FDA Fact Sheet on Hand Hygiene in Retail & Food Service Establishments
Food Service Safety Facts
The Food and Drug Administration (FDA) 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 one of several major factors in the spread of foodborne illnesses.
FDA's Food Code contains the Federal recommendations for preventing foodborne illness in restaurants, grocery stores, institutions and vending locations. Local, state and federal regulators use the FDA Food Code as a model to help develop or update their own food safety rules and to be consistent with national food regulatory policy. The Food Code contains specific hand hygiene guidance for retail and food service workers describing when, where, and how to wash and sanitize hands. Hand sanitizers, meeting specific criteria described in section 2-301.16 of the Food Code, may be used after proper hand washing in retail and food service.
CAN ALCOHOL-BASED HAND GELS SERVE AS A SUITABLE ALTERNATIVE TO HANDWASHING FOR RETAIL and FOOD SERVICE WORKERS?
CDC recently issued "CDC Guideline for Hand Hygiene in Healthcare Settings" (Morbidity and Mortality Weekly Reports, October 25, 2002). The 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. This exclusion is based on the differences in controlling common nosocomial pathogens in health-care settings and common foodborne pathogens in retail and food service settings. Some significant differences between health-care settings and retail/ food service settings include:
- TYPES OF PATHOGENS
The pathogens most commonly transmitted by hands in health-care settings differ from those in retail and food service settings. In health-care, nosocomial bacterial pathogens and lipophilic viruses predominate, while in food service and retail establishments we are primarily concerned with a different set of fecal pathogens. 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 titer, is a particular concern. CDC estimates the non-lipophilic virus, Norovirus (Norwalk-like virus) to be the leading cause of foodborne illness in the United States.
EFFICACY AND APPROVAL OF ALCOHOL-BASED HAND GELS
All alcohol-based hand gels applied to human skin are drugs, and must be covered by FDA's Over-the-Counter (OTC) Drug Review or by an FDA-approved new drug application to be legally marketed in the United States. Further, all ingredients, including emollients and perfumes that are constituents of alcohol hand gels used in retail and food service operations must be approved as indirect food additives.
Some in vitro and in vivo published studies suggest that alcohol-based hand gels are highly effective against nosocomial bacterial pathogens of major concern in health-care settings. However the antimicrobial efficacy of alcohol-containing handwashes for use in any setting remains under review by FDA. Some published 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 alcohol concentration, time, and viral variant, alcohol may not be effective against hepatitis A, or other non-lipophilic viruses.
SOIL ON HANDS
The types and levels of soil on the hands of health-care workers differ from food service/retail workers. The type of activities conducted in retail and food service may lead to increased potential for fatty and proteinaceous materials to be on the hands. The fatty and proteinaceous materials may or may not be visible on the hands. Proteinaceous material is known to interfere with and neutralize alcohol efficacy. Fatty substances can coat and protect pathogens from the action of alcohol. 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 using the alcohol-based sanitizers.
Proper handwashing, as described in the Food Code continues to serve as a vital and necessary public health practice in retail and food service. Using alcohol gel in place of handwashing in retail and food service does not adequately reduce important foodborne pathogens on foodworkers' hands. Concern about the practice of using alcohol-based hand gels in place of hand washing with soap and water in a retail or food service setting can be summarized into the following points:
- Alcohols have very poor activity against bacterial spores, protozoan oocysts, and certain nonenveloped (nonlipophilic) viruses; and
- Ingredients used in alcohol-based hand gels for retail or food service must be approved food additives, and approved under the FDA monograph or as a New Drug Application (NDA); and
- Retail food and food service work involves high potential for wet hands and hands contaminated with proteinaceous material. Scientific research questions 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 assure the best public health measures are in place for retail and food service establishments
- Ansari, S.A., Sattar, S.A., Springthorpe, S., Wells, G.A., and Tostowaryk, W., Dec. 1989. In vivo protocol for testing efficacy of hand-washing agents against viruses and bacteria: Experiments with Rotavirus and Escherichia coli. Appl. Environ. Microbiol., 55 (12): p. 3113-3118.
