[Federal Register Volume 67, Number 162 (Wednesday, August 21, 2002)]
[Proposed Rules]
[Pages 54138-54139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-21264]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket Numbers 98N-0496 and 00N-1633]
RIN 0910-AB24 and 0910-AB95


Import for Export; Reporting and Recordkeeping Requirements for 
Unapproved or Violative Products Imported for Further Processing or 
Incorporation and Subsequent Export; Marking Requirements for and 
Prohibitions on the Reimportation of Imported Food Products That Have 
Been Refused Admission Into the United States; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rules; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of two proposed rules. One proposed rule, which appeared in 
the Federal Register on November 24, 1998 (63 FR 64930), would have 
established reporting and recordkeeping requirements for certain 
products that are imported into the United States for further 
processing or incorporation into products that are then exported. The 
second proposed rule, which appeared in the Federal Register on January 
22, 2001 (66 FR 6502), would have established requirements for marking 
imported food that has been refused entry into the United States for 
safety reasons. FDA is withdrawing these proposed rules due to recent 
changes in Federal law.

DATES: The proposed rules are withdrawn August 21, 2002.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy, 
Planning, and Legislation (HF-23), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: On November 24, 1998, FDA published a 
proposed rule in the Federal Register (63 FR 64930) that would have 
established reporting and recordkeeping requirements for certain 
products that are imported under section 801(d)(3) and (d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 381(d)(3) and 
(d)(4)). These sections of the act allowed the importation of certain 
unapproved or otherwise noncompliant products or articles provided that 
those products or articles are further processed or incorporated into 
other products and then exported from the United States.
    On January 22, 2001, FDA and the Department of the Treasury jointly 
prescribed a proposed rule in the Federal Register (66 FR 6502) that 
would have allowed FDA to require food importers or consignees to mark 
imported foods if, for safety reasons, FDA had refused to allow such 
foods to enter the United States. The mark would have stated, ``UNITED 
STATES REFUSED ENTRY,'' and the proposed rule would have established 
the mark's size and required the mark to be affixed on packing 
containers holding the refused food and on invoices, bills of lading, 
and any other documentation accompanying the food when it is exported 
from the United States.
    We received comments on both rules and also held public meetings to 
discuss the proposed rule on the marking of refused food imports. After 
reviewing the comments, we wrote and intended to issue final rules in 
2002.
    On June 12, 2002, the President signed into law the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (Public 
Law 107-188). The new law contains provisions that change the legal 
context of the two proposed FDA regulations

[[Page 54139]]

described previously in this document. For example, the new law gives 
FDA express authority to require marking on any food product that had 
been refused admission into the United States whereas the proposed rule 
would have required marking on food refused admission for safety 
reasons only.
    The new law also significantly revises section 801(d)(3) of the 
act; it prescribes new reporting requirements that differ from those in 
the FDA proposed rule.
    Because of the changes brought about by the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002, FDA is 
withdrawing both proposed rules. FDA will consider whether new 
rulemakings or other actions are necessary to implement the new 
statutory requirements.

    Dated: August 13, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-21264 Filed 8-20-02; 8:45 am]
BILLING CODE 4160-01-S