FDA Issues Revised Version of its Compliance Policy Guide for Enforcing the Prior Notice Requirement for Imported Food

The FDA states that this Guide contains certain draft provisions - items 7 and 8 in Section C (Policy), that FDA is requesting comments on by April 4, 2005.

Draft Item 7: Imported Food Arriving from and Exiting to the Same Country

Draft item 7 in Section C states that food that is shipped by land through the U.S. is subject to the PN requirements (21 CFR 1.277(a)) even if it is shipped a short distance and travels from and to the same country. The FDA states that draft item 7 describes the specific policy regarding the enforcement of the PN requirements in this situation.

FDA/CBP should consider not taking regulatory action if PN is submitted by fax for food arriving from/exiting to the same country if certain conditions apply. The interim final rule requires that PN be submitted electronically through either the Automated Broker Interface of the Automated Commercial System (ABI/ACS) or the Prior Notice System Interface (PNSI). PN will be considered inadequate if it is submitted in any other form. However, under the below listed specific circumstances, if the PN is submitted by fax instead of through ABI/ACS or PNSI, the FDA and CBP may consider not taking regulatory action.

If there is a PN violation because the PN is submitted by fax instead of through ABI/ACS or PNSI and/or it does not contain the required information about the manufacturer or grower; the carrier's Standard Carrier Abbreviation Code (SCAC), International Air Transportation Association (IATA) code, or name and country of the carrier; the planned shipment information; and/or the FDA product code, the FDA and CBP staff should typically consider not taking regulatory action if:

The food being imported or offered for import is for shipment by land through the U.S., 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 is exported to the same country from which it was imported (i.e., Canada-U.S.-Canada or Mexico-U.S.-Mexico).

The importing conveyance is physically sealed before it enters the U.S. and the integrity of the aforementioned seal is maintained during the time the shipment is in-transit through the U.S. 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 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 less than one shipment per day).

The transportation route through the U.S. is relatively short (e.g., less than 100 miles).

Due to the geography, the only practical transportation route available for the shipment is through the U.S.

The PN is received by FDA at least 36 hours before the food arrives at the port of arrival to provide sufficient time for FDA to receive, review, and respond to the alternative form of PN submission.

Copy of invoice in lieu of PN submission. The FDA states that if a copy of invoice for the food is submitted in lieu of the PN submission, it should be legible and in English and the fax cover sheet should provide the remaining information, including the submitter, the anticipated port of arrival, and the anticipated time of arrival.

PN information that changes after FDA confirmation. The FDA notes that if any of the PN information (except the anticipated arrival information, the estimated quantity, or the planned shipment information) changes after FDA has confirmed the PN submission for review, the PN must be resubmitted (21 CFR 1.282(a)). However, the enforcement policy described above, including the amount of time FDA believes it will need to conduct its PN review, applies to re-submissions as well as original submissions.

PN Center should be consulted about alternative forms of PN. A submitter who is considering submitting an alternative form of PN for routine shipments of food that are shipped short distances by land in-transit through the U.S. should contact the FDA Prior Notice Center at 703-621-7809 before the first alternative submission.

Draft Item 8: Planned Shipment Information - HTS Code

Draft item 8 in Section C states that the FDA and CBP should typically consider not taking regulatory action when there is a PN violation because the PN submission does not include the 6-digit HTS code for the article of food.

However, the FDA reminds PN submitters that the HTS Code is required by CBP independent of PN. Therefore, filers should keep in mind that ABI/ACS will not accept a submission that lacks the HTS code.

(The FDA states that filers should refer to 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.)

- comments concerning these draft revisions are due by April 4, 2005

(See ITT's Online Archives or 11/04/04 news, 04110410, for BP summary of the November 2004 version of this Guide.)

FDA contact - Domenic Veneziano (703) 621-7809

FDA notice (D/N 2003D-0554, FR Pub 03/04/05) available at http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-4218.pdf

FDA's revised Guide (revised March 2005) available at http://www.cfsan.fda.gov/pn/cpgpn5.html