Minnesota Administrative Rules
Agency 144 - Health Department
Chapter 4626 - FOOD CODE; FOOD MANAGERS
PERSONAL CLEANLINESS
Part 4626.0085 - HAND ANTISEPTICS. 2-301.16
Universal Citation: MN Rules 4626.0085
Current through Register Vol. 49, No. 13, September 23, 2024
A. A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap must:
(1) comply with 1 of
the following requirements:
(a) 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. This publication is incorporated by reference, is subject to
frequent change, and can be found at
www.fda.gov/Drugs/InformationOnDrugs/ucml29662.htm [File Link Not
Available];P2 or
(b) have active antimicrobial ingredients
that are listed in the FDA monograph for OTC Health-Care Antiseptic Drug
Products as an antiseptic handwash;P2
(2) consist only of components
that the intended use of each complies with one of the following:
(a) a threshold of regulation exemption under
Code of Federal Regulations, title 21, section
17039;P2
(b)
Code of Federal Regulations, title 21, section 178, as regulated for use as a
food additive with conditions of safe use;P2
(c) a determination of generally recognized
as safe (GRAS). Partial listings of substances with food uses that are GRAS may
be found in Code of Federal Regulations, title 21, sections 182, 184, and 186,
and in the FDAs inventory of GRAS notices;P2
(d) a prior sanction listed under Code of
Federal Regulations, title 21, section 181;P2
or
(e) a food-contact notification
that is effective;P2 and
(3) be applied only to hands that are cleaned
as specified in part 4626.0070.P2
B. If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria under item A, subitem (2), use must be:
(1) followed by thorough
hand rinsing in clean water before hand contact with food or by the use of
gloves;P2 or
(2) limited to situations that involve no
direct contact with food by the bare hands.P2
C. A hand antiseptic solution used as a hand dip must be maintained clean and at a strength equivalent to at least 100 mg/L of chlorine.P2
Statutory Authority: MS s 31.101; 31.11; 144.05; 144.08; 144.12; 157.011
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