Regulatory Comments
Submitted by the National Restaurant Association
To: U.S. Food and Drug Administration
Date: September 21, 1999
Topic: Bare-Hand Contact of Ready-to-Eat Foods

The National Restaurant Association appreciates the opportunity to submit its views in this written statement on the BARE-HAND CONTACT OF READY-TO-EAT FOODS. As the leaders of the hospitality industry, we have had a long-standing commitment to food safety and the protection of our customers and are deeply interested in improving retail food safety and responsibly addressing this issue.

The National Restaurant Association founded in 1919 is the leading business authority for the nation's $354 billion restaurant industry comprised of over 815,000 restaurant locations. Our 37,000 members represent more than 170,000 individual full-service restaurants, quick-service units and cafeterias, institutions, hospitals, universities and military clubs. We have made multi-billion dollar investments in improving food safety and developing state of the art food safety education programs and improving restaurant food safety over the past 79 years. In cooperation with state and local health officials, the National Restaurant Association has been a partner in the development of numerous state food safety regulations, food safety educational programs and informational materials based upon industry research, current science, and Hazard Analysis Critical Control Point (HACCP). We have worked for over 20 years to improve hand-washing compliance at retail through our food safety education and training programs such as ServSafe.

Clearly, the current regulatory scheme to absolutely ban bare hand contact as noted in the 1999 FDA Food Code is impossible to comply with and not supported by scientific data (Fendler at al, Part I, 1998). It is our belief that food contact with unwashed contaminated hands or gloves can be a source of foodborne illness (Torok et al., 1997), and that responsible and effective action should be taken to effectively address this problem. However, rather than the unrealistic prohibition of all bare hand contact we believe the solution lies in improved hand washing compliance and effective hand washing management at retail (Sattar and Springthorpe, Cambridge Univ Press, 1996). Furthermore, all bare hand to food contacts does not involve the same level of risks as those, which involve greater intimacy, regularity, or volume of exposure. The key to improved food safety is proper hand washing focus and the elimination of dirty bare hand contact where appropriate. Simple "silver bullet" solutions like mandatory glove use or banning bare hand contact may be attractive to many, but practical information must be fully considered before any effective real solution can be developed and implemented (Fendler at al, Part II, 1998; Docket RPT-1).

The absolute prohibition of bare hand contacts or mandatory glove rule surfaced in 1993 FDA Food Code and has been addressed in numerous regulatory meetings, state and local government hearings since that time. As a result of the increased attention many in the restaurant industry and state and local regulatory officials have implemented effective hand washing intervention and regulatory strategies (Florida alternative, 1998 and California, CURFFL, 1999). In 1999 the FDA Food Code to recognized effective hand washing management in Annex 3 to the Food Code. However, the code language, which absolutely prohibits bare hand contact, was not changed to reflect this current public health reasoning regarding hand washing compliance and management.

Since 1993, and particularly after the 1997 version of the FDA Food Code, states began adopting the FDA Food Code and provisions, many with realistic changes to the bare hand contact prohibition section 3-301.11. The three most notable examples are Texas, California and Florida which have been able to effectively work with industry to improve hand washing compliance, protect public health and allow limited bare hand contact at retail. Clearly, these States by their actions have determined that there is no conclusive evidence that the mandatory use of gloves or utensils affords any greater level of protection in a restaurant setting than clean washed hands. Furthermore, their solutions recognized that there are many circumstances in foodservice settings in which it is logistically impossible to avoid all bare hand contact with ready-to-eat foods. Common tasks such as pealing shrimp, filling tacos, pealing fruit and steadying hot foods all potentially require direct hand contact.

There is no evidence that glove use has reduced the transmission of foodborne illness or lowered the number of foodborne illnesses in the few states that have implemented mandatory glove laws over those that have not (CDC, FoodNet 1998). From 1995 through 1998, epidemiological data developed through CDC's FoodNet data has also shown significant reductions in foodborne illnesses pathogens per 100,000 population nationwide. Clearly, the reductions in illnesses since 1995 are a reflection of the effective implementation of strategies incorporated at various steps by the food industry. In previous data (CDC summary, 1988 to 1992) CDC has cited "Poor personal hygiene" as a cause of illness less than 25 % (1 in 4-5) of the time when the cause was identified. Improper holding temperatures were cited as the number one cause in all years at 35% of the time. Since the CDC term personal hygiene may encompasses many practices, of which hand contact is only one, the real percentage due to dirty hand contact is likely to be significantly smaller. In any case the absolute number of illnesses associated with dirty hand contact is probably declining and clearly does not represent a growing or out of control problem.

