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Issue Number: Council III 014

Title

Hand Sanitizer Use between Glove Changes

Issue you would like the Conference to consider

According to current FDA Food Code requirements, hands must be washed between glove changes. The use of a Food Code-compliant hand sanitizer should be permitted in lieu of a full hand wash between glove changes. Enabling the use of effective hand sanitizer between glove changes when there is not visible soil present may enhance compliance with personal hygiene requirements and therefore reduce the risk of food borne disease. Specific procedures for glove removal should be provided and the requirement for hand washing between glove changes should remain when gloves have been torn or hands have become soiled.

Public Health Significance

CDC reports the number of food borne illness outbreaks associated with hand contact, with or without gloves, from 1998-2002 (Lynch et al, 2006) (Table 1) See Attachment for all Tables referenced. Norovirus is the dominant etiology for both bare-hand and gloved-hand contact. This is why hand washing before donning gloves the first time is essential. However, after hands have been washed, bacterial agents are the concern because they may be naturally present on some foods or on humans. Additionally, gloves may serve as "incubators" and allow bacteria to multiply inside the glove. This is not true for viruses; therefore use of hand antiseptics known to be effective against bacteria should be sufficient when changing gloves. Many hand antiseptics provide a 4 to 5 log reduction for vegetative bacteria through in vitro tests.

Hand antiseptic effectiveness

There are several test methods available to evaluate the efficacy of a hand antiseptic. Laboratory (in-vitro) tests are most frequently used for Food Code compliant hand antiseptics because they provide greater flexibility and the test can be conducted on a number of pathogens to determine their relative susceptibility to the hand care product. Laboratory-based methods also reduce the variation that may be observed between individuals (e.g., the amount of product used, the size of the hand, the thoroughness or rubbing, etc.).

Human subject tests (in-vivo) can be done to study the impact of additional factors such as the mechanical removal of the test organism on the hands. However, because human subjects are involved, generally a surrogate is used to represent pathogens and judgment is required to extrapolate the efficacy against a range of pathogens. The level of reduction observed through in-vivo testing is typically lower than that for in-vitro tests.

Table 2 provides an example of the variety of organisms that can be tested for a commercial Food Code compliant product, and lists the log reduction achieved using an in vitro test. Many of the organisms listed are not concerns for food borne illness. Results will vary by product, and potential by lab, strain, organism, and method used. For this study, 1 ml of culture was exposed to 10 ml of product for 15 sec then neutralized and plated for residual counts. (Swanson, 2009)

Alcohol is not the only active component that can provide an effective kill in a hand sanitizer. Table 3 provides an example of data for a hand antiseptic based on a quaternary ammonium compound. Because it is non-volatile, it may take longer for the product to evaporate than an alcohol based hand antiseptic, therefore the level of reduction for several periods of times is listed (Swanson, 2009).

References:

Lynch et al. 2006 Surveillance of food-borne disease outbreaks - United States, 1998-2002 MMWR 55(2210):1-34.

Swanson K 2009 Personal communication, December 17, 2009.

Recommended Solution: The Conference recommends...

that a letter be sent to FDA requesting that § 2-301.16 be amended by adding ¶ (D) with the following language:

2-301.16 (D) Hand antiseptics may be used in lieu of hand washing between glove changes that occur with no intervening contamination of food preparation by hands provided that:

(1) Hands are washed prior to donning gloves;

(2) Gloves are removed using a wrist-down motion, a hand antiseptic is applied to hands and thoroughly rubbed into the hands prior to regloving; and

(3) Hands must be washed if gloves are torn or hands become soiled.

Attachments

Submitter Information

Name Dan Roehl
Organization National Restaurant Association
Address 1200 17th Street, NW
Washington, DC 20036
Telephone 202.331.5900
Fax 202.331.2429
Email droehl@restaurant.org
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