[Federal Register Volume 66, Number 237 (Monday, December 10, 2001)]
[Notices]
[Pages 63713-63714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30489]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0532]


Food Code; 2001 Revision; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the 2001 revision of the Food Code (2001 Food Code). 
This 2001 revision was initiated in cooperation with the Conference for 
Food Protection (CFP or Conference) to help ensure that food sold or 
offered for human consumption by retail food establishments is safe, 
unadulterated, and honestly presented.

DATES: Submit written or electronic comments on the 2001 Food Code at 
any time.

ADDRESSES: Submit written requests for single copies of the 2001 Food 
Code to the Office of Field Programs (HFS-600), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204 (after December 14, 2001, the Center for Food 
Safety and Applied Nutrition's address will be 5100 Paint Branch Pkwy., 
College Park, MD 20740). Send two self-addressed adhesive labels to 
assist that office in processing your request. Submit written comments 
on the 2001 Food Code to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access and ordering information for the 2001 Food Code.

FOR FURTHER INFORMATION CONTACT: Glenda R. Lewis, Center for Food 
Safety and Applied Nutrition (HFS-627), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-8140. (After December 14, 
2001, the Center for Food Safety and Applied Nutrition's address will 
be 5100 Paint Branch Pkwy., College Park, MD 20740.)

SUPPLEMENTARY INFORMATION:

I. Background

    FDA provides assistance to Federal, State, local, and tribal 
governmental bodies with jurisdiction over food safety to help ensure 
that food provided to consumers by retail food establishments is not a 
vehicle of communicable diseases. A primary mechanism for providing 
that assistance is the regular publication of a model code that sets 
out FDA's best advice for a uniform system of regulation that is 
designed to help ensure that food sold or offered for human consumption 
by retail food establishments is safe, unadulterated, and honestly 
presented.
    In 1971, the CFP was established to provide a dialogue on food 
safety issues. The CFP is a voluntary organization comprised of 
Federal, State, and local regulatory officials, food industry 
representatives, consumer groups, and academia. The public also may 
participate in the CFP process. The Conference meets biennially for 
discussion among all parties regarding ways to improve food safety in 
the retail segment of the food industry. FDA recognizes the CFP as a 
voluntary national organization that is qualified to provide technical 
guidance and information toward the development and implementation of 
codes and standards pertaining to retail food service, retail food 
stores, and retail vending operations. At the 1986 meeting of the CFP, 
it was recommended that the three distinct model codes in existence at 
that time (retail food stores, food service facilities, and vending) be 
combined into a Food Protection Unicode. The CFP endorsed this 
approach, FDA concurred, and issued the first Food Code in 1993. FDA 
has issued subsequent versions of the Food Code every 2 years. 
Revisions to the Food Code are based in part on recommendations that 
are cooperatively developed by CFP members in response to issues 
submitted to the CFP by interested parties.
    The 2001 Food Code responds to recommendations made by the CFP and 
addresses needed clarifications, updates, and corrections. Significant 
changes between the 2001 Food Code and the 1999 Food Code include the 
following:
      A revised definition of juice, information on juice 
treated to control

[[Page 63714]]

pathogens, and information that addresses issues relating to juice 
provided to populations that are particularly vulnerable to foodborne 
illness;
      A revised definition of ``highly susceptible 
populations'' and new definitions relating to employee health including 
``exclusion'' and ``restriction'';
      New provisions for the refrigeration and labeling of eggs 
consistent with new requirements in the Code of Federal Regulations 
(CFR);
      An updated roast beef cooking chart consistent with new 
U.S. Department of Agriculture/Food Safety and Inspection Service 
criteria;
      A revised preface to recognize Federal performance 
standards relating to food products and processes. (Federal performance 
standards are acceptable, equivalent alternatives to the command-and-
control provisions that now provide specific times and temperatures for 
cooking);
      A new definition for ``shiga toxin-producing E. coli'' 
and a replacement of references to ``E. coli 0157:H7 ``with Ashiga 
toxin-producing E. coli'';
      Clarification of hand washing procedures with respect to 
time and water temperature; application of hand washing procedures to 
persons with prosthetic devices; and hand washing procedures before 
donning gloves;
      Clarification of the provisions relating to marking 
refrigerated, ready-to-eat food to indicate its shelf life;
      A new provision that allows the use of a thermometer 
embedded in a nonfood substance as a means of monitoring the 
temperature of food products in a refrigerator, as well as encouraging 
the use of small diameter probes for measuring the internal temperature 
of thin masses of food;
      New provisions that address backflow prevention devices 
for beverage carbonators;
      Additional references relating to time as a public health 
control and cooling; and
      Provisions updated to reflect consistency with the 
current CFR and guidances issued by Federal agencies.
    The 2001 Food Code is a level 1 guidance being issued consistent 
with FDA's good guidance practices regulation in Sec. 10.115 (21 CFR 
10.115). With certain exceptions, this regulation requires that the 
public be afforded an opportunity to comment on level 1 guidance 
documents before their implementation. FDA is not seeking public 
comment before implementing this edition of the Food Code because we 
have determined that it is not feasible or appropriate in accordance 
with Sec. 10.115(g)(2). The Food Code is revised biennially to keep it 
up-to-date. Each revision is based on comments received on a previous 
Food Code, as well as issues presented to the CFP for further 
development and discussion. Each revision also reflects current public 
comment. The Conference engages in outreach in a number of ways. First 
and foremost, its members communicate within their respective 
constituencies (industry--retail food store, food service, vending, 
processing; government--Federal, State, and local; consumer and 
academia). In addition, the Conference has a Web site at http://www.foodprotect.org; press releases go out to various organizations; 
and members receive a Conference newsletter. Thus, each revision of the 
Food Code is part of an ongoing dialogue and serves effectively as a 
``draft'' for the next revision.
    The 2001 Food Code does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such an approach satisfies the 
requirements of applicable statutes and regulations.

II. Comments

    The public may comment on this document at any time. The public may 
comment in one of two ways: (1) By participating in the CFP meeting 
held biennially for the purpose of, among other things, considering 
recommended changes to the Food Code; or (2) by commenting in writing 
or electronically to FDA. Comments submitted to the agency may be 
offered for consideration and vote at a subsequent CFP meeting.
    Interested persons, at any time, may submit written or electronic 
comments to the Dockets Management Branch (address above) on the 2001 
Food Code. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
2001 Food Code and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access and Ordering Information

    Persons with access to the Internet may obtain the document at 
http://www.cfsan.fda.gov/dms/guidance.html, http://vm.cfsan.fda.gov/list.html, or http://www.fedworld.com. In addition, the 2001 Food Code 
may be ordered from the National Technical Information Service, U.S. 
Department of Commerce, Springfield, VA 22161, 1-800-553-6847, in 
several formats: Docutek copy, spiral bound, Microsoft Word 97 files on 
diskette, enhanced electronic version on cassette or CD-ROM,
 including Adobe Reader. The enhanced versions include electronic 
features such as hypertext links that enable the reader to locate 
quickly a specific code provision and to read simultaneously the text 
of cross-referenced documents.

    Dated: December 5, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-30489 Filed 12-5-01; 4:08 pm]
BILLING CODE 4160-01-S