Section 246-215-02320. 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.]

RCW 43.20.050 and 43.20.145. WSR 13-03-109, § 246-215-02320, filed 1/17/13, effective 5/1/13.

Rules

246-215-02305,