Section 2-301.16 - Hand Antiseptics(A) A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall: (1) Comply with one of the following: (a) 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; Pf or(b) Have active antimicrobial ingredients that are listed in the FDA monograph for Over The Counter Health-Care Antiseptic Drug Products as an antiseptic handwash; Pf and(2) Consist only of components which the intended use of each complies with one of the following: (a) A threshold of regulation exemption under 21 CFR 170.39 - Threshold of regulation for substances used in FOOD-contact articles; Pf or(b)21 CFR 178 -Indirect FOOD ADDITIVES: Adjuvants, Production Aids, and Sanitizers as regulated for use as a FOOD ADDITIVE with conditions of safe use, Pf or(c) A determination of generally recognized as safe (GRAS). Partial listings of substances with FOOD uses that are GRAS may be found in 21 CFR 182 -Substances Generally Recognized as Safe, 21 CFR 184 -Direct FOOD Substances Affirmed as Generally Recognized as Safe, or 21 CFR 186 - Indirect FOOD Substances Affirmed as Generally Recognized as Safe for use in contact with FOOD, and in FDA's Inventory of GRAS Notices, Pf or(d) A prior sanction listed under 21 CFR 181 - Prior Sanctioned FOOD Ingredients, Pf or(e) A FOOD Contact Notification that is effective, Pf and(3) Be applied only to hands that are cleaned as specified under § 2-301.12. Pf(B) If a hand antiseptic or a chemical hand antiseptic solution used as a hand dip does not meet the criteria specified under Subparagraph (A) (2) of this section, use shall be: (1) Followed by thorough hand rinsing in clean water before hand contact with FOOD or by the use of gloves; Pf or(2) Limited to situations that involve no direct contact with FOOD by the bare hands. Pf(C) A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least 100 MG/L chlorine. PfWis. Admin. Code Department of Agriculture, Trade and Consumer Protection § 2-301.16
Adopted by,Register April 2015 No. 712, eff.5/1/2015.Amended by,Register August 2016 No. 728, eff. 9/1/2016.Adopted by, Register July 2020 No. 775, eff. 8/1/2020