(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 foodadditive 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 foodadditives: Adjuvants, production aids, and sanitizers as regulated for use as a foodadditive 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.