International Trade Law News

Published by Jacobson Burton Kelley PLLC

FDA has published a revised Compliance Policy Guide for prior notice of imported food. That document is available at WWW.CFSAN.FDA.GOV/~PN/CPGPN4.HTML. The following provides information on new prior notice (PN) edits/rejects and other system changes that will take effect on November 8, 2004.

MANUFACTURER REGISTRATION INFORMATION:

Customs and Border Protection (CBP) will continue to reject PN submissions unless a manufacturer registration number is provided for the manufacturer using the "PFR"
Affirmation of compliance (AOFC) or the FME" AOFC code and reason code is transmitted.

FDA will reject PN submissions made under the Prior Notice System Interface (PNSI) that contain a manufacturer registration number that is invalid (not on file or mismatched). FDA will also reject PN submissions received that contain a "FME" AOFC code if the reason code qualifier is invalid. Six new reason codes have been added to indicate why a registration number has not been transmitted. The new codes are I-M and O. Code N (NO) has been eliminated and use of this code or any other code not listed below will cause and FDA reject. With the addition of these new reason codes, zero-fill of the AOFC "PFR" qualifier field is no longer allowed and submission will cause an FDA reject.

FME QUALIFIER REASON CODES:

A. FACILITY IS OUT OF BUSINESS
B. FACILITY IS PRIVATE RESIDENCE
C. FACILITY IS A RESTAURANT
D. FACILITY IS RETAIL FOOD ESTABLISHMENT
E. FACILITY IS NON­PROCESSING FISHING VESSEL
F. FACILITY IS NON­BOTTLED DRINKING WATER COLLECTION AND DISTRIBUTION
ESTABLISHMENT
G. INDIVIDUAL GIFT ­ LABEL NAME/ADDRESS IN LIEU OF REGISTRATION NUMBER
H. GROWER ­ SATISFIES FARM EXEMPTION (21 CFR 1.226(B); 1.227(B)(3))
I. SAMPLES - QUALITY ASSURANCE, RESEARCH OR ANALYSIS PURPOSES ONLY
J. U.S. MANUFACTURING FACILITY THAT IS NOT REQUIRED TO REGISTER
K. UNABLE TO DETERMINE THE REGISTRATION NUMBER OF THE MANUFACTURER.
L. UNABLE TO DETERMINE IDENTITY OF MANUFACTURER - PROVIDING IDENTITY OF
MANUFACTURERS HEADQUARTERS
M. UNABLE TO DETERMINE IDENTITY OF MANUFACTURER OR HEADQUARTERS -
- PROVIDING INVOICING FIRMS IDENTITY
O. GIFT PACK FOR NON-BUSINESS PURPOSES PROVIDING SINGLE PRIOR NOTICE
AND IDENTITY OF PACKER

BILL OF LADING/AIRWAY BILL INFORMATION:

FDA will reject prior notice submissions for rail and sea modes of transportation unless the bill of lading number is provided using the "BOL" AOFC code and qualifier and submissions for air mode of the transportation unless the air waybill is submitted using the "AWB" AOFC code and qualifier.

The PNSI version 1.5 release notes describing system modifications made to reflect changes made in the in the Compliance Policy Guide are available at WWW.CFSAN.FDA.GOV/~PN/PNSIREV.HTML and also referenced and linked at WWW.CFSAN.FDA.GOV/~PN/PNOVIEW.HTML/.

HOLDING FACILITY INFORMATION:

PNSI has been modified to allow submission of holding facility information in the case where FDA has refused a food article. If FDA or CBP direct an article to a holding facility, a party with the knowledge of the holding facility location date available at the location, and a contact at the location associated with the prior notice must submit the information to the FDA. PNSI must be used to submit the holding facility information for PNSI initially submitted either through the Automated Commercial System (ACS) or through PNSI. PNSI now allows any party to submit the holding facility information, regardless of whether or not they transmitted the original prior notice. PN transmitters can search for PNS submitted via their account to submit holding facility information. If the PN was submitted through ACS or was submitted via PNSI by a PN transmitter using a different account, the identifying information for the article can be used to allow another transmitter to submit the holding facility information. Once holding facility information has been submitted, the transmitter can view the status of the holding facility information submission to determine if it was matched to a prior notice that was originally submitted.