[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Proposed Rules]
[Pages 49022-49023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2007-N-0465]


Label Requirement for Food That Has Been Refused Admission Into 
the United States

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the withdrawal of a proposed rule that published in the 
Federal Register. This proposed rule is not currently considered a 
viable candidate for final action. FDA is taking this action because 
this proposed rule does not reflect current technology and industry 
practice.

DATES: The proposed rule published September 18, 2008, at 73 FR 54106 
is withdrawn as of September 28, 2018.

ADDRESSES: For access to the docket, go to https://www.regulations.gov 
and insert the docket number found in brackets in the heading of this 
document into the ``Search'' box and follow the prompts, and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Holli Kubicki, Office of Regulatory 
Affairs, Office of Strategic Planning and Operational Policy, Food and 
Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857, 240-402-
4557, [email protected].

SUPPLEMENTARY INFORMATION: In 1990, FDA began a process of periodically 
conducting comprehensive reviews of its regulation process, including 
reviewing the backlog of proposed rulemakings that had not been 
finalized. As FDA removed many proposed rules not finalized, the Agency 
implemented a process of reviewing existing proposed rules every 5 
years.
    As part of this process and the Administration's regulatory reform 
initiative, we continue to conduct reviews of existing proposed rules. 
The review determines if the proposals are outdated, unnecessary, or 
can be revised to reduce regulatory burden while allowing FDA to 
achieve our public health mission and fulfill statutory obligations.
    As part of these efforts, FDA is withdrawing the proposed rule 
entitled ``Label Requirement for Food That Has Been Refused Admission 
Into the

[[Page 49023]]

United States'' (September 18, 2008, 73 FR 54106).
    The proposed rule does not reflect current technology and industry 
practice. For example, the proposed rule directed owners or consignees 
to affix labels to physical documents such as invoices, packing lists, 
bills of lading, and any other documents accompanying refused food. 
Many of these documents are now electronic. Therefore, since 
implementation of the proposed rule would not adequately address how to 
permanently mark electronic documentation accompanying refused food, it 
would not achieve the public health and efficiency benefits discussed 
in the notice of proposed rulemaking. As directed by section 304 of the 
FDA Food Safety Modernization Act (Pub. L. 111-353) that was enacted 
after FDA issued the proposed rule, FDA now requires, as part of its 
prior notice regulations, notice to FDA of the name of any country to 
which imported food has been refused entry. (See 21 CFR 1.281(a)(18).) 
This includes situations where the United States has refused entry, and 
it therefore provides FDA with information related to what the proposed 
marking rule would require.
    FDA may reassess how to effectively implement the labeling of 
documentation accompanying refused food and consider whether to issue a 
revised proposed rule in the future.
    The withdrawal of the proposal identified in this document does not 
preclude the Agency from reinstituting rulemaking concerning the issues 
addressed. Should we decide to undertake such a rulemaking in the 
future, we will re-propose the action and provide a new opportunity for 
comment. Furthermore, this proposed rule withdrawal is only intended to 
address the specific actions identified in this document, and not any 
other pending proposals that the Agency has issued or is considering. 
If you need additional information about the subject matter of the 
withdrawn proposed rule, you may review the Agency's website (https://www.fda.gov) for any current information on the matter.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21145 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P


