feed additive requirements.

Before the department approves a label for commercial feed that contains additives (including drugs, other special purpose additives, or nonnutritive additives), the distributor may be required to submit evidence satisfactory to the department proving the safety and effectiveness of the commercial feed when used according to the directions on the label.

Satisfactory evidence of the safety and effectiveness of a commercial feed that contains additives (including drugs, other special purpose additives, or nonnutritive additives) is established if one or more of the following apply:

(1) When the use of a commercial feed containing such additives either:

(a) Conforms to the requirements of the applicable regulation in 21 C.F.R.; or

(b) Are "prior sanctioned"; or

(c) Are "informal review sanctioned"; or

(d) "Generally recognized as safe" (GRAS) for such use.

(2) When the commercial feed is itself a drug, and

(a) Is generally recognized as safe (GRAS) and effective for the labeled use; or

(b) Is marketed subject to an application approved by the Food and Drug Administration under 21 U.S.C. 360b as amended effective on the date these rules were adopted.

(3) When one purpose for feeding a commercial feed is to immunize through some immunological process and the immunizing drugs or additives have been approved for the purpose through the Federal Virus, Serum and Toxins Act of 1913, as amended in 1985 (21 U.S.C. 151 et seq.).

(4) When the commercial feed is a directly fed microbial product and the:

(a) Product meets the particular fermentation product definition as defined in the Association of American Feed Control Officials official publication; and

(b) Required microbial content statement in the label is limited to the following: "Contains a source of live (viable) naturally occurring microorganisms"; and

(c) Source is stated with a corresponding guarantee expressed according to WAC 16-250-076 requirements.

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

(a) Product meets the particular enzyme definition in the Association of American Feed Control Officials official publication; and

(b) Enzyme is stated with a corresponding guarantee expressed according to WAC 16-250-076 requirements.

[Statutory Authority: Chapters 15.53 and 34.05 RCW. WSR 05-18-094, § 16-250-095, filed 9/7/05, effective 10/8/05; WSR 03-23-128, § 16-250-095, filed 11/19/03, effective 7/1/04.]

Chapters 15.53 and 34.05 RCW. WSR 05-18-094, § 16-250-095, filed 9/7/05, effective 10/8/05; WSR 03-23-128, § 16-250-095, filed 11/19/03, effective 7/1/04.

Rules

16-250-076,16-250-076,