[Federal Register Volume 64, Number 63 (Friday, April 2, 1999)]
[Notices]
[Pages 15978-15979]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8095]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0438]


Food Code Prohibition Against Bare Hand Contact With Ready-to-Eat 
Foods; Preparation of a White Paper for Review by the National Advisory 
Committee on Microbiological Criteria for Foods

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for data and information.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a request 
for scientific data and information to aid in the development of a 
white paper, or summary of current information, on the contamination of 
ready-to-eat foods associated with food preparation employees. FDA will 
present the white paper to the National Advisory Committee on 
Microbiological Criteria for Foods (NACMCF) for its review and 
recommendations. FDA is seeking NACMCF input on this food contamination 
issue at the request of the Conference for Food Protection (CFP).

DATES: Submit data and information by June 1, 1999.

ADDRESSES: Submit written data and information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John J. Guzewich, Center for Food 
Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-260-3847.

SUPPLEMENTARY INFORMATION:

I. Background

     FDA provides assistance to local, State, and Federal governmental 
bodies to ensure that the food that is provided to consumers by retail 
food establishments is not a vehicle of communicable diseases. One 
mechanism for providing that assistance is the publication entitled 
Food Code 1999 (1999 Food Code), which provides guidance on food 
safety, sanitation, and fair dealing that can be uniformly adopted by 
jurisdictions for regulating the retail segment of the food industry. 
The 1999 Food Code, which is published by FDA, is the cumulative result 
of the efforts and recommendations of many contributing individuals, 
agencies, and organizations, and it is developed under the auspices of 
the CFP.
     The CFP, which is an organization of government, industry, 
consumer, and academic members, meets every 2 years to discuss retail 
food safety issues and to make recommendations on changes to be made to 
the 1999 Food Code. Delegates of State regulatory agencies vote on 
these recommendations that, if passed, are shared with organizations 
interested in amending or adopting the code. Recommendations with which 
FDA concurs are incorporated in the following year's edition of the 
Food Code.
     In the 1998 CFP meeting, a number of issues were submitted for the 
CFP's consideration regarding section 3-301.11 of the 1999 Food Code, 
entitled ``Preventing Contamination from Hands.'' Section 3-301.11 
states, in part, that ``food employees may not contact exposed, ready-
to-eat food with their bare hands.'' The 1999 Food Code contains: A 
prohibition against ill or infected employees preparing food, a hand-
washing regimen, and a blanket prohibition against bare hand contact 
with ready-to-eat foods in order to ensure that the person-to-food 
fecal-oral transmission cycle is broken.
     Section 3-301.11 was added to the 1999 Food Code some years ago in 
response to outbreaks of food-borne illness caused by food that had 
been contaminated with pathogens transmitted by food preparation 
workers. Indeed, it is estimated that as many as one-third of the cases 
of food-borne illness can be attributed to contamination of food from 
food preparation workers. FDA believes that the significant number of 
illnesses transmitted by worker contamination of food demand vigorous 
and rigorous intervention measures.
     A number of the 1998 CFP issues opposed the current requirements 
in section 3-301.11 as too restrictive. In response, FDA proposed that 
the CFP defer consideration of many of the issues related to bare hand 
contact with ready-to-eat food and ask the NACMCF to review the issues 
and provide recommendations regarding unresolved scientific questions 
in time for FDA to report them to the 2000 CFP meeting. The delegates 
at the 1998 CFP meeting accepted the FDA recommendation.

[[Page 15979]]

II. Request for Data and Information

     FDA is preparing for presentation of this issue to the NACMCF by 
developing a white paper, i.e., a summary of current information from 
scientific literature and other sources, that identifies and evaluates 
both the risks related to microbiological contamination of ready-to-eat 
food by food preparation workers and the effectiveness of different 
interventions to prevent or minimize that risk (e.g., hand washing, 
hand sanitizers, disposable gloves, no bare hand contact). In order to 
ensure that this white paper contains all available data relating to 
the risks and effectiveness of interventions to prevent or minimize 
contamination of ready-to-eat food, FDA is requesting scientific data, 
studies, or other information related to the following questions and 
issues:
     1. FDA seeks scientific data or information on the risk of 
transmitting bacterial, viral, or parasitic pathogens from food 
preparation workers, via ready-to-eat food, to consumers, including 
scientific data and information relating to:
    a. The amount of hand contact that can result in the transfer of 
pathogens;
    b. Whether transient contact, such as might occur when placing a 
garnish on a plate or glass, can transfer pathogens;
    c. Whether pathogens can be transferred to raw produce while 
washing it, if bare hands are used; and
    d. Whether bare hands can transmit pathogens to dry food like toast 
or rolls.
     2. FDA seeks scientific data or information on the effectiveness 
of alternative interventions, either alone or in combination, including 
scientific data and information relating to:
     a. Hand washing with soap:
    i. What constitutes a properly done hand wash;
     How long should the hand-washing process last;
     What is the optimum temperature of the water;
     Whether the use of a nailbrush increases removal of 
pathogens;
     Whether it is likely that a nailbrush would become a 
fomite, that is, become contaminated, and transmit bloodborne or 
enteric pathogens to subsequent users;
     How long before subdermal pathogens recontaminate the 
skin's surface; and
     Whether hand-drying methods have an impact on microbial 
reduction.
    ii. Whether a double hand wash is significantly better than a 
properly done single wash.
    b. Hand-washing machines; whether the use of a hand-washing machine 
can be the ``equivalent'' to a properly done hand wash, and if so, 
under what conditions.
    c. Use of ``hand sanitizers:''
     i. Whether human skin can be ``sanitized;''
     ii. Whether chemical hand sanitizers are effective against all 
pathogens of concern;
     iii. Whether subdermal pathogens can recontaminate the skin and, 
if so, how long it would take; and
     iv. Whether the use of hand sanitizers can increase the number of 
pathogens on hands.
    d. Use of disposable gloves:
     i. Whether pathogens can increase in numbers on gloved hands;
     ii. Whether gloves are likely to become fomites themselves even 
when properly used, e.g., as they are being put on; and
     iii. Whether glove use procedures used in other venues are 
applicable in retail food establishments.
    e. Whether there are other interventions that should be considered 
to prevent or minimize microbial contamination of ready-to-eat food by 
food preparation employees.
     Finally, FDA is also interested in views on whether additional 
studies, either microbiological or epidemiological, are needed to fill 
existing knowledge gaps; and, if so, what kind of studies should be 
done.
     Interested persons may, on or before June 1, 1999, submit to the 
Dockets Management Branch (address above) the required data and 
information. Two copies of the data and information should be 
submitted, except that individuals may submit one copy. Data and 
information are to be identified with the docket number found in 
brackets in the heading of this document. Received data and information 
may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: March 25, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8095 Filed 4-1-99; 8:45 am]
BILLING CODE 4160-01-F