404 HANDS AND ARMS - HAND ANTISEPTICS

404.1 A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall:

1. (a) Comply with one of the following:
2. (1) Be an approved drug that is listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations based on safety and effectiveness; or
3. (2) Have active antimicrobial ingredients that are listed in the FDA monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products as an antiseptic handwash;
4. (b) Comply with one of the following:
5. (1) Have components that are exempt from the requirements of being listed in the federal food additive regulations as specified in 21 CFR 170.39- Threshold of regulation for substances used in food-contact articles;
6. (2) Comply with and be listed in 21 CFR Part 178- Indirect Food Additives: Adjuvants: Production Aids, and Sanitizers; or
7. (3) Comply with and be listed in 21 CFR Part 182 - Substances Generally Recognized as Safe, 21 CFR Part 184 - Direct Food Substances Affirmed as Generally Recognized as Safe, or 21 CFR Part 186 - Indirect Food Substances Affirmed as Generally Recognized as Safe; and
8. (c) Be applied only to hands that are cleaned as specified in section 401.

404.2 If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified in section 404.1(b), use shall be:

1. (a) Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; or
2. (b) Limited to employees working in situations that involve no direct contact with food by the bare hands.

404.3 A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least one hundred parts per million of chlorine (100 ppm chlorine) or twenty-five parts per million of iodine (25 ppm iodine) and changed every four (4) hours while in use.

404.4 A hand antiseptic solution used as a hand dip or a hand sanitizing station shall be provided and properly positioned and maintained in all food operations where food would normally undergo washing, cleaning, cooking or other processing activities.

404.5 Food employees shall have ready access to hand sanitizing stations when returning from toilet facilities, handwashing facilities, lunch and breaks, and whenever necessary while working.

404.6 Food operations shall provide at least one (1) hand sanitizing station:

1. (a) Inside entryways of food processing areas; and

(b) On each side of food processing tables, lines and equipment where food is being manipulated by hand; and

(c) For every ten (10) food employees at food processing tables, lines and equipment.

SOURCE: Final Rulemaking published at 56 DCR 5245 (July 3, 2009).