[Federal Register Volume 68, Number 55 (Friday, March 21, 2003)]
[Notices]
[Pages 13932-13933]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6843]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-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availability of a draft guidance document related to food security 
entitled ``Retail Food Stores and Food Service Establishments: Food 
Security Preventive Measures Guidance'' and a draft guidance document 
related to cosmetics security entitled ``Cosmetics Processors and 
Transporters: Cosmetics Security Preventive Measures Guidance.'' The 
draft guidance document entitled ``Retail Food Stores and Food Service 
Establishments: Food Security Preventive Measures Guidance'' is 
designed as an aid to operators of retail food stores and food service 
establishments (i.e., for example, 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 The draft guidance document entitled ``Cosmetics 
Processors and Transporters: Cosmetics Security Preventive Measures 
Guidance'' is designed as an aid to operators of cosmetics 
establishments (i.e., 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DATES: Submit written or electronic comments on the draft guidance 
documents by May 20, 2003, to ensure their adequate consideration in 
the preparation of revised guidances, if warranted. However, you may 
submit written or electronic comments at any time.

ADDRESSES: Submit written requests for single copies of the draft 
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 draft guidance documents 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 to the draft 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 6, 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.
    The agency reviewed and evaluated the comments it received (11 
written and 5 electronic). A number of the comments urged the agency to 
issue guidance that was specifically tailored for the retail food store 
and food service sector. Accordingly, FDA is issuing this draft 
guidance document entitled ``Retail Food Store and Food Service 
Establishments: Food Security Preventive Measures Guidance.''
    The draft guidance document entitled ``Retail Food Store and Food 
Service Establishments: Food Security Preventive Measures Guidance'' 
identifies the kinds of preventive measures that operators of retail 
food store and food service establishments (i.e., 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.
    FDA is also requesting 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, FDA 
also is announcing the availability of a draft guidance document 
entitled ``Cosmetics Processors and Transporters: Cosmetics Security 
Preventive Measures Guidance.'' The draft guidance document entitled 
``Cosmetics Processors and Transporters: Cosmetics Security Preventive 
Measures Guidance'' identifies the kinds of preventive measures that 
operators of cosmetics establishments can take to

[[Page 13933]]

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.
    Both draft guidance documents are level 1 guidances issued 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft guidance documents, when finalized, will represent 
the agency's current thinking on appropriate measures that retail food 
store, food service, and cosmetics establishments may take to minimize 
the risk of 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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments on either draft guidance 
document at any time. Two copies of any mailed 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 draft guidance documents and received comments 
are available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Copies of these draft guidance documents also are available on the 
Internet at http://www.cfsan.fda.gov/guidance.html.

    Dated: March 14, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-6843 Filed 3-19-03; 8:45 am]
BILLING CODE 4160-01-S