Handwashing versus alcohol-based gels--FDA information.

The Food and Drug Administration (EDA) and the Centers for Disease Control and Prevention (CDC) are working together to control the transmission of pathogens that can result in foodborne illnesses. Transmission of pathogenic bacteria, viruses, and parasites from raw food or from ill workers to food by way of improperly washed hands continues to be a major factor in the spread of foodborne illnesses.

FDA's Food Code contains specific hand hygiene guidance for retail and food service workers. It describes when, where, and how to wash and sanitize hands. Hand sanitizers, meeting specific criteria described in Section 2-301.16 of the code, may be used after proper handwashing.

Can Alcohol-Based Gels Be a Suitable Alternative to Handwashing in Food Service Settings?

CDC recently issued "CDC Guideline for Hand Hygiene in Healthcare Settings," at http://www.cdc.gov/handhygiene/ (Morbidity and Mortality Weekly Reports, October 25, 2002). This guidance document recommends alcohol-based hand gel as a suitable alternative to handwashing for health care personnel in health care settings. These guidelines were not intended to apply to food establishments. The control of common nosocomial pathogens in health care settings differs from the control of common foodborne pathogens in retail and food service settings. Some significant differences between health care settings and retail or food service settings are described below.

1. Types of Pathogens

The pathogens most commonly transmitted by hands in health care settings differ from those transmitted in retail and food service settings. In health care, nosocomial bacterial pathogens and lipophilic viruses predominate; in food service and retail establishments, fecal pathogens are the primary concern. Common nosocomial pathogens are typically transmitted from person to person in health care settings. In retail and food service settings, foodborne pathogens are transmitted through the fecal-oral route, from contaminated hands to food items. Controlling the transmission of fecal bacteria, enteric non-lipophilic viruses, and protozoan oocysts, which can contaminate hands with a very high liter, is particularly important. CDC estimates the non-lipophilic virus Norovirus (Norwalk-like virus) to be the leading cause of foodborne illness in the United States.

2. Efficacy and Approval of Alcohol-Based Hand Gels

All alcohol-based hand gels applied to human skin are drugs ant to be legally marketed in the United States must be covered by FDAIs Over-the-Counter (OTC) Drug Review or by an FDA-approved new-drug application. Furthermore, all ingredients, including the emollients and perfumes that are constituents of alcohol-based hand gels used in retail and food service operations, must be approved as indirect food additives.

Some in vitro and in vivo studies have suggested that alcohol-based hand gels are highly effective against nosocomial bacterial pathogens of major concern in health care settings. FDA is still reviewing, however, the antimicrobial efficacy of alcohol-containing handwashes for use in any setting. Some studies also indicate that moisture on the hands may interfere with alcohol efficacy. In addition, alcohol has been shown to be ineffective against protozoan oocysts, and, depending on the concentration of alcohol, the amount of time involved, and the viral variant, alcohol may not be effective against hepatitis A or other non-lipophilic viruses.

3. Soil on Hands

The types and levels of soil on the hands of health care workers differ from those on the hands of food service and retail workers. Retail and food service activities may increase the potential for workers to get fatty and proteinaceous materials--that may or may not be visible--on the hands. Proteinaceous material is known to interfere with and neutralize the efficacy of alcohol. Fatty substances can coat and protect pathogens. Soap, friction, and running water effectively remove the proteinaceous and fatty materials, and reduce pathogens of concern.

Existing data do not demonstrate that alcohol-based hand gel effectively reduces important infectious foodborne pathogens at levels that occur on food workers' hands, especially if the hands are soiled with fatty and proteinaceous materials. Even in health care settings, the CDC guidelines recommend soap and water handwashing on hands that are visibly soiled, or contaminated with proteinaceous material, rather than the use of alcohol-based sanitizers.

Conclusion

Proper handwashing, as described in the Food Code, continues to be a vital and necessary public health practice in retail and food service. Use of alcohol gel in place of handwashing with soap does not adequately reduce important foodborne pathogens on food workers' hands. The problems with using alcohol-based hand gels in place of handwashing in a retail or food service setting can be summarized as follows:

* Alcohols have very poor activity against bacterial spores, protozoan oocysts, and certain non-enveloped (non-lipophilic) viruses.

* Ingredients used in alcohol-based hand gels must be approved food additives, and they must be approved under the FDA monograph or through a new-drug application.

* Retail food and food service work involves a high potential for wet hands and hands contaminated with proteinaceous material. Scientific research has questioned the efficacy of alcohol on moist hands and hands contaminated with proteinaceous material.

FDA and CDC continue to work together to review new data and ensure that the best public health measures are in place for retail and food service establishments.

References for this report can be found at http://wwwcfsan. fda.gov/~comm/handhyg.html.