Rather than the unrealistic prohibition of all bare-hand contact incorporated in the 1999 FDA Model Food Code and advocated by some, the Association believes that the solution lies in improved hand-washing compliance, effective hand-washing management coupled with an effective education-and-training program, and glove use for high-risk situations. The Association approach is in keeping with recommendations made in September 1999, by the FDA scientific advisory committee (The National Advisory Committee on the Microbiological Criteria for Foods, NACMCF). The FDA asked the committee to study the scientific evidence on the topic in September 1999. After a full review of the existing science and two days of public testimony the committee concluded that while minimizing bare-hand contact provides an additional means of preventing disease transmission, "insufficient data exist to support the recommendation of a blanket prohibition of bare-hand contact". They went on to fully support a balanced approach to food bare hand contact including education, management, restriction of ill employees and appropriate handwashing instead of a proposed mandatory glove requirement.

We continue to believe that the ultimate solution to reducing poor personal hygiene and dirty hand contact, associated illnesses is an effective education and training program highlighting hand washing and hand washing management. The National Restaurant Association has developed and is delivering this training today through the ServSafe program. We challenge others to join with us in the expansion and delivery of food safety education and to greatly increase the 1,000,000 restaurant managers we have already trained and certified. Through consistent training we can improve hand washing compliance and management and fully address this issue.

The National Restaurant Association is not opposed to appropriate glove use and the reduction of bare hand contact. We have consistently supported a balanced approach that calls for effective hand washing and the use of gloves for high-risk situations. This philosophy recognizes that there are no "silver bullets" and that no one strategy is totally appropriate for all restaurant situations (Fendler at el, Part I, 1998).

The FDA and others have noted some of the failings of the current levels of hand washing compliance and management on many occasions and we find ourselves in agreement. Clearly, more work needs to be done to improve hand washing compliance and management however, the issue must be addressed directly. We welcome the opportunity to cooperatively develop hand washing compliance education and training programs. However, we should not expect any real improvement in hand washing compliance if we continue to cover the real problem with gloves (Bardell, 1995) or attempt to simply eliminate bare hand contact with a pen. Research has clearly shown that glove use is not an absolute barrier and may even add problems (Larson et al., 1989, Ehrenkranz, 1992, DeGroot-Kosolcharoen, et al, 1989, and Fendler et al., Part I, 1998) and sole reliance may only complicate the existing compliance issues.

The National Restaurant Association welcomes increased cooperative efforts to address the problem of food contamination and personal hygiene. We are consistently striving to develop and improve the effectiveness of employee training materials. We appreciate the opportunity to comment on this issue. Should you have any questions or comments, please feel free to call Steven Grover, VP, Health and Safety Regulatory Affairs at (202) 331-5986.

References

1. 1998 FoodNet Surveillance Results. Preliminary Report. Atlanta: Centers for Disease Control and Prevention; 1999.

2. Bardell D. Herpes simplex virus type 1 applied experimentally to gloves used for food preparation. J Food Protect 1995; 58: 1150-1152.

3. California, CURFFL, 1999

4. Centers for Disease Control and Prevention Surveillance for Foodborne-Disease Outbreaks- United States, 1988-1992

5. Findings of The National Advisory Committee on the Microbiological Criteria for Foods, regarding BARE-HAND CONTACT OF READY-TO-EAT FOODS, September 1999

6. Fendler EJ, Dolan MJ, Williams RA, Paulson DS. Handwashing and gloving for food protection part II: Effectivness. Dairy, Food Environ Sanit 1998; 18(12);824-829.

7. Fendler EJ, Dolan MJ, Williams RA. Handwashing and gloving for food protection part I: Examination of the evidence. Dairy, Food Environ Sanit 1998; 18(12); 814-823.

8. Industry Guidelines for 61C-4.010 (1) (d-g) FAC. Alternative to 1997 FDA Food Code 3-301.11 Preventing Contamination from Hands. Florida Department of Business and Professional Regulation, Division of Hotels and Restaurants.

9. Satter SA, Springthorpe VS. Transmission of vital infections through animate and inanimate surfaces and infection control through chemical disinfection. In: Hurst CJ, ed. Modeling disease transmission and its prevention by disinfection. Cambridge University Press; 1996. P.224-257.