[Federal Register Volume 68, Number 242 (Wednesday, December 17, 2003)]
[Notices]
[Pages 70278-70279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0092]


Food and Cosmetic Security Guidances; 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 a guidance document related to food security entitled 
``Retail Food Stores and Food Service Establishments: Food Security 
Preventive Measures Guidance'' (food security guidance) and a guidance 
document related to cosmetics security entitled ``Cosmetics Processors 
and Transporters: Cosmetics Security Preventive Measures Guidance'' 
(cosmetics security guidance). The food security preventive Measures 
Guidance'' is designed as an aid to operators of retail food stores and 
food service establishments (e.g., bakeries, bars, bed-and-breakfast 
operations, cafeterias, camps, child and adult day care providers, 
church kitchens, commissaries, community fund raisers, convenience 
stores, fairs, food banks, grocery stores, interstate conveyances, meal 
services for homebound persons, mobile food carts, restaurants, and 
vending machine operators). It identifies the kinds of preventive 
measures that operators may take to minimize the risk that food under 
their control will be subject to tampering or other malicious, 
criminal, or terrorist actions. The cosmetics security guidance is 
designed as an aid to operators of cosmetics establishments (e.g., 
firms that process, store, repack, relabel, distribute, or transport 
cosmetics or cosmetics ingredients). It identifies the kinds of 
preventive measures that operators may take to minimize the risk that 
cosmetics under their control will be subject to tampering or other 
malicious, criminal, or terrorist actions.

DATES: You may submit written or electronic comments on the guidance 
documents at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Retail Food Stores and Food Service Establishments: 
Food Security Preventive Measures Guidance,'' or ``Cosmetics Processors 
and Transporters: Cosmetics Security Preventive Measures Guidance'' to 
John Kvenberg, Center for Food Safety and Applied Nutrition (HFS-600), 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740. Include a self-addressed adhesive label to assist that office in 
processing your request.
    Submit written comments on the documents to the Division of Dockets 
Management (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 to the guidance documents.

FOR FURTHER INFORMATION CONTACT: John Kvenberg, Center for Food Safety 
and Applied Nutrition (HFS-600), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2359, e-mail: 
[email protected] or Donald W. Kraemer, Center for Food Safety 
and Applied Nutrition (HFS-400), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-2300, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Operators of retail food store, food service, and cosmetics 
establishments are encouraged to review their current security 
procedures and controls in light of the potential for tampering or 
other malicious, criminal, or terrorist actions and make appropriate 
improvements.
    FDA announced the availability of two guidance documents related to 
food security in the Federal Register of January 9, 2002 (67 FR 1224). 
They were entitled ``Food Producers, Processors, Transporters, and 
Retailers: Food Security Preventive Measures Guidance'' and ``Importers 
and Filers: Food Security Preventive Measures Guidance.'' The agency 
solicited public comment, but indicated that the two guidance documents 
would be implemented immediately in accordance with Sec.  10.115(g)(2) 
(21 CFR 10.115(g)(2)). The two guidance documents were prompted by the 
tragedies of September 11, 2001, and the resulting scrutiny of, and 
interest in, food safety and security that followed.
    A number of the comments on the two guidance documents urged FDA to 
issue guidance that was specifically tailored for the retail food store 
and food service sector. In response to these comments, the agency 
announced in the Federal Register of March 21, 2003 (68 FR 13932), the 
availability of a draft guidance document entitled ``Retail Food Store 
and Food Service Establishments: Food Security Preventive Measures 
Guidance.'' This draft guidance document identified the kinds of 
preventive measures that operators of retail food store and food 
service establishments (e.g., bakeries, bars, bed-and-breakfast 
operations, cafeterias, camps, child and adult day care providers, 
church kitchens, commissaries, community fund raisers, convenience 
stores, fairs, food banks, grocery stores, interstate conveyances, meal 
services for homebound persons, mobile food carts, restaurants, and 
vending machine operators) can take to minimize the risk that food 
under their control will be subject to tampering or other malicious, 
criminal, or terrorist actions.

[[Page 70279]]

    In that same March 21, 2003, Federal Register notice, the agency 
also requested comment on whether the agency's package of food security 
guidance documents should be expanded to include coverage of cosmetics, 
in addition to foods. To facilitate such comments, the agency announced 
the availability of a draft guidance document entitled ``Cosmetics 
Processors and Transporters: Cosmetics Security Preventive Measures 
Guidance'' (68 FR 13932). This draft guidance identified the kinds of 
preventive measures that operators of cosmetics establishments can take 
to minimize the risk that cosmetics under their control will be subject 
to tampering or other malicious, criminal, or terrorist actions. It 
takes the operator through each segment of the cosmetics production 
system that is within their control, in order to minimize the risk of 
tampering or other malicious, criminal, or terrorist action at each 
segment. Implementation of these measures requires commitment from both 
management and employees to be successful and, therefore, both should 
participate in their development and review.
    The agency solicited public comment on the draft guidance 
documents. FDA received three letters and three electronic responses, 
each containing one or more comments, from industry, consumer groups, 
and consumers in response to the draft guidance documents. The agency 
has reviewed and evaluated the comments and has determined that further 
modification of the guidance documents is unnecessary. The agency is 
therefore finalizing the draft guidances without revision.
    The guidance documents are level 1 guidances issued consistent with 
FDA's good guidance practices regulation (Sec.  10.115) relating to the 
development, issuance, and use of guidance documents.
    The guidance documents represent the agency's current thinking on 
appropriate measures that retail food store, food service, and 
cosmetics establishments may take to minimize the risk that foods or 
cosmetics under their control will be subjected to tampering or other 
malicious, criminal, or terrorist actions. They do not create or confer 
any rights for or on any person and do not operate to bind FDA or the 
public.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding these guidance 
documents. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. The guidance documents and 
received comments are available for public examination in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Copies of these guidance documents also are available on the 
Internet at http://www.cfsan.fda.gov/guidance.html. The guidance 
documents also can be viewed at: http://www.fda.gov/ohrms/dockets.

    Dated: December 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-31048 Filed 12-16-03; 8:45 am]
BILLING CODE 4160-01-S