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

Hands and arms—Hand antiseptics (2009 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 or OTC Health-Care Antiseptic Drug Products as an antiseptic handwash; and
(b) Comply with one of the following:
(i) Have components that are exempted from the requirement of being listed in federal FOOD ADDITIVE regulations as specified in 21 C.F.R. 170.39 – Threshold of regulation for substances used in FOOD contact articles; or
(ii) Comply with and be listed in:
(A) 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
(B) 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
(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.
[Statutory Authority: RCW 43.20.050 and 43.20.145. WSR 13-03-109, § 246-215-02320, filed 1/17/13, effective 5/1/13.]
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