FDA Proposes Labeling for Food Refused Entry into the U.S. to Reduce Port Shopping
The Food and Drug Administration has issued a proposed rule that would require owners or consignees to label imported food (including food for animals) that is refused entry into the U.S. which would read "UNITED STATES: REFUSED ENTRY." Comments are due by December 2, 2008.
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The proposal would require all owners or consignees to label the shipping container of food refused admission into the U.S., as well as any documents (including electronic documents) accompanying the food.
According to a FDA press release, the proposed rule is designed to reduce a practice known as "port shopping," in which some persons attempt to bring food refused entry by FDA back into the U.S. in the same condition by shipping it to another U.S. port. In addition, FDA is taking this action to facilitate the examination of imported food, and to implement part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
Proposed Labeling Requirements
FDA proposes to add a new 21 CFR 1.98, entitled "Label requirement on food imports refused admission in the United States," which would require:
labels which state "UNITED STATES: REFUSED ENTRY" to be affixed to shipping containers, as well as any other documents accompanying the refused food (i.e., invoices, packing lists, bills of lading, and any other documents accompanying the refused food).
for foods that are packaged, the label would be required to be clear, conspicuous, and permanently affixed to the food's shipping container1. For all foods, regardless of whether they are packaged in shipping containers, the label would be required to be clear, conspicuous, and permanently affixed to the top page of each document accompanying the refused food.
the owner or consignee to contact the FDA district office responsible for the food's entry and arrange to: (i) Affix the label(s) in FDA's presence or under its supervision; (ii) Submit photographs or other visual evidence to FDA to show that the label(s) was affixed; or (iii) Develop another means of showing, to FDA's satisfaction, that the label(s) was affixed. The owner or consignee would be required to affix the label(s) promptly, and would not be allowed to move the food until they have complied with the label requirements.
The FDA would also be allowed to seek reimbursement from the owner or consignee for expenses connected to the affixing of a label. These expenses would be computed on the basis of the FDA inspector's time, the per diem allowance under government regulations, travel costs, and administrative support costs. FDA would submit a list of expenses incurred to the owner or consignee.
1Under the proposed rule, the term "shipping container" is any container used to pack one or more immediate containers of the refused food, and an immediate container is any container that holds an imported food for retail sale. In some situations, the food's immediate container may be the same as the shipping container. The term "shipping container" excludes trailers, railroad cars, ships, and similar vehicles, vehicle components, and transportation-related items.
(See ITT's Online Archives or 06/14/02 and 10/10/02 news, 02061410 and 02101025, for BP summaries of the signing of Bioterrorism Act into law, and an FDA summary of its provisions affecting imported food products.)
FDA contact - Philip Chao (301) 827-0587
FDA proposed rule (D/N FDA-2007-N-0465, FR Pub 09/18/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-21813.pdf
FDA press release (dated 09/18/08) available at http://www.fda.gov/bbs/topics/NEWS/2008/NEW01888.html