[Federal Register: November 5, 2002 (Volume 67, Number 214)]
[Notices]
[Page 67410-67411]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05no02-67]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0137]


Regulatory Procedures Manual; Chapter 9, Imports, Subchapter:
Guidance Concerning Recommending Customs' Seizure and Destruction of
Imported Human and Animal Food That Has Not Been Reconditioned;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 67411]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft procedural guidance entitled ``Guidance
Concerning Recommending Customs' Seizure and Destruction of Imported
Human and Animal Food That Has Not Been Reconditioned.'' This draft
guidance will provide FDA field offices with procedures for
recommending seizure and destruction of foods that pose a significant
risk to public health.

DATES: Submit written or electronic comments on the draft guidance by
January 6, 2003, to ensure adequate consideration of the comments in
the preparation of the final guidance. However, you may submit written
or electronic comments at any time.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Import Operations and Policy (HFC-170),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your request. Submit written comments on the draft guidance
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electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph McCallion, Division of Import
Operations and Policy (HFC-170), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-6553, FAX 301-594-3787,
email: jmccalli@ora.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In July 1999, the Secretaries of Health and Human Services and
Treasury began development of new operational procedures to protect
consumers from unsafe imported food. A plan, announced in December
1999, was developed by FDA and the U.S. Customs Service (Customs) to
prevent distribution of unsafe imported food by destroying food
products that pose a significant risk to public health. This initiative
optimizes the statutory authorities and resources available to FDA and
Customs.
    Food products refused entry into the United States may be offered
subsequently for re-importation by importers who choose to circumvent
the import regulatory system or by importers who are unaware of the
previous refusal. FDA and Customs have worked together on numerous
cases to seize and destroy unsafe imported products regulated by FDA.
This draft guidance serves to delineate FDA's responsibilities for
collecting information, analyzing public health risk, recommending
seizure, and coordinating destruction of the violative imported food by
Customs. The purpose of this guidance is to ensure that imported food
that poses a significant risk to public health is not distributed or
exported and subsequently re-entered into U.S. commerce.
    The draft guidance entitled ``Guidance Concerning Recommending
Customs' Seizure and Destruction of Imported Human and Animal Food That
Has Not Been Reconditioned'' is level 1 guidance that is being
distributed for comment in accordance with FDA's regulation on good
guidance practices (21 CFR 10.115) relating to the development,
issuance, and use of guidance documents. The draft guidance represents
the agency's current thinking on this topic. It does not create or
confer any rights for, or on, any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see
ADDRESSES) written or electronic comments on the draft guidance by
January 6, 2003. 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. A copy of the draft guidance and received comments may be
seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday
through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.cfsan.fda.gov/~dms/guidance.html.

    Dated: April 5, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-27575 Filed 11-4-02; 8:45 am]
BILLING CODE 4160-01-S