[Federal Register Volume 67, Number 6 (Wednesday, January 9, 2002)]
[Notices]
[Pages 1224-1225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-542]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0583]


Food Security Guidance; 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 guidance documents related to food security 
entitled ``Food Producers, Processors, Transporters, and Retailers: 
Food Security Preventive Measures Guidance'' and ``Importers and 
Filers: Food Security Preventive Measures Guidance.'' ``Food Producers, 
Processors, Transporters, and Retailers: Food Security Preventive 
Measures Guidance'' is designed as an aid to operators of food 
establishments (i.e., firms that produce, process, store, repack, 
relabel, distribute, or transport food or food ingredients, or that 
prepare or distribute food at retail). It identifies the kinds of 
preventive measures that they can take to minimize the risk that food 
under their control will be subject to tampering or criminal or 
terrorist actions. ``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 can take to minimize the 
risk that food under their control will be subject to tampering or 
criminal or terrorist actions.

DATES: Submit written or electronic comments by March 11, 2002 to 
ensure their adequate consideration in the preparation of revised 
guidance, if warranted. However, you may submit written or electronic 
comments at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Food Producers, Processors, Transporters, and Retailers: 
Food Security Preventive Measures Guidance'' or ``Importers and Filers: 
Food Security Preventive Measures Guidance'' to John Kvenberg, Office 
of Field Programs (HFS-600), Center for Food Safety and Applied 
Nutrition (CFSAN), 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, Office of Field 
Programs (HFS-600), CFSAN, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 202-205-4187, e-
mail:[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Operators of food establishments, food importing establishments, 
and filers are encouraged to review their current procedures and 
controls in light of the potential for tampering or criminal or 
terrorist actions and make appropriate improvements. ``Food Producers, 
Processors, Transporters, and Retailers: Food Security Preventive 
Measures Guidance'' aids operators of food establishments (i.e., firms 
that produce, process, store, repack, relabel, distribute, or transport 
food or food ingredients, or that prepare or distribute food at 
retail). It is relevant to all sectors of the food system (i.e., from 
farm-to-table), including farms, aquaculture facilities, fishing 
vessels, producers, transportation operations, processing facilities, 
packing facilities, warehouses, retail, and food-service 
establishments. ``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.
    The two guidance documents are level 1 guidances issued consistent 
with FDA's good guidance practices regulation (GGPs) (21 CFR 10.115). 
The agency is soliciting public comment, but is implementing these two 
guidance documents 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. FDA believes it is 
critical to our national interest and the public health to make 
guidance on food security available to the food industry quickly. Thus, 
the agency has determined that prior public participation is not 
feasible or appropriate.
    FDA is also interested in comments on whether the guidance 
documents ``Food Producers, Processors, Transporters, and Retailers: 
Food Security Preventive Measures Guidance'' and ``Importers and 
Filers: Food Security Preventive Measures Guidance'' should be revised 
to include the following additional preventive measures:
     The use of tamper-evident packaging. FDA is particularly 
interested in information on: the utility of the various methods of 
tamper-evident packaging in minimizing the risk that foods so packaged 
will be subject to tampering or criminal or terrorist actions; and, the 
practicality of applying tamper-evident packaging to the broad spectrum 
of foods presently in commerce;
     The use of procedures and/or records that enable shipments 
of food from a food establishment or food importing establishment to be 
traced to shipments of food received by the food establishment or food 
importing establishment and vise versa. FDA is particularly interested 
in information on the types of procedures and/or records that are both 
practical and effective in facilitating trace-back of incoming 
shipments, trace-forward of outgoing shipments, and linkages between 
the two.
    These guidance documents represent the agency's current thinking on 
appropriate measures that can be taken by operators of food 
establishments, food importing establishments, storage warehouses, and 
filers to minimize the risk of food being subjected to tampering or 
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 
(address above) written or electronic comments on the guidance 
documents at any time. 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 guidance documents

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and received comments may be seen in the office above 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//dms/guidance.html. Submit 
electronic comments to http://www.fda.gov/dockets/ecomments.

    Dated: January 3, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-542 Filed 1-4-02; 4:12 pm]
BILLING CODE 4160-01-S