WAC 246-215-02320:

246-215-02315 << 246-215-02320 >> 246-215-02325

PDFWAC 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

(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.

[Statutory Authority: RCW 43.20.050 and 43.20.145. WSR 21-01-122, § 246-215-02320, filed 12/15/20, effective 3/1/22; WSR 13-03-109, § 246-215-02320, filed 1/17/13, effective 5/1/13.]