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HHS/FDA RIN: 0910-AF61 Publication ID: Spring 2018 
Title: Label Requirement for Food That Has Been Refused Admission Into the United States 

The final rule will require owners or consignees to label imported food that is refused entry into the United States. The label will read, "UNITED STATES: REFUSED ENTRY." The proposal describes the label's characteristics (such as its size) and processes for verifying that the label has been affixed properly. We are taking this action to prevent the introduction of unsafe food into the United States, to facilitate the examination of imported food, and to implement section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188).

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 1.98   
Legal Authority: 15 U.S.C. 1453 to 1455    21 U.S.C. 321    21 U.S.C. 342 and 343    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 381    42 U.S.C. 216    42 U.S.C. 264   
Legal Deadline:  None
Action Date FR Cite
NPRM  09/18/2008  73 FR 54106   
NPRM Comment Period End  12/02/2008    
NPRM; Withdrawal  08/00/2018 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Anthony C. Taube
Branch Chief
Department of Health and Human Services
Food and Drug Administration
Office of Regulatory Affairs, Office of Regional Operations, 12420 Parklawn Drive, ELEM-4051,
Rockville, MD 20857
Phone:240 420-4565
Fax:703 261-8625