9 January 2002
Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html
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[Federal Register: January 9, 2002 (Volume 67, Number 6)]
[Notices]
[Page 1224-1225]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja02-60]
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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:jkvenberg@cfsan.fda.gov.
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