[Federal Register Volume 67, Number 214 (Tuesday, November 5, 2002)]
[Notices]
[Pages 67410-67411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-27575]


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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 This draft 
guidance will provide FDA field offices with procedures for 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Import Operations and Policy (HFC-170), 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 Submit written comments on the draft guidance 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electronic access to the draft guidance document.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: [email protected].

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