[Federal Register: December 17, 2003 (Volume 68, Number 242)]
[Notices]
[Page 70278-70279]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de03-83]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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:
jkvenberg@cfsan.fda.gov 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:
dkraemer@cfsan.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov/guidance.html The guidance documents also can be viewed at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
/A>.
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