- Bellamy, K., Alcock, R., Babb, J.R., Davies, J.G., and Ayliffe, G.A.J., 1993. A test for the assessment of "hygienic" hand disinfection using rotavirus. J Hosp. Infect. 24, p. 201-210.
- Bidawid, H.S., Farber, J.M., and Sattar, S.A., 2000. Contamination of foods by food handlers: experiments on hepatitis A virus transfer to food and its interruption. Appl. Environ. Microbiol. 66 (7): p. 2759-63.
- Blech, M.F., Hartemann, P., and Paquin, J.L., 1985. Activity of non-antiseptic soaps and ethanol for hand disinfection. Zbl. Bakt. Hyg., I. Abt. Orig. B, 181, p. 496-512.
- Boyce, John M., Pittet, D. 2002. Guideline for Hand Hygiene in Health-Care Settings, Recommendations of the Healthcare Infection Control Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA/ Hand Hygiene Task Force, CDC MMWR, October 25, Vol. 51. pp. 1-45.
- Charbonneau, D.L., Ponte, J.M., and Kochanowski, B.A., 2000. A Method of Assessing the Efficacy of Hand Sanitizers: Use of Real Soil Encountered in the Food Service Industry. J. Food Protect., Vol. 63, No. 4, pp. 495-501.
- Crisley, F.D., and Foter, M.J., 1994. The Use of Antimicrobial Soaps and Detergents for Hand Washing in Food Service Establishments. J of Milk & Food Tech., pp. 278-284.
- Eggers, H.J., 1990. Experiments on Antiviral Activity of Hand Disinfectants. Some Theoretical and Practical Considerations. Zbl. Bakt. 273, p. 36-51.
- Kjolen, H., and Anderson, B.M., 1992. Handwashing and disinfection of heavily contaminated hands -- effective or ineffective. J Hosp Infect. 21, p. 61-71.
- Lilly, H.A., Lowbury, E.J.L., and Wilkins, M.D., 1979. Detergents compared with each other and with antiseptics as skin "degerming" agents. J.Hyg., Camb. 82: p. 89-93.
- Mbithi, J.N., Oct. 1993, Comparative in vivo efficiencies of hand-washing agents against hepatitis A virus (HM-175) and Poliovirus Type 1 (Sabin). Appl. Environ. Microbiol. 59 (10) p. 3463-3469.
- Moadab, A., Rupley, K., Wadhams, P., 2001. Effectiveness of a nonrinse, alcohol-free antiseptic hand wash, J. Am. Podiatr. Med Assoc. 91 (6): p. 288-293.
- Myklebust, S. 1989. Soap pH and the effectiveness of alcoholic hand antiseptics. Scand J Dent Res. 97: p. 451-5.
- Namura, D.S., Nishijima, S., Mitsuya, K. and Asada, Y., June, 1994. Study of the efficacy of antiseptic handrub lotions with hand washing machines. J. Dermatol. 21 (6): p. 405-10.
- Pietsch, H. 2001. Hand antiseptics: rubs versus scrubs, alcoholic solutions versus alcoholic gels. J. Hosp. Infect. 48 (Supplement A): p. 533-536.
- Sattar, S., Makonnen, A., Bueti, A.J., Jampani, H., and Newman, J., Aug. 2000. Activity of an alcohol-based hand gel against human adeno-, rhino-, and rotaviruses using the fingerpad method. Infect. Control Hosp. Epidemiol. 21: p. 516-519.
- Schurmann, W., and Eggers, H.J., 1983. Antiviral activity of an alcoholic hand disinfectant. Comparison of the in vitro suspension test with in vivo experiments on hands, and on individual fingertips. Antiviral Research, 3, p. 25-41.
- Wolff, M.H., Schmitt. J., Rahaus, M., and Konig, A., 2001. Hepatitis A virus: a test method for virucidal activity. Journal of Hospital Infection. 48 (Supplement A): S18-S22.