CBP and FDA to Enhance Edits/Validations for Prior Notice of Imported Food Effective August 13, 2004
U.S. Customs and Border Protection (CBP) has issued an administrative message stating that effective August 13, 2004, CBP and the Food and Drug Administration (FDA) will enhance the edits and validations for prior notice (PN) of imported food requirements under the Bioterrorism Act.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
Specifically, CBP states that in addition to the current edits and validations, ABI filers should concern themselves with the following data elements:
PN Confirmation Numbers. Filers should ensure if a PN confirmation (PNC) number is submitted with an entry, that it is valid, current and not cancelled, and that the PNC is transmitted as the first Affirmation of Compliance (AOC) in the FD01 Record. If invalid, expired, cancelled, or not in the FD01 record, FDA will reject.
FD3 or FD2 Merchandise.FD3, When PN Not Required. If submitting FDA specific data for merchandise marked as FD3 (PN may be required) in the tariff record and PN is not required, transmit the "PND" disclaimer as the first AOC in the FD01 Record along the FDA specific information for FDA admissibility. FDA will notify the ABI filer with a reject message if PN is required based on the product code. The filer must then resubmit the entry with the PN information, if the merchandise marked as FD3 in the tariff record does not require FDA review for either PN or FDA admissibility, disclaim the merchandise using the FD0 marker in the OA record as is done now.
FD2, When PN Required. If the filer submits an FDA product code that required PN for merchandise marked as FD2 (FDA clearance required) or FD1 (FDA clearance may be required) in the tariff record, and does not submit the PN data, FDA will reject the transaction and request that the filer submit PN data. If the filer submits PN data with a product code that does not require PN, FDA will send the filer the message "warning - PN not required". If the filer feels that PN is required, the product code should be validated for use in future submissions.
Food Facility Registration Number or Exemption Indicator. CBP will edit for the presence of the food facility registration number (AOC "PFR") or a food facility (FDA PN MFR) registration exemption indicator (AOC "FME" ). If one or the other is not present, CBP will reject the entry. FDA will validate the exemption reason. If invalid, FDA will reject the entry, and transmit code "E" in position 77 of the BN02 record in the BN application. (Valid codes are listed in Adm: 04-1667.)
CBP also states that the following reminders should be noted:
Consolidated consignee. When submitting a consolidated consignee with the entry, the filer must report the food and drug establishment indicator (FEI) at the FDA line level in positions 15-26 of the FD03 record.
Unit of Measure. PN required a minimum of one unit of measure with the appropriate quantity beginning in positions 5-14 and 15-18 in the FD02 record. Lack of a quantity and unit of measure for a PN generates a CBP reject.
BOL or AWB Number. Filers should submit the bill of lading (BOL) or Air Waybill (AWB) number as an AOC in the FD05 record in order to align the BOL - AWB with the appropriate FDA line for purposes of filing PN. BOL, AWB, data must be in the standard format. BOL or AWB information declared at the entry level is not translated to the FDA line.
FDA Expansion of Reject Reason Codes
CBP states that FDA is expanding the reject reason codes used to indicate edit failures, beginning August 13, 2004. The code appear in the BN application FD02 record from positions 64 - 78. Note that a code for a given position may vary as shown below:
| Description |
| foreign consignee |
| invalid registration: |
| R - missing registration |
| F - registration not on file |
| M- mismatch in registration |
| invalid quantity |
| invalid MID for manufacturer |
| invalid MID for shipper |
| invalid importer for FDA |
| invalid consignee for FDA |
| C - invalid consignee |
| U - unknown/consolidated consignee |
| invalid state/zip for US manufacturer |
| invalid country of origin |
| invalid country of shipping |
| other reject reason - call FDA |
| PN data required (applies to entry filers only) |
| use CP application to input PN data |
| Warning PN data not required (filer will not receive a |
| confirmation number) |
| invalid exemption (FME) qualifier |
| PN confirmation number (PNC) invalid |
| C - invalid PNC number |
| E - expired PNC number |
| X - cancelled PNC number |
CBP also lists the 13 administrative message numbers it has transmitted through ACS to the ABI filer (as well as their transmission date and title) that address PN functional requirements. The 13 message numbers are:
| 03-2619 | 03-2625 | 03-2891 |
| 04-0031 | 04-0586 | 04-0927 |
| 04-1147 | 04-1240 | 04-1667 |
CBP states that questions should be referred to the FDA PN Center at (866) 521-2297 or the filer's client representative.
Adm: 04-1779 (dated 08/10/04) available at http://www.brokerpower.com/cgi-bin/adminsearch/admmsg.view.pl?article=2004/2004-1779.ADM.
BP Note
This administrative message number is silent on whether Phase 4 of the CBP/FDA discretionary enforcement plan will be implemented on August 13, 2004, as previously stated in FDA's Compliance Policy Guide, CBP's Enforced Compliance Procedures and Penalty Mitigation Guidelines for PN of Imported Food, etc.
BP is checking on this issue, and will update subscribers when new information is available.