FDA Issues Revised Compliance Information on Prior Notice Submissions for Imported Food

The FDA states that this is the third posting of summary information describing Prior Notice (PN) submissions for imported food, and contains certain summary information from December through April and some snapshots of activity in July. According to FDA, it expects to continue to update information about PN even as the transition period ends.

(See ITT's Online Archives or 05/20/04 and 04/08/04 news, 04052010 and 04040815, for BP summaries of the May 2004 and April 2004 versions of this guide.)

PNSI Transmits Greater Percentage of Total PN Submissions than Anticipated

FDA states that it has been receiving about 160,000 PN submissions since February, with about 86% being submitted as additional information on transactions that already required submission to the CBP through the Automated Commercial System (ACS).

Additionally, 13% of PN were submitted through the FDA's Prior Notice System Interface (PNSI), and 1% came through a new interface referred to as "mini ABI" that CBP and FDA provided for submitting information through ACS on food shipments that do not require CBP ACS submission at the time of arrival in the U.S. (e.g. Transportation and Exportation, Immediate Transportation, and Foreign Trade Zones).

FDA notes that the percentage of submissions through its PNSI and the new "mini ABI" interface are steadily growing, and PNSI already transmits a greater percentage of the total than FDA had expected.

Entries Submitted With No PN Have Been Almost Eliminated

FDA states that since increased enforcement began in June 2004, entries submitted to CBP with no PN have been almost eliminated. FDA notes that although some problems still exist, only a small percentage (about 0.5%) fail to submit any PN information. (See ITT's Online Archives or 06/03/04 news, 04060305, for BP summary of Phase 3 of CBP and FDA's enforcement plan, which went into effect on June 4, 2004.)

According to FDA, most PN data is being submitted, with importer, consignee, product description, quantity, product code, and county of shipping all at or near 100% completion, as is carrier information for air, sea, and rail. However, FDA notes that carrier information for road transportation is difficult to address at a summary level due to certain SCAC and bill of lading issues. As a result, summary data on SCAC and billing of landing for road transportation is not included most of the document's graphs.

FDA states that for sea, rail, air, and/or road, completion of registration number and bill of lading is lower, and failure to submit a registration number for products that require one is a continuing concern. Of PNs submitted through ACS, 13% contain no registration information and 3% contain a registration number that is not on file at the FDA.

Timeliness of Submissions is Currently Under Review

FDA states that an area currently under review is the timeliness of submissions and notes that in the last week of June almost 7% of submissions through ACS were untimely as defined by the regulation. As with other types of violations, FDA notes that shipments with untimely prior notice submissions could be held at the border.

FDA Looking More Closely at Validity and Consistency of Data

FDA also states that it is looking more closely at the validity and consistency of the data being entered. For example, although a consignee is entered on 100% of the submissions through ACS, FDA's examination of the information entered indicates that almost 2% of consignee data indicates unknown/consolidated consignee, and not the ultimate consignee as required by the PN interim final rule. While 2% may seem small, FDA states that the actual number found to be invalid for the week ending July 3 was 2466. This percentage is also diminishing, but as the transition period ends, submitters need to improve the quality of their submissions.

Identification of Submitters and Transmitters Who Tend to be Error Prone

FDA states that it and U.S. Customs and Border Protection (CBP) are now actively identifying specific submitters and transmitters (brokers/filers) whose submissions tend to be error prone and are providing information to industry to encourage better compliance. FDA is also using the results of its compliance information to review some of the most problematic compliance areas to determine how best to improve compliance rates.

(See ITT's Online Archives or 08/13/04 news, 04081305, for BP summary of FDA's Phase 4 of its PN enforcement plan, which began August 13, 2004, with certain delays and leniencies.)

FDA Compliance Information (revised August 2004) available at www.cfsan.fda.gov/pn/pnsum.html