[Printable PDF]
[Federal Register: August 21, 2002 (Volume 67, Number 162)]
[Proposed Rules]
[Page 54138-54139]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au02-19]
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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DATES: The proposed rules are withdrawn August 21, 2002.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