FDA Revises Guidance on Prior Notice of Imported Food, Recordkeeping Under the Bioterrorism Act (Part II)
The Food and Drug Administration (FDA) has recently issued notices announcing the availability of a revised compliance policy guide on prior notice (PN) of imported food as well as the second edition of a questions-and-answers (Q&A) document regarding the final rule on establishment and maintenance of records under the Bioterrorism Act.
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This is Part II of a three-part series of summaries on these recently revised guidance documents. Part II describes changes made to the FDA's revised compliance policy guide (CPG) on PN of imported food. (See ITT's Online Archives or 11/29/05 news, 05112930, for Part I of this series of BP summaries. See future issue of ITT for summary of the Q&A document regarding records under the Bioterrorism Act).
Revised CPG Contains Finalized Sections on Transshipping Food, HTS Codes
The FDA has stated that this CPG provides written guidance to the FDA's and U.S. Customs and Border Protection's (CBP's) staff on enforcement of section 307 of the Bioterrorism Act and the agency's implementing regulations, which require PN for food imported or offered for import into the U.S.
FDA states that this CPG is being revised to finalize items 7 (Imported Food Arriving From and Exiting to the Same Country) and 8 (Planned Shipment Information - Harmonized Tariff Schedule code), which were added as draft items in the March 2005 version of this CPG.
Amended and finalized version of item 7. The FDA has amended item 7 by deleting two paragraphs from the draft version. The finalized version of item 7 now reads:
Food that is shipped by land through the United States is subject to the prior notice requirements, 21 CFR 1.277(a), even if it is shipped a short distance and travels from and to the same country. This section describes the specific policy regarding the enforcement of the prior notice requirements in this situation.
FDA and CBP staff should typically consider not taking regulatory action if there is no prior notice and each of the following conditions is met:
The food is exported to the same country from which it was imported (i.e. Canada-United States-Canada or Mexico-United States-Mexico).
Due to the geography, the only practical transportation route available for the shipment is through the United States.
The importing conveyance is physically sealed before it enters the United States and the integrity of the aforementioned seal is maintained during the time the shipment is in-transit through the United States. FDA and CBP should randomly examine the shipments to ensure that the food imported from the country is the same food that is exported back to that country.
The food being imported or offered for import is for shipment by land through the United States, and will not be manufactured, processed, packaged, unloaded or transferred from conveyance to conveyance, or modified in any other way while in transit.
The food being imported or offered for import represents a relatively regular/routine shipment by land that arrives at and exits from specific border crossings, such that FDA and/or CBP are sufficiently familiar with the typical shipment.
The number of the regular/routine shipments by land between the two border points is relatively low, e.g., an average of one or less shipments per day.
The transportation route through the United States is relatively short, e.g., less than 100 miles.
Before the import or series of imports, the FDA Prior Notice Center is contacted regarding the above. The public can contact the Prior Notice Center at 866-521-2297.
Finalized version of item 8. Item 8 is being finalized without change and reads:
FDA and CBP should typically consider not taking regulatory action when there is a prior notice violation because the prior notice submission does not include the 6-digit HTS code for the article of food.
However, prior notice submitters are reminded that the HTS Code is required by CBP independent of prior notice. See 19 CFR 143 Subpart D - Electronic Entry Filing, which sets forth the requirements for electronic filing, and specifically 19 CFR 143.32(f), which references the Customs and Trade Automated Interface Requirements (CATAIR) as the defining document for what data has to be submitted. Therefore, filers should keep in mind that ABI/ACS will not accept a submission that lacks the HTS code.
(See ITT's Online Archives or 03/07/05 news, 05030715, for BP summary of the March 2005 version of this CPG, which contains a transcription of draft items 7 and 8.)
FDA revised CPG (dated November 2005) available at http://www.cfsan.fda.gov/pn/cpgpn6.html