FDA Issue Finalized Regulations on Prior Notice for Food Imports U.S. Customs Systems Not Currently Ready for All Changes

Issue 37, May 11, 2009

The Food and Drug Administration has issued a final rule that makes a number of changes to its regulations on the submission of Prior Notices (PN) for food that is imported into the USA. The final rule was effective May 6, 2009. Below are highlights of the changes to the Prior Notice submission requirements-

-Timeline for Prior Notice Submission
Unchanged are the deadlines for PN submission before the food arrives at the port of arrival, which is- 8 hours for imports via vessel; 4 hours for imports via air or rail; and 2 hours for imports via road. However, the final rule now permits the PN to be submitted no more than 15 calendar days before the anticipated date of arrival for submissions made through FDA’s Prior Notice Submission Interface (PNSI) and no more than 30 calendar days before the anticipated date of arrival for submission made through ABI.

-Manufacturer identity required for all entry types
The final rule adds a definition for "manufacturer" and provides an alternative for identifying the manufacturer when the registration number is not known. In addition to the name of the manufacturer, the PN must contain either the registration number of the facility associated with the article of food; or, the full address of the site-specific facility and reason (see below for omitted reason codes) why no registration number is being provided. The final rule requires the identity of the manufacturer for all entry types, including transportation and exportation entries.

-Certain exemption "reason" codes can no longer be used
The final rule disallows the use of certain "reason” codes in lieu of providing the food facility registration number.

Specifically, the following reason codes should no longer be used-:

CBP notes that the above listed reasons will officially be omitted from the Customs and Trade Automated Interface Requirements (CATAIR) once the CBP programming changes are completed. Note that other reasons (A – F, H, and K) may continue to be used. (The reason codes are located in Appendix O of the CATAIR.)

-Use of express consignment operator/carrier tracking number in lieu of certain info
The final rule allows, when certain conditions are met, for the submission of the express consignment operator or carrier tracking number in lieu of the anticipated arrival information, bill of lading, or airway bill number and flight number, which the interim final rule required.
ACS programming to allow for the submission of the tracking number (in lieu of the above referenced data elements) has not been completed. At this time, any filer wishing to submit the courier tracking number in lieu of the above listed information may do so using PNSI.

-Fax number no longer required
The fax number for the PN transmitter or submitter is no longer required. Where ACS changes are incomplete and rejections are encountered, ABI filers may continue to include the fax number data as an optional element, or may choose to submit all zeroes in lieu of the actual number.

-Complete addresses required
The final rule requires the submission of the complete address for the shipper, importer, owner, and ultimate consignee (currently accomplished by ABI filers through the submission of a MID or social security number, tax identification (EIN) number or CBP-assigned number or encrypted version of the number for the identified firm) regardless of whether the facility's food facility registration is also provided. ABI filers may continue to provide the food facility registration numbers for the subject firms in order to facilitate timely FDA review.

-HTS code not required for PN purposes
The final rule does not require the submission of an HTS code for PN purposes. However, ABI filers should continue to submit HTS codes where required for CBP purposes.

-Privately owned vehicle carriers license plate reporting
The submission of the country of the license plate for privately owned vehicle carriers is no longer required. However, it continues to require the license plate number and the state or province that issued the plate. Where ACS changes are incomplete and rejections are encountered, ABI filers may continue to include the country of the plate in their transactions.

ACS/ACE Changes NOT Ready
U.S. Customs and Border Protection has issued a CSMS message noting the required Automated Commercial System (ACS) and Automated Commercial Environment (ACE) programming changes for the final rule are not yet in place. CBP sources have referenced that the updates are expected to be delivered as an “entirety” and may take months to complete.

Those who file PNs via CBP’s Automated Broker Interface (ABI) need to be familiar with the final rule changes since they will need to adjust/retain their PN submissions in ABI. CBP explains that that PNs filed through ABI will be transmitted to FDA for review against the requirements in the final rule. For example, PNs submitted through ABI that do not identify the site-specific manufacturer may be accepted for review initially, but upon review by FDA may be refused if they are later deemed inaccurate.

Alternatively, the FDA’s PNSI system may be used to file PNs that meet the amended requirements of the PN final rule.

A copy of the CSMS messages cab be viewed at- http://apps.cbp.gov/csms/viewmssg.asp?Recid=17603&page=&srch_argv=& srchtype=&btype=&sortby=&sby

Additional information on the FDA’s final rule on Prior Notice can be found at- http://www.cfsan.fda.gov/~pn/pnoview.html

Regards,

Paul E. Vroman
Manager, Regulatory & Compliance Consulting and Projects
DHL Global Forwarding