WAC 246-215-02320. Hands and arms — Hand antiseptics (FDA Food Code 2-301.16)

(1) A hand antiseptic used as a topical application, hand antiseptic solution used as a hand dip, or a hand antiseptic soap must: (a) Comply with one of the following: (i) Be an approved drug that is listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness; or (ii) Have active antimicrobial ingredients that are listed in the FDA monograph for OTC Health-Care Antiseptic Drug Products as an antiseptic handwash; and (b) Consist only of components which the intended use of each complies with one of the following: (i) A threshold of regulation exemption under 21 C.F.R. 170.39 – Threshold of Regulation for Substances Used in Food Contact Articles; or (ii) 21 C.F.R. 178 – Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers as regulated for use as a food additive with conditions of safe use; or (iii) A determination of generally recognized as safe (GRAS). Partial listings of substances with food uses that are gras may be found in 21 C.F.R. 182 – Substances Generally Recognized as Safe, 21 C.F.R. 184 – Direct Food Substances Affirmed as Generally Recognized as Safe, or 21 C.F.R. 186 – Indirect Food Substances Affirmed as Generally Recognized as Safe for use in contact with food , and in FDA's Inventory of gras Notices; or (iv) A prior sanction listed under 21 C.F.R. 181 – Prior Sanctioned Food ingredients; or (v) A food Contact Notification that is effective; and (c) Be applied only to hands that are cleaned as specified under WAC 246-215-02305 . (2) If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the requirements specified under subsection (1)(b) of this section, use must be: (a) Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; or (b) Limited to situations that involve no direct contact with food by the bare hands. (3) A hand antiseptic solution used as a hand dip must be maintained clean and at a strength equivalent to at least 100 mg /L chlorine.