[Federal Register Volume 68, Number 55 (Friday, March 21, 2003)]
[Notices]
[Pages 13931-13932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6842]



[[Page 13931]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0583]


Food Security Preventive 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 two revised, final guidance documents related to food 
security entitled ``Food Producers, Processors, and Transporters: Food 
Security Preventive Measures Guidance,'' and ``Importers and Filers: 
Food Security Preventive Measures Guidance.'' The revised, final 
guidance document entitled ``Food Producers, Processors, and 
Transporters: Food Security Preventive Measures Guidance'' is designed 
as an aid to operators of food establishments (for example, firms that 
produce, process, store, repack, re-label, distribute, or transport 
food or food ingredients). 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 revised, final guidance document entitled 
``Importers and Filers: Food Security Preventive Measures Guidance'' is 
designed as an aid to operators of food importing establishments, 
storage warehouses, and filers. It identifies the kinds of preventive 
measures that they may take to minimize the risk that food under their 
control will be subject to tampering or other malicious, criminal or 
terrorist actions.

DATES: You may submit written or electronic comments on either guidance 
document at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Food Producers, Processors, and Transporters: Food Security 
Preventive Measures Guidance'' or ``Importers and Filers: Food Security 
Preventive Measures Guidance'' to John Kvenberg, Office of Compliance, 
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 guidance documents to Dockets 
Management Branch (HFA-305), 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 food establishments, food importing establishments, 
and filers 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.
    The revised, final guidance document entitled ``Food Producers, 
Processors, and Transporters: Food Security Preventive Measures 
Guidance'' aids operators of food establishments (i.e., firms that 
produce, process, store, repack, re-label, distribute, or transport 
food or food ingredients). It is relevant to all sectors of the food 
system, including farms, aquaculture facilities, fishing vessels, 
producers, transportation operations, processing facilities, packing 
facilities, and warehouses. It is not intended as guidance for retail 
food store or food service establishments.
    The revised, final guidance document entitled ``Importers and 
Filers: Food Security Preventive Measures Guidance'' aids operators of 
food importing establishments, storage warehouses, and filers.
    Both guidance documents identify the kinds of preventive measures 
that operators can take to minimize the risk that food under their 
control will be subject to tampering or to criminal or terrorist 
actions. They take the operator through each segment of the farm-to-
table system that is within their control, in order to minimize the 
risk of tampering or of 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 guidance documents are level 1 guidances issued consistent 
with FDA's good guidance gractices regulation (GGPs) (Sec.  10.115 (21 
CFR 10.115)) relating to the development, issuance, and use of guidance 
documents.
    On January 9, 2002, FDA announced the availability of two guidance 
documents in the Federal Register (67 FR 1224). At that time, the two 
documents 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). 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.
    FDA received 11 written comments and 5 electronic comments on the 2 
guidance documents. The agency reviewed and evaluated these comments 
and modified the guidance where appropriate. A number of the comments 
urged FDA to issue guidance that was specifically tailored for the 
retail food store and food service sector. FDA agrees with the request. 
Accordingly, the draft guidance directed toward retail food stores and 
food service establishments is provided in ``Retail Food Store and Food 
Service Establishments: Food Security Preventive Measures Guidance,'' 
the availability of which is being announced elsewhere in this issue of 
the Federal Register. In that same notice, FDA is also announcing the 
availability of a draft guidance entitled ``Cosmetics Processors and 
Transporters: Cosmetics Security Preventive Measures Guidance.'' The 
original two guidance documents are now being made available as 
revised, final guidance. They no longer apply to retail food stores or 
food service establishments.
    The two final guidance documents represent the agency's current 
thinking on appropriate measures that can be taken by food 
establishments, importing establishments and filers to minimize the 
risk that food under their control will be subject 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 comments on the

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guidance documents at any time. Two copies of any mailed comments 
should 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. Received comments may be seen in the 
Dockets Management Branch 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.

    Dated: March 14, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-6842 Filed 3-19-03; 8:45 am]
BILLING CODE 4160-01-S